FDA: J&J, others must study safety of vaginal mesh
The FDA is ordering the makers of vaginal mesh implants to study the rates of organ damage and other complications following allegations that the devices have harmed women. The devices are used to treat incontinence and organ prolapse.
In a letter, Johnson & Johnson ($JNJ), C.R. Bard ($BCR), Covidien ($COV), Boston Scientific ($BSX) and a number of other companies are asked by the FDA to conduct three years of studies on the safety and effectiveness of the meshes. Patients have filed a number of lawsuits against manufacturers alleging the products failed, leading to complications and even death, as Bloomberg notes.
Last fall, an FDA expert panel met to consider reclassifying the meshes as Class III. They originally had been cleared under the 510(k) process. The panel recommended reclassification, but the FDA hasn't made its decision yet.
"We need to change how we do our premarket evaluations of these products," said Colin Pollard, director of the FDA's obstetrics and gynecology devices branch, said at the time. "We think the current 510(k) paradigm doesn't work for these products because we don't think we know enough about the safety and effectiveness."
Groups like Public Citizen have even entered the fray, going as far as to suggest a recall of all surgical mesh products made of non-absorbable synthetic material that are used during transvaginal surgery because they offer no benefits and pose serious risks.
However, the FDA isn't likely to heed such a call. "There's strong support in the clinical community that mesh serves a role for certain patients," the FDA's William Maisel told Bloomberg. "Our goal is not to completely remove these products from the market."
According to The Boston Globe, a Covidien spokesperson said the company had received the letter and will comply with the agency's requirements. Meanwhile, a Boston Scientific rep said she could not comment because she was unfamiliar with the matter.
A spokesman for J&J's Ethicon unit said in an email to Bloomberg that its meshes "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."
Panel mulls tougher rules for transvaginal meshes