Johnson & Johnson subsidiary Ethicon failed to provide adequate warnings about the safety of its vaginal mesh products, causing the unnecessary suffering of an Alabama woman and thousands of other women, according to a recent vaginal mesh lawsuit.

Plaintiff Brenda A. alleges that the Gynecare TVT mesh implanted surgically in 2011 to treat her stress urinary incontinence was defectively manufactured and designed, causing serious vaginal complications.

The vaginal mesh lawsuit accuses Ethicon of negligently manufacturing and selling defective and unreasonably dangerous products, and withholding information about the risk that transvaginal mesh may erode through the vagina, and cause infections and other injuries.

Transvaginal Mesh and Transvaginal Tension Free Vaginal Tape (TVT) are medical devices that are surgically implanted to treat Pelvic Organ Prolapse (POP) and/or Stress Urinary Incontinence (SUI).

SUI typically occurs in women after childbirth due to muscle weakness in the pelvic area, causing urine to leak from the body during such normal activities such as coughing, laughing, and exercising.

POP typically occurs in older women whose muscle and tissue groups in the uterus, bladder and pelvic region have become stretched and weakened. Women also have an increased risk of developing POP with menopause or a hysterectomy.

Transvaginal mesh surgery is supposed to strengthen the internal organs and prevent them from coming into contact with each other.

Johnson & Johnson’s Ethicon Women’s Health & Urology division is responsible for manufacturing many transvaginal mesh devices. This division of Johnson & Johnson offers treatments for a variety of female pelvic and reproductive organ health conditions.

Brand names of Johnson & Johnson/Ethicon’s transvaginal mesh devices include:

• Ethicon TVT
• Gynecare TVT
• Gynemesh PS
• Prolene Polypropylene Mesh Patch
• Secur

Vaginal Mesh Complications

In January 2012, the U.S. Food and Drug Administration (FDA) ordered the makers of vaginal mesh products to study the risks associated with the products.

The order came following the recommendation of an FDA advisory panel in September 2011. According to the FDA, between 2008 and 2010 the number of adverse events reports to the FDA about transvaginal mesh increased five-fold.

Not all transvaginal mesh products are affected by the FDA’s order. Those that are implanted through the abdomen are not included.

Vaginal mesh implant complications include:

• Mesh erosion into the vagina, bladder, intestines and uterus
• Infection
• Pelvic pain or neuropathic pain
• Urinary problems, including incontinence
• Development of urinary retention
• Bowel, bladder, and blood vessel perforation during insertion
• Vaginal scarring
• Dyspareunia (pain with sexual relations)
• Fistulas and recurrence of prolapsed organs

Johnson and Johnson’s Ethicon division continues to make these transvaginal mesh devices. There are more than 1,000 reported cases of women who have been seriously harmed by these medical devices.

Vaginal Mesh Lawsuits

Nearly 100,000 individual vaginal mesh lawsuits have been filed against various mesh manufacturers in the United States as a result of alleged vaginal mesh injuries.

In her lawsuit, Brenda is seeking restitution and punitive damages for Ethicon and Johnson & Johnson’s alleged gross negligence and failure to warn about dangerous vaginal mesh complications.

The Vaginal Mesh Lawsuit is Case No. 2:15-cv-12546, in the U.S. District Court for the District of New Jersey.