Guidance update on Breast Implant Associated Anaplastic Large Cell Lymphoma (BIA-ALCL)

The guidance on Breast Implant Associated Anaplastic Large Cell Lymphoma (BIA-ALCL) has been updated.

This resource provides updated information for patients and healthcare professionals.

People with breast implants do not need to have them removed in the absence of any symptoms that have been associated with this uncommon form of cancer.

Advice for patients

• BIA-ALCL is uncommon, but it is important that you know about the risks if you already have, or are considering having, breast implants.
• It is important that patients who are considering surgery talk with their surgeon to discuss the benefits and risks as part of a shared decision-making process. You should make sure that you understand the risks involved before giving your informed consent to the treatment option that is right for you.
• If you have developed a problem with a breast implant you should tell your surgeon and GP and also report it through the MHRA Yellow Card Scheme.

Advice for healthcare professionals

• Clinicians shall discuss the potential risk of BIA-ALCL when seeking informed consent of new patients, and with any patient returning for review of their breast implants.
• It is important to report cases of BIA-ALCL to the MHRA through your healthcare institution’s local incident reporting system and/or your national incident reporting authority as appropriate: England, Scotland, Northern Ireland, Wales. This will enable us to build a better picture of the prevalence of this disease.
• You should ensure patient’s details are recorded in the Breast and Cosmetic Implant Registry (BCIR).

Please see the key changes to the webpage which includes:

1. New, clearer wording on symptoms to look out for.
2. Strengthened text on informed consent and risks.
3. Updated wording on what clinicians should report to the MHRA.
4. A link to MHRA’s independent Plastic, Reconstructive and Aesthetic Surgery Expert Advisory Group’s (PRASEAG) new guidance document (‘Information about BIA-ALCL for people with breast implants’) discussing benefits and risks as well as links to a range of clinical guidelines.
5. Updates to BIA-ALCL confirmed cases and the estimated incidence, as part of our yearly commitment and increased transparency.
6. Updates to global regulatory and scientific positions; namely the final opinion by the Scientific Committee on Health, Environmental and Emerging Risks (SCHEER) which recommends further research (SCHEER) which recommends further research.