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Ethicon Media Monitoring 12/5/2017
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Blasingame Burch Freed From Ex-Client's Pelvic Mesh Suit
Dec 5, 2017 | Law 360
By Cara Salvatore
A West Virginia federal judge on Monday tossed a suit against Blasingame Burch Garrard & Ashley PC by a pelvic mesh class member who said she was pushed into a settlement and the money became property of her bankruptcy estate, saying a different court already settled the question of whose property it was. -
NJ Jury to Decide if J&J Mesh is Defective
Dec 4, 2017 | Legal Scoops
By Jacob Maslow
A jury in New Jersey will decide if Johnson & Johnson’s pelvic mesh is defective and if the company is responsible for injuries to a local woman. The decision comes more than nine years after the plaintiff had the mesh operation, which has left her in chronic pain. -
Vaginal mesh campaigner Chrissy Brajcic dies from sepsis after four-year battle
Dec 5, 2017 | Sky News
By Ajay Nair
Vaginal mesh campaigner Chrissy Brajcic has died reportedly from sepsis after a four-year battle with persistent infections. -
Vaginal mesh campaigner dies of sepsis after becoming resistant to antibiotics
Dec 5, 2017 | The Independent
By Harriet Marsden
A well-known campaigner against vaginal mesh procedures has died from sepsis, it has been reported. -
Courageous vaginal mesh campaigner, 42, DIES from sepsis after her controversial implant triggered a four-year battle with persistent infections
Dec 5, 2017 | The Daily Mail
By Stephen Matthews
A prominent vaginal mesh campaigner has died from sepsis which was triggered by her controversial implant, it has been reported. -
Consumer health groups push for total ban on pelvic mesh devices
Dec 5, 2017 | The Sydney Morning Herald
By Joanne McCarthy
Consumer health groups across Australia have called for a total ban on all pelvic mesh devices after the death of a Canadian mesh campaigner, and despite the objections of Australia's medical device regulator. -
Risk of Transvaginal Mesh Complications Leads Australian Regulator to Ban Devices
Dec 4, 2017 | RX Injury Help (blog)
By Sandy Liebhard
Australia’s Therapeutic Goods Administration (TGA) has banned the use of transvaginal mesh implantsin pelvic organ prolapse repair, after a review of the devices indicated that their risks do not outweigh their benefits.
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Blasingame Burch Freed From Ex-Client's Pelvic Mesh Suit
Dec 5, 2017 | Law 360
By Cara Salvatore
Law360, New York (December 4, 2017, 9:09 PM EST) -- A West Virginia federal judge on Monday tossed a suit against Blasingame Burch Garrard & Ashley PC by a pelvic mesh class member who said she was pushed into a settlement and the money became property of her bankruptcy estate, saying a different court already settled the question of whose property it was.
U.S. District Judge Joseph Goodwin granted the law firm's dismissal bid in the suit brought by Danna Morrison, who said the firm committed legal malpractice by pushing her to settle for $300,000. She also alleged the firm misrepresented what the settlement's effects on her bankruptcy would be.
The parties disagreed about whether the cause of action against the firm “accrued” before or after she filed for bankruptcy. If before, it would be property of the estate. Morrison filed for Chapter 7 in March 2011. Her bankruptcy closed that August but was reopened in September 2015. The complaint against the firm was filed in December 2011.
“The plaintiff now seeks to distance her cause of action from the bankruptcy estate, claiming that the alleged misconduct of [Blasingame Burch] discovered in 'late May 2016,' and her 'lost ... right to a trial by jury,' is the object of her complaint in this case. I disagree. It is clear from the complaint that the plaintiff seeks recovery of a perceived loss in damages stemming from the MDL case, as each claim turns on the acceptance of the settlement agreement in the MDL case,” the judge said.
“The plaintiff also argues that the cause of action must have accrued after the creation of the bankruptcy estate because the original bankruptcy petition predates even the procurement of [Blasingame Burch]’s services in anticipation of the MDL case. This, of course, ignores the reopening of the bankruptcy case in 2015, after the institution of the MDL case, and the fact that the bankruptcy estate identifies as property of the estate the proposed settlement agreement from the MDL case,” he said.
He said that the bankruptcy case had already answered the question of whether the settlement was property of the estate, and collateral estoppel thus applies, because she never objected.
