Loophole Allows Faulty Medical Devices To Be Sold With FDA Approval
Bloomberg reports that House Democrats are working to pass legislation that would close FDA 510(k) loopholes and protect patients from fast-tracked faulty medical devices such as DePuy metal-on-metal hip implants and transvaginal mesh implants. The 510(k) device approval process allows the FDA to approve new medical devices for market without clinical trial data if they are deemed substantially similar to previously approved products.
Currently, the FDA has the authority to disallow a device from entering the market only if “the older device has been ordered off the market by the agency or a court order.” Most companies voluntarily recall defective devices before they are ordered off the market by the FDA. As a result, even if the earlier version of the same implant, defibrillator, or other medical device is found to be defective, a new variation can be brought to market with the FDA’s approval despite the new device suffering from the same design flaw as its predecessor.
For example, the FDA “approved vaginal mesh implants even though some traced their designs to a product recalled by Boston Scientific Corp.” The new bill would give the FDA the power to “reject devices that have designs based on past products that were recalled for safety flaws.”
Jeffrey Shuren, director of the FDA’s Center for Devices and Radiological Health, summarized the current approval process to Bloomberg: “‘The challenge now is if there’s a problem, it can get replicated’ through future generations of devices.” Bloomberg reports that the FDA clears an average of 28 devices annually that “cite a predicate known to be recalled.”
Learn more about faulty medical devices and the legal rights of the injured.