As many are aware, there has been much recent publicity and discussion in the news about a rare type of lymphoma associated with breast implants and has been termed ‘Breast Implant Associated – Anaplastic Large Cell Lymphoma or BIA-ALCL.’ On July 24, 2019, Allergan Medical Corporation issued a worldwide recall of all of their textured surface breast implants and tissue expanders per request of the Food and Drug Administration (FDA) because of the association of BIA-ALCL with the ‘macro texturing’ or Biocell texturing on some Allergan devices. This recommendation was based on recently submitted Medical Device Reports (MDR’s) reporting an increase in worldwide cases of BIA-ALCL associated with these devices compared to other textured surface and smooth surface devices.
As a Board-Certified Plastic Surgeon and member of the American Board of Plastic Surgery (ASPS) and the American Society for Aesthetic Plastic Surgery (ASAPS), we are committed to patient safety, advancing quality of care, and practicing medicine and surgery based upon the best available scientific evidence. If you have received breast implants or tissue expanders and have any concerns or questions about this recent information and the Allergan recall and BIA-ALCL, we encourage you to make an appointment or call us at evolv Plastic Surgery and Medical Aesthetics so we can provide science-based and factual information specifically to you. I have over 30 years clinical experience in the use of various breast implants and tissue expanders in both cosmetic augmentation and breast cancer reconstruction as well as published research studying breast implant biomaterials and their function and safety.
Most Recent Science-based Facts:
- BIA-ALCL is extremely rare. There have been 573 confirmed cases worldwide, and considering the many millions of women with breast implants for both cosmetic enhancement and in breast reconstruction, the incidence is very low although significantly higher in association with deeper or ‘macro’ textured devices like Allergan’s Biocell surface.
- Because of their significant advantages in some patients, I have used textured breast implants and tissue expanders for over 30 years and have never had a confirmed case of BIA-ALCL in any patient.
- BIA-ALCL most always presents with new onset swelling, fluid accumulation around the implant (serum), and discomfort and can be consistently and quickly diagnosed with laboratory studies of the fluid aspirated around the implant. When detected early, removal of the implant and all of the scar tissue capsule around the device cures the problem. In rare cases left untreated, chemotherapy and/or radiation may be necessary.
- BIA-ALCL is not breast cancer but is a cancer of white blood cells (lymphoma) and is usually localized only in the scar tissue capsule around the implant and most often can be definitively treated by removal of the surrounding scar capsule (capsulectomy) and implant.
- Although only recently described and relatively rare, evolving research studies indicate that the development of BIA-ALCL is multifactorial and involves the interaction of 4 factors: textured surfaces, bacterial contamination, genetic susceptibility and time. It appears that deeper or more aggressive texturing increases risk and that there is no association with smooth surfaced implants.
- The FDA has clearly stated that if you are a patient with textured surface implants and are not experiencing any symptoms as described above, they are not recommending removal of the implants. If you have any questions about risk they are suggesting that each patient talk to their health care provider.
For patients in the U.S. who, as a result of the recall announcement on July 24, 2019, choose to replace their Bio cell textured device with a smooth surface device, in consultation with their Plastic Surgeon, Allergan Medical will provide Allergan smooth device replacements of a similar size at no charge to the patient. This Replacement Program will run for 12 months until July 24,2020.
Breast implant surgery, whether for cosmetic enhancement or for breast cancer reconstruction, when done by a Board-Certified Plastic Surgeon on the appropriate patient, can have a profound effect on improving quality of life for women of all ages. The other fundamental goal is long term patient safety and utilizing the best research-proven evidence or breast implants and bio materials. There are several safe choices available to patients when selecting implants. Research on BIA-ALCL is still developing, and it is important to focus on what is proven and scientifically validated.
We are encouraging any patient with implants or any patient considering breast augmentation or implant-based breast reconstruction to discuss these issues with a board-certified plastic surgeon with proven experience in breast surgery.
Links from reputable sources to learning more about these concerns.
If you should have any additional questions or concerns, please feel free to contact our office at 419-720-2008. We highly recommend annual exams to all our patients. We want everyone to put safety first, regardless of insurance coverage or not, therefore we offer annual complimentary breast exams to all our patients.
I thank you for your attention.
Frank Barone, MD