Prevention of Future Deaths reports · 2019
Regulation 28 report to prevent future deaths, reference 2019-0408, written 29 Nov 2019. A coroner writes one of these when an inquest reveals a risk that could cause further deaths unless something changes.
| Date of report | 29 Nov 2019 |
|---|---|
| Reference | 2019-0408 |
| Deceased | Leah Cambridge |
| Coroner | Kevin McLoughlin |
| Coroner area | West Yorkshire (East) |
| Category | Hospital Death (Clinical Procedures and medical management) related deaths |
| Source | judiciary.uk record · original PDF |
| Responses published | 3 |
Text extracted from the PDF text layer. Reproduced verbatim, including the scan's own layout.
ANNEX A
REGULATION 28: REPORT TO PREVENT FUTURE DEATHS (1)
NOTE: This form is to be used after an inquest.
REGULATION 28 REPORT TO PREVENT FUTURE DEATHS
THIS REPORT IS BEING SENT TO:
1.
C/O Joseph Hill, Solicitors, 220 High Road, Tottenham,
London N15 5AJ
2. The Secretary of State for Health, Mr Mathew Hancock
3. The General Medical Council
1
CORONER
I am Kevin McLoughlin, Senior Coroner, West Yorkshire (East), for the Coroner area of
West Yorkshire.
2
CORONER’S LEGAL POWERS
I make this report under paragraph 7, Schedule 5, of the Coroners and Justice Act 2009
and regulations 28 and 29 of the Coroners (Investigations) Regulations 2013.
3
INVESTIGATION and INQUEST
On 5 September 2018 an investigation was commenced into the death of LEAH LOUISE
CAMBRIDGE aged 29. The investigation concluded at the end of the Inquest on 22
November 2019. The conclusion of the Inquest was a narrative. The medical cause of
death was:
1a Adipose tissue (fat) embolism.
1b Cosmetic surgical procedure.
4
CIRCUMSTANCES OF THE DEATH
Leah L Cambridge aged 29 travelled to Izmir Turkey to undergo a cosmetic surgical
procedure under general anaesthetic, known as a Brazilian Butt Lift (‘BBL’).
The surgery commenced on Monday 27 August 2018 some 90 minutes after she was
admitted to the hospital at 08:17 hours. The BBL entailed harvesting fat from her
stomach using liposuction and then reinserting the fat, (once purified) into her buttocks
and thighs using a cannula. A complication arose during the procedure resulting in her
being pronounced dead at approximately 13:00 hours the same day. A post mortem
examination carried out in England revealed some fat had entered veins in her body
leading to a fat embolism, which then caused her death.
Evidence provided at the Inquest from an expert plastic surgeon indicated BBL
procedures involve risks considerably greater than any other cosmetic procedure. In
consequence, a reputable professional association of plastic surgeons in the UK has
declared a voluntary moratorium on BBLs.
The Inquest found that she was asked to sign her name some three dozen times on
pages of documents written in Turkish and English without being afforded time to read
and digest the contents. As the risks had not been adequately explained to her she
undertook the BBL procedure without appreciating the risks involved.
1
5
CORONER’S CONCERNS
During the course of the Inquest evidence revealed matters giving rise to concern. In my
opinion there is a risk that future deaths will occur unless action is taken. In the
circumstances it is my statutory duty to report to you.
The MATTERS OF CONCERN are as follows. –
(1) Notwithstanding
(a) the death of Ms Cambridge on 27.8.18; and
(b) concerns expressed in relation to the risks involved in BBL procedures
by a task force established under the auspices of the Aesthetic Surgery
Education and Research Foundation (ASERF); and
(c) a voluntary moratorium declared by the British Association of Aesthetic and
Plastic Surgeons (‘BAAPS’)
The Inquest heard evidence that some plastic surgeons in the UK continue to carry
out BBL procedures. Furthermore, that Elite Aftercare continue to facilitate other
clients to travel to Turkey for the purpose of BBL procedures to be undertaken by
surgeons such as
.
