Breast Implant Associated Anaplastic Large Cell Lymphoma
Publication Date: February 27, 2024
Last Updated: February 29, 2024
Summary of Recommendations
Recommendation #1
Use of macrotextured breast implants should be discontinued and surveillance of patients who received breast implants, smooth and textured surface, should be employed.
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Recommendation #2
Implant manufacturers should disclose publicly or for independent academic analysis, their internal surveillance data, detailing both the number of BIA-ALCL cases reported to them and their country-specific and global sales and implantation figures for their respective breast implants.
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Recommendation #3
No change in the use of smooth-surface breast implants is warranted at this time based upon BIA-ALCL.
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Recommendation #4
Currently available evidence is sufficient to determine that the association of textured breast implants to BIA-ALCL does meet the definition of causation based on the Bradford Hill criteria.
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Recommendation #5
An en bloc capsulectomy with explantation, resection of associated masses and excision of involved lymph nodes is recommended for patients with BIA-ALCL, when deemed appropriate as part of a multidisciplinary evaluation.
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Recommendation #6
Addition of chemotherapy/immunotherapy to surgical explantation of textured breast implants may be considered in patients with Stage IIA if disease is unresectable (invasive to critical structures) and is recommended for patients with Stage IIB or higher stage BIA-ALCL, when deemed appropriate as part of a multidisciplinary evaluation. Neoadjuvant immunotherapy may be considered for borderline resectable or locally advanced unresectable disease at diagnosis by achieving enough downstaging to permit a curative-intent surgery.
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Recommendation #7
Addition of radiation therapy (25 to 30 Gy) to surgical excision and explantation is recommended for patients with unresectable BIA-ALCL, when deemed appropriate as part of a multidisciplinary evaluation.
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Recommendation #8
Based on the potential for risk reduction, prophylactic explantation of macrotextured surface implants can be deemed reasonable. Furthermore, after implementing a risk stratification and surveillance plan, coupled with an informed discussion about the benefits of surgery, it may also be considered reasonable for explantation of any type of textured implant. It’s important to differentiate between the notion of a procedure being reasonable—referring to the potential to mitigate risk—and it being advisable. While we acknowledge the reasonableness of these procedures, the determination of their advisability rests solely with the discretion of the surgeon in consultation with the patient. Before the release of this consensus statement, government authorities and national surgical societies have not acknowledged the potential for risk reduction through prophylactic explantation. Consequently, they either did not recommend such procedures or simply had no existing recommendation on the matter.
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Recommendation #9
Prophylactic explantation of the contralateral textured breast implant is recommended in patients with a confirmed BIA-ALCL diagnosis due to the risk of unrecognized or occult bilateral disease.
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Recommendation #10
Preemptive notification of the risk of developing BIA-ALCL is recommended for all patients with textured breast implants. Occult fluid collections or masses may be recognized earlier in patients with textured silicone implants undergoing routine surveillance for gel leak.
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Recommendation #11
Genetic markers may have prognostic value and may implicate future therapeutic targets. Broad genetic testing of BIA-ALCL patients beyond clinical trials is not recommended at this time, however the further identification of markers may provide future indication for genetic testing.
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Recommendation #12
Evidence of pathways involving chronic inflammation and the acquisition of driving oncogenic events may be considered as increasing the risk for developing BIA-ALCL in patients with textured breast implants.
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The information in this patient summary should not be used as a substitute for professional medical care or advice. Contact a health care provider if you have questions about your health.
Title
Breast Implant Associated Anaplastic Large Cell Lymphoma
Authoring Organization
American Society of Plastic Surgeons
Publication Month/Year
February 27, 2024
Last Updated Month/Year
March 13, 2024
Country of Publication
US
Document Objectives
In the absence of high-quality evidence, there is a need to provide guidelines and multidisciplinary consensus recommendations on Breast Implant-Associated Anaplastic Large Cell Lymphoma (BIA-ALCL). The purpose of this expert consensus conference was to evaluate the existing evidence regarding the diagnosis, and management of BIA-ALCL caused by textured implants. The aim is to provide evidence-based recommendations regarding the management and prevention of BIA-ALCL.
Inclusion Criteria
Female, Adult, Older adult
Health Care Settings
Ambulatory, Outpatient, Operating and recovery room
Intended Users
Nurse, nurse practitioner, physician, physician assistant
Scope
Treatment, Management
Diseases/Conditions (MeSH)
D008223 - Lymphoma, D018427 - Breast Implants, D017728 - Lymphoma, Large-Cell, Anaplastic
Keywords
breast implants, Large Cell Lymphoma
Source Citation
Clemens MW, Myckatyn T, Di Napoli A, Feldman AL, Jaffe ES, Haymaker CL, Horwitz SM, Hunt KK, Kadin ME, McCarthy CM, Miranda RN, Prince HM, Santanelli di Pompeo F, Holmes SD, Phillips LG. Breast Implant Associated Anaplastic Large Cell Lymphoma: Evidence-Based Consensus Conference Statement From The American Association of Plastic Surgeons. Plast Reconstr Surg. 2024 Feb 27. doi: 10.1097/PRS.0000000000011370. Epub ahead of print. PMID: 38412359.