22 Cases of BIA-ALCL: Awareness and Outcome Tracking from the Italian Ministry of Health.

Background: To date, 359 cases of anaplastic large cell lymphoma in women with breast implants (BIA-ALCL) worldwide have been reported out of more than 10 million implanted patients but Health Care Authorities suspect this is a possible underestimation and the limited number of cases makes it difficult to clarify its etiology. The General Directorate of Medical Devices and Pharmaceutical Services of the Italian Ministry of Health (IMoH) has examined and studied the Italian BIA-ALCL cases, and the aim of this study is to report on the knowledge and experience gained on this new emerging disease. Patients and Methods: An official document has been diffused by the IMoH to all the Italian medical associations, aiming at encouraging all physicians to notify each BIA-ALCL case through the compilation of a specific on-line form. A retrospective study has been performed on the notified BIA-ALCL cases collected in the IMoH's database named DISPOVIGILANCE. Results: Research on DISPOVIGILANCE gives back a list of 22 Italian BIA-ALCL cases. The patients' mean age was 49.6 years (range 30 -71). The average time to the onset of the symptoms was 6.8 years (range 1-22). The average time to the diagnosis was 7.8 years (range 4 -22). The estimated incidence of the Italian BIA-ALCL cases related to 2015 is 2.8 per 100.000 patients. Conclusions: The BIA-ALCL pathogenesis remains unknown. The Italian Ministry of Health, together with scientific associations and other Competent Authorities worldwide, is working on the BIA-ALCL issue to increase awareness and knowledge of this disease by healthcare professionals. (C)2017American Society of Plastic Surgeons

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