Spain’s AEMPS Reports on Rare Lymphoma Linked to Breast Implants

The Agencia Española de Medicamentos y Productos Sanitarios (AEMPS) has confirmed 111 cases of breast implant-associated anaplastic large cell lymphoma (BIA-ALCL) since 2004, with 146 suspected cases reported according to its sixth follow-up report on the protocol for detecting this condition. The report, published on June 3, 2026, highlights the agency’s ongoing monitoring of this rare form of non-Hodgkin lymphoma linked to breast implants.

Key Statistics from AEMPS Report

• As of 2025, 10 suspected cases were reported, with nine confirmed.
• Of the 111 confirmed cases, 94 were associated with textured implants, four with polyurethane-coated implants, and 12 with unspecified implant types.
• The Comunidad de Madrid reported the highest number of confirmed cases (25 out of 36 notifications), followed by Andalucía (17 out of 24) and Catalunya (16 out of 22).

Understanding BIA-ALCL

BIA-ALCL is a rare lymphoma that can develop in women with breast implants. The AEMPS explains that the disease occurs when malignant cells infiltrate the fibrous capsule surrounding the implant or accumulate in the fluid near it. While the exact cause remains unclear, the agency notes that textured implants are more frequently associated with this condition.

Medical Response and Patient Care

The AEMPS reports that the clinical outcome for most patients has been favorable. In many cases, removal of the implants and the surrounding capsule was sufficient to control the disease, though some patients required additional treatments based on the lymphoma’s progression at the time of diagnosis.

Monitoring and Regulatory Actions

The AEMPS has maintained a strict surveillance system for BIA-ALCL since 2019, in collaboration with medical societies and European health authorities. The agency emphasizes the importance of continued monitoring to better understand risk factors and improve early detection.

Accessing AEMPS Resources

For detailed information, the AEMPS provides resources such as the sixth follow-up report and the CIMA database, which offers comprehensive data on pharmaceutical products and medical devices.

Patients and healthcare providers are encouraged to consult these resources for the latest updates on BIA-ALCL and implant safety.