Preview Newsletter
Ethicon Media Monitoring 4/18/2019
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FDA orders manufacturers to halt sales of vaginal mesh used in many pelvic procedures
Apr 17, 2019 | The Washington Post
By Laurie McGinley
The Food and Drug Administration on Tuesday ordered manufacturers of surgical mesh used for repairing a condition called pelvic organ prolapse to immediately stop selling their products, the latest turn in a years-long battle over the safety of the implants. -
FDA orders Boston Scientific, Coloplast to halt transvaginal mesh sales
Apr 18, 2019 | Fierce Biotech
By Conor Hale
Boston Scientific and Coloplast—the two remaining U.S. manufacturers of transvaginal surgical mesh—have been ordered by the FDA to halt the sale and distribution of those products across the country, effective immediately. -
FDA’s pelvic mesh ban spooks investors
Apr 17, 2019 | Mass Device
By Brad Perriello
The FDA’s ban on U.S. sales of pelvic mesh products for pelvic organ prolapse may have spooked investors, but should only have a minimal effect on the books at Boston Scientific (NYSE:BSX) and Coloplast(CPH:COLO-B) – the only companies still selling mesh for prolapse in the U.S. – according to analysts and the company. -
Pelvic Mesh Remains on the Market Despite FDA Decision!
Apr 17, 2019 | Mesh Medical Device News Desk
By Jane Akre
Mesh News Desk is trying to clear up some of the confusion concerning Tuesday’s FDA decision about POP mesh applications to market denied! -
J&J Dodges Pelvic Mesh Claims In Philadelphia Trial
Apr 17, 2019 | Law 360
By Matt Fair
A Philadelphia jury sided with a Johnson & Johnson unit on Wednesday when it shot down claims that an allegedly defective pelvic mesh implant designed to alleviate a woman’s incontinence had worsened the condition and caused her to start experiencing pain when having sex. -
Gynecological mesh: The medical device that has 100,000 women suing
Apr 17, 2019 | CBS News
By Scott Pelley
There is tremendous controversy about a surgical device implanted in more than two million American women. It's a strip of plastic called gynecological mesh. -
FDA halts sale of pelvic mesh after years of injury reports
Apr 17, 2019 | AP (In Fox News, New York Post, ModernHealthcare, Lewiston Morning Tribune, STAT)
U.S. health regulators on Tuesday halted sales of a type of surgical meshused to repair pelvic conditions in women, following years of patients’ reports of injuries and complications from the implants. -
Philadelphia jury sides with J&J in latest mesh injury trial
Apr 18, 2019 | Reuters
By Nate Raymond
A state court jury in Philadelphia on Wednesday cleared a Johnson & Johnson unit of liability in a lawsuit by a Pennsylvania woman who said she suffered severe injuries after being implanted with pelvic mesh to treat her urinary incontinence. -
Boston and Coloplast sink on mesh mess
Apr 17, 2019 | Vantage
By Elizabeth Cairns
The writing is on the wall for vaginal mesh products in the US. The FDA has instructed Boston Scientific and Coloplast to stop selling their meshes for transvaginal repair of pelvic organ prolapse (POP), saying there was no proof that their use was an improvement over surgery without them. -
FDA orders Boston Scientific, Coloplast to pull transvaginal mesh from market
Apr 17, 2019 | MedTech Dive
By Maria Rachal
FDA ordered Boston Scientific and Danish device maker Coloplast on Tuesday to immediately halt sale of surgical mesh products indicated for transvaginal repair of pelvic organ prolapse, simultaneously rejecting the premarket approval applications submitted by the only two remaining market players. -
FDA orders makers of transvaginal mesh to stop selling products immediately
Apr 17, 2019 | Consumer Affairs
By Amy Martyn
The Food and Drug Administration (FDA) is ordering the remaining companies that still sell transvaginal mesh for pelvic organ prolapse to take their products off the market. -
FDA orders medical device companies to stop selling pelvic mesh
Apr 17, 2019 | TheJournal.ie
By Michelle Hennessy
THE US FOOD and Drug Administration (FDA) has ordered medical device companies to stop all sales and distribution of surgical mesh used in surgeries to repair pelvic organ prolapse. -
The FDA Has Finally Stopped the Sale of Pelvic Mesh
Apr 17, 2019 | Jezebel
By Kelly Faircloth
After years of concern about the safety of vaginal mesh and several warnings that stopped short of an outright ban, the FDA has put a stop to its sale, which is often used to shore up weakened pelvic muscles that can lead to prolapse. -
FDA Bans Sale Of Pelvic Mesh Product Amid Reports Of Injuries In Women
Apr 17, 2019 | Tech Times
By Ted Ranosa
The Food and Drug Administration has ordered a ban on the sale and distribution of pelvic mesh products following claims of injuries inflicted to women. -
FDA’s pelvic mesh ban long overdue, says patient advocacy group
Apr 18, 2019 | Plastics News
By Norbert Sparrow
FDA has ordered Boston Scientific (Marlborough, MA) and Coloplast (Humlebaek, Denmark) to cease the sale and distribution of their surgical mesh products used in transvaginal repair of pelvic organ prolapse (POP).
Client Attorney Privileged/Attorney Work Product/At Request of Counsel
Online Sources
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FDA orders manufacturers to halt sales of vaginal mesh used in many pelvic procedures
Apr 17, 2019 | The Washington Post
By Laurie McGinley
The Food and Drug Administration on Tuesday ordered manufacturers of surgical mesh used for repairing a condition called pelvic organ prolapse to immediately stop selling their products, the latest turn in a years-long battle over the safety of the implants.
The agency said the companies, Boston Scientific and Coloplast, had not demonstrated a “reasonable assurance” of safety and effectiveness for the devices for use over the long term, and will have 10 days to submit plans for withdrawing them from the market.
The FDA action specifically affects surgical mesh used for the transvaginal repair of pelvic organ prolapse, which occurs when the muscles and tissues supporting the uterus, bladder or rectum become weak or loose. That can allow organs to drop or press into the vagina. The regulatory action does not apply to mesh used for other conditions, such as hernias or stress urinary incontinence.
The FDA move, its toughest action yet against the devices, comes after tens of thousands of women have filed lawsuits against mesh manufacturers claiming injuries including bleeding and pain. The agency said there has been an increase in reports of adverse events in the last several years involving the devices.
In 2016, the FDA reclassified the products as high-risk devices — subjecting them to the agency’s most stringent path for device oversight — and required manufacturers to obtain approval to continue to market them. Many manufacturers withdrew from the market amid the heightened regulatory scrutiny and the growing number of 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 pelvic organ prolapse,” said Jeffrey Shuren, director of the agency’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.”
Public Citizen, which first petitioned the FDA in 2011 to ban the products, welcomed the move, but said it came “too late for the thousands of women who have been irreparably harmed by these devices.” The group said it has been clear for several years that the products “are unsafe for treating pelvic organ prolapse and lack any clinically significant benefits in comparison to nonmesh products.”
