As most case series contain data for fewer than 100 patients with BIA ALCL, it is, unfortunately, difficult to accurately define the incidence of the disease.

Two of the larger studies evaluating the risk of BIA ALCL have come from the Netherlands. de Jong et al reported 11 cases of BIA ALCL in the Netherlands between 1990 and 2006.8 These patients were diagnosed at a median age of 40 years, though the age ranged from 24 to 68. All patients had implants for cosmetic reasons only.

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Compared with women without breast implants, there was an 18-fold increased risk of ALCL in the breast in those with implants. Yet while this increased risk appears high, one should note the overall number of women included in the study (close to 9 million) and the study period (17 years). This risk translates, roughly, to 1 to 3 cases per 1,000,000 women per year.

In another study conducted in the Netherlands, the authors reported a cumulative risk of breast-ALCL in women with implants at 29 and 82 per 1,000,000 at age 50 and 70 years, respectively.4

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A large retrospective study conducted in the United States identified 100 cases between 1996 and 2015.9 The mean age at diagnosis was 53 years, with an average time from implant to diagnosis of close to 11 years. The incidence rate was about 2 per 1,000,000 person-years, which was 68 times the risk of primary ALCL of the breast in those without implants.

Regardless of the indication and type of implant, patients who undergo this cosmetic procedure should be counseled on the increased risk of BIA ALCL, though the absolute risk is low.


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