Preview Newsletter
Ethicon Media Monitoring 7/12/2017
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Johnson & Johnson doubts vaginal mesh implants cause chronic pain, court hears
Jul 12, 2017 | The Guardian
By Christopher Knaus
Lawyers for the medical company Johnson & Johnson have argued there are “competing causes” of the chronic pain experienced by hundreds of Australian patients with its pelvic mesh implant. -
Report: J&J attempted to block French warning on transvaginal meshes
Jul 12, 2017 | Mass Device
By Fink Densford
Johnson & Johnson (NYSE:JNJ) attempted to stop health authorities in France from publishing a report which warned against the use of untested pelvic mesh devices for fear that it would damage their business, according to a new Guardian report. -
Mesh Makers Want Non-Residents Ousted from Philadelphia Court
Jul 11, 2017 | Mesh Medical Device Newsdesk
This story is just updated** Mesh makers, Johnson & Johnson and Boston Scientific want 97 transvaginal mesh plaintiffs ousted from Philadelphia Court of Common Pleas following a U.S. Supreme Court decision on personal jurisdiction. -
Kim Blieschke lobbies for change to pelvic mesh implant usage in Australia
Jul 11, 2017 | The Recorder
By Patrick Martin
‘You will be back on your feet within a couple of days.’ -
Port Pirie women report in national vaginal mesh implant complications survey
Jul 12, 2017 | The Recorder
As a class action against medical giant Johnson & Johnson begins in New South Wales over the company’s pelvic mesh device, complications surrounding mesh implants have been reported at Port Pirie. -
AU Mesh Trial Introduces Bleak Picture of Money Driven Physician
Jul 11, 2017 | Mesh Medical Device Newsdesk
In a class action trial of 700 Australian women who claim injuries from pelvic mesh, Johnson & Johnson documents reveal the sales pitch used to urge physicians to readily adopt the pelvic mesh implants. -
Vaginal mesh update: Johnson & Johnson tried to stop report about mesh implants
Jul 11, 2017 | Medical Plastics News
By Reece Armstrong
Johnson & Johnson allegedly tried to stop a report being published about its pelvic mesh devices, according to The Guardian.
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Johnson & Johnson doubts vaginal mesh implants cause chronic pain, court hears
Jul 12, 2017 | The Guardian
By Christopher Knaus
Medical company’s lawyers argue there are ‘competing causes’ for debilitating pain suffered by 700 women in class action
Lawyers for the medical company Johnson & Johnson have argued there are “competing causes” of the chronic pain experienced by hundreds of Australian patients with its pelvic mesh implant.
Three Johnson & Johnson group companies are fighting a major class action from 700 women, who allege faulty pelvic implants caused them debilitating pain.
Serious problems with the implants – used to treat two common complications of childbirth, pelvic organ prolapse and stress urinary incontinence – have given rise to class actions in the UK and US.
The Australian case, run by Shine Lawyers, alleges Johnson & Johnson failed to properly test the devices and played down their risk to both surgeons and patients. No randomised controlled trials were conducted, and it is alleged the testing that was conducted was too short term.Johnson & Johnson tried to prevent report about pelvic mesh devices, court hears
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Instead, the class action accuses Johnson & Johnson of embarking on an “aggressive marketing campaign” to sell the implants as a quick, easy, and therefore lucrative alternative to treatment options, such as native tissue repair.
This week Johnson & Johnson began its opening submission to the federal court, defending the devices and casting doubt on the causal link between the pelvic implants and the women’s chronic pain.
Its barrister, Steven Finch SC, said on Wednesday that the age and circumstances of the women meant there were “competing causes” for their pain.
He cited the example of one woman whose pain had not subsided after the device was removed.
Finch said the pain was later connected to a muscular-skeletal hip problem, which required a full hip replacement.
He said a pathologist who had examined excised tissue for Johnson & Johnson had found no evidence of nerve entrapment.
Part of the case against Johnson & Johnson is that the polypropylene mesh material oxidised and degenerated inside the body.
Finch earlier sought to cast doubt on that claim. He said the Prolene product used by Johnson & Johnson contained anti-oxidant agents. Even if oxidation had occurred, Finch said there was no evidence it had had any impact on the patients.
“Even if some of the processes were observed, we say that the objective, verifiable evidence is that there is no consequence,” Finch said.
One of the key complaints against Johnson & Johnson is that it sold the implantation procedure as a standardised and easily repeatable operation, when it was actually highly complex and required a skilled and experienced surgeon.
