111 Cases of Breast Implant-Associated Lymphoma Confirmed in Spain

The Spanish Agency of Medicines has received 146 notifications since 2012, with Madrid, Andalusia, and Catalonia reporting the highest number of cases.

Generic image of breast implant texture with blurred medical symbols.
IA

Generic image of breast implant texture with blurred medical symbols.

The Spanish Agency of Medicines and Medical Devices (AEMPS) has confirmed 111 cases of Breast Implant-Associated Anaplastic Large Cell Lymphoma (BIA-ALCL) in Spain since 2012.

The [Spanish Agency of Medicines and Medical Devices](https://www.aemps.gob.es/) (AEMPS) has reported that, as of 2025, 111 cases of Breast Implant-Associated Anaplastic Large Cell Lymphoma (BIA-ALCL) have been confirmed in Spain, based on 146 suspected cases notified since 2012. This rare type of non-Hodgkin lymphoma can affect various tissues, including the breast, in patients with breast implants, and is primarily associated with textured-surface implants, which have been most commonly used recently.
The autonomous community with the most notifications up to 2025 was Madrid, with 36 suspected cases and 25 confirmed. This is followed by Andalusia, with 24 notifications and 17 confirmed cases, and Catalonia, with 22 notifications and 16 confirmed cases. In 2025 alone, 10 notifications and 9 confirmed cases were recorded.
The AEMPS maintains close surveillance of this condition, also known as BIA-ALCL, in collaboration with medical societies and European authorities. This marks the sixth follow-up report from the protocol established for the detection and study of this disease in Spain.
To enhance the detection, diagnosis, and understanding of LACG, a protocol was developed in February 2019 and updated in 2024. This protocol guides healthcare professionals in identifying and treating cases, as well as in gathering relevant information.
According to the report, in 23 of the 111 confirmed cases, breast implants were placed for reconstruction after mastectomy, while in 45 cases, they were for aesthetic reasons. The indication for the remaining patients is not available.
A higher incidence of this lymphoma has been identified in textured-surface implants compared to smooth-surface ones. Of the 111 confirmed cases, 94 involved textured prostheses, 4 polyurethane, and the type of surface is unknown in 12 cases. Most cases showed a benign clinical course after implant removal, although four deaths associated with the condition have been reported in the medical device surveillance database.