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Endo to terminate vaginal mesh manufacturing to avoid litigation
Mar 1, 2016 | Fierce Medical Devices
By Varun Saxena
Facing billions in lawsuits related to its vaginal mesh implants for pelvic organ prolapse, Endo International ($ENDP) announced that it will close its Astora Women's Health device unit. Investors were unhappy that its efforts to find a suitor for the troubled division failed, and pushed the stock down 21% on the announcement. -
Endo Will Stop Making Pelvic Mesh and Close Women’s Health Division
Mar 1, 2016 | Mesh Medical Device News Desk
By Jane Akre
...The company then took its Apogee and Perigee pelvic organ transvaginal mesh (TVM) off the market and in doing so it relieved the company of the post-market monitoring. Ethicon, a division of Johnson & Johnson removed four meshes from the market in 2012 as well to obtain relief from the 522 orders as they are known within the FDA. # -
Kiwi woman forced to pay for operation in US to remove painful surgical mesh
Mar 2, 2016 | Stuff.co.nz
By Deidre Mussen
...Caroline Evans was in a group of New Zealand women rejected from an international court case in the US, seeking compensation from Ethicon, a subsidiary of Johnson & Johnson. -
Possible link between talcum powder and ovarian cancer 'inconclusive': HSA
Mar 2, 2016 | Examiner Gazette
By Sherry Padilla
...For instance, it is the target of at least 44,000 cases from women who say they were harmed by pelvic mesh devices made by its Ethicon unit, and about 8,000 against its DePuy subsidiary regarding Pinnacle metal-on-metal hip systems. "We're in this for the long haul", she said.
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Endo to terminate vaginal mesh manufacturing to avoid litigation
Mar 1, 2016 | Fierce Medical Devices
By Varun Saxena
Facing billions in lawsuits related to its vaginal mesh implants for pelvic organ prolapse, Endo International ($ENDP) announced that it will close its Astora Women's Health device unit. Investors were unhappy that its efforts to find a suitor for the troubled division failed, and pushed the stock down 21% on the announcement.
The company said that it did receive formal bids for Astora, but "by shutting down the business as opposed to selling it, we are able to reduce the potential for product liability related to future mesh implants, which would have not been achievable in the event of a sale of the Astora business," said CFO Suketu Upadhyay during the company's earnings call.
Endo paid $150 million in legal settlements related to its vaginal mesh in Q4. And more payments are on the way. The company recorded a $834 million pretax charge to increase the estimated product liability accrual. It had already set aside $1.4 billion to cover the legal costs at the end of the previous quarter, according to the Philadelphia Business Journal.
In response to mounting concerns about side effects, the FDA last month said it will require vaginal mesh implants to file a PMA application, and warned of several cases of severe pelvic pain, pain during intercourse, infection, bleeding, organ perforation and urinary problems from mesh eroding into surrounding tissues. Currently marketed implants must submit a PMA as well. They were initially cleared via the far less stringent 510(k) pathway.
The adverse events are not limited to Endo's vaginal mesh; Boston Scientific ($BSX) is also laboring under the strain of net litigation charges that topped $1 billion 2015, with vaginal mesh implants responsible for a good portion of that number.
Endo last year sold the men's health portion of its American Medical Systems device unit to Boston Scientific for $1.6 billion, and renamed the remaining portion Astora Women's Health. It acquired AMS for $2.9 billion in 2011.
The closure of Astora leaves the specialty pharma company with minimal exposure to devices. Endo operates South African company Litha Medical, which sells a variety of devices (and drugs) in its local market, according to the company website.
Astora also makes mesh implants to treat stress urinary incontinence, which are not the subject of the increased regulation or safety concerns. And the company's CE-marked mesh implant for fecal incontinence recently won the backing of an FDA advisory panel, making U.S. approval likely.
The fate of the implant in light of the closure of Astora is not yet clear.
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Endo Will Stop Making Pelvic Mesh and Close Women’s Health Division
Mar 1, 2016 | Mesh Medical Device News Desk
By Jane Akre
Facing billions in defective product lawsuits, Endo International will shut down its pelvic organ mesh unit, Astora Women’s Health, after a search for a buyer was unsuccessful.
