FDA's Medical Device Classification Process In Question

A panel of U.S. Food and Drug Administration (FDA) advisors has convened in Gaithersburg, MD to discuss the future of transvaginal mesh products. The meeting was called after an influx of adverse events, regarding the surgical application of transvaginal mesh, had been reported in recent years. According to officials at the FDA, the meeting will discuss the safety and effectiveness of transvaginal mesh products. Data submitted at the meeting will likely determine future regulations and restrictions that may need to be placed on the devices. Furthermore, a new ruling may also suggest a change in the medical device classification process.

Already under pressure from hundreds of lawsuits, medical device companies such as Johnson & Johnson and C.R. Bard may face future regulations that have the potential to cause overwhelming repercussions in the transvaginal mesh industry. If their products are deemed unsafe or ineffective at this weeks meeting, industry leaders may be required to provide the FDA with relevant safety information, just to keep their products on the market. Subsequently, a change in the medical device classification process could make it harder for the industry to develop future devices.

However, medical device manufacturers are not the only ones receiving intense scrutiny over the recent onslaught of adverse events related to transvaginal mesh devices. Marci Levin, a 65 year old New York marketing executive, has recently sued Johnson & Johnson after receiving a transvaginal mesh that may be responsible for severe pain and suffering. She said in an interview that she endures pain so intense that she can’t work, sleep through the night or have sex with her husband.

Subsequently, she also blames the FDA for what happened to her. Levin alleges that the FDA failed her when they didn’t require extensive testing before allowing J&J to sell the mesh implanted in her in 2007. The device was cleared under the agency’s 510(k) process, which allows approval without substantive studies if a product is “substantially equivalent” to others already on the market. Levin stated that the mesh she received was not tested properly before it was implanted in her. Furthermore, she was also told that “it was a real improvement, that this would be great and she would be back at work in two weeks.”

Adam Slater, a New Jersey attorney currently representing Mrs. Levin in her case against Johnson & Johnson, wrote to the FDA advisory committee conducting the meeting this week to let them know that “the 510(k) process utterly failed to protect the thousands of women who were implanted.” Slater also stated in his letter that “the FDA now has the opportunity to at least protect women on a going-forward basis.” Slater’s actions indicate that he, like many other consumer representatives, is pushing for increased regulations on transvaginal mesh products and perhaps a reclassification of the medical devices in question. If anything, Slater hopes his letter will help the FDA realize that transvaginal mesh devices need to be recalled.

Though the meeting will not come to any official conclusions this week, the FDA will poll the panel of researchers and physicians on whether to reclassify the devices and gather thoughts on how to conduct clinical studies. In doing so, the FDA hopes to avoid any future complications associated with transvaginal mesh devices.