On Tuesday Finch argued against such a notion. He said the plaintiffs had misinterpreted the word “reproducible”, which had been used in Johnson & Johnson’s communications to surgeons.
Surgeons, he argued, understood “reproducible” did not mean that every surgery would be the same, or that every cut would be made in the same place and in the same size.
“Reproducible is not a step-by-step set of instructions which you slavishly follow without thinking for yourself,” Finch said.
“It is a furphy which your honour should remove from your consideration of this case.”
The case continued before justice Anna Katzmann. It is expected to last six months.
https://www.theguardian.com/australia-news/2017/jul/12/johnson-johnson-doubts-vaginal-mesh-implants-cause-chronic-pain-court-hears
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Report: J&J attempted to block French warning on transvaginal meshes
Jul 12, 2017 | Mass Device
By Fink Densford
Johnson & Johnson (NYSE:JNJ) attempted to stop health authorities in France from publishing a report which warned against the use of untested pelvic mesh devices for fear that it would damage their business, according to a new Guardian report.
The French report came 2 years after the devices began to see use in Australia, where the company is facing a lawsuit from hundreds of women who claim to have been left with chronic and debilitating pain, ruined sex lives and other side effects from the devices, according to the paper.
Prosecutors in the Australian case claim that internal documents show that J&J knew it lacked proper trials for the devices, according to the report. Prosecutors claim that Johnson & Johnson sought to stop a report from French health authority Haute Autorité de Santé which concluded that the meshes should only be used in clinical research until a proper randomized trial was conducted.
Internal documents from company meetings reportedly showed that the company feared the report “could have a major impact on our business if made public,” and went on to say that work was needed to “stop the publication of the report,” according to the Guardian.
Prosecutors in the case claim that J&J did not appropriately test the devices, and instead initiated an aggressive marketing campaign for the meshes, according to the paper. The case is still ongoing.
Last month, a Pennsylvania state court jury reportedly cleared J&J’s ethicon in the 4th pelvic mesh bellwether to go to trial in Philadelphia, despite finding that the company’s TVT-Secur product was defectively designed and that Ethicon failed to warn of its risks.
http://www.massdevice.com/report-jj-attempted-to-block-french-warning-on-transvaginal-meshes/
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Mesh Makers Want Non-Residents Ousted from Philadelphia Court
Jul 11, 2017 | Mesh Medical Device Newsdesk
Mesh Medical Device News Desk, July 11, 2017 ~ * This story is just updated** Mesh makers, Johnson & Johnson and Boston Scientific want 97 transvaginal mesh plaintiffs ousted from Philadelphia Court of Common Pleas following a U.S. Supreme Court decision on personal jurisdiction.
**NEW* As of Monday, July 10, the judge in the District Court for the Eastern District of Missouri removed 20 talcum powder cases, citing a recent controversial U.S. Supreme Court decision on jurisdiction. **this story is in production*
Harris Martin Publishing is reporting the latest here.
Here is the background.
On June 19, a Missouri judge declared a mistrial in a lawsuit filed by the estates of three women who died, allegedly after long-term use of Johnson & Johnson’s talcum powder.
Nothing happened in the courtroom to cause the mistrial.
Instead, earlier the same day, the U.S. Supreme Court (SCOTUS) issued a decision that dealt a blow to injured consumers and their ability to seek redress in the court of their choosing.
In an 8-1 vote, the Supreme Court decided that allowing plaintiffs to take their grievances to a favorable court when they don’t live in that state, was venue shopping.
See SCOTUS on Bristol Myers Squibb and BSNF Railway on personal jurisdiction.
The one dissenting vote, Justice Sonia Sotomayor, saw nothing wrong with it, noting that nothing is unfair about taking a massive corporation to court when the plaintiffs are made up of both resident and non-resident plaintiffs. After all, the product is sold nationwide.
The reason the St. Louis judge declared the mistrial was that two of the three talcum powder plaintiffs were from another state. The trial was just beginning so the judge decided a mistrial would be easier than trying the case twice.
The St. Louis court has been a particularly favorable venue for these talcum powder-ovarian cancer cases, awarding millions and huge punitive damages to the injured women. Another 1,700 women are in line to have their cases heard there.
Now transvaginal mesh cases are facing the same test in another court.
The legal departments of mesh makers, Boston Scientific (BSC) and Johnson & Johnson (J&J), have asked the Philadelphia Court of Common Pleas to throw out nearly 100 cases filed by plaintiffs who do not reside in Pennsylvania.
