Preview Newsletter
Ethicon 11/28
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J&J Unit Put Pelvic Mesh Profit Over Safety, NJ Jury Told
Nov 27, 2017 | Law 360
By Daniel Siegal
Counsel for a woman alleging she has suffered debilitating pain from a pelvic floor support mesh product made by Johnson & Johnson unit Ethicon told a New Jersey jury during Monday opening statements that Ethicon had intentionally blown through safety measures in its greed for sales. -
This Painful Vaginal Implant May Be Banned in Britain. Is the U.S. Next?
Nov 28, 2017 | Newsweek
By Kate Sheridan
A type of mesh used in the vagina and linked to serious and painful complications may be banned in the United Kingdom. -
N.J. Pelvic Mesh Trial Naming Def J&J
Nov 27, 2017 | Mesh Medical Device News Desk
The case of Elizabeth and Tad Hrymock got underway in a Bergen Co. New Jersey courtroom today. She has filed a defective product lawsuit against Johnson & Johnson (J&J) and its Ethicon division, alleging the TVT-O and Prolift were defectively designed. -
Jury Hears Opening Statements In 1st New Jersey Pelvic Mesh Trial Since 2013
Nov 27, 2017 | Courtroom View Network
By David Siegel
A New Jersey state court jury heard opening statements on Monday in the second pelvic mesh product liability lawsuit to go to trial in the state and first trial to take place in the major hub for mesh-related cases since 2013. -
Pelvic mesh jury to decide if device is 'defective' and whether J&J should pay
Nov 27, 2017 | North Jersey
By Richard Cowen
A woman who is suing Johnson & Johnson over what she says was a faulty pelvic mesh implant finally got her day in court on Monday, more than nine years after the operation left her in chronic pain. -
British health watchdog recommends vaginal mesh ban
Nov 27, 2017 | Mass Device
By Brad Perriello
A British health watchdog reportedly plans to recommend that the National Health Service there ban vaginal mesh implants to treat pelvic organ prolapse, citing “serious but well-recognized safety concerns.” -
Vaginal mesh: Welsh use decision after watchdog advice
Nov 27, 2017 | BBC
A decision on whether to continue using vaginal mesh and tape for operations in Wales will be made once watchdog recommendations are published. -
Vaginal mesh operations for prolapse should be banned, watchdog to say
Nov 27, 2017 | The Guardian
By Hannah Devlin and Nicola Davis
Controversial vaginal mesh operations to treat prolapse should be banned as a routine treatment in England, new guidelines to be issued by the health watchdog will recommend. -
TOO LITTLE TOO LATE? Vaginal mesh implants that have left hundreds of women in agonising pain should be banned, Nice says
Nov 28, 2017 | The Sun
By Lizzie Parry
CONTROVERSIAL vaginal mesh implants are set to be banned, officials are expected to recommend. -
MESH HELL Vaginal mesh that has left hundreds of women in ‘excruciating pain’ soon to be banned in UK – but no plans in place to end use in Ireland
Nov 27, 2017 | The Sun
By Aoife Finneran
CONTROVERSIAL vaginal mesh implants could soon be banned in the UK – but there are still no plans to end the use of the devices here. -
Vaginal mesh implants should be banned, health watchdog says
Nov 27, 2017 | Metro
By Jen Mills
Controversial vaginal mesh implants, used to treat prolapses after child birth, may no longer be recommended under official guidance. -
Victory for women crippled by vaginal mesh implants: After years of our campaigning, the health watchdog finally advises ban
Nov 28, 2017 | The Daily Mail
By Lois Rogers
For years women have complained about damage caused by the plastic mesh inserted to treat their post childbirth damage — complaints that seemed to fall on deaf ears, until now. -
Vaginal mesh implants to fix prolapse should be banned says health watchdog body
Nov 27, 2017 | Wisbech Standard
By Kath Sansom
NICE is set to recommend that operations using controversial plastic mesh devices be stopped in a ruling to be officially announced on December 20. -
Vaginal mesh operations set to be banned
Nov 27, 2017 | Web MD
By Peter Russell
Vaginal mesh implants should be banned inthe NHS in England, the health watchdog has announced. -
Is victory in sight for Cambridgeshire's Sling the Mesh campaigner?
Nov 27, 2017 | ITV News
A mother from Cambridgeshire - who has campaigned for two years against a medical procedure that has left thousands of women in crippling pain - appears to have won a major victory.
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Online Sources
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J&J Unit Put Pelvic Mesh Profit Over Safety, NJ Jury Told
Nov 27, 2017 | Law 360
By Daniel Siegal
Counsel for a woman alleging she has suffered debilitating pain from a pelvic floor support mesh product made by Johnson & Johnson unit Ethicon told a New Jersey jury during Monday opening statements that Ethicon had intentionally blown through safety measures in its greed for sales.
During the first day of the trial before Bergen County Superior Court judge Rachelle Harz in Hackensack, Adam Slater of Mazie Slater Katz & Freeman LLC, representing plaintiffs Elizabeth and Tad Hrymoc, told a jury that J&J and Ethicon claim to put patient safety first, but willfully ignored signs that their Prolift mesh product was unsafe.
Slater said that when making medical devices, companies like Ethicon have a series of checks and measures to ensure patient safety, comparing them to a traffic stop light — and saying that the defendants weren’t just pushing a yellow light with the Prolift, but intentionally blowing through reds.
“Unfortunately, the reason they kept going through stop signs was the ambition to market products and make money,” he said.
Slater took a Prolift out of the box and showed it to the jury, saying that the defendants knew there was “too much mesh” in the “octopus-looking thing,” and that the size and density of the Prolift caused an inflammatory, scarring response in women’s bodies.
Slater said that Elizabeth Hrymoc, who was 62 years old when she had the mesh implanted in 2008, had suffered vaginal pain and pain when having sex since the mesh was implanted, and that despite multiple operations and procedures, she still suffers from chronic pain.
“She’s tried with Tad, over the years, sometimes to have sexual relations, she can’t do it, she can’t complete the act, it’s too painful,” he said.
Elizabeth Hrymoc and her husband Tad Hrymoc filed suit in 2009, joining thousands of women nationwide who have filed suits alleging Ethicon and J&J failed to fully disclose risks associated with its Gynecare Prolift mesh product, which was on the market from 2005 through 2012.
