Dr Julian Lewis: To ask the Secretary of State for Health and Social Care, what steps he will take to ensure patients giving consent to having bodily implants are fully informed of the health risks caused by implanted materials, with particular reference to (a) autoimmune disease and (b) fibromyalgia; and if he will make a statement.  [83224]

[Due for Answer on 2 December. Answered on 14 December.] 

HOLDING ANSWER: The Department of Health and Social Care has indicated that it will not be possible to answer this question within the usual time period. An answer is being prepared and will be provided as soon as it is available.

ANSWER

The Minister of State for Health (Edward Argar): The General Medical Council’s revised guidance ‘Decision making and consent’ came into effect in November 2020. The guidance specifies that doctors must give patients the information, time and support needed to make an informed decision about their treatment. As part of its consultation on the reform of medical device regulation in the United Kingdom, the Medicines and Healthcare products Regulatory Agency is currently considering what information should be provided to the patient at the point of consent and on receipt of the implant. The new regulatory approach is not yet finalised but the information considered includes warnings, precautions or measures to be taken by the patient or a healthcare professional and a caution that risk may emerge during use of an implantable device, including, where appropriate, on autoimmune disease and fibromyalgia. More information on the outcome of the consultation is expected to be published in early 2022. The Department is putting in place mechanisms to ensure that the patient voice is routinely heard. This includes the creation of a statutory role of the Patient Safety Commissioner.