The FDA is alarmed about the risk of complications with vaginal mesh used to treat pelvic organ prolapse and stress urinary incontinence. The Federal regulators are ordering manufacturers to conduct new medical studies on the surgical products’ safety.
FDA Notice Letter Sent
The FDA sent a letter to several medical device makers recently calling for the new postmarketing studies on transvaginal mesh. Many experts believe that this is the beginning of tighter regulations designed to protect women from bladder sling problems.
The letter was sent to 33 manufacturers of vaginal mesh products, including Johnson & Johnson, American Medical Systems (AMS), C.R. Bard and Boston Scientific.
Controversial 510(k) Fast-Track Approval Process
The vaginal mesh products have been approved through the FDA’s controversial 510(k) fast-track approval process, which only requires that they be substantially equivalent to a device that has already been approved for sale.
510(k) fast-track approval process means that there were no requirements for clinical studies or tests of safety or effectiveness before the medical devices were implanted in American women.
FDA Mandates New Studies
The FDA will now require 99 new postmarket studies, with 88 of those focused on surgical mesh for pelvic organ prolapse (POP) and 11 targeting single-incision mini-slings used to treat stress urinary incontinence (SUI). Manufacturers will have to submit study plans to the FDA showing how the studies will address the agency’s safety concerns.
Scope of the Problem
An estimated 300,000 synthetic transvaginal meshes were implanted in women in the U.S. in 2010.
In summer 2011, the FDA issued a warning about the risks of problems when vaginal mesh products are used. The regulatory agency indicated that it could find no benefit in using transvaginal mesh to treat POP when compared to older, safer alternatives.
Between 2008 and 2010, the FDA received more than 1,500 reports of transvaginal mesh complications, including erosion of the mesh into the vagina, contraction or shrinkage of the mesh, infections, pelvic pain and other complications.
A growing number of transvaginal mesh lawsuits have been filed in courts across the country by women who say that vaginal sling manufacturers created defective products and failed to warn doctors or patients adequately about the risk of complications.