FDA Issues Warning on Pelvic Mesh Used in Abdominal Surgery
The United States Food and Drug Administration (FDA) is warning doctors that the use of surgical mesh in some abdominal and vaginal repair surgeries can lead to serious complications. The mesh has been used to treat pelvic organ prolapse (POP), which occurs when organs such as the bladder, uterus, and bowel drop or bulge into the vagina due to weakness in the supporting structures. Surgeries to repair this condition have used surgical mesh manufactured by Boston Scientific, Covidien PLC, and other companies to support the organs after surgery. The mesh is implanted through either the abdomen or the vagina.
According to the FDA, transvaginal implementation of the mesh is "associated with clear risks" and "is a permanent implant -- complete removal may not be possible and may not result in complete resolution of complications." Reported complications include the mesh becoming exposed or protruding from vaginal tissue, pain, infection, bleeding, painful sexual intercourse, organ perforation during the implantation procedure, and urinary problems. The FDA further found that a review of studies from 1996 to 2010 showed that patients who underwent surgeries using the mesh were exposed to additional risks with no greater clinical benefit than patients who just had surgery with stitches and without the mesh. The FDA is convening an expert panel of gynecologists and obstetricians in September 2011 to further examine the safety and effectiveness of surgical mesh in treating POP.
Mesh Lawsuits Already Filed
Several lawsuits regarding the mesh have already been filed; there are approximately 75 patients suing Boston Scientific in California at present. The FDA has not decided to require a recall of the product. This has drawn criticism from public advocates such as the National Research Center for Women and Families who believe that the FDA has not gone far enough and are concerned about the continuing effects on patients while this product is still on the market.
If you or a family member underwent transvaginal placement of surgical meshto treat pelvic organ prolapse, you should discuss these recent findings of the FDA with your treating physician. You should also consult with an experienced trasnvaginal mesh attorney to determine the course of action that will best protect your rights.