Preview Newsletter
Ethicon Media Monitoring 4/17/2019
-
F.D.A. Halts U.S. Sales of Pelvic Mesh, Citing Safety Concerns for Women
Apr 16, 2019 | The New York Times
By Sheila Kaplan and Matthew Goldstein
The Food and Drug Administration on Tuesday ordered the two remaining medical device companies selling surgical mesh for the repair of pelvic organ prolapse to stop all sales and distribution in the United States. -
FDA Orders Makers of Women’s Surgical Mesh to Stop Selling the Products
Apr 16, 2019 | The Wall Street Journal
By Thomas M. Burton and Stephen Nakrosis
The U.S. Food and Drug Administration ordered the two makers of surgical mesh for women’s pelvic repair to take their products off the market, responding to years of complaints about pain, bleeding and scarring from the devices. -
FDA Halts Vaginal Mesh Sales; Boston Scientific Shares Fall
Apr 16, 2019 | Bloomberg
By Michelle Cortez and Jef Feeley
U.S. health regulators ordered two medical device companies to stop selling surgical mesh used in pelvic repair surgeries after saying there isn’t enough evidence that the product embroiled in thousands of lawsuits is safe or effective. -
FDA bans sales of transvaginal mesh amid safety concerns
Apr 16, 2019 | CNN
By Susan Scutti
Manufacturers of surgical mesh products must stop selling and distributing their products in the United States immediately, the US Food and Drug Administration ordered Tuesday. -
US Halts Sale of Vaginal Mesh Blamed for Thousands of Injuries
Apr 17, 2019 | ICIJ
By Sasha Chavkin
In a major women’s health action, the United States has blocked sales of vaginal mesh used for the treatment of pelvic organ prolapse, the U.S. Food and Drug Administration announced Tuesday. -
FDA bans Boston Sci, Coloplast sales of pelvic mesh
Apr 16, 2019 | Mass Device
By Nancy Crotti
The FDA has ordered Boston Scientific (NYSE:BSX) and Coloplast — the only remaining companies that sell pelvic mesh in the U.S. — to immediately halt sales and distribution of those products. -
FDA Orders Surgical Mesh Products Pulled From US Market
Apr 16, 2019 | Law 360
By Danielle Nichole Smith
The U.S. Food and Drug Administration on Monday ordered Boston Scientific and Coloplast — the only two remaining manufacturers of surgical mesh meant for the transvaginal repair of pelvic organ prolapse — to stop selling those mesh products in the U.S. -
J&J’s Rush To Market Made Mesh Patients Suffer, Jury Told
Apr 16, 2019 | Law 360
By Matt Fair
A Johnson & Johnson unit’s bid to protect its market dominance by rushing a pelvic mesh implant to market without sufficient clinical testing left a Philadelphia-area woman paying the price through worsening incontinence and pain she began experiencing with sex, a jury heard during closing arguments Tuesday. -
FDA orders Boston Scientific, Coloplast to stop selling surgical mesh
Apr 16, 2019 | CNBC
By Angelica LaVito
The Food and Drug Administration on Tuesday ordered Boston Scientific and Coloplast to stop selling surgical mesh used for some pelvic operations. -
FDA orders makers of surgical mesh products for pelvic collapse to stop selling immediately
Apr 16, 2019 | USA Today
By Charisse Jones
The Food and Drug Administration is ordering companies that produce mesh devices for women suffering from pelvic organ prolapse to end the sales of those products immediately. -
Boston Scientific ordered by FDA to stop selling gynecological mesh
Apr 16, 2019 | CBS
By Kate Gibson
The Food and Drug Administration on Tuesday ordered Boston Scientific and another maker of transvaginal surgical mesh implants to stop selling and distributing the product in the U.S. The move is the latest in a series by the agency in response to safety concerns regarding the devices implanted in more than 2 million women. -
FDA orders transvaginal surgical mesh pulled from market
Apr 16, 2019 | Reuters (also in CBC, The Daily Mail, Nasdaq)
By Saumya Sibi Joseph and Aakash Jagadeesh Babu
The U.S. Food and Drug Administration on Tuesday ordered makers of transvaginal surgical mesh implants to immediately stop sale and distribution of the products in the United States. -
US Halts Sales of Pelvic Mesh Tied to Injuries in Women
Apr 16, 2019 | Associate Press (also in Snopes, The Public's Radio,
By Matthew Perrone
U.S. health regulators on Tuesday halted sales of a type of surgical mesh used to repair pelvic conditions in women, following years of patients’ reports of injuries and complications from the implants. -
After injuries, FDA orders pelvic mesh off the market
Apr 16, 2019 | Star Tribune
By Joe Carlson
After years of advocacy by injured patients, the U.S. Food and Drug Administration has ordered the makers of mesh devices for the repair of pelvic organ prolapse to remove the products from the U.S. market. -
FDA Halts All US Sales of Surgical Mesh
Apr 16, 2019 | Regulatory Focus
By Zachary Brennan
Following thousands of patient lawsuits and a spike in adverse event reports, the US Food and Drug Administration (FDA) on Tuesday ordered the manufacturers of all remaining surgical mesh products indicated for the transvaginal repair of pelvic organ prolapse (POP) to stop selling and distributing their products in the US immediately. -
FDA Stops Sales of Transvaginal Mesh for Pelvic Organ Prolapse
Apr 16, 2019 | Drug Watch
By Michelle Llamas
The U.S. Food and Drug Administration has ordered manufacturers of all remaining transvaginal mesh devices for pelvic organ prolapse repair to stop selling their products immediately, according to the agency’s April 16, 2019 press release. -
FDA Pulls All Vaginal Mesh Products Off the Market
Apr 16, 2019 | Medscape
By Megan Brooks
The US Food and Drug Administration (FDA) today ordered the manufacturers of vaginal mesh products to stop selling and distributing their products in the US immediately, saying the companies failed to provide reasonable assurance that the products are safe and effective. -
FDA orders immediate stop to sales of mesh used for transvaginal repair
Apr 16, 2019 | Washington Examiner
By Kimberly Leonard
The Food and Drug Administration on Tuesday took the unusual step of ordering manufacturers to immediately stop selling surgical mesh used for transvaginal repair because it has caused infection, bleeding, and pain during sex. -
FDA orders Boston Scientific to withdraw surgical mesh product
Apr 16, 2019 | Boston Globe
By Max Reyes
Boston Scientific was ordered by the Food and Drug Administration on Tuesday to halt sales of controversial vaginal mesh products used in surgeries, saying the company had not proved they were safe to use. -
FDA Flips the Switch on Pelvic Mesh Manufacturers
Apr 16, 2019 | Medical Device and Diagnostics Industry
By Amanda Pedersen
After years of controversy surrounding the use of surgical mesh for transvaginal repair of pelvic organ prolapse (POP), FDA has ordered Boston Scientific and Coloplast to stop selling the mesh on the U.S. market immediately. -
FDA orders Boston Scientific to stop selling women's health product
Apr 16, 2019 | Worcester Business Journal
By Zachary Comeau
The U.S. Food and Drug Administration has ordered Marlborough medical device maker Boston Scientific and another manufacturer to immediately stop selling transvaginal surgical mesh products. -
FDA: No More Mesh for Prolapse Repair
Apr 16, 2019 | MedPage Today
By Charles Bankhead
The FDA ordered an end to sales of all remaining surgical mesh products used for transvaginal repair of pelvic organ prolapse. -
FDA Halts All Sales of Vaginal Mesh Products
Apr 16, 2019 | WebMD
The U.S. Food and Drug Administration on Tuesday announced a ban on the sale of all pelvic mesh products. -
* Breaking News * FDA Orders Mesh Makers to Stop Selling Prolapse Mesh!
Apr 16, 2019 | Mesh Medical Device News Desk
By Jane Akre
Even though the Food and Drug Administration began taking in mesh-related complaints in the early 2000’s and noted problems with pelvic organ prolapse (POP) mesh, it has taken until today to finally remove it from the market! -
Single mum left homeless, bedridden and unable to work from 'mesh' device demands action
Apr 17, 2019 | 9 News
By Sarah Swain
A single Victorian mother has been left bedridden and unable to work and she believes it is because of a controversial medical device she believes she didn’t even need. -
Hernia Mesh Secrets: Bruce Rosenberg Answers Hernia Patient Questions After Complications
Apr 16, 2019 | Mesh Medical Device News Desk
By Jane Akre
Bruce Rosenberg is a patient advocate an hernia mesh injured patient.
Client Attorney Privileged/Attorney Work Product/At Request of Counsel
Online Sources
-
F.D.A. Halts U.S. Sales of Pelvic Mesh, Citing Safety Concerns for Women
Apr 16, 2019 | The New York Times
By Sheila Kaplan and Matthew Goldstein
The Food and Drug Administration on Tuesday ordered the two remaining medical device companies selling surgical mesh for the repair of pelvic organ prolapse to stop all sales and distribution in the United States.
It is the most stringent action the F.D.A. has taken in the lengthy legal and medical battles over vaginal mesh, a synthetic product that has been implanted in millions of women to strengthen weakened pelvic muscles that can cause the bladder, the uterus and other organs to sag into the vaginal area.
The agency issued the decision against the two companies, Boston Scientific and Coloplast, at a time when multimillion-dollar verdicts against manufacturers of the devices continue to be awarded or upheld on appeal.
Litigation over pelvic mesh, also called transvaginal mesh, ranks as one of the largest mass tort cases in the nation’s history in terms of claims filed, number of corporate defendants and settlement dollars. Seven medical device manufacturers, including Boston Scientific and Johnson & Johnson, are paying nearly $8 billion to resolve the claims of more than 100,000 women.
For years, women and legal advocates have tried to persuade the F.D.A. that the pelvic mesh implant causes harm. As the number of serious complications increased significantly, the F.D.A. reclassified this type of pelvic mesh as high risk in 2016 and told manufacturers to submit more evidence that the devices were safe and would benefit patients with the condition.
In announcing its decision on Tuesday, the F.D.A. said that Boston Scientific and Coloplast, a Danish company, had not demonstrated a reasonable assurance of safety and effectiveness for the devices.
“In order for these mesh devices to stay on the market, we determined that we needed evidence that they worked better than surgery without the use of mesh to repair pelvic organ prolapse,” said Dr. Jeffrey Shuren, director of the F.D.A.’s Center for Devices and Radiological Health. “We couldn’t assure women that these devices were safe and effective long term.”
Deborah Kotz, a spokeswoman for the agency, said the two medical device companies had 10 days to submit a plan for how the mesh devices will be withdrawn from the market.
Shanin Specter, a lawyer who has won numerous big jury verdicts against firms that manufactured the pelvic mesh, said the F.D.A. should extend the decision to include mesh devices used for treatment of some urinary conditions.Editors’ PicksMartha Stewart’s Right-Hand ManI Had to Do It Without Telling My BelovedIs the Hudson Valley Turning Into the Hamptons?
“This is a good step forward,” he said. “But mesh used to treat stress incontinence also continues to devastate thousands of women, and the F.D.A. should act decisively there, too.”
Boston Scientific, which had filed two applications for its devices, criticized the agency’s action. “We are deeply disappointed by the F.D.A.’s decision on our premarket approval applications” for two products, said Kate Haranis, a spokeswoman for the company. The company, she added, believes that “the inaccessibility of these products will severely limit treatment options for the 50 percent of women in the U.S. who will suffer from pelvic organ prolapse during their lives.”
Ms. Haranis said its transvaginal mesh product portfolio accounts for roughly $25 million in sales annually, or about 1 percent of the company’s total sales. Its stock fell a little more than 4 percent on the news.
Lina Danstrup, a spokeswoman for Coloplast, said in an email that Restorelle DirectFix Anterior, the affected device, represents about 0.2 percent of group revenues. Coloplast’s stock also fell slightly on Tuesday.
Gynecologists have been implanting surgical mesh to repair pelvic organ prolapse since the 1970s, and they began using it for transvaginal repair of the condition in the 1990s. The mesh is implanted in the vaginal wall; complications have included bleeding, pain, inflammation and dislodging or protrusion through the wall that can cause infection. Many women have required a second surgery to repair the damage.
