Preview Newsletter
Ethicon Media Monitoring 1/24/2018
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WATCH: Irish woman explains the pain caused by vaginal mesh implant
Jan 23, 2018 | thejournal.ie
TONIGHT RTÉ’S PRIME Time reported on international scrutiny around vaginal mesh implants, which are used in operations to address stress urinary incontinence and pelvic prolapse. -
'Incontinence, groin pain, I find it hard to walk and physical relations with my husband are impossible'
Jan 24, 2018 | thejournal.ie
There is global scrutiny surrounding transvaginal mesh devices which are used in surgeries to treat conditions women can develop after a natural childbirth. Thousands of women have reported complications such as the mesh protruding through the vagina, chronic pain, and recurrent urinary tract infections. -
Australia Pulls Ethicon TVT Mesh Devices from the Market
Jan 23, 2018 | Mesh Medical Device Newsdesk
Last November the Australian government announced that the larger pelvic meshes to treat pelvic organ prolapse (POP) would be taken off the market because the risks outweighed the benefits. -
Vaginal mesh implants - a straightforward procedure that's causing constant agony for Southampton women
Jan 23, 2018 | Daily Echo
By Sally Churchward
THEY were told that it was a straightforward procedure that would end the difficulty of urinary incontinence. -
Mesh victims celebrate 'extraordinary' move by American pharmaceutical giant
Jan 24, 2018 | Newcastle Herald (Illawarra Mercury)
By Joanne McCarthy
AMERICAN pharmaceutical giant Johnson & Johnson has withdrawn its “gold standard” incontinence pelvic mesh slings from the Australian market after devastating evidence from women at a Senate inquiry and Federal Court civil case, and action by Australia’s medical device regulator. -
Johnson & Johnson Withdraws Ethicon’s Gynecare TVT Products from Australia Amid Continuing Transvaginal Mesh Lawsuits
Jan 24, 2018 | RX Injury Help
By Laurie Villanueva
Johnson & Johnson is withdrawing Gynecare TVT pelvic mesh devices manufactured by its Ethicon, Inc. subsidiary from the Australian market, after the company failed to meet a deadline for updating the products’ “instructions for use” set by that country’s medical device regulator.
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WATCH: Irish woman explains the pain caused by vaginal mesh implant
Jan 23, 2018 | thejournal.ie
TONIGHT RTÉ’S PRIME Time reported on international scrutiny around vaginal mesh implants, which are used in operations to address stress urinary incontinence and pelvic prolapse.
These are conditions women can suffer as a result of natural childbirth. Health watchdogs in a number of countries have suspended the use of some of these products, but surgeons in Ireland continue to use them.
In October last year, TheJournal.ie spoke to a number of Irish women who suffered complications after one of these surgeries. Margaret, above, was one of those women. She and other impacted women will be protesting outside Leinster House tomorrow to bring awareness to the issue.
https://www.thejournal.ie/vaginal-mesh-video-3813229-Jan2018/
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Jan 24, 2018 | thejournal.ie
There is global scrutiny surrounding transvaginal mesh devices which are used in surgeries to treat conditions women can develop after a natural childbirth. Thousands of women have reported complications such as the mesh protruding through the vagina, chronic pain, and recurrent urinary tract infections.
These procedures have been carried out on women in Ireland since the late 90s and are still performed today. Niamh describes how her life changed forever when what was described as “a simple operation” left her in pain, exhausted and meant she could no longer be intimate with her husband.
I WAS 48 when I first started to experience stress urinary incontinence. First, it was little leaks from coughing and sneezing, but it got so bad my bladder could empty spontaneously at any time – it was distressing.
My gynaecologist had me on medication for it at the start and physiotherapy, but none of that worked. I was offered an operation.
The surgeon would use a mesh sling to lift up my bladder. I have no recollection of being told of any complications.
I would never have agreed to the operation if I had known what was to come.
