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FDA Transvaginal Mesh Classification

The Food and Drug Administration (FDA) issued a notice in 2011 recommending that transvaginal mesh be classified as a Class III, high-risk medical device. The notice occurred after the FDA received reports that complications from transvaginal mesh rose by five times between 2008 and 2010.

This Food and Drug Administration classification means that complications associated with transvaginal mesh are “not rare” and that there is no evidence proving that transvaginal mesh repair surgeries for pelvic organ prolapse (POP) are more effective than traditional non-mesh repair.

Women who experienced problems with transvaginal surgical mesh have experienced side effects including vaginal mesh erosion, mesh contraction, severe pain, problems during sexual intercourse, bleeding, infection, urinary problems and organ perforation.

If you or a loved one received a transvaginal mesh implant during surgery and suffered side effects from the device, you may be eligible to file a lawsuit. For a free legal evaluation, contact the transvaginal mesh lawyers at Hissey Kientz, LLP by calling toll-free at 1-866-275-4454, or by filling out the free case evaluation form located on this page.

 

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