Background: Due to the lack of compulsory breast implant registries, exact information on the number of breast implant procedures is not available. According to the International Society of Aesthetic Plastic Surgery (ISAPS), 1,841,098 augmentation procedures were conducted in 2018 worldwide. In Germany, an estimated 66,000 breast implants are used annually, including approximately 7000 for reconstruction. Breast implant-associated anaplastic large cell lymphoma (BIA-ALCL), a rare but potentially fatal form of T‑cell lymphoma, has become a major focus of the discussion regarding the safety and quality of breast implants. Objectives: Determination of the epidemiology, risk factors, clinical characteristics, and current recommendations for the diagnosis and therapy of BIA-ALCL. Methods: Evaluation of current evidence and guideline recommendations. Results: In July 2019, the US Food and Drug Administration (FDA) revised their database and confirmed 573 cases of BIA-ALCL, including 33 deaths. In Germany, 22 cases were reported to the authorities (Bundesinstitut für Arzneimittel und Medizinprodukte, BfArM) until November 2019. The textured implant surface is currently being discussed as being the main risk factor; however, the exact pathophysiology remains unclear. Treatment of choice remains complete surgical resection while systemic therapy may be indicated in advanced cases. The prognosis of BIA-ALCL is favorable with a 5-year survival of 89%. Conclusions: BIA-ALCL is a rare but potentially fatal disease. Each confirmed case must be reported to health authorities (BfArM in Germany). Patients should be informed about BIA-ALCL risk before implant surgery. According to the current guidelines and recommendations of health authorities, removal of breast implants is not indicated in asymptomatic patients. An obligatory implant registry is planned to be introduced in Germany in 2021.
Research Areas and Centers
- Research Area: Luebeck Integrated Oncology Network (LION)
- Centers: University Cancer Center Schleswig-Holstein (UCCSH)