Mr. Specter said the mesh device used in pelvic organ prolapse surgery tends to be larger and more injury-producing than the devices used in surgery to treat stress urinary incontinence.
But even the small mesh devices have an unacceptably high complication rate, he said, in the range of 5 to 15 percent. “There was never a need for these mesh products,” he said, noting there is an alternative surgical procedure using a patient’s own tissue.Sign Up for NYT Parenting
From the team at NYT Parenting (launching soon!): Get the latest news and guidance for parents. We'll celebrate the little parenting moments that mean a lot—and share stories that matter to families.SIGN UP
The disputes over the safety of pelvic mesh have gone on for more than a decade. Until Tuesday, the F.D.A. had never formally demanded that the products be taken off the market, but it had issued several warnings about the devices. The agency said earlier that it had received reports of more than 10,000 complaints of serious injury and nearly 80 deaths as of last year.
Women who have already had the devices implanted and are not having problems with them should not take any action, other than to continue regular doctor visits, Ms. Kotz, the F.D.A. spokeswoman, said.
It has been estimated that nearly 10 million women worldwide have received mesh implants to treat weakening pelvic muscles and alleviate urinary incontinence. Roughly 10 to 15 percent have suffered complications, in some cases requiring the mesh to be removed.
In light of the litigation, warnings and complaints from women about severe pain and bleeding from mesh implants, some manufacturers, including Johnson & Johnson, had voluntarily stopped selling them.
More than 100,000 people filed claims against the major manufacturers in federal and state courts. Although some of the settlement figures have been large, women have complained that lawyers have taken a lot of the settlement money. Documents reviewed by The New York Times and interviews indicated that the average settlement for each woman was less than $60,000.
“If this had happened at the very outset of the litigation, we might have seen higher settlement values,” said Elizabeth Chamblee Burch, a law professor at the University of Georgia and an expert in pelvic mesh litigation. “It could help with the remaining cases. The plaintiffs themselves see this as a pretty huge victory and a victory that they wish had come a lot sooner.”
In recent years, sales of the pelvic mesh had declined as companies stopped selling the devices and the costs of litigation mounted. From 2010 to 2017, sales in the United States amounted to about $600 million, according to some estimates.
https://www.nytimes.com/2019/04/16/health/vaginal-pelvic-mesh-fda.html
-
FDA Orders Makers of Women’s Surgical Mesh to Stop Selling the Products
Apr 16, 2019 | The Wall Street Journal
By Thomas M. Burton and Stephen Nakrosis
The U.S. Food and Drug Administration ordered the two makers of surgical mesh for women’s pelvic repair to take their products off the market, responding to years of complaints about pain, bleeding and scarring from the devices.
The federal agency, following a safety hearing on the topic in February, said that Boston Scientific Corp. and Coloplast Corp. hadn’t demonstrated reasonable evidence that the mesh products worked better than surgery without the products.
Transvaginal mesh is used to treat a condition called pelvic organ prolapse, in which organs like the bladder, uterus and others sag into the vaginal area. It is estimated that about one in eight women has surgery in her lifetime to treat the condition.
The condition can be treated with conventional surgery that uses a woman’s own tissue. But some surgeons have maintained that the synthetic mesh product can lead to a more permanent repair. Mesh products also are used in hernia repair and urinary incontinence treatment, but these uses carry a lesser risk in the view of surgeons and they remain on the market.
Vaginal mesh products were first cleared in 1996 by the FDA for marketing. But complications, some severe, have been extensive, leading to litigation and billions of dollars in damages over crippling conditions and the need for multiple reoperations in many patients.
Boston Scientific, in a statement, said the company was “deeply disappointed by the FDA’s decision” regarding their products, adding “Patient safety is always our highest priority and we will work closely with the agency to understand its direction and determine next steps.”
The company also said it believes “the inaccessibility of these products will severely limit treatment options for the 50% of women in the U.S. who will suffer from pelvic organ prolapse during their lives.”
A Coloplast spokesperson wasn’t immediately available to comment.
In 2008, the federal agency issued a notice that serious complications were linked to mesh in some cases. In 2011, it reinforced that message by saying that the complications weren’t rare.
In the FDA’s search of its database on complications preparing for the safety hearing this year, it found 10,391 reports of serious injuries related to surgical mesh for women’s pelvic repair. Further, it said, the reports listed 77 deaths possibly related to the devices.
An advisory panel of outside doctors recommended to the FDA at the hearing this year that it take into account women’s reports of pain, sexual dysfunction and other conditions in making its decision about whether mesh should stay on the market.
“Women’s lives have been changed, and in some cases ruined” by mesh, according to hearing testimony from Diana Zuckerman, president of the consumer group National Center for Health Research.
Both companies at the time of the hearing said they considered mesh safe, effective and an important treatment option.
Jeffrey Shuren, director of the FDA’s medical-device center, said the FDA needed evidence that mesh worked better than surgery without mesh in order to keep the devices on the market. “That evidence was lacking,” said Dr. Shuren, “and we couldn’t assure women that these devices were safe and effective long-term.”
The companies will have 10 days to submit their plan to withdraw these products from the market, the FDA said.
Shares of Boston Scientific were down 5% in afternoon trading. American Depisitary Receipts in Coloplast were down 2.8%.
https://www.wsj.com/articles/fda-orders-makers-of-womens-surgical-mesh-to-stop-selling-the-products-11555432813
-
FDA Halts Vaginal Mesh Sales; Boston Scientific Shares Fall
Apr 16, 2019 | Bloomberg
By Michelle Cortez and Jef Feeley
U.S. health regulators ordered two medical device companies to stop selling surgical mesh used in pelvic repair surgeries after saying there isn’t enough evidence that the product embroiled in thousands of lawsuits is safe or effective.
The Food and Drug Administration told Boston Scientific Corp. and the Danish company Coloplast A/S “to stop selling and distributing their products in the U.S. immediately.” They were the last two companies selling surgical mesh for use during minimally invasive repair of pelvic organ prolapse, a common condition in women that develops when the muscles holding in the bladder and uterus weaken and the organs start to protrude from the vagina.
Vaginal mesh, which helps hold in the organs, was once made by 31 companies including Johnson & Johnson, C. R. Bard and Endo International Plc. The mesh was clouded by safety complaints after doctors started implanting it through the vagina in 2002, with complications including pain, infection and even death on rare occasions. The FDA recategorized mesh as a high-risk device in 2016 and required the companies to prove its benefits in order to keep the product on the market.
“The FDA has determined that the manufacturers, Boston Scientific and Coloplast, have not demonstrated a reasonable assurance of safety and effectiveness for these devices,” the agency said in a statement.
Vaginal mesh generates about $25 million in annual sales for Boston Scientific, according to Larry Biegelsen, an analyst at Wells Fargo & Co., who said the impact should be manageable. Vijay Kumar, an analyst at Evercore ISI, said the setback could lead Boston Scientific to lower its 2019 revenue estimates.
Boston Scientific shares were down 4 percent to $36.28 at 2:26 p.m. in New York, while Coloplast’s American depositary receipts fell 3.9 percent. Coloplast has settled the lawsuits brought against it by women who said they were harmed by the devices. Boston Scientific has set aside more than $900 million for legal liabilities, with most of it tied to mesh lawsuits.
The companies will have 10 days to submit their plans for withdrawing their devices, the agency said.
Boston Scientific, based in Marlborough, Massachusetts, decried the decision and said it would work with the agency to determine the company’s next steps.
“We are deeply disappointed by the FDA’s decision,” said Kelly Leadem, a company spokeswoman. “The inaccessibility of these products will severely limit treatment options for the 50 percent of women in the U.S. who will suffer from pelvic organ prolapse during their lives,” she said.
Vaginal mesh accounts for about 0.2 percent of group revenue for Humlebaek, Denmark-based Coloplast, said company spokeswoman Lina Danstrup, who declined to comment further. The company generated $2.6 billion in sales last year.
While some mesh makers -- like Coloplast -- have settled all their cases, Boston Scientific still faces about 18,000 suits over the controversial implants. Most of those cases are in settlement negotiations, company officials said in a February filing with the U.S. Securities and Exchange Commission.
Other device makers, such as J&J, still face more than 34,000 claims their mesh devices damaged women’s organs and left them in severe pain., according to a February SEC filing. Unlike Boston Scientific and Endo, J&J hasn’t announced a settlement program. Instead, the device maker is resolving suits on a case-by-case basis.
https://www.bloomberg.com/news/articles/2019-04-16/boston-scientific-ordered-to-halt-sale-of-mesh-targeted-in-suits
-
FDA bans sales of transvaginal mesh amid safety concerns
Apr 16, 2019 | CNN
By Susan Scutti
Manufacturers of surgical mesh products must stop selling and distributing their products in the United States immediately, the US Food and Drug Administration ordered Tuesday.
The FDA said it "has determined that the manufacturers, Boston Scientific and Coloplast, have not demonstrated a reasonable assurance of safety and effectiveness for these devices."Each year, thousands of women undergo transvaginal surgery to repair pelvic organ prolapse, a condition where weakened muscles and ligaments cause the pelvic organs to drop lower in the pelvis, creating a bulge or prolapse in the vagina.
In the 1990s, gynecologists began implanting surgical mesh for the transvaginal repair of the condition and in 2002, the first mesh device specifically for this purpose was cleared for use by the FDA, according to the agency's statement."We couldn't assure women that these devices were safe and effective long term," said Dr. Jeffrey Shuren, director of the FDA's Center for Devices and Radiological Health.
Women who have had transvaginal mesh surgically implanted should "continue with their annual and other routine check-ups and follow-up care," the FDA advised. "There is no need to take additional action if they are satisfied with their surgery and are not having complications or symptoms."
Patients who have complications or symptoms, including persistent vaginal bleeding or discharge, pelvic or groin pain or pain with sex, should notify their health care professionals. Women who may have been planning a surgical mesh procedure should discuss other options with their doctors.
Public Citizen, a consumer advocacy organization, petitioned for a ban against the mesh products in 2011 and then testified before an FDA advisory committee earlier this year, according to Dr. Michael Carome, director of the nonprofit's Health Research Group."Although we welcome this long-overdue action, this ban comes too late for the thousands of women who have been irreparably harmed by these devices," Carome said in a statement Tuesday.
"Since at least 2011, there has been clear evidence that these products are unsafe for treating pelvic organ prolapse and lack any clinically significant benefits in comparison to nonmesh products."
He added that "the agency's reckless delay in removing these mesh products from the market belies" Shuren's assertion that patient safety is the FDA's highest priority."If the agency had granted our 2011 petition promptly, thousands of women would have been spared serious, preventable life-altering harm," said Carome.
Medical device safety
The FDA said its Tuesday action to remove surgical mesh products from the market is part of its commitment to ensuring the safety of medical devices. In a November statement, the agency said that it "regulates more than 190,000 different devices, which are manufactured by more than 18,000 firms in more than 21,000 medical device facilities worldwide."
Last year, the FDA released its Medical Device Safety Action Plan, a program intended to overhaul the process for manufacturers that want to market medical devices in the nation.It was released around the same time as a year-long investigation by the International Consortium of Investigative Journalists, which included more than 250 journalists based in 36 countries and examined more than 8 million device-related health records.
In addition to uncovering thousands of deaths and millions of injuries presumably caused by medical implants, the report known as the "Implant Files" also claimed that manufacturers have paid out at least $1.6 billion across the globe to settle charges of regulatory violations, including corruption and fraud.
"Patients around the world have become unwitting test subjects for new medical technology," the consortium stated. "Often following the trusted advice of their doctors, they have been injured, maimed and killed by poorly-tested implants."
https://edition.cnn.com/2019/04/16/health/transvaginal-pelvic-mesh-fda-bn/index.html
-
US Halts Sale of Vaginal Mesh Blamed for Thousands of Injuries
Apr 17, 2019 | ICIJ
By Sasha Chavkin
In a major women’s health action, the United States has blocked sales of vaginal mesh used for the treatment of pelvic organ prolapse, the U.S. Food and Drug Administration announced Tuesday.
