The US Food and Drug Administration designates preamandment device like metal-on-metal hip systems, as a Class III or higher risk devices. The FDA was given a premarket authority on 1976, devices released prior to that year were considered preamendment device. The device was regulated under the 510 (k) premarket notification program of the FDA. However, study shows that metal-on-metal hip implants present some complications and many recipients of the device have experienced major problems and have taken legal actions. Based on the article published on New York Times, the metal-on-metal device complaints have surged this year, greater than the combined numbers of the past four years.
The 510(k) approval process of the FDA was questioned by the Institute of Medicine, saying that the process does not provide “a reliable and premarket screen of the safety and effectiveness” of devices submitted for approval. In response to the report, FDA acknowledged the agency’s need to be “open to additional proposals and approaches for continued improvement of our device review programs.”
In April 2010, the United Kingdom’s Medicines and Healthcare products Regulatory Agency issued a medical device alert that included specific follow-up recommendations for patients implanted with MoM hip implants. Blood tests and imaging for patients experiencing pain are included in the recommendations. August of the same year, a voluntary recall was initiated by the DePuy ASR on their total hip system. The DePuy ASR hips revision rates within 5 years were about 13 percent, according to the new, unpublished data of the UK joint ministry.
The safety and effectiveness of metal-on-metal hip implants is further evaluated by the FDA by looking and assessing at different areas. Manufacturers of the hip systems were asked to submit device retrieval analyses to the agency. FDA constantly appraises Medical Device Reports, post-approval study reports, data from several orthopedic device registries and published literature. With this strategy, they can have a clearer view and understanding of the association between metal debris and MoM hip systems.
Asymptomatic recipients of the metal implant are not obliged to submit themselves for blood tests and special imaging. The FDA recommends that asymptomatic patients continue to follow-up with their orthopedic surgeon as prescribed. Patients who are slowly developing symptoms of complication are advised to seek early help from orthopedic surgeon for major complications like DePuy hip recall to be prevented.