WASHINGTON, 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.
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.
"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."
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.
This order will finally require manufacturers to demonstrate clinical testing for safety and effectiveness before approval of new metal on metal hips. But at this time we are skeptical that any metal on metal hip implant could be safe for patients. Because of that, we urge the FDA to push all manufacturers of metal-on-metal hips to remove their products from the market, because of the high failure rates and high numbers of adverse events, especially experienced by women.
While the FDA has issued an alert about possible adverse events to the public, this does not guarantee that all affected patients have been given advice on monitoring their metal hips for problems. As was done in the UK, all patients with these implants should be notified about their risks and advised to get yearly tests for cobalt poisoning. Unless the FDA confirms that each manufacturer has done due diligence to notify every patient with these MoM hips, the problem has not been properly addressed.
The New York Times recently reported that a MoM hip sold by Johnson and Johnson had a 40% failure rate but the company continued to sell the remainder of their inventory, despite the knowledge of the failure rate. This kind of irresponsible behavior must stop. Requiring a more thorough review up front, as the current order proposes, will help to keep flawed devices from the market.
In addition, we strongly encourage the FDA to review and re-classify to PMA status all Class III implantable medical devices. Other high risk implanted medical devices like surgical mesh should also be put into the PMA approval track, requiring more clinical information. Patients suffering from harm due to surgical mesh implants have reported debilitating side effects from punctured organs to autoimmune disorders. Many have undergone multiple surgeries to remove the mesh, which has broken apart and traveled to other parts of the body.
Please move quickly to bring metal on metal hips and all other high risk implants under the PMA process so clinical evidence will be required to show their effectiveness and safety.
Consumers Union Safe Patient Project
506 West 14th Street Suite A
Austin TX 78701
|SOURCE Consumers Union|
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