Transvaginal Mesh Risk Label May Be Heightened by FDA
In the wake of mounting lawsuits against manufacturers of transvaginal mesh devices implanted in women to treat a litany of internal conditions, the U.S. Food and Drug Administration (“FDA”) is now moving to heighten the risk label associated with transvaginal mesh specifically used to treat pelvic organ prolapse (“POP”). The risk label for mesh devices used to treat POP will be heightened from “low” to “intermediate.”
If the new standard is adopted after a mandatory 90-day public comment period, manufacturers of transvaginal mesh devices used to treat POP will be required to provide clinical data demonstrating a reasonable assurance of safety and effectiveness prior to marketplace introduction.
Over the past several years, the FDA has taken several formal actions to address the dangers allegedly posed by the use of transvaginal mesh devices. In October 2008 the FDA released a Public Health Notification about serious complications associated with transvaginal placement of surgical mesh for POP and stress urinary incontinence (“SUI”). In July 2011, the FDA released an updated safety communication about serious complications associated with transvaginal POP repair with surgical mesh. In July 2011, the FDA released a review of urogynecologic surgical mesh adverse events and scientific literature, identifying serious safety and effectiveness concern. In September 2011, the FDA’s Obstetrics and Gynecology Devices Panel recommended reclassification of surgical mesh for transvaginal POP repair from class II to class III and to require premarket approval. Most recently, in January 2012, the FDA ordered manufacturers to conduct post-market surveillance studies to address specific safety and effectiveness concerns about surgical mesh used for transvaginal POP repair.
If you or a loved one has suffered serious personal injuries that you believe may be related to implantation of a transvaginal mesh device, you are urged to contact a transvaginal mesh attorney at Audet & Partners, LLP for a free, confidential case evaluation by calling (800) 965-1461, or by completing and submitting our online inquiry form on the right side of this page.