To ask the Secretary of State for Health and Social Care, what assessment his Department of the implications for his policies of France's National Agency for Medicines and Health Products' decision to ban macro-textured and polyurethane breast implants for cosmetic and reconstructive surgery.
Answered on
11 April 2019
The Medicines and Healthcare products Regulatory Agency (MHRA) is responsible for regulating medical devices in the United Kingdom.
The Agency is aware of the French National Agency for Medicines and Health Products’ (ANSM) announcement restricting the use of certain types of breast implants. This does not include all macro-textured breast implants on the French market.
France has said its approach is a precautionary measure as part of their ongoing investigation into Breast Implant Associated- Anaplastic Large Cell Lymphoma. This action goes further than the recommendations of ANSM’s own expert panel in February 2019.
Based on an analysis of the scientific evidence available and independent expert clinical advice received, it was confirmed there was no new evidence which would change the United Kingdom Regulator’s view, because there was nothing to indicate any increased risk to patients with these implants over what is already known.
At this time, the MHRA’s position is consistent with all other European Union member states.
The MHRA’s advice continues to be, if people have any questions about their implants, they should speak to their implanting surgeon or general practitioner.