There is a growing awareness and concern regarding the safety of breast implants as it relates to a rare form of lymphoma. The term for this disease process is Breast Implant Associated – Adult Large Cell Lymphoma (aka BIA-ALCL). This new occurrence in the world of breast implants has recently received great national and international fanfare, and there is a great deal of emotion surrounding this topic. Regardless of that, the facts of this disease process need to see the light of day. Here is the state of affairs:
- Specific early observations indicate that approximately 660 cases of BIA-ALCL have been diagnosed worldwide. It is important to note that not all these cases are within the United States. Also, nine deaths have been attributed to this specific disease process. Given the totality of breast augmentation/reconstruction worldwide, this is a small number, but significant and concerning nonetheless.
- There is an enormous association between textured implants and BIA-ALCL, with nearly 100% of cases being associated with textured implants. Causality has not been determined at this time, but ASPS/ASAPS, the FDA, and others are directly involved in this investigation.
- In response to the development of these processes, there is a national database set up named PROFILE, which is actively tracking BIA-ALCL in the United States.
- NO PATIENT OF OCEAN DRIVE PLASTIC SURGERY HAS A TEXTURED IMPLANT. Durkin has NEVER used textured implants as he did not feel they offered an improvement over non-textured implants. IF you are a patient of ours, and you have received breast augmentation or breast reconstruction, you are not at increased risk for this disease.
- Textured implants do appear to be associated with this disease process, both inside and outside the United States.
- Both France and Canada have restricted the use of textured breast implants in response to BIA-ALCL. In the United States, the FDA has created a task force to further study this phenomenon, as again, no causality from breast implants has been demonstrated.
I personally believe that every board certified Plastic Surgeon is aware of this phenomena and is paying close attention. Below, we have listed the FDA link to the raw data. There is also a link to the PROFILE database. If you have any further questions, please contact our office at your convenience.
FDA statement updated 2/6/2019
Link to PROFILE registry, sponsored by Plastic Surgery Education Foundation