BIA-ALCL and Textured Breast Implants: A Systematic Review of Evidence Supporting Surgical Risk Management Strategies

 

BIA-ALCL and Textured Breast Implants: A Systematic Review of Evidence Supporting Surgical Risk Management Strategies

 by Nelson, Jonas A.; McCarthy, Colleen; Dabic, Stefan; Polanco, Thais; Chilov, Marina; Mehrara, Babak J.; Disa, Joseph J

 Plastic and Reconstructive Surgery: May 2021 - Volume 147 - Issue 5S - p 7S-13S

 Background:  Breast implant–associated anaplastic large cell lymphoma (BIA-ALCL) is a significant public health concern for women with breast implants. The increase in incidence rates underscores the need for improved methods for risk reduction and risk management. The purpose of this study was to perform a systematic review to assess surgical risk reduction techniques and analyze communication/informed consent practices in patients with textured implants.

 Methods: A systematic review of the literature was conducted in PubMed (legacy), Embase (Embase.com), and Scopus with four search strategies including key terms centered around breast reconstruction and BIA-ALCL.

Results: A total of 571 articles were identified, of which 276 were included in the final review after duplicates were removed. After review, no articles were determined to fit the inclusion criteria of demonstrating data-driven evidence of BIA-ALCL risk reduction through surgical measures, demonstrating a significant lack of data on risk reduction for BIA-ALCL.

Conclusions: Risk management for BIA-ALCL is an evolving area requiring additional investigation. Although removal of textured devices in asymptomatic patients is not currently recommended by the Food and Drug Administration, variability in estimates of risk has led many patients to electively replace these implants in an effort to decrease their risk of developing BIA-ALCL. To date, however, there is no evidence supporting the concept that replacing textured implants with smooth implants reduces risk for this disease. This information should be used to aid in the informed consent process for patients presenting to discuss management of textured breast implants.

Not All Breast Explants Are Equal: Contemporary Strategies in Breast Explantation Surgery

 

Not All Breast Explants Are Equal: Contemporary Strategies in Breast Explantation Surgery

 

by Tanna, Neil; Calobrace, M. Bradley; Clemens, Mark W.; Hammond, Dennis C.; Nahabedian, Maurice Y.; Rohrich, Rod J.; Zhang, Ben H.; Bregman, Dana; Perry, Adam D. 

 

Plastic and Reconstructive Surgery: April 2021 - Volume 147 - Issue 4 - p 808-818

 

Summary:

Breast implant removal and replacement has been a common secondary breast procedure in the long-term maintenance of breast augmentation, but more recently growing concerns about silicone-related systemic illness, breast implant-associated anaplastic large cell lymphoma (BIA-ALCL), and changing perceptions of aesthetic beauty have seen breast implant removal without replacement become increasingly requested by patients. Explantation can be challenging, especially when performed with a total capsulectomy. Currently, there is no evidence regarding whether a partial or total capsulectomy has any effect on BIA-ALCL risk mitigation in patients that have textured implants without disease. Total capsulectomy with incomplete resection of a mass can contribute to hyperprogression of BIA-ALCL and death. There have also been cases of BIA-ALCL diagnosed years after removal of the textured device and “total capsulectomy.” Therefore, the common practice of simple prophylactic capsulectomy in a textured implant to mitigate future disease has not been established and at the current time should be discouraged. In addition, aesthetic outcomes can be quite variable, and patients should have appropriate preoperative counseling regarding the indications and contraindications for explantation, associated risks, financial implications, and postoperative appearance. The authors review salient aspects related to the planning and management of breast implant removal.

Does Breast Implant–Associated ALCL Begin as a Lymphoproliferative Disorder?

Does Breast Implant–Associated ALCL Begin as a Lymphoproliferative Disorder?

by Kadin, Marshall E.; Adams, William P. Jr.; Inghirami, Giorgio; Di Napoli, Arianna 

Plastic and Reconstructive Surgery: January 2020 - Volume 145 - Issue 1 - p 30e-38e

Summary: Breast implant-associated anaplastic large cell lymphoma (BIA-ALCL) has been included as a provisional entity in the revised version of the World Health Organization Classification of Tumors of Haematopoietic and Lymphoid Tissue. To increase opportunities to intervene with early diagnosis, treatment, and possible prevention, it is important to consider that BIA-ALCL may evolve from a preexisting lymphoproliferative disorder characterized by (1) an indolent localized (in situ) disease in approximately 80 percent of reported cases; (2) a requirement for external cytokine stimulation for cell survival; (3) CD30+ cells in some clinically benign seromas/capsules; (4) undetected T-cell clonality in some cases; (5) JAK/STAT mutations in only a minority of cases; and (6) cure by capsulectomy and implant removal in most cases. BIA-ALCL resembles CD30+ cutaneous lymphoproliferative disorder: ALK−, CD30+ anaplastic cells with an aberrant T-cell phenotype; overexpression of oncogenes (JUNB, SATB1, pSTAT3, SOCS3) in lymphomatoid papulosis; frequent apoptosis; complete spontaneous regression in lymphomatoid papulosis; and partial spontaneous regression in cutaneous ALCL. Unlike CD30+ cutaneous lymphoproliferative disorder, BIA-ALCL cannot be readily observed over time to study the different steps in progression to ALCL. BIA-ALCL also shares features of lymphomas of mucosa-associated lymphoid tissue, which are clinically indolent, initially localized, antigen driven, and caused by Gram-negative bacteria. Further studies of cytokines, clonality, mutations, and other biomarkers are needed to identify possible premalignant steps in the evolution of benign late seromas to BIA-ALCL.