In March 2008 I had my operation. Within 48 hours of being released I was in the emergency department. Diagnosed with an infection, I was given antibiotics and sent home again. I felt mostly fine, but I did notice I had to stand and bend over to empty my bladder properly.
Four years later I started getting recurring urinary tract infections and I was constantly on antibiotics. I was worried about the amount I was taking and I had begun to notice a sore sensation in my vagina so I went to see a urologist. A cystoscopy revealed my bladder was covered in red blotches from the infections.
In an appointment with a different urologist, he told me he could feel where he thought the mesh was protruding into my vagina and causing the pain. He told me he could remove this portion of the mesh and I agreed to this.
The partial remove left its own problems.
My complications have been extremely difficult to deal with. As you can imagine any physical relationship with my husband is impossible. This is very stressful and embarrassing to have to discuss with anyone, even the urologist. While my family and close friends would know my situation, I am from a small town in Cork – I would feel embarrassed if people found out about me.
I now have urge incontinence, pain in my groin on the side of the partial removal, pain in my lower abdomen and find it hard to walk any great distance because of pain and weakness. I am constantly tired and can only do so much housework before I have to rest.
Everything I do is affected by mesh. I have to ask ‘Will I be able?’ before I go anywhere or do anything. I couldn’t, for instance, go shopping for four or five hours, I would feel like I was going to collapse with weakness in my legs and pain. I hope someday to have grandchildren, but I know I will be physically unable to enjoy them or even mind them as I had hoped to do.
I am only 58 years of age and I feel as if I am 90.
This afternoon I will be protesting at Leinster House with other women affected by vaginal mesh complications. I’ll be joined by my husband who is very supportive.
It is important to me to let the people in Ireland know how devastating this mesh is. I would hate anyone to go through what I am going through today.
I want politicians to know that we went for a so-called simple operation to repair an embarrassing issue. We have ended up having our lives devastated.
I think my life is changed forever and I will have to live with that until the day I die, all because of this “simple operation”.
Niamh is a 58-year-old mother-of-one from Co Cork. She is one of a number of women in Ireland who have reported painful complications after an operation using surgical mesh. She and other members of the Mesh Survivors Ireland group will protest at 12pm outside Leinster House today.
https://www.thejournal.ie/readme/vaginal-mesh-protest-pain-physical-3812361-Jan2018/
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Australia Pulls Ethicon TVT Mesh Devices from the Market
Jan 23, 2018 | Mesh Medical Device Newsdesk
Mesh Medical Device News Desk, January 23, 2018 ~ Last November the Australian government announced that the larger pelvic meshes to treat pelvic organ prolapse (POP) would be taken off the market because the risks outweighed the benefits.
Now in another setback to mesh makers, Johnson & Johnson’s Ethicon TVT mesh devices can no longer be sold in that country because it failed to update its warnings. However, many other pelvic meshes remain on the market in Australia.
Johnson & Johnson has been forced to withdraw all of its TVT mesh devices from the Australian market after it failed to update its warning label by a government imposed deadline.
The Australian Therapeutics Good Administration (TGA) ordered all transvaginal mesh makers to update instruction to include all known complications by January 17, 2018.
While Boston Scientific and Coloplast met the deadline, J&J did not.
Complications include mesh erosion, groin pain, bladder and vaginal perforation, severe chronic pain and infection, painful sex, nerve pain, need for repeat surgeries, need for mesh removal, among other complications. Mesh makers have been accused by plaintiffs’ lawyers of underplaying complications, omitting complications, and failing to fully inform doctors about potential adverse events.
J&J and its Ethicon division did not meet the January deadline therefore TGA deregistered the entire line of Gynecare TVT products including mid-urethral vaginal slings to treat stress urinary incontinence (SUI).
Those that can no longer be imported include:
Johnson & Johnson – TVT Abbrevo, TVT Exact Retropubic system, Gynecare TVT-Obturator, Gynecare TVT device, and Gynecare TVT w. Abdominal.
