Transvaginal Mesh Recall

More patient advocates are calling for a transvaginal mesh recall, as reports of horrific and life-altering complications associated with the use of pelvic mesh products continue to mount. Unfortunately, few vaginal mesh recalls have been issued in recent years, and most of these products remain on the market. But even in the absence of a transvaginal mesh recall, victims of these devices may still be entitled to compensation for their medical bills, lost wages, pain and suffering, and other damages. The vaginal mesh lawyers at Bernstein Liebhard LLP are already representing scores of women allegedly injured by these products, and continue to offer free case evaluations to anyone harmed by pelvic mesh. If you suffered life-altering complications as a result of transvaginal mesh, we urge you to contact one of our attorneys today to learn more about your legal options.

ProteGen Transvaginal Mesh Recall

The majority of transvaginal mesh devices on the market today were approved via the U.S. Food & Drug Administration’s (FDA) 510(k) approval system, which does not require that a device undergo human testing if it can be shown that it is “substantially equivalent” to a predicate product – a similar device that has already been granted approval by the FDA. The predicate for most of the pelvic mesh devices used in transvaginal surgeries was a Boston Scientific product called ProteGen. Ironically, ProteGen was the subject of a vaginal mesh recall in 1999, just three years after its launch, due to an alarming number of complications associated with the device. Even so, the FDA continued to approve 510(k) applications for transvaginal mesh devices that were based on the ProteGen design long after it was pulled from the market.

Ethicon Ends Sales of Gynecare Vaginal Mesh Devices

In the summer of 2012, Johnson & Johnson’s Ethicon subsidiary decided to end sales of four Gynecare pelvic mesh products: the Prolift, Prolift+ M, TVT Secur and Prosima devices. While the company said it would continue to sell a fifth Gynecare product, Gyencare Gynemesh, it was modifying its label to restrict its use to abdominal procedures. Ethicon maintained that the sales suspension did not constitute a transvaginal mesh recall, and asserted the decision had been made for commercial reasons, not safety concerns.

Is a Transvaginal Mesh Recall a Possibility?

While few transvaginal mesh recalls have been announced up to this point, it’s impossible to rule out such an action in the future. The FDA, which is currently reviewing the safety of pelvic mesh used in the transvaginal repair of pelvic organ prolapse and stress urinary incontinence, is considering a proposal to reclassify such products as Class III medical devices, which would make them ineligible for 510(k) approval. In January 2012, the agency ordered 33 manufacturers of transvaginal mesh to conduct post-market safety studies of their products. It’s unclear what other action the FDA may seek, but there is always a possibility that the agency will take a harder stance and order a vaginal mesh recall at some point in the future.

Have Questions about a Transvaginal Mesh Lawsuit? Contact a Lawyer Today.

If you’re thinking about filing a transvaginal mesh lawsuit, it’s important that you speak with an experienced medical device lawyer as soon as possible. The attorneys at Bernstein Liebhard LLP are actively involved in vaginal mesh litigations underway in both state and federal courts, and are offering free legal evaluations to victims of transvaginal mesh injuries. To discuss your case with one of our attorneys today, please give our firm a call at today.