I am concerned at the lack of intervention and control of BBL procedures by the
regulatory authorities in the UK.
(2) In order to make an informed decision as to the wisdom of undertaking effective
cosmetic surgical procedures such as BBL, it is important that the person involved
receive adequate information regarding the mortality and morbidity risks involved.
In order to read and absorb such information it needs to be provided prior to any
commitment being made or expense incurred. The Inquest into the death of Ms
Cambridge heard that she was provided with a substantial quantity of material (some
of which was written in Turkish) on the morning of the surgery and required to sign
each page. The Inquest found she had insufficient time to digest this complex
material, even if she was in a frame of mind to try, shortly before being taken to
theatre. My concern is that informed consent is not obtained.
(3) If BBL procedures continue to be permitted in the UK, I consider there is a need for
the regulatory authorities to consider providing guidance on the surgical techniques to
be employed and the information to be provided before a person incurs expense.
6
ACTION SHOULD BE TAKEN
In my opinion action should be taken to prevent future deaths and I believe you and your
organisation have the power to take such action.
7
YOUR RESPONSE
You are under a duty to respond to this report within 56 days of the date of this report,
namely by 1 February 2020. I, the Coroner, may extend the period.
Your response must contain details of action taken or proposed to be taken, setting out
the timetable for action. Otherwise you must explain why no action is proposed.
8
COPIES and PUBLICATION
I have sent a copy of my report to the Chief Coroner and to the following Interested
Persons, the family of Leah Louise Cambridge.
I have also sent it to the following who may find it useful or of interest.
1.
British Association of Aesthetic and Plastic Surgeons (BAAPS) F.A.O.
2
, The Royal College of Surgeons of England, 34-43 Lincoln’s Inn Fields,
London WC2A 3PE.
2.
, Hospital of St John and St Elizabeth, 60 Grove End Road, St
John’s Wood, London NW8 9NH.
3. The American Society of Aesthetic and Plastic Surgeons (ASAPS).
4.
5.
o, 38 Newbury Street, Boston, Mass 02116, USA.
, Izmir Ozel Can Hastanesi, Ataşehir Mahallesi, 8019/16. Sk. No:18,
35630 Çiğli/İzmir, TURKEY
6.
r, Izmir Ozel Can Hastanesi, Ataşehir Mahallesi, 8019/16. Sk.
No:18, 35630 Çiğli/İzmir, TURKEY
7. BBC
8. Yorkshire Post Newspapers
I am also under a duty to send the Chief Coroner a copy of your response.
The Chief Coroner may publish either or both in a complete or redacted or summary
form. He may send a copy of this report to any person who he believes may find it useful
or of interest. You may make representations to me, the coroner, at the time of your
response, about the release or the publication of your response by the Chief Coroner.
9
[DATE] [SIGNED BY CORONER]
29 November 2019
3
3 responses published against this report on judiciary.uk. A response is a body's written reply to the coroner's concerns; publication is at the discretion of the Chief Coroner's office, so an absent response does not mean nobody replied.
a Dr From: Sent: 29 January 2020 13:12 To: Baker, Sharon Subject: RE: LEAH LOUISE CAMBRIDGE Dear Sir/Madam, I am writing in connection with the above matter. I have received and read the Regulation 28 report and Record of Inquest and hereby comply with your response deadline of 1st February 2020 With regards to your concerns, recommendations of actions and response, I 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. I 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. I hope this email satisfies your requirements, but please feel free to contact me with any further information you may require. Yours _ Wakefield Council spam filter - powered by Forcepoint. Click here to report this email as spam.