Elizabeth Hrymoc contends that she had the Prolift implanted to treat a pelvic prolapse, but that it contained a design defect, and that the defendants knew it was risky but kept this information from consumers.
She is also alleging that the defendants failed to warn of the risks associated with a second J&J medical device, Trans Vaginal Tape, known as TVT, that was implanted to treat her stress urinary incontinence. The plaintiffs are seeking punitive damages.
The Hrymocs’ suit, however, is just the second pelvic mesh suit against Ethicon to go to trial in New Jersey, where the company is headquartered.
On Monday afternoon, Judith Wahrenberger of Ruprecht Hart Weeks & Ricciardulli LLP, representing the defendants, told the jury that Slater’s opening statement was just one side of the story.
Wahrenberger said the evidence shows the implant products were safe and effective, and that Elizabeth Hrymoc had a host of preexisting medical issues, including abdominal pain, pain with sex and urinary complaints, that were now being attributed to the products.
The Hrymoc trial kicked off almost a year after the New Jersey Supreme Court declined to review a jury’s $11.1 million award to the plaintiff in the first pelvic mesh case against Ethicon to head to trial in the state.
In that December 2016 order, the justices denied Ethicon and J&J’s petition for review of an Appellate Division’s affirmation of a verdict that found jurors heard sufficient evidence showing Linda Gross’ doctor might have offered different guidance had he possessed more information about the Ethicon product’s risks.
And in Philadelphia, juries held Ethicon liable and imposed damages of nearly $50 million in four cases dating back to December 2015, before the company broke its losing streak in June, when jurors agreed plaintiff Kimberly Adkins had not suffered any injuries from the TVT mesh.
Gross, like the Hrymocs, was represented by Mazie Slater Katz & Freeman LLC.
Arguing for the Hrymocs was Adam M. Slater of Mazie Slater Katz & Freeman LLC.
Arguing for Ethicon was Judith Wahrenberger of Ruprecht Hart Weeks & Ricciardulli LLP.
The case is Elizabeth Hrymoc et al. v. Ethicon et al., case number L-13696-14 in the Superior Court of the State of New Jersey, Bergen County.https://www.law360.com/newjersey/articles/988506/j-j-unit-put-pelvic-mesh-profit-over-safety-nj-jury-told
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This Painful Vaginal Implant May Be Banned in Britain. Is the U.S. Next?
Nov 28, 2017 | Newsweek
By Kate Sheridan
A type of mesh used in the vagina and linked to serious and painful complications may be banned in the United Kingdom. According to the BBC, the U.K.’s National Institute for Health and Care Excellence (NICE) may recommend the devices be used only in research.
The mesh is intended to help keep women's pelvic organs in place inside their bodies. The problem may sound extreme, but it is both real and common. The condition, known as pelvic organ relapse, or POP, happens because organs move around during pregnancy and delivery.
As a result, the muscles that keep a woman's uterus and bladder in place can weaken, causing the organs to drop down. The shift can be uncomfortable and make it difficult for women to control their bladders. Some organs may even start to poke out from the vaginal opening. An estimated 200,000 American women undergo surgery following childbirth to treat POP.
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But for some women, the mesh has caused more problems than it has solved. The plastic mesh meant to secure the placement of their organs began to cut into their tissue instead, causing extreme pain. About one in 15 women who had the mesh implanted in the U.K. eventually had it taken out, The Guardian reported in August.
These mesh implants have also been controversial in the United States. One woman, Ella Ebaugh, 51, was awarded $57 million in damages after she sued the manufacturer of the mesh used to treat her urinary incontinence. In the U.S., nearly 55,000 people are suing Johnson & Johnson, a major manufacturer of the product, according to the company's 2016 annual report. Class-action lawsuits against the company have also been filed in Israel and Canada. Other class-action lawsuits over the mesh are ongoing in the U.S. and Australia, The Guardian reported in September.
In April, Johnson & Johnson was ordered to pay $20 million to a woman in New Jersey for mesh-related damages, Bloomberg reported. In 2016, California, Washington and Kentucky sued the company over its marketing of the device, alleging that the company didn't provide enough information about the mesh's possible side effects. (The company told Reuters that the subsidiary that marketed the mesh, Ethicon, "acted appropriately and responsibly.")
Many of the lawsuits emphasize the extraordinary pain linked with the mesh. One woman told the BBC that she had to quit her job; another said she considered suicide and that she and her husband haven't been able to have sex in four years. One woman, writing about her experience in an opinion piece for The Guardian, said a lawyer had contacted her about women who say the mesh eventually forced them to have their bladders removed.
Britain's national healthcare system, the NHS, isn’t obliged to follow NICE’s recommendations, the BBC noted. The U.S. Food and Drug Administration does not regulate doctors' medical decisions directly, but if the agency were to take the extraordinary step of mandating a recall of the devices, that could be binding on manufacturers.
The FDA has known for several years about the hazards of this product, first approved to treat POP in 2002. By 2010, the FDA had already received nearly 4,000 reports of adverse events associated with the mesh, according to documents from a meeting held in 2011 to review the use of the device; three people died because of complications after the mesh-placing surgery between 2008 and 2010.
After that meeting, the agency concluded that serious complications were “not rare” and that there wasn’t “conclusive evidence" that the mesh actually made surgeries more effective for patients.
Short of a recall, the FDA has done other things to address the issues with the mesh, reclassifying both the product and the instruments used with it to categories that give the agency more oversight. The agency also asked companies with instruments used with the mesh that are already on the market to go back to the FDA for clearance by January 2018, according to the Federal Register. However, no steps to outright ban vaginal mesh in the U.S. have yet been taken.
http://www.newsweek.com/painful-vaginal-implant-may-be-banned-britain-us-next-722939
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N.J. Pelvic Mesh Trial Naming Def J&J
Nov 27, 2017 | Mesh Medical Device News Desk
The case of Elizabeth and Tad Hrymock got underway in a Bergen Co. New Jersey courtroom today. She has filed a defective product lawsuit against Johnson & Johnson (J&J) and its Ethicon division, alleging the TVT-O and Prolift were defectively designed.
This is the first of many cases to be heard in Hackensack, New Jersey.
