Consumers Union Urges FDA to Adopt Stricter Approval Process for Metal Hip ImplantsApr 23, 2013
Consumers Union yesterday released a letter that has been sent to the U.S. Food and Drug Administration (FDA) urging the agency to adopt a proposed rule requiring metal hip implants to be reviewed through the agency's premarket approval (PMA) process to prove that the devices are safe and effective.
The letter, signed by Lisa McGiffert, director of Consumers Union's Safe Patient Project, and more than 11,000 consumers called on the FDA to reclassify metal-on-metal hips and all high-risk implantable medical devices under the PMA process, which requires clinical evidence of effectiveness and safety before a device can be sold, the Wall Street Journal reports. Under current rules, medical device manufacturers can seek expedited approval under the FDA’s 510(k) process if the manufacturer can demonstrate the device’s similarity to a previously approved device.
“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,” McGiffert wrote. “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.” The full text of the letter appears in the Wall Street Journal and is also available at www.SafePatientProject.org.
The group expressed skepticism that any metal-on-metal hip implant “could be safe for patients” and urged that all such devices be removed from the market. Although the FDA has issued a safety alert to the public, the Safe Patient Project says that this is not enough, according to the Wall Street Journal. The group asks that patients with metal hips be individually notified of the risks and advised to get yearly tests for cobalt poisoning.
Surgical mesh is another implantable device that Consumers Union wants the FDA to reclassify. Patients with surgical mesh implants have reported “debilitating side effects from punctured organs to autoimmune disorders,” and many have needed multiple surgeries to remove the mesh, the letter said.