FDA Renews Safety Warnings for Transvaginal Mesh Complications

July 2011

Earlier this month the Food and Drug Administration (FDA) issued safety warnings for surgical mesh products used to repair pelvic organ prolapse – a condition that is common among older women.

Pelvic organ prolapse is a condition that is caused by the weakening of the pelvic muscles and ligaments. These muscles support organs like the bladder and uterus. Due to childbirth, menopause, hysterectomy, and other situations, they can slip out of place and cause medical complications. Surgery can correct pelvic organ prolapse by using stitches or a surgical mesh piece inserted through the abdomen or vagina.

The FDA issued a safety alert for the procedure in 2008 due to reports of health complications. It received more than 1,500 complaints between January 1, 2008, and December 31, 2010. Placing mesh through the vagina has shown to be much more problematic. In 2010, there were over 100,000 pelvic organ repairs recorded; three-quarters involved inserting the surgical mesh through the vagina.

While some physicians are concerned the alerts will stop surgeons from doing the procedures, about 10 percent of patients who undergo the surgery may experience complications – with the risk of debilitating problems. Complications have included mesh failure, infection, pain, urinary problems, perforation of the bladder and blood vessels, vaginal scarring, and recurrence of pelvic organ prolapse.

The FDA issued the safety warnings to alert women about the risks and to be cautious. Patients should check the surgeon’s experience level with pelvic organ repair procedures, ask questions, and attend follow-up screenings for potential complications.

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