The Medicines and Healthcare products Regulatory Agency (MHRA) is the UK regulator responsible for breast implants as medical devices. It sets standards, monitors safety and issues guidance.
Key MHRA roles and guidance
- Requiring implants to meet safety and quality standards before use.
- Collecting adverse-incident reports and running the implant registry.
- Publishing guidance on BIA-ALCL, including UK case numbers and reporting rates.
- Guidance on symptoms reported as breast implant illness, noting the current absence of a single recognised disease and ongoing research.
Reporting concerns
Patients and clinicians can report problems with implants to the MHRA via the Yellow Card scheme, which helps build the evidence base. See safety updates.