Millions of Americans receive medical implants yearly and those who do presume that the implants are safe and will alleviate, or at least help to ease, their specific medical problem. However, according to a May 2012 article in Consumer Reports, “Dangerous Devices”, most implants (artificial joints, defibrillators, surgical mesh) have not been tested for safety and effectiveness. The “testing” is done on the patient who has the medical device implanted. In other words, patients are living with implants that often times give them more pain and suffering than not having had the implant at all. According to the article, the FDA is not testing medical devices and most times all that is needed for the device to be placed on the market is for the manufacturers to “. . . file some paperwork and pay the Food and Drug Administration a user fee of roughly $4,000 to start selling a product that can rack up millions of dollars in revenue. . . .” Frequently, it takes years before the FDA even tests a product or reclassifies it to a high-risk category.
It is crucial for doctors, as well as their patients, to research a medical implant thoroughly before implantation, as the consequences can be debilitating. An orthopedic surgeon, for example, who had an all-metal hip replacement (the same type of device he implanted in his patients) experienced medical issues of increased chromium and cobalt levels in blood, sleep disturbance, constant pain, mood swings and anxiety, hearing loss, tinnitus, and visual problems.
Meiselman, Denlea, Packman, Carton & Eberz P.C. offers legal advice to physicians on medical issues. If you need legal assistance or guidance on a matter regarding your practice, please call our office.
Source: http://www.pagingdrblog.com/2012/05/08/safety-of-medical-implants-questionable/
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