Boston Scientific said in a statement that the company was “deeply disappointed” by the agency’s decision, adding that “patient safety is always our highest priority.” The company said the FDA action will “severely limit” options for women seeking treatment for pelvic organ prolapse.
Coloplast declined to comment.
The FDA said that surgeons began using surgical mesh to repair abdominal hernias beginning in the 1950s. In the 1970s, gynecologists began implanting surgical mesh for abdominal repair of pelvic organ prolapse and two decades later for the transvaginal repair of the condition, the FDA said. In 2002, the first mesh device for transvaginal repair of pelvic organ prolapse was cleared by the agency as a device that carried “moderate risk.”
About 1 in 8 women have surgery to repair the condition, and a subset of the procedures use the mesh, the agency said. It added that the proportion of women undergoing the mesh procedures decreased after the FDA began issuing warnings.
The agency said the women who have had transvaginal mesh used for their condition don’t need to take any action if they are satisfied with their surgeries and don’t have any symptoms. But they should notify their physicians if they have vaginal bleeding or discharge, pelvic or groin pain or pain during sex, the agency said.
https://www.washingtonpost.com/health/2019/04/16/fda-orders-surgical-mesh-pelvic-operations-off-market/?utm_term=.de33723221a9
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FDA orders Boston Scientific, Coloplast to halt transvaginal mesh sales
Apr 18, 2019 | Fierce Biotech
By Conor Hale
Boston Scientific and Coloplast—the two remaining U.S. manufacturers of transvaginal surgical mesh—have been ordered by the FDA to halt the sale and distribution of those products across the country, effective immediately.
The agency said it determined the companies did not prove that their mesh products were safe and effective for the repair of pelvic organ prolapse, following their reclassification as higher-risk, Class III devices in 2016.
This meant manufacturers were required to submit new premarket approval applications—including evidence that the use of mesh products worked better than repair procedures using native tissues after three years.
“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, director of the FDA’s Center for Devices and Radiological Health, said in a statement.
“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,” Shuren added.
Though not a recall, the two companies now have 10 days to provide the FDA with their plans for withdrawing the products from the market. Boston Scientific had filed two PMAs for its Uphold LITE Vaginal Support System and its Xenform Soft Tissue Repair System, while Coloplast had filed for its Restorelle DirectFix Anterior device.
In a statement to FierceMedTech, Boston Scientific said it is “deeply disappointed by the FDA’s decision,” and 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.”
“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. Additionally, Coloplast said that it would comply with the FDA’s findings.
Both Boston Scientific and Coloplast, as well as other past manufacturers, have been the subjects of multimillion-dollar lawsuits and settlements over the devices—with the Denmark-based Coloplast reportedly paying $16 million to settle lawsuits in 2014, and Boston Scientific finding itself hit with a $100 million verdict. Johnson & Johnson, meanwhile, paid out $120 million to settle thousands of suits in early 2016.
While the products may no longer be used in new patients, both companies are required to continue their postmarket surveillance studies. The FDA said that women who have had transvaginal mesh placements should continue with their routine follow-up care, and that there is no need for additional action if they are not having complications or symptoms such as pelvic or groin pain, or persistent vaginal bleeding or discharge.
The agency has reported an increase in reported adverse events linked to surgical mesh over the past several years. The FDA issued new recommendations for use in July 2011, and later that year ordered manufacturers to conduct new postmarket studies, after which most companies elected to stop selling the products.
However, the consumer advocacy group Public Citizen deemed the agency’s latest actions long overdue. The organization had petitioned (PDF) the FDA in 2011 to stop the marketing of all non-absorbable surgical mesh products in the indication, and to order a full recall as well. The petition was denied in 2014.
“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,’” 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.”
https://www.fiercebiotech.com/medtech/fda-orders-boston-scientific-and-coloplast-to-halt-transvaginal-mesh-sales
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FDA’s pelvic mesh ban spooks investors
Apr 17, 2019 | Mass Device
By Brad Perriello
The FDA’s ban on U.S. sales of pelvic mesh products for pelvic organ prolapse may have spooked investors, but should only have a minimal effect on the books at Boston Scientific (NYSE:BSX) and Coloplast(CPH:COLO-B) – the only companies still selling mesh for prolapse in the U.S. – according to analysts and the company.
Yesterday the FDA ordered an immediate halt to sales and distribution of Boston’s Uphold Lite and Xenform products and Coloplast’s Restorelle DirectFix. Today Boston said the ban is expected to deliver a $25 million top-line hit, which amounts to about 0.003% of its annual revenues.
“Boston Scientific continues to assess any potential additional impact to the business,” the company said, noting that it will update investors during its first-quarter results report next week.
For Coloplast, prolapse mesh sales represent roughly 0.2% of its total revenues, “therefore the financial impact is immaterial and does not impact our financial guidance,” the company said today. Coloplast reported revenues of roughly $2.49 billion for its last fiscal year.
“Our mission at Coloplast is making life easier for people with intimate healthcare needs. Pelvic organ prolapses can be a painful, embarrassing and a debilitating issue for the women who suffer from it. While mesh sales to treat POP in women account for approximately 0.2% of our global revenue, we firmly believe that patients and their physicians should have a choice of therapies. We are disappointed with the FDA’s decision because it reduces the treatment options for women with POP. We remain committed to providing alternative therapies,” CEO Kristian Villumsen said in prepared remarks.
Still, investors pushed both stocks down yesterday and today, with BSX shares closing off -4.3% at $36.17 apiece yesterday; the stock was down -1.2% to $35.73 per share today in mid-morning activity in New York. In Copenhagen, COLO-B shares were down -2.7% to kr678.40 today.
Analysts said the selloffs are over-done.
“Overall we view any negative impact to sales as minimal,” SVB Leerink analyst Danielle Antalffy wrote yesterday in a note to investors. “But, understandably so, investor concern seems to be focused around litigation risk and could justify the selloff we’re seeing today. However, we followed up with management and view any litigation risk around FDA’s order as minimal.”
Boston had already settled 95% of the transvaginal mesh product liability lawsuits it faced as of the end of last year, Antalffy noted.
“While this is a credit negative for Boston Scientific – one of the two remaining manufacturers of this product – Moody’s does not expect the impact to be material,” added Moody’s senior vice president Scott Tuhy in a statement emailed to MassDevice.com. “Boston Scientific has stated its global surgical mesh business is about 1% of total sales. Of that 1% of revenue, not all will be impacted by the FDA announcement because some of Boston Scientific’s mesh business is outside of the US or is sold for different indications.”
https://www.massdevice.com/fdas-pelvic-mesh-ban-spooks-investors/
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Pelvic Mesh Remains on the Market Despite FDA Decision!
Apr 17, 2019 | Mesh Medical Device News Desk
By Jane Akre
Mesh News Desk is trying to clear up some of the confusion concerning Tuesday’s FDA decision about POP mesh applications to market denied!
There is a lot of confusion about the Tuesday announcement by the FDA to stop the sale of the remaining POP transvaginal meshes.
