The study was published May 15, 2013, in the Journal of the American Medical Association and examined long-term effectiveness and outcomes of abdominal sacrocolpopexy. Abdominal sacrocolopopexy is a surgery to repair pelvic organ prolapse in which mesh is used to hold organs in place. The study examined outcomes in patients up to seven years following abdominal sacrocolpopexy, to determine risks associated with the procedure. In all, 215 women were involved in the study, with 126 being evaluated at seven years post-surgery.
Researchers found that at seven years, the risk of mesh erosion was 10.5 percent. “Abdominal sacrocolpopexy effectiveness should be balanced with long-term risks of mesh or suture erosion,” researchers noted.
The study did not single out any one type of transvaginal mesh, but various companies have been accused of not adequately warning women about the risks associated with their products. Complications reportedly include erosion of the mesh through the abdominal wall, pelvic pain, pain during intercourse and organ perforation. Now, many companies that manufacture transvaginal mesh products face lawsuits alleging their products harmed women who had them implanted.
READ MORE BARD AVAULTA TVM LEGAL NEWS
On July 13, 2011, the US Food and Drug Administration (FDA) issued a Safety Communication, warning about the risk of serious complications associated with transvaginal mesh used to treat pelvic organ prolapse. At the time, the FDA noted that serious complications associated with transvaginal mesh for pelvic organ prolapse are not rare, contrary to what the agency had previously reported. The FDA also noted that it was not clear that transvaginal pelvic organ prolapse repair with mesh was any more effective than other non-mesh repair.