The Guardian newspaper did not confirm whether or not those products that remain on hospital shelves can still be used.
*New Add* The Gynecare products listed above are all still sold in the U.S. The TGA does not address are Artisyn Y-Shaped mesh and Gynecare PS, which are also still sold and marketed in the U.S.
REACTION
The president of the Royal Australian and New Zealand College of Obstetricians and Gynaecologists, Professor Steve Robson said J&J products were probably the most used to treat SUI, reports The Guardian.
He is quoted as saying “In fact, I think it’s regrettable it won’t be available for a while, but there are other similar products.” Dr. Robson said mid-urethral tapes are an appropriate treatment for SUI and are “very safe.”
Mini-slings are not being removed from the Australian Register of Therapeutic Goods (ARTG), just mid-urethral slings.
Since 2013, 45 devices have been removed from urogynecological use by the TGA. Additional devices have been removed by the mesh maker.
At the present time, a product liability lawsuit involving 700 Australian women is wrapping up in Sydney. Closing arguments are reportedly set to begin next week by the Shine Lawyers.
Buzzfeed quotes Professor Christopher Maher who estimates more than 200,000 mesh implant surgeries have been performed in Australia.
MET THE DEADLINEAt the same time, some mesh makers did meet the deadline. They include:
Boston Scientific devices:Advantage Single Handle Kit (UPN M0068502000);Advantage Fit – single (UPN M0068502110);Advantage Fit – 5 pack (UPN M0068502111);Lynx Suprapubic Mid-Urethral Sling Sys. (UPN M0068503000);Lynx Suprapubic Sling Syst 5-Pack (UPN M0068503001);Obtryx Curved Single System Device (UPN M0068504000);Obtryx Halo Single System Device (UPN M0068505000);Obtryx Halo System 5-Pack (UPN M0068505001);Obtryx II, Halo, Single unit (UPN M0068505110); andObtryx II, Halo, 5 pack (UPN M0068505111).
Coloplast devices:Aris (UR3010);Aris kit with Aris mesh (UR3105); andSupris kit with Aris mesh (519562)
Last November, Australia’s TGA announced it planned to remove transvaginal mesh products to treat pelvic organ prolapse (POP). TGA felt the benefits of using transvaginal mesh products to treat POP did not outweigh the risks.Devices that remain on the market include the Boston Scientific Xenform Tissue Repair Matrix, Upsylon Y-Mesh Kit, (neither to be implanted transvaginally). Boston Scientific Advantage Range, Lynx Range, Obtryx Range had to undergo updated precautions added to the label.
Coloplast Restorelle Range may not be implanted transvaginally. Coloplast Aris, Aris kit with Aris mesh, Supris kit with Aris mesh, could only stay on the market with updated information.
In June 2012, J&J withdrew four Gynecare pelvic mesh products in the U.S. including Prolift, Prolift +M, TVT Secur and Prosima. ###
https://www.meshmedicaldevicenewsdesk.com/australia-pulls-ethicon-tvt-mesh-devices-market/
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Jan 23, 2018 | Daily Echo
By Sally Churchward
THEY were told that it was a straightforward procedure that would end the difficulty of urinary incontinence.
But, instead, Eleanor May-Johnson and Suzie, both from Southampton, are among thousands of women in the UK whose lives have been blighted by vaginal mesh implants.
The implants are used to treat pelvic organ prolapse and incontinence in women, often following childbirth.
The mesh is usually made from synthetic polypropylene and is intended to repair damaged or weakened tissue.
The implants have been widely used throughout Europe, Australia and North America, since the early 2000s.
But NHS data indicates that one in 15 women who have had mesh implants have had to have them removed.
And mesh campaigners, as well as the Labour Party, are calling for use of mesh plants to be immediately halted and are urging the government to carry out a full public enquiry into the controversial procedure, which is causing some women severe pain and incontinence, while mesh campaigner Chrissy Brajcic died from sepsis.