That included the Boston Scientific Uphold, Xenform and Coloplast Restorelle Direct.
Many polypropylene pelvic meshes remain on the market and are not affected by this FDA decision!
This includes meshes used to treat pelvic organ prolapse (POP), a condition where pelvic organs sag with gravity and need shoring up.
Deborah Kotz at the FDA informs Mesh News Desk that the Y-shape mesh is still marketed for the treatment of POP.
They include Artisyn Y shaped mesh made by Ethicon, Upsylon Y mesh made by Boston Scientific, and the Restorelle Y shape for sacrocolpopexy. These can be placed robotically or laparoscopically.
These POP meshes are used through an abdominal surgery are considered moderate risk and are considered Class II medical devices. They therefore do not have to go through premarket approval and clinical trials as mandated in the up-classification of transvaginal POP mesh by the FDA in 2016.
A surgeon can still choose a sheet of polypropylene mesh and cut her own mesh implant for an abdominal POP implant. Sheets of mesh, the same mesh used for hernia repair, are still Class II and available on the market.
Incontinence Mesh
Of course, all of the meshes used for stress urinary incontinence remain on the market including the TVT, TVT-O, TVT-Abbrevo, TVT-Exact (all Ethicon); Boston Scientific Advantage Fit, Lynx Suprapubic and Obtryx. These are “slings” that hammock the urethra then enter through the groin or through the abdomen.
Slings, POP mesh and hernia mesh are primarily fashioned from polypropylene (PP) and continue to be used despite the thousands of complications experienced globally that include chronic pain and infection, mesh shrinkage, sexual dysfunction, systemic autoimmune reactions, nerve damage and mesh erosion, among other conditions.
Hernia mesh implant in about one million patients a year are reporting these same complications and litigation is underway as is the recognition that this is becoming a major public health issue.
The FDA decision marks a stop but in no way signals the end of the use of transvaginal mesh as a whole!
As the public becomes more aware, women and men seeking hernia repairs are asking more questions but doctors too are providing more answers, some untruthful such as “it’s different mesh,” or the “bad stuff has been recalled.”
Mesh News Desk has heard these reports from the newly implanted people and it is unfortunate.
Ultimately, we may find that polypropylene is the culprit and, as a search for a better more biocompatible material is underway, patients offered a mesh implant should ask about their other options, whether their doctor can perform a native tissue repair, a suture alone repair, and whether the material offered is polypropylene.
If so, you might seek another opinion.
https://www.meshmedicaldevicenewsdesk.com/pelvic-mesh-remains-on-the-market-despite-fda-decision/
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J&J Dodges Pelvic Mesh Claims In Philadelphia Trial
Apr 17, 2019 | Law 360
By Matt Fair
A Philadelphia jury sided with a Johnson & Johnson unit on Wednesday when it shot down claims that an allegedly defective pelvic mesh implant designed to alleviate a woman’s incontinence had worsened the condition and caused her to start experiencing pain when having sex.
Despite agreeing that J&J subsidiary Ethicon Inc. had negligently designed, marketed and sold its TVT-Secur mesh implant, the jury found that the negligence was not a cause of any of the injuries that Philadelphia-area resident Malgorzata Krolikowski said she suffered from the device.
It was a rare trial victory for Ethicon in a mesh case in Philadelphia, as juries in six previous cases had awarded a total of nearly $145 million in damages to women who suffered injuries as a result of their implants.
“Obviously we’re disappointed,” said Colin Burke, an attorney with Kline & Specter PC representing Krolikowski, “but we respect the jury’s decision.”
He said he took solace, however, in the jury’s finding of negligence.
“They found that the defendants, Ethicon and Johnson & Johnson, were negligent,” he said. “We had the evidence to prove that.”
The jury’s decision, which came after about six hours of deliberation, caps a three-and-a-half-week trial over a TVT-Secur implant that Krolikowski received in 2008 after complaining to her doctors about stress urinary incontinence.
Despite the implant, however, Krolikowski said that her condition did not improve and that it significantly deteriorated over the years.
In addition, she claimed that she began experiencing pain and urine leakage when she had sex.
Elia Robertson, another Kline & Specter attorney representing Krolikowski, told jurors during opening arguments last month that the complications, along with the resulting embarrassment and humiliation, had interfered with the woman’s ability to strike up romantic relationships.
Krolikowski argued that Ethicon had rushed the TVT-Secur to market in September 2006 despite significantly limited clinical testing that produced troubling results: a 30% failure rate and a 60% rate of complications in the 31 women the implant was tested on.
Ethicon pulled the product from the market in 2012.
The company argued at trial that there was no way to link Krolikowski’s injuries to her mesh implant, and that the product couldn’t be deemed defective simply because it had failed to cure her incontinence.
“An imperfect result does not equate to a defect,” Andrea La’Verne Edney, an attorney with Butler Snow LLP representing Ethicon, told jurors during opening arguments. “Just because the device didn’t work and cure 100 percent doesn’t mean it was a defective device.”
The company argued that the likely source of Krolikowski’s pain during sex was either preexisting uterine fibroids or the abnormal position of her uterus.
Krolikowski's was the first of nine mesh trials that have gone to verdict that did not involve more serious injuries, including claims that the mesh had actually sawed through soft tissue and become expoed in the vagina.
Burke told Law360 that he believed jurors may have been swayed by evidence that Krolikowski did not seek treatment for her worsening incontinence or her pain with intercourse for years leading up to her decision to file suit.
“Unfortunately, because of our client’s financial situation and insurance situation there was a gap in her medical history,” he said. “We think that may have been a determinative factor for the jury.”
Ethicon spokeswoman Mindy Tinsley told Law360 that the company believed the jury had reached the proper conclusion.
"We empathize with women suffering from stress urinary incontinence, which can be a serious and debilitating condition," she said. "There are various treatment choices for women with this condition seeking to improve their quality of life, including surgical treatment with implantable mesh, which is backed by years of clinical research and is considered by most doctors to be the gold standard treatment. The jury’s decision reflects the facts in this case. The evidence showed Ethicon’s TVT-Secur device was properly designed and did not cause the plaintiff’s alleged injuries."
Krolikowsi’s case is one of nearly 90 mesh-related cases that Ethicon is facing as part of a mass tort program in Philadelphia.
Trial in another case began on Monday, while another trial is expected to pick back up next week after being placed on hiatus last month due to a defense witness’s health complications.
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 Bartlit 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/1150983/j-j-dodges-pelvic-mesh-claims-in-philadelphia-trial
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Gynecological mesh: The medical device that has 100,000 women suing
Apr 17, 2019 | CBS News
By Scott Pelley
There is tremendous controversy about a surgical device implanted in more than two million American women. It's a strip of plastic called gynecological mesh. The manufacturers and several medical societies say the implant is safe. But more than 100,000 women are suing. And together, they make up the largest multi-district litigation since asbestos. One of the largest manufacturers of gynecological mesh is Boston Scientific, a medical device maker with $9 billion in sales. Millions of patients benefit from its pacemakers, stents and other devices. But Boston Scientific has attracted 48,000 lawsuits which claim that its mesh can inflict life-altering pain and injury.
