Leah Cambridge

Dear Sir/Madam, Lam writing in connection with the above matter_ have received and read the Regulation 28 report and Record of Inquest and hereby comply with your response deadline of Ist February 2020 With regards to your concerns, recommendations of actions and response, would like to respond and confirm that the trading vehicle that I operated (Elite Aftercare Turizm Seyahat Tasimacilik Ve Pazarlama Ic ve Dis Ticaret Ltd) has ceased trading since the conclusion of the inquest. would be interested to see the recommendations of the other parties that you have contacted such as The Royal College of Surgeons and The British Association of Aesthetic and Plastic Surgeons this email satisfies your requirements, but please feel free to contact me with any further information you may require _

Dear Mr McLoughlin, Coroner regulation 28 letter – Leah Cambridge I am writing in response to your letter following the tragic death of Leah Cambridge after undergoing a Brazilian lift cosmetic procedure. May I add my condolences to Leah’s partner, her three children and their families and friends at this difficult time. It’s vital that we work together to do everything we can to improve patient safety in her memory. The General Medical Council (GMC) is an independent UK healthcare regulator that helps to protect patients and improve medical education and practice across the UK.
• We decide which doctors are qualified to work here and we oversee UK medical education and training.
• We set the standards that doctors need to follow, and make sure that they continue to meet these standards throughout their careers.
• We take action to prevent a doctor from putting the safety of patients, or the public's confidence in doctors, at risk. Every patient should receive a high standard of care. Our role is to help achieve that by working closely with doctors, employers and patients, to make sure that the trust patients have in their doctors is fully justified. Thank you for sharing a copy of your report, which I have read. The GMC shares your concerns about the three important issues you have raised in relation to this case and I will address each of these in turn. Control and intervention by regulatory authorities where clinics undertake such procedures in the UK or refer patients overseas. We are aware of the British Association of Aesthetic Plastic Surgeons (BAAPS) voluntary moratorium on these procedures and it is right that they are considering these issues in the interests of patient safety.

Our guidance is clear that doctors must provide treatments based on the best available evidence. If a doctor believes a cosmetic intervention is unlikely to deliver the desired outcome, or be of benefit to the patient, they must not provide it. It is important to reduce risks for patients from cosmetic surgery practice and we’ve had extensive discussions with organisations such as the Nuffield Trust and the Royal College of Surgeons (England) to better understand how we can achieve this. The insights they shared with us helped to inform the development of the framework for GMC-regulated credentials launched in June 2019. This defines GMC-regulated credentials as discrete areas of practice where gaps in training or service have raised concerns about patient safety. Cosmetic surgery is an area of practice that has been prioritised for a GMC regulated credential (see below for fuller details). If there are any serious concerns about the fitness to practise of individual doctors registered with the GMC to work in the UK, we have the power to investigate and take any appropriate action to protect the public. If you have any specific concerns about named doctors please let us know so we can establish if they are registered with the GMC and consider if there are grounds to investigate. Doctors registered with the GMC may also work in other countries and we can take action to deal with concerns about their fitness to practise arising from activity anywhere in the world. You express understandable concern about organisations based in the UK referring patients overseas for cosmetic procedures. Concerns about the activity of independent clinics based in the UK arising from this case should be referred to the systems regulators and improvement bodies to consider. These are different in each of the jurisdictions of the UK: the Care Quality Commission (in England), Healthcare Improvement Scotland, Healthcare Inspectorate Wales and the Regulatory Quality and Improvement Authority (in Northern Ireland). Whilst I understand you are advocating for legislative change to prohibit this procedure, we do not have powers to create legislation or outlaw specific treatments. I know you have written to the Secretary of State for Health and Social Care about this. Information for patients to enable them to make an informed decision to consent before committing to surgery or incurring expense. It’s critical that patients receive all the information they need about the risks of harm and potential complications involved in such invasive treatments. Our core guidance for doctors Good medical practice (2013) sets out the principles of good practice. We also publish a range of supporting explanatory guidance, including guidance on consent, which emphasises the importance of giving patients the information they want or need, in a way they can understand, in order to support them in making decisions about their care. We also make clear that consent is an ongoing process and does not end when the patient signs a form.

