The Ministry of Health reports 102 cases of rare lymphoma associated with breast implants.

The Spanish Agency for Medicines and Health Products (AEMPS), which is part of the Ministry of Health, has reported 137 suspected cases , 102 of which are confirmed , of anaplastic large cell lymphoma associated with breast implants since monitoring was implemented a decade ago.

Most cases of anaplastic large cell lymphoma (ALCL) had a benign clinical course after removal of the periprosthetic capsule and implants, although some required associated treatment, depending on the clinical stage. However, four cases of death have been reported to the medical device surveillance database.

The Spanish National Health Service (AEMPS) reminds us that "ALCL associated with breast implants is a rare disease" and that breast implants carry inherent risks, including common events such as rupture and contracture, or more remote ones such as ALCL.

"Breast implants are not lifelong products, and they may very well require replacement over time. Therefore, it is vital that people undergoing breast implant surgery be properly informed and counseled before making their decision," the report states.

By 2024, the region with the most notifications was Madrid, with 24 confirmed cases out of 35 notifications , followed by Andalusia with 15 confirmed cases out of 22 reported.

The indication for breast implants in 23 of the 102 confirmed cases was the need for reconstruction after mastectomy, and in 43 cases it was for cosmetic reasons. In the remaining cases, information on the indication for implant placement is not available.

In cases of associated ALCL, it has been identified that it is more frequently associated with breast implants with a textured shell than with smooth ones. However, it should be noted that until a few years ago, these were also the most commonly used breast implants. Of the 102 confirmed cases, 88 involved implants with a textured shell , 2 were polyurethane, and in 12 cases, the type of shell was unknown.

This alert system, developed in collaboration with medical societies and other Member States of the European Union (EU), closely monitors breast implant-associated anaplastic large cell lymphoma (BIA-ALCL).

The report is prepared as part of the Agency's actions derived from the protocol for the detection and study of ALCL cases associated with breast implants, developed in February 2019 by the Advisory Committee on Breast Implants and Related Diseases, together with experts in medical oncology and hematology and hemotherapy, which was updated in 2024 taking into account the latest publications and advances regarding this disease.

The objectives of this clinical protocol are to detect cases of ALCL associated with breast implants ; to establish the steps healthcare professionals should follow in the event of suspected ALCL associated with breast implants, for proper diagnosis, identification, and subsequent treatment; and to gather information to assess a possible association between ALCL and breast implant implantation.

The Spanish Agency for Medicines and Health Products (AEMPS), which is part of the Ministry of Health, has reported 137 suspected cases , 102 of which are confirmed , of anaplastic large cell lymphoma associated with breast implants since monitoring was implemented a decade ago.