Boston Scientific Mesh Lawsuit Filed Over Complications From Obtryx II Mid-Urethral Sling System

Women are still filing transvaginal mesh lawsuits, as older implants continue to fail long after the products were removed from the market.

More than six years after federal regulators banned the devices from the market, women like Yvonne Cummings are still developing injuries and complications from transvaginal mesh implants.

According to a complaint (PDF) filed on November 24 by Yvonne Cummings and her husband, Brian, she received an Obtryx II mesh implant nearly a decade ago, which required removal early last month after complications developed. 

The lawsuit, filed in the U.S. District Court for the District of Massachusetts, names Boston Scientific as the defendant.

Transvaginal Mesh Problems

Transvaginal mesh products like the Obtryx II were marketed and sold by Boston Scientific Corporation and a number of different companies for years to treat pelvic organ prolapse or female stress urinary incontinence. They involved the use of synthetic mesh, often made of polypropylene, to reinforce a weakened vaginal wall or support the bladder.

However, more than a decade ago, the U.S. Food and Drug Administration (FDA) began warning about transvaginal mesh problems, such as the mesh eroding into the vagina, contracting or shrinking, which led to infections, pelvic pain, vaginal scarring and other painful complications.

Ultimately, in 2019 the agency removed all transvaginal mesh from the market, indicating Boston Scientific and other manufacturers had failed to establish that the implants provided more benefits than the substantial and life-altering health risks that came with them.

As part of its decision to remove transvaginal mesh products from the market, the FDA cited postmarketing surveillance studies from manufacturers, including two conducted by Boston Scientific, which found that there was little difference in the effectiveness of vaginal mesh like those implanted into Cummings and traditional transvaginal native tissue repair procedures.

Mesh Failure Lawsuit

However, the warning came too late for Cummings, according to her lawsuit. She underwent placement of a Boston Scientific Obtryx II Mid-Urethral Sling System in October 2016.

Cummings’ complaint indicates that due to problems with the mesh, she suffered numerous complications and injuries, including mesh erosion into the surrounding tissues, chronic pelvic pain, pelvic inflammation, dyspareunia (pain during intercourse), and vaginal bleeding.

The complaint states that Cummings underwent vaginal mesh excision surgery on November 4 to remove the implant, but may still require additional procedures. Even with further treatment, she is expected to continue experiencing significant pain, disfigurement and other lasting complications.

Cummings and her husband present claims of defective design, failure to warn, negligence and loss of consortium.

Boston Scientific and other companies have faced more than 100,000 product liability lawsuits in recent years, each involving allegations that individuals 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.

Breast Mesh Lawsuit Investigations

In recent years, similar polypropylene mesh materials once used in transvaginal and hernia repair procedures have been remarketed for use as “internal bras” during breast reconstruction and cosmetic breast surgeries. These devices are promoted as providing internal support to the breast tissue, much like traditional surgical mesh. However, women have begun reporting breast mesh side effects strikingly similar to those seen with earlier mesh implants.

Reported injuries include chronic pain, inflammation, hardening of the breast, nerve damage and recurrent infections. Some women have also experienced mesh shrinkage, deformation of the breast and the need for surgical removal of the implanted material. These complications often require multiple revision surgeries and may result in permanent cosmetic or functional damage.

As a result of these growing concerns, attorneys are now investigating breast mesh lawsuits against manufacturers, alleging that companies failed to warn patients and surgeons about the risk of mesh erosion and long-term complications.

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