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Johnson & Johnson’s $5m mesh settlement could push costs higher
Apr 7, 2016 | Mass Device
By Brad Perriello
Johnson & Johnson (NYSE:JNJ) subsidiary Ethicon could be facing a steeper-than-expected tab when it comes to settling the more than 46,000 product liability lawsuits brought over its pelvic mesh products, after details about 1 settlement became public in a legal filing. -
Dr. Raz Tells Docs Why He Will Not Use Synthetic Mesh Slings!
Apr 8, 2016 | Mesh Medical Device News Desk
By Jane Akre
For those of you new to the mesh debate, this explanation by Dr. Shlomo Raz, a urologist from UCLA, lays out the debate.
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Johnson & Johnson’s $5m mesh settlement could push costs higher
Apr 7, 2016 | Mass Device
By Brad Perriello
Johnson & Johnson (NYSE:JNJ) subsidiary Ethicon could be facing a steeper-than-expected tab when it comes to settling the more than 46,000 product liability lawsuits brought over its pelvic mesh products, after details about 1 settlement became public in a legal filing.
J&J agreed to pay $5 million to settle plaintiff Pamela Wicker’s lawsuit alleging that its Prolift mesh caused her injuries, Bloomberg reported. Wicker’s lawyer, Adam Slater, revealed the $5 million payment in a November 2015 filing seeking Judge Brian Marinotti’s approval for his $1.65 million legal fee, according to the news service.
In January, the New Brunswick, N.J.-based healthcare giant agreed to pay $120 million to settle the 1st 2,000 to 3,000 suits it’s facing. The amount of the Wicker settlement could mean that the cost of settling the cases moves much higher, according to Carl Tobias, a product-liability law expert the University of Richmond in Virginia.
“This settlement is a bad sign because it shows investors it’s going to cost a lot more to deal with this liability than people expected,” Tobias told Bloomberg.
The Wicker case “presented unique circumstances,” J&J told the news service via email. While the estimated cost of the mesh litigation isn’t broken out, “the company appropriately discloses overall litigation expenses.”
“From time to time we have agreed to resolve some cases,” J&J said. “We will not discuss the terms of resolutions, nor discuss our ongoing litigation strategy.”
Last month a New Jersey appeals court upheld an $11.1 million jury awardin another Prolift case; in February, a Philadelphia jury docked the company $13.5 million in a suit filed over its Ethicon transvaginal polypropylene tape; J&J is appealing that verdict.
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Dr. Raz Tells Docs Why He Will Not Use Synthetic Mesh Slings!
Apr 8, 2016 | Mesh Medical Device News Desk
By Jane Akre
For those of you new to the mesh debate, this explanation by Dr. Shlomo Raz, a urologist from UCLA, lays out the debate.
A 29 minute webcast at the annual meeting last year of the American Urological Association (AUA) entitled “Surgery for Stress Incontinence – With vs. Without Mesh,” features two prominent doctors debating the use of pelvic mesh – Dr. Paulo Palma, a professor of Urology from Brazil (pro mesh use) and Dr. Shlomo Raz, urologist from UCLA.
Made of polypropylene plastic, surgical mesh is used to help reinforce tissues that may have allowed organs to fall in the pelvic floor.
Dr. Raz had used mesh and taught its use for many years before noticing that some of his patients returned, some up to a dozen years later, with complications. Others have noted that mesh is not inert, meaning it takes on a life of its own and is constantly undergoing changes including, but not limited to, degradation, erosion, shrinkage, contraction.
Dr. Paulo Palma, defends implanting synthetic slings with mesh to treat stress incontinence. He calls them minimally invasive, and a gold standard he says there is a 49% cure rate for Burch Procedure, 66% cure rate for incontinence with a sling.
TVT-S
In this 30 minute webinar, Dr Palma says the worst fixation of a mini-sling was the TVT-Secur which is no longer on the market.
About 15 minutes in, Dr. Raz says many mini-slings were ineffective and that’s why they are off the market. Even though he had a good result after implanting about 1,800 distal urethral implants with 10 cm of soft prolene mesh attached to a vicryl suture, he would note erosion, UTI’s and pelvic pain, five to ten years after implantation. As a result he has abandoned the use of synthetic mesh.
In the last five years, Dr. Raz says he has removed about 1,300 mesh implants due to erosions, vaginal pain and infections.
Why do they occur?
To answer that question, UCLA started a Biofilm Project. Beginning with 1,300 patients with sling procedures mesh segments were taken from the midline and distal area (away from the midline) and amplified to discover live bacterial colonies growing in the mesh.
The theory is that unavoidable contamination with vaginal bacteria during placement may result in bacterial biofilms on the mesh.
“Twenty percent of the patients with mesh removed have systemic symptoms – skin rash, losing hair, lung issues, sinuses – we are looking at the immunology of the chronic bacteria creating systemic effects.”
As a result, Dr. Raz abandoned totally synthetic mesh slings. Today he does fascia lata and bladder suspensions, which have a good patient outcome.
Taking the facial sling from the Ileo-tibial band in the leg to harvest 5 to 10 cm of tissue, then using a fascial stripper to cut the sling results in what Dr. Raz calls an excellent quality sling with minimal pain and quick recovery.
“I agree, mesh is a good surgery for incontinence, but I , after doing so many, have discovered I cannot do it anymore. I don’t provide a good care for my patients because I discovered you put mesh through a contaminated vaginal area, and the patient with pelvic pain bacteria DNA causing live bacteria in the mesh that can cause potential problems.”
Three million slings have been done he estimates. Last year’s publication of a five year longitudinal followup study of slings finds their effectiveness decreased over time as did quality of life issues.
Listen to the webcast here: http://www.aua2015.org/webcasts/webcast_play.cfm?videoID=1820&agendaid=8052
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