April 18, 2013
/PRNewswire-USNewswire/ -- Consumers Union urged the U.S. Food and Drug Administration today 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.
to the FDA signed by more than 11,000 consumers, Consumers Union called on the agency to re-classify
high risk implantable medical devices under the PMA process so clinical evidence will be required to show their effectiveness and safety before the devices can be sold.
"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," said
, Director of Consumers Union's Safe Patient Project (
). "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."
A copy of Consumers Union's letter to the FDA follows:
April 18, 2013
Food and Drug Administration Docket No. FDA-2011-N-0661
To Whom It May Concern:
Consumers Union and the more than 11,000 people signing this letter due to their concern about high-risk implants are in full support of the FDA proposal (Docket No. FDA-2011-N-0661) to require all metal on metal (MoM) hips to be reviewed through the agency's premarket approval (PMA) process. It is too late for thousands of people who have been harmed by these implants that were cleared for market through a loophole in the law that allowed them to be sold without thorough review by the FDA to assure safety, even though they were classified as "high risk."
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.