Spain Reports 111 Confirmed Cases of Rare Breast Implant-Associated Lymphoma Since 2012 Monitoring Began

The Spanish Agency of Medicines and Medical Devices confirmed 111 cases of anaplastic large cell lymphoma associated with breast implants through 2025. The agency has also received 146 suspected reports of the condition since it began monitoring in 2012. The figures appear in the sixth follow-up report on the national protocol for the detection and study of breast implant-associated ALCL.

The report draws on notifications registered in the Medical Devices Vigilance System. Madrid recorded the highest number of reports among Spain’s autonomous communities. Andalusia, Catalonia and the Valencian Community followed with the next highest counts.

Breast implant-associated ALCL is an uncommon type of non-Hodgkin lymphoma that develops in immune system cells within the capsule of tissue surrounding an implant rather than in breast tissue itself. Aemps has conducted specific monitoring of the condition for years in coordination with medical societies and European health authorities.

The agency stated that breast implant-associated ALCL remains a rare disease and that its incidence stays low relative to the large number of women who have breast implants.

It stressed the need to maintain surveillance and improve early detection. Research conducted so far indicates a multifactorial origin. Factors under study include the type of implant, certain genetic predispositions, and possible inflammatory processes or contamination linked to the implant.

Experts noted that no definitive causal relationship has been established and that the precise mechanism triggering the lymphoma is still unknown.