Cosmetic Breast Augmentation Risk Awareness Tool
New Cosmetic Breast Augmentation Risk Awareness Tool for patients to use when considering cosmetic breast implant surgery.
Supporting informed decisions about breast implants
The MHRA has developed a new risk awareness tool to help people considering cosmetic breast augmentation to understand the risks and make informed choices. This follows a project by the MHRA to understand perceptions of risk, which highlighted the need for clearer communication about risks.
The risk awareness tool is designed for patients considering cosmetic breast augmentation. It can also be used by surgeons during consultations. We recommend that the risk awareness tool is provided to patients at their first consultation or at their first contact with a hospital or clinic about breast augmentation surgery.
What does the risk awareness tool provide
The Cosmetic Breast Augmentation Risk Awareness Tool includes:
- a checklist of the known potential risks with breast implants
- the potential risks of surgery
- information to take into account when considering breast augmentation surgery
It also provides
- a breast implant record section, which can be used to record details regarding the patients appointments, consultations, planned surgery and implant details
- a notes section for patients to record any useful information from consultations or to note any questions that they would like to ask their surgeon during the consultation.
The information is aligned with the Your Guide to Breast Augmentation information sheet written by the Association of Breast Surgery (ABS), British Association of Aesthetic Plastic Surgeons (BAAPS) and the British Association of Plastic, Reconstructive and Aesthetic Surgeons (BAPRAS).
How to use the risk information tool
The tool can be used alongside the information leaflet for a more detailed description of the risks. The tool is not designed to replace the informed consent procedure between the patient and their surgeon. It can support detailed conversations about potential risks during consultations.
What patients told us
We asked for feedback from a group of patients during the development of the risk information tool. Patients said it helped them feel more informed and prepared. Patients agreed the tool had two main uses:
- for surgeons to give to potential patients at their first consultation
- as an online resource for individuals to focus their own research.
The engagement exercise recommended that clinics and surgeons should be encouraged to adopt the tool as soon as possible.
MHRA recommendations
Advice for patients:
- Before you have breast implant surgery, talk with your surgeon to discuss the benefits and risks as part of a shared decision-making process.
- Make sure that you fully understand the risks involved before giving your informed consent to the treatment option that is right for you.
- If you are considering breast implant surgery, download the Cosmetic Breast Augmentation Risk Awareness Tool to help you understand the potential risks associated with breast implants and augmentation surgery.
- You can also use it to support discussions during your consultations with your surgeon. Your surgeon may also provide you with the tool.
- Read the Your Guide to Breast Augmentation information sheet for further detail about the current known risks associated with breast implants and cosmetic augmentation surgery.
Advice for healthcare professionals:
- Provide your patients with the risk awareness tool at their first consultation or when they first contact your hospital or clinic.
- Discuss the benefits and risks of breast augmentation surgery with your patient as part of the shared decision-making process; this risk awareness tool can be used to support these discussions
Provide feedback on the Cosmetic Breast Augmentation Risk Awareness Tool
In August 2025 the MHRA launched a pilot of the Cosmetic Breast Augmentation Risk Awareness Tool.
As part of the pilot exercise, we have written to key stakeholders to inform them of our recommendation to use the tool and to invite them to participate in the pilot. This includes the ABS, BAAPs and BAPRAS and private clinics.
We will be monitoring feedback on the use of the tool in clinical practice to assess its effectiveness. Please provide any feedback to AIC@mhra.gov.uk.
Documents
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