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Hip Replacement Complaints Soar As FDA Scrambles

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The Food and Drug Administration (FDA) has received more complaints about all-metal hip replacement devices in the past six months, than in the past four years combined, the New York Times reported.

The majority of complaints are from patients who have had a metal-on-metal hip replacement device removed, or will soon undergo surgery to have the device removed. Though the devices were marketed as lasting 15 years or more, many are failing within a few years of implant.

The Johnson & Johnson A.S.R. devices are garnering the most complaints, and were recalled last year. The most serious complaints include blood poisoning from the metal shedding tiny particles of cobalt and chromium.

The FDA has requested studies regarding how quickly the devices are failing, and all associated health risks from the manufacturers, however, the device makers are having difficulty recruiting the number of patients needed to perform sound studies.

Because complaints made to the FDA are not uniform, as manufacturers must file reports, doctors and patients are not required to do so, it is very difficult to get a firm handle on the cause of the problems.

Meanwhile, lawsuits regarding the nearly all metal-on-metal hip replacement devices are mounting, and doctors are steadily choosing to use alternative devices, like metal and plastic combination devices, for their patients.
 disclaimer: This article: Hip Replacement Complaints Soar As FDA Scrambles was posted on Wednesday, August 24th, 2011 at 7:44 pm at and is filed under Medical Device Lawsuits.

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