By Courtney Jorstad  |  January 1, 2014

Category: Legal News

Ethicon vaginal meshAn Illinois woman and her husband have filed a vaginal mesh lawsuit against Ethicon Inc. and Johnson & Johnson after she experienced complications after having the Gynecare TVT Obturator System surgically implanted.

The TVT-Obturator is advertised as using “the trusted mesh used in over 1.5 million patients over 11 years, and in a three year prospective clinical trial demonstrated a 97 percent overall success rate.”

Melissa and Richard Cain’s lawsuit has joined the Pelvic Repair System Products Liability Litigation multidistrict litigation (MDL) currently underway in federal court in the Charleston Division of West Virginia.

According to her vaginal mesh lawsuit, Mrs. Cain had the TVT-Obturator implanted at the Heartland Regional Medical Center in Marion, Ill. by Dr. Scott Joyner on Aug. 3, 2007 to correct problems she was having with female stress incontinence.

Stress urinary incontinence (SUI) 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. SUI 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.

From 2006 to 2008, the U.S. Food & Drug Administration (FDA) received more than 1,000 reports of complications linked with surgical mesh devices to treat stress urinary incontinence and pelvic organ prolapse.

The side effects associated with urethral support systems and vaginal mesh products 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 of vaginal mesh complications can be quite costly and may include additional surgery, IV therapy, blood transfusions, and drainage of hematomas or abscesses that developed as the result of the faulty vaginal mesh or bladder sling products.

The FDA issued a Safety Communication on July 13, 2011 saying that “serious complications associated with surgical mesh for transvaginal repair of POP (pelvic organ prolapse) 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 and bladder sling lawsuits since the FDA’s 2011 report.

The Cains are charging Ethicon with negligence, manufacturing defect, failure to warn, defective product, design defect, common law fraud, fraudulent concealment, constructive fraud, negligent misrepresentation, negligent infliction of emotional distress, beach of express warranty, breach of implied warranty, violation of consumer protection laws, gross negligence, unjust enrichment, and loss of consortium.

The vaginal mesh MDL is In Re: Ethicon Inc., Pelvic Repair System Products Liability Litigation, MDL No. 2327, in the U.S. District Court for the Southern District of West Virginia, Charleston Division.

If you or someone you know has had similar side effects or symptoms caused by a transvaginal mesh, bladder sling or vaginal sling implant, legal options are available to you. Learn more and get a free legal consultation regarding a claim’s eligibility at the Vaginal Mesh Sling Class Action Lawsuit Investigation. Experienced legal professionals have access to medical experts to assess whether or not a vaginal mesh implant may be playing a role in your current pain, discomfort or other serious side effects, so act now.

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