Transvaginal pelvic mesh linked to serious complications
Victims of defective transvaginal pelvic mesh products are beginning to file a new wave of lawsuits against the manufacturers of the synthetic mesh, following the shocking results of a clinical study that ended in fall of 2010 after finding dangerous complications of "erosion" causing pain and infection.
The vaginal mesh products are manufacturered by several companies, including Ethicon/Gynecare/Johnson & Johnson and C.R.Bard, Inc. - both of which are already named in the litigation in New Jersey that consolidates multiple cases before Judge Carol E. Higbee. The products are sometimes used - instead of the more traditional technique of "colpopexy" - to treat pelvic organ prolapse (POP). The mesh is also used to treat stress urinary incontinence (SUI).
In October 2008, the FDA issued warnings to doctors, saying the transvaginal placement of the surgical mesh products had triggered more than 1,000 reports of adverse events associated with the products, manufactured by at least nine different companies. At that time, the FDA still believed the problems were "rare". However, problems continued to mount.
In fall of 2010, medical researchers published a medical journal article revealing problems uncovered in a clinical study conducted from 2007 through 2009 (Obstetrics & Gynecology: August 2010 - Volume 116 - Issue 2, Part 1 - pp 293-303; "Vaginal Mesh for Prolapse: A Randomized Controlled Trial"; Iglesia, Cheryl B. MD, et al.).
In September 2011, the FDA Advisory Committee hearings were held in Gaithersburg, Maryland to determine the safety and efficacy of transvaginal mesh for the treatment of pelvic organ prolapsed and stress urinary incontinence following FDA's Safety Alert to the manufacturer's of these products on July 13, 2011. The FDA stated, among other things, it's concern of an increase in medical device reporting of adverse events numbering over 3,000 from January 1, 2008 - December 31, 2010 and growing concern among professional societies.
Patients would have been better off with traditional treatment, according to the article's lead author, Dr. Cheryl B. Iglesia, director of female pelvic medicine and reconstructive surgery at Washington Hospital Center in the District of Columbia.
"The bottom line is not only there were more complications," Dr. Iglesia said, "but the mesh didn't prove any better than traditional surgery."
The researchers conducting a clinical trial of the vaginal mesh products were forced to stop the study in August 2009 before it was completed, because the problems they were seeing in patients were too severe to continue the research. More than 15 percent of women in the study experience the dangerous and painful condition known as "erosion" in which the skin splits and the mesh protrudes.
In the earlier FDA warnings, further problems were noted:
The most frequent complications included erosion through vaginal epithelium, infection, pain, urinary problems, and recurrence of prolapse and/or incontinence. There were also reports of bowel, bladder, and blood vessel perforation during insertion. In some cases, vaginal scarring and mesh erosion led to a significant decrease in patient quality of life due to discomfort and pain, including dyspareunia."
The judge presiding over consolidated cases in New Jersey recently issued an order designating a new caption for the cases, as "In re Pelvic Mesh / Gynecare Litigation" (Higbee; NJ; Jan. 3, 2011) (includes cases of products made by Ethicon, Ethicon Women's Health & Urology, Gynecare, and/or Johnson & Johnson, even if case includes other products) (defendants also include Boston Scientific Corporation, American Medical Systems, Caldera Medical) (Judge Carol E. Higbee, Superior Court of New Jersey, Law Division, Atlantic County).
Lawyers at Anderson Law Offices, Cleveland, Ohio , are currently investigating the full extent of the problems associated with these pelvic mesh products, the various manufacturers involved, and all legal actions available to recover compensation for victims. Lawyers at the firm are available to review individual cases and discuss the best course of action.
