Patient Perception of Risk Project

The MHRA has worked with a research organisation to understand how people having breast implant surgery perceive risks around their implants. Our work specifically focused on Breast Implant Associated-Anaplastic Large Cell Lymphoma (BIA-ALCL).

Specific objectives were:

exploring what risk and safety information patients received throughout the surgery pathway
understanding how patients process and use this information
exploring the range of competing priorities and influences on awareness and conceptualisation of risks.

This research aimed to inform our continued work to better understand patient perception of risk and to take forward improved risk communication systems around these medical devices.

This research study consisted of in-depth interviews and surveys with people who have had or were planning to have breast implant surgery. This included a mix of patients who had undergone cosmetic breast surgery, revision surgery and breast reconstruction surgery. The full report can be found below.

Key Findings

The research found that whether for cosmetic, revision or reconstructive surgeries, most people who were interviewed were highly motivated to have breast implant surgery. Many participants noted they sourced information from social media and tended to focus on the surgery and recovery period rather than the potential risks of having implants.

Many people in the study struggled to recall any information on the risks of breast implant surgery. In some cases, people may have received information about these risks, but they did not recall the details. Therefore, the research agency concluded from their findings that there were opportunities to improve risk communication.

We have reviewed the findings from the research and, in collaboration with the Plastic, Reconstructive and Aesthetic Surgery Expert Advisory Group (PRASEAG), formulated an action plan to improve the systems for communication of risk for people receiving breast implants.

Action Plan:

To explore and make available tools that will support the risks of breast implants to be better verbally communicated to patients
To develop better written information available to patients regarding the risks of breast implants

The aim is to improve how the risks of breast implants are communicated to patients both via the written information received and in verbal discussion throughout the patient’s surgical pathway.

Our response

We have worked with manufacturers to ensure that the risks of BIA-ALCL are detailed in the implants Instructions For Use (IFU) and patient brochures.

We recommend that prospective individuals are provided with information about breast implant surgery and possible complications either in written format or via an online link to information sheets jointly written by the Association of Breast Surgery (ABS), the British Association of Aesthetic Plastic Surgeons (BAAPS) and the British Association of Plastic, Reconstructive and Aesthetic Surgeons (BAPRAS).

The MHRA is introducing requirements for manufacturers to provide implant cards as part of the the future regulatory framework for medical devices.This will enable patients to know which device they have had implanted.

We have developed a Cosmetic Breast Augmentation Risk Awareness Tool to help improve how the risks of breast implants are communicated to patients via written information and to support the verbal discussions about risk with their surgeon during consultations. We recommend that the risk awareness tool is provided to patients at their first consultation or at their first contact with their hospital or clinic.

Ongoing Work

We are looking to develop a similar tool for breast reconstruction surgery.

We are engaging with private clinics and other stakeholders to ensure responsible communication of risks regarding implants and surgery.

Documents

Perceptions of risks associated with breast implant surgery Report, Revealing Reality July 2022

PDF, 713 KB, 28 pages

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Cosmetic Breast Augmentation Risk Awareness Tool

Breast implant associated anaplastic large cell lymphoma (BIA-ALCL)

Symptoms sometimes referred to as Breast Implant Illness

Breast implants – patient perception of risk research