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Rules For Transvaginal Devices Tightened, FDA Says

First Posted: Jan 04, 2016 07:45 PM EST
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The U.S. Food and Drug Administration (FDA) announced Monday that they are strengthening rules regarding the use of vaginal mesh implants to treat pelvic organ prolapse in women--a health issue that occurs when muscle and tissue in the pelvic floor stretch, weaken or tear, resulting in the bladder, bowel or uterus to bulge into the vaginal area. 

The devices were reclassified from a "moderate" to "high" risk category. 

"These stronger clinical requirements will help to address the significant risks associated with surgical mesh for repair of pelvic organ prolapse," said Dr. William Maisel, deputy director of science and chief scientist for the FDA's Center for Devices and Radiological Health, in a news release. "We intend to continue monitoring how women with this device are faring months and years after surgery through continued postmarket surveillance measures."

Now, manufacturers must submit pre-market approval applications to the FDA in order to help the agency determine the safety and effectiveness of the implant, according to Health Day.

In the 1970s, doctors used surgical mesh to strengthen pelvic floor muscles and help repair pelvic organ prolapse. However, problems oftentimes resulted, ranging from infection to urinary problems, bleeding and pain during intercourse.

"These stronger clinical requirements will help to address the significant risks associated with surgical mesh for repair of pelvic organ prolapse," Dr. William Maisel, deputy director of science and chief scientist at the FDA Center for Devices and Radiological Health, added. "We intend to continue monitoring how women with this device are faring months and years after surgery through continued post-market surveillance measures."

However, the new requirements do not apply to mesh products that are used when treating other conditions, including hernias or urinary incontinence.

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