A woman from California has added her transvaginal mesh lawsuit to the Ethicon multidistrict litigation now pending in a West Virginia federal court.

Plaintiff Nichole W. says she was implanted with a TVT vaginal mesh product in February 2015.

The TVT is a pelvic mesh product manufactured by Ethicon Inc. and used to treat stress urinary incontinence in women. Based on allegations of complications related to the TVT mesh, Nichole’s transvaginal mesh lawsuit names Ethicon and its parent company Johnson & Johnson as defendants.

According to the master complaint for the multidistrict litigation, the use of mesh implants to treat pelvic organ prolapse and stress urinary incontinence in women developed from similar techniques used since the 1950s to repair abdominal hernias.

Mesh products specific to these gynecological applications began to be available in 1996, when the FDA approved the first mesh device made to treat stress urinary incontinence. Since then, other types of meshes, slings and tapes have earned FDA approval.

Transvaginal Mesh Accusations Against Ethicon

Plaintiffs allege through the master complaint that the defendants purposely concealed critical information about the complications that can develop from transvaginal mesh implants.

The master complaint states that the polypropylene used to make these mesh products is incompatible with human tissue. It tends to stimulate an immune response that degrades the implant and leads to other adverse reactions, the complaint says.

Plaintiffs also allege that the implantation process is likely to result in damage to nerves and internal organs, particularly resulting from the anchors used to put the mesh in place. The mesh also allegedly suffers from “creep,” or gradual elongation and deformation after being under prolonged tension inside the patient’s body.

Women implanted with pelvic mesh products have reported such complications as infection, fistula, inflammation, growth of scar tissue, perforation of organs, pain during sexual intercourse, nerve damage, shortening of the vagina, and urinary and fecal incontinence, according to the master complaint.

The plaintiffs say that medical and scientific studies have determined that these complications result from the mesh products themselves and are not the results of errors in the implantation process.

The plaintiffs cite a 2008 FDA Public Health Notification that described over 1,000 reports of adverse events received by the FDA over a three-year period, all related to transvaginal mesh complications.

In a 2011 Safety Communication, the FDA reported that it had continued monitoring reports of transvaginal mesh complications and that such reports were “not rare.” The FDA described these reports as an area of “continuing serious concern.”

Despite these many reports of transvaginal mesh complications, plaintiffs say the defendants misrepresented these products as safe and effective treatments for pelvic organ prolapsed and stress urinary incontinence. Plaintiffs say they relied on these allegedly false representations when they decided to use vaginal mesh products.

Plaintiffs also accuse the defendants of essentially dodging the FDA’s full approval process for medical devices by using the Section 510(k) process. This process allows expedited approval, without full clinical trials, for medical devices that are “substantially equivalent” to other devices already approved.

The Ethicon MDL is pending in the U.S. District Court for the Southern District of West Virginia under MDL no. 2327. Nichole’s individual Transvaginal Mesh Lawsuit is filed under case no. 1:15-CV-07245.