About the French prohibition of textured breast implants: is it justified or over-cautious? The EUSOMA, ESSO/BRESSO position

About the French prohibition of textured breast implants: is it justified or over-cautious? The EUSOMA, ESSO/BRESSO position

The Breast: August 2019 Volume 46, Pages 95–96

by M.J. Cardoso, L. Biganzoli, I.T. Rubio, Leidenius M, Curigliano G, Cutuli B, Marotti L, T. Kovacs, L. Wyld 

After the publication of the EUSOMA position regarding breast implant associated anaplastic large cell lymphoma (BIA-ALCL) and the use of textured implants in January 2019 [1], the medical devices regulatory authority in France, the ANSM (National Agency of Medicine and Health Products), has recently banned all use of textured surface breast implants. This decision was based on concerns about the risk of BIA ALCL which may be more likely in women with textured versus smooth surfaced implants [2].

Theories of Etiopathogenesis of Breast Implant–Associated Anaplastic Large Cell Lymphoma

Theories of Etiopathogenesis of Breast Implant–Associated Anaplastic Large Cell Lymphoma

by Rastogi, Pratik; Riordan, Edward; Moon, David; Deva, Anand K.  

Plastic and Reconstructive Surgery: March 2019 - Volume 143 - Issue 3S - p 23S–29S

Summary: Breast implant–associated anaplastic large cell lymphoma is a malignancy of T lymphocytes that is associated with the use of textured breast implants in both esthetic and reconstructive surgeries. Patients typically present with a delayed seroma 8–10 years following implantation or—less commonly—with a capsular mass or systemic disease. Current theories on disease pathogenesis focus on the interplay among textured implants, Gram-negative bacteria, host genetics, and time. The possible roles of silicone leachables and particles have been less well substantiated. This review aims to synthesize the existing scientific evidence regarding breast implant–associated anaplastic large cell lymphoma etiopathogenesis.

Current Risk Estimate of Breast Implant–Associated Anaplastic Large Cell Lymphoma in Textured Breast Implants

Current Risk Estimate of Breast Implant–Associated Anaplastic Large Cell Lymphoma in Textured Breast Implants

 by Collett, David J.; Rakhorst, Hinne; Lennox, Peter; Magnusson, Mark; Cooter, Rodney; Deva, Anand K.  

Plastic and Reconstructive Surgery: March 2019 - Volume 143 - Issue 3S - p 30S–40S

Background: With breast implant–associated anaplastic large cell lymphoma (BIA-ALCL) now accepted as a unique (iatrogenic) subtype of ALCL directly associated with textured breast implants, we are now at a point where a sound epidemiologic profile and risk estimate are required. The aim of this article is to provide a comprehensive and up-to-date global review of the available epidemiologic data and literature relating to the incidence, risk, and prevalence of BIA-ALCL. Methods: All current literature relating to the epidemiology of BIA-ALCL was reviewed. Barriers relating to sound epidemiologic study were identified, and trends relating to geographical distribution, prevalence of breast implants, and implant characteristics were analyzed. Results: Significant barriers exist to the accurate estimate of both the number of women with implants (denominator) and the number of cases of BIA-ALCL (numerator), including poor registries, underreporting, lack of awareness, cosmetic tourism, and fear of litigation. The incidence and risk of BIA-ALCL have increased dramatically from initial reports of 1 per million to current estimates of 1/2,832, and is largely dependant on the “population” (implant type and characteristics) examined and increased awareness of the disease.

Conclusions: Although many barriers stand in the way of calculating accurate estimates of the incidence and risk of developing BIA-ALCL, steady progress, international registries, and collegiality between research teams are for the first time allowing early estimates. Most striking is the exponential rise in incidence over the last decade, which can largely be explained by the increasingly specific implant subtypes examined—driven by our understanding of the pathologic mechanism of the disease. High-textured high-surface area implants (grade 4 surface) carry the highest risk of BIA-ALCL (1/2,832).

