Transvaginal Mesh (TVM) is generally used in surgical procedures that treat Pelvic Organ Prolapse (POP) or Stress Urinary Incontinence (SUI). POP occurs when the tissue holding pelvic organs becomes weak or stretched. SUI is a leakage of urine during moments of physical activity such as laughing, coughing or sneezing which increase pressure on the bladder.
The FDA has issued multiple public safety warnings about the use of transvaginal mesh. The first came in October 2008 when the agency alerted consumers to the more than 1,000 reports of adverse effects associated with the medical devices when they were used to treat POP and SUI. During a three-year period, the most common complications reported were erosion of the device and organ perforations. Surgeons were advised to use caution with the implants and to explain all the risk factors – including permanent body changes – which patients could suffer.