A recent Health Canada safety advisory comes following an updated safety review of breast implants and the associated risk of BIA-ALCL. According to the April 6, 2022 Health Canada advisory "Advisory - Updated safety review of breast implants underscores the continuing importance of monitoring for cancer; increased risk with highly textured … [Read more...]
FDA Sets New Regulations for Breast Implant Manufacturers
An October 2021 article, "FDA sets stronger safety warnings for breast implants", addresses the Food and Drug Administration's (FDA) new requirements for breast implant manufacturers. The new regulations will require patients receive detailed information about the potential risks and complications of implants prior to receiving surgery. However, … [Read more...]
BIA-ALCL Current Recommendations and Potential Future FDA Guidance Changes
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...]
BIA-ALCL Case Studies Confirm Importance of Proper Treatment
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...]
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...]