In a new transvaginal mesh lawsuit, a woman from Maine says she wasn’t properly warned about the risks of pelvic mesh complications.

Plaintiff Aline B. is suing defendants Johnson & Johnson and its subsidiary Ethicon Inc.

Aline says that in 2008, she was surgically implanted with a Gynecare TVT-Secur pelvic mesh device, allegedly manufactured by Ethicon.

She soon began experiencing complications that she says were directly caused by the implant.

Aline claims that if J&J and Ethicon had properly warned her about the risks of transvaginal mesh complications, she never would have agreed to have the Gynecare TVT-Secur mesh implanted.

According to Aline’s transvaginal mesh lawsuit, doctors have used surgical mesh products to repair hernias as far back as the 1950s. Gynecological surgeons adapted these materials and techniques in the 1970s to treat organ prolapse.

Today, J&J and Ethicon have designed and marketed surgical mesh kits specifically for the treatment of pelvic organ prolapse and stress urinary incontinence in women.

In pelvic organ prolapse, a weakening or stretching of the tissue that holds the pelvic organs in place causes them to displace downward into the vagina. Women with stress urinary incontinence experience a leakage of urine in moments of physical exertion.

FDA Responds With Multiple Warnings

After an earlier public notice describing over 1,000 reports of adverse events related to these products over a three-year period, the FDA announced in July 2011 that “serious complications associated with surgical mesh for transvaginal repair of POP are not rare” (emphasis in original).

From 2008 through 2010, the FDA says it received 2,874 reports of transvaginal mesh complications.

The most frequent problems reported to the FDA during that time included “mesh erosion through the vagina (also called exposure, extrusion or protrusion), pain, infection, bleeding, pain during sexual intercourse (dyspareunia), organ perforation, and urinary problems.”

Some patients reported suffering neuro-muscular problems, vaginal scarring or shrinkage, recurrence of prolapse, and emotional problems.

Aline’s transvaginal mesh lawsuit also cites a Joint Committee Opinion of the American College of Obstetricians and Gynecologists that noted some women will require surgical intervention to correct their pelvic mesh complications.

The opinion recommends that “[p]elvic organ prolapse vaginal mesh repair should be reserved for high-risk individuals in whom the benefit of mesh placement may justify the risk.”

Transvaginal Mesh Lawsuit Claims Failure to Warn

Aline argues that J&J and Ethicon knew about these problems at the same time they were marketing their mesh devices as safe and effective.

She says the defendants have published promotional materials that create “exaggerated and misleading expectations” as to the safety and utility of these products.

In fact, Aline claims, the defendants actively suppressed information about the complications that had been reported in conjunction with these devices. She says they knew pelvic mesh products were not safe for their intended purposes and that they could and would cause serious medical problems.

Aline’s transvaginal mesh lawsuit raises claims for failure to warn, design defect, manufacturing defect, negligence, breach of express and implied warranties, negligent and intentional misrepresentation, constructive fraud, fraudulent concealment, unjust enrichment, and violation of state consumer protection laws.

She seeks an award of compensatory, punitive, and double or triple damages, plus reimbursement of her attorney’s fees and costs of the litigation.

The Transvaginal Mesh Lawsuit is Case No. 2:16-cv-06760 in the U.S. District Court for the District of Maine.