The implant related mortality risk and the rationale for prophylactic explantation of patients at high risk of BIA-ALCL
Fabio Santanelli di Pompeo, MD PhD.
Sapienza University of Rome, Rome, Italy.
Background: Prophylactic explantation of patients at high risk has not been yet indicated because of the low incidence of BIA-ALCL, the unproved efficacy and surgical related risk. BIA-ALCL risk (1:335-1:3.345) proved 3.000-300 times higher than the expected by Carcinogenic risk analysis (9:1,000,000) in patients with two textured/PU Silimed implants, and a presumed total max exposure of 3,026 Man Made Mineral Fiber (ICEAG 2016). Efficacy remains difficult to be calculate without proper trial, while Implant Related Mortality (IRM) can be. Methods: Mean age for 1st implant positioning (A1P), Implant Life Span (ILS) and Woman Life Expectancy (WLE) were obtained from literature. Implant Mortality Risk (IMR) was calculated as the intrahospital mortality after implantation, explantation or exchange, and investigated on 99,694 patients, matching three National Italian database (2012-2019). Results: Mean A1P in breast augmentation is 34yy, but not known in reconstruction. As the mean age for breast cancer is 62yy, with an augmentation/reconstruction ratio of 4:1, mean A1P regardless of indication can be presumed as 34x0.75+62x0.25=41yy. With a mean ILS of 9yy, and WLE 85yy, a woman on average will replace her implants 4 times; IRM risk was 0:99.964. Conclusion: Given the high Rupture (24-39%), Replantation (14% at 3yy, 49% at 10yy), and Reoperation (12%-71.5% at 10yy) rates, and a neglectable IMR of 0:99.964 vs a relevant BIA-ALCL mortality risk of 1:33,4, it should be possibly taken in consideration to explant patients at high risk to prevent BIA-ALCL since recall demonstrated not creating an additional burden on health care system in USA.
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