Another medical device that the Food and Drug Administration (FDA) approved through its controversial “fast-track” 501(k) process has turned out to be not only ineffective, but harmful.
Transvaginal mesh is a surgical implant used to treat pelvic organ prolapse, a condition in which a woman’s uterus, bladder or rectum slips out of place. The FDA approved the device for use in treating the condition in 2002 without requiring it to fulfill clinical trial data requirements because, as per 501(k)-process requirements, the device’s manufacturer had proven it was “substantially similar” to other products already on the market.
Problems with transvaginal mesh first emerged in 2008, when the agency alerted doctors that it had received more than a thousand manufacturer reports between 2005 and 2007 of complications stemming from the device. Since 2008, reports of severe complications—including erosion, when the skin breaks and the mesh protrudes—have increased five-fold. That dramatic rise prompted the FDA earlier this month to release an updated advisory concluding that there is little evidence the device improves pelvic organ prolapse, and that it actually exposes patients to significant risks.
Do you believe you’ve been harmed by transvaginal mesh or another medical device? Contact Hodes Milman 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.
