FDA Warns: ‘Serious Complications’ Arise From Vaginal Mesh Implants

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Nucleus Medical Art, Inc.

Surgical mesh implants used to treat weakening in the pelvic region, a particularly common problem after childbirth, may actually do more harm than good, the Food and Drug Administration (FDA) reports Wednesday.

In the last three years, the agency said, it has received almost 3,000 reports of complications from transvaginal mesh that was inserted surgically to treat pelvic organ prolapse.

Pelvic organ prolapse occurs when one of the pelvic organs — most commonly the bladder, but also possibly the urethra, uterus, vagina, small bowel or rectum — slips from its regular location to press against the vagina, causing pain and discomfort.

This occurs when the muscles and ligaments that should hold the organs in place are weakened or stretched. Most often a pelvic organ prolapse takes place after childbirth, or after a hysterectomy.

Doctors can use surgical mesh to repair those weakened tissues. Implants are put in to reinforce the vaginal wall, or to support the urethra to prevent urine leakage. MedPage Today, a news service for physicians, reports that at least 100,000 such procedures were performed in the U.S. in 2010.

However, in its advisory on Wednesday, the FDA reports:

[S]erious complications associated with surgical mesh for transvaginal repair of [pelvic organ prolapse] are not rare. Furthermore, it is not clear that transvaginal [pelvic organ prolapse] repair with mesh is more effective than traditional non-mesh repair in all patients […] and it may expose patients to greater risk.

The most freqent complications reported, according to the FDA, were “mesh erosion through the vagina (also called exposure, extrusion or protrusion), pain, infection, bleeding, pain during sexual intercourse (dyspareunia), organ perforation, and urinary problems.”