Therefore, because the claims belonged essentially to the bankruptcy trustee, the bankruptcy trustee was the only person with standing to litigate against the law firm, and so Morrison didn't have standing, Judge Goodwin said.
Any coercion towards Morrison would be “entirely independent” of the settlement signoff that counted, which was the trustee's, the judge said.
Morrison hired Blasingame Burch to represent her after she had complications from a pelvic reconstruction surgery during which mesh products were used. The complaint notes the products that are alleged to have contributed to the complications were “believed to be manufactured and distributed by Covidien, C.R. Bard” and other companies.
In late 2015, Morrison alleges, her firm advised her to accept a settlement offer from the mesh maker in question, not identified in the complaint, even though she preferred to go to trial, as she believed she could recover a higher amount from a trial verdict.
After filing the mesh liability lawsuit, Morrison also had a personal bankruptcy due to medical bills. Blasingame Burch, after informing the bankruptcy trustee of the settlement, informed her that she could appeal to a bankruptcy special master for a higher settlement amount, continuing to push back against her desire to go to trial.
Morrison is represented by Michael Richardson of Tidwell Izell & Richardson.
Blasingame Burch Garrard & Ashley is represented by Andrew Godbold and William Godbold III of Leitner Williams Dooley Napolitan PLLC.
The case is Morrison v. Blasingame Burch Garrard & Ashley PC, case number 1:17-cv-00165, in the U.S. District Court for the Eastern District of Tennessee.https://www.law360.com/productliability/articles/991174/blasingame-burch-freed-from-ex-client-s-pelvic-mesh-suit
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NJ Jury to Decide if J&J Mesh is Defective
Dec 4, 2017 | Legal Scoops
By Jacob Maslow
A jury in New Jersey will decide if Johnson & Johnson’s pelvic mesh is defective and if the company is responsible for injuries to a local woman. The decision comes more than nine years after the plaintiff had the mesh operation, which has left her in chronic pain.
Elizabeth Hrymoc filed suit against the company in Bergen County’s Superior Court. Judge Rachelle L. Harz is presiding over the case.
Hrymoc’s attorney told the jury that J&J knew that one of two mesh devices implanted in her client was defective. Her attorney alleges that the company did not provide patients with adequate information on the potential risks of the implant.
The attorney pointed out that Johnson & Johnson is a $70-billion company, and that it should pay for its mistakes.
Thousands of lawsuits have been filed in New Jersey over the defective mesh implants, but Hrymoc’s case is only the second one to come to trial. A jury awarded Linda Gross $11.1 million in damages in the first trial.
Hrymoc’s trial is expected to last until after the holiday season. She is seeking punitive damages and compensatory damages for her pain and suffering.
The jury will decide whether the evidence presented by Hrymoc’s attorney supports the claims made by plaintiff.
Johnson & Johnson maintains that its pelvic mesh devices aren’t necessarily defective, although the company removed its Prolift device from the market in 2012.
J&J’s attorneys argued that Hrymoc’s complications were natural risks of the surgery and not the result of a defective product.
The plaintiff’s attorney showed the jury documents that suggested the company as concerned about the mash potentially eroding the vaginal wall. J&J put the device on the market despite these concerns.
Once inserted, according to Hrymoc’s attorney, the mesh can harden because of scar tissue. In some cases, the mesh can pierce through the vaginal walls. Hrymoc underwent three surgeries to correct the issue, but they were all unsuccessful.
J&J argues that the plaintiff’s doctor was aware of the risks and explained them to Hrymoc before the procedure.
https://www.legalscoops.com/nj-jury-to-decide-if-jj-mesh-is-defective/
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Vaginal mesh campaigner Chrissy Brajcic dies from sepsis after four-year battle
Dec 5, 2017 | Sky News
By Ajay Nair
Vaginal mesh campaigner Chrissy Brajcic has died reportedly from sepsis after a four-year battle with persistent infections.
The 42-year-old Canadian's husband Tony confirmed her death on Facebook after she set up a campaign to raise awareness of the dangers of mesh implants, used to treat organ prolapse and urinary incontinence.
The plastic implants can be used to support organs such as the vagina, uterus, bowel, bladder or urethra which have prolapsed during childbirth.
However, they can shrink, twist and cut through internal tissue and have left many in unbearable pain.
