Spain’s medicines agency has confirmed 111 cases of a rare lymphoma associated with breast implants, after reviewing suspected reports submitted through the country’s medical device surveillance system.
The Spanish Agency of Medicines and Medical Devices, known as AEMPS, said it had received 146 suspected reports of breast implant-associated anaplastic large cell lymphoma up to 2025, of which 111 had been confirmed. The first case was reported in 2012.
The figures were published in the agency’s sixth follow-up report on Spain’s protocol for detecting and studying the disease. AEMPS said the report is based on notifications received through the national Medical Devices Surveillance System.
Breast implant-associated anaplastic large cell lymphoma, also known as BIA-ALCL, is a rare type of non-Hodgkin lymphoma. It does not originate in breast tissue, but develops in immune system cells and is linked to the capsule of scar tissue that can form around an implant.
AEMPS said it has been closely monitoring the condition for several years, together with medical societies and competent authorities in other EU member states.
The agency said the clinical protocol is intended to improve detection, diagnosis and treatment, while also collecting information that could help assess the possible association between the disease and breast implants.
According to the report, the disease appears to have a stronger relationship with textured implants, which have been widely used in recent years. However, experts say its origin is likely to be multifactorial and the exact mechanism that triggers the lymphoma is still not fully understood.
Factors under study include the type of implant used, possible genetic predisposition, inflammatory processes and contamination associated with implants.
AEMPS stressed that BIA-ALCL remains rare, particularly when compared with the large number of women with breast implants. It also notes that, in most cases, the condition is less aggressive than forms of anaplastic large cell lymphoma not linked to implants and is often confined to the capsule surrounding the implant.
Madrid recorded the highest number of reports, followed by Andalusia, Catalonia and the Valencian Community.
Spanish health authorities said continued reporting by healthcare professionals and patients is essential to improve understanding of breast implant safety and support early detection.
Source: Euronews