Surgeons use Boston Scientific's gynecological mesh like a sling to relieve urinary incontinence and to lift organs that shift after pregnancy. Gwyn Madsen had a Boston Scientific implant in 2012.
Gwyn Madsen: It felt like a cheese grater inside of me.
Like thousands of others who have filed suit, she says she suffered pain, which in her case, left her hardly able to sit or play with her children.
Gwyn Madsen: It felt like the material was pulling on the muscles and I'd get shooting pains you almost felt like there was something inside of you that was like sandpaper back and forth, every time you'd walk.
Boston Scientific has fought allegations like Gwyn Madsen's for years. They declined an interview for our story but the company told us, "Nearly one million women have been successfully treated… We have extensively tested the [plastic] resin to confirm its composition, safety and performance." The American Urogynecological Society has also said that plastic mesh is "safe and effective." But that's not what many doctors are finding.
Dr. Michael Margolis: The mesh causes a chronic inflammatory reaction.
Dr. Michael Margolis is a surgeon who has removed 350 mesh implants. He's been a witness in lawsuits against Boston Scientific.
Dr. Michael Margolis: The slings I've removed are substantially altered in their architecture. They are shrunk by at least 50% in width; they are encased in scar tissue. The pores here, these openings here are shrunk substantially.
Dr. Margolis recently removed this type of Boston Scientific mesh. It had been implanted in his patient for life, but after two years, it looked like this.
Dr. Michael Margolis: It was folded, it was contracted, it was embedded in scar tissue, it was choking off the urethra. It was 50% the size of its original implant. I measured it, as I always do.
Scott Pelley: These are things that are not supposed to happen?
Dr. Michael Margolis: Of course not. This implant is not supposed to change.
The mesh is made of a plastic called polypropylene, a common material in packaging. Boston Scientific had clearance from the FDA to use a brand of polypropylene called "Marlex" made in Texas by a subsidiary of Chevron Phillips. But in 2004, Chevron Phillips became concerned about medical use of Marlex. It issued a warning that it must not be used for "permanent implantation in the human body." Duane Priddy is a leading plastics engineer and a fellow of the American Chemical Society.
Duane Priddy: I can't, in my wildest imagination, imagine anybody that's knowledgeable in the science of plastics ever deciding that it was appropriate to use polypropylene in the human body. It's well known that its oxidatively unstable.
Duane Priddy has been a witness in mesh lawsuits, but he is not part of any litigation against Boston Scientific. He explained to us that oxygen breaks up polypropylene. The plastic has antioxidant additives but they dissipate over time.
Duane Priddy: Once those antioxidants are consumed, they're no longer there to do their job, polypropylene will rapidly disintegrate and fall apart.
Scott Pelley: In layman's terms, oxygen eats plastic.
Duane Priddy: That's correct.
In 2005, Chevron Phillips cut off Boston Scientific's supply of Marlex. Later, when Boston Scientific appealed, Chevron Phillips replied, "We are simply not interested in this business at any price." Boston Scientific estimated that it would run out of Marlex by 2012. George Vialle, director of Global Supply Chain wrote, this plastic resin "supports a $120 million in annual revenue… I can not [sic] overstate the importance of getting more." Boston Scientific had to have Chevron Phillips Marlex because that plastic was already accepted by the FDA.
Chris DeArmitt: They looked everywhere. They looked at least 20 different companies all around the world. They were looking for stocks of material.
Chris DeArmitt is a plastics engineer who researched Boston Scientific for one of the women suing the company.
Chris DeArmitt: they really struggled. There was a big panic on because they had a big stockpile. They ran out. And they realized they were gonna have to source more.
That struggle is revealed in company documents that we found in court records. This report shows, in 2010, a second supplier refused to sell polypropylene "for use in medical device." Boston Scientific's global sourcing division decided to use a middleman with "no direct link to BSC" so the plastic makers wouldn't know the true buyer. But that plan failed.
Chris DeArmitt: They're looking for material and they're desperate. They can't find it locally so they find it in China. And they literally say, "We have to be careful here. Some of these look more credible than other ones." They are not convinced that it's real material.
A broker in China, called Emai, said it had tons of Marlex imported from Chevron Phillips in Texas. Boston Scientific's man in China wrote his superiors, "do we need to ask [Emai] if this material is supposed to be used in medical implantable?" Boston Scientific's director of materials management replied, "please don't tell them where we will use it. It could scare them away."
That same month, the FDA issued a damning report. Over five years, the FDA found that mesh supporting organs after pregnancy, had resulted in nearly 4,000 "reports of injury, death, and malfunction" and complications including "pain, infection, urinary problems, bleeding and organ perforation." "Serious adverse events," the FDA said, "are not rare." Now, Boston Scientific had even more reason to believe that if it switched plastics the FDA would require years of tests which might fail. The company's best hope appeared to be the plastic in China but then came the red flags.
Boston Scientific's own procedures required documents and import records that proved that the plastic was Marlex from Texas. But Chinese broker, Emai, didn't have any documents to verify authenticity. Boston Scientific checked the lot numbers on the bags and confirmed through Chevron Phillips, three times, that the numbers were fraudulent. Even the bags were fake. Chevron Phillips says the printing on the counterfeit bag, on the right, is full of errors from the color to the name of the Texas city where Marlex was made. Evidence was mounting that the plastic in China was counterfeit, so Boston Scientific ordered tests to compare it with original Marlex.
Chris DeArmitt: They analyzed 11 different parameters, looking at the two plastics side by side, done, the same tests. Nine of those were different. Two were the same, nine were different. And of those nine that were different, four of those parameters were very different. And somehow, from that, they concluded that it was the same material.
Scott Pelley: How did they come to that conclusion?
Chris DeArmitt: Well, I'm wondering that too. I mean, how can you look at two things side by side and say, "Yes, it's the same stuff."
In an email from the address of Ann Charest, manager for plastics in Boston Scientific's global sourcing division, there's speculation about the Chinese plastic's lack of documents. "It may not have been imported through proper channels" or it may have been "redistributed enough times, the original paperwork has been lost/forgotten…" Facing a deadline, with those test results, no documents and having learned the lot numbers were fake, Charest concludes, "I believe this is the right material." Boston Scientific bought enough of the Chinese plastic to last 30 years. We hired plastics engineer Duane Priddy as an independent consultant to analyze Boston Scientific's own tests of the Chinese plastic. We found the test results in court documents.
Duane Priddy: I would predict a significant difference in the antioxidant stability, or I should say the oxidation resistance of those products in the human body.
Scott Pelley: The Chinese product is inferior?
Duane Priddy: Absolutely. Yes.
Scott Pelley: Is the Chinese product something that you would imagine being placed inside the human body for 20, 30, 40 years.
Duane Priddy: Absolutely not.
Scott Pelley: How long would it likely last?
Duane Priddy: A few months.
Teresa Stevens: I started to have problems right away. I told the doctor while I was in the hospital, I couldn't feel my bladder, I couldn't feel when I had to go.