Despite already having had two operations to remove mesh that had become loose, Eleanor, a midwife, is still in constant discomfort.
Meanwhile, Suzie has undergone five surgeries to remove mesh after it began to cause her severe pain, and is still in constant agony. At just 42 she has been medically retired and has gone from working in a high pressure job as an analyst for an insurance company, with an active lifestyle including ten hours of tae kwondo training a week, to having to alternate between sitting on the sofa or lying down, unable to find relief from her intense pain.
Eleanor, now 46, developed urinary incontinence following the birth of her three children, now aged 29, 24 and 21.
The condition worsened over time, and in December 2005, she had surgery to implant TVT (tension-free vaginal tape).
But within less than nine months, she had mesh exposure – a fragment had broken off and was visibly sticking out of her body. It was, of course, extremely painful.
She had surgery to remove the fragment, but five years later, the same problem happened again and further surgery was necessary.
“I was told that it was extremely rare and that my surgeon had never seen it happen five years later,” she says.
“I thought I was just unlucky, but then a couple of years ago I began to see the stories about mesh implants in the media, and realised that it wasn’t that rare after all, and a significant number of women have had problems that are much worse than mine.
“I still have more mesh inside me. I can feel a piece right by my urethra, and along one side of my vagina. I know it will be difficult to remove, because these are such sensitive structures and the mesh was designed to bond with the body’s tissues.”
Eighteen specialist mesh centres have been set up across the country for women experiencing problems related to mesh implants, but demand is high and waiting lists are long.
Eleanor was referred to University College London Hospitals (UCLH) in November, but the waiting list for a consultation is around eight months, with a similar wait for surgery after that.
“It feels like there is a ticking time bomb inside you,” she says.
“I feel very let down my the manufacturers of this device. It wasn’t communicated to women that there might be any complications. I was just told about the usual risks of having surgery.”
Eleanor has become involved with pressure and awareness group Sling the Mesh, which is calling on the government to ban all mesh and tape implants in the UK, a move which has already happened in Scotland.
While a number of women are taking legal action regarding their implants, Eleanor is not sure whether she will do so.
“The NHS doesn’t have any money and I don’t want to sue the NHS. I would rather go after the manufacturer but I’m outside of the ten year limitation period. However, I wasn’t aware of there being general issues with the device until two years ago.
“We’re asking the government to change the law so that we can go after the manufacturer.”
Eleanor adds that she wonders if the problem is being underestimated in part because women are being falsely perceived as being over dramatic about their symptoms.
“Women are often told that they are imagining their pain, that they’re depressed or that they’re mentally ill,” she says.
“I feel very angry and let down.”
Suzie developed urinary incontinence following the birth of her daughter, now 19. She had TVT surgery in 2012 and it was immediately apparent that something was not right.
“I never really recovered,” says the 42-year-old from Southampton.
“At my post-operation check, my surgeon said that something wasn’t right and thought that perhaps I was allergic to the material.”
A couple of months after the implant, Suzie was back in surgery again, but unfortunately it wasn’t all removed.
She has had a further four operations to remove the mesh but some still remains in her body.
Suzie was referred by her GP to specialists at UCLH in October, but found out last week that her referral had not been received so has had to start the process again.
In the meantime, she is left in what she describes as constant and horrendous pain.
“It is like someone is stabbing me in the groin and twisting the knife. When I try to walk, it feels like something is literally cutting into my urethra. It’s excruciating. I also have a constant feeling like severe period pain.
“I also have main in my lower back and hips – it feels like my pelvis is twisted.
“The worst pain is trying to wee. I find myself screaming and crying. It’s like trying to pass razorblades. It’s easier when Im incontinent as at least it’s not as painful as actually trying to wee. It’s got to the stage where I don’t think it can get anymore painful, but then it does.”