With that, potentially $46 million in recent transvaginal mesh injury awards would be challenged.
On June 30, 2017, J&J motioned the court with the misspelled title of, ”Preliminary Ojbections for lack of personal jurisdiction”
Read it here.J&J’s attorneys say the plaintiffs lacked personal jurisdiction.
To make its point, Ethicon attached the appeals of Ms. Hammonds and Carlino, both out-of-state plaintiffs who were awarded $12.5 and $13.7 in separate trials by the Philadelphia court.
Another plaintiff, Ms. Engleman, was awarded $20 million by the Philadelphia jury. She resides in New Jersey, but had surgery in Philadelphia, which could satisfy the personal jurisdiction criteria.
If the mesh makers get their way, $46 million in recent jury awards would be voided.
Another recent jury award ($2.16 million) in the Philadelphia court went to Sharon Beltz who resides in Pennsylvania.
Boston Scientific’s lawyers also filed a motion arguing that at least six plaintiffs who do not live, work or were injured in Pennsylvania should also have their cases dismissed.
BSC wants the court to reconsider its objection to personal jurisdiction that it filed with the court two years ago.
While defendant corporations call out nonresident plaintiffs, it should not go unmentioned that Boston Scientific is incorporated in Delaware.
BSC takes advantage of the business-friendly tax advantages of that state, but BSC has no principal place of business in Delaware. Its headquarters are in Massachusetts.
If the court agrees, there would be a review of 1,700 talcum powder lawsuits pending in Missouri and 180 transvaginal mesh cases pending in Philadelphia.
Ironically, J&J won its first pelvic mesh case recently.
However, Kimberly L. Adkins is from Ohio, so theoretically, it too would be dismissed from this jurisdiction. ###
http://www.meshmedicaldevicenewsdesk.com/mesh-makers-want-non-residents-ousted-philadelphia-court/
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Kim Blieschke lobbies for change to pelvic mesh implant usage in Australia
Jul 11, 2017 | The Recorder
By Patrick Martin
‘You will be back on your feet within a couple of days.’
For Port Pirie mother of three Kim Blieschke, her doctor’s words were a relief.
The year was 2006. The young mother of three had given birth to her third child, Ash, a beautiful baby boy five years earlier.
Kim’s joy was overwhelming; her path to motherhood had been anything but easy.
Of her three labours, two went for more than 24 hours, while Ash tipped the scales at 4.5 kilograms (10 pounds).
She had suffered a prolapse of the uterus, bowel and bladder – a common occurrence for mothers who have challenging labours – since 2001 and decided to fix the issue.
Her gynecologist recommended a new ‘gold-standard’ procedure – a transvaginal mesh implant surgery called a ‘Prolift’.
She agreed to the surgery, trusting the doctor and favouring the short recovery time.
As it turned out, her prolapse was only the beginning of her problems.
“I knew from the minute that I woke up from the operation that something wasn’t right,” Kim said.
She was told her operation was only going to take an hour. Two hours later, she awoke in agony.
Laying in recovery for six hours, nurses were unable to control her excruciating pain.
Something had gone horribly wrong, but it took time for Kim to realise the extent of the problem.
“The next day I found that I had great hand-sized bruises on my buttocks,” she said.
“When I asked what they were from, the doctor said to me that they were from giant needles that they push through your muscles to implant the mesh.
“I was never told anything about that before the surgery.”
The ‘Prolift’ surgery and technology was new to the Australian market, with women like Kim promised a quick and easy fix to prolapse, incontinence and other vaginal damage issues.
Kim described the mesh as a “great big shade-sail” which sits above the vagina to support the internal muscles and organs from falling down.
After pushing through bouts of pain for three months after the surgery, she was forced to visit her GP.
Her situation only got worse.
Her body had begun to reject the mesh, treating it as a foreign body. Her auto-immune system was attacking the implant.
“My GP examined me and found that the mesh had begun to erode from the side of my vagina,” she said.
“I had necrotic flesh. The prolapse impacted my life, but nowhere near as much as the mesh implant surgery.”
Four minor surgeries without anesthetic were undertaken to cut the mesh but each had little impact on her pain.
She went on to have another 10 major surgeries between 2007 and 2015 in Australia to try and remove the mesh without success.
Painkillers were futile as she tried to control her almost indescribable pain.
