FDA and Vaginal Mesh Manufacturers Square Off at Meeting; FDA Says Mesh Not Proven Safe or Effective for Vaginal Prolapse

In an attempt to avoid, what could be, overwhelming ramifications for medical device manufacturers, industry leaders in transvaginal mesh production have acknowledged the need for increased safety studies and label changes for their products. This acknowledgement comes in response to a meeting that is currently being held to decide the fate of transvaginal mesh products. An advisory committee to the U.S. Food and Drug Administration (FDA) has convened in Gaithersburg, MD to determine the safety and effectiveness of the products in question.

Further review of the safety and effectiveness concerns that have plagued the surgical application of transvaginal mesh, may result in future regulations. Results of the committee will likely have unprecedented ramifications on the transvaginal mesh industry. In a move to avoid a detrimental set back, industry leaders, led by Johnson & Johnson proposed that new versions of the devices require clinical trials before they can be sold and existing implants be tracked for safety.

Their proposal halted the advancement of a recommendation from the FDA last month that suggested the devices be reclassified, further subjecting them to stricter regulatory controls.

Proponents of the idea to reclassify transvaginal mesh devices acknowledge that doing so would give the FDA control over future clinical trials that the manufacturers are obligated to conduct. Julia Corrado, a clinical reviewer attending the meeting, told the advisory committee that keeping the devices under the old 510(k) system “would mean a new device only needs to be as good as a device currently on the market and we are concerned that is not good enough.”

Denise Elser, a Chicago-area physician speaking for the American Congress of Obstetricians and Gynecologists admittedly stated that there is not enough evidence to establish whether or not the benefits of transvaginal mesh outweigh the risks. However, she does suggest that implementing a future registry control may help the process in deciding the safety and effectiveness of these devices.

Members of the National Surgeons’ group addressed the advisory committee with the idea of limiting the numbers of implants used. Subsequently they believe that well-trained physicians operating on carefully chosen patients will help to minimize the occurrence of adverse events.

However, Ginger Glaser, a senior director for Endo Pharmaceuticals, based in Chadds Ford, Pennsylvania said that the FDA can continue approving meshes as “moderate-risk” devices while still requiring additional safety studies or labeling changes. Glaser identifies that the FDA can still regulate mesh products without reclassifying them. Many manufacturers believe that there is significant evidence that existing studies have already proven that transvaginal mesh is safe and effective.

The FDA, however, is continuing to weigh a U.S. Institute of Medicine report that suggest eliminating the original 510(k) process in which moderate-risk devices are evaluated. Under the current process, devices only need to demonstrate that they are “substantially equivalent” to others already on the market. According to the Institute of Medicine report, a new process should be devised that provides reasonable assurance of the safety and effectiveness of moderate-risk devices.

The FDA is considering the idea of updating this process because they believe that the surgical application of transvaginal mesh has not demonstrated an effectiveness that is acceptable. William Maisel, deputy director of the FDA Center for Devices and Radiological Health said that “the clinical effectiveness of surgical mesh for transvaginal repair of pelvic organ prolapse has not been demonstrated.”

The panel of outside advisers is meeting today and tomorrow on whether mesh devices are safe and effective. If not, companies may be required to provide more data to keep their products on the market. Most were approved under an abbreviated FDA process known as 510(k) that required manufacturers to show only that they were similar to already cleared devices.