"Some patients' mobility will decline to the point of needing walkers or wheelchairs to get around and other serious events up to and including death can occur from subsequent operations," Redberg said. "And that's just for the metal-on-metal implants."
An Obscure Loophole
These high-risk metal-on-metal devices avoid going through clinical trials because of FDA loopholes in the 510(k) clearance, which allow them into the marketplace by claiming "substantial equivalence," which means they are similar to already approved devices or "predicate devices."
"All you have to do is show that your device is substantially similar to a number of other devices," Redberg said. "And some of those devices which were originally approved have been recalled or pulled off the market, but their original approval was still allowed for those 'predicate devices' that claimed 'substantial equivalence.'"
Even voluntarily recalled devices can serve as predicates under the 510(k) clearance as long as the FDA did not require their removal from the market or a court did not find they were misbranded or misrepresented in any way.
"High-risk medical devices should go through randomized clinical trials done in people so we can assure patients they are safe and effective," Redberg said. "Even the more stringent pre-market approval (PMA) process doesn't always mean that you actually have gone through randomized clinical trials, so we have to make sure these devices not only go through pre-market approval but randomized clinical trials as well."
Questions to Ask
For patients who are in the process of undergoing a medical procedure, Redberg suggests they stay informed and ask many questions.
"Just like for any kind of procedure, I would ask, 'Are there scientific data that show this procedure or device is going to help me?'" Redberg said. "'Has it been studied in clinical trials? Has it been studi
|Contact: Leland Kim|
University of California - San Francisco