Chamber and committees

It is the responsibility of the MHRA to regulate medical devices in the UK, and the Scottish Government will act as necessary, according to its advice.

I refer the member to the answer to question S5W-07740 on 17 March 2017. All answers to written Parliamentary Questions are available on the Parliament's website, the search facility for which can be found at http://www.parliament.scot/parliamentarybusiness/28877.aspx

Neither Scottish Government Ministers nor officials have met with, or contacted, manufacturers in relation to mesh devices.

Until the Independent Review’s recommendations are published it is not possible to comment on them. In general terms, clinical research in Scotland is governed by the Scottish Executive Health Department Research Governance Framework for Health and Community Care, published in 2006. The RGF sets exacting and well established standards around the ethics, science, patient care, information, health and safety, finance and quality research culture for clinical research studies. It also details the responsibilities and accountabilities of key people and organisations involved in research studies to ensure robust governance arrangements are in place to assure these standards are maintained. The full document is available from the Scottish Government website.

http://www.gov.scot/Topics/Research/by-topic/health-community-care/chief-scientist-office/6864/6933.

Records suggest that there are fewer than five current legal cases involving the use of mesh to treat hernias.

Decisions around the circumstances in which the use of mesh in any individual patient’s treatment is appropriate are a matter between the patient and the clinicians involved in her case. The Independent Review is expected to publish its final report during the spring. Health Boards will take appropriate action depending on the report's recommendations.

Non-mesh treatments include both surgical and non-surgical interventions. Surgical interventions include the use of simple suture repairs or the use of host native tissue.

I understand that all relevant evidence available has been considered by the Review. The passage of time between the publication of the Interim Report and the forthcoming Final Report is due to the Review awaiting the publication of several key studies.

I refer the member to the answer to question S5W-07740 on 17 March 2017. All answers to written Parliamentary Questions are available on the Parliament's website, the search facility for which can be found at http://www.parliament.scot/parliamentarybusiness/28877.aspx

Informed consent and shared decision making are expected prior to any procedure being carried out. The Chief Medical Officer goes into this in more detail in her Realistic Medicine report.

http://www.gov.scot/Resource/0051/00514513.pdf.