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FDA Releases Safety Communication with Updated Transvaginal Mesh Complications

July 13, 2011 — The FDA released a Safety Communication in order to update doctors and patients about serious complications associated with transvaginal placement of surgical mesh. While an initial Public Health Notification warned of health complications in 2008, the FDA is updating its information to include the fact that the serious risks of transvaginal repair with mesh are not rare and patients may be at risk of complications previously unknown before 2008.

Surgical mesh is a medical device used to repair weakened or damaged tissue, particularly in pelvic organ prolapse (POP) or to support the urethra to treat stress urinary incontinence (SUI). POP occurs when tissues holding the pelvic organs weaken or stretch, causing the organs to bulge (or prolapse) into the vagina or past the vaginal opening. SUI occurs when there is a leakage of urine during physical activity, including coughing, sneezing, laughing or exercise.

During their lifetime, 30 to 50 percent of women may experience POP, but only 2 percent will develop symptoms. Organs that can be involved in prolapse include the bladder, the uterus, the rectum, the top of the vagina, and the bowel.

When used in urogynecologic (conditions affecting the female pelvic organs) procedures, surgical mesh is permanently implanted through the vagina to reinforce the vaginal wall.

On October 20, 2008 the FDA initially warned of serious, but rare complications associated with surgical mesh, also known as vaginal or transvaginal mesh. Due to reports of complications, the FDA identified transvaginal mesh as an area of concern.

Recently, however, the FDA issued an update to this report, based on continued research that proved transvaginal mesh to be more dangerous than previously thought. In particular, complications associated with transvaginal mesh are not rare, as initially believed.

As the FDA reports:

“The FDA is issuing this update to inform you that serious complications associated with surgical mesh for transvaginal repair of POP are not rare. This is a change from what the FDA previously reported on Oct. 20, 2008. Furthermore, it is not clear that transvaginal POP repair with mesh is more effective than traditional non-mesh repair in all patients with POP and it may expose patients to greater risk.”

The FDA came to these conclusions after reviewing information from previous data from 2005-2007, as well as new reports received between January 2008 and December 2010.

On October 20, 2008, the FDA reported receiving “over 1,000” adverse event reports associated with vaginal mesh devices used in POP and SUI repair. Since then, the FDA received 2,874 new reports — 1,503 associated with POP repairs and 1,371 associated with SUI repairs.

The most common and consistently reported complication is mesh erosion through the vagina (also known as exposure, extrusion or protrusion). Other common complications include pain, infection, bleeding, dyspareunia, organ perforation and urinary problems. Less frequent complications included recurring prolapse, neuro-muscular problems, vaginal scarring or shrinkage, and emotional problems. Many of these complications required additional surgery or hospitalization.

Mesh contraction or shrinkage is a complication that went unreported prior to 2008. Mesh contraction can cause vaginal shortening, tightening and pain.

On top of reviewing adverse event cases, the FDA also reviewed scientific literature from 1996-2011 regarding surgical mesh use in POP and SUI. As a result, the FDA found that transvaginal mesh does not improve symptomatic results or the quality of life over non-mesh treatments. It may introduce risks not present in non-mesh surgeries.

As a result of the FDA’s recent findings, the FDA is convening a safety and effectiveness panel on September 8-9, 2011. The panel, called the Obstetrics-Gynecology Devices Panel of the Medical Device Advisory Committee, will discuss and make recommendation about transvaginal mesh use for POP and SUI.

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