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Ethicon Media Monitoring 6/14/17
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C.R. Bard’s Pelvic Mesh Removed From the Market
Jun 13, 2017 | Mesh Medical Device Newsdesk
Bard relieves its website of all pelvic mesh products with no fanfare or notice. -
The Vaginal Mesh Scandal: Update
Jun 13, 2017 | Medical Plastics News
By Lu Rahman
With the news that over 800 women with vaginal mesh implants were planning to take legal action against the NHS and medical device manufacturers such as Johnson & Johnson – the largest maker of vaginal mesh – Lu Rahman looks at some of the issues surrounding this product.
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C.R. Bard’s Pelvic Mesh Removed From the Market
Jun 13, 2017 | Mesh Medical Device Newsdesk
Mesh Medical Device News Desk, June 13, 2017 ~ Bard relieves its website of all pelvic mesh products with no fanfare or notice.
In April, it was announced that C.R. Bard, a medical device manufacturer, was to be sold to Becton Dickinson (BD) for $24 billion.
In what could be surmised to be a house cleaning move, Bard appears to have cleared all of its pelvic meshes from its inventory.
At one time, medical device maker, C.R. Bard of Murray Hill, New Jersey, had a dozen or so transvaginal pelvic mesh devices on the market.
From its Covington, Georgia plant Bard made:
Avaulta Plus™ BioSynthetic Support System for POP ( Pelvic organ prolapse)
Avaulta Solo™ Synthetic Support System for POP
Faslata® Allograft – human graft tissue
Pelvicol® Tissue for SUI (stress urinary incontinence)
PelviSoft® Biomesh for SUI
Pelvitex™ Polypropylene Mesh for SUI
Today, they are all gone from the website.
The last day Bard could sell all of its SUI products was December 31, 2016, but according to the company, hospitals and facilities may use up any products remaining on the shelf.
The reason given was “economic.”With more than 15,000 product liability cases pending against Bard consolidated in multidistrict litigation (MDL) in federal court in West Virginia, and nearly 1,000 cases pending against Bard in multidistrict litigation in New Jersey, economic reason is as good an excuse as any.
Not only does the company website have no mention of products under the Women’s Health category, but the revelation that Align was taken off the market was uncovered during a recent case management conference.
“They stopped selling all Align products in the summer of 2016,” trial attorney Adam Slater told Mesh News Desk, who adds that he has discovery on that issue as he prepares to take Bard to trial over its pelvic mesh implants.
See a MND story here.
In terms of mesh, the company continues to sell hernia mesh through its Bard Davol division.
Two requests for comment from the Bard company headquarters went unanswered.
The removal of products may not have a substantial impact on current mesh product liability litigation.
IS IT A SOFT RECALL?
This isn’t the first time the company has quietly removed problematic meshes from the market.
Bard stopped selling Avaulta Plus, used to treat pelvic floor prolapse, in July 2012, around the same time it lost a product liability case against plaintiff, Christine Scott, who was eventually awarded $3.6 million by a Bakersfield, California jury. The Scott case was the first transvaginal mesh case to go to trial.
The U.S. Food and Drug Administration (FDA) has received a number of adverse event reports on Bard Avaulta. See one here.
Last week, the federal court entered an order to create the Fleming, Nolen & Jez Bard Qualified Settlement Fund, the Wagstafff & Cartmell Qualified Settlement Fund and last month the Aylstock, Witkin, Kreis & Overholtz Qualified Settlement Fund.
Bard is one of six manufacturers with claims gathered in Charleston, West Virginia where there are more than 102,000 pelvic mesh trials consolidated and pending. The first Bard trial in this federal MDL was the bellwether case by Plaintiff Donna Cisson, who was awarded $2 million by a jury in 2013.
In August 2015, Bard agreed to settle 3,000 mesh cases for $200 million. In 2014, Bard agreed to a $21 million settlement to resolve 500 defective product lawsuits.
According to its 10-K SEC report, so far Bard has agreed in principle to settle about 11,000 claims including 560 in 2014; 6,285 in 2015; and 4,155 in 2016. These number include unfiled and previously unknown claims held by various plaintiffs’ law firms.
The company anticipates additional transvaginal mesh trials over the next 12 months, which may include consolidated trials.
Since early 2013, Bard has received subpoenas from a number of State Attorneys General seeking information related to the sale and marketing of certain products such as hernia and women’s health that are being litigated. (p. 19, SEC report). These matters are pending. There can be no assurance that a resolution will be reached or what the terms of any such resolution may be.
HERNIA MESH
Bard’s 10-K form says As of December 31, 2016 approximately 25 federal and 65 state lawsuits involving individual claims by approximately 90 plaintiffs, as well as one putative class action in the United States are currently pending against the company regarding Composix Kugel and certain other hernia repair products.
