A new bi-partisan bill introduced by Texas Republican Lloyd Doggett in May, 2019 aims ensure that doctors file adverse event reports of defective medical devices. The Medical Device Guardians Act (H.R. 2915), will require physicians to file an adverse event report with the FDA if they encounter a patient who has complications from a medical device implant. Lawmakers are hopeful the new legislation will increase the transparency of medical device dangers so patients can make more informed decisions on whether a medical device implant is worth the risk.
Is the FDA is nothing more than an industry puppet, with medical device manufacturers pulling all of the strings? Likely spurred by increasing public scrutiny, the FDA recently publicized more than 6 million medical device incident reports hidden from the public by device makers over the past two decades through a process known as “alternative summary reporting.” After much public and media scrutiny, this so-called reporting mechanism is finally being phased out.
The U.S. Food and Drug Administration (FDA) announced on April 30, 2019 that they will not ban textured breast implants. This type of implant has been definitively linked to a type of lymphoma called BIA-ALCL. They have been banned in 38 countries including all of Europe plus Canada. Australia will most likely follow suit in short order. 732 cases of BIA-ALCL and 21 deaths have been confirmed worldwide. So, what gives?
Although metal-on-metal hip replacements are no longer for sale in the U.S., they continue to cause patient injury and illness. Hip replacement systems manufactured using metal-on-metal fabrication can cause metallosis as well as fail prematurely, requiring revision surgery. This article identifies the device manufacturers at fault and provides information on what to do if you think you are a victim.
If your doctor has recommended a a hip or knee replacement, he or she may unknowingly be causing more harm than good. Each year, millions of patients are outfitted with a medical device implant such as surgical mesh for prolapse, metal and plastic ball and socket joints for hip replacements, IVC filters for those at risk of clotting, the list goes on. Unfortunately, for many patients implanted with a medical device, the results are far from what they expected. Unlike the pills you get from your pharmacist, most medical devices do not have to undergo clinical testing on humans before being offered to patients.
The U.S. Food and Drug Administration has released over 20 years of reports, called "adverse events reports, which documented harmful incidents caused by defective medical devices. Too little and too late, this "program", which allowed some major medical device manufacturers to keep safety issues hidden from patients and doctors, has now been stopped.
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 Wilentz, Goldman & Spitzer, P.A. 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