Pennsylvania’s Fourth Transvaginal Mesh Trial Nears Conclusion, As Jury Deliberations Commence

Published on May 25, 2017 by Laurie Villanueva

Pennsylvania’s fourth transvaginal mesh trial is nearing its end, as jury deliberations were scheduled to begin today in the Philadelphia Court of Common Pleas. The Pennsylvania mass tort program has already concluded three pelvic mesh trials, all of which resulted in multimillion dollar judgments against Johnson & Johnson and its Ethicon, Inc. division.

The case currently at trial was filed on behalf of a 45-year-old woman who allegedly experienced chronic pain and discomfort following implantation of Ethicon’s Gynecare Prolift mesh to treat stress urinary incontinence and pelvic organ prolapse more than a decade ago. She claims that the Prolift device was rushed to market without adequate testing, and asserts that she was never fully warned of its risks.

Johnson & Johnson and Ethicon are named defendants in more than 54,000 transvaginal mesh lawsuits pending in courts nationwide. The Pennsylvania litigation concluded its third trial last month, with a jury awarding $2.5 million in compensatory damages and $17.5 million in punitive damages to a woman implanted with TVT-Secur mesh. Two previous transvaginal mesh plaintiffs were awarded $12.5 million and $13.5 million by the juries hearing their cases.

Transvaginal Mesh Background

Transvaginal mesh products are used to treat women suffering from pelvic organ prolapse and/or stress urinary incontinence. In 2008, the  U.S. Food & Drug Administration (FDA) disclosed that such devices had been linked to at least 1,000 reports of serious injuries over a three year period, including mesh erosion, scarring and adhesions, infections, vaginal bleeding, organ perforations, and recurrence of prolapse or incontinence.

In July 2011, the agency disclosed that it had received more than 2,800 medical device reports related to transvaginal mesh, including reports of injury, death, and malfunction. More than 1,500 reports were associated with pelvic organ prolapse repairs, and 1,371 were associated with stress urinary incontinence (SUI) repairs.

“The FDA is issuing this update to inform you that serious complications associated with surgical mesh for transvaginal repair of POP are not rare,” the notification stated. “This is a change from what the FDA previously reported on Oct. 20, 2008. Furthermore, it is not clear that transvaginal POP repair with mesh is more effective than traditional non-mesh repair in all patients with POP and it may expose patients to greater risk.”

The FDA has since strengthened requirements for transvaginal mesh used in pelvic organ prolapse repair. Among other things these devices are no longer eligible for the agency’s 510(k) clearance program, which allowed these products to come to market without the benefit of human clinical trials.

In 2012, Ethicon announced it would stop selling four transvaginal mesh devices, including the Prolift product. The company maintained that the decision was the result of “changing market dynamics” rather than safety concerns. However, the FDA had previously ordered more than 20 vaginal mesh manufacturers, including Ethicon, to conduct further research into the risks associated with their products.

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