Teresa Stevens had a Boston Scientific mesh implant in 2014 after the company began using the Chinese plastic.
Teresa Stevens: Sometimes when I went to the doctor, I would have an infection, sometimes when I went I didn't. So, but I was having pain every time I would void. So, a lot of times I would have some blood. So, I knew something was wrong.
In 2016, she had her mesh implant removed by Dr. Michael Margolis who told us the Chinese plastic's lack of documents is a concern.
Dr. Michael Margolis: This is an experimental material. Implantation of this into anyone is human experimentation but without consent. Because this is novel material. We don't know how this affects humans, it's never been tested before.
Chris DeArmitt: I would say the material they're buying maybe is fine for making a park bench. Maybe it's fine for making a disposable cup. But that's a totally different situation when you're looking at something that will be in the body for 40 or 50 or 60 years. There's a whole different level of analysis and confidence that you need. And I don't see that here.
Scott Pelley: The FDA requires Boston Scientific and companies like it to understand every step in the supply chain. In other words, who made the material, who packaged it, who shipped it, et cetera. How much did Boston Scientific understand about that supply chain?
Chris DeArmitt: They don't seem to know where the material is coming from. Nobody knows who the original manufacturer is. Nobody knows and that's a big deal, right? You have to take a record of every lot, was it contaminated? Has it been tested? And they don't know any of those, any of those answers.
Boston Scientific also faced hurdles in getting the 16 tons of plastic out of China. The counterfeit bags were labeled "Texas." But, with no import records, Boston Scientific's man in China wrote, "If we don't get rid of the original bags… if it is caught by customs we will be in trouble." A plan to hide the bags in plain wrappers was approved in an email sent from the address of Charles Smith, a director in Boston Scientific's urology and women's health division. "We can over bag." The email reads. Pictures of the overbagging operation were then distributed to many company executives for their approval. On its declarations, Boston Scientific told the Chinese the plastic was made in China. It told U.S. Customs the plastic was made in the U.S.
Because of lawsuits by Teresa Stevens, Gwyn Madsen, and thousands of others, the FDA looked into Boston Scientific's experience with the Chinese plastic. The FDA declined an interview but wrote, "We… did not find any indication that the change in [plastic] resin led to an increase in adverse events. We have confidence in our… findings."
Scott Pelley: The FDA recently reviewed these same test results and they said that the Chinese mesh, quote, "does not raise new safety or effectiveness concerns." What do you make of that?
Duane Priddy: That's shocking. It's hard for me to imagine somebody looking at that data and generating an opinion that it is acceptable for use in the human body.
Scott Pelley: Is your analysis something that any other expert in plastics would see immediately?
Duane Priddy: Yes.
Scott Pelley: This is not a close call?
Duane Priddy: No.
As we said, Boston Scientific declined an interview but it wrote, "Any allegations continuing to question the integrity or legitimacy of our [plastic] resin are false and irresponsible." We wondered whether Boston Scientific mesh products still contain the Chinese polypropylene smuggled into the United States, so we purchased 15 Boston Scientific mesh kits and sent them to a leading plastics lab. All of them matched the Chinese plastic.
https://www.cbsnews.com/news/boston-scientific-gynecological-mesh-the-medical-device-that-has-100000-women-suing-2019-04-17/
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FDA halts sale of pelvic mesh after years of injury reports
Apr 17, 2019 | AP (In Fox News, New York Post, ModernHealthcare, Lewiston Morning Tribune, STAT)
U.S. health regulators on Tuesday halted sales of a type of surgical meshused 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 US 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.foxnews.com/health/fda-halts-pelvic-mesh-sales-after-injury-reports
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Philadelphia jury sides with J&J in latest mesh injury trial
Apr 18, 2019 | Reuters
By Nate Raymond
A state court jury in Philadelphia on Wednesday cleared a Johnson & Johnson unit of liability in a lawsuit by a Pennsylvania woman who said she suffered severe injuries after being implanted with pelvic mesh to treat her urinary incontinence.
Jurors in the Philadelphia Court of Common Pleas returned a defense verdict for J&J’s Ethicon unit in the latest trial to result from tens of thousands of lawsuits nationally alleging defective pelvic mesh devices caused women to suffer severe pain, bleeding, urinary problems and other serious injuries.
https://www.reuters.com/article/health-johnsonjohnson/philadelphia-jury-sides-with-jj-in-latest-mesh-injury-trial-idUSL1N22001V
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Boston and Coloplast sink on mesh mess
Apr 17, 2019 | Vantage
By Elizabeth Cairns
The writing is on the wall for vaginal mesh products in the US. The FDA has instructed Boston Scientific and Coloplast to stop selling their meshes for transvaginal repair of pelvic organ prolapse (POP), saying there was no proof that their use was an improvement over surgery without them.
The decision prompted respective 4% and 3% drops in Boston’s shares and Coloplast’s ADRs, despite the fact that mesh sales made up only a tiny fragment of either company’s revenues. Perhaps shareholders took the efforts the groups had made to try to convince the FDA as a waste of money.
And tried they had. All the pelvic meshes on the US market have been cleared for sale, over the past several decades, via the 510(k) route. In 2016 the products were reclassified as high risk when used for minimally invasive POP surgery, necessitating a premarket approval (PMA) submission. Rather than gather evidence and apply for approval, almost all of the 30 or so mesh manufacturers, which included Johnson & Johnson and CR Bard, simply stopped selling the devices.
Boston and Coloplast were the only two companies to apply for PMAs – two in Boston’s case, for the Uphold Lite and Xenform products, and one for Coloplast’s Restorelle DirectFix. While the FDA was reviewing these submissions the meshes were allowed to remain on sale.
But now the FDA has turned the submissions down, stating that they failed to demonstrate “a reasonable assurance of safety and effectiveness”. Boston and Coloplast are reported to make around $25m and $6m a year from use of the devices in POP, less than 1% of either company’s overall sales.
Europe
The situation in Europe, with its decentralised regulation of medical devices, is, from medtechs’ point of view, arguably more forgiving.
In 2015 the European Commission’s Scientific Committee on Emerging and Newly Identified Health Risks recommended that implantation of mesh for the treatment of POP via the vaginal route only be considered in complex cases, and in particular after failed primary repair surgery, or when other surgical procedures have already failed or are expected to fail.
While there is no Europe-wide regulator to demand that device makers stop selling vaginal meshes, the devices could still come to be removed from the market. If marketing authorisation were to be withdrawn by a national regulator the other national authorities would be bound to make the same recommendation.
For example, in December the French national agency for the safety of medicines and health products suspended the CE mark for Allergan’s Microcell and Biocell textured breast implants after these were linked to a rare form of lymphoma.
Despite pieces of advice from various sources that use of vaginal meshes be avoided in transvaginal POP surgery, they remain on sale in Europe for this application.
Litigation
According to Boston, half of women in the US will experience POP during their lives, and the FDA says about one in eight American women undergo POP surgery, though not all of these procedures are transvaginal.