The move came after tens of thousands of patients in the U.S. and across the world have reported serious complications, including intense pain and bleeding, after they were implanted the medical device, which is commonly used to prevent the bladder and uterus from dropping or pressing into the vaginal area.
“Patient safety is our highest priority, and women must have access to safe medical devices,” said Dr. Jeffrey Shuren, the director of the FDA’s Center for Devices and Radiological Health, in a press release from the agency. “The FDA has committed to taking forceful new actions to enhance device safety and encourage innovations that lead to safer medical devices.”
The FDA’s decision requires Boston Scientific and Coloplast, the two manufacturers of mesh products sold to treat organ prolapse in the United States, to present a plan within the next 10 days for pulling their brands of vaginal mesh from the market.
For many patients and doctors, the ban was long overdue. Reports of vaginal mesh cutting into sensitive organs and breaking apart inside women’s bodies have surfaced for years.
Vaginal mesh is one of a dozen or so devices that featured prominently in the Implant Files, a global investigation by the International Consortium of Investigative Journalists. ICIJ’s investigation found that many medical devices later blamed for high numbers of injuries and even deaths, including mesh, were approved in the U.S. without first undergoing clinical trials.
The investigation also found that the FDA and other regulatory agencies have allowed problem devices to remain on the market even as evidence mounts that they pose unacceptable health threats.
More than 100,000 women worldwide have filed lawsuits against manufacturers charging that they were harmed by faulty mesh products, ICIJ reported.
Other countries have previously taken action to restrict vaginal mesh, including Australia, where mesh for prolapse has been banned, and the United Kingdom and Ireland, where it has been suspended from use.
At a public hearing in February, an FDA panel of experts heard from women who described devastating trauma, including the inability to have sex without intense pain.
“It destroys a woman from the inside out,” testified Jody Callahan, who described undergoing numerous surgeries to remove fragments of mesh from her body.
In 2016, the FDA switched the device to its highest risk category and directed manufacturers to conduct clinical trials if they wanted to keep selling it.
At the February hearing, Boston Scientific and Coloplast researchers presented studies that they said showed that mesh performed better at treating prolapse than alternative treatments and with similar rates of complications.
Tuesday’s decision reflects the FDA’s verdict that it found these studies to be unconvincing. The agency stated in its announcement that the companies had failed to prove the long-term safety or effectiveness of vaginal mesh used for organ prolapse.
The products ordered removed from sale are Boston Scientific’s Uphold Lite Vaginal Support System and Xenform Soft Tissue Repair Matrix and Coloplast’s Restorelle DirectFix.
Other surgical mesh products, such as those used to treat hernias or incontinence, are unaffected by the decision. Women who currently have vaginal mesh implants for prolapse are advised not to take additional action unless they experience complications or other symptoms.
https://www.icij.org/investigations/implant-files/us-halts-sale-of-vaginal-mesh-blamed-for-thousands-of-injuries/
-
FDA bans Boston Sci, Coloplast sales of pelvic mesh
Apr 16, 2019 | Mass Device
By Nancy Crotti
The FDA has ordered Boston Scientific (NYSE:BSX) and Coloplast — the only remaining companies that sell pelvic mesh in the U.S. — to immediately halt sales and distribution of those products.
The two companies have not demonstrated a “reasonable assurance of safety and effectiveness for these devices” used to treat pelvic organ prolapse (POP) since the agency reclassified them as high-risk in 2016, the FDA said. As part of the reclassification, manufacturers were required to obtain premarket approval (PMA) applications, the agency’s most stringent device review pathway.
The FDA found that Boston Scientific and Coloplast failed to demonstrate an acceptable long-term benefit of these devices compared to transvaginal surgical tissue repair without the use of mesh (native tissue repair), leading it to conclude that “these products do not have a reasonable assurance of safety and effectiveness.” It gave the companies 10 days to submit their plan to withdraw these products from the market.
“In order for these mesh devices to stay on the market, we determined that we needed evidence that they worked better than surgery without the use of mesh to repair POP. That evidence was lacking in these premarket applications, and we couldn’t assure women that these devices were safe and effective long term,” said Dr. Jeffrey Shuren, director of the FDA’s Center for Devices and Radiological Health, in a prepared statement. “Patient safety is our highest priority, and women must have access to safe medical devices that provide relief from symptoms and better management of their medical conditions. The FDA has committed to taking forceful new actions to enhance device safety and encourage innovations that lead to safer medical devices, so that patients have access to safe and effective medical devices and the information they need to make informed decisions about their care.”
Gynecologists began implanting surgical mesh for abdominal repair of POP in the 1970s and, in the 1990s, for surgical repair of POP. The FDA cleared the first mesh device for transvaginal repair of POP for use as a class II moderate-risk device in 2002. That use has been under fire for years as women filed lawsuits complaining of pain, excessive bleeding and loss of sexual function. The FDA said it saw a “significant increase” in the number of adverse events reported about various manufacturers’ pelvic mesh products, which have also have been subject to repeated recalls and lawsuits that have yielded multi-million-dollar settlements. The agency issued its first safety communication about pelvic mesh in 2011.
Media investigations published in the past year — including Netflix’s July 2018 documentary “The Bleeding Edge” and the International Consortium of Investigative Journalists’ Implant Files have also drawn greater public attention to patient problems with pelvic mesh and other medical devices. Former FDA analyst Madris Tomes, now CEO of medtech safety software company Device Events, said she was pleased by the agency’s move.
“There are similar issues with hernia mesh but perhaps doctors will better understand that native tissue repair should always be the first choice,” Tomes said in an email to MassDevice.
“We are deeply disappointed by the FDA’s decision on our premarket approval applications (PMAs) for the Uphold LITE vaginal support system and the Xenform soft tissue repair matrix, and believe the inaccessibility of these products will severely limit treatment options for the 50% of women in the U.S. who will suffer from pelvic organ prolapse during their lives,” said Boston Scientific spokeswoman Kate Haranis in an email to MassDevice. “Patient safety is always our highest priority and we will work closely with the agency to understand its direction and determine next steps.”
Coloplast declined to comment on the ban.
In 2018, reports surfaced that Johnson & Johnson (NYSE:JNJ) tried to stop health authorities in France from publishing a report that warned against the use of untested pelvic mesh devices.
Ireland also temporarily suspended all transvaginal mesh procedures for the treatment of stress urinary incontinence or pelvic organ prolapse at Health Service Executive funded hospitals last year. The country said that the suspension would stay in place “until a set of conditions to mitigate the risks of injury are met.”
A recent FDA transvaginal mesh advisory panel agreed that vaginal mesh products should continue being offered as an option to women with pelvic organ prolapse, but that improvements were needed, both in depth and length, for both premarket and postmarket studies of the devices, MedTech Dive reported. Premarket approval studies should follow patients out to at least 18 to 24 months, while postmarket studies should follow patients to five years, the panel agreed.
Boston Scientific shares dropped from $38.09 to $35.64 on the news before 1 p.m. Eastern time before recovering slightly.
https://www.massdevice.com/fda-bans-boston-sci-coloplast-sales-of-pelvic-mesh/
-
FDA Orders Surgical Mesh Products Pulled From US Market
Apr 16, 2019 | Law 360
By Danielle Nichole Smith
The U.S. Food and Drug Administration on Monday ordered Boston Scientific and Coloplast — the only two remaining manufacturers of surgical mesh meant for the transvaginal repair of pelvic organ prolapse — to stop selling those mesh products in the U.S.
The order stems from the agency's reclassification of the devices as high-risk in 2016, which required their manufacturers to submit premarket approval applications to continue marketing them in the U.S., according to the FDA. The order covers Boston Scientific Corp.'s Uphold Lite Vaginal Support System and Xenform Soft Tissue Repair System, and Coloplast AS' Restorelle DirectFix Anterior Mesh.
The two manufacturers will have 10 days to submit their plan for withdrawing the products from the market, the statement said. All other mesh products meant for the transvaginal repair of pelvic organ prolapse were removed from the market in 2018 when their manufacturers declined to submit premarket approval applications, according to the FDA.
Jeffrey Shuren, the director of the FDA's Center for Devices and Radiological Health, said the agency determined Boston Scientific and Coloplast had to show their mesh devices worked better to repair pelvic organ prolapse than surgeries that didn't use mesh in order for those products to stay on the market.
"That evidence was lacking in these premarket applications, and we couldn't assure women that these devices were safe and effective long term," Shuren said in a statement. "Patient safety is our highest priority, and women must have access to safe medical devices that provide relief from symptoms and better management of their medical conditions."
According to the statement, premarket approval applications are the FDA's "most stringent device review pathway." Ultimately, the agency found that the manufacturers didn't give an "adequate assessment" of their devices' long-term safety, or show they had an "acceptable long-term benefit" as compared to native tissue repair, which doesn't use mesh, in their applications.
Boston Scientific said in a statement that the company would "work closely with the agency to understand its direction and determine next steps."
"We are deeply disappointed by the FDA's decision on our premarket approval applications for the Uphold Lite Vaginal Support System and the Xenform Soft Tissue Repair Matrix, and believe the inaccessibility of these products will severely limit treatment options for the 50% of women in the U.S. who will suffer from pelvic organ prolapse during their lives," the company said.
The FDA and Coloplast each declined to comment Tuesday.
Boston Scientific has faced litigation over its manufacturing of other vaginal mesh devices, such as the Pinnacle Pelvic Floor Repair Kit. At the end of January, a federal judge said that the company had paid more than $7 billion to resolve tens of thousands of cases, and the company indicated in an annual report filed with the U.S. Securities and Exchange Commission that it was close to having resolved about 50,000 cases and claims related to its pelvic surgical mesh implants.
https://www.law360.com/articles/1150443/fda-orders-surgical-mesh-products-pulled-from-us-market
-
J&J’s Rush To Market Made Mesh Patients Suffer, Jury Told
Apr 16, 2019 | Law 360
By Matt Fair
A Johnson & Johnson unit’s bid to protect its market dominance by rushing a pelvic mesh implant to market without sufficient clinical testing left a Philadelphia-area woman paying the price through worsening incontinence and pain she began experiencing with sex, a jury heard during closing arguments Tuesday.
Colin Burke, an attorney with Kline & Specter PC, told jurors that J&J subsidiary Ethicon Inc. had disregarded the health and safety of women like his client, Malgorzata Krolikowski, and launched its so-called TVT-Secur implant after testing it on only 31 people over a five-week period.
Of the 31 women who received the implant prior to its release in September 2006, Burke said that 30% saw the device fail and 60% experienced some form of complication.
But Burke said Ethicon ignored the warnings signs to the detriment of Krolikowski and others who eventually received the implants.
“They had the opportunity to do the right thing and they chose not to, and it wasn’t an accident,” he said. “They made deliberate and intentional decisions. They showed what they were really about, and it wasn’t the health and safety of women like Ms. Krolikowski.”
Krolikowski is the ninth woman to bring claims before a Philadelphia jury over alleged defects in Ethicon’s line of mesh implants, which are designed to treat symptoms of stress urinary incontinence.
Juries in six of those cases have returned damages totaling more than $145 million.
According to her attorneys, Krolikowski received a TVT-Secur implant in October 2008 to treat minor urinary stress incontinence, which she characterized as “bothersome” and “annoying,” although “not life altering.”
But she says the implant did not improve her condition and that her incontinence only worsened over the years.
In addition, she says that she began experiencing pain and urine leakage during sex — complications that have interfered with her ability to find a new romantic partner after the death of her husband in 2001.
She filed suit in January 2014, and a trial in her case kicked off in Philadelphia at the end of March.
Burke’s closing argument Tuesday focused heavily on internal Ethicon documents that he said revealed the company had fast-tracked the TVT-Secur to maximize profits despite concerns among doctors it worked with about the device’s safety and efficacy.
He pointed to a portion of a company marketing presentation that admitted to a perception that Ethicon was “guilty of cardinal sin related to surgical products, a rush to market in the absence of sound data.”
“Why did they rush this product to market without proper testing?” he asked. “We know why: money. It was a business decision.”
But Sean Gallagher, an attorney with Bartlit Beck LLP representing Ethicon, said that Krolikowski had failed to show that the mesh had actually caused any of the injuries at issue in her lawsuit.
