In lieu of the rising medical concerns relating to metal on metal hip replacement implants, the FDA has recently proposed an order that would require manufacturing companies to show these products are safe.

If metal hip implant makers want to continue to market these metal on metal hip replacement implants then the companies must demonstrate their medical devices are safe for human use.

This order comes as a response to a number of reported hip replacement problems in recent review as well as data from over 100 studies observing metal hip replacement problems.

In particular, the studies noticed that the problem of hip replacement metal poisoning was a common problem, and that hip implant complications occurred in women and patients who received larger sized metal on metal hip replacement implants.

The FDA explained that when the different components of the metal on metal hip replacement implants interact, metal ions are released into the bloodstream leading to further hip replacement problems.

The metal ions can damage the bone or soft tissue surrounding the implant, leading to intense pain and often a need for revision surgery. The FDA further stated that there is no diagnostic method currently available to determine the level of hip replacement poisoning for patients to experience side effects.

Overview of Hip Replacement Metal Poisoning

A recent meeting of the FDA’s Orthopedic Surgery and Rehabilitation Devices Advisory Committee prompted the order after a number of panel members stated they were not comfortable making recommendations based on the current data available.

In the proposed order, the FDA wants “to require the filing of a premarket approval application (PMA) or a notice of completion of a product development protocol (PDP)” for metal on metal hip replacement implants.

Previously, manufacturing companies were allowed to market these metal on metal hip replacement implants without needing premarket approval, which requires data of the safety and efficiency of the product.

Furthermore, the agency is requiring manufacturing companies submitting a premarket approval application to “include valid scientific evidence to demonstrate reasonable assurance of the safety and effectiveness of the device for its intended use.” These companies may also be able to the change the classification of the devices, based on new information.

In May 2011, the agency ordered post market surveillance research from all metal on metal hip replacement implant manufacturers, but the studies have been slow and may not be able to provide sufficient information anyways.

As for the current proposed order, the FDA will be accepting comments regarding the proposal for three months after it is published in the Federal Register. When the final order is published, manufacturers will have 90 days to file a premarket approval application or product development protocol application.

Metal on metal hip replacement implants have been subject to a number of recalls and product liability lawsuits from patients who have already been injured by these metal on metal hip replacement implants.

Potential claimants should contact a specialized lawyer to determine if they have a metal on metal hip replacement implant lawsuit.