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Consumer and Manufacturer Costs for Surgical Mesh and Metal-on-Metal Hip FDA Clearance

January 1, 1970 · FLEMING | NOLEN | JEZ, L.L.P.

When a physician tells you that a medical device can improve your life, most people assume that the device has been tested for safety and effectiveness. However, this is rarely the case. In fact, most medical devices on the market have received clearance from the Food and Drug Administration (FDA) by merely filing paperwork and paying about $4,000 for a user fee. George Fleming, with Fleming, Nolen & Jez, recently commented that, “this treats the people receiving the device like guinea pigs to determine if the device is truly safe and effective. In addition, if the initial testing is done in the market, there is no way to properly track the safety and effectiveness of the device.” The FDA only tracks safety and effectiveness based on the voluntary reporting by doctors, manufacturers and patients, which voluntary system is severely underused.

AsConsumer Reports published in their May 2012 magazine, Diana Zuckerman, Ph.D. of the National Research Center for Women & Families, a nonprofit advocacy organization, stated that the medical device standards make no sense. Only a small number of devices are assumed by the FDA to be “high risk.” The FDA only requires testing on this small number of high risk devices, which compared to prescription drug testing uses smaller testing groups and is less rigorous. Manufacturers use this system to their advantage, fighting with the FDA for their device to not be considered high risk and therefore not requiring pre-market testing.

Transvaginal surgical mesh, used to treat pelvic organ prolapse and stress urinary incontinence, was one type of device where the FDA cleared the device without testing. The FDA thought that the first transvaginal mesh was similar enough to a predicate device, abdominal hernia mesh, that no testing was required. However, hernia mesh and transvaginal mesh are different because they are inserted into the body differently, are used in a different part of the body and have different outcomes. This first transvaginal mesh was then recalled in approximately 1999 due to safety concerns. Unfortunately for consumers, transvaginal mesh manufacturers, like Bard, Johnson & Johnson, American Medical Systems, and Boston Scientific, have followed this method to get additional transvaginal mesh products and kits onto the market without the need for testing. Finally, in 2012, about ten years after the first transvaginal mesh kits hit the market, the FDA has ordered 33 companies to conduct the first-ever post-market safety study of these products.

Themetal-on-metal hip, also known as all-metal hip, is another faulty device where safety and effectiveness testing was not required prior to placing the device on the market. The FDA cleared the metal-on-metal hip based on a predicate device despite the fact that the FDA had such devices on its high-priority list. After using the public as the testing ground, DePuy recalled all 93,000 ASR XL hips due to safety concerns. Only within the past year did the FDA take action for metal-on-metal hip manufacturers to also conduct post-market safety study of these products. The FDA also plans to have additional hearings on the metal-on-metal hip implants in late June 2012.

In 2011, a panel from the Institute of Medicine further commented on the FDA’s device approval process stating it needs overhauled. However, instead, Congress is currently debating a new law which would keep the present system intact and allow for an agreement between the FDA and manufacturers to get the device to market sooner. Congressman Markey, however, disagrees with this approach and has recently submitted the SOUND Act for consideration, which would require more stringent standards before a device, like transvaginal mesh or metal-on-metal hip, is placed on the market. In the meantime, while Congressmen fight over what the law should be, device manufacturers are still manipulating the FDA process to avoid testing of their devices before making the device available to the public.