Welcome to Hackensack New Jersey, Bergen Co., the new location for thousands of product liability lawsuits that promise to be heard against defendant Johnson & Johnson over its family of polypropylene pelvic meshes.
J&J is one of seven mesh makers who developed a polypropylene polymer to spin into a mesh to be permanently implanted in women as a treatment for pelvic organ prolapse and stress urinary incontinence. The same mesh is used for hernia repair.
This latest trial will educate jurors on how the products made it to market. Prolift had a questionable path to FDA clearance as past trials have shown to jurors.
Bergen County is one of the locations for thousands of transvaginal mesh trials. Philadelphia has more than 100 lined up for trial and Charleston, West Virginia is where more than 104,000 are consolidated in something called multidistrict litigation waiting for either settlement or to go before a jury.
Prolift explant from unknown recipient
The case is Elizabeth Hrymoc v Ethicon, Case No. L-13696-14,heard in New Jersey Superior Court, Bergen Co., NJ.
North Jersey dot com, reports on the trial that began Monday, November 27th pitting Elizabeth Hrymock and her husband, Tad, against J&J and its subsidiary Ethicon.
Hrymoc (RYE-mock) had two pelvic mesh devices, the TVT-O (obturator) and Prolift, made by J&J implanted in 2008 to control incontinence and prolapse.
She has undergone three attempted removals and today suffers from chronic pain, which she claims she began suffering immediately after implantation. She says she had no informed consent.
While TVT-O is still on the market, implanted to treat incontinence, Prolift was removed in June 2012, along with three other of its problematic meshes.
The U.S. Food and Drug Administration (FDA) has now reclassified pelvic organ prolapse meshes like Prolift as “High Risk” and wants manufacturers to prove its safety and efficacy before its marketed, something that is not required of class II or moderate risk devices such as incontinence mesh, such as the TVT and TVT-O.
FINALLY UNDERWAY
Adam Slater, the plaintiff attorney with Mazie Slater, tells NorthJersey.com the couple is grateful their trial is finally underway. “They have waited nine years for the chance to tell their story to a jury and hold Johnson & Johnson accountable, not just for themselves, but for the thousands of other women who still await their day in court.”
J&J told NorthJersey.com through a spokeswoman in an email, “We empathize with Ms. Hrymoc’s medical situation, along with those of all women suffering from stress urinary incontinence and pelvic organ prolapse.” She added, “Pelvic mesh has helped improve the quality of life for many women with serious, debilitating conditions.”
J&J is facing more than 55,000 similar cases worldwide including a class action case of 700 women currently underway in Sydney Australia.
Expect the Hrymock trial to last at least four weeks before Judge Rachelle Harz. If past trials are any indication, juries tend to award plaintiffs millions including huge punitive damages to punish a company for bad corporate behavior.
Take for example the case of Plaintiff Linda Gross heard in 2013 in Atlantic City New Jersey. She was awarded $11.1 million in damages. J&J appealed the case which took years to finally be resolved. Other plaintiff damages from Philadelphia have amounted to $12 million, $20 million, $12.5 million and $13.5 million.
The last pelvic mesh trial in the Philadelphia Court of Common Pleas yielded a $57 million award to Ella Ebaugh, the highest jury award in that court.
See MND coverage here.
COURTROOM VIEW NETWORK
Mesh Medical Device News Desk (MND) attempted to share coverage camera with Courtroom View Network as it has done in the past, but the defense objected. CVN almost lost its camera in the courtroom in Kansas City (read MND coverage here) when one reader of MND, “Maria Garcia” commented and the defense counsel objected.
At that point CVN almost lost its camera rights and MND was excluded. Maria Garcia is excluded from commenting on MND after failing multiple requests to identify herself.
https://www.meshmedicaldevicenewsdesk.com/n-j-pelvic-mesh-trial-naming-def-jj/
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Jury Hears Opening Statements In 1st New Jersey Pelvic Mesh Trial Since 2013
Nov 27, 2017 | Courtroom View Network
By David Siegel
A New Jersey state court jury heard opening statements on Monday in the second pelvic mesh product liability lawsuit to go to trial in the state and first trial to take place in the major hub for mesh-related cases since 2013.
Plaintiff Elizabeth Hrymoc and her husband Tad sued Johnson & Johnson’s Ethicon unit after she had two of the company’s pelvic mesh devices surgically implanted to treat incontinence. Her lawsuit claims the mesh was defectively designed, and that despite three operations attempting to remove it she still suffers from chronic severe pain.
Ethicon maintains the mesh devices implanted in Hrymoc were not defective and have successfully helped thousands of women suffering from incontinence and pelvic organ prolapse, a condition where internal organs like the bladder fall to a lower position in the abdomen than normal.
The trial is being webcast and recorded gavel-to-gavel by Courtroom View Network.
Hrymoc’s attorney Adam Slater told jurors during his opening statement that both of the mesh devices she received, the Prolift and TVT-Obturator, contained a porous plastic called polypropylene. He said he would present evidence during the trial proving that Ethicon knew polypropylene could potentially injure vaginal tissue, but failed to provide adequate warnings about the supposed risks of the implants.
Plaintiff attorneys representing women in mesh cases argue the chemical reaction between polypropylene mesh and bodily fluids can cause it to become stiff and brittle and in some cases become impossible to completely remove.
Polypropolene mesh has been used for decades to treat hernias, but Slater told the jury he would present internal Ethicon documents allegedly showing that company knew the material posed much greater risks when implanted in vaginal tissue, but withheld those risks from patients and physicians.
Ethicon attorney Judy Wahrenberger told jurors that pelvic mesh products using polypropylene offered women a much safer option for treating incontinence and pelvic organ prolapse than more invasive surgical procedures used before their development.
The company has argued in court papers that it properly tested the Profit and TVT-Obturator implants and was fully transparent with both patients and physicians about their potential benefits and risks.
The U.S. Food & Drug Administration signed off on mesh implants as an approved treatment for pelvic organ prolapse in 2002, however since then thousands of women throughout the country filed lawsuits claiming they suffered debilitating side effects from the mesh. In 2016 the FDA redesigned pelvic mesh implantation as a high-risk procedure.
