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Surgical device under FDA scrutiny

Vaginal mesh implant poses potential health risks.

The U.S. Food and Drug Administration released an advisory yesterday (July 13) regarding a surgical mesh implant used to treat incontinence or strengthen vaginal tissue that has become weakened due to childbirth, reports the L.A. Times.

The vaginal mesh implant is also used to treat a condition called pelvic organ prolapse, where a woman’s uterus, bladder or rectum can slip out of place.

FDA officials said in the advisory that they saw little evidence of the mesh helping with prolapse recovery, especially when compared to the number of risks it can pose to women.

Since 2008, complaints of serious complications – including erosion, where the device protrudes through broken skin, and vaginal shrinkage caused by the device contracting – have increased five-fold.

"We don’t think it would be appropriate to remove the products from the market right now," said Dr. William Maisel with the FDA.

Instead, Maisel explained, the FDA is concerned with getting the information out to patients and doctors so that they can make informed decisions about whether or not to use the surgical mesh.

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