Transvaginal Mesh Attorneys Explain FDA Reclassification

Share Article

Transvaginal Mesh Attorneys Babbitt, Johnson, Osborne and Le Clainche explain the FDA proposal to reclassify surgical mesh to a “high risk” device for pelvic organ prolapse (POP).

Joseph A. Osborne Transvaginal Mesh Attorney

Joseph A. Osborne, Transvaginal Mesh Attorney

When medical device manufacturers put profits ahead of patient safety their products often fail and cause harm.

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 on April 29th, 2014, 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.”

Joseph A. Osborne of Babbitt Johnson Osborne & Le Clainche is member of the Plaintiff's Steering Committee for the multi-district litigation case against transvaginal mesh device manufacturers. Mr. Osborne believes the FDA’s proposal for reclassification is a first step in requiring mesh manufacturers to complete clinical trials and more testing before submitting their application for FDA approval.

“When medical device manufacturers put profits ahead of patient safety their products often fail and cause harm,” states Osborne. “While reclassification would obviously add to their costs, it would also hopefully make transvaginal mesh products much safer for patients in the future.”

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.

According to Mr. Osborne, 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 (MDL-2187). He anticipates more nationwide lawsuits will be filed as these continue to fail nationwide.

Unfortunately, this information comes too late for the thousands injured by the very transvaginal mesh product meant to correct pelvic organ prolapse,” says Osborne.” “Through the legal system, we can hold medical device manufacturers accountable for their negligence,”

Mr. Osborne encourages 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 or 561-684-2500.

About Babbitt, Johnson, Osborne and Le Clainche
Since 1965, the law firm of Babbitt, Johnson, Osborne and Le Clainche, 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, Osborne and Le Clainche can help, visit or call (888) 666-0523.

Share article on social media or email:

View article via:

Pdf Print