Friday, January 18, 2013

FDA order would tighten metal hip implant rules.

The Wall Street Journal (1/18, B3, Burton, Subscription Publication, 2.29M) reports that the Food and Drug Administration released a proposed order Thursday to bar medical device manufacturers from selling metal-on-metal artificial hip joints until they are able to provide data to substantiate the safety of the products. Under the proposed rules, companies seeking approval to market any new metal-on-metal hip products would also be required conduct human clinical trials to test the safety and efficacy of the devices.

        Reuters (1/18, Dey) reports that the FDA said it is proposing the stronger regulation because metal-on-metal hip implants are more likely to cause tissue damage and other complications than standard implants, which combine either a ceramic or a metal ball with a plastic socket.

        Bloomberg News (1/18, Edney) adds that the agency said that although it "doesn't have enough data to specify the amount of metal ions present in blood that would produce an adverse effect," consumers who "think their hip isn't functioning properly should be considered for metal ion testing. Adverse events related to the ion levels include skin rash, visual impairments, depression, kidney impairment and thyroid dysfunction."

        According to Modern Healthcare (1/18, Lee, Subscription Publication, 71K), the FDA last year "requested post-market studies of metal-on-metal implants from 21 device manufacturers." Additionally, a series of metal-on-metal hip implant recalls "led to broader questions about why implantable devices have been approved under the expedited 510(K) pathway rather than the more rigorous premarket approval process," which requires manufacturers to submit clinical trial data. Such concerns prompted Federal legislators to "include a provision in last year's user-fee agreement legislation that allows the FDA to reclassify devices by order rather than by regulation."

        CQ (1/18, Adams, Subscription Publication) notes that the "public has 90 days to comment" on the FDA proposal. After the "order is official, the companies will have 90 days to submit scientific data to the agency." CQ adds that the agency also released a safety notice Thursday, "offering new treatment advice to physicians with patients who have all-metal hip implants."

        Medscape (1/18, Lowes) says the draft order the agency released was based primarily on an FDA assessment, which "includes the evaluation of published studies and the findings of an FDA Orthopedic and Rehabilitation Advisory Panel meeting in June 2012." MedPage Today (1/18, Frieden) adds that, for the assessment, the FDA reviewed "more than 100 studies of metal-on-metal hip implants."

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