Introduction

Approximately 35 million women worldwide have breast implants. According to estimates, more than two million Brazilian women have breast implants, making Brazil the second-largest market for breast implants in the world.

Breast implants with silicone prostheses started in 1962. Since then, several studies have aimed to uncover and analyze the impacts of these substances on the body.

In 2011, the United States Food and Drug Administration (FDA) identified a potential link between breast implants and an uncommon form of non-Hodgkin lymphoma called anaplastic large cell lymphoma (ALCL). In 2016, the World Health Organization (WHO) guidelines ratified the disease as breast implant-associated anaplastic large cell lymphoma (BIAALCL).¹

A rare type of lymphoma, BIA-ALCL has gained prominence in the last 2 decades due to the increased number of cases reported. The exact incidence of BIA-ALCL remains unknown, but it is estimated to be of approximately 1 case per 30 thousand women with implants per year, with an average time for disease development after implantation of 10 years.²

According to regulatory agencies, the risk of disease development is associated with textured-surface breast implants.³ Breast implant-associated anaplastic large cell lymphoma may occur in the seroma cavity or involve the pericapsular fibrous tissue. Most patients present with peri-implant effusion and, less frequently, with a mass. Diagnosis relies on aspirating the peri-implant effusion and confirming CD30 positivity in the sampling cells. However, diagnostic confirmation can be a challenge. Combining the presence of characteristic cells with the results of flow cytometry and immunohistochemistry can aid in obtaining an accurate diagnosis.⁴ Most patients have an excellent prognosis after complete capsule removal and surgical implantation of a prosthesis with negative margins.⁵

Objective

The present study aimed to analyze cases of BIA-ALCL treated by plastic surgeons in the Federal District, Brazil.

Materials and Methods

The current retrospective observational study started with data collection from medical record analysis after obtaining informed consent from plastic surgeons and patients in Brasília, Federal District, Brazil, in 2024. We used demographic data to analyze implant features (type, texture and year of implantation), postdiagnosis treatment, and prognosis. The Ethics Committee of Hospital Daher Lago Sul approved the study.

Results

Demographic Data and Implant Features The average age at diagnosis of BIA-ALCL was 45 years, while the average time of implant use was 8.3 years, which suggests that the disease may manifest late after placement.

All cases involved polyurethane implants, indicating a potential association between this type of prosthesis and the development of BIA-ALCL. Among our patients, three presented with comorbidities (one had rheumatoid arthritis, the second presented with insulin resistance, and the third had breast cancer) (►Table 1).

Table 1 - Demographic data of the study sample

Symptomatology and Diagnosis

The most common initial symptom was seroma (►Fig.1), followed by intense mastalgia and capsular contracture in one case. In all cases, periprosthetic fluid aspiration with cytopathological analysis was crucial for the diagnosis of BIA-ALCL (►Table 2).

Table 2 - Diagnoses of the study sample

Cases	Initials	Symptoms	Laboratory
1	GCLAO	Sudden increase in left breast volume, with little pain. Seroma puncture performed (►Fig. 1).	Lab/Diagnose
2	VCR	Slight increase in left breast volume. Fluid puncture performed.	Diagnose
3	FSSFC	Breast augmentation and seroma in March 2023. The third puncture revealed BIA-ALCL.	Diagnose
4	AJBSB	Painless seroma in the left breast in January 2023. Puncture with BIA-ALCL diagnosis	Lâmina
5	KLBCGB	Intense mastalgia, capsular contracture, December 2022	Diagnose
6	DCM	Itching, night sweats, skin lesions	Diagnose

Abbreviation: BIA-ALCL, breast implant-associated anaplastic large cell lymphoma.

Table 2 - Diagnoses of the study sample

Treatment and Prognosis

All cases underwent breast implant removal and capsulectomy. This approach represented the primary treatment for BIA-ALCL in the current study (►Figs. 2 and 3). None of the patients required adjuvant chemotherapy nor radiation therapy due to the absence of distant disease. One patient opted for new microtextured breast implants 8 months after removing the affected implants.

The general prognosis was favorable, with all patients showing good progress after treatment (►Table 3).

Table 3 - Treatment and prognosis of the study sample

Cases	Initials	Surgery	Supplementary treatment required	Notes	Prognosis
1	GCLAO	Implant removal and en bloc capsulectomy with implant exchange.	No	No abnormalities on positron emission tomography– computed tomography	Good
2	VCR	Prosthesis removal and en bloc capsulectomy on the left side, without placement of new implants (►Fig. 2). After the anatomopathological report showing no capsular disease, a new implant was placed on the left side, and the right-sided implant was replaced on December 11, 2023.	No		Good
3	FSSFC	Implant removal with en bloc capsulectomy, breast reconstruction with the remaining tissue, with no fat grafting nor new implant placement (►Fig. 3).	No		Good
4	AJBSB	Explantation, capsulectomy, and adhesion sutures between the breast tissue and the pectoralis major muscle. No fat grafting or implant placement at the same time.	No	An oncology follow-up ruled out distant disease, enabling a new implant 8 months after the explant (placement of microtextured implants in the submuscular plane)	Good
5	KLBCGB	Explantation, capsulectomy, and adhesion sutures between the breast tissue and the pectoralis major muscle. No fat grafting nor implant placement at the same time.	No	Cytological and anatomopathological examinations concluded that the disease was confined to the fluid. Follow-up with oncology did not indicate adjuvant treatment.	Good
6	DCM	Explantation, lymphadenectomy, and breast reconstruction with mastopexy without implants.	No		Good

