The Spanish Agency of Medicines and Medical Devices (AEMPS) has recorded a total of 146 communications of suspected anaplastic large cell lymphoma (ALCL) related to breast implants in Spain up to 2025, of which 111 have been verified as confirmed cases.
This data is collected in the sixth monitoring report of the "Protocol for the detection and study of anaplastic large cell lymphoma (ALCL) associated with breast implants in Spain," which analyzes notifications sent since 2012 through the Medical Device Surveillance System.
The report details that, by autonomous communities, the majority of accumulated notifications up to 2025 come from Madrid, followed by Andalusia, Catalonia, and the Valencian Community.
The AEMPS has maintained for years a "close follow-up," in coordination with scientific societies and the competent authorities of the other member states of the European Union, of anaplastic large cell lymphoma (ALCL) linked to breast implants, also known as BIA-ALCL (Breast Implant-Associated Anaplastic Large Cell Lymphoma).
With the aim of optimizing early detection, diagnostic approach, and knowledge of this pathology, in February 2019 the Advisory Commission on Breast and Related Implants, along with specialists in Medical Oncology and Hematology and Hemotherapy, launched a specific protocol for the study of ALCL cases associated with breast implants. This document was reviewed and updated in 2024 to incorporate the most recent scientific evidence and advances in the management of this disease.
Among the goals of this clinical protocol are the identification of ALCL cases in women with breast implants, the definition of the actions that professionals should take in case of clinical suspicion to facilitate an adequate diagnosis, classification, and treatment, as well as the collection of data to assess a possible relationship between ALCL and breast implants.
Within the competencies of this commission is the analysis of the information gathered on confirmed cases of ALCL associated with breast implants that are reported to the AEMPS. The conclusions of this review are published annually in the corresponding monitoring report prepared by the Agency.
A rare non-Hodgkin lymphoma
According to the AEMPS, ALCL associated with breast implants constitutes a rare form of non-Hodgkin lymphoma that can affect various tissues, including the breast, in individuals carrying this type of prosthesis.
It is currently included within a group of lymphoproliferative disorders with a wide range of clinical presentations. The key criterion for diagnosis is the constant detection of malignant cells infiltrating the periprosthetic capsule or present in the periprosthetic fluid.
At present, it is considered that ALCL linked to breast implants has a multifactorial origin, in which three main elements could be involved: the type of implant, genetic predisposition, and possible contamination.
Ongoing research has not yet conclusively demonstrated a causal relationship between ALCL and breast implants (BIA-ALCL), nor has the cause or mechanism involved in the appearance of this lymphoma been fully clarified.
In cases of ALCL where the implant identification is available, it has been observed that the lymphoma appears more frequently in patients with textured breast implants than in those with smooth-surfaced implants. However, to date, no controlled clinical trials have been conducted that directly compare homogeneous groups of patients with smooth versus textured prostheses.
In March 2021, the Scientific Committee on Health, Environmental and Emerging Risks (SCHEER) issued a new opinion on the situation of ALCL associated with breast implants. Its conclusions indicate that breast implants continue to offer a reasonable guarantee of safety and efficacy, despite the increase in the incidence of reported cases in recent years.
Studies indicate a higher risk
Research from the Memorial Sloan Kettering Cancer Center (MSKCC) in the United States determined that women with breast cancer and mutations in the BRCA1 or BRCA2 genes who underwent breast reconstruction with textured implants after a mastectomy had a 16-fold higher risk of developing anaplastic large cell lymphoma associated with breast implants, a rare type of lymphatic system cancer, compared to those without such genetic alterations.
This is the first large-scale study to evaluate whether the incidence of LACG is higher in women carrying a mutation in BRCA, also responsible for between 5 and 10 percent of breast cancer cases. Having a harmful mutation in the BRCA1 or BRCA2 genes increases the likelihood of developing various tumors, including breast, ovarian, pancreatic, and certain skin cancers.
Previous research had already revealed a link between textured implants and the development of LACG, which led to their withdrawal from the European and US markets in 2019.