Over 8,500 of those lawsuits were consolidated in New Jersey, where Ethicon is based, in addition to sprawling mesh-related dockets in state court in Philadelphia and federal multi district litigation consolidated in West Virginia.
At least 31 mesh-related cases have gone to trial against defendants including Ethicon, Boston Scientific and C.R. Bard Inc., with plaintiffs prevailing on 22 occasions and receiving awards exceeding $1 million each time, though juries have also returned defense verdicts, including a federal jury in Texas that cleared Ethicon in a case involving a TVT-S implant on November 13.
However only one of those verdicts took place in New Jersey. That case, which went to trial in Atlantic County in 2013 and was also recorded by CVN, resulted in an $11.1 million verdict against Ethicon that was ultimately affirmed by the New Jersey Supreme Court in 2016. Adam Slater also represented the plaintiff in that case.
Since the Gross verdict many mesh manufacturers, including Ethicon, struck numerous large scale settlements in the hopes of winnowing down the the still massive mesh dockets pending throughout the country. Despite those settlements, thousands of cases remain pending.
The current trial before Judge Rachelle Harz is expected to conclude by Christmas. The full proceedings are available gavel-to-gavel for CVN subscribers, along with previous pelvic mesh trials in California, Texas, Missouri, Massachusetts and New Jersey.
The Hrymocs are represented by Mazie Slater Katz & Freeman LLC.
Ethicon is represented by Wahrenberger & Pietro LLP, Riker Danzig Scherer Hyland & Perretti LLP, and by Butler Snow LLP.
The case is captioned Elizabeth Hrymoc and Tadeusz Hrymoc v. Ethicon Inc., et al. case number L-13686-14 in Bergen County Superior Court.
http://blog.cvn.com/jury-hears-opening-statements-in-1st-new-jersey-pelvic-mesh-trial-since-2013
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Pelvic mesh jury to decide if device is 'defective' and whether J&J should pay
Nov 27, 2017 | North Jersey
By Richard Cowen
A woman who is suing Johnson & Johnson over what she says was a faulty pelvic mesh implant finally got her day in court on Monday, more than nine years after the operation left her in chronic pain.
Elizabeth Hrymoc came to Superior Court in Bergen County with her husband, Tad, and sat stoically during opening arguments of the civil trial before Judge Rachelle L. Harz.
Hrymoc, a 71-year-old research technician from South River in Middlesex County, is one of tens of thousands of women nationwide who have sued Johnson & Johnson after receiving pelvic implants between 2005 and late 2012, and are seeking damages in what is the largest tort claims litigation in history.
Her attorney, Adam Slater, told the jury that Johnson & Johnson knew that one of the two pelvic mesh devices implanted in Hrymoc in 2008 was faulty, and that the company did not adequately inform patients of the potential risks.
Slater reminded the jury of six men and four women that Johnson & Johnson is a corporation with an estimated worth of $70 billion, and that it should pay for its mistakes.
"We know that the only language they speak is money," Slater told the jury at the end of his opening statement."And the only way to deter them and to punish them is to make them pay."
Although thousands of cases have been filed in New Jersey alone, this is only the second case to come to trial in the state. In the first trial, a jury awarded the plaintiff, Linda Gross, $11.1 million in punitive and compensatory damages.
Jury awards in neighboring Pennsylvania have been quite large as well, ranging from $10 million to $20 million.
The trial is expected to last at least until Christmas. Hrymoc is seeking compensatory damages for pain and suffering as well as punitive damages.
The standard of proof is different in a civil case as opposed to a criminal trial. In a criminal trial, the jury weighs the evidence and decides whether a prosecutor's case was proved "beyond a reasonable doubt."
READ MORE: Pelvic mesh case goes to trial with Johnson & Johnson as defendant
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In a civil case, the jury decides by a "preponderance of the evidence," which means a civil jury weighs whether the evidence supports the claims made by the plaintiff.
As it has done in other cases, Johnson & Johnson continued to maintain that its pelvic mesh products aren't necessarily defective, even though one of them, known by the brand name Prolift, was taken off the market in August 2012.
One of three attorneys for the defense, Judy Wahrenberger, told the jury that Hrymoc, who received the Prolift device, had a long history of pelvic problems and had suffered from complications that, while unfortunate, were the natural risks of surgery, and not the result of a product defect.
"In the real world, complications occur," Wahrenberger said. "It's not necessarily that the product is defective."
She added that the evidence would show that Hrymoc suffered from "complications, combined with pre-existing conditions."
Hyrmoc was 62 years old and was suffering from pelvic pain and incontinence when she had two pelvic mesh devices implanted in her vagina in June 2008. Like many women, Hrymoc suffered from a gradual weakening of the vaginal walls, which caused her internal organs to sag and bulge, a condition known as organ prolapse.
The mesh devices she received were a Prolift and trans-vaginal tape, known as TVT. Both were developed in the early 2000s by Johnson & Johnson and its medical research subsidiaries Gynecare and Ethicon.
As its first witness, the plaintiff called Scott Ciarroca, the project leader for Ethicon in 2003 when it was developing pelvic mesh products. Slater showed the jury documents that suggested the company was concerned about the potential for pelvic mesh devices to erode the vaginal wall, but put the product on the market nonetheless.
Doctors had been using mesh inserts, which are made of polypropylene, since the 1970s to treat hernias. Working with a French company, Gynecare set about making a mesh that could act as a sling that could be inserted into the vagina to help support sagging organs, which frequently caused incontinence.
But Slater told the court that that once inserted, the mesh is frequently hardened by scar tissue, and in extreme cases it can erode and poke through the vaginal walls. Three surgeries meant to correct the problem were unsuccessful, and Hrymoc was left with chronic pain, unable to engage in sexual relations without extreme pain, he said.
Slater said he will present documents and email correspondence proving that Ethicon knew that mesh had potentially disastrous side effects, but that the information was kept from Hrymoc's doctor. Slater said the products, which Johnson & Johnson began selling in 2004 and 2005, should never have been put on the market.
"The defective design is unreasonably dangerous," Slater said. "It is a stupid idea."
Johnson & Johnson says the doctor who implanted the devices in Hrymoc knew the potential risks and discussed them with her. Wahrenberger told the jury that in the coming weeks, a parade of doctors will testify before them, and all will agree on one thing.
