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Ethicon Monitoring 10/15/2018
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The Million-Dollar Deal Behind the Vaginal Mesh Implant Mess
Oct 13, 2018 | Daily Beast
By Tanya Basu
In the last two decades, millions of women have turned to vaginal mesh implants as a possible solution to two annoying problems: urinary incontinence and pelvic organ prolapse, where body parts shift out of place after childbirth or later in life. -
Judge Rejects Bard's Motions to Toss $68M Pelvic Mesh Verdict
Oct 15, 2018 | New Jersey Law Journal
By Charles Toutant
A New Jersey state judge in Bergen County denied a motion by C.R. Bard on Thursday to throw out a $68 million verdict awarded to a woman injured by defects in the company’s pelvic mesh products. -
Boston Scientific touts 3-year Solyx stress urinary incontinence mesh trial data
Oct 12, 2018 | Mass Device
By Fink Densford
Boston Scientific (NYSE:BSX) this week released three-year data from a study of its Solyx single incision sling system intended to treat stress urinary incontinence, touting that the trial met all primary and secondary endpoints. -
Women from the Fens urged to attend a major review into mesh implants in Cambridge
Oct 13, 2018 | Cambs Times
By Kath Sansom
A tour of the UK to speak to women experiencing complications from pelvic mesh implants is inviting women from Fenland. -
National apology over pelvic mesh implants
Oct 15, 2018 | Infosurhoy
By Marta Subat
Thousands of Australian women whose lives have been ruined by vaginal mesh implants have received an apology from the federal government.
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The Million-Dollar Deal Behind the Vaginal Mesh Implant Mess
Oct 13, 2018 | Daily Beast
By Tanya Basu
In the last two decades, millions of women have turned to vaginal mesh implants as a possible solution to two annoying problems: urinary incontinence and pelvic organ prolapse, where body parts shift out of place after childbirth or later in life.
But as tens of thousands of lawsuits illustrate, the simple device wasn’t the miracle many were sold on. Some women say the mesh left them in chronic pain, caused infection, and interfered with their sex life.
And now, an investigation published by the British Medical Journal suggests problems with the implants—plastic or surgical mesh shaped into a supportive hammock and placed in the body under local anesthesia—go back to the beginning and are clouded by allegations of payment and questionable studies.
The implant was invented by Swedish obstetrician Ulf Ulmsten, who signed a licensing agreement in 1997 with Johnson & Johnson subsidiary Ethicon.
The first round of tests conducted by Ulmsten had an incredible result: 84 percent of women cured of incontinence within two years. But it was based on just 75 specially selected women in Uppsala, Sweden—a clear case of statistical bias—and each operation was done by gynecologists who worked for Ulmsten, according to investigative journalist Jonathan Gornall.
Johnson & Johnson offered the doctor a $1 million payout if he could come up with even better results on the second round of tests, Gornall reported, citing a licensing agreement contained in court files. Ulmsten came through with a 91 percent success rate.
This second round of studies also involved a small sample: 131 women in six Swedish and Finnish hospitals.
Based on just those two studies and “despite no knowledge of long term outcomes and the compromised nature of the evidence supporting its efficacy, [vaginal mesh implants were] quickly nodded into play by regulatory bodies and rapidly adopted by surgeons around the world,” the BMJ article says.
How Ulmsten, who has since died, was paid without drawing notice was also troubling, the investigation found. He created a company, Medscand, for financial transactions with Ethicon and registered it as the inventor of the implant in regulatory and patent protection paperwork in the United States. In 2001, the U.S. arm of British-based medical device firm Cooper Surgical bought Medscand for $12 million.
Johnson & Johnson confirmed the $1 million payment to Gornall but not the purpose of it, the report says. The company said it “paid Mescand a total of $24,525,000 to purchase all assets associated with the TVT [tension-free vaginal tape] business."
Earlier this year, Johnson & Johnson put out a statement through the Society of Urodynamics, Female Pelvic Medicine & Urogenital Reconstruction that said the mesh had been independently tested:
“In the 20 years that have passed since the study was published in 1998, hundreds of clinical studies with no connection to Dr Ulmsten or Ethicon, including over 100 randomised, controlled trials, have evaluated the clinical performance of TVT, further validating its safety and effectiveness. Scientists from around the world who have conducted and reviewed independent research on pelvic mesh agree it is an important treatment option for women [and] several medical societies comprised of physicians practising in the field of female pelvic medicine have published position statements recognising mid-urethral slings (such as TVT) as the gold standard for the treatment of stress urinary incontinence.”— Johnson & Johnson
Before vaginal mesh, the surgical treatment for female urinary incontinence was colposuspension, in which the "neck" of the bladder is picked up to squeeze the urethra, then attached to the pelvic bone—a painful operation that often requires days in the hospital.