During her final months, she posted a series videos, attracting thousands of views on Facebook, detailing her struggle with the controversial device.
In one of her final online posts, she vowed to "never stop fighting" for her cause and added: "This is a life or death issue."
Following her death last week, her husband wrote: "It's clear by all of your messages that Chrissy was truly a special woman and touched the lives of many people."
The death comes a week after the National Institute for Health and Care Excellence (NICE) recommended banning mesh procedures in the UK, which are used on thousands of women each year.
Earlier this year Professor Carl Heneghan, who specialises in evidence-based medicine, also warned against the implants and said some of the devices had not been clinically tested and, "unlike in the Thalidomide scandal, you are unable to see the extent of the women's injuries".
Women affected have been left unable to walk with some reporting organ erosion, nerve damage and loss of sexual function.
Mrs Brajcic had her polypropylene mesh TVT (tension-free vaginal tape) implanted four years ago after she gave birth.
The type of mesh is the most commonly prescribed in the UK to treat mild incontinence.
However, she suffered nerve damage and was in constant pain following the procedure.
After an operation to remove the device a year later, she was back in hospital being treated for urinary tract infections, eventually becoming resistant to antibiotics.
She was readmitted to hospital suffering from sepsis in October.
In one of her final posts, Mrs Brajcic wrote: "Funny how after going septic and almost dying now I'm getting respect and being treated well by doctors.
"All it took was dying to get better care and better pain management. I will take it... it's better than fighting for my care."
https://news.sky.com/story/vaginal-mesh-campaigner-chrissy-brajcic-dies-from-sepsis-after-four-year-battle-11157067
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Vaginal mesh campaigner dies of sepsis after becoming resistant to antibiotics
Dec 5, 2017 | The Independent
By Harriet Marsden
Chrissy Brajcic suffered from chronic infections after she was implanted with the scandal-hit mesh
A well-known campaigner against vaginal mesh procedures has died from sepsis, it has been reported.
Christina Brajcic, 42, of Ontario, Canada, is believed to be the first woman to die in what has become known as the vaginal mesh scandal – the subject of an Independent long read this year – which Conservative MP Alec Shelbrooke called “the new thalidomide”.
Her death comes just a week after the UK-based National Institute for Health and Care Excellence (NICE) recommended banning vaginal mesh as a routine treatment for prolapse. Professor Carl Heneghan, an expert in medical device regulation, says this essentially amounts to a “backdoor-ban” – but that it had come too late to help the thousands of women whose lives have been irreparably damaged.
The insertion of a plastic mesh device to treat hernia, prolapse and incontinence – in particular, the transvaginal mesh procedure, used on around 10,000 UK women a year – has come under increasing public scrutiny as reports have emerged of high rates of complication and inadequate medical trialling.
Women have been left unable to work, walk or even sit down after complications, including chronic pain, organ erosion and perforations, nerve damage and loss of sexual function. Some have reported feeling suicidal – all as a result of a treatment often performed for minor incontinence.
After her second son was born four years ago, interior designer Brajcic was implanted with a polypropylene mesh TVT (tension-free vaginal tape), the most commonly prescribed in the UK, to treat mild incontinence: “a gold standard, minimally invasive” procedure. But just a few hours after her surgery, she explained to CTV W5, “The pain got worse, and worse, and worse, and finally it was like my insides were ripping out.”
The surgery left her bedridden, suffering nerve damage and constant pain. A year later, she received a five-hour operation to remove the mesh device – which, as they are designed to be permanent, had to be extracted piece by piece. Afterwards, she was treated in hospital at least once a month for related urinary tract infections, and eventually became resistant to the antibiotics she was receiving.
By the end of October, Brajcic was readmitted to hospital suffering from sepsis, a life-threatening bodily response to infection that can end in organ failure.
On 15 November, she posted on Facebook: “Funny how after going septic and almost dying now I’m getting respect and being treated well by doctors. All it took was dying to get better care and better pain management. I will take it...its better then fighting for my care.”
On Wednesday, according to her husband Tony, “her heart stopped”. The family await the results from a toxicology exam, but believe that her death can be linked directly related to her mesh.
Brajcic had already launched a lawsuit against Johnson & Johnson, the company that made her device, joining thousands of Canadian and American women and 800 in the UK who are already involved in litigation against various mesh providers.
She also campaigned relentlessly against mesh procedures, selling T-shirts and ribbons to raise awareness and funds for sufferers.
