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Ethicon Media Monitoring 1/14/2019
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Physicians hit again at girls blighted by vaginal mesh implants
Jan 13, 2019 | Infosurhoy
By Denis Bedoya
Tens of thousands of women are suing the makers of vaginal mesh implants that left them in chronic pain. -
Northern Ireland mesh removal service ‘needs specialists’
Jan 11, 2019 | Belfast Telegraph
By Donna Deeney
A service for removing mesh implants must bring in outside expertise as surgeons in Northern Ireland have little experience in the field, a campaigner has said.
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Physicians hit again at girls blighted by vaginal mesh implants
Jan 13, 2019 | Infosurhoy
By Denis Bedoya
Tens of thousands of women are suing the makers of vaginal mesh implants that left them in chronic pain.
Some are incontinent, some with permanent pelvic pain, many say it ruined their marriages, their ability to work, their relationship with their children.
Those who’ve filed lawsuits accuse the device makers of duping doctors into performing and recommending operations that could not be reversed, had clear risks, with the capacity to cause life-long, agonizing side effects.
But in an unexpected turn, a group of doctors has hit out at the victims and their lawyers.
The union of 63 Washington surgeons signed a letter to state Attorney General Bob Ferguson, who is fronting the lawsuit against Johnson & Johnson, declaring that all surgeries carry risks, they were not misled, and the risks associated with vaginal mesh are not out of the ordinary for a medical device.
The lawsuit says the companies failed to disclose risks associated with the products.
But in their letter, the doctors said they were never deceived and that the case is based on a misconception about how they assess dangers posed by medical procedures.
‘We have served on national and regional medical societies in women’s health,’ wrote Dr. Jeffrey Clemons, a pelvic reconstructive surgeon in Tacoma. ‘It is astonishing to us that the AG is proceeding with this lawsuit without first availing themselves of the significant experience and expertise of this group.’
Doctors in California are drafting a similar letter to Attorney General Xavier Becerra, and the president of the American Urogynecologic Society, which represents 1,900 medical professionals, has issued a statement expressing some of the same concerns.
Clemons and two other doctors who signed the Washington letter have been retained by defense counsel as consultants in the case, but Clemons said he wrote it without payment or assistance from Johnson & Johnson.
At issue is ‘transvaginal mesh’ — plastic mesh products that are implanted to correct a variety of pelvic floor disorders.
They came on the U.S. market in the late 1990s to treat stress urinary incontinence — a condition triggered by physical activity like coughing, sneezing or running that is common and sometimes debilitating in women after childbirth. The treatment involves using a thin mesh strip, called a ‘mid-urethral sling,’ to support the urethra, the tube that carries urine away from the bladder.
The products were so successful — one of the most significant advances in women’s health in recent decades, the physicians said — that companies began developing similar mesh products to treat another condition, called pelvic organ prolapse.
In such cases, pelvic organs such as the uterus and bladder drop from their normal position due to muscle weakening. A sheet of mesh can be used to support the pelvic floor.
However, treating pelvic organ prolapse with mesh proved problematic after those products were introduced in 2004. They were more likely to bring serious complications, including permanent incontinence, severe discomfort and an inability to have sex.
The U.S. Food and Drug Administration issued warnings in 2008 and 2011, and companies pulled most of the transvaginal mesh products for organ prolapse from the market.
Tens of thousands of women have filed liability claims against Johnson & Johnson and other companies, with some saying they knew nothing about the potential complications.
The doctors say Washington’s lawsuit conflates the acceptable risks of using pelvic mesh to treat incontinence with the less tolerable risks of using it for pelvic organ prolapse. They’re worried it could force mid-urethral slings off the market, though the attorney general’s office says that’s not the goal.
Washington, California, Kentucky and Mississippi are pursuing lawsuits that claim Johnson & Johnson deceived doctors and patients, and that the surgeries ruined some women’s quality of life. They say product marketing brochures and instruction pamphlets should have contained much more detail about the risks.
The company updated its instruction pamphlets in 2015 — effectively admitting the earlier versions were inadequate, Washington state says.
‘The purpose of our lawsuit is to require Johnson & Johnson to disclose to doctors and patients the serious risks associated with surgical mesh,’ Ferguson said in an emailed statement. ‘Johnson & Johnson knew about these risks for years and misrepresented them for more than a decade, even as it sold thousands of these devices in Washington.’
Washington’s lawsuit seeks fines for each alleged violation of the state’s Consumer Protection Act, an amount that could easily run into the millions. The attorney general’s office also wants to bar Ethicon from representing that its surgical mesh is superior to traditional treatments, such as repair using the patient’s tissue, and it says a key question is whether the pamphlets could have deceived the least sophisticated surgeons, not the most sophisticated.
