The Consumers Union is urging the U.S. Food and Drug Administration to adopt a proposed rule that would mandate a premarket approval process (PMA) for metal-on-metal hip implants so that the devices’ safety and efficacy may be determined before their release to the market.
In a comment letter it sent to the FDA and that was signed by more than 11,000 consumers, the Consumers Union asks the federal regulator to re-classify all high-risk implantable medical devices under the PMA process. The movies meant to ensure clinical evidence will be required to show devices’ efficacy and safety prior to release.
“Thousands of patients have been seriously injured by faulty metal-on-metal hip implants and other medical devices that were never properly tested before being cleared for sale,” the letter, signed by Lisa McGiffert, Director of Consumers Union’s Safe Patient Project (www.safePatientProject.org), said, in part. “It’s time to stop experimenting on patients and require more rigorous safety testing of all high risk implants to prevent flawed medical devices from reaching the market.”
As we’ve written, Congress gave the FDA authority over medical devices in 1976 and allowed it a quick review process for new devices it deemed were substantially equivalent to already approved medical devices. The expedited process became known as a 510(k) review. In 1976, medical devices played a much smaller role in medicine.
In recent years, the 510(k) process has been criticized because the complexity of the thousands of devices on the current market have rendered the expedited process inadequate. In stark contrast to the more intense process for drug approvals, the FDA only mandates that medical device makers simply demonstrate that a device does what the maker says it does, and that the device poses no undue safety risks. Unlike a new drug, a device approved under the 501(k) rules does not have to be shown to be effective.
The 510(k) process is the most common review path to market for lower-risk medical devices; to be legally marketed, a device maker need only submit a premarket notification or 510(k) demonstrating that the new or modified product is substantially equivalent to another legally marketed medical device. But, manufacturers often make changes or modifications to a device after FDA clearance; for instance, incorporating new technology or upgrading certain device aspects. Many changes do not require a 510(k) submission. But, when the changes could significantly affect the product’s safety or efficacy, or constitute a major change to the intended use of the device, another 510(k) must be submitted.
Metal-on-Metal (MoM) hip devices are among some of the more controversial devices approved under the 510(k) process. In fact, the letter stated, “We also strongly support the proposal’s requirement for makers of hip implants in this category that are already on the market to provide critical safety information to the agency within 90 days. However, it is troublesome that MoM hips can continue to be commercially distributed up to 90 days after the FDA order.”
DePuy’s Pinnacle and ASR metal hips and other metal-on-metal hip implants have not only been the subject of thousands of lawsuits, but have also raised safety concerns due to reports suggesting that such devices have a tendency to fail early in the post-operative period.