Guidance

Squamous cell carcinoma (SCC) and different types of lymphomas occurring in the capsule around breast implants

Published 7 August 2023

What we know

MHRA is aware of a very small number of cases of squamous cell carcinoma (SCC) and different types of lymphoma, found within the fibrous capsule that forms around breast implants. These have been reported worldwide and in published research. This is an emerging issue and the MHRA is closely monitoring for cases of SCC or lymphoma in the UK occurring in the capsule around breast implants. Cases of SCC or different types of lymphoma are extremely uncommon.

Cases have been seen with both silicone and saline filled, and smooth and textured implants. Due to the rarity of these cancers, there is insufficient information at this time to determine whether a certain population is more at risk, and no one type, or manufacturer of breast implants has been identified to be at higher risk.

SCC and the other types of lymphoma are different from Breast Implant Associated Anaplastic Large Cell Lymphoma (BIA-ALCL) and can occur in the breast of patients without breast implants.

The United States Food and Drug Administration (FDA) recently published an updated safety alert on this issue. We have been working closely with clinical stakeholders including the Association of Breast Surgery (ABS), British Association of Aesthetic Plastic Surgeons (BAAPS) and the British Association of Plastic, Reconstructive and Aesthetic Surgeons (BAPRAS). A joint statement by them has been published with further information, this can be viewed by accessing the links to the Associations webpages.

What we are doing

The MHRA are continuing to closely monitor for cases of SCC and other types of lymphoma and the published literature. We will promptly investigate any UK reports of these issues. We will continue to work closely with other regulators across the world and seek advice from the independent expert group, the Plastic, Reconstructive and Aesthetic Surgery Expert Advisory Group (PRASEAG) as appropriate.

We will make further updates to our recommendations to patients and healthcare professionals where necessary.

Current recommendations

Recommendations for patients

If you currently have breast implants:

  • Continue to routinely monitor your breasts for any changes to them including swelling, redness, or pain.
  • If you experience changes to your breasts or any symptoms go to your GP or implanting surgeon for advice.
  • If you develop a problem with your breast implant, report this to the MHRA via the Yellow Card scheme.

If you are considering having breast implants:

  • Ensure you obtain written information about breast implant surgery, including the benefits and possible complications. Read a guide to breast augmentation written by breast augmentation specialists.
  • Discuss the benefits and risks of breast implants with your healthcare professional.

Recommendations for healthcare professionals

If you are a surgeon performing breast implant surgery:

  • Include the potential risk and association of SCC and different types of lymphoma within the informed consent procedure for new patients.
  • Report any suspected or actual adverse incidents involving these devices through your healthcare institution’s local incident reporting system and/or your national incident reporting authority as appropriate: England and Wales. See further information on the information that should be provided.