Texas Woman Sues Ethicon Over Gynecare Vaginal Mesh Erosion

A Texas woman who allegedly suffered serious complications from a Gynecare vaginal mesh implant has sued Ethicon Inc., the manufacturer of the mesh.. The plaintiff filed her transvaginal mesh lawsuit in U.S. District Court, Eastern District of Texas (Marshall) on October 17; 2012.

Plaintiff implanted with Gynecare mesh to treat POP

According to the complaint, in December of 2010 the plaintiff was diagnosed with several forms of pelvic organ prolapse (POP): cystocele, meaning that the wall between her bladder and vagina had weakened and allowed the bladder to droop into the vagina; rectocele, meaning that the end of the large intestine (rectum) was pushing against and moving the back wall of the vagina; and vault prolapse, meaning that the upper portion of the vagina was sagging or droppings down into the vaginal canal or outside of the vagina.

To treat these conditions, the plaintiff had surgery and was implanted with the Gynecare Prosima vaginal mesh, manufactured by Ethicon. But she subsequently experienced mesh erosion and other mesh problems, the lawsuit claims, which has caused her to suffer chronic bladder infections, painful intercourse, spotting, and incontinence.

Ethicon knew or should have known of device’s risks, lawsuit states

The plaintiff’s attorney states in the lawsuit that Ethicon knew or should have known that the Gynecare Prosima mesh was dangerous and defective, and had a high risk of “knotting” when used in a reasonably foreseeable manner.

The lawsuit brings multiple counts against Ethicon including failure to warn, manufacturing defect, negligence, strict liability, and breach of warranty. The plaintiff is seeking financial compensation for her pain and suffering, medical expenses, and lost income.

Vaginal mesh litigation

The plaintiff is far from alone in experiencing vaginal mesh problems. In just the two-year period from 2008 to 2010, the FDA received 1,500 reports of problems with vaginal mesh implants. In 2011, the FDA issued a warning about vaginal mesh devices, warning that they could cause complications such as mesh erosion, organ perforation, vaginal scarring, pain, infection, bleeding, dyspareunia, and urinary problems, and that such complications were “not rare.”

Following the FDA’s warning, many women who have suffered such complications filed lawsuits against the makers of the vaginal mesh devices – so many, in fact, that five separate MDLs (multidistrict litigations) have been established to consolidate lawsuits against the different vaginal mesh manufacturers.

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