Instead, he said, Burke had simply tried to smear the company.
“This morning, you saw something extraordinary,” he said. “Mr. Burke stood up in his closing argument, and he barely mentioned Ms. Krolikowski at all.”
He cast doubt on whether Krolikowski’s mesh could be deemed a cause of her incontinence, given that it was a problem she was experiencing even before she received the implant.
“If I’m taking aspirin for a headache and it doesn’t completely cure the headache, you wouldn’t say the aspirin caused the headache,” he said.
He also added that Krolikowski had other complications that could be the cause of her pain with sex.
In particular, he pointed to her history of uterine fibroids, for which she underwent surgery in October 2012, as well as the abnormal position of her uterus in her body.
The jury began deliberating late Tuesday afternoon.
Krolikowski is represented by Elia Robertson and Colin Burke of Kline & Specter PC.
Ethicon is represented by Julie Callsen and Jennifer Steinmetz of Tucker Ellis LLP, Sean Gallagher of Barlit Beck LLP, Andrea La’Verne Edney of Butler Snow LLP, and Kimberly Gustafson Bueno of Scott Douglas & McConnico LLP.
The case is Malgorzata Krolikowski v. Ethicon Inc., case number 140102704, in the Court of Common Pleas of Philadelphia County, Pennsylvania.
https://www.law360.com/articles/1150581/j-j-s-rush-to-market-made-mesh-patients-suffer-jury-told
-
FDA orders Boston Scientific, Coloplast to stop selling surgical mesh
Apr 16, 2019 | CNBC
By Angelica LaVito
The Food and Drug Administration on Tuesday ordered Boston Scientific and Coloplast to stop selling surgical mesh used for some pelvic operations.
The agency said the companies “have not demonstrated a reasonable assurance of safety and effectiveness for these devices.” The companies have 10 days to submit their plans to withdraw the products from the market.
Shares of Boston Scientific closed down 4.34% and Coloplast closed down 2.46% on Tuesday.
Boston Scientific said it was “deeply disappointed by the FDA’s decision “and believe the inaccessibility of these products will severely limit treatment options for the 50% of women in the U.S. who will suffer from pelvic organ prolapse during their lives.”
“Patient safety is always our highest priority and we will work closely with the agency to understand its direction and determine next steps,” it added.
Coloplast said it will comply with the FDA’s order and stop selling the product and said it represents only 0.2% of its total revenue.
Manufacturers were required to submit applications with the FDA and receive approval in order to keep selling the devices in the U.S. after the agency reclassified them in 2016. The agency wanted evidence showing they worked better than surgery without using the mesh to repair pelvic organ prolapse, Jeffrey Shuren, director of the FDA’s Center for Devices and Radiological Health, said in a statement.
“That evidence was lacking in these premarket applications, and we couldn’t assure women that these devices were safe and effective long term,” he said.
The mesh was used for transvaginal repair of pelvic organ prolapse, a condition where muscles supporting the pelvic organs become weak or loose, allowing the organs to drop into or out of a woman’s vagina. Surgical mesh has been used to fix the condition since the 1950s. However, the FDA in recent years has warned about the risks associated with the devices.
Boston Scientific was the subject of a CBS “60 Minutes” investigation last spring that examined how the manufacturer faced 48,000 lawsuits claiming its mesh “can inflict life-altering pain and injury.”
The FDA said about 1 in 8 women has surgery to repair the condition, and a subset of these surgeries are completed transvaginally with the use of surgical mesh. However, the percentage of women undergoing transvaginal POP mesh procedures has decreased in recent years after the FDA began issuing warnings about risks associated with the procedure.
Johnson & Johnson stopped selling its mesh products in 2012, citing “changing market dynamics.”
https://www.cnbc.com/2019/04/16/fda-orders-boston-scientific-coloplast-to-stop-selling-surgical-mesh.html
-
FDA orders makers of surgical mesh products for pelvic collapse to stop selling immediately
Apr 16, 2019 | USA Today
By Charisse Jones
The Food and Drug Administration is ordering companies that produce mesh devices for women suffering from pelvic organ prolapse to end the sales of those products immediately.
The companies, "Boston Scientific and Coloplast, have not demonstrated a reasonable assurance of safety and effectiveness for these devices,'' the agency said Tuesday in a statement.
The products are supposed to assist in transvaginal repair as a result of POP, but their ability to stay on the market was put in jeopardy three years ago when the FDA labeled them high-risk. That classification meant the manufacturers had to apply for "premarket approval,'' the highest bar to clear to keep selling.
The companies have 10 days to say how they will pull the devices off the market.
“In order for these mesh devices to stay on the market, we determined that we needed evidence that they worked better than surgery without the use of mesh to repair POP,'' Jeffrey Shuren, director of the FDA’s Center for Devices and Radiological Health, said in the statement. "That evidence was lacking in these premarket applications, and we couldn’t assure women that these devices were safe and effective long term.”
Surgical mesh began to be used for POP-related transvaginal repair in the 1990s, and roughly a decade later, a mesh product got the green light for such surgeries. At the time, the device was considered to pose a moderate risk. But the FDA grew increasingly concerned after reports of negative effects spiked, and the number of patients receiving mesh has dropped.
In their premarket applications, the two device makers failed to show that mesh created a better outcome than the alternative, tissue repair. Both companies, however, will have to check up on patients who have had the mesh implanted and who are part of studies the FDA already ordered.
"Women who have had transvaginal mesh placed for the surgical repair of POP should continue with their annual and other routine check-ups and follow-up care,'' the FDA said. "There is no need to take additional action if they are satisfied with their surgery and are not having complications or symptoms.''
https://www.usatoday.com/story/money/2019/04/16/fda-orders-halt-sales-mesh-products-transvaginal-repair/3488144002/
-
Boston Scientific ordered by FDA to stop selling gynecological mesh
Apr 16, 2019 | CBS
By Kate Gibson
The Food and Drug Administration on Tuesday ordered Boston Scientific and another maker of transvaginal surgical mesh implants to stop selling and distributing the product in the U.S. The move is the latest in a series by the agency in response to safety concerns regarding the devices implanted in more than 2 million women.
Commonly used to repair weak or damaged tissue and provide support in the event of pelvic organ prolapse, or POP, the FDA said it is acting to protect the health of thousands of women who undergo transvaginal surgery each year. Neither Boston Scientific nor Coloplast, a Danish manufacturer, have demonstrated the safety or efficacy of the devices, according to the agency.
"In order for these mesh devices to stay on the market, we determined that we needed evidence that they worked better than surgery without the use of mesh to repair POP," Jeffrey Shuren, a physician and director of the FDA's Center for Devices and Radiological Health, said in a statement.
Boston Scientific said in a statement to CBS MoneyWatch that it is "deeply disappointed by the FDA's decision." The medical device maker said the FDA order would limit treatment options for "the 50 percent of women in the U.S. who will suffer from pelvic organ prolapse during their lives." The company added that it would work with the agency as it determines next steps.
Coloplast said the FDA order involved just one of its products. It declined further comment.
The FDA in 2016 reclassified the mesh as high risk, requiring Boston Scientific and Coloplast to get approval under the agency's most stringent review process to continue selling the devices. The controversial devices, which are made of synthetic or biological material, have sparked tens of thousands of lawsuits by women claiming the mesh had caused life-altering pain and injury.
About one in eight women has surgery to repair their pelvic organ prolapse during their lifetime, with a portion of those surgeries completed transvaginally using surgical mesh, according to the FDA. The percentage of transvaginal POP mesh procedures has declined in recent years amid warnings about the associated risks.
https://www.cbsnews.com/news/boston-scientific-ordered-by-fda-to-stop-selling-gynecological-mesh/
-
FDA orders transvaginal surgical mesh pulled from market
Apr 16, 2019 | Reuters (also in CBC, The Daily Mail, Nasdaq)
By Saumya Sibi Joseph and Aakash Jagadeesh Babu
The U.S. Food and Drug Administration on Tuesday ordered makers of transvaginal surgical mesh implants to immediately stop their sale and distribution in the United States, the latest action by the agency to tackle safety issues related to the devices.
The FDA said Boston Scientific Corp and Coloplast A/S did not demonstrate a reasonable assurance of safety and effectiveness of these devices in their premarket applications. The companies will have 10 days to submit their plan to withdraw these products from the market, the FDA said in a statement here
In 2016, the agency reclassified the mesh as class III or high risk, requiring its makers to obtain approval from the FDA’s most stringent device review pathway in order to continue selling the products.
The devices, made of synthetic or biological material, are commonly implanted in women to repair weakened or damaged tissue and provide support in cases of pelvic organ prolapse.
The prolapse occurs when the muscles and tissues supporting the pelvic organs - the uterus, bladder, or rectum - become weak or loose, resulting in one or more of the organs to drop or press into or out of the vagina.
Boston Scientific and Coloplast are the only companies that still sell and distribute meshes for this use, the FDA told Reuters.
Boston Scientific said it was “deeply disappointed” by the FDA’s decision and will work with the agency to determine the next steps.
“The inaccessibility of these products will severely limit treatment options for the 50 percent of women in the U.S. who will suffer from pelvic organ prolapse during their lives,” the company said in an emailed statement.
Coloplast said the order involved only one of its products, accounting for around 0.2 percent of total revenue. The Danish company declined to comment further.
Tens of thousands of lawsuits have been filed in recent years against medical device manufacturers claiming their transvaginal mesh implants caused pain, perforations, urinary problems, bleeding and other injuries. The lawsuits were filed against Boston Scientific, Coloplast, Johnson & Johnson and C.R. Bard, now a unit in Becton Dickinson and Co.
J&J said it has not sold its mesh product since 2012.
Other companies had to remove their products from the market last year because they did not submit required premarket approval applications, the FDA said.
A large portion of the $929 million in Boston Scientific’s legal reserves at the end of 2018 was related to the company’s surgical mesh, Needham and Co analyst Mike Matson said, adding that products account for around 1 percent of company revenue.
Boston Scientific shares were down 4 percent at $36.24 in late afternoon trading.
https://www.reuters.com/article/us-fda-surgicalmesh/fda-orders-transvaginal-surgical-mesh-pulled-from-market-idUSKCN1RS1QN
-
US Halts Sales of Pelvic Mesh Tied to Injuries in Women
Apr 16, 2019 | Associate Press (also in Snopes, The Public's Radio,
By Matthew Perrone
U.S. health regulators on Tuesday halted sales of a type of surgical mesh used to repair pelvic conditions in women, following years of patients’ reports of injuries and complications from the implants.
The Food and Drug Administration ordered the two remaining makers of the mesh — Boston Scientific and Coloplast — to stop selling it immediately, saying the companies failed to show the mesh is safe for long-term use. Several other major manufacturers, including Johnson & Johnson, previously stopped making the mesh.
The FDA action does not apply to surgical mesh used to treat other conditions such as hernias or incontinence.
Boston Scientific said it was “deeply disappointed,” by the agency’s decision which the company said “will severely limit treatment options” for women. Coloplast, based in Denmark, declined to comment.
Tens of thousands of lawsuits have been filed against mesh manufacturers by women who have reported pain, bleeding and infection tied to the devices. In some cases, the mesh can shift out of place, puncturing internal organs or the abdomen wall. Those problems sometimes require multiple surgeries to remove or reposition the mesh.
Starting in the 1990s, gynecologists adapted surgical mesh to treat pelvic collapse in women, which can cause the bladder or reproductive organs to slip out of place, causing pain, constipation and urinary issues. The FDA first approved the mesh specifically for that use in 2002 and manufacturers promoted mesh as a way to speed patients’ recovery time compared to surgery with stitches.
But the FDA received thousands of reports of injuries and issued a series of warnings. In 2016, the agency reclassified the mesh as high-risk.
The agency said Tuesday that women with the pelvic mesh should continue regular checkups. There is no need to have the mesh removed if patients are not having problems or symptoms. The FDA order applies to mesh that is inserted through the vagina with a small incision, not mesh inserted through the abdomen with a larger incision.
About 1 in 8 women in the U.S. undergo some form of surgery to treat pelvic collapse problems, according to the FDA. Regulators said use of the mesh targeted by their latest action has decreased in recent years due to safety concerns.
