DePuy Metal Hip Recall

Following widespread recalls on medical devices, including 90,000 metal-on-metal DePuy ASR hip implants in 2010, the FDA commissioned the Institute of Medicine to examine their process of medical device approval. On July 29, 2011, the Institute of Medicine issued a report that finds serious and fundamental problems in the current regulatory system.

As noted in the Baltimore Sun, the 510(k) process began in 1976, when the FDA was given responsibility for approving medical devices. Congress legislated that devises already on the market would continue to be sold without testing, and further specified in Section 510(k) of the bill that new moderate-risk devices, such as hip implants and heart monitors, could be approved if they were “substantially equivalent” to existing products. Through the 510(k) process, as the “substantially equivalent” approval standard came to be known, thousands of FDA-approved medical devices have been approved based on similarities to older devices.

The Institute of Medicine found that the 510(k) process is so broken that it needs to be eliminated, and “concludes that the FDA’s finite resources would be better invested in developing an integrated premarket and postmarket regulatory framework.”

The Institute of Medicine notes that “no premarket regulatory system…can guarantee that all new medical devices will be completely safe,” and that “robust postmarketing surveillance is essential.” Of postmarket regulation, the panel recommends the FDA should implement a “strategy to collect, analyze, and act on medical device aftermarket performance information,” and should use tools such as “seizing or banning a device, when necessary.”  The panel also found as a special need better oversight on devices with computer software — a category that reportedly includes about half of all new medical devices.

The 2010 recall of DePuy ASR hip implants illustrates the potential negative ramifications from the FDA’s 510(k) “substantially equivalent” standard for approving medical devices.  As explained in the The New England Journal of Medicine, the DePuy ASR had been approved by the FDA based on similarities to existing implants, even though the device made a significant change in material by using a metal alloy cup from a different hip device retrofitted to a standard hip implant. The metal-on-metal design was “touted as a major innovation,” but had never been tested.

The New England Journal of Medicine states, the DePuy ASR implant “failed at the astonishing rate of at least one in eight…Before it was recalled in 2010, the ASR had been implanted in nearly 100,000 patients, and the result was a public health nightmare.”

“The public thinks that if the FDA clears and ‘approves’ a device that safety and effectiveness has been considered. But that is not always the case,” stated David R. Challoner, a physician who headed the panel, in The Washington Post.

Learn more about the DePuy ASR hip recall and litigation.

Related posts:

1. Flaws of FDA Medical Device Approval Highlighted by DePuy Hip Recall
2. Study Faults Approval Process for Medical Devices
3. New England Journal of Medicine: “Astonishing” Failure Rate for DePuy ASR Hip Implants
4. GAO Adds to Concerns About Medical Device Approval Process
5. The DePuy Hip Recall Highlights The Need For A New Medical Device Safety System Reports The New York Times