"You will hear from every doctor that every surgery has the potential for complications," she said.
http://www.northjersey.com/story/news/2017/11/27/pelvic-mesh-jury-decide-if-device-defective-and-whether-j-j-should-pay/893504001/
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British health watchdog recommends vaginal mesh ban
Nov 27, 2017 | Mass Device
By Brad Perriello
A British health watchdog reportedly plans to recommend that the National Health Service there ban vaginal mesh implants to treat pelvic organ prolapse, citing “serious but well-recognized safety concerns.”
In recommending that the implants be limited to research use only, the U.K.’s National Institute for Health & Care Excellence said “evidence of long-term efficacy [for implants treating organ prolapse] is inadequate in quality and quantity,” according to the BBC.
Randomized, controlled trials “showed no added benefit of using mesh compared with native tissue repair,” according to the NICE report. “[W]hen complications occur, these can be serious and have life-changing consequences.”
More than 92,000 women had vaginal mesh implants in England between April 2007 and March 2015, the BBC reported, citing NHS data. About one in 11 women experienced problems with the implants, according to the data.
The proposed ban does not mention the use of pelvic mesh to treat female urinary incontinence, the British news service said.
In the U.S., tens of thousands of product liability lawsuits have been filed against medical device companies over their respective pelvic mesh offerings.
Last month a federal appeals court upheld a plaintiff’s $27 million win over Boston Scientific (NYSE:BSX) in a product liability lawsuit brought over its Pinnacle pelvic mesh, a month after Johnson & Johnson (NYSE:JNJ) subsidiary Ethicon was hit with a $57.1 million verdict in a pelvic mesh case out of Pennsylvania.
http://www.massdevice.com/british-health-watchdog-recommends-vaginal-mesh-ban/
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Vaginal mesh: Welsh use decision after watchdog advice
Nov 27, 2017 | BBC
A decision on whether to continue using vaginal mesh and tape for operations in Wales will be made once watchdog recommendations are published.
The BBC learned on Monday health watchdog NICE is to recommend a ban on the use of mesh operations for treating organ prolapse in England.
Pontypridd MP Owen Smith, chair of the all-party parliamentary group on mesh, has called for Wales to suspend usage.
A Welsh Government task and finish group started meeting last month.
It is reviewing use of the mesh.
Mesh implants, which include different types of plastic tape and slings, are used to ease incontinence and to support organs such as the vagina, uterus, bowel, bladder or urethra which have prolapsed after childbirth.
A Welsh Government spokeswoman said: "We are currently reviewing the use of vaginal mesh and tape and will await the NICE recommendations."
http://www.bbc.com/news/uk-wales-42135710
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Vaginal mesh operations for prolapse should be banned, watchdog to say
Nov 27, 2017 | The Guardian
By Hannah Devlin and Nicola Davis
Controversial vaginal mesh operations to treat prolapse should be banned as a routine treatment in England, new guidelines to be issued by the health watchdog will recommend.
The draft guidance, seen by the Guardian, states that mesh implants for prolapse should now only be used in the context of research.
The news has been welcomed by those campaigning to raise awareness of the potential complications suffered by some women who have been treated with mesh implants.
Some have experienced the implant cutting into the vagina or surrounding organs, while others have been left with chronic pain, and in extreme cases been unable to walk.
The guidance from the National Institute for Health and Care Excellence (Nice) only relates to operations to treat prolapse, where the front or back wall of the vagina has descended into or outside of the vagina, with the mesh used to support the vaginal walls. The draft guidance does not affect the use of mesh implants for incontinence, which accounts for the majority of such operations.
The use of mesh for prolapse has fallen significantly in recent years, with mounting evidence that it is less effective than traditional surgery and has higher rates of women experiencing problems.
Kath Sansom, a campaigner at Sling the Mesh, called for the publication of the full Nice guidelines, which include those relating to the use of mesh for incontinence, to be expedited.
“The full guidelines for all prolapse mesh and incontinence mesh are due out 2019 but that is way too long to wait,” she said. “Nice must bring those guidelines forward to 2018. It is unacceptable to hold off until 2019.”
In the documents, to be published after consultation in December, Nice said there were “serious but well-recognised safety concerns” and that “evidence of long-term efficacy [for implants treating organ prolapse] is inadequate in quality and quantity”.
It added that “when complications occur, these can be serious and have life-changing consequences”, but said “most commentaries received from patients reported satisfaction with the procedure”.
However, a spokesperson for Nice warned that the final guidance had not been officially released, and that the draft was subject to change.
A spokesperson for Nice said: “Our official guidance on the use of vaginal mesh is not due out until 20 December. We will not be issuing a comment until then.” NHS England declined to comment.
The draft guidance is an about-turn for Nice, who in their previous guidelinesfrom 2008 were upbeat about the use of mesh for prolapse.
This year the Guardian reported that more than 800 women are suing the NHS and the manufacturers of vaginal mesh implants after experiencing serious complications.
Owen Smith, the Labour MP for Pontypridd, who has raised concerns about the use of vaginal mesh implants, said: “This is essentially a ban on the use of mesh to treat prolapse, as there is no research context in which it’s likely to be used.
“It’s also another move towards clinicians recognising the scale of the risk associated with mesh and an acknowledgement that mesh has been too widely seen as a quick fix for patients.”
Emma Hardy, the Labour MP for Kingston upon Hull West and Hessle, said she was delighted to hear the draft guidelines proposed that vaginal mesh operations should be banned from treating organ prolapse in England.
“I encourage the NHS to take up this recommendation as the step will prevent the injury of a lot of people in the future,” she said.
But she added that the guidelines did not go far enough. “It does not help those who have already been injured by mesh nor does it do anything to help those suffering because of TVT [tension-free vaginal tape] operations.
“To help them, we need a fully retrospective audit and, if necessary, compensation for those affected.”
Sohier Elneil, a consultant urogynaecologist at University College hospital, who was at one point involved with the Nice committee on the issue, welcomed the news.
“Nice looked at extensive evidence and in particular looked at patient experience as part of the evidence, and came to the conclusions that given it was lacking in good long-term evidence with regards to complications, felt it should be done under research-only conditions,” she said.Advertisement
“This means patients will not be subjected to a procedure which has not been fully validated.”