In October, Labour MP Emma Hardy brought the issue to Parliament, with a cross-party group demanding a suspension pending full investigation into the scandal. However, minister for care and mental health, Jackie Doyle-Price, ruled out a public inquiry or a suspension.
The week Brajcic died, Australia’s medical regulatory body, the Therapeutic Goods Administration (TGA), banned mesh as a treatment for POP (pelvic organ prolapse), saying in a statement that “the benefits of using transvaginal mesh products do not outweigh the risks to the patient”.
Former Scottish health secretary Alex Neil recently described the issue as a “global catastrophe” and is calling for an international summit. Back in 2014, officials in Scotland called for all mesh devices to be banned, including those used to treat hernias. READ MOREHundreds take legal action over 'barbaric' vaginal mesh implants
Kath Sansom, founder of Sling the Mesh, a prominent campaign group fighting the treatment in the UK, told The Independent: “Chrissy must not die in vain. Her death has shocked and upset women around the world. She only had a mild stress incontinence problem from childbirth and physio probably could have fixed it. Now she has lost her life. This is wrong in every way. This is shocking.”
Sansom, who has launched a Just Giving pageto raise money for Brajcic’s children, added: “Many women in groups globally are close to being antibiotic-resistant – and then what? Benefits do not outweigh the risks of this operation. It’s time to say enough is enough.”
https://www.independent.co.uk/news/uk/transvaginal-vaginal-mesh-surgery-stress-urinary-incontinence-sui-uti-tvt-antiobiotic-resistance-a8092006.html
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Dec 5, 2017 | The Daily Mail
By Stephen Matthews
· Christina Brajcic, from Ontario, Canada, passed away on Thursday from sepsis
· She posted an array of videos detailing her struggle with mesh on her Facebook
· A crowdfunding page reported that her sepsis was caused by her vaginal mesh
· Tributes have flooded in for the 'courageous' campaigner from around the world
A prominent vaginal mesh campaigner has died from sepsis which was triggered by her controversial implant, it has been reported.
Christina Brajcic, 42, from Ontario, Canada, passed away on Thursday following a four-year battle with persistent infections - as a result of her mesh.
During her final few months, she posted an array of videos detailing her struggle with the scandal-hit devices on her Facebook page.
Tributes have flooded in for the 'courageous' interior designer, who helped to raise awareness of the 'catastrophic' mesh, which leaves many in crippling pain.
The implants, which can shrink, twist, curl and cut through internal tissue, have ruined the lives of thousands of women, leaving some on the brink of suicide.
Ms Brajcic's death follows landmark moves by English and Australian health officials to recommend the controversial implants should no longer be used.
It is expected that the NHS will follow the guidance from Nice, the Government's healthcare adviser - despite not being obligated to do so.The verdict comes after the Government released its three-year investigation into the mesh scandal last September. It rejected calls for a ban at the time.
Australian watchdogs also banned the use of vaginal mesh implants for prolapse last week after a review found 'the benefits do not outweigh the risks'.
However, vaginal mesh remains a viable option for surgeons operating on women suffering from incontinence in both countries.
When did her problems begin?
Before her operation to have TVT mesh fitted in 2013, Ms Brajcic was 'fit and active', according to a fundraising page created since her death.
Ms Brajcic, who had her own business, endured mild stress incontinence following the birth of her two sons, Ben and Jake.
However, soon after the procedure she suffered debilitating pain - a complaint that has been raised by thousands of other women with the mesh fitted.
She then began to get constant infections - a problem suffered by scores of women that MailOnline has reported on since it backed calls for a ban.
Ms Brajcic eventually became resistant to antibiotics, having been given so many during her four year battle with vaginal mesh complications.
It's reported she would be pumped full of strong medication in her local hospital's emergency department at least once a month.
Fundraising efforts
Kath Sansom, founder of Sling The Mesh, created a JustGiving page to raise £1,000 to send to Ms Brajcic's young sons. So far, it has raised £947.
Writing on the post, Ms Sansom, 49, said: 'Chrissy was a courageous woman who, despite her suffering, remained, calm, strong and beautiful.
'Let her death not be in vain.' Ms Sansom also described her as 'determined to spread the message to stop other women suffering'.
