The four named meshes are:
Prosima Pelvic Floor Repair System
Prolift Pelvic Floor Repair System
Prolift MTM Pelvic Floor Repair System
These are the four vaginal mesh implants named in a pair of letters that were sent to the federal judge who is overseeing the multidistrict litigation in Charleston, West Virginia and the state court judge overseeing litigation in Atlantic City, New Jersey.
Thousands of cases have been filed by women against 9 mesh manufacturers, Johnson & Johnson’s Ethicon division among them, who claim the products cause complications that include mesh erosion into the vagina and organs, pelvic and nerve pain, infection, mesh migration, a return of incontinence and prolapse, and in some cases death.
“Ethicon has no present intention to commercialize these products in the future, but it has requested that FDA allow it 120 days to cease commercialization. This time period would permit Ethicon to notify its customers, and provide those hospitals and surgeons with sufficient time to select alternative treatment options for their patients,” the J&J unit wrote the judges as published by Pharmalot.
“Ethicon will also discontinue or revise, as appropriate, all marketing materials during this time. Ethicon will continue to report adverse events and provide medical communications for these products, consistent with applicable regulations; however, Ethicon has requested that FDA’s Office of Surveillance and Biometrics place the existing 522 orders requiring additional studies for these products on hold. Ethicon is awaiting written confirmation of that plan.”
J&J will update the product label for the Gynecare Gynemesh PS to further restrict its use for abdominal sacrocolpopexy procedure. The company has requested sales be allowed to continue of the Gynecare Gynemesh PS while a label change is underway.
J & J still has not followed through on an FDA order issued last January for it and 30 other mesh manufacturers to conduct post-market studies on organ damage among the women already implanted with vaginal mesh. (Background story here).
The Prolift has been in the news lately. Recall that it was put on the market in 2005 without any regulatory okay from the FDA. The FDA only caught on when J & J went to get the approval for a similar mesh and named it as a predicate. The FDA went ahead and approved both meshes in May 2008.
An Ethicon spokesman tells Ed Silverman’s Pharmalot that “this is not a product recall. We continue to have confidence in the safety and efficacy of these products. Our decision to discontinue these products is based on their commercial viability in light of changing market dynamics, and is not related to safety or efficacy.”
The company plans to phase out the products over the next 12 months.
This is just the latest in a long line of defective product recalls for the pharmaceutical and medical device giant. J&J has seen recalls of over-the-counter cold products, hip replacement devices, epilepsy drugs, contact lenses, not to mention eroding consumer confidence.
The outstanding question now is how many of the other manufacturers will follow suit and give up the marketing of lucrative medical devices for female pelvic health. With thousands of lawsuits amassing in West Virginia and New Jersey, no doubt lawyers will use the withdrawal to their advantage to argue the company knew all along it has a product liability problem yet sold the devices anyway.
And the FDA’s controversial 510(k) approval product is now front and center. With no requirements for safety and efficacy, 510(k) allows a medical device, even those moderate to high-risk, to be placed on the market with an exchange of paperwork.
The Institute of Medicine last year said that 510(k) was ‘fatally flawed’ and should be abolished. In a report by the US Government Accountability Office last year, the FDA was slammed for a failure to recall products and regulate high-risk devices approved under 510(k).
It is the same approval process that has allow metal-on-metal hips be marketed and defibrillator leads, both defective which are later found defective when they injured unsuspecting patients.
Links to PDF copies of the Ethicon letters, June 4, 2012: :
FDA January 2012- 522 studies ordered
GAO, June 2009 – Medical Devices, Shortcomings in FDA’s Premarket Review, Postmarket Surveillance, and Inspections of Device Manufacturing Establishments
Ethicon Gynecare products
MDND, March 21, J&J Sold Vaginal Mesh Implant Without FDA Approval
MDND, August 21, 2011, Study Halted Due to Mesh Complications
MDND- Mesh Makers Who Received 522 orders