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FDA Orders Transvaginal Mesh Studies

Jan 5, 2012 | Parker Waichman LLP

As part of its ongoing safety review of transvaginal mesh devices, the U.S. Food & Drug Administration (FDA) has asked 33 manufactures of such products to conduct safety studies assessing their use in procedures to repair pelvic organ proplapse (POP) and stress urinary incontinence (SUI).  According to various media reports, Johnson & Johnson, C.R. Bard Inc., Endo Pharmaceuticals Holding Inc., Boston Scientific Corp. and other companies have been sent letters from the FDA requesting the studies.   They have 30 days to respond.

"We believe there are certain uses of mesh where we need additional data to help guide the clinical community," William Maisel, deputy director of science for the FDA's device-approval center, told Bloomberg News. "Our goal is to make sure the right women use it at the right time."

In its letters, the FDA asks the manufacturers to collect as much as three years of data on the safety and effectiveness of the implants. 

Patient advocates cheered the FDA's action.

"Now these companies are going to have to tell the truth," said Lana Keeton, the Austin, Texas, founder of Truth In Medicine, an advocacy group for mesh patients

Transvaginal  products are implanted to provide support for a woman’s organs in the pelvis, which drop, fall, bulge or protrude (prolapse) into the vaginal wall due to weakened or stretched muscles that occur from childbirth, pregnancy and other causes. In July, the U.S. Food & Drug Administration (FDA) said in a safety communication that it had received 1,503 reports of serious complications associated with transvaginal mesh used in POP repair, including mesh erosion through the vagina, pain, infection, bleeding, and pain during sexual intercourse, organ perforation, and urinary problems. The agency also said that its review had not seen any evidence that POP repair with transvaginal mesh offers any additional benefits compared to other treatment methods.

FDA staff has proposed that such devices be moved to the agency's high -risk medical device category, which does not allow 510(k) clearances.  Under the FDA proposal, transvaginal mesh devices already on the market would be allowed to remain, but manufacturers would have to conduct studies to asses their safety and effectiveness.

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