A national law firm has filed three lawsuits on behalf of women who were allegedly injured by transvaginal mesh devices manufactured by American Medical Systems, Boston Scientific Corp. and Ethicon, Inc. According to a statement issued by Parker Waichman LLP, the lawsuits allege that the companies’ transvaginal mesh implants caused the plaintiffs to suffer permanent injury, permanent and substantial physical deformity, and loss of bodily organ system.
The three lawsuits, which were filed in federal courts in Tennessee, Arizona and Georgia, claim the plaintiffs received transvaginal mesh devices during surgical procedures to treat pelvic organ prolapse (POP) and/or stress urinary incontinence (SUI). The Tennessee complaint names devices manufactured by American Medical Systems, including the Perigee System with IntePro Lite, the Apogee System with IntePro Lite, and MiniArc Sling. The Georgia lawsuit names Boston Scientific Corp.’s Obtryx Transobturator Mid-Uretheral Sling System, while the Arizona plaintiff was allegedly injured by the Gynecare Prolift device marketed by Ethcion, Inc., a division of Johnson & Johnson.
The lawsuits allege that the devices the plaintiffs received were defective, and create an unreasonable risk of injury and other adverse health consequences for patients, including, but not necessarily limited to, vaginal erosion, infection, extrusion, perforation, chronic pain and/or abscess.
“The injuries suffered by these three plaintiffs are typical of the kinds of complaints we’re hearing every day from women who have received transvaginal mesh implants during surgeries to repair POP and SUI,” Gary P. Falkowitz, a lawyer with Parker Waichman LLP, said in a statement. “These complications are life-changing, and in many instances, the victims of transvaginal mesh injuries will never be able to recover their previous quality of life.”
This past July, the U.S. Food & Drug Administration (FDA) said in a Safety Communication that it had received 2,874 new reports of complications associated with transvaginal surgical mesh procedures from January 2008 through December 2010. Of these, 1,503 reports were associated with POP repairs and 1,371 associated with SUI repairs. Injuries attributed to the use of transvaginal mesh devices include inflammation and infection, pain from mesh shrinkage, and pain and bleeding due to extrusion of mesh through the vaginal wall. According to the FDA, even when women undergo surgery, sometimes multiple surgeries, to have defective mesh removed, complications continue because it is almost always impossible to completely remove the device.
Transvaginal mesh devices were mostly approved through the agency’s 510(k) fast-track approval process, which grants access to the market without much pre-market safety testing, based on the idea that the products were similar in design to a previously-approved device. However, the FDA is considering rescinding 510(k) approvals for transvaginal mesh devices used in POP repair, and has asked the makers of such devices to conduct safety studies of the products.