Johnson & Johnson recently agreed to pay $117 million into a transvaginal mesh settlement resolving defective device claims.

The company, which is the largest health product manufacturer in the world, faces claims that their transvaginal mesh products violated state consumer protection laws because the risks were not fully disclosed by the company.

Transvaginal Mesh Settlement Details

The new transvaginal mesh settlement will resolve claims brought by the attorneys general of 41 states and the District of Columbia. In addition to monetary payments, the settlement requires Johnson & Johnson to warn patients about the risks associated with their products and cease any misleading safety claims.

According to the Ohio attorney general, their investigation showed that Johnson & Johnson hadn’t sufficiently warned consumers about the risks associated with transvaginal mesh products – resulting in alleged violations of consumer protection laws.

Johnson & Johnson says it has not admitted any wrongdoing by settling the case against them. Meanwhile, California’s attorney general has sought $800 million in damages following conclusion of a trial earlier this month.

Transvaginal Mesh: Overview

Transvaginal mesh products are sling-like implantable devices which provide support to the pelvic organs such as the bladder, uterus, and others. By lifting these organs and anchoring them on the abdominal wall, transvaginal mesh can help treat conditions such as pelvic organ prolapse and stress urinary incontinence.

Pelvic organ prolapse occurs when the muscles and ligaments supporting the pelvic floor start to weak for a variety of reasons including childbirth. In women with pelvic organ prolapse, the pelvic organs can fall out of place or bulge down the vaginal opening. Transvaginal mesh helps to hold these organs up and reinforce the vaginal wall.

Stress urinary incontinence is any unintentional urination occurring during physical movement or activities such as coughing, sneezing, laughing, running, or anything else which puts pressure on the bladder. This is more common in older women and women who have given birth. Transvaginal mesh aims to treat this condition by supporting the urethra and holding up the bladder.

Ethicon, a Johnson & Johnson subsidiary, offered several transvaginal mesh products including the Gynecare Prolift, Gynecare TVT, and Gynecare Prosima implants.

Unfortunately, transvaginal mesh products from Johnson & Johnson and other manufacturers are associated with serious complications. After being implanted with transvaginal mesh products, women have allegedly experienced pain during intercourse, urinary problems, reoccurring pelvic organ prolapse, vaginal scarring, perforated organs (bladder, bowel, blood vessels, etc.), mesh erosion into the vagina, infection, various organ injuries, and more.

These issues have resulted in thousands of people filing lawsuits against Johnson & Johnson and other manufacturers. Some of these lawsuits are settled by the recent Johnson & Johnson transvaginal mesh settlement, although thousands of claims are still pending against the manufacturers and other companies.

Due to the complications associated with transvaginal mesh products, the U.S. Food and Drug Administration (FDA) recently halted the sale of these devices if used for transvaginal repair of pelvic organ prolapse. This includes products used to treat pelvic organ prolapse if the repair surgery is done through the vagina. Transabdominal mesh surgery (done through the abdomen) is not affected by this FDA action.