Breast Implant-Associated Anaplastic Large Cell Lymphoma
The following is a discussion of BIA-ALCL because although it is exceedingly rare, it has gotten a lot of media attention lately. This is a very slow-growing breast tumor that is probably associated with both bacterial contamination of a very rare bacterium, Ralstonia, as well as a textured implant. As of this update in August 2019, since it was discovered in 1997, there have been 288 cases in the U.S, and worldwide there have been 735 cases since it was discovered in 1997 (ref.1). It appears that the risk is 33 patients for every million textured implants. (ref.2). It usually presents as an obvious fluid collection or a mass around implants eight to ten years after surgery. The survival rate is 94% at three years after treatment, which is often just the removal of the capsule and the implant. The risk of developing BIA-ALCL is the same among breast cancer and cosmetic patients, silicone and saline patients. It is unique to textured implants.
Recently, Allergan has stopped producing and selling textured implants (July 24, 2019) because of BIA-ALCL. All the implants I have used in the past few years in my practice have been smooth, not textured. I am also very meticulous in my sterile technique, using antibiotic and antiseptic rinses in the pocket that would make bacterial growth more unlikely. Nonetheless, for several years, I did prefer textured implants especially for breast augmentation because of the lower risk of encapsulation, so it possible that you may have textured implants. I feel strongly that once I’ve placed an implant in one of my patients, they need to stay in my practice. I will always want a copy of a patient’s mammogram report and I will encourage my patients to continue to follow up with me because what we know about breast implants will continue to evolve. I will be the best person to keep my patients informed.
Allergan recently announced (July 30. 2019) that they will replace any of their textured implants with a smooth implant at no cost for one year through July 2020. Allergan will be sending out a letter to every patient who has textured implants explaining their policy so you may be receiving a letter. Be aware, that although the implant is being covered by Allergan, there will still be the expenses of surgery fees, anesthesia fees and facility fees. Please come in for a consultation if you are interested in replacement.
Please note that the FDA and ASPS (American Society of Plastic Surgeons) recommendations are still not recommending removal of the textured implants if you do not have symptoms of BIA-ALCL due to low risk.
On another note, the FDA, has also said that silicone implant patients should have an MRI to check for rupture and implant integrity. If you are due for an MRI, our office will be happy to help you get that scheduled.
1 – Global Adverse Event Reports of BIA-ALCL, An International Review of 40 Government Authority Databases, Plastic and Reconstructive Surgery, May 2017
2 – U.S. Epidemiology of BIA-ALCL, Plastic and Reconstructive Surgery, May 2017