Sling The Mesh has almost quadrupled in members in recent months. Nearly 4,600, mostly sufferers, now support the cause to ban vaginal mesh implants.
When did the scandal come to light?
The scandal came to light in April, when the NHS tried to dodge media attention over the implants that left hundreds of women in agony.
Senior doctors immediately called for a public inquiry into the controversial mesh, with some saying the scandal could be akin to thalidomide.
At the time, it was reported that at least 800 women were suing the NHS and device manufacturers. However, it is unsure how many women are now looking to take action in Britain.
Mesh, introduced 20 years ago and dubbed 'gold-standard', was promoted as a quick, cheap alternative to complex surgery for incontinence and prolapse.
Because it did not require specialist training to implant, outraged women have since begged for tougher regulations to conduct such surgery.
High-risk device in the US
Vaginal mesh has been considered a high-risk device for nearly a decade in the US, with bodies accepting up to 40 per cent of women may experience injury.
Some studies, published in an array of scientific journals, have shown that pain, erosion and perforation from the surgery can strike up to 75 per cent of women.
The alarming evidence prompted officials in three US states to suspend the practice and saw them call for an urgent review into its safety.
Scottish officials asked for it to be suspended in Scotland in 2014 pending a similar review, but hundreds of women are still believed to be having the surgery.
More than 10,000 women a year are fitted with mesh. But only 4,800 have suffered lacerations and nerve damage from the mesh breaking into tiny fragments.
However, campaigners stress these are just the tip of the iceberg and that actually there are thousands more - but they have been kept silent.
Leading mesh manufacturer Johnson & Johnson was forced to pay out $57 million in September to a woman fitted with the implant.
Ella Ebaugh, 51, from Philadelphia, was awarded the eight-figure sum after a jury found the company to be negligent and its product defective.
Anyone wanting to donate to Ms Brjacic's family can do so here.
http://www.dailymail.co.uk/health/article-5143843/Prominent-vaginal-mesh-campaigner-42-DIES-sepsis.html
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Consumer health groups push for total ban on pelvic mesh devices
Dec 5, 2017 | The Sydney Morning Herald
By Joanne McCarthy
Consumer health groups across Australia have called for a total ban on all pelvic mesh devices after the death of a Canadian mesh campaigner, and despite the objections of Australia's medical device regulator.
In a joint media release on Tuesday the chief executives of groups in five states and the ACT said the Therapeutic Goods Administration had "unfinished business" after it announced a targeted ban of prolapse mesh and some incontinence sling devices on November 28, but stopped short of a total pelvic mesh ban.
The TGA announced a ban on all prolapse mesh devices that are transvaginal – meaning surgery through the vagina rather than the abdomen – and a group of problematic sling devices, but said there was good evidence supporting "gold standard" midurethral mesh sling devices to treat urinary incontinence.
Consumer health groups argue the catastrophic injuries suffered by some women using the "gold standard" mesh sling devices was not outweighed by benefits experienced by the majority.
The push for a total ban also follows evidence from individual doctors and doctors' groups to a Senate inquiry on pelvic mesh that emphasised low complication rates were obtained by skilled, experienced doctors, but complication rates could rise sharply with unskilled or inexperienced surgeons.
Royal Australian College of Obstetricians and Gynaecologists president Dr Stephen Robson told the inquiry there was "a need for a formal mechanism to ensure that training in new surgical techniques should be undertaken by experienced surgeons with an ongoing audit of the cases they do".
"We have been recommending this, but we don't have any actual power to enforce our recommendations," Dr Robson said.
Health Issues Centre Victoria chief executive Danny Vadasz said the US drug and device regulator had identified 2874 reports of injury, death and malfunction of mesh implants over three years to 2010. Of these 1371 were associated with stress incontinence repairs, the majority using "gold standard" midurethral slings.
"Given the noted under-reporting of complications and a dearth of retrospective data, how could any woman make an informed decision about the risk of undergoing mesh surgery?" Mr Vadasz said.
The consumer health groups released the statement backing Australian women who called for a total ban on Monday after the death of well-known Canadian mesh campaigner Christina Lynn Brajcic, 42, the day after the TGA announced its targeted mesh and sling ban.
Mrs Brajcic died one month after emergency treatment for sepsis after chronic infections following mesh surgery using an incontinence sling device in 2013. A formal cause of death is yet to be determined.
