Breast implant-associated anaplastic large cell lymphoma (BIA-ALCL) is a rare cancer of the immune system. BIA-ALCL has been closely linked with textured surface breast implants. What Causes BIA-ALCL? While BIA-ALCL is rare, it is very serious and potentially fatal if not treated properly. According to this December 2020 article, "Etiology of … [Read more...]
Black Box Warning Label Change for Breast Implants Finalized by the FDA
Since our previous article, “New BIA-ALCL Cases Identified in Updated FDA Report“, the FDA has finalized labeling guidance for breast implant manufacturers. The FDA label change is now requiring a black box label warning for the breast implant devices. In recent years, many textured breast implants have been linked to BIA-ALCL (breast … [Read more...]
New BIA-ALCL Cases Identified in Updated FDA Report
Since our previous article, "Most American Women Are Unaware of BIA-ALCL", the FDA has released an update on reports of breast implant-associated anaplastic large cell lymphoma (BIA-ALCL). The update includes new BIA-ALCL case reports through January 5, 2020. What's New in BIA-ALCL Cases? Currently, the FDA analysis of global medical device … [Read more...]
Most American Women Are Unaware of BIA-ALCL
Since our previous article, Allergan Aesthetics Launches Tracking Campaign for U.S. Breast Implant Patients, recent news articles report the majority of American women are unaware of breast implant-associated anaplastic large cell lymphoma (BIA-ALCL). Studies on BIA-ALCL Knowledge According to a July 2020 Practice Update article, 500 women … [Read more...]
Allergan Aesthetics Launches Tracking Campaign for U.S. Breast Implant Patients
Since the July 2019 voluntary recall of textured breast implant Biocell, pharmaceutical company Allergan has been under fire. The recall came after research linked the implant with cases of breast implant associated anaplastic large cell lymphoma (BIA-ALCL). Allergan plans to launch a tracking campaign for U.S. breast implant patients in the near … [Read more...]
Advances Made in Understanding and Treatment of BIA-ALCL
Since our previous article regarding the connection between textured breast implants and Breast Implant-Associated Anaplastic Large Cell Lymphoma (BIA-ALCL), additional information on understanding the disease and its treatment has surfaced. Background on BIA-ALCL and Recent Legislation While the cause of BIA-ALCL was initially believed … [Read more...]
Cancer Linked to Breast Implants: Is it Considered Rare Anymore?
As you may know from our previous articles, specific kinds of textured breast implants have been banned and recalled in countries due to their link to a cancer called Breast Implant-Associated Anaplastic Large Cell Lymphoma (BIA-ALCL). France, Canada, and Australia have banned Allergan’s textured breast implants and the U.S. FDA has recalled them. … [Read more...]
FDA Proposes New Recommendations for Breast Implant Labels
The FDA has come up with a draft guidance list of labeling changes that they recommend be made by breast implant manufacturers to address the safety concerns threatening women all over the world. The recent October 2019 article from The New York Times, “Women Should Be Warned of Breast Implant Hazards, F.D.A. Says”, tells us that “Agency officials … [Read more...]
TGA Regulations on Breast Implant Products
Implants in Australia Back in July, health officials in Australia recommended the ban of textured implants. Our previous July 2019 article, "Textured Breast Implants Ban: Onto Australia", discussed the type of implants up for suspension by Australia's Therapeutic Goods Administration (TGA). Now in Australia, textured breast implants being … [Read more...]
FDA Recalls Allergan Textured Implants
We have consistently provided updates on the situation of Breast Implant-Associated Anaplastic Large Cell Lymphoma (BIA-ALCL) in relation to textured implants. Every article prior to this one has discussed how other countries have banned textured breast implants or how the FDA has been monitoring the issue. As of July 24, 2019 the FDA has finally … [Read more...]
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