The Food and Drug Administration (FDA) has told hip implant manufacturers that they have to prove their products are safe if they want to continue to market them. This regulatory change comes after numerous studies showed that metal-on-metal hip implants have high failure rates and can lead to serious injuries.
Approximately 500,000 people in the United States have received all-metal artificial hips. Though designed to be more durable than their plastic and metal counterparts, they tend to fail early and more often. As a result, thousands of patients have required painful correction surgery and in some instances, metallic debris from the implants led to severe tissue and bone damage from metal poisoning called metallosis.
Previously, hip implant manufacturers were only required to show that their product was similar to one already on the market and did not have to conduct clinical studies before selling them. Under the FDA's new guidelines, manufacturers must now file a "premarket approval application (PMA)" that includes valid scientific evidence demonstrating the safety and effectiveness of their product.
Additionally, the agency urged healthcare providers to be aware of metal poisoning in patients who have received metal-on-metal hip implants. Symptoms include: skin rash, cardiomyopathy (heart disease), neurological changes like auditory or visual impairments, psychological changes including depression, renal function impairment, and thyroid dysfunction.
Experts believe that it will take a year for the new rules to be finalized. Manufacturers will then have 90 days to submit their data.
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