FDA Orders Vaginal Mesh Manufacturers to Study Safety Issues

With vaginal mesh lawsuits mounting, the FDA has ordered 33 vaginal mesh device manufacturers to undertake a 3 year study to determine their effectiveness as well as their safety in treating two approved uses-pelvic organ prolapse and female urinary incontinence.
In recent years, the transvaginal mesh makers have been receiving complaints about mesh failures and their ineffectiveness in treating either of the two conditions for which the device was originally approved under the government’s 510(k) system, which allows products to reach the market without human testing if the agency decides they’re similar to devices already for sale. In October, Bloomberg News reported many implants can trace their approvals back to a Boston Scientific Corp. mesh recalled for safety concerns in 1999.
According to Bloomberg, “Almost 300,000 synthetic meshes were implanted in U.S. women in 2010 to treat incontinence or shore up pelvic muscles, the agency estimates. The devices’ alleged failures have spurred more than 650 lawsuits against manufacturers and heightened scrutiny of the FDA program that cleared the products for sale without human testing. The letters ask each manufacturer to collect data on the results and potential complications of transvaginal procedures, in which the hammock-like meshes are threaded in place through an incision in the vagina. The FDA said in July that it wasn’t clear from available studies whether the devices provided a benefit over older methods in certain cases.”