Stress Incontinence Treatment Goes Horribly Wrong, Lawsuit Alleges

A Kansas woman who sought treatment for stress urinary incontinence has filed a vaginal mesh lawsuit against Johnson & Johnson’s Ethicon division for problems she allegedly had with two of their bladder sling products.

On May 27, 2011, Barbara Shafer had the Gynecare Prosima and Gynecare TVT Abbrevo implanted at Providence Medical Center in Kansas City, Kan. by Dr. Lisa Lorenzetti. Following the implantation procedure, she allegedly suffered complications that led her to file this vaginal mesh lawsuit.

The Abbrevo is used to treat female stress urinary incontinence (SUI), and the Prosima is used to repair pelvic organ prolapse (POP). The two products are both involved in multidistrict litigation (MDL) in the Charleston Division of West Virginia.

Reports of Bladder Sling Implant Problems Number in Thousands

Stress incontinence is the leaking of urine when there is a “stress event,” which can include coughing, sneezing, laughing or lifting–in other words, anything that puts pressure on the abdomen. Stress incontinence occurs as the result of weakened pelvic muscles and connective tissue that support the bladder and urethra. There can be several causes of SUI including pregnancy, childbirth, menopause, obesity, smoking and previous pelvic surgery. More than 15 million Americans suffer from SUI.

There are non-surgical treatments for stress incontinence, but if they don’t work, surgery may be the only option. Shafer opted to have the vaginal mesh implant surgery to treat the condition.

Pelvic organ prolapse develops in women due to child birth, a hysterectomy, or menopause. During childbirth the muscles and ligaments are stretched and can tear causing them to become too weak to hold the organs in place. As a result, the bottom of the uterus, the floor of the bladder, the rectum or all three can sag and even protrude into the vagina. Vaginal mesh slings and bladder sling implants are implanted to hold the organs in place where the muscles have failed.

There have been several reports of adverse side effects linked to some of the products designed to solve SUI and POP. Between 2006 and 2008, the U.S. Food & Drug Administration (FDA) received more than 1,000 reports of complications linked with vaginal mesh implants to treat SUI as well as POP.

The side effects associated with urethral support systems and vaginal mesh implants include erosion through the vaginal epithelium, which is the tissue lining the inside of the vagina, infection, pain, urinary problems, and recurrence of the prolapse or incontinence problem as well as bowel, bladder and blood vessel perforation that can occur during the insertion of the mesh and bladder sling products.

Treatment may include additional surgery, IV therapy, blood transfusions, and drainage of hematomas or abscesses that developed as the result of the faulty vaginal mesh implant or bladder sling products, and they can become quite costly.

The FDA issued a Safety Communication on July 13, 2011 saying that “serious complications associated with surgical mesh for transvaginal repair of POP are not rare.”

“Mesh contraction (shrinkage) is a previously unidentified risk of transvaginal POP repair with mesh that has been reported in the published scientific literature and in adverse event reports to the FDA,” the report continued. “Reports in the literature associated with mesh contraction with vaginal shortening, vaginal tightening and vaginal pain.”

The FDA concluded that “it is not clear that transvaginal POP repair with mesh is more effective than traditional non-mesh repair in all patients with POP and it may expose patients to greater risk.”

There have been a growing number of vaginal mesh implant and bladder sling lawsuits since the FDA’s 2011 report.

Shafer’s vaginal mesh lawsuit has been added to the multidistrict litigation currently underway, In Re: Ethicon Inc., Pelvic Repair System Products Liability Litigation, MDL No. 2327, Case No. 2:13-cv-27621, in the U.S. District Court for the Southern District of West Virginia, Charleston Division.

Help for Victims of Bladder Sling Complications

If you had revision surgery to repair damage caused by vaginal mesh, or you have surgery scheduled, you may be able to take legal action against the device manufacturer. These companies have already paid out millions of dollars in vaginal mesh lawsuit settlements and are continuing to settle cases. Don’t delay – see if you qualify to pursue compensation for medical bills, pain and suffering, and other damages by filling out the short form at the Transvaginal Mesh, Bladder Sling Class Action Lawsuit Investigation.