Ulmsten’s outpatient procedure bypassed these issues by snaking the plastic "hammock" in through the vagina to shoulder the urethra, using just a local anesthetic.
But as the procedure’s popularity grew, so did reports of problems. Women complained about debilitating chronic pain, painful sex, and genital tearing, and there was an international outcry against Johnson & Johnson. By 2014, women had brought nearly 60,000 lawsuits worldwide.
Earlier this week, the Australian government apologized to affected women and promised regulation overview. Two days before the BMJ report came out, Britain’s National Institute for Health and Care Excellence imposed tighter restrictions on who can get an implant.
In 2016, the FDA backpedaled on its approval of vaginal mesh implants, reclassifying it as a "high-risk medical device" but not banning it or outright questioning its safety. And last year, the FDA determined polypropylene resin, a material commonly found in water bottles used to create many meshes, was safe and effective.
In August, the FDA issued a statement that said products used to treat prolapse like the vaginal mesh implant were associated with serious complications that were not rare and questioned whether it had better outcomes than colposuspension.
Earlier this year, a New York Times investigation highlighted doctors a new issue related to vaginal mesh: doctors were urging women who had not experienced side effects to get them removed in procedures that sometimes resulted in injury but earned the physicians hefty fees.
https://www.thedailybeast.com/the-million-dollar-deal-behind-the-vaginal-mesh-implant-mess
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Judge Rejects Bard's Motions to Toss $68M Pelvic Mesh Verdict
Oct 15, 2018 | New Jersey Law Journal
By Charles Toutant
A New Jersey state judge in Bergen County denied a motion by C.R. Bard on Thursday to throw out a $68 million verdict awarded to a woman injured by defects in the company’s pelvic mesh products.
Access to full text unavailable – subscription required.
Story can be found here:
https://www.law.com/njlawjournal/2018/10/12/judge-rejects-bards-motions-to-toss-68m-pelvic-mesh-verdict/?slreturn=20180915052953
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Boston Scientific touts 3-year Solyx stress urinary incontinence mesh trial data
Oct 12, 2018 | Mass Device
By Fink Densford
Boston Scientific (NYSE:BSX) this week released three-year data from a study of its Solyx single incision sling system intended to treat stress urinary incontinence, touting that the trial met all primary and secondary endpoints.
Boston Scientific said it presented the full results from the trial yesterday at the annual scientific symposium of the American Urogynecologic Society.
The Marlborough, Mass.-based company said it enrolled a total 281 patients in the trial at 21 sites looking to compare efficacy and adverse events for non-inferiority of the Solyx system versus the gold-standard transobturator mid-urethral sling procedure.
The study was part of a post-market surveillance trial required by the FDA to be performed by all manufacturers of mesh products, Boston Scientific said. The company touted it as the first of three such studies it will complete, with remaining data expected to be released next year.
“This trial exemplifies our rigorous commitment to patient safety and our drive to positively impact the lives of the 31 million women with pelvic floor disorders. Our journey doesn’t stop there. We have invested in 16 additional pelvic floor studies to continue building the body of clinical evidence for our women’s health products, including mesh sling systems,” Boston Scientific medsurg prez David Pierce said in a press release.
The primary endpoint in the trial was treatment success defined by a composite of objective measure and any subjective self-reported improvement in stress urinary incontinence using the Patient Global Impression of Improvement at three years. Secondary endpoints included adverse events and indication of reoperation or retreatment.
Results indicated that the group treated with the SIS was deemed non-inferior to the TMUS group in composite treatment success with both intention-to-treat and per protocol analysis. Treatment success rate was 90.4% in the SIS group, versus 88.9% in the TMUS group. Rates of procedure or device-related serious adverse events at three years amongst SIS groups were non-inferior to the TMUS group, Boston Scientific said.
“These findings provide a high degree of evidence supporting the safety and effectiveness of the Solyx SIS System, as compared to transobturator mid-urethral sling (TMUS) procedures, and reinforce the use of a minimally invasive procedure for SUI. The results have the potential to impact millions of women with SUI by offering confirmation about the Solyx SIS System as a viable, first-line surgical treatment option for these patients,” study principal investigator Dr. Amanda White of the University of Texas Dell Medical School said in a prepared statement.
Last month, Boston Scientific said it launched its LithoVue Empower retrieval deployment devicedesigned to be used with the LithoVue single-use digital flexible ureteroscope during ureteroscopic kidney stone retrieval procedures.
https://www.massdevice.com/boston-scientific-touts-3-year-solyx-stress-urinary-incontinence-mesh-trial-data/
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Women from the Fens urged to attend a major review into mesh implants in Cambridge
Oct 13, 2018 | Cambs Times
By Kath Sansom
A tour of the UK to speak to women experiencing complications from pelvic mesh implants is inviting women from Fenland.
