From this recent FDA Safety Communication "UPDATE: Reports of Squamous Cell Carcinoma (SCC) in the Capsule Around Breast Implants" we get the following information about the new reporting system for cases of breast implant-associated lymphoma -- the shorthand term for breast implant-associated anaplastic large cell lymphoma (BIA-ALCL): As of March … [Read more...]
Breast Implants Lymphoma Cancer ALCL Case Numbers Increasing Rapidly in the US
There is some new medical research about current population-based estimates of the incidence of breast implants-associated anaplastic large cell lymphoma (BIA-ALCL) -- more commonly called breast implants lymphoma cancer -- in the US, and the findings are rather alarming. From this recent news report, "ALCL Increasing Rapidly in US Women as … [Read more...]
Health Canada Breast Implant Safety Review Shows High Risk of BIA-ALCL with Textured Implants
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 … [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...]