A variety of surgical meshes are used for other applications too, such as treatment of stress urinary incontinence and hernia repair. These procedures have not been linked with the same adverse events as transvaginal POP repair, and the products will remain on the market.
Meanwhile, the lawsuits relating to vaginal meshes lumber on. According to its 2017/18 annual report Coloplast has spent DKr4.7bn ($712m) to settle US lawsuits alleging injury resulting from the use of transvaginal surgical mesh products. It estimated that more than 95% of known US lawsuits had been settled, and it had a war chest of DKr500m for the rest.
Boston, meanwhile, spent $103m on litigation, primarily in connection with transvaginal surgical mesh claims, in 2018 alone. As of February 5 around 53,000 product liability cases or claims related to transvaginal mesh products had been asserted against Boston, and the group had entered into or was finalising agreements to resolve approximately 50,000 of these. None of these agreements saw Boston make any admission of any liability or wrongdoing.
https://www.evaluate.com/vantage/articles/news/policy-and-regulation/boston-and-coloplast-sink-mesh-mess
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FDA orders Boston Scientific, Coloplast to pull transvaginal mesh from market
Apr 17, 2019 | MedTech Dive
By Maria Rachal
FDA ordered Boston Scientific and Danish device maker Coloplast on Tuesday to immediately halt sale of surgical mesh products indicated for transvaginal repair of pelvic organ prolapse, simultaneously rejecting the premarket approval applications submitted by the only two remaining market players.
The action comes two months after the FDA's Obstetrics and Gynecology Devices Panel agreed that data available was insufficient to determine long-term safety and effectiveness, and that doctors could be more selective in choosing patients.
While the meeting was intended to facilitate discussion on factors like study design and physician training, the agency cited the panel's recommendation that mesh companies must demonstrate superior product effectiveness and comparable safety to native tissue repair at 36 months as grounds for Tuesday's move, saying the manufacturers failed to provide data meeting that standard.
"That evidence was lacking in these premarket applications, and we couldn't assure women that these devices were safe and effective long term," FDA's Center for Devices and Radiological Health Director Jeff Shuren said in a news release.
Consumer rights advocacy group Public Citizen petitioned FDA to ban the class of devices in 2011. "This action unfortunately comes nearly a decade too late for the thousands of women who have been irreparably harmed," said Mike Carome, head of the organization's health research arm.
The device makers have maintained the safety of the products. Boston Scientific said it is "deeply disappointed" in a statement to MedTech Dive and believes "the inaccessibility of these products will severely limit treatment options" for women with pelvic organ prolapse (POP). A Coloplast spokesperson declined to comment.
At February's panel, Boston Scientific pitched its Uphold Lite Vaginal Support and Xenform Soft Tissue Repair systems and Coloplast presented on its Restorelle DirectFix Anterior product, touting new and improved product design.
The applications were required as part of a 2016 FDA decision to up the regulatory authority over transvaginal mesh, moving it into the highest-risk Class III device category.
That change built on momentum from a similar meeting of the same FDA panel in 2011, which resulted in the agency issuing '522' postmarket study mandates to 34 manufacturers in 2012, including former mesh makers C.R. Bard and Johnson & Johnson's Ethicon, at which point nearly all chose to exit the market.
Moody's Senior Vice President Scott Tuhy downplayed the impact on Boston Scientific, noting the company's global surgical mesh business accounts for about 1% of its total sales, a fraction of which are sold in the U.S. for the transvaginal pelvic organ prolapse repair indication.
Medical societies and provider groups had backed keeping the products on the market as an option for certain patients, and some expressed qualms with the FDA's decision.
Geoffrey Cundiff, president of the American Urogynecologic Society, told MedTech Dive he was "not entirely surprised by the announcement," and supports the superiority standard behind it. Still, he was surprised by how quickly FDA obtained three-year data from the companies and reviewed it following the meeting.
The FDA news release did not, however, specify a path forward for women with pelvic organ prolapse for whom native tissue repair has not been effective. The February panel raised non-inferiority as a potential standard in those cases.
"What's lost here is that ... there are some populations of patients for whom added risk is offset by added durability," Cundiff said, noting that other mechanisms for inserting surgical mesh, such as through a more invasive abdominal approach, have not been taken off the table by FDA.'The proper thing to do'
Biostatistician Rick Chappell, a panelist who participated in both the 2011 and 2019 meetings, told MedTech Dive he was surprised by FDA's announcement, but said it "seems like the proper thing to do until they get long-term follow-up."
"Then and now they have no reliable evidence about what these devices do," besides in the very short term, he said. At the February meeting, he said he felt he owed it to patients "not to be here in another eight years."
"It was heartbreaking," he said of the patient testimony he heard during his panel tenures.
Symptoms like bleeding and vaginal scarring and outcomes like mesh erosion and recurrent POP are among the effects spurring tens of thousands of lawsuits against manufacturers that are still ongoing.
FDA reported identified 11,274 medical device reports submitted from January 2008 to October 2018 related to mesh for POP, including 10,391 reports of serious injury, 806 reports of device malfunctions, and 77 reports of death.
But a presentation at the February meeting by former FDA manager turned independent device data analyst Madris Tomes showed there may have been more than 69,000 POP mesh-related MDRs as of January 2019, including 393 deaths.
Tomes called Tuesday's decision a "pleasant surprise," but noted FDA's action does not address potential problems caused by mesh indicated for other uses.
Surgical mesh continues to be available for cases of stress urinary incontinence, hernias and breast reconstruction. Her data analysis showed more than 139,000 total MDRs have been filed across all types of surgical mesh.
"I'd like to see them take it a step forward," Tomes said of FDA extending scrutiny across mesh types. "I'm not sure they're ready to go that far yet."
Diana Zuckerman, president of the National Center for Health Research, echoed that idea.
"FDA's requiring clinical trials for mesh used for pelvic organ prolapse 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 an email.
FDA said the companies have 10 days to submit market withdrawal plans to the agency and noted they will still be required to complete follow up with participants in the 522 postmarket approval studies previously mandated by the agency. Shares of Boston Scientific were down about 4.3% Tuesday, while Coloplast stock fell close to 2.5%.
https://www.medtechdive.com/news/fda-orders-boston-scientific-coloplast-to-pull-transvaginal-mesh-from-mark/552861/
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FDA orders makers of transvaginal mesh to stop selling products immediately
Apr 17, 2019 | Consumer Affairs
By Amy Martyn
The Food and Drug Administration (FDA) is ordering the remaining companies that still sell transvaginal mesh for pelvic organ prolapse to take their products off the market.
The agency has been issuing advisories about transvaginal mesh since 2011, but this is its most stringent action on mesh to date. Boston Scientific and Coloplast have ten days to submit a plan to the FDA explaining their exit strategy, the agency says.
In a statement to CNBC, Boston Scientific described the news as disappointing. Coloplast said that the news makes minimal difference to its bottom-line, as mesh only represents 0.2 percent of the company’s total revenue.
