Product Liability

Safety of vaginal mesh used to repair pelvic organ prolapse under review

Surgical placement of mesh used to repair pelvic organ prolapse (POP) poses more risks than benefits to women, according to an updated safety communication issued this week by the Food and Drug Administration (FDA). The agency says it will convene an expert panel in the fall to determine whether the vaginal mesh should be banned from the market.

Pelvic organ prolapse occurs when the internal structures that support the pelvic organs, such as the bladder, uterus and bowel, become so weak or stretched that the organs drop from their normal position and bulge or prolapse into the vagina. While not a life-threatening condition, women with POP often experience pelvic discomfort; disruption of their sexual, urinary and defecatory functions; and an overall reduction in their quality of life.

Surgery to repair POP can be performed through the abdomen or transvaginally, through the vagina, using stitches, or with the addition of surgical mesh to reinforce the repair and correct the anatomy.

The FDA issued a safety communication in 2008 because of mounting adverse event reports associated with the transvaginal placement of the mesh. Since then, the number of adverse events has continued to climb. Between 2008 and 2010, the FDA received 1,503 adverse event reports associated with the mesh used for POP repair, five times as many as the FDA had received between 2005 ad 2007. The reports do not always differentiate between vaginal and abdominal procedures.

The most commonly reported complications from surgical mesh include the mesh becoming exposed or protruding out of the vaginal tissue, pain, infection, bleeding, pain during sexual intercourse, organ perforation from surgical tools used in the mesh placement procedure, and urinary problems. Some cases required additional surgery or hospitalization to treat complications or to remove the mesh.

Any side effects with surgical mesh used for POP procedures should be reported to the FDA MedWatch Adverse Event Reporting Program at www.FDA.gov/MedWatch.

Sources:
FDA
Boston.com