Prevention of Future Deaths reports · 2019

Leah Cambridge

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 report29 Nov 2019
Reference2019-0408
DeceasedLeah Cambridge
CoronerKevin McLoughlin
Coroner areaWest Yorkshire (East)
CategoryHospital Death (Clinical Procedures and medical management) related deaths
Sourcejudiciary.uk record · original PDF
Responses published3

The report

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

Responses

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.

Response from Elite Aftercare (PDF)
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.
Response from The Department of Health and Social Care (PDF)
¢ 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
Response from The General Medical Council 1 (PDF)
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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