FDA Enhances Warning on Medical Product for Pelvic Surgery

The FDA has taken the unusual step of issuing a second warning regarding the use of transvaginal surgical mesh, a product used to treat such conditions such as a prolapsed uterus. The FDA issued an initial safety communication in 2008 due to the number of “adverse events” reported by doctors using the product. From 2008 until 2010, the FDA received another 1503 reports of adverse events, five times as many as were received in the previous two-year period (although the reports did not always differentiate how the mesh was used).

While the product has not been recalled, two alerts and the greater-than-usual number of patient problems could signify that this medical device is potentially defective. It could also mean that doctors are not properly trained in how and when to use the product or that the product is being improperly marketed.

Surgical mesh is used in cases of pelvic organ prolapse (POP). This occurs when the bladder, uterus or bowel become weak or stretched and drop from their normal position into the vagina. This condition can create discomfort and interfere with normal functioning. It can be repaired with surgery through the abdomen or through the vagina. It is when the surgery is done vaginally that the mesh has created problems.

Medical complications of transvaginal use of surgical mesh include:

  • Mesh becoming exposed or protruding from the vaginal wall
  • Pelvic pain and pain during intercourse
  • Infection
  • Bleeding
  • Organ perforation during surgery
  • Urinary problems

Some patients needed additional surgeries, which puts patients at risk for more complications. The FDA warned doctors to consider the mesh to be a permanent implant and that complete removal might not be possible. Furthermore, the FDA reported that there was no evidence that the use of mesh Рrather than stitches Рprovided any greater clinical benefit.

Doctors are charged to “do no harm” but the use of surgical mesh in transvaginal procedures may do just that.

Source: FDA Website: “Surgical placement of mesh to repair pelvic organ prolapsed poses risks,” July 13, 2011.