Transvaginal pelvic mesh linked to serious complications
Important Update: Public Citizen Urges Recall of Surgical Mesh
The consumer advocacy group Public Citizen on Aug. 25, 2011, petitioned the U.S. Food and Drug Administration (FDA) to immediately ban the sale of all non-absorbable surgical mesh products used for transvaginal repair of pelvic organ prolapse (POP).
Public Citizen declared in their petition that the FDA immediately ban the sale of all non-absorbable surgical mesh designed specifically for transvaginal repair of POP and order all non-absorbable mesh manufacturers to recall the products designed for POP. The group also urged the FDA to require that all of these products be reclassified as a class III device, requiring them to go through prospective clinical trials proving they are safe and effective.
The advocacy group’s petition said that these devices were no more beneficial in POP surgery than surgery without using the mesh and had high rates of complications which often required further surgery. Sometimes the additional surgeries were unsuccessful, resulting in “life-altering harm” to these patients, the consumer advocacy group alleged.
POP is a condition that occurs in women, usually after the stress of childbirth, causing the weakened tissues of the pelvic floor to prolapse or bulge into the vagina. POP can result in pelvic discomfort, and interfere with urinary, defecatory, and sexual function in addition to other daily activities. Vaginal mesh is used to support the weakened tissue in and around the vagina to pull the organs back into their normal position.
Defective Transvaginal Pelvic Mesh
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.).
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 Aylstock, Witkin, Kreis & Overholtz, in Pensacola, Florida, 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.
Mentor OB tape and Bard Avaulta mesh complications
Many patients have experienced problems similar to those noted above with Mentor OB Tape and the Bard Avaulta Mesh vaginal sling.
Mentor OB Tape is manufactured by the Mentor Corporation. Bard Avaulta Mesh is manufactured by C. R. Bard, Inc.
These products are marketed as solutions for the treatment of stress urinary incontinence (SUI) and pelvic organ prolapse (POP). However, the use of these products has led to serious complications for numerous women.
The Mentor OB tape was pulled from the market in 2006, due to numerous reports of serious complications. Lawyers for numerous victims of the Mentor OB tape products reached a settlement with the defendant manufacturer just before the first trial on related injuries was set to begin in June 2010. Many other victims have already filed additional lawsuits, while others are still eligible to file new lawsuits.
The Bard Avaulta vaginal mesh, were among those targeted by FDA warnings issues in 2008 and the subsequent revealing report by Dr. Iglesia and colleagues in 2010, describing a clinical study ended in 2009 due to serious problems with surgical mesh use.
The Bard product is marketed as the Avaulta Anterior and Posterior Biosynthetic Support System.