In April 2019 the FDA warned women and physicians about the link between textured breast implants and anaplastic large cell lymphoma (BIA ALCL). Since that time, France and Canada have banned the sale and use of these types of implants. Now, Australia may be following suit. The Therapeutic Goods Administration recommends cancelling, suspending and recalling some textured implants citing evidence of this correlation. Specifically, all of the 107 women diagnosed with BIA ALCL had textured breast implants. Five of these women died from the disease. BIA ALCL develops anywhere from three to 14 years post-surgery and it is not detectable via mammogram.More>>
For decades the FDA allowed medical device manufacturers to file “adverse event” reports of defective and harmful medical devices in a database that is only accessible by FDA employees. Adverse events reports contain information on device complications and malfunctions resulting in patient injury, pain and suffering and death. Since 1997 this database, called the Alternative Summary Reporting (ASR) program, effectively hid this critical data pertaining to the safety and efficacy of hundreds of implanted devices from patients and physicians. Until June 21, 2019, thirteen manufacturers were permitted to file ASR reports.More>>
Johnson & Johnson group settlement won't pay for $millions in medical bills owed by Juliana LaDue to treat cardiomyopathy from metal poisoning. Juliana's Pinnacle metal-on-metal hip replacement sickened her with chromium and cobalt levels nearly one hundred times the standard range, ultimately leading to congestive heart failure.More>>
Sales of the Pinnacle Hip Replacement System, manufactured by DePuy, a medical device divison of Johnson & Johnson, were halted in 2013 but that was too late for many recipients who needed revision surgery. Larger settement amounts will be awarded to those with more serious injuries and illnesses caused by this metal-on-metal hip implant. These include hip pain, hip replacement failure, infection, tissue necrosis and metallosis.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