Boston Scientific Faces Vaginal Mesh Lawsuit Alleging Obtryx II Exposed Patients to Unreasonable Risk of Problems
Women continue to file vaginal mesh lawsuits against Boston Scientific and other manufacturers, years after most products were removed from the market due to an alarming number of complications and health risks associated with the designs.
In a complaint (PDF) filed last month in the U.S. District Court for the Southern District of Indiana, Tanya Davis indicates that problems with Boston Scientific Obtryx II mesh placed in her body only four years ago has left her with severe injuries, including pelvic pain and dyspareunia, abdominal pain, urinary problems, prolapse and incontinence. The lawsuit names Boston Scientific Corporation as the defendant.
Transvaginal mesh products like the Obtryx II have been marketed and sold by Boston Scientific Corporation and a number of different companies over the past decade, for treatment of pelvic organ prolapse or female stress urinary incontinence. Most of the products were introduced under a controversial FDA “fast track” approval process, which allowed manufacturers to introduce new products based on the design of prior mesh, without conducting thorough research to evaluate the safety or effectiveness of the specific designs.
Following widespread reports of vaginal mesh complications, including infections, erosion of the mesh into the vagina and organ perforation, the FDA required manufacturers to conduct post-marketing research and most companies decided to withdraw their products.
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According to the lawsuit, Davis received an Obtryx II System in May 2018, to treat her urinary incontinence. However, after experiencing painful and debilitating complications, Davis had vaginal mesh explanted in May 2020; just two years after it was implanted.
“Neither Plaintiff nor her physicians and/or healthcare providers were warned that the Obtryx II was unreasonable dangerous or of the risks of the product, outlined herein, even when used exactly as intended and instructed by Defendant,” the lawsuit indicates. “To the contrary, Defendant promoted and sold the type of product implanted in the Plaintiff and thousands of women like Plaintiff, to healthcare providers as a safe alternative to other procedures that did incorporate Defendant’s products.”
After determining the health risks outweighed the benefits, which could be achieved by other treatment options, the FDA ordered all medical device manufacturers to cease making and selling transvaginal mesh in April 2019.
As part of that decision, the agency mandated Boston Scientific and Coloplast conduct postmarketing surveillance studies, known as the 522 studies, to look at the effectiveness and safety of transvaginal mesh for the treatment of pelvic organ prolapse (POP).
According to the findings of the two Boston Scientific 522 studies, there was little difference in the effectiveness of vaginal mesh and traditional transvaginal native tissue repair procedures.
Boston Scientific and other companies have faced more than 100,000 product liability lawsuits in recent years, each involving allegations that individual suffered painful and debilitating injuries from transvaginal mesh. While the manufacturers have collectively paid billions in individual vaginal mesh settlements to resolve personal injury and wrongful death claims in recent years, hundreds of individual cases are still proceeding through state and federal courts.
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