¢ From Nadine Dorries MP Parliamentary Under Secretary of State for Mental Health, Department Suicide Prevention and Patient Safely of Health & i 39 Victoria Street Social Care saint Sel SW1H OEU 020 7210 4850: Your Ref: 15961 Our Ref: PFD-1197564 Mr Kevin McLoughlin HM Senior Coroner, West Yorkshire (Eastern District) HM Coroner's Office and Court 71 Northgate Wakefield WF1 3BS 24 tL January 2020 Dose My Noor, Thank you for your correspondence of 29 November 2019 to Matt Hancock about the death of Miss Leah Louise Cambridge. | am replying as Minister with responsibility for cosmetic regulation. Firstly, | would like to say how very sorry | was to read of Miss Cambridge's death and the circumstances that led to this tragic event. | can only begin to imagine the pain and heartache this will have caused to those who knew and loved Leah, and | hope her family will accept my sincere condolences. | share your concerns about the risks associated with undertaking cosmetic procedures abroad and in particular, the gluteal fat grafting procedure, commonly known as the ‘Brazilian Buttlift’, for which | understand the risks are considerably greater than other cosmetic procedures. The Department is awaiting the findings of research and advice being prepared by the US- based Inter-Society Gluteal Fat Grafting Task Force into the Brazilian Buttlift procedure. In the meantime, we strongly urge consumers to do their research before opting for a cosmetic surgery procedure, and to choose a doctor regulated by the General Medical Council (GMC) in the UK. Further information is available at NHS.UK/cosmetic- procedures. In relation to your specific concerns, | can advise the following. With regard to regulation, in England, any hospital or clinic providing cosmetic surgery must be registered with the Care Quality Commission (CQC). Hospitals and clinics must make sure all staff hold the appropriate qualifications, competence, skills and experience to safely perform their job. Where an inspection has been completed, the CQC publishes quality ratings online. CQC guidance on the scope of registration is available on its website’. In the UK, only doctors registered with the GMC may perform cosmetic surgery. Some surgeons will also be on a specialist register (e.g. plastic surgery) with the GMC. The Royal College of Surgeons (RCS) operates a cosmetic surgery certification scheme. The scheme, which is voluntary, provides recognition to surgeons who have the appropriate training, qualifications and experience to perform cosmetic surgery. The certification scheme is designed to identify to patients those surgeons who have acquired the right training and experience to operate safely, and to help patients choose their surgeon wisely. The certification scheme is underpinned by GMC and RCS guidance on cosmetic surgery”. The GMC has published guidance on the professional standards expected of all doctors:: The GMC also publishes ethical guidance for doctors who perform cosmetic procedures. This includes guidance on responsible marketing, informed consent and assessing the best interests of the patient before agreeing to undertake a procedure‘. It is essential that patients are fully informed about the procedure, the associated risks are made clear and there is a period for reflection before consent is obtained. The Department will be updating existing guidance about surgical fat transfer procedures, which the Brazilian Buttlift falls under, to reference the procedure. The Department is liaising with stakeholders to check the latest clinical information and expects the updates to guidance to be made by March 2020. Once the Inter-Society Gluteal Fat Grafting Task Force into the Brazilian Buttlift procedure has reported its findings, the Department will review whether further information should be published on the procedure. Finally, it is not within the Department of Health and Social Care’s remit to restrict or impose conditions on companies who facilitate cosmetic surgery holidays abroad. However, we strongly recommend that people do not travel abroad for cosmetic surgery as the clinics and surgeons may not be subject to the same levels of regulation, safety and training as in the UK. The standards set by the GMC and the RCS represent good practice and where someone is considering a cosmetic procedure abroad, we urge them to carefully consider the standards of care that apply in the country where the procedure will be carried out. https://www, org.uk/sites/default/files/20151 0000 e_of registration quidance ted _M: 201 | hope this reply is helpful. Thank you for bringing these concerns to my attention. NADINE Node
02 March 2020 Mr Kevin McLoughlin Coroner’s Office and Court 71 Northgate Wakefield WF1 3BS 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. Yours sincerely Professor Colin Melville Medical Director and Director, Education and Standards
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