Transvaginal Mesh Attorneys Explain FDA Reclassification
Transvaginal Mesh Attorneys Babbitt & Johnson P.A. explain the FDA proposal to reclassify surgical mesh to a “high risk” device for pelvic organ prolapse (POP)
WEST PALM BEACH, FL. May 2014 – After six years and thousands of lawsuits for transvaginal mesh injuries, the U.S. Food and Drug Administration (FDA) is proposing to reclassify surgical mesh for pelvic organ prolapse (POP) repair to a “high-risk device.” A physician’s news service called, Med Page Today, published an article titled: “FDA Wants High-Risk Label for Transvaginal Mesh” explaining that the reclassification will mandate an FDA review of safety and effectiveness prior to considering approval for the marketplace.
The FDA also proposed reclassification of certain instruments used to perform POP repair by changing them from “low-risk” to an “intermediate-risk device.”
Transvaginal mesh is a synthetic or biologic material that has been permanently implanted in women to repair pelvic organ prolapse (POP) that occurs when the muscles in a woman’s pelvic area begin to weaken, causing organs to bulge or shift out of place. Currently, transvaginal mesh products are generally able to obtain FDA approval without clinical trials as long as the product is “substantially equivalent” to a product already on the market. However, in 2008, the FDA issued a safety communication due to increasing concerns about adverse events associated with the transvaginal placement of mesh. From 2008 to 2011, the FDA received 1503 adverse event reports associated with mesh used for POP repair, five times as many as the agency received from 2005 to 2007.
There are currently more than 40,000 transvaginal mesh lawsuits already filed across the country with more than 3,000 lawsuits a month are being filed against the makers of transvaginal mesh. He anticipates more nationwide lawsuits will be filed as these continue to fail nationwide.
Our West Palm Beach attorneys encourage individuals who have been injured by transvaginal mesh implants to contact specialized transvaginal mesh injury attorneys for a free confidential consultation and case evaluation at www.babbitt-johnson.com or (561) 375-2841.
About Babbitt & Johnson P.A.
Since 1967, the law firm of Babbitt & Johnson P.A., in West Palm Beach, Florida has been seeking justice for its clients against people and businesses whose negligent behavior has caused serious injury. To find out more about how Babbitt & Johnson P.A. can help, visitwww.babbitt-johnson.com or call (561) 375-2841.
Additional Sources:
Federal Register: FDA’s Proposal: https://www.federalregister.gov/articles/2014/05/01/2014-09907/reclassification-of-surgical-mesh-for-transvaginal-pelvic-organ-prolapse-repair-and-surgical
Federal Register: FDA’s Proposal for POP instruments:https://www.federalregister.gov/articles/2014/05/01/2014-09909/effective-date-of-requirement-for-premarket-approval-for-surgical-mesh-for-transvaginal-pelvic-organ
FDA News Release Re: Surgical Mesh and POP risks:http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm262752.htm