FDA 2008 Warning About Transvaginal Mesh Devices

In 2008, the U.S. Food and Drug Administration (FDA) issued an important alert about potentially serious complications associated with transvaginal mesh devices. The alert, issued to healthcare practitioners on October 20, 2008, described the potential complications as rare but serious.

The FDA's 2008 Concerns

From 2005 – 2008, the FDA received more than 1,000 reports from nine different transvaginal surgical mesh makers about complications associated with the mesh devices when the devices were used to treat pelvic organ prolapse and stress urinary incontinence.

Specifically, the most frequent complaints included:

• Erosion of the device into the vagina.
• Infection.
• Pain.
• Urinary problems.
• Recurrence of the organ prolapse or incontinence.

Additionally, some instances of bowel, bladder, and blood vessel perforation were also reported.

Some patients experienced a significant change in their quality of life and required additional surgical procedures because of the side effects and complications of the transvaginal mesh devices.

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2008 FDA Recommendations

In 2008, the FDA recommended that physicians receive specialized training for each mesh placement technique, be vigilant about potential complications, and thoroughly inform patients about the risks for serious complications. Doctors and hospitals were also reminded of their responsibility to report serious injuries to the FDA.

It is important to note that while transvaginal mesh products are still on the market and this FDA warning is still applicable, the FDA issued additional warnings about the potential complications of vaginal mesh products in 2011.

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