Sharon Hodgson MP, the shadow minister for public health, said: “The reports that mesh will be banned for treating organ prolapse in England are a step in the right direction but the government have to be clear about their position on this.
“The updated Nice guidance is not due until the end of December. Ministers should take a lead and step in to take these products off the market while the guidance is being prepared.
“Labour is calling for a pause whilst a full inquiry uncovers the extent of the harm done by mesh implants so we can be sure that this never happens again.
“Mesh implants have left women in permanent pain, unable to walk, and unable to work. This is an ongoing public health scandal and the government need to get all the facts into the public domain and do much more to support those affected.”
https://www.theguardian.com/society/2017/nov/27/vaginal-mesh-operations-should-be-banned-health-watchdog-to-say
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Nov 28, 2017 | The Sun
By Lizzie Parry
CONTROVERSIAL vaginal mesh implants are set to be banned, officials are expected to recommend.
Draft guidelines from health watchdog Nice say the implants should not be used for routine operations.
The implants are commonly used to treat pelvic organ prolapse and incontinence.
Botched ops using the implants have left hundreds of women suffering agonising after effects.
They can cut into the vagina and women have described constant and horrific pain, leaving them unable to walk, work or have sex.
Now, Nice are expected to recommend they are only used for research and not routine surgery, the BBC's Victoria Derbyshire show revealed.
The official guidance is due to be published next month.
One expert said he expects the NHS will take up those guidelines, after top doctors warned the vaginal mesh scandal is "bigger than Thalidomide".
Prof Carl Heneghan, from Oxford University, said the draft recommendations were too little too late.
"Seven years I have been watching this emerge - it is absolutely farcial how bad it is," he told the BBC.
"Either they're burying their heads in the sand or they don't know what they're doing."
But the health service it not compelled to listen to Nice, and a ban would also require action from the Department of Health and the Medicines and Healthcare products Regulatory Agency (MHRA).
Nice's current guidance on the use of vaginal mesh implants states the procedure "should only be used with special arrangements for clinical governance, consent and audit or research".
As the weeks went by I started to get burning pains in my vagina. I described it as – imagine a hedgehog covered in chilli sauceKath SansomFounder Of Sling The Mesh Campaign
In October mum-of-two Kath Sansom called for the procedures to be banned, blasting the practice "barbaric" and accusing it of driving some women to the brink of suicide.
The 49-year-old journalist told The Sun Online it was a "tragedy" it had taken ten years of campaigning for MPs to debate the issue in Parliament.
She said: "That's ten years of women being maimed with unnecessary, life-changing injuries that have been ignored, which is so upsetting."
Kath founded Sling The Mesh, a campaign group, to warn women of the dangers of transvaginal tape after her vaginal mesh implant left her barely unable to walk.
She had the implant in March 2015 as treatment to try and cure mild incontinence after the birth of her second child.
But almost instantly, she recalled knowing something was very wrong.
"As the days went by the pain got worse and worse," she said.
"I had a deep, intense, toothache-like pain in my legs and groin, and my feet didn't feel like they were attached to my legs.
"It felt like someone had slashed my feet with a knife.
"The pain was so bad that I would feel sick, it was horrible.
"As the weeks went by I started to get burning pains in my vagina. I described it as - imagine a hedgehog covered in chilli sauce."
Kath said thankfully her GP listened and referred her straight away.
Seven months later she had the device removed in Oxford.
Afterwards, the pain in her vagina cleared within a week.
In October, ministers faced fresh calls for a public inquiry over the implants, which have been offered to women to treat pelvic organ prolapse and incontinence after childbirth.
Labour's Emma Hardy urged the Government to suspend operations using mesh implants while a "full retrospective and mandatory audit of all interventions using mesh" is carried out.
She said mesh implants had "affected thousands" of people across the country.
https://www.thesun.co.uk/news/5008360/vaginal-mesh-implants-should-be-banned-nice/
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Nov 27, 2017 | The Sun
By Aoife Finneran
CONTROVERSIAL vaginal mesh implants could soon be banned in the UK – but there are still no plans to end the use of the devices here.
The mesh is inserted as a bladder support to treat stress incontinence or pelvic organ prolapse.
However, in some cases it can cut through internal tissues, leaving patients in extreme pain.
Thousands worldwide have complained of crippling side-effects, with some taking legal action.
Now a report from the UK’s National Institute for Health and Care Excellence is expected to propose that the devices should no longer be used as a routine treatment, and should only be fitted after patients have been made aware of the risks.
The recommendations, which are likely to be adopted by the NHS, have sparked renewed calls for the procedure to be banned here.
Several Irish women have already come forward to reveal how the device left them in excruciating pain.
But as the HSE does not record the number of procedures which involve mesh implants, it’s impossible to know how many are affected.
Mum-of-two Lesley-Anne Stephens says it’s “extremely frustrating” that Ireland isn’t following Britain’s lead.
She said: “If the UK can get all the information and see that this has to be banned, what’s wrong with people here that they can’t ban it too?
“They’ve been fighting for this in England for years, and I hope to God they get it banned there because it will force people here to pay attention.
“The longer this goes on, the more upset and angry I get. It’s devastating to think that while we’re waiting for it to be banned here, more women are getting it inserted.”
Lesley-Anne, from Kilbride, Co Carlow, had a mesh implant inserted 17 months ago to treat stress incontinence.
But instead of curing the problem, the 20-minute procedure ultimately left her in constant agony.
She said: “I was told that I’d be a different person afterwards, that it would change my life.”
Instead Lesley-Anne and her husband Darren were worried after she was left with stabbing pain and bleeding. She later discovered the device had cut through the vaginal wall.
Unfortunately, despite undergoing two surgeries to remove the mesh, she is still in immense pain.
Lesley-Anne said: “I haven’t gotten any better. I can’t drive. If I go out in the car I need a cushion under me, and walking too far would kill me.”
Sadly, she’s also dealing with “huge regret” that she didn’t research the procedure in advance.
https://www.thesun.ie/news/1858425/vaginal-mesh-that-has-left-hundreds-of-women-in-excruciating-pain-soon-to-be-banned-in-uk-but-no-plans-in-place-to-end-use-in-ireland/
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Vaginal mesh implants should be banned, health watchdog says
Nov 27, 2017 | Metro
By Jen Mills
Controversial vaginal mesh implants, used to treat prolapses after child birth, may no longer be recommended under official guidance.