Pelvic mesh is the latest medical device for women to have safety issues long after they were approved. Last year, the FDA placed heavy restrictions on the birth control implant Essure, which was tied to allergic reactions, pain and bleeding. Its manufacturer, Bayer, subsequently pulled it from the market. Previously, the FDA warned against using a surgical tool for removing uterine fibroids because it could inadvertently spread cancer.
Like most medical devices on the market, the FDA approved pelvic mesh through a regulatory pathway that reviews new products based on their similarities to decades-old devices already on the market, rather than new testing in patients.
Last November, the FDA announced plans to revamp that system so that medical devices would use more up-to-date technology.
Wells Fargo analyst Larry Biegelsen said in an investment note that Boston Scientific’s two pelvic mesh products generated about $25 million in 2018, or less than a fraction of a percent of the company’s annual sales.
https://www.apnews.com/d300c9ac673b4bcf8226f5dc13dd5909
-
After injuries, FDA orders pelvic mesh off the market
Apr 16, 2019 | Star Tribune
By Joe Carlson
After years of advocacy by injured patients, the U.S. Food and Drug Administration has ordered the makers of mesh devices for the repair of pelvic organ prolapse to remove the products from the U.S. market.
The announcement Tuesday came after years of scrutiny and well over 100,000 lawsuits from women around the world who said the mesh products caused painful complications. Makers of the products include two companies with major operations in Minnesota, Coloplast A/S and Boston Scientific Corp.
Organizers with the patient-activist group Medical Device Problems offered lukewarm praise for the FDA’s action, saying it took too long to happen and did not go far enough.
“These mesh devices were on the market for over 20 years, leaving tens of thousands of women to live with permanent disabilities and disfigurement. We feel the announcement, while a step in the right direction, also does not go far enough; it does not address other mesh devices that are causing similar life-altering injuries,” wrote Amanda Dykeman, the Illinois-based founder of Medical Device Problems.
Women who were scheduled to have mesh implanted to treat pelvic organ prolapse (POP) will need to discuss other treatment options with their doctors, the FDA said in its announcement. The decision does not apply to similar mesh products used to treat stress urinary incontinence.
Manufacturers said the decision to remove transvaginal mesh products for POP from the market may have negative effects for some patients.
“We are deeply disappointed by the FDA’s decision on our premarket approval applications,” Boston Scientific spokeswoman Kate Haranis said via e-mail. The company believes that “the inaccessibility of these products will severely limit treatment options for the 50% of women in the U.S. who will suffer from pelvic organ prolapse during their lives.”
Mesh products were originally used in surgery to repair abdominal hernias. Since the 1990s, plastic mesh has been used to treat the common condition of pelvic organ prolapse, which happens when the muscles and tissues supporting the uterus, bladder, or rectum become weak or loose, allowing one or more pelvic organs to drop or press into or out of the vagina, according to the U.S. Office on Women’s Health.
Although the mesh is supposed to reinforce the tissues and prevent prolapse, thousands of women say the treatment led to more pain. The FDA examined thousands of reported injuries and found the most commonly reported problems included severe pelvic pain, pain during intercourse, infection, bleeding, organ perforation and urinary problems from mesh eroding into surrounding tissues.
Pelvic floor disorders
Though embarrassing to talk about, pelvic floor disorders including POP, urinary incontinence and fecal incontinence affect one in five women in the U.S., with POP alone affecting about 3% of all women. The FDA said about 1 in 8 women will have surgery of some form to repair POP.
Dr. Emanuel Trabuco, chairman of the urogynecology division at the Mayo Clinic in Rochester, said there’s a range of different treatment options for POP, both surgical and nonsurgical, that don’t involve the use of the vaginal mesh “kits” sold by the device companies. He said the overall concern over mesh complications may have unfortunately caused women to avoid any type of care.
“Other treatment options are available to treat stress incontinence and pelvic organ prolapse, and women shouldn’t be scared to talk to their physicians,” Trabuco said. He also noted that the clinical data support the idea that mesh kits for POP have a different risk profile than mesh for urinary incontinence, even though the devices appear similar.
Makers of the devices have been steadily working to settle the litigation around the products, while simultaneously insisting that the products are safe and effective when used as directed.
The FDA has been examining complaints about mesh devices used for POP since at least 2011. In 2016, the agency moved the devices into its highest-risk category of surgical products, forcing the manufacturers to decide whether to fund new studies to meet the higher standards for safety and effectiveness, or pull out of the market. The devices were previously in a lower-risk category that required far less safety testing to gain clearance.
Boston Scientific and Coloplast opted to submit new premarket applications to the FDA to show that their products were at least as safe and effective as native-tissue repair.
Then in February, the agency’s expert panel on the devices met and decided the FDA should require manufacturers to present evidence that mesh has a superior level of effectiveness to native tissue repair at 36 months and a comparable level of safety.
“That evidence was lacking in these premarket applications, and we couldn’t assure women that these devices were safe and effective long term,” said Dr. Jeffrey Shuren, director of the FDA’s medical device division, in the announcement.
Stock prices drop
Shares of Boston Scientific stock dropped more than 4% to about $36 on the news Tuesday afternoon. Analysts with Leerink Partners noted that although mesh products for POP account for about $25 million, or 1%, of Boston Scientific’s annual sales, investors appeared to be selling the stock out of concern over litigation. Leerink said the sell-off was out of proportion to the risk, because Boston has already settled the vast majority of the roughly 40,000 lawsuits pending against it.
A Coloplast spokesperson declined to comment Tuesday. The affected devices made up about 0.2% of Coloplast revenue. Company stock dropped 3% Tuesday.
The FDA has given Boston Scientific and Coloplast 10 days to submit plans to withdraw the products from the market. The action affects Boston Scientific’s Uphold Lite Vaginal Support System and the Xenform Soft Tissue Repair Matrix, and Coloplast’s Restorelle DirectFix device.
The not-for-profit advocacy group Public Citizen, which asked the FDA to ban the devices in 2011, welcomed Tuesday’s action by the FDA but criticized the agency for allowing thousands of women to be hurt long after it knew that the devices had not demonstrated a reasonable assurance of safety.
“Since at least 2011, there has been clear evidence that these products are unsafe for treating pelvic organ prolapse and lack any clinically significant benefits in comparison to nonmesh products,” Public Citizen said in a statement. “If the agency had granted our 2011 petition promptly, thousands of women would have been spared serious, preventable life-altering harm.”
http://www.startribune.com/fda-orders-pelvic-mesh-devices-off-the-market/508652212/
-
FDA Halts All US Sales of Surgical Mesh
Apr 16, 2019 | Regulatory Focus
By Zachary Brennan
Following thousands of patient lawsuits and a spike in adverse event reports, the US Food and Drug Administration (FDA) on Tuesday ordered the manufacturers of all remaining surgical mesh products indicated for the transvaginal repair of pelvic organ prolapse (POP) to stop selling and distributing their products in the US immediately.
Since FDA reclassified surgical mesh products to class III (high risk) in 2016, the agency said the two manufacturers, Boston Scientific and Coloplast, did not demonstrate a reasonable assurance of safety and effectiveness for these devices. The reclassification came after FDA received thousands of reports of injuries, including pelvic pain and bleeding, caused by the devices.
A strongly worded FDA safety communication in 2016 also caused the use of surgical mesh to decline. Some manufacturers voluntarily recalled and discontinued manufacturing their transvaginal mesh products in recent years too. These include C.R. Bard’s Avaulta Plus transvaginal mesh and the GyneCare product line from Ethicon, a division of Johnson & Johnson, which continues to face lawsuits.
“In order for these mesh devices to stay on the market, we determined that we needed evidence that they worked better than surgery without the use of mesh to repair POP. That evidence was lacking in these premarket applications, and we couldn’t assure women that these devices were safe and effective long term,” said Jeffrey Shuren, director of FDA’s Center for Devices and Radiological Health.
The companies will have 10 days to submit their plan to withdraw these products from the market.
And although these products can no longer be used in patients moving forward, Boston Scientific and Coloplast are required by FDA to continue follow-up of the subjects already enrolled in their postmarket surveillance studies.
In February, FDA also convened an advisory panel to solicit expert input on how to evaluate the safety and effectiveness of surgical mesh for transvaginal repair of POP.
“The panel recommended that to support a favorable benefit-risk profile, the effectiveness of surgical mesh for transvaginal repair of POP should be superior to native tissue repair at 36 months and the safety outcomes for surgical mesh for transvaginal repair of POP should be comparable to native tissue repair,” FDA said.
Boston Scientific filed two PMAs for its devices, the Uphold LITE Vaginal Support System and the Xenform Soft Tissue Repair System, and Coloplast filed a PMA for its device, Restorelle DirectFix Anterior. FDA said it agreed with panel’s recommendations, “and because such data were not provided by manufacturers in their PMAs, the FDA decided not to approve them.”
Boston Scientific told Focus in a statement: "We are deeply disappointed by the FDA’s decision on our premarket approval applications (PMAs) for the Uphold LITE Vaginal Support System and the Xenform Soft Tissue Repair Matrix, and believe the inaccessibility of these products will severely limit treatment options for the 50% of women in the U.S. who will suffer from pelvic organ prolapse during their lives. Patient safety is always our highest priority and we will work closely with the agency to understand its direction and determine next steps."
The nonprofit Public Citizen added in a statement: "Although we welcome this long-overdue action, this ban comes too late for the thousands of women who have been irreparably harmed by these devices, long after the FDA knew the devices had 'not demonstrated a reasonable assurance of safety."https://www.raps.org/news-and-articles/news-articles/2019/4/fda-halts-all-us-sales-of-surgical-mesh
-
FDA Stops Sales of Transvaginal Mesh for Pelvic Organ Prolapse
Apr 16, 2019 | Drug Watch
By Michelle Llamas
The U.S. Food and Drug Administration has ordered manufacturers of all remaining transvaginal mesh devices for pelvic organ prolapse repair to stop selling their products immediately, according to the agency’s April 16, 2019 press release.
The action comes after the FDA convened an advisory panel on Feb. 12, 2019 to solicit input from experts on how to evaluate the risks and benefits of mesh placed through the vagina for repair of pelvic organ prolapse, a condition in which organs drop into the vagina, usually after childbirth. The controversial implant has been blamed for complications such as severe pelvic pain, bleeding, vaginal erosion and death.
The agency reviewed data provided by manufacturers, and it did not find evidence that transvaginal mesh for POP works better than surgery without mesh to repair weakened pelvic muscles. Thousands of women undergo transvaginal surgery for POP each year, and this order is the latest aimed at protecting these women, the agency said in its press release.
Patient advocates and consumer watchdog groups applaud the FDA’s crackdown on mesh.
“The FDA has made the right decision,” Diana Zuckerman, president of the National Center for Health Research, told Drugwatch in an emailed statement. “Since it is well known that surgical mesh can cause very painful and serious complications, we agree with the FDA that it should not be approved for use in procedures where there are no benefits compared to surgery without mesh.”
The affected mesh devices are Boston Scientific’s Uphold LITE Vaginal Support System and the Xenform Soft Tissue Repair System and Coloplast’s Restorelle DirectFix Anterior.
The FDA is giving the companies 10 days to submit a plan to withdraw their devices. They must also continue to follow-up with patients who are already enrolled in their 522 clinical trials.No ‘Reasonable Assurance of Safety and Effectiveness’
After the FDA reclassified transvaginal mesh for POP as a high-risk device in 2016, the agency required manufacturers to submit new safety and effectiveness data. Most manufacturers, including Johnson & Johnson, simply pulled their devices off the shelves instead of doing additional studies.
That left Boston Scientific and Coloplast.
To continue selling their devices, the companies had to submit a premarket approval (PMA) application with additional data to prove the effectiveness of surgical mesh for transvaginal repair of POP.
“The panel recommended that to support a favorable benefit-risk profile, the effectiveness of surgical mesh for transvaginal repair of POP should be superior to native tissue repair at 36 months and the safety outcomes for surgical mesh for transvaginal repair of POP should be comparable to native tissue repair,” the FDA press release said.
