Monday, January 16, 2012

Under Fire: Transvaginal Mesh Manufacturers Defend Device amid Stern Criticism

Recent FDA warnings regarding the controversial transvaginal mesh implant have resulted in a staunch defense of the device and its safety by the mesh manufacturers. Although the FDA has talked of reclassifying the mesh implant from a Class II to a Class III, requiring much more stringent clinical testing as well as human trials, Boston Scientific, one of the makers of the mesh is strongly urging against that potential change. Boston Scientific continues to assert that mesh products are a viable—and valuable—option for surgeons who treat women with pelvic organ prolapse or urinary stress incontinence. Further, they believe that mesh products offer a safe and effective alternative to non-mesh treatments and that the FDA’s current 510(k) requirements for a Class II device are appropriate for the transvaginal mesh.

FDA Warnings

The first warning issued by the FDA came in 2008 and warned of possible complications associated with transvaginal mesh implants, stating such complications were “not rare”. A more recent warning by the FDA went even further when it contended that it was unclear whether pelvic organ prolapse repair using mesh implants had any real advantage over traditional POP surgery without mesh and could expose patients to potentially serious risks.

Mesh Manufacturer’s Concerns

During the FDA advisory meeting, another maker of the mesh, Cook Medical, filed a letter asking the FDA to consider giving different treatment to meshes made from different materials. This request was based on the theory that there are significant differences between non-absorbable synthetic mesh products as opposed to biologic grafts which are not cross-linked. Another maker of the mesh, Johnson and Johnson—who has come under serious fire recently due to complications from their mesh implants—agreed with prior FDA reports which recommended simple label changes could warn women and their physicians of the potential risks of mesh implants.

Both Johnson and Johnson and C.R. Bard have become the target of over 500 lawsuits filed by women who claimed the mesh used in their POP or SUI surgeries caused serious internal injuries and chronic pain. The lawsuits were a direct result of the over 4,000 adverse event reports which have been filed since 2005. Most all the makers of the mesh devices agreed that any new applications for transvaginal mesh products should be subject to clinical testing, but strongly resisted the proposed reclassification of their mesh product. Johnson and Johnson and Endo Pharmaceuticals suggested that new device versions require clinical trials while existing implants have safety tracking controls. The manufacturers of mesh devices still believe strongly in their product, believing that while it may not be the best resolution for every patient in every case, it nonetheless offers a reliable and safe outcome for many women with pelvic organ prolapse or stress urinary incontinence.

The FDA’s Response

The FDA panel appears to be leaning toward requiring new device applications to undergo more stringent testing while allowing existing mesh products to remain on the market—a kind of grandfather clause for the existing mesh manufacturers. The FDA also strongly cautions physicians to sensibly consider other, more traditional options as well as ensuring their patients are thoroughly apprised of potential mesh complications. Because mesh is considered a “permanent” implant, it is not always possible to completely remove all traces of the mesh when erosion has occurred. In certain cases removal of the mesh may not fully resolve the underlying medical issue. A recent report from the FDA’s Obstetrics & Gynecology Devices Panel recommended moving the mesh implants to a higher risk category stating they may be exposing patients to unnecessary risks while offering few benefits over more traditional surgeries.

Is an FDA Decision on the Horizon?

Should the FDA decide to reclassify the mesh devices as high-risk (as opposed to their present classification as moderate-risk) the manufacturers would fall under significant additional obligations such as receiving approval of manufacturing procedures, being subject to plant inspections and dealing with longer review periods. Changing the current classification of the mesh implant device would also require the FDA to oversee clinical trials conducted by the individual corporations.

In spite of the potential hardships a reclassification would place on manufacturers, many believe that allowing the device to remain in its present classification—meaning any new device must only be as good as the device currently on the market—is simply not good enough to ensure the safety of women. It is unclear when the FDA will render their final decision on the mesh devices, however several mesh manufacturers are feeling the weight of the issue in falling stock prices and additional lawsuits.

Author: Sullo & Sullo Attorneys

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