Baroness Cumberlege is leading the review, and is talking to women whose lives have been changed beyond repair, following an operation performed to treat conditions mostly caused by having babies.
Kath Sansom, of Sling The Mesh campaign group, which has 7,000 members, said: “The pain this procedure can cause is indescribable.
“I’ve been in contact with many women in Cambridgeshire who are suffering serious complications from mesh implants used to treat incontinence and prolapse.
“This procedure was promoted as a ‘quick fix’ for urinary stress incontinence – but the plastic can twist, shrink, go brittle and fragments fall off inside the body.
“It can attach and slice through organs causing chronic pain, sepsis, loss of sex life and for some women they need to have their bladder or bowel removed.
“Women contact our group feeling suicidal from the pain pelvic mesh implants have caused them.
“If you, or a loved one, have been experiencing complications following the procedure then I urge you to share your story with Baroness Cumberledge and the Government’s independent review.”
A survey in Sling The mesh showed that eight in ten women suffer pain from mesh implants that affects daily life.
Half suffer constant painful urinary tract infections and a A third have been forced to give up work.
One in six have suffered a marriage breakdown and one in seven are unable to care for their young children.
Seven out of 10 have lost their sex life while six out of ten suffer depression and anxiety from the daily pain.
The same polypropylene plastic material is also used to fix hernias and a growing number of people are joining the support group suffering pain from hernia mesh, Kath said.
In July, NHS England accepted a recommendation to temporarily suspend pelvic mesh implants until March 2019.
• The Independent Medicines and Medical Devices Safety Review hearing for pelvic mesh implants is at Homerton Conference Centre, Hills Road, Cambridge, on Monday October 15 from 1.30pm to 3pm. Anyone can turn up to tell their story on the day. There is no need to book.
• Travel expenses can be reimbursed as part of the review Participants will need to submit all travel receipts, with economy or standard class used on public transport whenever possible.
• Those unable to attend can email their experiences to Reviewteam@kcl.ac.uk.
• A free counselling service is also available for anyone who needs support as a result of participating in the review. The Hotline can be reached on 0121 314 7075.
• The BMJ publish a podcast talking to three women whose lives have been affected by pelvic mesh implants.
http://www.cambstimes.co.uk/news/baroness-cumberlege-mesh-cambridge-1-5735220
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National apology over pelvic mesh implants
Oct 15, 2018 | Infosurhoy
By Marta Subat
Thousands of Australian women whose lives have been ruined by vaginal mesh implants have received an apology from the federal government.
Health Minister Greg Hunt on Wednesday acknowledged the pain and suffering of those caught up in what turned out to be a global medical scandal.
“On behalf of the Australian government, I say sorry to all of those women with the historic agony and pain that has come from mesh implantation which have led to horrific outcomes,” he told the ABC on Wednesday.
“My message to them is your voice has been heard, and not just heard but acted upon.”
Vaginal mesh implants have been given to about 8000 Australian women since the 1990s to treat pelvic floor damage.
Many were treated for stress incontinence and prolapse, often after giving birth, resulting in chronic and debilitating pain and the inability to have sex.
The federal government has now tabled its response to a Senate inquiry, which heard horror stories from women who had the implants.
It supports, or supports in principle, 12 out of 13 committee recommendations which included mandatory reporting of adverse effects on women, more information about the risks of implants and better training for doctors and surgeons.
The government’s central response is to work with the states and territories to set up a voluntary national register of mesh recipients recording the issues they experienced.
“I would like to see it set up by the end of 2019, if not the middle of the year,” Mr Hunt said.
Patient lobby groups want to make it compulsory for health practitioners to report side-effects of implantable devices.
While the federal government supports this, it cannot act because it would be outside its powers.
“We will encourage the states and territories to adopt mandatory standards,” Mr Hunt said.
But mesh victim Gai Thompson wants more from the government.
“It’s fine for the health minister to say he is sorry but even the health minister says tracking the pain ‘is out of his jurisdiction’…well how are you helping these women then?” Ms Thompson said.
“The bottom line is pharmaceutical companies are earning millions out of it. I want to know if the health minister would allow his mother, daughter or wife to have this surgery.
“If the answer is no? Why is the product still on the market?”
Ms Thompson is one of 1300 women currently involved in a class action conducted by Shine lawyers against mesh companies.
The federal government has also established Medicare benefit payments for the removal of pelvic mesh implants and related treatments.
Medicare items have also been changed to restrict the use of the mesh in surgeries for pelvic organ prolapse.
The states and territories are being asked to conduct an audit of the devices.
http://infosurhoy.com/cocoon/saii/xhtml/en_GB/news/national-apology-over-pelvic-mesh-implants/
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