Changes Needed - FDA Looks into Metal Hip Implants Testing | The ...

Posted by Michael MonheitJuly 24, 2012 11:41 AM

The Food and Drug Administration will be focusing scrutiny on the safety and efficacy of metal-on-metal hip replacement implants in response to increased international concern over the higher than normal incidence of complications, including the need for removal of the all metal devices. The devices in question have been implicated in over 16,800 adverse events since their introduction in 2000, after coasting through the FDA?s questionable 510k ?fast track? approval process, which allows manufacturers to skip normal testing protocols if a new device is similar to others already in use. This is the same approval process that allowed the introduction of the Gynecare Prolift vaginal mesh systems that are also currently being studied for their serious complications and side effects.

Medical manufacturers, such as Johnson & Johnson and Zimmer Holding, Inc., introduced metal-on-metal implant implants as a more reliable and long-lasting alternative to traditional polyethylene plastic or ceramic and metal combination devices. Between the years 2006 and 2007, metal-on-metal implants were used in 30% of all hip replacement procedures, but that number has fallen to approximately 10% in the years since. The decrease comes as a result of registries in both the United States and abroad reporting higher incidences of complications with the all metal implants, which have a revision (replacement) rate of six percent, three times higher than the replacement rate for the older ceramic or plastic devices. Additionally, authorities in Great Britain are now recommending that patients with all metal implants undergo annual blood screenings to insure that metal ions produced by friction between device components is not leaking into surrounding tissues.

This is frightening news for the approximately 500,000 people currently living with the metal-on-metal devices, and has prompted product recalls from companies like Johnson & Johnson, which recalled its ASR hip replacement system in 2010, and has allotted $3 billion to cover potential lawsuits related to its use.

The FDA?s advisory panel, which convened in late June, will provide recommendations on the continued use of metal-on-metal implants. Even if the panel recommends discontinuation, it is unlikely to cause a disruption of hip replacement procedures, as the earlier ceramic or plastic and metal combination devices still offer a safer and more reliable alternative.

Source: http://central-pennsylvania.legalexaminer.com/medical-devices-and-implants/changes-needed-fda-looks-into-metal-hip-implants-testing.aspx?googleid=303070

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