Evaluating Breast Implants Characteristics and Replacements in BIA-ALCL Onset: A Multicenter Case-Control study

Breast Implant-Associated Anaplastic Large Cell Lymphoma (BIA-ALCL) is an uncommon malignancy caused by textured implants. Specific implant characteristics or replacement patterns were investigated in relation to BIA-ALCL onset.

In this multicenter, retrospective case-control study, data were collected from 327 women (39±13 years) with breast implants and no malignancy, and 94 age-matched BIA-ALCL cases (1:4 matching), across one U.S. and two European centers. Surgery indication, implant manufacturer, volume, surface texture, indwelling time, and history of replacements were analyzed. Associations with BIA-ALCL were assessed using conditional logistic regression analysis.

All BIA-ALCL cases were linked to implant roughness >10µm. Implant volume was positively associated with 81% higher likelihood of BIA-ALCL (OR per 100cc= 1.81, 95%CI [1.35, 2.44]). Breast reconstruction was associated with 47% lower odds of BIA-ALCL compared to cosmetic augmentations (OR= 0.53, 95%CI [0.33, 0.85]). One implant replacement was associated with 82% lower likelihood of BIA-ALCL compared to no replacement (OR= 0.18, 95%CI [0.10, 0.31]). Replacing from textured to smooth (OR= 0.06; 95% CI [0.013, 0.303]) or smooth to textured implants (OR= 0.06; 95% CI [0.013, 0.303]) had significantly lower likelihood of BIA-ALCL, compared to receiving another textured implant.

Study findings of no BIA-ALCL association to specific manufacturers or to implant roughness <10µm, support the evidence that surgeons and patients should consider breast implant roughness in treatment decisions among primary or secondary asymptomatic patients.