On June 4, 2012, Ethicon, a subsidiary of Johnson & Johnson, announced the discontinuation of the following products:
The Gynecare Prolift Kit
The Gynecare Prolift +M Kit (A Prolift Kit with partially absorbable properties)
The Gynecare Prosima Kit
The Gynecare TVT Secur
The Recalled Products:
The “POP Kits”
The Prolift and Prosima products, made of a synthetic woven polypropylene mesh, are pre-formed and pre-packaged in "kits" for application in pelvic organ prolapse (POP) procedures. Commonly known as "POP Kits," these products are aggressively marketed to OBGYNs and gynecological surgeons as a minimally invasive answer to POP repair. Surgeons are misled into believing these surgeries offer little to no risk of complications and then wrongly pass that information on to their patients. Each year, about 75,000 women are given mesh implants for pelvic organ prolapse repair per yea. In most cases, women receive mesh implants such as the Prolift and Prosima kits in lieu of more "traditional" procedures such as the natural colporrhapy procedure or the abdominal sacrocolpopexy.
The TVT Mini-Sling
The Gynecare TVT Secur part of a class of Stress Urinary Incontinence (SUI) devices known as "mini slings." Synthetic SUI slings like the Gynecare TVT and the TVT-O have been on the market since the late 1990s, and thanks mostly to capitalistic medicine and the 510(k) process, synthetic mini slings were born as the next step in "sling technology." Their designs require only a single intra-vaginal incision (as opposed to standard TVT or TVT-O designs that entail two additional abdominal or upper-thigh incisions). Mini-slings are marketed as a "micro-invasive" approach to SUI surgery, and the TVT Secur is the only product involved in the recall.
More Recalls in the Near Future?
This recall is the first movement by a pelvic mesh manufacturer to stop production and withdraw a group of pelvic mesh products as a response to FDA scrutiny and rising pressure from potential litigation. Last July, the FDA issued a warning of the high incidence of adverse effects associated with the use of transvaginal mesh for pelvic organ prolapse procedures, and issued scrutinizing warnings and further recommendations. The FDA also plans further post-market studies on both pelvic organ prolapse mesh and synthetic "mini-slings."
Ethicon is also seeing pressure from a dual state court/federal court lawsuit attacks. More than 400 cases since September 2010 have come to light.
Synthetic pelvic organ prolapse mesh has been strongly criticized in scientific literature and by members of the medical community. Several alternative options exist for POP repair that do not involve transvaginal placement of mesh. Further, these alternatives do not pose the terrible and disabling side effects that come with transvaginal mesh such as permanent tissue and nerve damage, and mesh degradation and erosion. It is now obvious to many that transvaginal pelvic organ prolapse mesh should be removed from the market.
Ethicon was the first to make this move and remove its pelvic organ prolapse devices. The company announced that it would no longer manufacture the above-referenced products and asked that it be allowed 120 days for full cessation. Ethicon also indicated that it would restrict the indication of its Gynemesh product (pre-formed Prolene sheet mesh) to use in abdominal sacrocolpopexy repair. This essentially means that Ethicon will be withdrawing its entire lineup of polypropylene synthetic mesh devices used in transvaginal POP repair.
We hope other manufacturers will follow Ethicon’s lead in withdrawing transvaginal pelvic organ prolapse mesh.
Other pelvic organ prolapse mesh kit products to look out for are C.R. Bard's Avaulta Family Products, American Medical Systems' Apogee/Perigee and Elevate Products, and Boston Scientific's Pinnacle and Uphold Products.
The high profitability of these devices makes recalls difficult, but human life is wroth the effort. If you had a POP Kit or Mini Sling implanted, it is important to act quickly to protect your rights because you may be entitled to compensation. For more information on this recall, contact LaBovick Law Group.
Details of the recall announced by Levin Papantonio Thomas Mitchell Rafferty & Proctor, P.A.