When it comes to BIA-ALCL, Risk reduction does not mean total elimination of risk.
- jemmaquilleuse
- 18 août 2023
- 3 min de lecture
This blog covers a topic that is passionately debated amongst the health care community but also in the advocacy community.
It adresses and opens the discussion about the risks and benefits of removing your breast implants and/or capsules to reduce the risk of BIA ALCL even if you have no signs or symptoms of disease at this time.
I would like to thank Jennifer Cook, BIA ALCL survivor and BISA’s director of BIA-ALCL advocacy for the text below.
It was first publish on the Facebook support group BIA-ALCL in women with breast implants.
And with her permission, I am sharing here this important, probably life changing information.
Jennifer Cook is probably the most knowledgeable non-health professional there is when it comes to everything BIA-ALCL.
Her profound understanding of the science in this matter and her ability to transmit and popularize the information is unique.
She is investing precious time staying on top of the most recent studies, articles and publications for the benefit of all women with breast implants.
Her devotion to the cause is fierce and her level of retention of all the details surrounding this man-made cancer makes her a precious ressource not only for patients but also for the medical community.
Jennifer I salute the time you invest in this, your passion and devotion.
I truly appreciate your help and collaboration.
It means more than these words can describe.
I profoundly admire you and on behalf of thousands of women out there, THANK YOU.
You can read about Jennifer’s story here:
You can join her support group here.
-Landmark 2023 Commentary by Dr. Mark Clemens Supports Prophylactic Removal of Textured Implants in Select Asymptomatic Patients for Reducing Risk of BIA ALCL-
“If you have textured implants or remaining capsule from prior textured implants, this commentary may help you have an informed discussion with your doctors about the risk and benefits of removing your implants and/or capsules to reduce the risk of BIA ALCL even if you have no signs or symptoms of disease at this time.
Below I will highlight some of my key understandings from the article.
The commentary is a response to this research article published late last year: Fabio Santanelli Di Pompeo, MD, PhD, Demosthenes Panagiotakos, PhD, Guido Firmani, MD, Michail Sorotos, MD, PhD, BIA-ALCL Epidemiological Findings From a Retrospective Study of 248 Cases Extracted From Relevant Case Reports and Series: A Systematic Review, Aesthetic Surgery Journal, 2022
Because of this new research, Dr. Clemens believes we should be “encouraged that risk reduction for BIA-ALCL is possible and reasonable.”
Dr. Santanelli di Pompeo’s research presents “clear and convincing evidence” that textured implant removal or replacement to smooth implants may reduce risk of BIA ALCL.
Patients individual risk for BIA ALCL and individual risk for surgery complications should both be considered in the prophylactic removal decision-making process. Those that may be at higher risk for BIA ALCL include those over the age of 45 and those with BRCA and Li Fraumeni p53 mutations.
Separately published research by Dr. Santanelli shows that “an additional explant procedure performed to mitigate BIA-ALCL risk carried minimal chance of morbidity and a surgery mortality rate of zero in a study of nearly 100,000 oncologic and non-oncologic breast implant patients.”
Separately published research by Cordeiro and colleagues shows risk of BIA ALCL “to be as high as 1:100 in breast reconstruction with Biocell devices.”
Additional studies are needed to determine whether removing the capsule increases the level of risk reduction for BIA ALCL. It is logical to think that it does, but current data is not sufficient to answer the question.
If a patient does have their capsule removed because of concern for BIA ALCL, thorough evaluation of the capsule for BIA ALCL is recommended. The recommended protocol for such screening involves a standardized process using CD30 immunohistochemistry and sampling twelve regions of the capsule.
Risk reduction does not mean total elimination of risk. Patients should “continue to monitor for and report to their surgeon with any abnormal findings with their breasts.” Rare cases showing the occurrence of BIA ALCL after total capsulectomy do not negate the evidence that risk reduction is possible.
Dr. Clemens thinks the FDA and national societies will continue to have no recommendation on whether patients should explant or keep their textured implants thus reserving the decision to surgeons and patients. According to Dr. Clemens, “[a] strategic ambivalence accepts and allows for those that perform the procedure without admonishing those that do not.”
Dr. Clemens wonders whether insurance providers will provide coverage for “risk reducing” explantations. He is pessimistic about such coverage for aesthetic patients given that insurance coverage for the actual oncologic treatment of confirmed BIA ALCL in such patients is increasingly denied.
Dr. Clemens reminds us that: ”Implant manufacturers and insurance companies are first responsible to their shareholders, whereas only physicians bear the responsibility of patient care and advocacy.” “
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