“The pain went on, and on, and on … it was like a deep nerve-burning pain,” she said.
“The mesh had adhered into my bowel, bladder, rectum, encroached on my nerves.
“I was told by four surgeons that the only way I could get the implant out was if I removed my bowel or bladder.
“If I couldn’t get this mesh out, I was going to be bed-ridden.”
Kim said no surgeon in Australia knew how to remove the mesh completely.
In desperation, she looked overseas and found a doctor in St. Louis, Missouri, who claimed to know how to remove the implant.
After substantial remote correspondence, she journeyed to the United States to have the mesh removed.
The upfront cost, excluding the surgery, was $50,000.
In the 11 years since her initial surgery, Kim said she had spent “hundreds of thousands of dollars” on surgeries, travel, pain medication and lost work.
She suffers painful reminders of her surgery each day.
“I have permanent nerve damage in my hip and leg, no feeling in my two little toes … there are days when I can’t physically get out of bed because I have so much pain,” she said.
“I used to ride bikes, swim … I can’t do anything like that any more.
“It causes painful sex, to the point where you can’t have sex.
“I have a pelvic floor that is destroyed, I am all but incontinent.
“There are women whose marriages have disintegrated because there is only so much people can take.”
In spite of her situation, she was determined to tell her story to support and protect other women suffering similar struggles.
“For years I thought I was the only one that this had happened to,” she said.
“I have been told many times that I am crazy and that I don’t have pain. I know my body and I know what pain is.
“I am strong but there are some days when I am just in tears.
“I am angry, but that doesn’t get you anywhere and that is why I am speaking out.”
In 2013, during the midst of her health crisis, she lobbied governments across the country for changes to the use of pelvic mesh implants without success.
It was only in 2016 when she flew to Melbourne to lobby federal Senator Derryn Hinch that she had a breakthrough.
She said the controversial senator was crucial in instigating a federal Senate inquiry, which is seeking to understand the extent of the technology’s use in Australia.
No records of Australian mesh implant procedures have been kept.
The Australian Government’s Therapeutic Goods Administration only updated their list of potential side-effects for surgical mesh complications in August last year.
The mother of three continues to support women across the country by managing a Facebook group dedicated to offering help to those suffering from mesh implant complications.
Her story was also one of many submitted to the Senate inquiry and the 700-strong class-action against Johnson & Johnson. She nominated herself to be called as a witness to both hearings.
The ‘Prolift’ technology is included in the class action against Johnson & Johnson.
She hoped to attend the class-action hearing in Sydney this week, but admitted it would be challenging.
“I have spoken to a few women who were over there last week, and some of them where aghast at some of the evidence that was coming out,” she said.
She had a simple wish for the outcomes of the class-action and Senate inquiry.
“I hope it is banned, hope they put up big warnings about this stuff,” she said.
“There is no way any amount of money could change what has happened to me in my life.
“It has cut me and a lot of other women down in the prime of our lives.”
http://www.portpirierecorder.com.au/story/4782330/the-pain-went-on-and-on-and-on/
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Port Pirie women report in national vaginal mesh implant complications survey
Jul 12, 2017 | The Recorder
As a class action against medical giant Johnson & Johnson begins in New South Wales over the company’s pelvic mesh device, complications surrounding mesh implants have been reported at Port Pirie.
The Victorian-based not-for-profit consumer advocate, Health Issues Centre, conducted a survey into the impact of Transvaginal Mesh Implants for submission to a federal Senate inquiry.
More than 2000 women have been surveyed by HIC across Australia, with five women from Port Pirie responding to the survey. The technology has been used to treat complications caused by childbirth.
Of those respondents who had implants, about half claim to have been adversely affected, citing problems such as chronic incontinence, abdominal pain, painful intercourse and marital breakdown.
The Senate inquiry was seeking to understand the extent of the technology’s use in Australia – no records of mesh implant procedures performed in Australia have been kept.
Health Issues Centre chief executive officer Danny Vadasz said while the figures are just the “tip of the iceberg”, they are finally providing a clearer picture of the unfolding tragedy.
“Even the Therapeutic Goods Administration, which is conducting its own due diligence into the adverse impact of the implants, has had minimal success,” Mr Vadasz said.
“From July 2012 to 1 June 2016, it only received 99 adverse events reports involving urogynaecological surgical meshes.”
Mr Vadasz believes the transvaginal mesh tragedy will eclipse the Thalidomide disaster of the ‘50s and ‘60s which is estimated to have affected approximately 200 women across Australia.
