You’re not alone if you’ve never heard of “Alternative Summary Reporting.” It’s been around for decades, and the FDA has decided to finally end what many considered to be a reckless, even dangerous practice that has allowed medical device manufacturers to hide malfunctions of their devices from the public. The FDA has specific requirements for … [Read more...]
3M Earplug Lawsuits
If you served in the military between 2003 and 2015 and have suffered tinnitus and/or hearing loss after using dual-sided earplugs issued by the military, you may be able to recover substantial compensation for your injuries. Hundreds of lawsuits are now underway against 3M Company, the military contractor that supplied the defective earplugs. … [Read more...]
Textured Breast Implants and Immune System Cancer
Textured breast implants have been linked to an increased risk of developing a cancer of the immune system called breast implant associated anaplastic large cell lymphoma (BIA ALCL). Although it is a highly treatable form of lymphoma, it can be difficult to diagnose because it is a rare form of cancer with symptoms that mimic other breast problems. … [Read more...]
Cancer-stricken Women Demand FDA Ban Breast Implants that Made Them Ill
The FDA came under fire March 25 from women demanding that certain “cancer-causing breast implants” be banned. Breast implant-associated anaplastic large cell lymphoma, known as BIA-ALCL, was the topic at a two-day hearing where the women pressed an FDA advisory panel to recommend more long-term research, bans or restrictions on certain products, … [Read more...]
Cyberonics Vagus Nerve Stimulator Recalls
So far, there have been at least six recalls of model 106 generators used to power Cyberonics vagus nerve stimulator (VNS) therapy systems. The VNS therapy systems are implanted devices used to treat seizures and epilepsy. The U.S. Food and Drug Administration (FDA) has received more than 10,000 reports of injuries and death in people who have … [Read more...]
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