The FDA has increased its oversight regarding the Metal-on-Metal hip implant device industry this week. The FDA decided recently to require companies to submit a premarket approval (PMA) application for two types of metal-on-metal hip replacement devices. These include devices with a cemented acetabular component and ones with an uncemented acetabular component. The FDA’s statement notes that applications should include “any risks known, or that should be reasonably known” and that “full reports of all nonclinical and clinical information from investigations on the safety and effectiveness of the device.” Several metal-on-metal hip implant makers have been under scrutiny over the last several years when their devices were found to cause serious medical injuries and lead to device failure. Defective devices manufactured by Biomet, Stryker, DePuy, Johnson & Johnson, Wright and Zimmer have been linked to documented medical injuries.
To read the entire statement from the FDA, please visit here.
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