After reviewing the PMAs, the FDA determined manufacturers “have not demonstrated a reasonable assurance of safety and effectiveness.”
“In order for these mesh devices to stay on the market, we determined that we needed evidence that they worked better than surgery without the use of mesh to repair POP. That evidence was lacking in these premarket applications, and we couldn’t assure women that these devices were safe and effective long term,” Dr. Jeffrey Shuren, director of the FDA’s Center for Devices and Radiological Health, said in the agency’s press release.Implants Sold Without Clinical Trial Data
These implants were originally cleared for sale through the controversial 510(k) process, which allows devices on the market without rigorous testing.
“Too many women and men have been harmed by surgical mesh that was allowed on the market without any requirement for clinical trials,” Zuckerman told Drugwatch. “Even when FDA expressed concern about surgical mesh for POP in 2016, too many surgeons continued to use it.”
The FDA began slowly chipping away at mesh after it held its first committee meeting in 2011, and thousands of women have been waging a war against the device for years.
Many have filed lawsuits against mesh makers such as Johnson & Johnson’s Ethicon unit, Boston Scientific and Coloplast. In a 2018 report, 60 Minutes called the consolidated mesh litigation, which includes tens of thousands of lawsuits, “the largest multi-district litigation since asbestos.”‘Problems Don’t End with POP Mesh’
While many advocates laud the FDA for their decision, others claim safety issues don’t end with pulling POP mesh from the market.
Removing POP mesh is a “wonderful start,” patient advocate and mesh survivor Tammy Jackson told Drugwatch. Jackson told her mesh story in the Netflix documentary The Bleeding Edge. She points out that mesh for stress urinary incontinence remains on the market.
“It’s made from polypropylene [like] POP mesh. SUI mesh causes the same complications,” she said. “The problems don’t end with POP mesh being removed.”
She calls on the FDA and medical device industry to “do the right thing” and stop making and marketing pelvic mesh.
Zuckerman says the agency should require clinical trials for all mesh used in surgeries.
“FDA’s finally requiring clinical trials for mesh used for pelvic organ prolapse (POP) was an important first step, but the thousands of patients harmed by surgical mesh clearly show that clinical trials should be required for all types of surgical mesh,” she said.
In the meantime, the FDA has told women who are currently implanted with mesh to continue to see their doctors for routine check-ups. If they are satisfied with their surgery, they don’t need to take action. But women who suffer from vaginal bleeding or discharge, pelvic or groin pain, or pain with sex should notify their health care providers.
https://www.drugwatch.com/news/2019/04/16/fda-stops-sales-of-transvaginal-mesh-for-pelvic-organ-prolapse/
-
FDA Pulls All Vaginal Mesh Products Off the Market
Apr 16, 2019 | Medscape
By Megan Brooks
The US Food and Drug Administration (FDA) today ordered the manufacturers of vaginal mesh products to stop selling and distributing their products in the US immediately, saying the companies failed to provide reasonable assurance that the products are safe and effective.
The three vaginal mesh devices available in the United States are Boston Scientific's Uphold LITE and Xenform, and Coloplast's Restorelle DirectFix Anterior.
The companies have 10 days to submit their plan to withdraw these products from the market.
Over the past several years, the FDA has seen a significant increase in the number of reported adverse events associated with the use of surgical mesh for transvaginal repair of pelvic organ prolapse (POP).
As a result, the agency has taken a series of escalating steps, including reclassifying the devices from class II (moderate risk) to class III (high risk).
As part of this reclassification, the manufacturers were required to submit premarket approval (PMA) applications, the agency's most stringent device review pathway, in order to continue marketing their devices in the United States.
In February, the FDA convened an advisory panel to solicit input from experts on how to evaluate the safety and effectiveness of surgical mesh for transvaginal repair of POP.
As reported by Medscape Medical News, the panel recommended that to support a favorable benefit–risk profile, surgical mesh should be superior to native tissue repair at 36 months and the safety outcomes for surgical mesh should be comparable to native tissue repair.
The FDA agreed with these recommendations, and because the manufacturers did not provide the required data in their PMAs, the FDA declined to approve them.
"In order for these mesh devices to stay on the market, we determined that we needed evidence that they worked better than surgery without the use of mesh to repair POP. That evidence was lacking in these premarket applications, and we couldn't assure women that these devices were safe and effective long term," Jeffrey Shuren, MD, director of the FDA's Center for Devices and Radiological Health, said in the statement.
The manufacturers are required to continue to follow women already enrolled in their "522" postmarketing studies.
Women who have had transvaginal mesh placed for the surgical repair of POP are advised to continue with annual and other routine check-ups and follow-up care. Women who are satisfied with their surgery and are not having complications or symptoms do not need to take any additional action. Women who experience complications or symptoms, such as persistent vaginal bleeding or discharge, pelvic or groin pain, or pain with sex, should speak with their healthcare provider.
https://www.medscape.com/viewarticle/911882
-
FDA orders immediate stop to sales of mesh used for transvaginal repair
Apr 16, 2019 | Washington Examiner
By Kimberly Leonard
The Food and Drug Administration on Tuesday took the unusual step of ordering manufacturers to immediately stop selling surgical mesh used for transvaginal repair because it has caused infection, bleeding, and pain during sex.
Surgeons use the mesh to give support to tissue that has become weak. The FDA said it could no longer be used to treat pelvic organ prolapse, a condition in which a woman's organs begin to fall toward the vagina and bulge outside the body.
Boston Scientific and Coloplast, the companies that sell the mesh, have 10 days to tell the FDA how they plan to take their product off the market.
The FDA previously issued a warning about the risks of using mesh because of reports of infection and bleeding and that women's organs were tearing. The mesh also starts to erode over time and starts falling out of the body, which requires more surgery. Since that time, surgeries to treat prolapse with mesh have fallen.
"We couldn’t assure women that these devices were safe and effective long term,” Dr. Jeffrey Shuren, director of the FDA’s Center for Devices and Radiological Health, said in a statement.
Mesh used in prolapse was reclassified in 2016, which means that manufacturers had to submit their products for review by federal regulators to be allowed to stay on the market.
The FDA ultimately determined that the companies hadn't shown that the mesh was safe or effective after scrutinizing the products and holding meetings about them over the course of roughly eight years. More than 100,000 lawsuits have been filed against manufacturers for mesh side effects, and other countries such as Australia have banned it. Roughly 200,000 women in the U.S. have surgery every year to treat prolapse.
The FDA recommended that women who have already had surgery to place the mesh in their pelvic areas should continue to have routine checkups with their doctors but that they shouldn't be concerned unless they have symptoms such as pain during sex or vaginal bleeding.
https://www.washingtonexaminer.com/policy/healthcare/fda-orders-immediate-stop-to-sales-of-mesh-used-for-transvaginal-repair
-
FDA orders Boston Scientific to withdraw surgical mesh product
Apr 16, 2019 | Boston Globe
By Max Reyes
Boston Scientific was ordered by the Food and Drug Administration on Tuesday to halt sales of controversial vaginal mesh products used in surgeries, saying the company had not proved they were safe to use.
The FDA action follows years of legal battles and hundreds of millions of dollars in settlements involving Boston Scientific and other makers of vaginal mesh products after thousands of women complained of extreme discomfort from the mesh.
After designating the products as high-risk in 2016, the FDA required Boston Scientific and a second manufacturer to submit applications demonstrating the mesh was safe to use in surgeries to repair a condition known as pelvic organ prolapse, or POP.
“That evidence was lacking in these premarket applications, and we couldn’t assure women that these devices were safe and effective long term,” Dr. Jeffrey Shuren, director of the FDA’s Center for Devices and Radiological Health, said in a news release.
The FDA also ordered a second maker, Coloplast, to withdraw its vaginal mesh product.
In 2016, the FDA reclassified surgical mesh products intended for transvaginal repair to indicate they were the most high risk of devices the agency evaluated, according to an agency statement. The reclassification required companies manufacturing the mesh to submit the devices for an approval process defined as the agency’s most stringent, the FDA said.
In a statement, Boston Scientific said it was disappointed by the FDA’s decision and said the order will limit treatment options for patients who have pelvic organ prolapse.
“Patient safety is always our highest priority and we will work closely with the agency to understand its direction and determine next steps,” the company said.
According to a spokeswoman for Boston Scientific, the company’s transvaginal mesh business represents approximately 1 percent of its total annual sales, which approached $10 billion in 2018.
The company’s stock price fell just over 4 percent on Tuesday, to close at $36.17.
Debbie Wang, an analyst with Morningstar who’s followed Boston Scientific since 2003, said the company is doing well financially, and the hit the stock took Tuesday likely represented an overreaction from investors.
The FDA’s decision to block further sales of the company’s mesh products, she added, didn’t come as a surprise.
“There’s been so much controversy over the transvaginal mesh, and we know there seems to be a high level of complications with it,” Wang said.
Marlborough-based Boston Scientific and other vaginal mesh makers have been sued thousands of times by women who claimed the mesh caused extreme discomfort and other conditions. In February, Boston Scientific reported it had settled or was in talks to settle approximately 50,000 of 53,000 cases and claims.
Wang compared the agency’s decision regarding transvaginal mesh to those it made on silicone-gel-filled breast implants, which were also subject to a reclassification by the FDA after concerns arose about safety.
“It can take years before we get to the point where the regulatory body decides to actually take this kind of a stand,” she said.
https://www.bostonglobe.com/business/2019/04/16/fda-orders-boston-scientific-withdraw-surgical-mesh-product/PeSfiazB6b0J2Q8mTnhUjO/story.html
-
FDA Flips the Switch on Pelvic Mesh Manufacturers
Apr 16, 2019 | Medical Device and Diagnostics Industry
By Amanda Pedersen
After years of controversy surrounding the use of surgical mesh for transvaginal repair of pelvic organ prolapse (POP), FDA has ordered Boston Scientific and Coloplast to stop selling the mesh on the U.S. market immediately. The agency said the manufacturers have not demonstrated a reasonable assurance of safety and effectiveness for these devices, which is the premarket review standard that now applies to them since FDA decided they were high risk in 2016.
“In order for these mesh devices to stay on the market, we determined that we needed evidence that they worked better than surgery without the use of mesh to repair POP. That evidence was lacking in these premarket applications, and we couldn’t assure women that these devices were safe and effective long term,” said Jeffrey Shuren, MD, director of the FDA’s Center for Devices and Radiological Health. “Patient safety is our highest priority, and women must have access to safe medical devices that provide relief from symptoms and better management of their medical conditions."
But considering how long these devices were on the market, and how many women have complained of major health problems since having transvaginal procedures that use surgical mesh, some say the action is too little, too late.
"Everyone at Medical Device Problems applauds this decision, but we feel it was not made soon enough," Amanda Dykeman, co-founder of Medical Device Problems said on behalf of the patient advocacy group. "These mesh devices were on the market for over 20 years, leaving tens of thousands of women to live with permanent disabilities and disfigurement."
The group also said the action taken by FDA on Tuesday is a step in the right direction but does not go far enough because it does not address other mesh devices that have been linked to similar life-altering injuries, such as hernia mesh.
"Today's announcement serves to highlight the structural defects in the 510(k) clearance process and serves as a warning for all other medical devices approved through this same pathway," Dykeman said. "While this is one great small step for one harmful medical device, thousands of devices that might not meet the basic litmus test of 'reasonable safety and effectiveness' remain on the market."
Surgical mesh used for transvaginal repair of POP was initially brought to the U.S. market through the 510(k) clearance pathway but in 2016 FDA reclassified the devices and told manufacturers they would have to submit and obtain approval through the more stringent premarket approval (PMA) review pathway in order to keep their devices on the market.
Boston Scientific filed two PMAs for its devices, the Uphold LITE Vaginal Support System and the Xenform Soft Tissue Repair System, and Coloplast filed a PMA for its device, Restorelle DirectFix Anterior.
"We are deeply disappointed by the FDA’s decision on our premarket approval applications (PMAs) for the Uphold LITE Vaginal Support System and the Xenform Soft Tissue Repair Matrix, and believe the inaccessibility of these products will severely limit treatment options for the 50% of women in the U.S. who will suffer from pelvic organ prolapse during their lives," Boston Scientific said in a statement provided to MD+DI. "Patient safety is always our highest priority and we will work closely with the agency to understand its direction and determine next steps."