The company voluntarily recalled certain sizes and lots of the Composix Kugel products beginning in December 2005.
In June 2000, the Composix Kugel lawsuits were transferred to an MDL in US District Court for the District of Rhode Island. That court stopped accepting new cases in the second quarter of 2014 and it was terminated in November 2016. ###
http://www.meshmedicaldevicenewsdesk.com/c-r-bards-pelvic-mesh-removed-market/
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The Vaginal Mesh Scandal: Update
Jun 13, 2017 | Medical Plastics News
By Lu Rahman
With the news that over 800 women with vaginal mesh implants were planning to take legal action against the NHS and medical device manufacturers such as Johnson & Johnson – the largest maker of vaginal mesh – Lu Rahman looks at some of the issues surrounding this product.
Vaginal mesh implants, made from polypropylene, are used to treat pelvic organ prolapse and incontinence following childbirth. However, some have been found to cut into the vagina, causing discomfort. Some of the women say they have been left unable to walk or have sex.
Bloomberg reported that Johnson & Johnson had been ordered to pay $20 million to a woman from New Jersey who said her TVT-Secur mesh had left her in constant pain.
Issues surrounding these implants aren’t new. According to the Aberdeen Evening Express, last year an allegation was made against Boston Scientific that it had used polypropylene from an area of China known for its use of counterfeit materials and that it had been used in mesh implants used in Scotland.
According to the newspaper, Boston Scientific said: “These allegations are simply not true. We stand by our products, our testing and verification of the Marlex used in our products, and we continue to reject any allegations that this resin is counterfeit or adulterated.”
In 2016 Johnson & Johnson agreed to pay over $120 million in relation to 2,000-3,000 US legal cases brought by women who claimed to have suffered organ damage due to vaginal mesh.
In the same year, the FDA reclassified surgical mesh for transvaginal repair of pelvic organ prolapse (POP) from a moderate-risk device (class ll) to a high-risk one (class lll) and gave manufacturers 30 months to prove that their products safe and effective.
In the UK, the debate continues. In The Guardian, Kath Sansom said: ‘The NHS and MHRA say the risk of complications with these operations is 1-3% but a report in the journal Nature by nine leading medics puts that risk at 15%. In the US the Food and Drug Administration recently released figures that said the trocar hooks used to implant the mesh cause injuries for up to 39% of women having a prolapse mesh and 29% of women having a mesh inserted for incontinence.’
Mediplus has been working with clinicians to develop a range of silicone pessaries which are an effective way to manage pelvic organ prolapse. The company is championing this non-surgical alternative – devices placed in the vagina which lift the walls and uterus back into place. The company says its products help more than 32,000 UK women each year.
Pelvic floor product manager, Francesca McCabe said: “Often, when women seek medical advice, they are offered surgery as the only solution without discussing the non-surgical options such as lifestyle, physiotherapy aided pelvic floor exercises and pessaries.”
Pessaries are non-invasive, improve the quality of life for the patient and it enable women to continue normal, everyday activities.
McCabe said: “We have had excellent results with many women reporting results similar to those expected with surgical correction. It has also shown a significant improvement in enjoyment of life and physical activities.”
Research carried out by the Mayday University Hospital, in Croydon, supports this view. The study evaluated prolapse, bladder, bowel and sexual symptoms 12 months after pessaries were inserted, demonstrating that vaginal pessaries were a simple and effective method of alleviating prolapse symptoms even in the longer term. It also concluded that it offered improvements in quality of life compared to the debilitating effects of pelvic organ prolapse. Overall, the research highlighted the effectiveness of pessary use.
Currently there are no UK protocols for pessary management. To address this, a James Lind Alliance Pessary Priority Setting Partnership has been set up by the Nursing, Midwifery and Allied Health Professions research unit at Glasgow Caledonian University to identify the top ten priorities for future research in relation to pessaries.
McCabe, who is a member of the Steering Group, added: “The research group is made up of people with relevant expertise, experience, and involvement with pessaries and by working together we can add to the current knowledge and evidence-base regarding pessary use.”
Andrew Loughney, medical director, Liverpool Women’s Hospital added: “Prolapse of the uterus or of the vaginal wall is very common, especially in women who have previously had children or who are older. Sometimes it needs no treatment but if it is causing symptoms, simple lifestyle changes and pelvic floor exercises can be effective.
“Pessaries can also be useful. They were first used more than two thousand years ago in the time of Hippocrates. They have an excellent safety profile and with the modern materials and designs now available, they can give significant long term benefit.”
http://www.medicalplasticsnews.com/news/the-vaginal-mesh-scandal-update/
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