Question to the Department of Health and Social Care:

To ask the Secretary of State for Health and Social Care, how many women have been affected by faulty PIP breast implants in Truro and Falmouth constituency.

The Breast and Cosmetic Implant Registry (BCIR), set up in 2016, collects all implant data, and explant data where possible.

Practically, it is always difficult and often impossible to identify a model and product code on an explant. If explanted devices, or patients undergoing explant, cannot be linked to data collected at time of implant, then this often reduces explant data to 'patient, surgeon, location, date'. This in turn makes it impossible to monitor trends in explant/failure.

NHS England is in the process of clarifying and mandating the detail required in the BCIR and other device-related collections. This will place a greater responsibility on trusts to either identify a device at the point of explant, or to identify the device from internal trust records created during the same patient's implant procedure.

This will only be possible if the implant and explant are performed at the same trust. It is then the intention of NHS England to provide the same matching service for implant/explant where the trusts differ.

This solution will, when implemented, give a full, proactive picture of device longevity/risk, for the purposes of research and surveillance, alongside the existing ability to identify patients affected by a device recall notice.

Alongside this work, as part of the its reforms to the Medical Devices Regulations 2002, the Medicines and Healthcare products Regulatory Agency (MHRA) has introduced updated requirements for the post-market surveillance of medical devices, including implants, enabling both the manufacturer and the MHRA to identify issues with medical devices more easily and where necessary, for the MHRA to take fast action to safeguard public health.

Later this year, the MHRA intends to introduce a requirement for clinicians to provide patients with an implant card and information regarding any warnings, precautions, or measures to be taken by the patient or healthcare professional. This will strengthen transparency and support patients in understanding their implants.