Consumer Reports is stepping into the debate about the medical device approval process, recommending that the Food and Drug Administration require more rigorous testing to prevent defective medical devices from going to market.
The magazine and its advocacy arm Consumers Union wants the FDA to require implants and other medical devices undergo testing to prove they are safe and effective. The FDA began classifying medical devices into three categories in 1976 and stated manufacturers would be required to show clinical data before approval of Class III products, the most at-risk category.
But the FDA routinely clears new medical devices under a process known as 510, in which manufacturers are required to bypass clinical testing if they can show a device is “substantially equivalent” to another device already on the market.
Consumers Reports is calling on Congress to require testing as part of the FDA’s approval process for medical devices. Next, it wants the practice of “grandfathering” high-risk implants stopped. Finally, the organizations seek an improvement to the system for notifying patients of medical device failures.
Currently, the system largely relies on physicians who are supposed to notify patients, but this is a problem when doctors stop practicing.
Without changes to the system, Consumer Reports said patients cannot properly protect themselves.
The magazine highlighted three types of defective medical devices which have caused injuries in recent years:
Surgical Mesh: This device was approved several years ago based on its relationship to a product used in the 1950s, even though the two products were inserted differently and treated different areas of the body. The FDA refused calls to recall surgical mesh, but in January ordered 33 companies to conduct the first-ever post-market safety studies of the product. The FDA is also considering reclassifying surgical mesh into a Class III category.
The Consumer Reports article shares the story of a 54-year-old woman who has undergone eight surgeries to correct her transvaginal mesh complications.
Artificial All-Metal Hips: DePuy Orthopedics recalled its ASR XL all-metal hip implant in 2010 after the FDA received about 400 complaints in two years from patients. The two metal parts were rubbing against each other, breaking and spreading metal particles into the blood stream. Injury reports about all-metal hip implants grew after that, with the FDA receiving more than 5,000 reports about hip implants in the first six months of 2011, according to a New York Times article. DePuy hip implants was estimated to account for 75 percent of those injury reports.