The Food and Drug Administration, or FDA, reported nearly 2,500 medical devices were implanted in 2008. Of these 2,500 devices, currently only 14 devices are required to have a comprehensive tracking system in place.
Without a proper tracking system medical recalls can be ineffective. Several patients who have the devices in place may not be aware of any recalls affecting them. These patients may experience life threatening injuries by not having the implant devices removed. Some doctors may also continue to use recalled devices.
In 2006, the company Hem-o-lok, who makes surgical clips, issued a recall notice. According to Hem-o-lok their clips could dislodge in the patients body and cause serious, even life-threatening consequences. Two years later a surgeon completed a kidney transplant from Michael King to King’s wife. The surgeon used a Hem-O-Lock clip to block off Michael King’s renal artery. The clip became dislodged and King bled to death.
The Fadem's foundation has been lobbying to have a more centralized tracking system put in to place for medical implant devices. The health care reform being considered by congress also includes a detailed plan for the United States to have its first tracking system in place for artificial limbs and implant devices.
However, for now the only devices required by the FDA to have a tracking system include pacemakers, mechanical heart valves and breast implants; leaving thousands of devices unmonitored.
If you have an artificial limb or medical device implanted you may run the potential of life threatening injuries, or even death, if that device was to malfunction. Relying on mailed letters and postings on medical company websites does not always get the information out to everyone who needs it. Take special care to monitor the device on your own; do not disregard any mail from the maker, watch special news bulletins and check the company’s website frequently.
If you or someone you know has already been injured or even killed from a medical implant device a personal injury attorney may be able to assist you. Medical recalls and health care information can be difficult to understand. A licensed attorney will be able to help you sort through all of your information and get you the compensation you deserve.
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