FDA Initiates Probe into Possible Hip Replacement Metal Poisoning
Last Updated on June 27, 2017
The Food and Drug Administration (FDA) has continued to express worries about the negative effects of metal-on-metal hip replacement, recently ordering twenty-one hip manufacturers to conduct further studies into possible metal poisoning of patients. On May 6, the FDA sent letters to Johnson & Johnson (J&J) and other prosthesis producers to research whether their products are shedding metallic debris to such a degree that they could lead to metal poisoning.
A small number of patients in which high levels of metal ions in the bloodstream may have caused other types of symptoms or illnesses elsewhere in the body.
According to the New York Times, the companies contacted will have thirty days to submit proposals for post-market studies of hip implants. These studies will have to include blood tests to determine the level of metal ions that have made their way into the bloodstream. The FDA cites medical reports of "a small number of patients in which high levels of metal ions in the bloodstream may have caused other types of symptoms or illnesses elsewhere in the body, including effects on the heart, nervous system, and thyroid gland." High levels of cobalt and chromium have been found in the blood of some patients who experienced failed hip replacement.
Metal-on-metal hip replacements have been the subject of intense scrutiny since reports by studies and orthopedists have claimed an extremely high failure rate of artificial hips. This probe comes less than a year after DePuy Orthopaedics (a subsidiary of J&J) issued a DePuy hip recall of a replacement which had been implanted in 93,000 patients around the world. The failures of the DePuy ASR hip replacements have already accounted for over one thousand lawsuits, and the possibility of metal poisoning will most likely spark a new series of lawsuits. If you or a family member has had negative side effects believed to be caused by metal-on-metal hip replacement, contact our experienced hip implant attorneys to pursue compensation for replacement, medical bills, lost wages, and pain and suffering.
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