Suzie’s life now could hardly be more different to before her surgery. She had a well-paying full-time job, and often travelled with work. Having divorced her daughter’s father, she was also busy as a single mum, and filled the rest of her time with lots of hobbies, including tae kwondo training – she has a black belt – walking, running, playing the piano and socialising.
Now, she can only get about using a mobility scooter or, on a good day, a walking aid, and is largely confined to the house, due to double incontinence, pain and lack of confidence.
“It has made my life unbearable,” she says.
“I’m very depressed. I have shut myself off from my friends. I can’t really go out. I used to be very fit and sociable. Now I’m just at home and I hardly speak to anybody.
“I can’t express how horrible it is. I can’t get any relief from the pain. I can’t sleep. I can’t do any of the things I used to enjoy doing. I can’t even play piano because it’s too painful to sit at it.
“I just alternate between short spells of either lying down or sitting on the sofa. There’s nothing else I can do to relieve the pain.
“It has been bad for a couple off years, but it’s got worse recently,and the last six weeks have been a living hell.”
Suzzie would like to see the government suspend the use of all mesh implants while a full public enquiry is carried out and to give the NHS a cash injection, to provide mesh awareness training in the NHS so that women can be referred for the treatment they need and to bring down waiting times.
“It is incredibly expensive to see someone privately, and I just don’t have that kind of money. I used to have a fantastic job where I made good money, and now I’m struggling to make ends meet, with no future prospects whatsoever.
“I feel very let down. We weren’t warned that this could happen and now the NHS isn’t in a position to offer us the treatment that we need to fix it”
A survey of members of campaign group, Sling The Mesh, shows how previously healthy women must adjust to devastating new normals if they suffer complications after a quick fix operation for prolapse or incontinence.
The survey of 570 women comes before a Westminster mesh think tank meets on Tuesday, January 30.
It shows seven out of ten women lose their sex lives and six out of ten suffer depression, while one in seven lose their marriage/partners.
A third give up work completely, while one in five reduce their hours to cope.
More than half suffer constant urinary infections (UTI/cystitis), and one in 20 are becoming antibiotic resistant, a dangerous condition which puts them at risk of sepsis.
The survey shows that the majority (two thirds) had a mesh tape to fix incontinence – the type of mesh that surgeon society, RCOG says is an effective treatment for many women. Only a third had prolapse mesh – vaginal prolapse mesh was effectively banned at the end of last year.
Commenting on the survey, Chair of the APPG on Surgical Mesh Implants, Owen Smith MP said: “These results are truly heart-breaking and show the shocking extent of the suffering some women are facing following mesh implant surgery. Many of the issues detailed in the survey are life-changing and cannot be ignored. I am calling on the Government to urgently conduct a full audit of all patients who have been treated with mesh and a undertake a prospective registry of any new patients. Until we have a clear understanding of the long term risks and benefits of mesh, its use should be suspended.”
Kath Sansom of Sling The Mesh said: “The survey shows the personal devastation. We have women in the group who are suicidal, who don’t want to carry on because the pain is so intense. Yet previously they led healthy lives.
“Surgeon societies know there are big problems as 18 specialist mesh centres have been set up across England. Also conferences are being held on how to deal with mesh litigation.
“Surgeons only monitor women for around three months after an operation so have no idea of the scale of suffering as some problems take months or years to cut in. There is little reliable audit to back up claims it is a long term solution because there is no National Register like there is for hip implants.”
Of those surveyed, further results include: eight out of ten suffer pain when walking, seven out of ten lose their sex lives and six out of 10 suffer depression and anxiety.
http://www.dailyecho.co.uk/news/15886000.A_straightforward_procedure_that__39_s_causing_constant_agony_for_Southampton_women/
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Mesh victims celebrate 'extraordinary' move by American pharmaceutical giant
Jan 24, 2018 | Newcastle Herald (Illawarra Mercury)
By Joanne McCarthy
AMERICAN pharmaceutical giant Johnson & Johnson has withdrawn its “gold standard” incontinence pelvic mesh slings from the Australian market after devastating evidence from women at a Senate inquiry and Federal Court civil case, and action by Australia’s medical device regulator.
