Background: There has been increasing evidence in recent years that breast implants can, in rare cases, be associated with the development of an anaplastic large-cell lymphoma (ALCL).
Methods: This review is based on relevant publications retrieved by a selective search in PubMed for articles that appeared from the time of the initial description of breast-implant-associated ALCL onward (1997 to January 2018), and by a further search in German nationwide databases.
Results: 516 pathologically confirmed cases of breast-implant-associated (BIA) ALCL were documented around the world until February 2018; seven of these arose in Germany and were reported to the Federal Institute for Drugs and Medical Devices (Bundesinstitut für Arzneimittel und Medizinprodukte, BfArM). In approximately 80% of the affected women, the BIA-ALCL manifested itself as a late-developing seroma at the implant site; in the rest, as a solid tumor with or without an accompanying seroma. The mean implant exposure time ranged from 7 to 13 years on average. 16 fatalities have been reported worldwide. Among the 7 cases reported in Germany, four women had undergone breast reconstruction with implants after breast cancer surgery, and two had undergone breast augmentation surgery. In all patients, the entire capsule-and-implant unit was resected. One patient underwent chemotherapy and one further patient underwent chemotherapy and adjuvant radiotherapy.
Conclusion: The risk that a woman with breast implants will develop a primary anaplastic large-cell lymphoma is estimated at 0.35 to 1 case per million persons per year. The incidence of implant-associated ALCL is thus very low, yet nevertheless markedly higher than that of other primary lymphomas of the breast. Because of the low case numbers, recommendations for the diagnostic evaluation and treatment of this entity have not been adequately evaluated. Treatment with primary curative intent for BIA-ALCL confers a much better prognosis than when performed for a systemic ALCL. Whenever a patient with a breast implant presents with a late-developing seroma, BIA-ALCL should be included in the differential diagnosis. This diagnosis is reportable.