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FDA: Some mesh implants now deemed 'high risk'

It's taken a few years for the Food and Drug Administration to take clearer action regarding transvaginal mesh implants, but now it has. Early this month, the FDA issued two pronouncements, both aimed at trying to reduce what one official calls "the significant risks associated with surgical mesh for repair of pelvic organ prolapse (POP)."

Readers of this blog know this issue is one that we have been tracking for some time. In one post in 2014, we made note of one malpractice suit that settled for $73 million. And a couple of weeks ago, we reported on another victim who is in line to receive more than $12 million for the pain and suffering she has endured because of a 2009 mesh implant.

Under the new FDA rules, manufacturers of existing mesh products intended for transvaginal implant for organ prolapse have 30 months to submit evidence to the FDA showing the safety and effectiveness of their products. Those seeking to market new devices will have to first obtain FDA approval.

In addition to requiring makers to clear those hurdles, regulators reclassified transvaginal mesh implants now on the market as high-risk devices. They had been listed as moderate-risk devices. In making the announcement, the FDA also said that it will continue long-term monitoring of women after surgery to see how they fare.

POP is a condition that occurs when tissue at the floor of the pelvis gets weak or tears. Though it's not life-threatening, women who suffer POP can experience low back pain, pelvic pressure, discomfort during sex or problems evacuating the bowel or bladder.

Surgical mesh as a means to treat organ prolapse has been used for decades, but it's only been since 2002 that mesh devices were approved for transvaginal implant. And in the years since, reports of problems associated with apparently defective implants have been increasing.

It must be noted that the latest FDA action applies only to mesh devices marketed for repair of POP by transvaginal implant. Still, the action is an important acknowledgment of the health problems that can result. If you have had an implant and are concerned, you owe it to yourself to speak with an attorney to learn your options for possible compensation. 

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