A Wisconsin woman alleges she suffered injuries after being implanted with the Pinnacle Pelvic Floor Repair Kit and the Aris Trans-obturator Tape. The lawsuit also alleges that these transvaginal mesh implants are defective, and holds the defendants liable for failing to warn about the risks.
According to the complaint, the woman was implanted with the Pinnacle Pelvic Floor Repair Kit and the Aris Trans-obturator Tape in April 2010 and alleges that these devices are defective and caused her a number of serious injuries.
The lawsuit also alleges that the defendants knew about these risks and failed to warn the plaintiff, her doctor, and other consumers.
The plaintiff is suing for negligence on three counts of strict liability—including design defect, manufacturing defect, and failure to warn—breach of express and implied warranty, fraudulent concealment, and punitive damages.
According to the U.S. Food and Drug Administration (FDA), the most common complications associated with transvaginal mesh devices potentially include:
- Mesh erosion through the vagina—exposure, extrusion, or protrusion
- Pain during sexual intercourse (dyspareunia)
- Organ perforation
- Urinary problems
The FDA has also stated that complications linked to transvaginal mesh implants are “not rare” and has warned that use of these devices may actually be more harmful when compared to alternative methods for treating pelvic organ prolapse (POP). The FDA asked 33 manufacturers of vaginal mesh device products, including Johnson & Johnson, to conduct post-market safety studies so that the effect of vaginal mesh on organ damage and other health concerns may be better understood.
Recently, the first transvaginal mesh lawsuit to go to trial led to an $11.1 million verdict in favor of the plaintiff and was the first of 4,000 Gynecare Prolift cases expected to go to trial. Johnson & Johnson was ordered to pay $3.35 million in compensatory damages and $7.76 million in punitive damages, according to a prior Bloomberg News report.
The recent case was filed on behalf of the Wisconsin woman was filed by national law firm, Parker Waichman LLP. The lawsuit was filed on April 30, 2013 in the U.S. District Court for the Southern District of West Virginia, Charleston Division (Case No. 2:13-cv-09647) where it is one of many cases pending in the multidistrict litigation entitled In Re: Boston Scientific Corp. Pelvic Repair System Products Liability Litigation, MDL No. 2326. Boston Scientific Corporation, Johnson & Johnson, Ethicon, Inc., Mentor Worldwide LLC, and Coloplast Corp. have been named as defendants in this case.