Johnson & Johnson, the largest maker of transvaginal mesh for pelvic organ prolapse, stopped selling the product in 2012. The company framed the move as a marketing decision at the time.
Patient advocates say that FDA’s announcement, while encouraging, is too little, too late.
“These mesh devices were on the market for over 20 years, leaving tens of thousands of women to live with permanent disabilities and disfigurement,” says a statement from Medical Device Problems, a patient advocacy group.Curbing side effects
While the FDA says that most mesh products are proven safe and have been on the market since the 1950s, device companies didn’t start selling transvaginal mesh to treat pelvic organ prolapse until the late 1990s.
The device is made of plastic and is designed to act as a hammock of sorts for women suffering from pelvic organ prolapse, a condition in which the muscles that hold the pelvic organs become weak. Because the mesh is inserted through the vagina, the device industry described the procedure as a low-risk, minimally-invasive surgery.
But hundreds of thousands of lawsuits worldwide describe a litany of horrific side effects linked to mesh.
“We know the actions taken by the FDA today would not have transpired without the tireless voices of those women who refused to remain silent victims of the devastation mesh for pelvic organ prolapse caused them and their families,” the statement from Medical Device Problems adds.
The FDA’s order does not affect all mesh products; device-makers can still sell pelvic mesh to treat stress urinary incontinence, a condition caused by childbirth. Mesh is also used in hernia repair surgeries, but some patient advocates say that using mesh in any soft tissue comes with an unacceptably high risk of devastating side effects.
Sales of the prolapse mesh products dropped in 2016 after the FDA reclassified them as high-risk devices and ordered further study into their effectiveness.
“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 non-mesh products,” consumer advocacy group Public Citizen says in a statement.
https://www.consumeraffairs.com/news/fda-orders-makers-of-transvaginal-mesh-to-stop-selling-products-immediately-041719.html
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FDA orders medical device companies to stop selling pelvic mesh
Apr 17, 2019 | TheJournal.ie
By Michelle Hennessy
THE US FOOD and Drug Administration (FDA) has ordered medical device companies to stop all sales and distribution of surgical mesh used in surgeries to repair pelvic organ prolapse.
Painful complications have been reported by thousands of women across the world – including in Ireland – following procedures involving the use of vaginal mesh devices.
In November last year Minister for Health Simon Harris confirmed the suspension of all surgeries involving these devices until the HSE implements a number of recommendations.
Vaginal mesh devices are used in operations to treat stress urinary incontinence (SUI) and pelvic organ prolapse (POP); two conditions women can suffer from after natural childbirth or in their later years.
A report from the Chief Medical Officer in Ireland last year found devices known as transvaginal mesh implants (TVMIs), used for the treatment of pelvic organ prolapse, are no longer regarded as appropriate as the first line treatment.
Dr Tony Holohan said these devices should only now be used in the management of complex cases, where other treatment options have failed or are not appropriate.
Now the regulator in the US has ordered the two remaining manufacturers of mesh products for the transvaginal repair of pelvic organ prolapse (POP) to stop selling and distributing their products in the country immediately. These are the same products Ireland’s CMO deemed inappropriate as first-line treatment.
In a statement 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”.
As part of a 2016 reclassification of the devices as high risk, manufacturers were required to submit and obtain approval of premarket approval (PMA) applications, the agency’s most stringent device review pathway, in order to continue marketing their devices in the US.
Jeffrey Shuren, director of the FDA’s Center for Devices and Radiological Health said the FDA needed evidence that the devices worked better than the other procedure for POP that does not use mesh. The alternative procedure uses native tissue to repair the prolapse.
This evidence was lacking in the applications and the FDA “couldn’t assure women that these devices were safe and effective longterm”.
“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,” he said.
The Irish suspension
In Ireland, the use of these devices in the transvaginal treatment of prolapse is only expected to continue in complex cases.
However the use of other vaginal mesh devices is likely to recommence – including for treatment of prolapse.
The Chief Medical Officer said there was an evidence base to support the use of abdominally placed mesh (as opposed to transvaginally placed, which is a different procedure).
He also found there was evidence to support the use of what is known as a mid-urethral sling (made from the same mesh material) for the treatment of stress urinary incontinence.
Many of the Irish women who reported complications had the sling surgery to address their incontinence. Their complications include chronic pain, reduced mobility and recurrent infections.
Many have spoken of an inability to be intimate with their partners and some have had to have multiple surgeries to remove parts of the mesh after it moved inside them, sometimes eroding through the vagina.
The current pause on the use of these particular devices in Ireland will remain in place pending the implementation of three “urgent recommendations”.Surgery should only be carried out by appropriately trained surgeons on the specialist registrar who have undertaken relevant subspeciality training. HSE should establish a list or registry of persons qualified to undertake them.Develop appropriate patient information material and consent material.Develop and maintain data collection of all mesh procedures in HSE hospitals. Holohan referenced safety concerns about other devices such as breast implants and hip prostheses and the need for long-term monitoring.
The CMO’s report stated that many women who have undergone these procedures have had satisfactory outcomes and he highlighted the fact that a number of women suffering from these conditions have had their procedures postponed.
However the Mesh Survivors Ireland group, which represents women who suffered complications, has expressed concerns about the lifting of the suspension.
“[The report] recognises that the consent procedures and pathways were lacking and the HSE did not take heed of warnings of the device,” said solicitor and spokesperson for the group Melanie Power after the publication of the report last year.It recognises under reporting by clinicians, a lack of readily available data on the number affected due to failings in the HSE system which all beg the question; how can complications rates as provided by Irish consultants be calculated?
“The suspension must continue until the science behind the device proves it is safe. Irish women deserve quality independent research before a lift on the suspension is considered.”
https://www.thejournal.ie/fda-mesh-prolapse-4596589-Apr2019/
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The FDA Has Finally Stopped the Sale of Pelvic Mesh
Apr 17, 2019 | Jezebel
By Kelly Faircloth
After years of concern about the safety of vaginal mesh and several warnings that stopped short of an outright ban, the FDA has put a stop to its sale, which is often used to shore up weakened pelvic muscles that can lead to prolapse.
The New York Times reported on the move, which affects the two companies still selling the product in America, despite mounting legal challenges. (You have probably seen TV ads soliciting plaintiffs for lawsuits involving transvaginal mesh.) The call was made out of concerns about complications and longterm safety:
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.Outstream Video
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“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 the FDA’s Dr. Jeffrey Shuren, adding that, “We couldn’t assure women that these devices were safe and effective long term.” That said, the FDA said that women who’ve already had the surgery done and haven’t had any problems don’t need to do anything, besides continuing to check in with their doctor.
The decision doesn’t extend to mesh used to treat stress incontinence, another distressingly common condition that really ought to have a better treatment at this point. Wild that women’s bodies are just a great big mystery!
https://jezebel.com/the-fda-has-finally-stopped-the-sale-of-pelvic-mesh-1834105810
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FDA Bans Sale Of Pelvic Mesh Product Amid Reports Of Injuries In Women
Apr 17, 2019 | Tech Times
By Ted Ranosa
The Food and Drug Administration has ordered a ban on the sale and distribution of pelvic mesh products following claims of injuries inflicted to women.
