Victims of failed transvaginal mesh products are asking why the U.S. Food and Drug Administration did not take a more aggressive approach on behalf of women’s safety in the approval process of these medical devices.
FDA critics are focusing in on the fact that some manufacturers of mesh products seemingly took advantage of an expedited approval process they say failed to scrutinize the products enough.
Did that process enable some transvaginal mesh products to earn FDA approval and generate millions of dollars for the manufacturers while not undergoing the rigorous testing and reviews that many medical products must undergo?
The FDA regulatory system in question is the 510(k) expedited approval process, which essentially is a loophole that allows some manufacturers of medications and medical devices to win backdoor approval to place their products in the marketplace.
The way the rules are set up now, some new drugs or medical devices qualify for approval if they are similar to existing FDA-approved products and allowed to be sold with FDA sanction.
This process became part of a recent court case in a transvaginal mesh lawsuit in which a judge ruled that just because a medical device was approved by this process it didn’t mean that women couldn’t sue on the grounds that the devices were unsafe and not adequately tested.
The question of the validity of the 510(k) process was raised again recently when the FDA ordered over 30 of these mesh manufacturers to conduct post-market safety tests in the wake of allegations that the products were unsafe.
Transvaginal mesh for many years was a frequently used medical device chosen by surgeons to treat such medical conditions as pelvic organ prolapse and urinary continence that occur in women as they age and their abdominal muscles weaken.
The FDA has twice issued public health warnings expressing concerns about the dangers of transvaginal mesh, most recently in 2011
The FDA released safety communications concerning the device in 2008 and again in 2011 and summed up the problem in this wording:
“Many women who have undergone transvaginal mesh implantation have experienced severe health complications that have significantly altered their lives. As noted in the FDA’s safety communication the problems are often both physical and emotional and can require serious medical intervention.”