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FDA's recent order, communication on hip implants: Part II

Please see our immediately preceding products liability blog post of this past Tuesday for relevant background information regarding the FDA's recent issuance of a proposed order aimed at manufacturers of metal-on-metal (MOM) hip implants. The instant post serves as a tandem communication on that subject and provides readers with additional information on the order and the history leading up to it.

For starters, that history is replete with stark evidence concerning design defects in the product offerings of various medical device makers that have led to adverse personal injury outcomes in many consumers across the country, including in New Jersey.

Metal-on-metal hip implants have in fact been at the center of two large and significant product recalls within just the past several years. One of those involved the 2008 recall of medical device maker Zimmer's Durom Acetabular Component. The other and more widely reported recall related to Johnson & Johnson's DePuy ASR implant. We have touched on that latter recall and the onslaught of lawsuits brought by plaintiffs in both federal and state courts for injuries they sustained from the DePuy implant in several blog articles, most recently in our post dated August 22, 2012.

Under the FDA's proposed order calling for MOM implant makers to submit a premarket approval application, the manufacturers must use "valid scientific evidence to demonstrate reasonable assurance of the safety and effectiveness" of their products. The agency noted that, while all hip implants have risks, MOM implants have "unique risks" caused by metal particles wearing off the device and metal ions being released into users' bloodstreams.

In a "Safety Communication" posted the same day as the FDA's proposed order, the agency made specific recommendations to orthopedic surgeons and also urged them to fully inform their patients about MOM implant risks.

Please contact Breslin & Breslin for a free consultation regarding any questions or concerns you or a family member has regarding a metal-on-metal hip implant.

Source: MedPage Today, "FDA clamps down on metal-on-metal hips," Joyce Frieden, Jan. 17, 2013

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