Based in Eden Prarie, Minnesota, Astora will close March 31 to “reduce the potential for product liability related to future mesh implants.” the company says. Endo is based in Dublin, Ireland where it enjoys a lower tax-base than it had in Pennsylvania, reports the Wall Street Journal.
ENDO/ AMS
Endo Health Solutions acquired women’s urology products when it took over American Medical Systems (AMS) in 2011 for $2.9 billion. In doing so, it also acquired more than 22,000 lawsuits that claimed the polypropylene mesh was defective and doctors were not adequately warned about the complications associated with the mesh. Last year Endo sold the men’s health division to Boston Scientific for $1.6 billion, reports Fierce Medical Devices here.
By closing Astora, the company will limit its exposure to expensive lawsuits filed by women who were implanted with the AMS meshes.
AMS makes the Perigee, Elevate and Apogee transvaginal mesh (TVM) used to treat pelvic organ prolapse (POP), a common condition in women following pregnancy, due to weak collagen or as a result of aging. Apogee and Perigee are no longer for sale in the U.S. according to the AMS website.
AMS also makes the Sparc and Monarc slings to treat urinary incontinence, using a narrow strip or sling to support the urethra.
According to the company’s website the Apogee Vaginal Vault Prolapse Repair System and thePerigee Transobturator Anterior Prolapse Repair System are “not available for sale in the U.S.”
The company won the CE approval in Europe for a fecal incontinence mesh implant which recently won approval by an FDA expert panel.
In the company’s Securities and Exchange Commission filing in 2013, AMS said it plans to “vigorously defend themselves in the remaining mesh product liability cases and in any new cases that may arise.”
The FDA recently announced that it would tighten regulations and required more stringent proof of safety and efficacy before mesh for pelvic organ prolapse could enter the market. The FDA gave mesh makers 30 months before it imposed the more stringent premarket approval or PMA, which is required of drugs. Currently mesh is classified as a moderate risk or class II device. The change will reclassify them as class III or higher risk.
Was On The Settlement Track
In June 2013, Endo Health Solutions Inc. agreed to pay $54.5 million to settle some outstanding lawsuits that have been filed by women who were implanted
with the Perigee, Apogee and Elevate transvaginal mesh implants. See the Master Settlement here.In March of the same year, the company announced it had put aside $520 million to cover the cost of litigation or settlement. Endo also recorded a pretax charge off about $316 million at the end of 2013 which brought its product liability fund to about $520 million.
In its SEC filing, Endo Health Solutions Inc. said that an estimated 500 million women worldwide may suffer from urinary or fecal incontinence and around 400,000 surgeries are performed around the world annually to correct some form of pelvic organ floor prolapse.
Endo Under Investigation by AG Office
Also in March 2013, in the Endo annual report released by the Securities and Exchange Commission, Endo admitted it had received subpoenas from several states investigating the overpayment for its pelvic mesh products. The California Attorney General’s office is one of those states which issued a subpoena to Endo.
Post-Approval Monitoring Ordered
In January 2012, the U.S. Food and Drug Administration ordered pelvic mesh makers of mesh for pelvic organ prolapse, to conduct post-approval monitoring on the rates of organ damage and complications among the women implanted with its transvaginal meshes used for pelvic organ prolapse.
AMS received 19 orders but had honed that down to sixteen “for various commercial reasons” it said in an SEC filing. The company then took its Apogee and Perigee pelvic organ transvaginal mesh (TVM) off the market and in doing so it relieved the company of the post-market monitoring. Ethicon, a division of Johnson & Johnson removed four meshes from the market in 2012 as well to obtain relief from the 522 orders as they are known within the FDA. #
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Kiwi woman forced to pay for operation in US to remove painful surgical mesh
Mar 2, 2016 | Stuff.co.nz
By Deidre Mussen
Excruciating agony from a surgical mesh implant has forced a Kiwi mother to pay more than $50,000 for an operation in the United States.
It has finally eased Pukekohe 50-year-old Caroline Evans' horrific pain that ruined nearly nine years of her life.
She is one of hundreds of Kiwis and hundreds of thousands worldwide who blame their severe health problems on mesh implants, which are devices used to repair and provide extra support to weakened structures in someone's body, such as pelvic organ prolapse, stress incontinence and hernias.
While some people's synthetic implants can be removed in New Zealand, no surgeons here have the expertise to cut out the type of "bladder sling" that Evans had.