In their letter last month, the surgeons insist they were never misled — nor could they have been, because they don’t rely on a company’s marketing materials or instruction pamphlets to divine the risks of medical devices.
Instead, the letter said, they rely on their education, journals, conferences, textbooks and other unbiased sources, and they counsel their patients accordingly.
In declarations filed in King County Superior Court, some said Ethicon paid for them to undergo training that fully explored the devices’ risks, and others said they learned about the uses and risks from those specially trained doctors.
Clemons and the other surgeons do not dispute that some women have suffered complications from the use of mesh to treat incontinence, but they say any surgery has risks, and the risks of that procedure are well within accepted norms. Millions of women worldwide have been treated with mid-urethral slings.
The letter cited a recent large study of the English National Health Service database that found complications prompted the removal of mesh slings in just 1.4 percent of patients within the first year after surgery, 2.7 percent within five years and 3.3 percent within nine years.
In fact, Clemons said, the mid-urethral sling has become the ‘gold standard’ among surgical options for stress urinary incontinence because it offers better outcomes than other types of surgery, can be performed on heavier patients who otherwise would be ineligible for surgery, and requires less cutting and recovery time.
The Washington Attorney General’s Office said in a court filing the fact that doctors obtain also risk information elsewhere does not excuse the companies from ensuring their instructional pamphlets are ‘truthful and complete.’
The office agreed that many women have had positive outcomes with the devices and said it does not seek to restrict access to them.
Nevertheless, the state is relying on an expert witness, Dr. Bruce A. Rosenzweig, a gynecologist at Rush University Medical Center in Chicago, who insisted in a deposition that polypropylene mesh is an ‘unsafe material to be placed permanently in the female pelvis.’ That position is contrary to the scientific literature, according to the surgeons’ letter.
Clemons is a retired Army colonel who spent a decade as the chief of urogynecology and pelvic reconstructive surgery at Madigan Army Medical Center. He serves on the board of the American Urogynecologic Society and has performed about 1,250 mid-urethral sling surgeries; he used to cut his own mesh slings before Ethicon’s came on the market.
After filing the lawsuit, the Washington Attorney General’s Office tried to recruit him as an expert witness, he said. Although he is a fan of Ferguson’s Democratic politics — Clemons donated $550 to his re-election campaign last month — he declined.
‘I’m not anti-Bob Ferguson at all,’ Clemons said. ‘I just disagree with him on this.’
http://infosurhoy.com/cocoon/saii/xhtml/en_GB/health/physicians-hit-again-at-girls-blighted-by-vaginal-mesh-implants/
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Northern Ireland mesh removal service ‘needs specialists’
Jan 11, 2019 | Belfast Telegraph
By Donna Deeney
A service for removing mesh implants must bring in outside expertise as surgeons in Northern Ireland have little experience in the field, a campaigner has said.
Northern Ireland has had a mesh centre in Belfast, operated by a multi-disciplinary team and recognised by the Royal College of Obstetrics and Gynaecologists, since early 2018.
Last year, 163 procedures were performed at the centre, although the BBC reported that the Health and Social Care Board had only stated that "at least four women have had mesh removed".
The centre will not become fully operational until March.
The implants are used to treat pelvic organ prolapse and incontinence after childbirth, but since 2017 growing numbers of people have told of how they have caused them severe pain.
Jackie Harvey from the Sling the Mesh support group said that while funding for a fully operational regional centre is welcome it must have surgeons with expertise in removing mesh.
"What we would like to see is that this service or centre is staffed by surgeons who have been properly trained in mesh removal and not surgeons with 'transferable skills'," the campaigner said.
"I am not convinced the surgeons in Northern Ireland have the expertise in removing mesh simply because no one here has any real experience."
Ms Harvey said the top surgical team in this field is based in London "and between them have removed around 600 meshes, whereas here the number is in single figures".
A spokeswoman for the Health and Social Care Board said the Belfast Health and Social Care Trust (BHSCT) was accredited as a mesh centre in 2018, "but required funding and resources to ensure the infrastructure was in place to fully function as a regional centre".
"Business cases were submitted to the Department of Health for this and also for the purchase of a translabial 3D scanner," she said.
"The BHSCT currently manages referrals from across the region and the multi-disciplinary team discusses the management of each individual case referred."
https://www.belfasttelegraph.co.uk/news/uk/northern-ireland-mesh-removal-service-needs-specialists-37700490.html
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