The move this month has been described as “extraordinary” and “fantastic” by consumer and women’s health groups which campaigned strongly for their removal, but a backward step by doctors who said the “gold standard” TVT incontinence devices had helped tens of thousands of Australian women since they were introduced in 2004.
Johnson & Johnson withdrew before a January deadline to meet new Therapeutic Goods Administration (TGA) guidelines announced in December requiring companies to warn that devices could lead to complications including severe and chronic pain, groin pain and bladder perforation.
On Tuesday the TGA released an updated list of pelvic mesh devices available in Australia which showed only two companies still marketing 13 devices, down from about 100 devices and multiple companies in 2013. The Johnson & Johnson mesh slings can continue to be implanted in Australian women until supplies run out.
The TGA in November banned all prolapse pelvic mesh devices implanted via the vagina because of little or no evidence backing their safe use. In December it banned a small group of problematic incontinence slings and issued new guidelines requiring remaining incontinence devices, including the “gold standard” slings, to clearly warn of the risks to women.
Johnson & Johnson’s decision to withdraw surprised women and consumer health groups after the TVT devices – whose prototype and early procedure were developed in Australia – were strongly backed by doctors giving evidence at a Senate inquiry and Federal Court case brought by more than 800 Australian mesh victims against Johnson & Johnson.
The Johnson & Johnson devices have repeatedly been described as the “gold standard” slings to treat incontinence because of recognised trials supporting their use.
But Robyn Ramster, Lynda Garlinge and Hunter woman Teigan – who experienced severe and extreme complications after she was implanted with a Johnson & Johnson incontinence sling when she was 22 – said the slings were just as capable of destroying women’s lives as the more recognised problem devices used to treat prolapse.
“We’re paying the price for their experiments on women,” said Mrs Garlinge, 68, who spent nearly a decade dealing with severe and disabling complications after surgery for incontinence in 2004 without knowing she was one of the earliest cases to receive a TVT mesh sling.
Her doctor was dead by 2014 when she read surgery notes saying she had been implanted with a Johnson & Johnson TVT sling without her consent.
“I felt like I’d been raped. That’s how I felt,” she said.
I’ve lost the best years of my life and now I’m going to lose the rest. I get so angry. How could this have happened?Lynda Garlinge
Mrs Garlinge said Johnson & Johnson’s withdrawal from Australia was “good news, but they would have kept on putting these things into women if they hadn’t been found out”.
“I’ve lost the best years of my life and now I’m going to lose the rest. I get so angry. How could this have happened?” Mrs Garlinge said.
Robyn Ramster, 64, lived with chronic pain and urinary tract infections after she was implanted with a Johnson & Johnson TVT mesh sling for incontinence in 2005.
When she sought help from doctors she was told her problems could not be linked to the TVT device “because it was known to have worked so well for so many women”, she said.
In 2017 she had surgery which a doctor described as “scraping the mesh off your bladder”.
She was pleased on Wednesday to hear that Johnson & Johnson had withdrawn its devices from Australia but “the sad thing is it took so long for people to listen to us”.
“It was only because of the publicity that women like me started hearing other women describing what was happening to them, and suddenly thinking ‘That’s me. That’s happening to me’,” Mrs Ramster said.
She said the rapid uptake of pelvic mesh devices and slings in Australia, without doctors, doctors’ groups and regulators properly scrutinising the research manufacturers were relying on, was “disgraceful”.
Consumer Health Issues Centre chief executive Danny Vadasz described Johnson & Johnson’s withdrawal as “an extraordinary decision”.
“It suggests they have concluded that a withdrawal from the Australian market is preferable to continued scrutiny,” Mr Vadasz said.
“Under such circumstances it’s extraordinary that some health professionals are calling for stock still in circulation to be used up rather than withdrawn and are focussed on finding equivalent substitutes. When will the penny drop?”