Several people who had the implants reported pain so intense they considered suicide, while others said they were unable to have sex after the operation.
Manufacturers Johnson and Johnson were sued for £42,500,000 by a woman who said she would ‘suffer for the rest of her life’ from the surgery.
The National Institute for Health and Care Excellence (Nice) is due to issue final guidance on the mesh, which is meant to reinforce the vaginal wall, next month.
BBC’s Victoria Derbyshire show has reported that Nice will recommend that the devices should no longer be used.
Nice’s recommendations are not mandatory, and if officials wanted to ban the use of the implants it would also take action from the Department of Health and the Medicines and Healthcare products Regulatory Agency (MHRA).
When it updates the guidance, the options are that the devices are no longer recommended for use; that they should only be used for research purposes; or that they should only be used when patients have been told about the potential side risks.
At present, the regulator says the procedure ‘should only be used with special arrangements for clinical governance, consent and audit or research’.
http://metro.co.uk/2017/11/27/vaginal-mesh-implants-should-be-banned-health-watchdog-says-7112441/
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Nov 28, 2017 | The Daily Mail
By Lois Rogers
For years women have complained about damage caused by the plastic mesh inserted to treat their post childbirth damage — complaints that seemed to fall on deaf ears, until now.
For it was reported yesterday that the government healthcare adviser, the National Institute for Health and Care Excellence (NICE), is going to recommend the controversial implant should no longer be routinely used because of ‘serious safety concerns’.
A NICE guidance document, due to be published on December 22nd but leaked yesterday, says using the mesh for pelvic organ prolapse (POP) operations, where the material is inserted through the vagina to support the womb, should no longer be offered as a routine op and should be available for research only.
Further guidance is due in 2019, but after pressure from MPs and Sling The Mesh, a group representing 4,400 injured women, it is expected the final guidance will be brought forward — and recommend a complete ban.
An estimated 200,000 women across the UK have had the implants since they were introduced in the late Nineties to treat incontinence, or repair damage where ligaments supporting the womb have collapsed.
A large proportion of women given the mesh have not had problems, but as Good Health has highlighted, in some women it has fragmented and ‘migrated,’ cutting through tissue and causing nerve damage, chronic pain and infection, leaving them unable to walk properly, work or have sex.
The safety admission has opened the floodgates to one of the biggest compensation claims in NHS history. David Golten, a London lawyer representing more than 500 women, believes hundreds more will come forward and the damages ‘could run into billions’.
‘It is the first time any of the medical authorities have admitted this procedure is dangerous,’ he told Good Health.
For the women affected it’s a vindication — of sorts, says Kath Sansom, who set up Sling The Mesh, and has suffered permanent damage to her coccyx as a result of the procedure. ‘Doctors tried to make us feel we were making a fuss about nothing.
‘The latest publication in a scientific journal in September, using the NHS’s data, showed at least 10 per cent of women implanted with this mesh suffer complications requiring overnight hospital treatment, and we know the real figure is much higher.’
Grandmother Jemima Williams, 57, from Barry, South Wales, has had 18 operations to remove fragments of the mesh since 2002, when it was implanted in her to treat post-childbirth incontinence. Jemima, who is married to a GP, suffers chronic pain, walks with a stick and has been told she will need a colostomy bag because of permanent nerve damage.
‘There are many of us who have been told we can’t take legal action because it is too long after surgery,’ she says. ‘We are going to start pressuring the Government to lift the ten-year bar on litigation.’
The claims will centre on whether women were warned of the risks and therefore gave informed consent to the operation, whether the surgeons botched the implants, and, most importantly, whether the mesh was suitable for use in the first place.
Although the mesh starts off flexible it appears to become brittle once implanted. Once it has broken up and begun to ‘migrate’, removal becomes almost impossible without causing further damage.
Jemima has been on a long waiting list to see Sohier Elneil, a consultant urogynaecologist at University College Hospital in London, who has developed a rare expertise in treating women whose meshes have disintegrated.
‘Removing this material is a real problem and has now become a major part of my clinical practice,’ Miss Elneil says. ‘These women are suffering terribly.’
Carl Heneghan, a professor of evidence-based medicine at Oxford University and a campaigner for better regulation for medical devices, says the use of the tape for pelvic prolapse was accepted by the Medicines and Healthcare Products Regulatory Agency (MHRA) in 2005, after what he says was minimal testing of one year.
‘Why in the first place didn’t they say the mesh should only be used in the context of research?’ he told Good Health. ‘Why has the MHRA spent 12 years ignoring the evidence this mesh is dangerous?
‘We apparently allowed a device on to the market even though we didn’t know what happened to it beyond one year in the human body. It should have been tested for a minimum of five years.’
Kath Sansom says there has been no guidance on what women who already have the mesh should now do. ‘Should they be demanding to have it removed or what,’ she says. ‘We know it can break up more than ten years after it’s been implanted. Lots of women, including those who don’t have problems, must now be very worried.’
Meanwhile, women with incontinence or prolapse are in the dark about whether or not they should accept a mesh implant, or insist on being referred to a consultant with the skills to do a ‘native tissue’ repair. This procedure, which involves complex internal stitching, has fallen out of favour since the introduction of the mesh, which seemed to offer a quicker, cheaper alternative.
Wael Agur, a urogynaecologist surgeon from the university of Glasgow, said this week that there has been a resurgence of interest in the traditional repair technique since the problems of mesh have become widely known.
So far the MHRA and NHS England, which jointly approved the use of the mesh, have declined to comment. Both said they would not make a statement on the leaked draft of the NICE guidance because they have not seen it.
A spokesman for the Royal College of Obstetricians and Gynaecologists (RCOG) told us: ‘We are aware that some women experience complications following mesh surgery many years after the procedure.
‘We are pleased that a learning resource for GPs has been created so that women with mesh complications receive the appropriate support and can be swiftly referred to specialist centres that have a multi-disciplinary team of professionals who can listen, advise and support them.’
