FDA to Issue New Metal Hip Implant Regulations

According to an article in the New York Times, the United States Food and Drug Administration is planning to launch new metal hip implant regulations. Due to a large number of metal-on-metal hip implant recalls in the past few years, the FDA will place the devices in a higher-risk category that will require a more rigorous FDA review prior to approval.
Under the proposed guidelines, the agency will require all metal-on-metal hip implant manufacturers to prove that the devices are effective and safe prior to market entry. This ruling applies to devices under development and devices currently on the market.
Under current guidelines, manufacturers don’t have to conduct clinical studies if their devices are similar to other products on the market. The new initiative by the FDA is designed to close a loophole in 30-year-old federal law under which healthcare devices are regulated.
Many traditional hip replacements are made from a combination of plastic and metal; these devices usually last for at least 15 years. However, all-metal hips, devices that have received little clinical testing, are failing at a very high rate within a few years of implantation.
Patients with these faulty metal hip implants must undergo expensive and painful operations for replacement. In addition, the shearing force between all-metal components has lead to the dispersion of microscopic metal fragments through a patient’s body. This has caused extensive damage to joints and tissue.
Impacted companies include Johnson & Johnson, Smith & Nephew, Biomet and several others.