22 Cases of Breast Implant–Associated ALCL: Awareness and Outcome Tracking from the Italian Ministry of Health

22 Cases of Breast Implant–Associated ALCL: Awareness and Outcome Tracking from the Italian Ministry of Health

Campanale, A et al 

Plastic and Reconstructive Surgery: January 2018 - Volume 141 - Issue 1 - p 11e–19e

Background: To date, 359 cases of anaplastic large cell lymphoma (ALCL) in women with breast implants (breast implant–associated ALCL [BIA-ALCL]) worldwide have been reported among more than 10 million patients who have received implants, but health care authorities suspect this is a possible underestimation, and the limited number of cases makes it difficult to clarify its cause. The General Directorate of Medical Devices and Pharmaceutical Services of the Italian Ministry of Health has examined and studied the Italian BIA-ALCL cases. 
Methods: An official document has been diffused to all medical associations, aiming at encouraging all physicians to notify each BIA-ALCL case. A retrospective study has been performed on the notified BIA-ALCL cases collected in the database named Dispovigilance. Results: Research on Dispovigilance returns a list of 22 BIA-ALCL cases. The mean patient age was 49.6 years (range, 30 to 71 years). The average time to the onset of the symptoms was 6.8 years (range, 1 to 22 years). The average time to diagnosis was 7.8 years (range, 4 to 22 years). The estimated incidence of the Italian BIA-ALCL cases related to 2015 is 2.8 per 100,000 patients. Conclusions: The pathogenesis of BIA-ALCL remains unknown. The establishment of a national breast implant registry is needed to better understand some aspects of this disease. Future genetic studies on the population affected could clarify why only some patients with implants develop this disease.

Breast Implant–Associated Anaplastic Large Cell Lymphoma in Australia and New Zealand: High-Surface-Area Textured Implants Are Associated with Increased Risk

Breast Implant–Associated Anaplastic Large Cell Lymphoma in Australia and New Zealand: High-Surface-Area Textured Implants Are Associated with Increased Risk
Loch-Wilkinson, A et al
Plastic and  Reconstructive Surgery: October 2017 - Volume 140 - Issue 4 - p 645–654

Background: The association between breast implants and breast implant–associated anaplastic large cell lymphoma (ALCL) has been confirmed. Implant-related risk has been difficult to estimate to date due to incomplete datasets. 
Methods: All cases in Australia and New Zealand were identified and analyzed. Textured implants reported in this group were subjected to surface area analysis. Sales data from three leading breast implant manufacturers (i.e., Mentor, Allergan, and Silimed) dating back to 1999 were secured to estimate implant-specific risk. 
Results: Fifty-five cases of breast implant–associated ALCL were diagnosed in Australia and New Zealand between 2007 and 2016. The mean age of patients was 47.1 years and the mean time of implant exposure was 7.46 years. There were four deaths in the series related to mass and/or metastatic presentation. All patients were exposed to textured implants. Surface area analysis confirmed that higher surface area was associated with 64 of the 75 implants used (85.3 percent). Biocell salt loss textured (Allergan, Inamed, and McGhan) implants accounted for 58.7 percent of the implants used in this series. Comparative analysis showed the risk of developing breast implant–associated ALCL to be 14.11 times higher with Biocell textured implants and 10.84 higher with polyurethane (Silimed) textured implants compared with Siltex textured implants. 
Conclusions: This study has calculated implant-specific risk of breast implant–associated ALCL. Higher-surface-area textured implants have been shown to significantly increase the risk of breast implant–associated ALCL in Australia and New Zealand. The authors present a unifying hypothesis to explain these observations.

U.S. Epidemiology of Breast Implant–Associated Anaplastic Large Cell Lymphoma

U.S. Epidemiology of Breast Implant–Associated Anaplastic Large Cell Lymphoma

Doren, E L et al
Plastic & Reconstructive Surgery: May 2017 - Volume 139 - Issue 5 - p 1042–1050

Background: Breast implant–associated anaplastic large cell lymphoma (ALCL) is a distinctive type of T-cell lymphoma that arises around breast implants. Although rare, all cases with adequate history have involved a textured breast implant. The objective of this study was to determine the U.S. incidence and lifetime prevalence of breast implant–associated ALCL in women with textured breast implants. 
Methods: This is a retrospective review of documented cases of breast implant–associated ALCL in the United States from 1996 to 2015. The incidence and prevalence were determined based on a literature and institutional database review of breast implant–associated ALCL cases and textured breast implant sales figures from implant manufacturers’ annualized data. 
Results: One hundred pathologically confirmed breast implant–associated ALCL cases were identified in the United States. Mean age at diagnosis was 53.2 ± 12.3 years. Mean interval from implant placement to diagnosis was 10.7 ± 4.6 years. Forty-nine patients had breast implants placed for cosmetic reasons, 44 for mastectomy reconstruction, and seven for unknown reasons. Assuming that breast implant–associated ALCL occurs only in textured breast implants, the incidence rate is 2.03 per 1 million person-years (203 per 100 million person-years), which is 67.6 times higher than that of primary ALCL of the breast in the general population (three per 100 million per year; p < 0.001). Lifetime prevalence was 33 per 1 million persons with textured breast implants. 
Conclusions: This study demonstrates a statistically significant association between textured breast implants and breast implant–associated ALCL. Although women with a textured breast implant have a low risk of developing breast implant–associated ALCL, the current U.S. incidence is significantly higher than that of primary ALCL of the breast in the general population.