When the Food and Drug Administration announced last month that it couldn’t guarantee the long-term safety and efficacy of vaginal mesh products — medical devices that have been on the market for decades — the collective response from tens of thousands of women harmed by the products sounded something like this: Duh." The New York Times Editorial Board recommends three changes to the current FDA approval system for medical devices sold in the U.S.
Faced with the possibility that a bout of abnormal heartbeats could end his life, in 2006, Dr. Marc Sicklick had a small device implanted in his chest that would shock it back into rhythm. Soon he would struggle with another life-or-death choice: whether to remove the Sprint Fidelis, which was deemed dangerous and recalled in 2007 after it had been implanted in hundreds of thousands of patients.
Over 700,000 knee replacement surgeries are done each year in the U.S., giving many people a renewed ability to live life to the fullest. The overwhelming percentage of knee replacements is successful and patients can expect a lifespan of 15 years or more.
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Medical Device Watch is sponsored by Keefe Law Firm. The medical device approval process in the U.S. allows for the sale of some devices that have not been tested in clinical trials on humans. Our goal is to help people protect themselves from the physical, emotional and financial harm that can be caused by medical devices that are defective.LEARN MORE