A few years ago, the public was given the first vaginal mesh FDA warning — that is, the U.S. Food and Drug Administration (FDA) began to issue cautions about the complications and side effects associated with vaginal mesh products (which are often referred to as “surgical mesh” products and “bladder slings”).
2008 FDA Vaginal Mesh Warning
In 2008, the FDA released its first public health communication cautioning doctors about the risks associated with surgical mesh. Issued in response to surgical mesh manufacturers’ receipt of “over 1,000” adverse-event reports associated with attempts to remedy pelvic organ prolapse (POP) and stress urinary incontinence (SUI) by placing surgical mesh transvaginally (that is, through a woman’s vagina as opposed to through her abdomen), the 2008 FDA warning stated that vaginal mesh complications were serious, but “rare.”
2011 FDA Vaginal Mesh Warning
Between the 2008 release of that Health Safety Communication and 2010, serious complaints about complications related to the use of surgical mesh to treat POP increased five-fold, according to the FDA. Moreover, the agency’s systematic review of the relevant scientific literature published from 1996 to 2011 “showed that transvaginal POP repair with mesh does not improve symptomatic results or quality of life over traditional non-mesh repair.”
Accordingly, the FDA issued another safety communication on July 13, 2011, this time announcing that “serious complications associated with surgical mesh for transvaginal repair of POP are not rare. This is a change from what the FDA previously reported on Oct. 20, 2008. Furthermore, it is not clear that transvaginal POP repair with mesh is more effective than traditional non-mesh repair in all patients with POP and it may expose patients to greater risk.”
Find Out if You Are Entitled to Compensation
If you or someone you love has suffered from side effects related to the transvaginal placement of surgical mesh, submit this simple secure form so we can conduct a free and confidential evaluation of your eligibility to file a surgical mesh lawsuit.
We are sensitive to the suffering that transvaginal placement of surgical mesh patients have undergone. We will act in your best interests and make the process of helping you to obtain compensation as simple for you as possible.