• 16
  • September
    2011

In 2008, the U.S. Food and Drug Administration evaluated reported complications following the placement of transvaginal mesh to treat pelvic organ prolapse (POP) and stress urinary incontinence (SUI) and stated that serious complications are rare. After an in-depth review of medical literature on transvaginal surgical mesh implantation and increased reports of serious complications following the procedure, however, the FDA has issued an alert warning health-care providers and patients that serious complications are a greater threat than previously reported.

According to the FDA, surgical mesh is used to repair weakened or damaged tissue and is commonly used to reinforce a weakened vaginal wall after POP occurs or to support the urethra in women who experience SUI. The surgical-mesh implantation is intended to be permanent.

Following its analysis of additional reported serious complications and its review of relevant medical literature, the FDA now says the implantation of transvaginal surgical mesh to repair POP is "an area of continuing serious concern." The FDA also stated that its review revealed that:

  • Implanting transvaginal mesh introduces risks not present in other non-mesh surgeries to repair POP
  • Surgical mesh implanted abdominally to repair POP may result in lower rates of post-surgery complications

Among other things, the FDA also reported that the most common serious complication following transvaginal mesh implantation is mesh erosion, which can cause patients to require several surgeries and can be "debilitating" to women. In some cases, multiple surgeries were not sufficient to fix complications following transvaginal mesh implantation. Therefore, the FDA is urging health-care providers to recognize that POP can be treated without mesh in most cases, thereby avoiding the risk of these and other serious personal injuries following transvaginal mesh implantation.

If you have a transvaginal mesh implant contact your physician to make sure you are not at risk. Additionally, if you are experiencing complications, a knowledgeable personal injury attorney may be able to help you receive compensation for your suffering.

Source: FDA, Update on Serious Complications Associated with Transvaginal Placement of Surgical Mesh for Pelvic Organ Prolapse, 13 July 2011