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...]
FDA Makes Adverse Drug Reactions Easier to Find with New Search Tool
On September 28, 2017, the FDA released a new search tool that allows patients, doctors, and others to see the adverse events reported for a particular drug or medical device by searching the product name, patient age, adverse event type and date, or timeframe in which an event occurred. This tool is referred to as the FDA Adverse Events … [Read more...]