In May, Boston Scientific noted that its urogynecologic mesh products account for about 1% of the company's total sales.
A Coloplast spokesperson told MD+DI that the Restorelle DirectFix Anterior product represents 0.2% of group revenues. The company declined to comment further.
In February, FDA convened an advisory panel to solicit input from experts on how to evaluate the safety and effectiveness of surgical mesh for transvaginal repair of POP. The American Urogynecologic Society (AUGS) provided written testimony for that panel meeting in support of keeping the devices on the market. In its testimony, AUGS acknowledged the safety concerns around these devices and proposed ways to maximize the safety of their use while also improving the availability of well-trained providers to "more skilfully address the unintended outcomes associated with their use."
"AUGS feels that women are better served when there are more options for their treatment, and transvaginal mesh for prolapse is a very reasonable and possibly advantageous option for women to consider under certain conditions," the group said in its testimony. "... Different patients experience pelvic floor disorders differently, underlining the need for nonsurgical options, which may have decreased efficacy, but balanced against a lower risk of complication."
Ultimately, the panel recommended that to support a favorable benefit-risk profile, the effectiveness of surgical mesh for transvaginal repair of POP should be superior to native tissue repair at 36 months and the safety outcomes for surgical mesh for transvaginal repair of POP should be comparable to native tissue repair. FDA agreed with these recommendations, and because such data were not provided by the manufacturers in their PMAs, the agency decided not to approve them.
Boston Scientific and Coloplast now have 10 days to submit plans to withdraw these products from the U.S. market, FDA said. The companies are also still required to continue follow-up on patients already enrolled in their 522 studies.
Surgical mesh has come up a number of times in the past year through various media investigations.
Last year a 60 Minutes segment brought unwanted attention to transvaginal mesh devices with a particularly harsh focus on Boston Scientific (the company spoke out about the controversial story in an interview with MD+DI soon after the report aired). The report claimed that the company made transvaginal mesh devices using counterfeit materials smuggled from China.
Boston Scientific denied any wrongdoing and received support from surgeons as well as AUGS. These products, which tend to get lumped together as "pelvic mesh," are designed to treat women who suffer from pelvic organ prolapse or stress urinary incontinence. The implants are made with polypropylene resin, which has previously been linked to a wide array of patient complications. A month after the 60 Minutes report aired, a Massachusetts jury backed Boston Scientific in a product liability case involving two of the company's transvaginal mesh devices.
As Dave Pierce, president of Boston Scientific's urology and pelvic health division, told MD+DI in May, it would have been easier for the company to jump ship from the transvaginal mesh business, as many other manufacturers did, back when FDA put out a medical device directive regarding the use of mesh for POP and stress urinary incontinence. Instead, the company chose to stay in the space and work with FDA and medical societies like AUGS to address the concerns associated with the products.
"And we did so because we felt like females who have these issues need options and we're proud of the fact that we stayed in this business," Pierce said during that interview.
Keeping the mesh implants on the market required a significant investment on Boston Scientific's part, Pierce added, as the company has conducted studies mandated by FDA. The company has also worked with AUGS to ensure surgeons who use the products have extensive training, he said.
"You've seen other companies leave the space altogether. It would have been easier to do that," Pierce said. "But we, as an executive committee, made the decision to stay in this, to absorb the additional expense and complexity, because it's the right thing to do for women."
The Netflix documentary The Bleeding Edge also shed light on how surgical mesh has adversely impacted patients.
FDA is in the process of modernizing its 510(k) clearance pathway, which was adopted in 1976 and now accounts for the majority of medical devices the agency reviews. One of the biggest proposed changes has to do with the use of older predicate devices as a means of demonstrating the safety of new medical devices. Nearly 20% of current 510(k)s are cleared based on a predicate that's more than 10 years old. That's not to say the products are unsafe, the agency said, but it does mean that some devices may not be continually improving. FDA said it will pursue additional actions that will allow the agency to retire outdated predicates, especially in cases where safer or more effective technology has emerged.
https://www.mddionline.com/fda-flips-switch-pelvic-mesh-manufacturers
-
FDA orders Boston Scientific to stop selling women's health product
Apr 16, 2019 | Worcester Business Journal
By Zachary Comeau
The U.S. Food and Drug Administration has ordered Marlborough medical device maker Boston Scientific and another manufacturer to immediately stop selling transvaginal surgical mesh products.
In a Tuesday announcement, the FDA said the companies "have not demonstrated a reasonable assurance of safety and effectiveness for these devices," which is the agency's premarket review standard now applying to the products since the agency reclassified them as high risk in 2016.
Premarket approval was needed in order for the devices to stay on the market, the FDA said.
Boston Scientific and Denmark-based Coloplast will have 10 days to submit their plan to withdraw the products from the market.
In a statement, Jeffrey Shuren, director of the FDA's Center for Devices and Radiological Health, said the agency determined it needed evidence showing the devices worked to repair pelvic organ prolapse better than corrective surgery without the devices.
"That evidence was lacking in these premarket applications, and we couldn't assure women that these devices were safe and effective long term," Shuren said.
The FDA's ban on these products includes two from Boston Scientific, the Uphold LITE Vaginal Support System and the Xenform Soft Tissue Repair System.
In a statement, Boston Scientific said it was deeply disappointed by the agency's decision.
The company said the inaccessibility of the products will severely limit treatment options for 50% of women in the U.S. suffering from pelvic organ prolapse.
"Patient safety is always our highest priority, and we will work closely with the agency to understand its direction and determine next steps," the company said.
The products have somewhat been the subject of national scrutiny. According to a "60 Minutes" report from last May, more than 48,000 lawsuits relating to the devices have been filed.
http://www.wbjournal.com/article/20190416/NEWS01/190419970/1002
-
FDA: No More Mesh for Prolapse Repair
Apr 16, 2019 | MedPage Today
By Charles Bankhead
The FDA ordered an end to sales of all remaining surgical mesh products used for transvaginal repair of pelvic organ prolapse.
According to the announcement, the FDA determined that "manufacturers, Boston Scientific and Coloplast, have not demonstrated reasonable assurance of the safety and effectiveness of these devices." In 2016, the FDA reclassified the mesh as class III (high risk) devices, requiring manufacturers to obtain approval of premarket approval applications (PMAs), the agency's most stringent level of review. The manufacturers have 10 days to submit a plan to withdraw all remaining products from the market.
"In order for these mesh devices to stay on the market, we determined that we needed evidence that they worked better than surgery without the use of mesh to repair POP," Jeffrey Shuren, MD, of the FDA Center for Devices and Radiological Health, said in a statement. "That evidence was lacking in these premarket applications, and we couldn't assure women that these devices were safe and effective long term."
In use since the 1950s for hernia repair, surgical mesh's clinical applications expanded in repair of POP, initially abdominal procedures in the 1970s and then transvaginal repair in the 1990s, according to the FDA. The agency cleared the first mesh device for transvaginal repair of POP in 2002.
About 10%-15% of women have surgery to repair POP in their lifetimes. The proportion of transvaginal procedures using surgical mesh decreased after the FDA issued warningsabout risks associated with transvaginal mesh.
In February, an FDA advisory committee concluded that a favorable recommendation for the mesh devices' benefit-risk profile would require a demonstration of superior effectiveness versus native tissue repair at 36 months and at least comparable safety outcomes.
"The FDA agreed with these recommendations, and because such data were not provided by manufacturers in their PMAs, the FDA decided not to approve them," according to the FDA statement.
Boston Scientific and Coloplast will be required to continue follow-up of patients who underwent transvaginal repair procedures using the mesh products in "522" clinical studies. Women with the mesh in place should continue with annual or routine check-ups and follow-up care, and no action is needed so long as they remain satisfied with the surgery and are not having complications, the FDA advised.
"Patients should notify their healthcare professionals if they have complications or symptoms, including persistent vaginal bleeding or discharge, pelvic or groin pain, or pain with sex," according to the statement.
In response to the FDA announcement, representatives of Boston Scientific issued the following statement:
"We are deeply disappointed by the FDA's decision on our premarket approval applications for the Uphold™ LITE Vaginal Support System and the Xenform™ Soft Tissue Repair Matrix, and believe the inaccessibility of these products will severely limit treatment options for the 50% of women in the U.S. who will suffer from pelvic organ prolapse during their lives."
"Patient safety is always our highest priority and we will work closely with the agency to understand its direction and determine next steps."
A spokesperson for Coloplast said the company will comply with the FDA decision to halt sales of the products, but noted that the FDA action is not a recall and has no impact on other Coloplast products.
https://www.medpagetoday.com/obgyn/generalobgyn/79271
-
FDA Halts All Sales of Vaginal Mesh Products
Apr 16, 2019 | WebMD
The U.S. Food and Drug Administration on Tuesday announced a ban on the sale of all pelvic mesh products.
The surgical mesh is typically used to repair pelvic organ prolapse (POP) and incontinence, but reported side effects have included permanent incontinence, severe discomfort and an inability to have sex.
"In order for these mesh devices to stay on the market, we determined that we needed evidence that they worked better than surgery without the use of mesh to repair POP," said Dr. Jeffrey Shuren, director of the FDA's Center for Devices and Radiological Health. "That evidence was lacking in these premarket applications, and we couldn't assure women that these devices were safe and effective long term."
Simply put, the remaining makers of the mesh devices -- Boston Scientific and Coloplast -- failed to prove the long-term safety or benefit of their devices, the FDA said in a news release.
The companies will have 10 days to submit plans to withdraw these products from the market, the FDA said. Most pelvic mesh products have already been taken off the market, according to the Associated Press.
The products are the subjects of lawsuits by the states of Washington, California, Kentucky and Mississippi. Those states claim that pelvic mesh maker Johnson & Johnson did not fully disclose safety risks, the AP has reported.
But some doctors who specialize in female pelvic medicine oppose the lawsuits, saying the procedure can work for some women.
Surgical mesh has been used since the 1950s to repair abdominal hernias. Implanting surgical mesh for abdominal repair of POP began in the 1970s. In 2002, the first mesh device for transvaginal repair of POP was approved by the FDA as a moderate-risk device.
About one in eight women will need surgery to repair POP, and a portion of such surgeries have been done transvaginally with the use of surgical mesh.
However, the FDA has issued repeated warnings about the risks associated with using transvaginal mesh for POP repair.
Women who've had the procedure should continue with routine check-ups. No additional measures are needed if they are satisfied with their surgery and don't have complications or symptoms, the FDA said Tuesday.
Those who do have complications or symptoms -- such as persistent vaginal bleeding or discharge, pelvic or groin pain or pain with sex -- should see their health care provider, the agency added.
They should also inform their health care provider if they have surgical mesh, especially if they're scheduled for another surgery or medical procedure.
Women who were planning to have transvaginal mesh repair of POP should discuss other treatment options with their doctors, the FDA advised.
https://www.webmd.com/women/news/20190416/fda-halts-all-sales-of-vaginal-mesh-products
-
* Breaking News * FDA Orders Mesh Makers to Stop Selling Prolapse Mesh!
Apr 16, 2019 | Mesh Medical Device News Desk
By Jane Akre
Even though the Food and Drug Administration began taking in mesh-related complaints in the early 2000’s and noted problems with pelvic organ prolapse (POP) mesh, it has taken until today to finally remove it from the market!
The U.S. Food and Drug Administration announced today it will order the makers of the larger pelvic meshes to treat pelvic organ prolapse (POP) to stop selling the devices.
The move is a follow-up to a February meeting where a panel of experts listened to citizens and patient advocacy groups about the long-term dangerous complications of POP mesh. See MNDcoverage here.
At the time, three POP meshes remained on the market with the makers hoping to clear a regulatory hurdle that required clinical trials.
But the FDA determined that the manufacturers, Boston Scientific and Coloplast, had not demonstrated a reasonable assurance of safety and effectiveness of these devices.
