A new pelvic mesh lawsuit takes Ethicon Inc. and Johnson & Johnson Co. to task for failing to warn about the risks associated with pelvic mesh implants.

Plaintiff Rhonda B. says that in August 2009 she was treated for symptomatic stress urinary incontinence using a Gynecare pelvic mesh system.

Because of alleged defects in that system, she claims, she now suffers from “pain, dyspareunia, urinary incontinence, erosion and prolapse of her bladder.”

Rhonda’s pelvic mesh lawsuit takes issue specifically with the Gynecare TVT SECUR System and the Gynecare Prolift System. Both products are made by Ethicon Inc., a subsidiary of Johnson & Johnson.

Rhonda claims that the Gynecare system was defectively designed and manufactured, inadequately tested, and sent to market with insufficient warnings about the risk of pelvic mesh side effects. She says the defendants knew about the risks associated with their products but failed to adequately warn the public about them.

Her pelvic mesh lawsuit raises claims under the Louisiana Products Liability Act for unreasonably dangerous composition and construction, unreasonably dangerous design, inadequate warning, and breach of warranty.

Rhonda seeks compensation for her medical expenses, emotional distress, physical pain and suffering, inconvenience, and loss of enjoyment of life. She seeks an award of damages and reimbursement of costs and attorneys’ fees with interest, plus any other relief she may be entitled to.

Pelvic Mesh Lawsuit Background

Mesh implants like the Gynecare system at issue in Rhonda’s pelvic mesh lawsuit are sometimes used in gynecological treatment to reinforce a weakened vaginal wall.

This surgical technique can be used to treat pelvic organ prolapse, a condition in which weakened tissue fails to hold pelvic organs in place, allowing them to bulge into the vagina.

It can also be used to treat stress urinary incontinence, a leakage of urine during moments of physical exertion like exercise, coughing, sneezing or laughing.

Rhonda cites two communications issued by the FDA warning the medical community about the risk of pelvic mesh complications like “erosion of the mesh material, infection, bleeding, pain, organ perforation, and urinary problems.”

In the first communication, issued in October 2008, the FDA warned health practitioners that using transvaginal mesh implants to treat pelvic organ prolapse and stress urinary incontinence can lead to rare but potentially serious complications.

The agency said that over the prior three years, it had received over 1,000 reports from manufacturers of surgical mesh about pelvic mesh side effects.

These reports stated that in some cases, pelvic mesh eroded through the tissue inside the vagina. Patients reported pain, infection, urinary problems, and recurrence of the prolapse or incontinence that the implants were supposed to treat.

The process of implanting the mesh came with its own reports of complications, such as perforation of the bowel, bladder or blood vessels. Treating the reported pelvic mesh complications required IV therapy, blood transfusions, drainage of hematomas or abscesses, or surgical removal of the mesh itself, the agency said.

The FDA updated this notice with a second communication issued in July 2011, to announce that further observation of post-market reports revealed that pelvic mesh side effects are not a rare occurrence.

Since issuing the earlier communication, the FDA said it received over 2,800 new reports of pelvic mesh complications, filed between January 2008 and December 2010. That number has grown.

If you or someone you love has been injured by pelvic mesh complications, they may be eligible to file a vaginal mesh lawsuit. Experienced pelvic mesh attorneys can help you decide the best options.

The Pelvic Mesh Lawsuit is Case No. 2:12-cv-02605 in the U.S. District Court for the Southern District of West Virginia. Charleston Division.