The U.S. Food & Drug Administration (FDA) warned yesterday that transvaginal mesh products have been associated with serious and painful complications, especially when used in pelvic organ prolapse (POP) repair. According to the agency, it has received more than 2,800 complaints about <"http://www.yourlawyer.com/topics/overview/transvaginal_mesh_injuries">transvaginal mesh complications since it last issued a warning in 2008. In three of those cases, women died.
Transvaginal mesh products are marketed by several companies, including <"http://www.yourlawyer.com/topics/overview/american-medical-systems-ams-transvaginal-mesh-erosion-side-effect-lawsuit">American Medical Systems (AMS), C.R. Bard and Mentor. In addition to POP, the products are used in surgeries to treat stress urinary incontinence (SUI).
Over the past several years, AMS, C.R. Bard and Mentor have all been named in lawsuits filed by women who claim to have been injured as a result of transvaginal mesh complications. Most recently, a Texas woman filed suit in California claiming an AMS transvaginal sling eroded, shrunk and part of it extruded into her vagina. The complaint alleges that AMS failed to warn patients about the risk of vaginal mesh side effect. At least two similar lawsuits have been filed in Delaware.
Last October, litigation involving C.R. Bardâ€™s Avaulta mesh was consolidated as part of a multidistrict litigation for pretrial proceedings in the U.S. District Court for the Southern District of West Virginia. Settlements were reached in a number of Mentor ObTape vaginal mesh lawsuits as well.
When the FDA last issued a warning about such products, it had received 1,000 complaints regarding transvaginal mesh complications. According to yesterday’s FDA transvaginal mesh warning, since then the agency has received 1,503 more reports associated with POP repairs and 1,371 associated with SUI repairs. Most of these complications involved mesh erosion through the vagina, pain, infection, bleeding, pain during sexual intercourse, organ perforation, or urinary problems.
Studies reviewed by the agency indicated that about 10 percent of women who have the mesh placed transvaginally experience mesh erosion within 12 months of surgery and that more than half of them require additional surgeries to remove the mesh. In some cases, even multiple surgeries will not resolve the complication. When that occurred, the complications severely affected the victims’ quality of life.
The FDA seemed to put particular emphasis on transvaginal mesh POP repair, stating complications from this procedure are NOT rare – a change from the position it took in 2008. The agency also it was not clear that POP repair involving transvaginal mesh was better than traditional non-mesh procedures, and may actually expose patients to greater risk of complications.
According to the agency, the 1,503 adverse event reports associated with POP procedures was five times as many as the FDA received from 2005 to 2007. The warning also noted that a previously unidentified complication associated with transvaginal POP repair – mesh contraction or shrinkage – has been reported in the published scientific literature and in adverse event reports to the FDA since its 2008 alert.