Doctors use surgical mesh to help women suffering from incontinence and a condition known as pelvic organ prolapse or POP. However, several reports have surfaced regarding patients developing side effects such as severe discomfort, permanent incontinence, and an inability to engage in sex.
The states of California, Kentucky, Mississippi, and Washington have filed lawsuits against manufacturers on behalf of victims of pelvic mesh complications. They claim that makers did not fully disclose the health risks associated with their products.
This led to the FDA putting a hold on the marketing of surgical mesh.
"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," the agency said.
"That evidence was lacking in these premarket applications, and we couldn't assure women that these devices were safe and effective long term."What Is Pelvic Organ Prolapse?
Pelvic floor disorders continue to be a major concern for many women. In fact, one in every five develops conditions such as fecal incontinence, urinary incontinence, and pelvic organ prolapse, according to Women's Health.
Patients who develop POP experience a weakening of the muscles and ligaments supporting their pelvic organs. This causes the organs to drop lower in their pelvis, resulting in a bulge in their vagina (prolapse).
The condition commonly occurs in women years after they have given birth. It can also happen following a hysterectomy or after patients enter their menopause stage.
While POP develops less frequently compared to urinary or fecal incontinence, the condition does affect as much as three percent of American women.
Older women have been shown to be more susceptible to POP compared to younger women. It is also more common among whites and Hispanics than members of other race or ethnic groups.
There are also instances where women develop more than one disorder, such as urinary incontinence with POP.
Several treatments are available to address pelvic organ prolapse. Patients are recommended a particular procedure, depending on the type of POP they have, their symptoms, their age, and other health issues. Doctors also factor in whether the patient is sexually active.
POP sufferers may undergo the following procedures:
Pessary Insertion
Pelvic floor muscle therapy
Changing eating habits
Colpocleisis (surgery to close the vagina)
Surgery to support the uterus or vagina
For sexually active women, doctors recommend undergoing surgery to address pelvic organ prolapse. The procedure sometimes involves using the patient's own body tissue or a surgical mesh to repair POP. The FDA has enforced strict safety guidelines regarding the use of such devices.Issues With Pelvic Mesh Products
Some POP patients who received pelvic mesh surgery reported of developing complications, such as pain in pelvis or groin, pain during sex, and persistent vaginal bleeding or discharge.
Several consumer protection groups, including Public Citizen, called for a ban against the use of such devices as early as 2011. They believe pelvic mesh products are only injuring many women.
Dr. Michael Carome, director of Public Citizen's Health Research Group, welcomed the FDA's decision to stop the sale and distribution of surgical mesh.
However, he said the move may have come too late for the thousands of POP sufferers, who were left with irreparable damages because of the devices.
In its ban announcement, the FDA said pelvic mesh makers Coloplast and Boston Scientific failed to provide a reasonable assurance that their products are safe and effective to use.
https://www.techtimes.com/articles/241718/20190417/fda-bans-sale-of-pelvic-mesh-product-amid-reports-of-injuries-in-women.htm
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FDA’s pelvic mesh ban long overdue, says patient advocacy group
Apr 18, 2019 | Plastics News
By Norbert Sparrow
FDA has ordered Boston Scientific (Marlborough, MA) and Coloplast (Humlebaek, Denmark) to cease the sale and distribution of their surgical mesh products used in transvaginal repair of pelvic organ prolapse (POP). The ban, announced on April 16, follows numerous reports of patients suffering major health problems associated with surgical mesh over the course of many years. The Netflix documentary The Bleeding Edge and a report on 60 Minutes last year brought renewed public attention to the safety of these devices. Now, FDA has acted, but in the eyes of some patient groups, it’s too little, too late.
In its April 16 news release, FDA said that it had determined that Boston Scientific and Coloplast had not demonstrated a reasonable assurance of safety and effectiveness for these devices. This is the “premarket review standard that now applies to [these devices] since the agency reclassified them in Class III (high risk) in 2016. As part of the 2016 reclassification, manufacturers were required to submit and obtain approval of premarket approval (PMA) applications, the agency's most stringent device review pathway, in order to continue marketing their devices in the U.S.,” wrote FDA. The companies now have 10 days since the agency announced the ban to submit their plan to withdraw these products from the market.
Plastic mesh has been used to treat POP, which occurs when the muscles and tissues supporting the pelvic organs weaken or become loose, since the 1990s. Upon reclassifying the device to Class III in 2016, the FDA wrote in a news release that it had seen “a significant increase in the number of reported adverse events associated with the use of surgical mesh for transvaginal POP repair.” 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.
Most synthetic vaginal mesh is made with polypropylene. Researchers at the UK University of Sheffield say that they have developed a polyurethane-based material that is better suited to this application because of its flexibility and likeness to human tissue. Their research was published in February 2018 in the Journal of Neurourology and Urodynamics.
Boston Scientific and Coloplast market three surgical mesh products for transvaginal repair of POP, said FDA, and in reviewing the PMAs, the agency found that they failed to provide an adequate assessment of the long-term safety of the devices or to demonstrate their long-term benefit compared with using native tissue.
Patient advocacy group Medical Device Problems applauded the decision but felt it should have been made sooner. "These mesh devices were on the market for over 20 years, leaving tens of thousands of women to live with permanent disabilities and disfigurement,” said the group in a statement posted on its website. It also noted that FDA’s announcement “serves to highlight the structural defects in the 510(k) approval process and serves as a warning for all other medical devices approved through this same pathway . . . that might not meet the basic litmus test of reasonable safety and effectiveness." The group cited hernia mesh and breast and hip implants as devices that merit greater scrutiny.
Indeed, last week France banned textured and polyurethane-coated breast implants, which have been linked with a rare form of cancer. FDA has investigated the link between these types of breast implants and anaplastic large cell lymphoma but has not called for their removal from the U.S. market.
Boston Scientific took a financial hit when FDA announced the U.S. ban of of its two surgical mesh products. Its stock price dropped 7% on Wednesday, and the company expects the decision to result in a $25 million loss in its 2019 revenue, according to sister brand MD+DI referencing an SEC filing. Coloplast told MD+DI that its surgical mesh product represents 0.2% of group revenues and would not comment further.
Boston Scientific published a statement on its website expressing its “deep” disappointment in FDA’s decision, noting that the “inaccessibility of these products will severely limit treatment options for the 50% of women in the U.S. who will suffer from POP during their lives.” It is important to note, the company added, that “there are a variety of surgical mesh products designated for different conditions. The FDA’s recent decision is limited to mesh for the transvaginal repair of pelvic organ prolapse and does not extend to mesh used to treat stress urinary incontinence. As a global leader in women’s health, Boston Scientific remains steadfast in our commitment to helping women and all patients live better and healthier lives.”
https://www.plasticstoday.com/medical/fda-s-pelvic-mesh-ban-long-overdue-says-patient-advocacy-group/205952187160646
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