Cosmetic Breast Augmentation Risk Awareness Tool

AI Summary

The Medicines and Healthcare products Regulatory Agency (MHRA) has introduced a new Cosmetic Breast Augmentation Risk Awareness Tool to enhance patient safety and informed decision-making. Launched as a pilot in August 2025, following a February 2025 evaluation of patient risk perceptions, this initiative addresses the critical need for clearer communication regarding the potential complications of breast implant surgery. The tool includes a risk checklist, an implant record tracker, and consultation notes, developed in alignment with major surgical associations like BAAPS and BAPRAS. The guidance identifies a gap in how risks are currently perceived and communicated to patients. To resolve this, the MHRA recommends that healthcare professionals and clinics provide the tool at the first point of patient contact. It is designed to supplement, not replace, the formal informed consent process by encouraging shared decision-making and detailed discussions between surgeons and patients. Required actions for healthcare providers include the immediate adoption of the tool in clinical practice and the provision of feedback to the MHRA (AIC@mhra.gov.uk) to evaluate its effectiveness during the pilot phase. Patients are advised to utilize the tool to research risks and record consultation details, ensuring they fully understand the implications of the procedure before proceeding.