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
2022 BIA-ALCL UPDATE
This is an update to the information I posted on my website in 2019 concerning BIA-ALCL.
Allergan or McGhan Biocell textured implants were released in 1996 and pulled from the market in 2019.
They were used because they had a lower incidence of encapsulation and malposition and enabled a teardrop or shaped implant to stay in place.
BIA-ALCL (breast Implants Associated Anaplastic Large Cell Lymphoma) is an unusual malignancy that is associated with heavily textured implants. It was initially thought to be extremely rare but with the passage of time is now classified as an “unusual” occurrence. As of June 2022, there are 389 cases of BIA-ALCL in the United States. The risk is currently estimated to be somewhere between 1 in 300 and 1 in 1000 patients.
The presentation tends to be fluid collection or a mass and the likelihood of developing a tumor increases over time. Fortunately, the tumor is very curable if diagnosed early.
The course of action for patients with textured implants remains controversial. The FDA and the American Society of Plastic and Reconstructive Surgeons advise that surgery is not necessary at this point, but this recommendation may change as the incidence seems to be slowly increasing. They also do not recommend against surgery, just that it is not mandatory.
The surgical options are: removing the implant, exchange it for a smooth implant, a total capsulectomy (removing the scar tissue around the implant) with or without replacement. Currently most surgeons feel that a capsulectomy is a significantly invasive procedure that is higher risk than the implants themselves and not warranted, considering the current low number of BIA-ALCL patients. Allergan will give you a free set of implants, but unfortunately it is not helping to cover the cost of the surgery otherwise.
We do not have enough long-term data for me to guide you definitively in this decision. My current practice tends to be removal with implant exchange since the risk of BIA-ALCL tends to increase the longer the implants have been in, with a biopsy of the capsule if it appears unusual in any way. You do not have to do anything surgically, but please continue to have regular
mammograms if you have had a breast augmentation, and an ultrasound or MRI every two or three years if you have had a breast cancer diagnosis after mastectomy. I can help order these tests.
I will continue to post updates on BIA-ALCL as new information emerges. Please do not hesitate to come in for consultation or contact me for further information at email@example.com.