A transvaginal mesh recall could be the opening gong of the death knell for the plastic mesh catastrophe unfolding across the nation. At the very least, transvaginal mesh (TVM) litigation took a step forward for plaintiffs this week when Johnson & Johnson’s Ethicon division informed the FDA that it intended to recall four of its Gynecare products: the Prolift Kit, Prolift +M Kit, Prosima Kit and TVT Secur.
The announcement is the latest in a series of troubling developments that began in July last year when the FDA reported a five-fold increase in deaths, injuries and/or malfunctions associated with transvaginal mesh (TVM) used in pelvic organ prolapse repair (POP) procedures. That report was followed in September 2011 by an advisory panel which urged the FDA to reclassify mesh products as “high-risk.” Then in January 2012, the FDA ordered several manufacturers to conduct further studies regarding the “side effects” and complications associated with their products.
The FDA has announced that it could find no benefit to the patient in placing the mesh as compared to not placing it and using traditional forms of POP repair. Despite that FDA announcement, more than 300,000 POP surgeries are performed each year – nearly one third of them with mesh. In the last three years the FDA has received thousands of adverse event reports concerning surgical mesh used specifically for POP repair surgery. The long list of complications from mesh insertions includes:
• mesh erosion
• severe pain
• urinary problems
• vaginal bleeding
• organ perforation
• recurrent organ prolapse
• vaginal scarring or shrinkage
• emotional problems
Pelvic Organ Prolapse
POP occurs when a pelvic organ, such as the bladder, uterus, and/or rectum, drops (prolapses) from its normal spot in the lower belly. The drop occurs because the muscles retaining these organs become weak or stretched due to age and/or childbirth. The organ drop can cause issues in the functionality of the organ and/or the surrounding organs. Between 30-60 % of women will experience POP in their lifetimes.
The recalled Prolift and Prosima products consist primarily of synthetic woven polypropylene mesh. The pre-formed, pre-packaged mesh is sold in “kits” for use in pelvic organ prolapse (POP) surgery. Commonly referred to as “POP Kits,” these products are often marketed aggressively to OBGYNs and gynecological surgeons as a minimally invasive POP repair solution. Surgeons are led to believe by Big Pharma salesmen that there is little to no risk of complications, and they pass that information on to their patients. Upwards of 75,000 women receive mesh implants for pelvic organ prolapse repair per year. In most cases, women receive mesh implants such as the Prolift and Prosima kits instead of undergoing more “traditional” procedures such as the natural colporrhapy procedure or the abdominal sacrocolpopexy.
The recalled Gynecare TVT Secur belongs to a class of Stress Urinary Incontinence (SUI) devices called “mini slings.” Synthetic SUI slings such as the Gynecare TVT and the TVT-O have been on the market since the late 1990’s. Thanks in large part to capitalistic medicine and the 510(k) process, synthetic mini slings were born as the next step in “sling technology.” Due to their design that requires a single intra-vaginal incision (as opposed to standard TVT or TVT-O designs that require two additional abdominal or upper-thigh incisions), mini-slings are marketed as “micro-invasive” approaches to SUI surgery. While the TVT Secur is the only product involved in the recall, Ethicon continues to market its lineup of “standard” TVT devices such as the TVT, the TVT-O, and the TVT Exact.
Transvaginal Mesh Lawsuits
Ethicon also faces pressure from both state and federal court lawsuits. Since September, 2010, the In re Pelvic Mesh/Gynecare Litigation has been centralized in the Superior Court of New Jersey in Atlantic County (before Judge Carol E. Higbee). In February 2012, federal Multi-District Litigation (MDL) No. 2327, the In re Ethicon, Inc., Pelvic Repair System Products Liability Litigation was formed in the Southern District of West Virginia (before Judge Joseph R. Goodwin). Approximately 400 cases have been transferred to MDL 2327 since February.
Efficacy, Safety in Question
Synthetic pelvic organ prolapse mesh has been heavily criticized in scientific literature and by members of the medical community. Several alternatives exist for POP repair that do not involve transvaginal placement of mesh. Those alternatives also do not pose the horrific, disabling side effects that transvaginal mesh products pose, such as mesh degradation and erosion, along with permanent nerve and tissue damage.