Vaginal Mesh Recall

Published on June 21, 2013 by Sandy Liebhard

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As reports of mesh erosion, infection and other devastating injuries continue to pour in, more and more women are calling for a total transvaginal mesh recall. Unfortunately for many individuals who have been injured by these implants though, few recalls have been issued.

You may still be eligible to file a case against the manufacturer whose product injured you, however. In the absence of a vaginal mesh recall, find out if you are entitled to receive compensation for out-of-pocket medical expenses, as well as lost wages, pain and suffering and other damages by contacting an attorney at Bernstein Liebhard LLP to learn about your legal rights. An attorney at the Firm can be reached directly at .

Transvaginal Mesh Recall

vaginal mesh recallDespite no announcement of a vaginal mesh recall, thousands of cases are currently pending in U.S. courts after being brought by women who allege injuries from the devices. In separate federal litigations currently underway in the U.S. District Court, Southern District of West Virginia, approximately 20,000 transvaginal mesh lawsuits alleging pain, infection, organ perforations and other side effects have been filed. Products marketed by medical device manufacturers including C.R. Bard Inc., American Medical Systems, Boston Scientific and Johnson & Johnson’s Ethicon unit have been named in these cases.

The attorneys at Bernstein Liebhard LLP are representing hundreds of women in lawsuits involving transvaginal mesh devices.

ProtoGen Serves as Prototype for Future Devices after Vaginal Mesh Recall

Despite a transvaginal mesh recall in 1999 that affected Boston Scientific’s ProtoGen device, the product began serving as a predicate for several implants introduced in the future. The device was recalled three years after its launch when a high number of vaginal mesh complication reports were filed with the U.S. Food and Drug Administration (FDA). Regardless, devices resembling the ProtoGen were approved via the agency’s 510(k) process in years to follow.

Some Products Removed From Market Amidst Mounting Transvaginal Mesh Lawsuits

As Ethicon began preparing to face a growing nationwide litigation involving some of its devices, the Johnson & Johnson subsidiary pulled the Gynecare Prolift, Prolift+M, TVT Secur and Prosima implants from the market. The company stressed that this decision did not signify a mesh recall, and was put into action for commercial, rather than safety reasons. Its Gynecare Gynemesh remained on the market, but its labeling was adjusted to include use in only abdominal procedures.

Also in 2012, C.R. Bard took similar action with its line of Avaulta products. The manufacturer noted the potential new safety regulations from the FDA as part of its reasoning for taking the devices off the market.

Will a Mesh Recall Be Issued in the Future?

Whether a transvaginal mesh recall will be issued in the future remains uncertain, but lawsuits alleging injuries from this class of devices continue to be filed. The FDA has proposed new regulations that would classify the devices as Class III, making them ineligible to receive clearance through the agency’s 510(k) process. This process allows a device to enter the market if the manufacturer can prove it to be equivalent to one that has already been approved. In January 2012, the agency ordered 33 transvaginal mesh manufacturers to conduct post-market safety studies on their products in order to continue selling them. It is unclear what other actions will be taken in the future.

Lawsuits Continue to Be Filed in U.S. Federal, State Courts

Vaginal mesh lawsuits are steadily moving forward in courts around the U.S., where they have begun to head to trial. Recently, a trial in West Virginia federal court concluded in August 2013 with a damage award of more than $2 million to a woman who experienced complications caused by C.R. Bard’s Avaulta Plus implant. In March 2013, a similar verdict was reached by a jury in New Jersey Superior Court, who granted over $11 million to a woman who sustained injuries after receiving Ethicon’s Prolift implant. These victories were realized in the absence of a transvaginal mesh recall.

Thinking about Filing a Case? Contact Bernstein Liebhard LLP Today.

For women who sustained injuries stemming from transvaginal mesh, the time is now to start the process of filing a lawsuit. Call the qualified legal staff at Bernstein Liebhard LLP to have your questions answered at .