Women waging losing battles against cellulite saw a rare beacon of hope last month, when the Food and Drug Administration cleared "the world's first and only" one-time laser treatment clinically proven to reduce cellulite by disrupting its underlying structure. Finally, a trusted path to dimple-free thighs.
Or is it? What does the FDA's blessing of fat-melting Cellulaze, as well as all the other medical devices cleared each month, really mean? While there's nothing to indicate Cellulaze is anything but safe and effective, consumers should know an FDA go-ahead is not a guarantee. The agency conducts a risk-benefit analysis that allows an item to be marketed for particular indications — sometimes requiring little or no testing.
The most stringent review process for medical devices is pre-market approval (PMA), for high-risk Class 3 devices such as pacemakers, defibrillators and anything life-sustaining or life-threatening. Manufacturers must submit scientific evidence from clinical trials demonstrating "reasonable assurance" of safety and effectiveness. Just 1 percent of devices go to market via PMA, and only these are considered FDA "approved."
The vast majority of devices that undergo FDA review are moderate-risk Class 2 devices such as medication pumps and surgical lasers like Cellulaze, granted FDA clearance through a controversial process called 510(k). (Low-risk Class 1 devices, like stethoscopes and gauze, are exempt from review.)
Products get 510(k) clearance if they're found to be "substantially equivalent" to a legally marketed device, meaning they have the same intended use and technological characteristics — or, if not, that the differences don't raise serious concern.
There's no requirement of clinical testing to determine the safety and effectiveness of 510(k) submissions, though the FDA does ask for clinical data in about 10 percent of cases. For example, the FDA required laser manufacturer Cynosure to conduct a trial for Cellulaze, which uses a laser already on the market but was adding a new intended use for the short-term reduction in the appearance of cellulite. The three-month trial of 57 women, scored by blind evaluators judging photographs, found a reduction in the appearance of cellulite and minimal side effects, including mild discomfort, bruising, swelling and numbness.
To be clear, there have been no concerns raised about Cellulaze, which is being used as an example here because, hey, cellulite reduction is exciting.
Some consumer advocates worry that insufficient testing in the 510(k) system lets unsafe or ineffective products slip through. As the chain of "substantially equivalent" devices grows, the less likely it is the new ones bear any resemblance to the original, and usually there's been no evaluation of safety or effectiveness in between, said Dr. Michael Carome, deputy director of the Health Research Group at Public Citizen, a nonprofit consumer rights group.
Devices later found faulty or even recalled aren't automatically removed from the list, Carome said, so new products could be cleared based on tainted precedents. A new House bill called the SOUND Devices Act (HR 3847) aims to close that loophole.
The Institute of Medicine, a nonprofit under the National Academies that provides policy guidance, said in a report last year that the 510(k) process is unreliable and recommended it be scrapped.
Meanwhile, the FDA is under pressure from medical device manufacturers and some members of Congress who say the review processes are too time-consuming and unpredictable, delaying U.S. citizens access to new technologies by two years compared with other countries, according to the Advancing Medical Technology Association, which represents medical device manufacturers. The FDA says review of 510(k) and PMA submissions takes 90 days and 180 days, respectively. AdvaMed puts the average at 146 days and 326 days.
Keep yourself informed
The FDA posts safety alerts and recalls for medical devices at http://www.fda.gov/medicaldevices/safety.