Medical device intended to help women could be dangerous
Susan Kim, Stephanie Graham
Susan Kim reportsPhoto: Video by tmj4.com
MILWAUKEE- The products seem harmless enough -- mesh devices used to treat Pelvic Organ Prolapse -- a common problem women experience after child-birth, menopause, and weight gain.
More than 350,000 women undergo surgery for this condition in the U.S. each year. Thousands of those women say the thin material is causing them severe pain and emotional distress. Attorney Michael McNamara has heard complaints from more than 100 women.
"It is the most personal of personal injuries that I've seen in over 20 years of doing personal injury work," McNamara explains.
It's so personal--no woman would come forward and talk about it. In some cases, the pelvic tissue begins to erode creating more health problems.
"The tissue is gone -- and the surgeons are in a very difficult situation in terms of revision surgeries. Women have come to us surgery after surgery and they are left with no real options except live with chronic infections, incontinence, serious pain," McNamara says.
So why in the world would these mesh products be allowed on the market? Because of a loophole in the FDA's 510(k) approval process. According to a report by the Institute Of Medicine -- a moderate-risk device that is substantially equivalent to any previously 510(k) cleared device can be cleared for marketing -- in an effort to facilitate innovation.
"There's movements afoot with regard to recalls, there's movements afoot with regards to the way the FDA approves these processes," McNamara adds.
The FDA has come under heavy criticism, and now it's under pressure by industry experts and lawmakers to change the process. The FDA responded last July -- ordering new postmarket studies with the mesh manufactures and alerting the medical community of the concerns.
Mary Beth Ritchey is Associate Director for the Postmarket Surveillance Studies for the FDA. She says, "In September, we had a panel meeting and then in January of this year, we sent out orders to begin the process -- saying to the companies these are our exact questions that remain open and they need to be addressed."
Although the FDA has recommended the 33 manufacturers do extensive testing -- for now, the mesh devices will stay on the market.
McNamara says, "They are still heavily marketed, heavily used, heavily recommended."
The FDA is also considering reclassifying these mesh devices from class two to class three -- a higher-risk category that would require clinical trials before approval.
A Massachusetts congressman has launched a bill -- called the 'Sound Act' -- that would let the FDA reject a device if it's been shown to be faulty.