Question to the Department of Health and Social Care:

To ask the Secretary of State for Health and Social Care, what assessment he has made of the potential merits of a public inquiry into the safety of PIP breast implants.

There are currently no plans to commission a public inquiry into the safety of Poly Implant Prothèse (PIP) breast implants.

As part of the Medicines and Healthcare products Regulatory Agency’s (MHRA) market surveillance for medical devices, we worked with the National Health Service and other health partners to ensure the PIP issue was properly investigated. PIP breast implants were withdrawn from the market in 2010. It is important to note that while PIP implants are associated with a higher risk of rupture, leading to symptoms such as tenderness or swollen lymph glands, there is no evidence linking ruptured PIP implants to serious long-term health issues.

As with any medical device, breast implants do not come without risks. The current advice from the MHRA remains that anyone with a PIP breast implant should consult with their doctor about the possibility of removal. The NHS and MHRA provide guidance for patients on the available options for PIP implant removal. This is available at the following link:

https://www.nhs.uk/conditions/pip-implants/

Since PIP breast implants were withdrawn, two independent reviews have identified lessons learnt, specifically the Howe Review in 2012 and the Keogh Review in 2013. The health system has since enacted important changes. As a result of the Keogh Review, since 2016 the Breast and Cosmetic Implant Registry collects data on all types of breast implant and removal surgeries in England and Scotland, aiming to help detect emerging safety issues and trace patients if necessary.

The MHRA is developing a future regulatory framework for medical devices that will ensure that patients have access to the safe and effective medical devices they need. The first step is the introduction of new Post-Market Surveillance regulations, which will come into force in June, and will put in place strengthened legal requirements for how manufacturers monitor and report on their devices once they are being used in the real world. We intend to follow this with updates to the UK Medical Device Regulations later this year, which will bring further improvements to device traceability and patient safety by introducing additional measures that must be taken before a product can be placed on the market. This will include requirements for unique device identifiers, implant cards, new rules to ensure that claims are consistent with the intended purpose, and changes to the classification of some medical devices, such as implantables, to better reflect the potential risks to patients and ensure risk proportionate requirements for manufacturers.