SUMMARY: Breast implants are among the most commonly used medical devices and the number of women with breast implants diagnosed with Anaplastic Large Cell Lymphoma in the breast (breast-ALCL) have increased over the past 10 years. The FDA in 2011, identified a possible association between breast implants and the development of Anaplastic Large Cell Lymphoma (ALCL), and there has been growing body of medical literature describing the natural history and long term outcomes of the disease. In 2016, the World Health Organization designated Breast Implant-Associated Anaplastic Large Cell Lymphoma (BIA-ALCL) as a T-Cell Lymphoma that can develop following breast implants.
The incidence of ALCL is higher with macrotextured implants than smooth implants. It has been postulated that textured implants have an increased surface area and a local inflammatory response, elicited by silicone-derived products or specific bacterial species adherent to the prosthesis surface (Biofilm) may play a role, potentiating capsular contracture and increasing T-cell response and possible conversion to BIA-ALCL. It remains unclear however, whether certain women including those with proven BRCA mutations have a genetically determined increased risk to develop lymphoma when exposed to breast implants via a genetically determined altered or exaggerated local immunological response. There are presently no evidence-based guidelines on how this condition should be detected, treated or followed up. It is however, suggested that any seroma more than 6-12 months after breast implantation, in the absence of infection, should be evaluated with ultrasonography and mammography, to identify a mass or lymph nodes that are suspicious for lymphoma. The seroma should be aspirated and the fluid analyzed for cytology, cultures, flow cytometry and cell block. If cytology is negative, patients should be closely monitored for recurrence of seroma. Biopsy should be performed if a mass is present, and if ALCL is confirmed, patients will respond to capsulectomy and removal of the implant, as ALCL confined within the capsule often have an indolent course and good prognosis. In contrast, patients who present with a distinct mass may have a more aggressive disease course and poor prognosis, and require chemotherapy and/or radiation therapy. Postoperatively evaluation if BIA-ALCL is confirmed, should include a PET-CT scan and bone marrow biopsy to rule out systemic disease. It is recommended that patients receive clinical follow up at least every 6 months for 5 years along with breast ultrasonography for 2 years, and those who undergo reinsertion of the implant should be followed up beyond 5 years.
In this publication, a case-control study was conducted, comparing the prevalence of breast implants between women with primary breast-ALCL and women with primary breast lymphomas other than ALCL, using a comprehensive Dutch pathology database. The purpose of this study was to determine the relative and absolute risks of breast ALCL in women with breast implants. The authors identified all patients diagnosed with primary Non Hodgkin Lymphoma in the breast between 1990 and 2016 and retrieved clinical data, including breast implant status, from the treating physicians, through the population-based nationwide Dutch pathology registry. They then calculated the risk of breast-ALCL in women both with and without breast implants.
The estimated prevalence of breast implants in women aged 20-70 years was 3.3%. It was noted that among 43 patients with breast-ALCL (median age 59 years), 32 had ipsilateral breast implants, compared with 1 among 146 women with other primary breast lymphomas. The median time to development of Breast Implant-Associated Anaplastic Large Cell Lymphoma (BIA-ALCL) was 13 years after an implant was placed. Most cases of BIA-ALCL (75%) in this Dutch study were associated with macrotextured implants and the Complete Remission rate was 90% after treatment and only 6% of the 32 affected women died of disseminated disease. In this study, the number of women with implants needed to cause 1 breast-ALCL case before age 75 years was 6920. Affected patients had implants for cosmetic reasons alone, for reconstruction in transgender surgery, after breast cancer surgery, and after prophylactic mastectomy for high breast cancer risk.
It was concluded that breast implants are associated with increased risk of breast-ALCL, but the absolute risk remains small. With an increasing number of breast implant insertions, the need for increased awareness among the public, medical professionals, and regulatory bodies is imperative and it is essential to promote alternative cosmetic procedures, and recognize this rare clinical entity. Breast Implants and the Risk of Anaplastic Large-Cell Lymphoma in the Breast. de Boer M, van Leeuwen FE, Hauptmann M, et al. JAMA Oncol. 2018;4:335-341.