On June 4, 2012, Ethicon, a subsidiary of Johnson & Johnson, announced that it would discontinue production 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 Prolift and Prosima products consist of synthetic woven polypropylene mesh. The mesh is pre-formed and pre-packaged (see pictures above) in "kits" for use in pelvic organ prolapse (POP) surgery. Commonly referred to as "POP Kits," these products are typically aggressively marketed to OBGYNs and gynecological surgeons as a minimally invasive solution to POP repair. Surgeons are led to believe that is little to no risk of complications and pass that information on to their patients. An estimated 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 TVT Mini-Sling
The Gynecare TVT Secur belongs to a class of Stress Urinary Incontinence (SUI) devices known as "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 largely in 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 a "micro-invasive" approach to SUI surgery. 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 (pictured below).
A Sign of Things to Come?
This recall is the first movement by pelvic mesh manufacturer to cease production and withdraw a group of pelvic mesh products from the market in an apparent response to both FDA scrutiny and increasing pressure from mounting litigation. Last July, the FDA issued a news release warning of the high incidence of adverse events associated with use of transvaginal mesh for pelvic organ prolapse repair and issued scrutinizing warnings and further recommendations. The FDA held an ADCOM meeting in September and subsequently announced that mesh used in pelvic organ prolapse repair needed to be reclassified from a Class II to a Class III device. The FDA ordered further post-market studies on both pelvic organ prolapse mesh and synthetic "mini-slings."
In addition to regulatory activity, Ethicon is facing pressure from a dual state court/federal court lawsuit attack. Since September, 2010, the In re Pelvic Mesh/Gynecare Litigation has been centralized in the Superior Court of New Jersey in Atlantic County (Judge Carol E. Higbee). Then, in February of this year, federal MDL No. 2327, the In re Ethicon, Inc., Pelvic Repair System Products Liability Litigation was formed in the Southern District of West Virginia (Judge Joseph R. Goodwin). Approximately 400 cases have been transferred to MDL 2327 since February.
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. Further, those alternatives do not pose the horrific and disabling side effects that transvaginal mesh poses such as mesh degradation and erosion, and permanent tissue and nerve destruction. It simply makes sense that transvaginal pelvic organ prolapse mesh be removed from the market.
Ethicon was the first to make this move and remove its pelvic organ prolapse devices. In its letter to Judge Higbee and Judge Goodwin, Ethicon announced that it would no longer produce the above-referenced products and asked that it be allowed 120 days for full cessation. Further, Ethicon indicated that it would restrict the indication of its Gynemesh product (pre-formed Prolene sheet mesh) to use in abdominal sacrocolpopexy repair. Essentially, this means that Ethicon is announcing that it will be withdrawing its entire lineup of polypropylene synthetic mesh devices used in transvaginal POP repair.
In light of the FDA's scrutiny and available literature (and lack of literature) over the safety and efficacy of mini-slings, Ethicon also appears to be scrapping its mini sling product. Ethicon will likely firmly hold onto its more "traditional" TVT and TVT-O sling products. One can expect that, for now, Ethicon will continue to posture that its TVT and TVT-O products are safe and effective.
One can hope that manufacturers will follow suit with regard to the withdrawal of transvaginal pelvic organ prolapse mesh. Other pelvic organ prolapse mesh kit products to watch out for are:
Pelvic Organ Prolapse: Tips for the Practitioner
Without a doubt, Ethicon's decision to remove these defective products will result in a safer surgical atmosphere for women suffering from POP. One will hope that other manufacturers will follow suit. This move by Ethicon can be seen as a concession of the dangerous nature of these products.
From a larger picture, the pelvic mesh practitioner looking for mesh cases needs to keep a few things in mind. First, the dangerous characteristics of the Gynecare Prolift, Prosima, and TVT Secur devices are not necessarily purely device-specific. Many characteristics such as method of insertion, product composition, mesh density, porosity, and weave are defects that affect the entire class of products. For example, the defects inherent in the Prolift device transcend company lines and mirror many of the same defects of the Avaulta and Pinnacle devices. Simply put, using polypropylene mesh in pelvic surgery is unnatural and unreasonably dangerous, especially when the mesh is used in a "POP Kit" for pelvic organ prolapse repair.
As such, for those seeking transvaginal mesh cases, it would likely be ineffective and myopic to begin specifically seeking only Prolift, Prosima, and/or TVT Secur cases. Rather, the practitioner's focus should remain on being able to differentiate POP and SUI products and identify a client's device as early as possible. Those currently working with transvaginal mesh cases know that the typical client or prospective client will often not be able to differentiate the type of mesh that they received and will almost always be unable to inform the mesh attorney of the manufacturer, model, and lot number of the device. For now, absent some form of patient notification process, there is no quick and easy way to identify any product in question. The mesh attorney must rely on the rapid collection of medical records and their ability to communicate and gather information as effectively and efficiently as possible.