The RCOG website has a special section to help worried patients. Go to rcog.org.uk and search for ‘mesh information for the public’.
http://www.dailymail.co.uk/health/article-5122641/Victory-women-crippled-vaginal-mesh-implan.html
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Vaginal mesh implants to fix prolapse should be banned says health watchdog body
Nov 27, 2017 | Wisbech Standard
By Kath Sansom
NICE is set to recommend that operations using controversial plastic mesh devices be stopped in a ruling to be officially announced on December 20.
The guidelines say the mesh implants should only be used for research and not routine operations - campaigners have welcomed what they say is a back door ban.
Patient safety campaign group Sling The Mesh, which has 4,400 members, said: “These are not infrequent complications. They are common, serious and a personal tragedy for every woman involved.
“The NHS, Government and MHRA are in institutional denial about the number suffering.”
NICE said there were “serious but well-recognised safety concerns” and that “evidence of long-term efficacy [for implants treating organ prolapse] is inadequate in quality and quantity”.
It added that “when complications occur, these can be serious and have life-changing consequences”.
Guidelines on the mesh sling tapes to treat incontinence, and prolapse placed via the stomach, are due out in 2019.
MP Owen Smith and Emma Hardy are calling for those guidelines to be published earlier amid concerns from hundreds of patients across Britain.
Some implants can cut into the vagina, nerves, tissue, bladders, bowels and wombs.
Women have been left in permanent crippling pain, unable to walk, work or have sex.
Surgeons do not have to act on findings it receives from NICE but insurers look at surgical decisions based on NICE rulings.
The mesh implants are made of polypropylene and manufactured by different companies.
The main brand used in England are those by Johnson and Johnson.
They are used to support weakened tissue that causes incontinence or prolapse often caused by childbirth.
MP Emma Hardy said all mesh implants need to be suspended while the NHS carries out a retrospective audit to find out the true number suffering.
And while the MHRA says women need to report to their Yelllow Card scheme, MP Emma Hardy said many have never heard of it.
Many are ignored by their GP when they ask for help with problems they suspect are caused by mesh implants, she added.
Around 500 women in the UK are involved in a group action with lawyers Wedlake Bell against mesh makers Johnson and Johnson.
• Sling The Mesh has found that many surgeons claim they don’t use mesh but are using tape. Campaigners say it is a tape made of plastic mesh so by denying this they are breaking patient consent guidelines.
• Many surgeons insist they “don’t use that mesh in the media” because they implant their prolapse mesh through the tummy (transabdominally) and not vaginally. But the implant ends up in the same position - the vaginal vault - and patient experience on Sling The Mesh shows the issues are just as grave whether it is placed vaginally or abdominally.
http://www.wisbechstandard.co.uk/news/vaginal-mesh-prolapse-banned-by-nice-implants-1-5297671
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Vaginal mesh operations set to be banned
Nov 27, 2017 | Web MD
By Peter Russell
Vaginal mesh implants should be banned inthe NHS in England, the health watchdog has announced.
The recommendation comes after many women reported severe pain and disability after having the devices fitted.
In draft guidance, the National Institute for Health and Care Excellence (NICE) says they should only be used for research purposes.
Vaginal mesh implants are used to treat urinary incontinence and pelvic organ prolapse after childbirth.
The meshes are made by different manufactures from a plastic called polypropylene. They are used to support organs such as the vagina, womb,bladder, or urethra which may have been weakened while giving birth.
Pelvic painIn April this year, the BBC reported that more than 800 women in the UK are taking legal action against the NHS and the makers of vaginal mesh implants.
Some women have reported that the devices have perforated the lining of the vagina, leaving them in permanent pain, unable to walk or have sex.
One woman, Margie Maguire, 41, told the Victoria Derbyshire programme: "I havechronic pelvic pain on a daily basis and I'm on 9 different medications when I have a pain attack. These can last from 2 to 6 hours at a time and is like having a heart attack."
Another woman described how the mesh had cut its way through the wall of her vagina "like a cheese-wire".
'Insufficient evidence'The NICE recommendations say that current evidence on the safety and effectiveness of vaginal meshes is "insufficient in quality and quantity".
It says all 'adverse events' involving the devices should be reported to the Medicines and Healthcare products Regulatory Agency (MHRA).
In April, the MHRA released figures showing there were 733 adverse incidents in the UK for stress urinary incontinence and 346 for pelvic organ prolapse between 2012 and 2016.
The draft guidance is open for consultation until 22nd December 2017.
Final guidance is expected in March 2018.
A review earlier this year in Scotland concluded that vaginal meshes should not be routinely offered to women with stress urinary incontinence or pelvic organ prolapse.
https://www.webmd.boots.com/women/news/20171127/vaginal-mesh-operations-ban
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Is victory in sight for Cambridgeshire's Sling the Mesh campaigner?
Nov 27, 2017 | ITV News
A mother from Cambridgeshire - who has campaigned for two years against a medical procedure that has left thousands of women in crippling pain - appears to have won a major victory.
The National Institute for Health and Care Excellence (Nice) is due to issue new guidance on the use of controversial vaginal mesh implants next month.
But a draft report seen by the BBC's Victoria Derbyshire show suggests the watchdog will recommend the devices should no longer be used.
It would mark the end of a long battle for Wisbech journalist Kath Sansom, who began her Sling the Mesh campaign in 2015.
She had the procedure to treat incontinence after childbirth - but was left in debilitating pain. She soon found out many other women were in the same situation.
"I had terrible pain in my groin and in my legs. Sometimes it fells like there's knives cutting into me. It rang alarm bells because I knew you should be over it quite quickly. You're told it was this very easy operation."– KATH SANSOM, SLING THE MESH
A spokesman for Nice said its guidance would be published on December 20 and the watchdog would not comment until then.
Even if the watchdog does decide the mesh should not be used, its recommendations are not mandatory.
If officials wanted to ban the use of the implants it would also take action from the Department of Health and the Medicines and Healthcare products Regulatory Agency (MHRA).
Kath's campaign reached Westminster last month, when ministers faced fresh calls for a public inquiry into the implants - which have been offered to women to treat pelvic organ prolapse and incontinence after childbirth.
http://www.itv.com/news/anglia/2017-11-27/is-victory-in-sight-for-cambridgeshires-sling-the-mesh-campaigner/
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