She estimates she has spent about $130,000 on operations and treatment for her surgical mesh problems. ACC declined her treatment injury claim, but medical insurance partly paid for some procedures, including $5000 for her American operation.
The US operation was possible only because her mother mortgaged her home to loan her money for the procedure, which she had last August in St Louis.
"I wish I could do that for the other ladies with mesh who aren't as fortunate," she said.
Her problems started in November 2006 when she had a mesh implant in Auckland to fix mild urinary incontinence caused by childbirth.
Immediately afterwards, she started experiencing excruciating pain and suffering frequent infections. For the next nine years, she had numerous investigations, painkillers, antibiotics and operations for pain and infections.
In 2007, she had an IUD contraceptive removed and a hysterectomy, because doctors suspected they were causing the infections and pain.
Unaware that it was the mesh "sling" that was causing her problems, she had a second mesh implant for a bowel prolapse in 2009, which worsened her pain.
Three years ago, her husband saw a TV programme on surgical mesh and realised that was her problem.
She returned to the surgical team who did the first operation to seek help. They operated and cut the bladder tape, but failed to remove it.
In 2013, she had an 11-hour operation at a private Wellington hospital to remove the 15cm bowel mesh, which eased some pain after a long recovery period.
Another surgeon in Auckland attempted to remove the bladder mesh in May last year, but cut out only a small portion of the tape.
Finally, she turned to the American surgeon, who had successfully operated on a number of Australians. He managed to completely remove her remaining mesh in a four-hour operation.
Relief was almost instant. Now, she rarely takes painkillers, the fog in her head from powerful pain medications is lifting, she can garden, and is back walking her dogs.
"I have a future that's not lying in my bedroom. In fact, I hardly ever lie in my bedroom any more," she says, laughing.
"Yeah, I've been given back my life."
THE BACKGROUND:
Caroline Evans was in a group of New Zealand women rejected from an international court case in the US, seeking compensation from Ethicon, a subsidiary of Johnson & Johnson.
In 2014, the judge hearing the case said the Kiwi women could gain compensation from ACC.
Between July 2005 and the end of last year, ACC said it paid out more than $9 million for 469 surgical mesh claims. It rejected 108 claims, including Evans's.
A Facebook support group, Mesh Down Under, has lobbied the Government for a commission of inquiry into surgical mesh use in New Zealand. Parliament's health select committee is due to report on the question in the next few months.
Committee chairman Simon O'Connor said on Tuesday: "The stories we have been told about are dreadfully painful. [Surgical mesh] is something that has continued to be used here. New Zealanders need to be sure whether we should continue it or not."
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Possible link between talcum powder and ovarian cancer 'inconclusive': HSA
Mar 2, 2016 | Examiner Gazette
By Sherry Padilla
Both cases had alleged that their ovarian cancer was caused by their decades-long use of the J&J's talc-powder products for feminine hygiene. The jury deliberated for just under five hours before awarding her family $10 million in compensatory damages, along with $62 million in punitive damages.
More cases will be filed soon and lawyers at several plaintiffs' firms who have worked on the Fox case have confirmed of investigating thousands of additional claims. Some stated courts have been considered more plaintiff-friendly than federal courts, where Berg presented her case.
In the February 18 order, the U.S. District Court for the Eastern District of Missouri canceled a March 3 final pretrial conference and said that all recent trial briefing filed by the parties should be re-filed in accordance with the new date. The company on Tuesday issued a statement expressing sympathy for Fox's family but disagreeing with the verdict. Some of the complaints also allege that evidence of talc has been found in the ovarian tumors of the women named in the lawsuits.
The verdict is the first by a U.S. jury to award damages over the claims, the lawyers said. She died this past fall, just 2 ½ years after being diagnosed with ovarian cancer. In its natural state, talc can contain asbestos, which is a known carcinogen - but according to the American Cancer Society, commercial products containing talc have been asbestos-free since the 1970s.
For J&J, the thousands of talc cases may not be their biggest concern as the company is facing many other lawsuits over its larger set of products.
For instance, it is the target of at least 44,000 cases from women who say they were harmed by pelvic mesh devices made by its Ethicon unit, and about 8,000 against its DePuy subsidiary regarding Pinnacle metal-on-metal hip systems. "We're in this for the long haul", she said.
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