A TGA spokesperson said Johnson & Johnson withdrew supply of its mid-urethral sling devices to enable them to consider their options in response to the TGA’s request from December.
“From 17 January 2018, Johnson & Johnson had decided to withdraw supply. Use of devices supplied prior to the 17 January date is at the discretion of the medical practitioner and the individual patient,” the spokesperson said.
Johnson & Johnson did not respond to a request for comment.
http://www.illawarramercury.com.au/story/5187054/johnson-johnson-withdraws-gold-standard-pelvic-mesh-slings-from-australia/
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Jan 24, 2018 | RX Injury Help
By Laurie Villanueva
Laurie Villanueva is an attorney with Bernstein Liebhard LRX Injury Help
Johnson & Johnson is withdrawing Gynecare TVT pelvic mesh devices manufactured by its Ethicon, Inc. subsidiary from the Australian market, after the company failed to meet a deadline for updating the products’ “instructions for use” set by that country’s medical device regulator.
The move comes as more than 700 Australian women – and tens of thousands of others throughout the United States – pursue transvaginal mesh lawsuits that seek compensation for injuries and complications allegedly associated with Ethicon’s pelvic mesh implants.Ethicon Gynecare TVT Products No Longer Appear on TGA Register
According to the Guardian, the Australian Therapeutics Good Administration (TGA) had asked all transvaginal mesh manufacturers to update their products’ “instructions for use” with new adverse event information – including severe chronic pain, groin pain and bladder perforation – by January 17th.
Johnson & Johnson did not meet that deadline and its Gynecare TVT implants no longer appear on the TGA’s register of products that can be lawfully supplied in Australia.
A spokesperson for Johnson & Johnson told BuzzFeedNews that the products were placed “on hold” due to the TGA’s new rules.
“The company is assessing the new requirements and the global regulatory implications,” the spokesperson said. “Importantly, this is not a product recall and no action is required by patients who have received TVT products. No new orders will be shipped to customers.”
In June 2012, Johnson & Johnson and Ethicon announced it would no longer sell four Gynecare pelvic mesh products in the U.S., including Prolift, Prolift+M, TVT Secur and Prosima mesh.Transvaginal Mesh and the FDA
Transvaginal mesh devices are implanted in women who suffer from pelvic organ prolapse and stress urinary incontinence. In addition to Ethicon, other pelvic mesh manufacturers include American Medical Systems, Inc., Boston Scientific Corp., Cook Medical, Inc. and Coloplast Corp.
Since 2008, the U.S. Food & Drug Administration (FDA) has issued several warnings regarding the serious and life-changing adverse events that may occur following implantation of transvaginal mesh, including mesh erosion, scarring and adhesions, chronic pain, infections, and organ damage. In 2011, the agency retreated from its earlier position that complications associated with transvaginal mesh prolapse repair were a rare occurrence.
Just last year, the FDA reclassified transvaginal mesh implants indicated for use in pelvic organ prolapse surgery as high-risk medical devices. Among other things, the reclassification made those implants ineligible for the agency’s 510(k) clearance program, which does not require a device to undergo human clinical trials before coming to market.Transvaginal Mesh Lawsuits & Verdicts
Tens of thousands of women throughout the United States have since filed transvaginal mesh lawsuits against Ethicon and other pelvic mesh manufacturers. Of 32 cases that have gone to trial, 23 have concluded with verdicts for the plaintiffs and damage awards in excess of $1 million.
The most recent trial involving Ethicon ended in December, with a New Jersey Superior Court jury awarding $15 million in compensatory and punitive damages to a woman who was implanted with Gynecare TVT-O mesh.
https://www.rxinjuryhelp.com/news/2018/01/23/johnson-johnson-withdraws-ethicons-gynecare-tvt-products-from-australia-amid-continuing-transvaginal-mesh-lawsuits/
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