Experts Testify in Nation’s First Ethicon Prosima Transvaginal Mesh Trial
A Dallas County District Court jury is currently hearing arguments in the nation’s first trial of a transvaginal mesh lawsuit involving Ethicon, Inc.’s Prosima device. According to Law360.com, the panel has already heard testimony from several plaintiff’s experts who claim that the Johnson & Johnson subsidiary did not disclose the product’s risks to doctors.
The case currently at trial was filed on behalf of a woman who received the Prosima mesh implant in 2012 to treat pelvic organ prolapse. The complaint charges that the device was defectively designed and has caused the plaintiff chronic pain ever since its implantation.
Testimony: Prosima “Defective,” Studies Raised “Red Flags”
During the second day of testimony, a regulatory expert and a urogynecologist who appeared on behalf of the plaintiff told jurors that Ethicon’s own studies suggested that an alternative prolapse treatment using natural tissue was safer than the Prosima procedure. They also asserted that the company never told doctors that patients who were treated with Prosima were more likely to need a second procedure compared to those who underwent natural tissue surgery.
According to Peggy Pence, an expert in U.S. Food & Drug Administration (FDA) regulation, the Ethicon Prosima studies raised numerous “red flags” about bleeding, tissue erosion, and other vaginal mesh complications that weren’t noted in information that accompanied the device. Urogynecologist Bruce Rosenzweig also maintained that Ethicon’s “instructions for use” were dishonest about the Prosima’s risks.
“Prosima is defective,” Rosenzweig said, according to Law360.com “The risks outweigh the benefits. It is unreasonably dangerous.”
Prosima was one of four transvaginal mesh devices Ethicon decided to stop selling in 2012. While all of the implants were involved in the transvaginal mesh litigation, the company has always maintained that its decision to suspend sales was driven by commercial factors, rather than safety concerns.
Transvaginal Mesh Lawyers Accepting Inquiries
The transvaginal mesh lawyers at Bernstein Liebhard LLP are representing hundreds of women who were allegedly harmed by Prosima and other mesh implants used to treat pelvic organ prolapse and stress urinary incontinence. If you would like to learn more about filing a lawsuit, please contact our office at 877-779-1414.