After the U.S. Food and Drug Administration (FDA) requested that Allergan remove certain models of its textured breast implants from the U.S. market, the company initiated a worldwide recall of its BIOCELL textured breast implants and tissue expanders. Earlier this year, the FDA said the evidence did not warrant banning the implants, but after … [Read more...]
FDA Finally Ends Practice of “Alternative Summary Reporting”
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...]
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...]
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