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FDA Reports16,800 Metal On Metal Hip Implant Adverse Events | The Legal Examiner Phoenix.

FDA Reports16,800 Metal On Metal Hip Implant Adverse Events

Jackie Fedeli Contributor  (215) 985-0300; Posted by Jackie Fedeli June 25, 2012 9:00 AM

One June 27th and 28th, the FDA is planning an Assembly to examine the safety of metal on metal hip implants. Last year, the FDA ordered all manufacturers of metal on metal hip replacement systems conduct their own post market surveillance and report on the successes and failures of their products. This order came in response to the growing concern of the safety of these products following several warnings and recalls due to reports of high early failure rates and a link to metal poisoning.

Metal on Metal Hip Implants didn’t really take off in popularity until 2006. Once these products reached the early and late majority, we started to see problems. In 2008, Zimmer Inc. recalled their Zimmer Durom Cup Hip Socket Implant. Two years later in 2010, Johnson & Johnson recalled from their DePuy Orthopedics division, the DePuy ASR Total Hip Replacement. Globally, J & J recalled 93,000 ASR hips. 37,000 of those were in the United States due a high early failure rate. More than 12% of the devices needed to be replaced within five years. Revision surgeries for Metal on metal Hip Implants totaled 14,131.

In total, 16,800 adverse event reports have been filed for various metal on metal hip implant system. These reports are resulting in a growing amount of lawsuits from individuals clamming the manufacturers are negligent for these faulty devices. Johnson and Johnson faces 6,000 lawsuits alone for their faulty hip implants. Recipients of recalled Zimmer, and the Biomet M2A Magnum Hip Implant are also seeking justice.

At first, many of the device manufacturers blamed the surgeons, saying that the doctors failed to implant the device properly, and that their in house doctors had no trouble implanting the device properly. Surgeons and consumer advocates pointed out that it was the manufacturers doctors that designed these devices and the statistics were flawed in favor of the manufacturer. The disagreement between doctors and surgeons did not end with that. Med Page Today recently reported that Physicians believe the Post Market Studies will also be flawed. The FDA gave little specifics on reporting, leaving the possibility of inconsistencies from one manufacturer to another. For example, there was no specific qualification for measuring chromium and cobalt ions in the blood. This will leave the interpretation up to each individual device manufacturer, and we may not get an accurate look at metal on metal hip implant devices as a whole.

Also, it may be impossible to determine whether or not they have an early failure rate. The lifetime of the device is supposed to be roughly 15 years. The FDA can only order a Post Market Study for 3 years. A device that lasts 5 years, and in ineffective, will get by as being effective, if it makes it past the 3 year mark.

The timeframe of the study may also contribute to its ineffectiveness. The FDA is only able to require the study for 3 years. The devices in question are supposed to last 15 years. If we cannot measure

Perhaps the FDA’s upcoming meeting will be a good chance to reevaluate the parameters of the study and the overall safety of metal on metal orthopedic devices.