A transvaginal mesh lawsuit filed by a Florida woman has joined the multidistrict litigation stemming over allegations that the pelvic mesh product caused severe health complications.

Plaintiff Stacy P. says that in December 2013 she was implanted with two different transvaginal mesh products: Boston Scientific’s Advantage Transvaginal Mid-Urethral Sling System, and a Gynecare TVT Abbrevo Continence System made by Ethicon Inc.

She is now suing manufacturers Boston Scientific, Ethicon, and Ethicon’s parent company Johnson & Johnson over complications associated with those two devices.

This transvaginal mesh lawsuit joins a total of over 60,000 other similar claims in six different multidistrict litigations, all overseen by Judge Joseph R. Goodwin in a West Virginia federal court.

Transvaginal Mesh Complications

Women hoping to treat pelvic organ prolapse or stress urinary incontinence are implanted with a transvaginal mesh, sling, tape, and other similar products.

In pelvic organ prolapse, weakened pelvic muscles allow organs to droop into the vagina; a transvaginal mesh can be used to hold the organs in their proper place. In stress urinary incontinence, a transvaginal mesh can be used to support the urethra when pelvic muscles fail.

Use of implanted vaginal mesh to control these conditions first began in the 1970s as an adaptation of surgical techniques used to correct abdominal hernias. In 1996, the first transvaginal mesh device made specifically for these gynecological conditions received FDA approval. Several other similar devices were also approved over the next few years.

However, thousands of recipients of transvaginal mesh implants have reported a variety of related complications. Some implantations have resulted in erosion of the surrounding tissues and perforation of organs. More serious complications have required surgical revision.

Transvaginal Lawsuits

In the Boston Scientific multidistrict litigation that Stacy is joining, plaintiffs allege that certain aspects of the Boston Scientific products make them defective. Plaintiffs claim that the monofilament polypropylene used in the Boston Scientific products is not inert but in fact promotes a negative immune response that leads to inflammation of the pelvic tissue in many recipients.

Plaintiffs also allege that transvaginal mesh products are prone to contraction inside the body. They cite a 2011 Safety Communication issued by the FDA, noting that according to both scientific literature and adverse event reports to the FDA, some instances of mesh contraction had resulted in “vaginal shortening, vaginal tightening and vaginal pain.”

Despite these alleged flaws, plaintiffs say the defendants continued to market transvaginal mesh products as safe and effective and preferable to alternative procedures. They allege the defendants understated the risks of transvaginal mesh complications and underreported instances of mesh failure. They also allege that the defendants failed to perform adequate clinical studies.

Plaintiffs in the multidistrict litigations also include spouses of transvaginal mesh recipients bringing claims for loss of consortium. Loss of consortium is a type of claim that the spouse of a victim can bring to seek compensation for the effect of the wrongful act on the marital relationship.

The Transvaginal Mesh Lawsuit is Case No. 2:15-CV-12988 and MDL No. 2326 in the U.S. District Court for the Southern District of West Virginia.