Final opinion on the safety of breast implants in relation to anaplastic large cell lymphoma: Report of the scientific committee on health, emerging and environmental risks (SCHEER)

The Scientific Committee on Health, Environmental and Emerging Risks (SCHEER) was requested by the European Commission (EC) to provide a scientific opinion on the safety of breast implants in relation to anaplastic large cell lymphoma (ALCL). There are several types of textured breast implants; surface textures of breast implants are not all manufactured in the same way, and breast implants with diverse surface textures may also present different benefits. The magnitude of the risk per type of textured implant is difficult to establish due to the low incidence of the breast implants associated anaplastic large cell lymphoma (BIA-ALCL). Therefore, risk assessments per implant type are needed. Overall SCHEER considers that there is a moderate weight of evidence for a causal relationship between textured breast implants and BIA-ALCL, particularly in relation to implants with an intermediate to high surface roughness.The pathogenic mechanisms are not fully elucidated; current hypotheses include genetic drivers, chronic inflammation resulting either from bacterial contamination, shell shedding of particulates, or shell surface characteristics leading to friction, or by implant associated reactive compounds. Reporting of new BIAALCL cases by the national clinical registries is critically important to obtain a better estimate of the risk of BIAALCL for patients with a breast implant.

Automated summary

The SCHEER was requested to provide a scientific opinion on the safety of breast implants in relation to ALCL by the EC. Different surface textures of breast implants may present different risks, but the causality between textured breast implants and BIA-ALCL is considered moderate. New cases reported by national clinical registries are crucial for estimating the risk of BIA-ALCL.