Recent medical opinions cast more doubt on FDA’s clearance of vaginal mesh products

A joint opinion by the American College of Obstetricians Gynecologists and the American Urogynecologic Society recommends that vaginal mesh be used in only the most severe cases of pelvic organ prolapse.

Vaginal mesh implants – used to treat patients suffering pelvic organ prolapse (POP) – were initially cleared for use by the FDA in 2001. The FDA's approval was given based on a comparison of vaginal mesh products to similar products used for hernia procedures. The approval process bypassed the extensive trials and testing required of most products.

Since 2001, patients who have had vaginal mesh products implanted have suffered a high incidence of bad outcomes. Most commonly, the mesh causes the vaginal wall to erode, leading to pelvic pain, pain during intercourse, and a variety of frightening, harmful and permanent physical injuries.

Due to these health risks, the American College of Obstetricians and Gynecologists (ACOG) and the American Urogynecologic Society (AUGS) issued an opinion cautioning women with POP against receiving surgery to implant transvaginal patches. The joint opinion advises that because the injuries caused by these products are permanent and potentially so severe, only women with the greatest risk of highly adverse POP side effects should consider the implantation of vaginal mesh products.

The ACOG and AUGS's opinion, issued Nov. 21, 2011, also attested to the urgent need to develop a nationwide registry to document surgical outcomes involving vaginal mesh. Such an archive would help track the dangers of transvaginal mesh across demographics and help determine how best to limit its uses.

You can read the entire press release here. More information on POP and the legal issues related to vaginal slings is available here. For information on legal options for those harmed by vaginal mesh, fill out the form below, and a representative will be in touch with you shortly.

Click To Talk To Us Online