Consumer protection activist organisation, Consumers Union has urged the U.S. FDA 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.
Consumers Union is described as the policy and action end of the organisation known as Consumer Reports, Within Consumers Union there exists a specific group which is focused on patient safety. It is this group that is strongly encouraging the FDA to formally adopt its own proposal that would require all metal on metal (MoM) hips to be reviewed through the agency’s premarket approval (PMA) process.
In a comment letter to the FDA signed by more than 11,000 consumers, Consumers Union called on the agency to re-classify all 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. The letter can be found here.
Consumers Union Comments
“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 Lisa McGiffert, Director of Consumers Union’s Safe Patient Project (www.safePatientProject.org). “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.”
Source: Consumers Union