FDA: 36 Dead From Breast Implant-Associated Lymphoma Since 2019, Hundreds Sickened
Agency also verifies Breast-Q module as a tool to help assess women's satisfaction with implanted devices
The US FDA reports the numbers on women globally who've died or been sickened by two types of breast implant illnesses.
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Allergan PLC announced that it would take its Biocell textured breast implants and tissue expanders off the market worldwide shortly after the US FDA released additional information linking the use of the implants to a rare cancer.
'Do Your Job': To The Dismay Of Patients, FDA Panelists On Breast Implants Advise Better Risk Warnings, Not Recalls
Despite pleas from breast implant patients at a March 25-26 US FDA advisory committee meeting for the agency to take off the market silicone and saline breast implants that have initiated a serious range of symptoms in some women, the panel instead recommended FDA get out stronger public advisories warning of the risks of breast implants and a lymphoma associated with the products.
US FDA is now aware of 414 cases of breast implant-associated anaplastic large cell lymphoma. The agency says that updated medical literature estimates of the lifetime risk of textured breast implanted patients developing BIA-ALCL range between 1 in 3,817 to 1 in 30,000.