On January 17, 2013, the U.S. Food and Drug Administration (FDA) announced that it is requiring pre-market approval for all metal-on-metal hip implants, including the submission of clinical data that demonstrates the safety and effectiveness of their products.
This new proposal would require manufacturers of two categories of existing metal-on-metal products to submit new marketing applications, in order for their devices to remain on the market. It also proposes that future metal-on-metal hip devices would also have to go through the PMA route. The manufacturers could either submit the pre-market approval application or complete a product development protocol for FDA review.
The proposal was released in conjunction with a FDA safety communication to all orthopedic surgeons, recommending that they conduct metal ion testing and imaging examinations for metal-on-metal hip patients who show adverse symptoms.
Medical devices were first regulated under federal law known as the Medical Device Amendments of 1976, under which manufacturers were not required to conduct clinical studies prior to selling their devices. They only needed to demonstrate that the pre-market devices resembled implants that were already on the market. Last year Congress granted new powers to the FDA, in order to deal with legacy medical device technology. The FDA issued this new pre-market approval, requiring metal-on-metal (MoM) hip arthroplasty implant manufacturers to submit pre-market approval applications, as their first course of action since receiving their new power last year from Congress.
There is so much evidence demonstrating the premature failure of MoM systems, resulting in severe tissue and bone damage due to tiny particles of metallic ions (debris) released into the body during artificial joint movement.
An internal analysis conducted by Johnson & Johnson in 2011 not long after it recalled a troubled hip implant estimated that the all-metal device would fail within five years in nearly 40 percent of patients who received it, newly disclosed court records show.
In 2011, the FDA ordered manufacturers of all metal-on-metal hip implants to conduct post-marketing studies to determine whether the MoM implants were depositing high levels of metallic debris due to the components grinding together.
In 2012, a panel reviewed the safety and efficacy data.
Metal-on-metal implant devices have been the subject of international scrutiny because of the large number of patients experiencing adverse events, requiring revision surgeries, as compared to non-metal-on-metal hip implants.
The FDA plans to provide guidance to orthopedic physicians and surgeons monitoring patients who have received all-metal hips and for the very first time, the regulatory agency will recommend that patients who are experiencing pain or adverse symptoms possibly indicating failure of the device, undergo routine testing to detect the levels of metallic ions in their blood.
Hopefully with the FDA’s new proposal requirements, the public will be protected and medical manufacturers will have to conduct clinical studies before being allowed to sell their devices in the U.S. Most people assume the devices their surgeons implant in their bodies have undergone rigorous testing and are safe.