“Dr. Nagel, you kind of answered in your presentation the FDA’s efforts towards breast implant safety registry’s tracking but maybe I could just ask a clarification question based on your presentation, with regards to the [FDA] update from September 8th on squamous cell carcinoma and B-cell lymphoma?
One of the frequent questions that we get from patients and also surgeons is, ‘Was there an impetus for that warning?’
Some of the citations that were given by the FDA showed the case reports over the last decade. And so was there any reason to the timing right now, or something that precipitated it?” — Dr. Mark W. Clemens, MD, MBA, FACS
“Well thank you, Dr. Clemens, and you’re right about the chronicity of reports they go back even past the last decade.
But our team continually evaluates post-market data and part of that looks at the current literature and information that forums such as this presents.
We have a team, a breast implant team, that meets every week and we continually evaluate information on breast implants.
You know, it’s accumulation of information that led to our looking further into this and we realize that although this safety signal may be relatively early compared to a lot of the other signals that are out there, it certainly warranted further investigation, as we’re doing now.
One thing leads to another sometimes and it wasn’t just the squamous cell carcinomas.
As we started to look further into the data, we realized that there are all sorts of other so-called various lymphomas that are not the BIA-ALCL.
They’re not even all B-Cells and there are various T-Cell lymphomas so it’s a growing and evolving body of data that led us to realize that this is time for at least the initial communication and more to follow.” — Dr. Steven Nagel, MD, FACS, US FDA
[October 1, 2022, Houston, Texas, 8th International Breast Surgery Workshop & 4th World Consensus Conference on BIA-ALCL. Dr. Mark W. Clemens, MD, MBA, FACS is an Associate Professor in plastic surgery, University of Texas MD Anderson Cancer Center. Dr. Steven Nagel, MD, FACS is the Medical Officer, Office of Surgical and Infection Control Devices, for the U.S. FDA]