Table 3 - Treatment and prognosis of the study sample

Discussion

Our data corroborates the epidemiological and clinical characteristics described in the literature about BIA-ALCL. The mean age at diagnosis, the latency time after implant placement, and the predominance of polyurethane implants are consistent with other studies.

The present study also highlights the significance of early symptom recognition, especially seroma, for the timely diagnosis of BIA-ALCL. Diagnostic aspiration of peri-implant fluid is essential for the definitive diagnosis.⁶

Guidelines for Collection and Packaging of Late Periprosthetic Breast Effusions

Percutaneous puncture: Collect 10 to 50 mL of effusion (use ultrasound guidance for small collections).

Avoid prior drainages, as they reduce the tumor load for later analysis.

If taking the specimen IMMEDIATELY to the laboratory, there is no need to add a fixation medium.

If it takes more than 1 hour to get to the laboratory, add absolute alcohol in a 50/50 ratio to the fluid, or 70% alcohol in a 2/3 ratio of alcohol and 1/3 of fluid, or formalin (10%, buffered) in a 50/50 ratio.

Report on the medical order the fixative used, the time of the prosthesis, the effusion time, the condition, type, and texture of the prosthesis, how many milliliters were punctured, the characteristics of the fresh fluid, whether there was an associated palpable mass or palpable axillary lymph node, imaging data (if any), and other relevant clinical findings.

Request a cytopathological examination, preparation of a cell block, and immunocytochemical study with CD30 cell count (differential for BIA-ALCL).

It is possible to store 3.0 to 4.0 mL of the fluid in a dry cerebrospinal fluid tube (requested in advance from the clinical laboratory) for flow cytometry for hematologic neoplasms (CD30) – order it separately.

Fig. 1 - Patient with sudden left breast volume increase. (A) Frontal view. (B) Left oblique view.

Fig. 1 - Patient with sudden left breast volume increase. (A) Frontal view. (B) Left oblique view.

Note: Puncture and cytological diagnosis should precede capsulectomy/en bloc explantation whenever possible. This enables the postdiagnostic optimization of staging (positron emission tomography–computed tomography; PET-CT) and surgical planning.

Fig. 2 - Comparison of the preand postoperative aspects of left prosthesis removal and en bloc capsulectomy without placement of new implants. (A) Preoperative frontal view. (B) Postoperative frontal view.

Fig. 2 - Comparison of the preand postoperative aspects of left prosthesis removal and en bloc capsulectomy without placement of new implants. (A) Preoperative frontal view. (B) Postoperative frontal view.

During surgery, after en bloc explantation, puncture the effusion for adequate fluid preservation, enabling diagnostic confirmation and correct staging.

Treatment with immediate implant removal and total capsulectomy has been proven to be effective in controlling the disease. Most patients did not require adjuvant chemotherapy or radiation therapy.⁷

Reimplantation of breast implants after BIA-ALCL treatment is an individualized decision that should be made cautiously and occur under strict medical supervision. No patient received fat grafting to improve the esthetic outcome. The overall prognosis was favorable, with all patients showing good progress after treatment. This highlights the significance of early diagnosis and adequate management.

Recommendations

Increased awareness of BIA-ALCL among the medical community and patients.

Implementation of standardized protocols for BIA-ALCL diagnosis and treatment.

Prospective data collection in multicenter studies to expand knowledge about the disease and identify potential risk factors.

Fig. 3 - Comparison of the preand postoperative aspects of implant removal with en bloc capsulectomy and breast reconstruction using the remaining tissue, with no fat grafting or new implant placement. (A) Preoperative right lateral view. (B) Preoperative frontal view. (C) Preoperative left lateral view. (D) Postoperative right lateral view. (E) Postoperative frontal view. (F) Postoperative left lateral view.

Fig. 3 - Comparison of the preand postoperative aspects of implant removal with en bloc capsulectomy and breast reconstruction using the remaining tissue, with no fat grafting or new implant placement. (A) Preoperative right lateral view. (B) Preoperative frontal view. (C) Preoperative left lateral view. (D) Postoperative right lateral view. (E) Postoperative frontal view. (F) Postoperative left lateral view.

Conclusion

It is worth emphasizing that the current study presents a low number of cases, which limit the generalizability of the conclusions. Further studies with larger samples are needed to confirm the findings and deepen our understanding of BIA-ALCL.

Despite its limitations, the present study provides valuable information about BIA-ALCL, contributing to improving diagnosis, treatment, and monitoring of this rare disease. Disseminating knowledge about BIA-ALCL is essential for proper patient care and to prevent new cases.