The class action against Johnson & Johnson in NSW is being filed by 700 women.
The Australian Commission on Safety and Quality in Health Care estimates 100,000 women have had pelvic mesh implants since the late 1990s, but the number of women who have been adversely impacted is unknown.
The HIC’s survey and study is ongoing and can be accessed online.
The findings of the Health Issues Centre survey as of May, 2017:
· 73% of the 1,571 respondents had undergone mesh implants. This equated to 1,141 women.
· 49% of the 1,141 women said they experienced adverse effects from their mesh implant. 415 cited incontinence, 318 abdominal pain, 313 pain during intercourse and 127 breakdown of their marriage or other personal relationship.
· 41% of women who had been adversely impacted believe they were not fully informed before agreeing to the procedure. Another 22% felt things had not gone according to what they had originally been told, leaving 35% that believe they had made an informed choice.
· 34% of the women reported their adverse impact as “discomforting” while 30% said it was “debilitating” and 12% “unendurable”.
· While 61% of the women who had been adversely impacted sought remedial medical assistance, only 10.6% reported this made things better. For 40% it didn’t make any difference while for 11% it made matters worse. 39% were simply told there was nothing that could be done.
· 48% of overall respondents were over the age of 60.
http://www.portpirierecorder.com.au/story/4772227/mesh-implants-impact-port-pirie-locals/
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AU Mesh Trial Introduces Bleak Picture of Money Driven Physician
Jul 11, 2017 | Mesh Medical Device Newsdesk
Mesh Medical Device News Desk, July 10, 2017 ~ In a class action trial of 700 Australian women who claim injuries from pelvic mesh, Johnson & Johnson documents reveal the sales pitch used to urge physicians to readily adopt the pelvic mesh implants.
It’s estimated 8,000 Australian women were implanted with pelvic mesh beginning in 2005.
Here is a review of the recent coverage of this precedent setting trial.
In an Opinion piece in The Herald, Saturday, July 8, reporter Joanne McCarthy writes about a revealing document introduced in the first day of this class action trial, expected to last six months.
Entitled, “The Practice-Driven Physician,” it was an aggressive marketing campaign authored by Ethicon in 2010, that was intended for physicians who would be the ready and willing market for upcoming pelvic mesh devices to treat incontinence and prolapse.
The J&J target doctor was highly motivated to succeed and to grow a positive reputation as well as revenue by adopting the eight-minute procedure to treat incontinence or pelvic organ prolapse.
Ideally, the doctor could charge more and perform four procedures before lunch. There is no mention of the patient in this sales pitch.
As an example, the ideal doctor is quoted as saying he, “just got back from a week in St. Moritz- fabulous ski conditions. I picked up the Lamborghini on Friday. An amazing machine.”
That kind of doctor.
Two women, who have had to stand during much of the trial due to their pelvic injuries, were met by McCarthy outside the courtroom, visibly shocked and horrified by the description.
McCarthy equates mesh injuries to child abuse carried on by institutions she reported on in Australia. Both involve abuse of power and a lack of consent.
She writes, “Doctors do not want to hear this, and some will no doubt be angered by the comparison. But the medical industry – for that is what the mesh device scandal exposes – has to face what that Johnson & Johnson document says. Women patients have been reduced to things.”
ABC.net.au reports a lawyer for Johnson & Johnson, Steven Finch SC told the court that transvaginal mesh has been used to treat a wide variety of pelvic-floor problems, including urinary incontinence and organ prolapse.
“All devices have pros and all have cons. It’s not defective if a device has a con,” he said.
“The fact the device is associated with a rate of failure is simply one of its features.”
J&J TRIES TO SPIKE REPORT
Reporter Christopher Knaus, reports that the case of 700 women is being heard before Justice Anna Katzmann in federal court in Sydney, Australia.
In week one, The Guardian reports the plaintiffs’ lawyers told jurors women were used as guinea pigs after J&J tried to stop French health authorities from publishing warnings about the use of untested pelvic mesh.
Just as occurred in the states, the Australian version of the Food and Drug Administration, the Therapeutic Goods Administration (TGA), did no testing and required no clinical trials before the mesh devices were placed on the market.
Ethicon, the medical device division of Johnson & Johnson, told doctors the devices were inexpensive and simple to implant in women.
There would be many women in need, especially as the baby boomer generation aged. More devices would mean more income to a medical office. But there was a problem – without randomized controller clinical trials the scant testing on dogs, sheep and cadavers was insufficient or too short-term.