In a statement on Monday the TGA said Mrs Brajcic's death was tragic, but "we don't know the circumstances surrounding it".
There is "a different risk benefit profile" between midurethral slings for incontinence and the prolapse mesh devices banned in November, the TGA said.
"While there are obviously a number of Australian women who have had problems from the surgery, the total number of women operated on is extremely large," it said.
The TGA conceded it did not know "exact numbers".
"The weight of evidence thoroughly supports midurethral slings for stress incontinence. The TGA is not banning the midurethral slings and this position is consistent with all overseas regulators," a TGA spokesperson said.
The health groups called on the TGA to immediately establish a mesh user registry similar to the Australian Orthopaedic Association national joint replacement registry, and to undertake retrospective health checks of the many thousands of women who have had pelvic mesh implants since the late 1980s.
A registry "would ensure there is a central database of device types implanted by women and a way to track complications", the health groups said.
http://www.smh.com.au/national/health/consumer-health-groups-push-for-total-ban-on-pelvic-mesh-devices-20171205-gzz8uc.html
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Risk of Transvaginal Mesh Complications Leads Australian Regulator to Ban Devices
Dec 4, 2017 | RX Injury Help (blog)
By Sandy Liebhard
Sandy Liebhard is an Senior Partner at Bernstein Liebhard LLP
Australia’s Therapeutic Goods Administration (TGA) has banned the use of transvaginal mesh implantsin pelvic organ prolapse repair, after a review of the devices indicated that their risks do not outweigh their benefits.
The Australian transvaginal mesh ban also includes devices known as mini-slings, which are used to treat stress urinary incontinence.
The TGA’s decision to ban the implants followed a review of the latest international studies and an examination of the clinical evidence for each transvaginal mesh product sold in Australia.
“Based on this new information, and since the publication by the TGA of the Results of review into urogynaecological surgical mesh implants, the TGA is of the belief that the benefits of using transvaginal mesh products in the treatment of pelvic organ prolapse do not outweigh the risks these products pose to patients,” the agency said in a statement dated November 28th.
Since the TGA began its review in 2013, 45 transvaginal mesh implants have been removed from use by the agency. Another 43 have been canceled from Australia’s Registry of Therapeutic Goods, while two others have been limited to non-urogynaecological procedures. Additional devices have been removed from the Registry by their manufacturers.
The TGA’s transvaginal mesh ban will take effect on January 4, 2018.Transvaginal Mesh and the FDA
The U.S. Food & Drug Administration (FDA) launched a safety review of transvaginal mesh in 2008, after the devices had been linked to more than 1,000 reports of complications, including:Mesh erosion through vaginal epitheliumInfectionPainUrinary problemsRecurrence of prolapse and/or incontinenceBowel, bladder, and blood vessel perforationVaginal scarringChronic painPain during sexual intercourse
The FDA published an update in 2011, after the number of transvaginal mesh complications reported to its database tripled. More than 1,500 of the new reports involved implants used for prolapse repair, while over 1,370 were associated with stress urinary incontinence repair.
“The FDA is issuing this update to inform you that serious complications associated with surgical mesh for transvaginal repair of POP are not rare,” the agency said. “This is a change from what the FDA previously reported on Oct. 20, 2008. Furthermore, it is not clear that transvaginal POP repair with mesh is more effective than traditional non-mesh repair in all patients with POP and it may expose patients to greater risk.”
Last year, the FDA reclassified transvaginal mesh indicated for prolapse repair as Class III (high risk) medical devices, making the implants ineligible for the agency’s 510(k) clearance program. That program allows a medical device to come to market without undergoing human clinical trials as long as a manufacturer can show that the product is “substantially equivalent” to a device that has already been subject to the FDA’s stricter premarket approval protocols.Transvaginal Mesh Litigation
Since 2008, hundreds of thousands of U.S. women have filed transvaginal mesh lawsuits accusing device manufacturers of failing to adequately test their implants or provide doctors and patients with adequate warnings of their risks.
Numerous transvaginal mesh trials have been convened in the ensuing years, with juries delivering verdicts for both plaintiffs and defendants. A significant percentage of claims have also been settled, though thousands remain pending in federal and state courts throughout the country.
https://www.rxinjuryhelp.com/news/2017/12/04/risk-of-transvaginal-mesh-complications-leads-australian-regulator-to-ban-devices/
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