We will be publishing a revised version of the guidance later this year which will place even greater emphasis on giving adequate time for a patient to digest the information and reach a decision about treatment. It will be supported by tailored materials for specialties where we know there are issues with applying the guidance in practice. Our guidance for doctors who offer cosmetic interventions also clearly states that doctors must discuss risks in advance, must give patients time for reflection and must be satisfied that the procedure will be of benefit to the patient. Paras 17-18 say:
17. If a patient requests an intervention, you must follow the guidance in Consent, including consideration of the patient’s medical history. You must ask the patient why they would like to have the intervention and the outcome they hope for, before assessing whether the intervention is appropriate and likely to meet their needs.
18. If you believe the intervention is unlikely to deliver the desired outcome or to be of overall benefit to the patient, you must discuss this with the patient and explain your reasoning. If, after discussion, you still believe the intervention will not be of benefit to the patient, you must not provide it. You should discuss other options available to the patient and respect their right to seek a second opinion. Our guidance on financial and commercial arrangements and conflicts of interest says doctors should tell patients about their fees before seeking consent to treatment. A serious or persistent failure to follow our guidance may give rise to a fitness to practise concern. Finally, we also publish a leaflet for patients to raise awareness of the things to consider when seeking cosmetic treatment abroad. We urge those who seek care abroad to consider whether the standard will match that which we expect of doctors in the UK. The need for guidance on surgical techniques and information to be provided to patients before they give consent We expect doctors to keep up their professional knowledge and skills up to date and work within the limits of their competence. We do not provide clinical guidance on surgical techniques, that is the role of other bodies such as the Royal Colleges of Surgeons.

We expect doctors to use their judgement when applying the high-level principles in our guidance on consent (as above) in their interactions with patients. Further information You may find it helpful to consider the following additional information: a the work we are doing to reduce risks to patients undergoing cosmetic surgery through credentialing. b regulatory oversight of doctors in Turkey Reducing the risk to patients posed by cosmetic surgery through credentialing

We began a phased introduction of GMC-regulated credentials late last year, starting with five early adopters in priority areas. These are currently going through our approval processes, to allow us to test and learn if any changes are needed to the credentialing framework or to our processes. One of the early adopters we are working with is a proposal from the Royal College of Surgeons (England) on cosmetic surgery. We have been working with the College as they prepare their submission, and we expect it to enter our approval processes later in 2020. We have set up task and finish groups to allow stakeholders from the profession, government and training organisations to help review the first credentials and input into processes. We will also hold a review point once the early adopter credentials have been through the approval processes, allowing further engagement and evaluation, before we proceed with accepting more submissions for future credentials. Alongside this work, we are considering how to identify and prioritise areas for future GMC-regulated credentials. In the meantime, we are continuing conversations with organisations interested in putting forward a proposal for a credential. While GMC-regulated credentials may help clarify the capabilities of some doctors performing cosmetic surgical interventions, there are wider regulatory and social changes necessary to protect people from cosmetic surgery risks such as better regulation of sites, devices and more explicit expectations about communicating these risks with potential clients. GMC-regulated credentials will not be mandatory for doctors working in a specific area of practice, as the GMC does not have the legal authority to make any postgraduate training mandatory, including credentials. This is similar to working in a specialty, where it is not a requirement for a doctor to have specialist registration in an area of practice, to work in that area. Regulatory oversight of doctors in Turkey

I have outlined our role in investigating concerns about doctors who are registered

with the GMC, working anywhere in the world. If you have any concerns about the fitness to practise of individual, named doctors working in Turkey who are not registered with the GMC you should notify the relevant medical regulator as set out below. Medical regulation in Turkey is split between the Ministry of Health and the Turkish Medical Association. If a doctor has only worked in the public sector in Turkey and has chosen not to join the Medical Association, the Ministry of Health is their regulator. If they work in the private sector their regulator is the Medical Association. Contact details are provided below: Turkish Medical Association

Tel. 0090 312 2313179 GMK Bulvari Sehit Danis Tunaligil Sok No 2 / 17-23 Maltepe Ankara 06570 Ministry of Health

Tel. 0090 312 585 67 00 Kültür Mah. İçel Sokak No: 2 Kızılay-Çankaya Ankara 06420

I hope this information is of some assistance to you.