History of BIA-ALCL In 2011, the Food and Drug Administration (FDA) reported 34 cases worldwide of Breast Implant-Associated Anaplastic Large Cell Lymphoma (BIA-ALCL), bringing this unique disease into the public eye for the first time. Since then, BIA-ALCL has been recognized internationally as a distinct type of cancer, and prompted the 2019 … [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 … [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...]
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...]
Allergan Textured Breast Implants Recalled In Europe Due To BIA-ALCL
In December 2018 France’s National Agency for the Safety of Medicines and Health Products (ANSM) announced that Allergan textured breast implants can no longer be marketed in France and elsewhere in Europe. As regards what the FDA is doing on this developing medical device safety issue, we turn to this NBC News piece, “Allergan’s textured breast … [Read more...]
Several 2018 Breast Implant Lymphoma Cancer Lawsuits Already Filed
Background Breast Implant-Associated Anaplastic Large Cell Lymphoma (BIA-ALCL) is a type of non-Hodgkin's lymphoma, which is a cancer of the cells of the immune system. This rare T-cell lymphoma can develop as a result of breast implants, though the mechanism of injury is not fully understood at this time. However, based on current data from the … [Read more...]
FDA Provides Updated Number of Breast Implants Lymphoma Cancers
About BIA-ALCL The U.S. Food and Drug Administration (FDA) has been aware of the possible connection between breast implants and breast implant-associated anaplastic large cell lymphoma (BIA-ALCL) since 2011. This condition is a rare type of non-Hodgkin’s lymphoma, which is a cancer of the immune system, rather than a cancer of the breast … [Read more...]