JANUARY 4, 2012 ~ Bloomberg reports that the Food and Drug Administration’s division that oversees medical devices has ordered surgical mesh manufacturers to study how often synthetic mesh harms women by causing infection and organ damage. (story is here)
The order follows an FDA report last summer of a five-fold jump in the number of deaths or injuries and complications in women implanted with transvaginal mesh for incontinence and pelvic organ prolapse (POP). Thirty-three manufacturers of urogynecologic surgical mesh for pelvic organ prolapse, and 11 makers of mini-slings used for stress urinary incontinence were sent letters from the FDA January 3, including Johnson & Johnson and C.R. Bard.
The makers must collect data for three years on the safety and effectiveness of the permanent medical device implants.
With about 300,000 synthetic implants used in U.S. women in 2010, the unusually high complication rate, which is largely unknown, has sparked hundreds of lawsuits against manufacturers as well as greater questions about the FDA approval process, known as the 510(k), that allows mesh to be marketed without any safety clearances or clinical trials.
Presently, the manufacturer need only claim its medical device is equivalent to a device already on the market. But in the case of today’s synthetic mesh, the so-called predicate device, Boston Scientific’s ProteGen sling, was removed from the market over safety concerns in 1999.
The FDA has no system in place to spark a review of the devices that named it as a predicate.
The letters ask each manufacturer to determine whether a vaginal surgery, called transvaginal, where a cradle-like mesh is threaded through the pelvis, provides any benefit over a traditional surgical option without mesh.
In response to the FDA letter, Johnson & Johnson spokesman, Matthew Johnson, told Bloomberg in an e-mail,
“Ethicon’s transvaginal mesh devices are already among the most studied devices on the market, and we will continue to support their use in surgical repair with clinical evidence, through investigator-initiated and company-sponsored trials.”
Johnson has never returned the numerous phone calls from Mesh News Desk requesting to see those studies.
The request is in response to the growing number of patient complaints and vocal patient advocacy groups who believe this revelation finally requires companies to tell the truth and not just public relations spin.
Last July 13, the FDA issued a Safety Communication that warned consumers and health care providers of a range of complications from mesh such as erosion, infection, perforation, mesh shrinkage among other problems. And it stated:
“Furthermore, it is not clear that transvaginal POP repair with mesh is more effective than tradition non-mesh repair in all patients with POP and it may expose patients to greater risk.”
An expert panel gathered by the FDA last September to consider a recall, recommended transvaginal synthetic mesh be reclassified as “high-risk” which would required patient safety clinical trials by the manufacturers.
Bloomberg reports the requests also went out to Endo Pharmaceuticals Holding Inc., of Chadds Ford, Pennsylvania, and Boston Scientific of Natick, Massachusetts. They have 30 days to respond.