Barrister Duncan Graham SC said “It was sell first, test later. The women who had them implanted were part of an experiment, they were guinea pigs.”
THE FRENCH REPORT
In 2007, Ethicon was concerned about a French report.
It concluded clinical research was needed on Ethicon’s pelvic organ prolapse (POP) mesh Prolift, before the pelvic mesh could be approved or cleared for market.
At that time, Prolift was already being sold in Australia and had been for two years, reports The Guardian.
Minutes from an Ethicon meeting said the company feared the report “Could have a major impact on our business if made public.”
SAFE AND EFFECTIVE
A New England Journal of Medicine article published in 2011, Anterior Colporrhaphy versus Transvaginal Mesh for Pelvic-Organ Prolapse, was supportive of the mesh devices.
Two years later, JAMA revised the report, admitting the study was edited by Ethicon.
The authors, Daniel Altman among them, had been paid consulting fees. Ethicon reviewed and edited the pre-submission draft of the manuscript. The conflict of interest disclosure did not contain that information.
There were significant differences to the articles.
The article said the mesh could be implanted in a standardized technique, negating the complexity of the surgery beyond the skills of a lesser-trained inexperienced surgeon.
Instead, according to an article in The Lancet in December, women with pelvic mesh implant were roughly three times more likely to suffer a complications and twice as likely to require revision surgery compared to women who had surgery using sutures alone. ###
http://www.meshmedicaldevicenewsdesk.com/au-mesh-trial-introduces-bleak-picture-money-driven-physician/
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Vaginal mesh update: Johnson & Johnson tried to stop report about mesh implants
Jul 11, 2017 | Medical Plastics News
By Reece Armstrong
Johnson & Johnson allegedly tried to stop a report being published about its pelvic mesh devices, according to The Guardian.
French authorities were planning to release a report on the mesh devices in 2007 which found that the devices required a proper randomised controlled trial before they could be approved.
The report showed that the Johnson & Johnson mesh products should only be used in clinical research until a trial had been completed. At this point in time the devices had been on the Australian market for two years.
Johnson & Johnson feared that the report could have a major impact on its business if made public. Concern was raised by Johnson & Johnson's subsidiary Ethicon. Meeting minutes showed in court detailed Ethicon stating that work was needed to "stop the publication".
The trial involving over 700 women started in Australia’s federal court earlier this month. The women are alleging that Johnson & Johnson’s vaginal mesh implant was not adequately tested and that the company failed to warn patients and surgeons of the risk.
It’s not the first time Johnson & Johnson has had controversy surround its vaginal mesh implant. In 2016the company agreed to pay over $120 million in relation to 2,000-3,000 US legal cases brought by women who claimed to have suffered organ damage due to vaginal mesh.
MPN discussed the issue earlier this year, with editor Lu Rahman writing that “vaginal mesh implants, made from polypropylene, are used to treat pelvic organ prolapse and incontinence following childbirth. However, some have been found to cut into the vagina, causing discomfort. Some of the women say they have been left unable to walk or have sex.”
The trial is expected to last for six months and it's possible Johnson & Johnson will have to pay out hundreds of millions to the affected women.
Speaking about Johnson & Johnson’s involvement in the case, barrister Tony Bannon SC said that the company did not properly communicate the risks of the vaginal mesh to either patients or surgeons and instead marketed the benefits of the products to surgeons.
Speaking during the trial’s opening statement, Bannon said: “They were overwhelmed by a tidal wave of aggressive promotion, designed to persuade both surgeons and patients of the quick, easy one operation able to resolve the particular difficulties.”
After facing legal action in the United States, Johnson & Johnson stopped selling the mesh. The company claimed it was a commercial decision.
Whilst Johnson & Johnson claim the vaginal mesh was supported by clinical research, clinicians involved in testing the device allegedly knew the risks the mesh presented.
Bannon cited an email exchange involving a French doctor who was running a clinical trial for the Johnson & Johnson implant. The doctor, Bernard Jacquetin allegedly stated that he wouldn’t like his own wife to undergo this procedure.
Johnson & Johnson has been unable to ascertain the total number of women adversely affected by the vaginal mesh implants. The company has sold over 100,000 mesh implants and stated that it’s the preferred option for pelvic conditions such as incontinence and pelvic organ prolapse.
http://www.medicalplasticsnews.com/news/hunderds-o/
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