“In order for these mesh devices to stay on the market, we determined that we needed evidence that they worked better than surgery without the use of mesh to repair POP. That evidence was lacking in these premarket applications, and we couldn’t assure women that these devices were safe and effective long term,” said Jeffrey Shuren, M.D., director of the FDA’s Center for Devices and Radiological Health.
Boston Scientific was hoping its Uphold LITE Vaginal Support System and Xenform Soft Tissue Repair System, and Coloplast its Restorelle Direct Fix Anterior, could stay on the market.
Instead of clinical trials, now required by the reclassification as “High-Risk” by the FDA in 2016, the manufacturers hoped to use post-approval studies (known as 522) to submit as part of their premarket approval (PMA) applications instead, but the agency rejected those assurances.
The panel believes a POP mesh repair should be superior to a native tissue repair at 36 months and the safety should be comparable to a native tissue repair.
The data was lacking to provide those assurances, according to the agency.
“Even though these products can no longer be used in patients moving forward, Boston Scientific and Coloplast are required to continue follow-up of the subjects already enrolled in their 522 studies.”
The companies have ten days to submit their plans on how they will withdraw the products from the market.
ADD* There is no restriction on mesh placed abdominally for POP repair. This order refers to meshes placed through incisions in the vagina.
The FDA and Mesh
The FDA issued its first Public Safety Notification about pelvic mesh in 2008 when it determined that complications were “rare.” By 2011, the agency reversed itself and said mesh complications were “not rare” and the benefits did not outweigh the risks based on the number of complication reports coming into the FDA.
Still POP mesh was allowed to remain on the market and there were no recalls issued.
By 2012, the FDA ordered 522 post-approval studies to 40 mesh manufacturers to determine the health of the women already implanted in the U.S. Instead of complying, many makers simply removed their pelvic mesh from the market.
The actual complication rate of pelvic or incontinence mesh is unknown since the FDA does not requiring monitoring. Rates may range from 5% to 30%, according to post-market studies.
Polypropylene mesh was originally used for hernia repair but retrofitted to a woman’s body and sold in kits, beginning in 1997.
Hernia mesh is still made out of polypropylene and many people implanted are experiencing the same types of complications including chronic pain, chronic infection, autoimmune reactions to a foreign body, mesh erosion and nerve pain.
At least one leading former mesh proponent, Dr. Shlomo Raz of UCLA, stopped using all meshes because he was seeing patients with complications return after a decade or more.
POP Mesh
POP mesh is used to shore up sagging organs and is usually placed between the uterus and colon (posterior) or uterus and bladder (anterior). Made of polypropylene, the arms of the device are firmly implanted into muscle and ligament and cannot be removed.
Uphold and Restorelle are made of the polymer polypropylene and promise larger pores to minimize the buildup of infection and scar plate formation, a problem with the previous generation of POP pelvic meshes.
While the POP mesh placed between the uterus and colon (posterior placement) is off the market because of the complications, such as sepsis, the focus of this panel hearing was the three remaining POP meshes placed on the front of the vagina (anterior placement).
A Global Mesh Issue
Many of the POP meshes were deemed to be defective by implanted women and became part of the lawsuits amassed in multidistrict litigation (MDL) in Charleston, West Virginia where more than 104,000 cases were filed. This is the largest MDL ever formed in one courthouse.
Thousands more defective product cases have been filed against the seven mesh manufacturers globally including Britain, Scotland, Israel, So Africa, New Zealand and Australia.
Ethicon ( Johnson & Johnson), C.R Bard, Boston Scientific and American Medical Systems produced the largest number of pelvic mesh implants in the late 90s and 2000’s. The vast majority are made of polypropylene, the same plastic used for indoor-outdoor carpets and the top of Tic-Tac boxes.
Juries in dozens of product liability trials have agreed that POP mesh was defectively designed and the warnings to the end user doctors was inadequate.
Quiet Recalls of POP Mesh
Ethicon, which amassed more defective product lawsuits than any other mesh manufacturer, produced the Prolift POP mesh. Citing business reasons, J&J’s Ethicon division quietly removed it from the market in 2012, without acknowledging its problems.
At the same time it removed three other meshes TVT-Secur, Prosima (POP mesh) Prolift +M.
AMS sold Apogee and Perigee POP mesh but AMS was sold to Endo and eventually closed in March 2016 due to litigation costs.
Pinnacle, made by Boston Scientific was quietly removed from the market in May 2011, three years after it was launched.
J&J still sells mesh used for stress urinary incontinence (SUI) also made of the same polypropylene. That mesh is smaller and forms a ribbon or “sling” that is placed under the urethra for support then threads outside of the body.
The American Urogynecologic Society refers to slings as the “Gold Standard” for the treatment of incontinence, yet the same complications are reported with its use.
Women with POP Mesh – What Should They Do?
The FDA says women who have had POP mesh implanted should continue with their annual check-ups. Mesh removal is not needed if they are satisfied with their surgery and have no complications. Women who had been recommended for POP mesh repair surgery should seek other options.
https://www.meshmedicaldevicenewsdesk.com/breaking-news-fda-orders-mesh-makers-to-stop-selling-prolapse-mesh/
-
Single mum left homeless, bedridden and unable to work from 'mesh' device demands action
Apr 17, 2019 | 9 News
By Sarah Swain
A single Victorian mother has been left bedridden and unable to work and she believes it is because of a controversial medical device she believes she didn’t even need.
Jazmin Wilson, 38, from Cobram in Victoria even became homeless a few years ago, unable to work and in crippling pain. Her issues all started when a pelvic mesh was used in her hysterectomy.
She is unable to do even simple tasks like dress herself, take her dog for a walk or even use the bathroom, and said she has been forced to give up various jobs.
Ms Wilson has to use a stick or walking frame to leave the house, and sometimes has to resort to ‘adult nappies’.
As the USA's Food and Drug Administration today announced a ban on some types of the device, she called for more help for those already affected in Australia, including disability payments.
While a Senate Inquiry last year into the issue has seen a new register set up for the future use of devices - some of which have already been removed from use - not enough has been done for those already suffering, she said.
“It feels like there’s a cheesegrater inside that’s been set on fire every single day,” Ms Wilson told nine.com.au.
“I do feel angry because I didn’t need it in the first place.
“I think that they should ban all the mesh.”
Ms Wilson’s ordeal started when she went for a hysterectomy due to complications from having her four children 11 years ago.
She said the surgeon told her she needed the mesh to prevent incontinence, something she doesn’t believe is true.
Soon after the surgery, her health went downhill.
She developed pain in her abdomen, which got worse, until one morning seven years ago, she woke up unable to walk.
“I ended up having to go in a wheelchair and wear adult nappies,” she told nine.com.au.
Simple outings, with children Teagan, 20, Jake, 17, Madison, 15, and Hayley, 12, became impossible.
But doctors told her she had joint swelling and gave her pain killers.
When she suggested her illness could be linked to the mesh, she was dismissed, she said.
Things didn’t improve, and she was eventually forced to give up work as a cleaner and bartender, and claim Newstart payments.
Other medics diagnosed conditions such as fibromyalgia – and one even told her she was in pain because she “was too fat.”
Finally, a few years ago, an MRI scan showed what she was told were stress fractures in her pelvis, and tears inside her body.
Again, she said medics discounted her beliefs the injuries were caused by the device, and sent her away with painkillers.
Ms Wilson went back to work part time at a food takeaway outlet - but was simply too sick to keep it up.
She lost her home because she couldn’t pay the rent, and had to stay with family and friends until she could find somewhere more affordable.
Ms Wilson, who is part of an ongoing class action, admitted things have become so bad, she has considered taking her own life.
While she has found a surgeon in the US who is an expert at removing mesh, the surgery costs $20,000 and is a complex procedure which is likely to leave her incontinent.
An estimated 150,000 Australian women – and many men - have had the devices implanted since 1998, and over the past few years, complaints of severe complications have snowballed.
Health Minister Greg Hunt apologised to women who have been affected by the ‘horrific outcomes’ last year.
He said he wants a voluntary register be set up to log complaints.
However, charity Mesh Injured Australia is demanding more action, including compensation and disability payments.
Spokeswoman Andrea Walter said they believe there is a ‘tsunami’ of patients still to come forward, with many not yet connecting symptoms.
“We applaud the government committing $2.3 m to a prospective pelvic floor surgical register for those going forward - the new mesh injured,” she told nine.com.au.
“It does nothing for those already injured and permanently disabled by mesh.
“We demand a full independent retrospective mesh implant register that all implants are researched, and logged, so that people can be issued with recall if necessary.”
Today, the US halted sales of a type of surgical mesh used to repair pelvic conditions in women, following years of patients' reports of injuries from the implants.
https://www.9news.com.au/national/womens-health-news-pelvic-mesh-fda-class-action-australia-news/4347191a-5fd7-41b3-b7be-4d5ad74c82d1
-
Hernia Mesh Secrets: Bruce Rosenberg Answers Hernia Patient Questions After Complications
Apr 16, 2019 | Mesh Medical Device News Desk
By Jane Akre
Bruce Rosenberg is a patient advocate an hernia mesh injured patient. See his Mesh News Desk profile here.
Bruce has a very interesting story and, not unlike many hernia mesh patients, he went from doctor to doctor to try and find someone to address his complications. As a result, the former social worker, became an advocate and a member of the American Hernia Society where he keeps up on the latest science and doctors in the field.
Mesh News Desk occasionally asks Bruce to weigh in on serious hernia complication issues. See a post from last August here.
Thank you Bruce!!! Your Question
Rob Writes:
“I had hernia surgery down by my testicles the doctor said it I was a medium but they didn’t have a medium mesh only large, he told me he folded it over. Do I have cause to be worried? Also he said I should be on light duty for a couple of months but when I went back for a checkup he released me with no restrictions”….
Bruce Rosenberg, Patient Advocate writes in response:
“This is your typical patient who is basically told the minimum, as any more info would become more concerning so the doctor doesn’t want him to be worried. A larger mesh is used to make sure the defect is fully covered, and as he knows the mesh will shrink back a bit anyways. I don’t understand “folded it over.” I would need to read his operative report to see if the surgeon explained why he did that.
“The patient shouldn’t be concerned unless he begins to have pain or pressure. Would need to know the name of the device to determine if folding it is appropriate. He states it is in the area of the testicles, so was his hernia so advanced that it had fallen into his scrotum? Is he obese or a smoker? (height and weight?) What type of work does he do?
“If he plans to go back to work, depending on what he does the best advice is that he should not lift anything heavy…for the rest of his life.
“You can have this patient contact me directly. I don’t think he should worry so much and he should follow his surgeon’s advice for now, keeping in mind common sense about heavy lifting. He had a hernia so he has a significantly higher chance of developing another one due to an already weakened abdominal wall.
“The important thing that all hernia patients need to consider is that their abdominal wall CANNOT truly be permanently repaired to heal back to the way it was before they developed the hernia. Hernia is a disease of weakened collagen and tissue allowing structures such as bowel, omentum (fat) or other organs to protrude out of position which can create pain, pressure on nerves and spermatic cord/vas deferens, and even incarcerate/block the bowel. The patient is held together by sutures, the mesh (as a bridge across the defect) they can tear this back apart if they increase intra-abdominal pressure beyond the ability of the repair to hold them from separating again. Tissue does not grow back together.
“The idea was that mesh would decrease the amount of tension across the defect so it wouldn’t be so tight and pull apart, the problem is that it creates excessive foreign body response in many people (too many) with ensuing inflammation and pain. Natural suture repairs (Shouldice, McVay, Bassina, Desarda) are tighter at first, but hopefully the surrounding tissue will stretch over time and become more comfortable (over several months the patient begins to feel more normal) as opposed to mesh which if it does contract and stiffen with excessive scarring will incite pain, could possibly contract into a ball (“Meshoma”) or even split in the middle, adhere to nerves, bowel, bladder, arteries, etc, become infected…an absolute tragedy if any of this happens which is way worse that a pure tissue repair failing.”
https://www.meshmedicaldevicenewsdesk.com/hernia-mesh-secrets-bruce-rosenberg-answers-hernia-patient-questions-after-complications/
Client Attorney Privileged/Attorney Work Product/At Request of Counsel
Online Sources
Add recipients
Suggested