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On July 13, 2011 the FDA issued an important new warning about transvaginal mesh devices.
The warning updated a previous 2008 warning that informed patients and physicians of the potential risks associated with transvaginal mesh devices and clarified that the FDA no longer considered transvaginal mesh complications to be rare.
Additionally, the FDA announced that the incidences of transvaginal mesh complications are higher than the incidents of complications for other types of surgery to repair pelvic organ prolapse or treat stress urinary incontinence.
How Common are Transvaginal Mesh Complications?
From January 1, 2008 – December 31, 2010 the FDA received 2,874 reports of transvaginal mesh complications. That is in addition to the more than 1,000 reports received from 2005 – 2007.
Risks Associated with Transvaginal Mesh Devices
The identified risks include, but may not be limited to:
- Internal bleeding
- Vaginal scarring
- Vaginal wall narrowing
- Urinary problems
- Mesh erosion in to vaginal tissue
- Pain during intercourse
- Recurrence of pelvic organ prolapse and/or stress urinary incontinence.
The FDA Recommendations
The FDA has not yet banned transvaginal mesh devices. However, the agency is urging doctors to recognize that in most cases pelvic organ prolapse can be treated without transvaginal mesh and to make sure their patients are fully informed of the risks they face. The FDA is also recommending that patients talk to their surgeons about options, be diligent about follow up care, and recognize the signs of a potential side effect so that they can seek prompt treatment.
If you have, or are considering, a transvaginal mesh device to treat pelvic organ prolapse or stress urinary incontinence, we urge you to heed the FDA warnings and talk to your doctor.