Bureau of Food and Drug Analysis considers “grace period” for makers of hazardous product
Earlier this year, the U.S. Food and Drug Administration (FDA) officially acknowledged that transvaginal mesh, a medical device used to treat a condition called pelvic organ prolapse, in fact does not appear to improve the condition—and even exposes its users to significant risks. The agency advised healthcare providers and patients of the findings and proposed re-classifying transvaginal mesh as a class III medical device (which would make the approval process for new transvaginal mesh products more rigorous).
Since then, however, the FDA has indicated willingness to let manufacturers of transvaginal mesh have a “grace period” in pulling the product from the market and conducting further study—this despite having received, over the past six years, thousands of reports of severe complications arising from the product. These reports have increased five-fold just since 2008.
“A grace period allowing continued marketing of these devices would recklessly endanger women,” Daniel Elliott, a urologic surgeon specializing in female urology and pelvic organ prolapse, said in a statement from the nonprofit organization Public Citizen. “There is sufficient data available…indicating that the risks of serious complications from these devices far outweigh their benefits.
If you believe that you have been harmed by transvaginal mesh or another medical device, contact Hodes Milman Liebeck for a free case evaluation. We’re aggressive personal injury and medical malpractice lawyers based in Orange County, serving all of California. We have the experience to take on the medical industry and have achieved multi-million dollar verdicts for our clients.