Unregistered practitioners of cosmetic surgery, the implications for the
patient and how the issue should be addressed
Oireachtas Joint Committee on Health and Children
Thursday 18th of December 2014, in Committee Room 2, LH2000, Leinster House
Margaret O’Donnell MB FRCSI FRCS(Plast), President, Irish Association of Plastic
Surgeons Consultant Plastic Reconstructive & Aesthetic Surgeon,
Blackrock Clinic & St Vincent’s Private Hospital
Submission by The Irish Association of Plastic Surgeons (IAPS)
Summary
• Widespread Patient Safety Issue
• Non-medical practitioners treating medical conditions such as skin cancers
• Non-surgeons doing surgery
• Patients abandoned when commercial clinics close
• Misleading and factually incorrect advertising
• Online purchasing of prescription medication
• Lack of Regulation
• No overall regulating body
Introduction
When you get into a taxi, you expect the driver has passed a driving test, and holds a
licence. Yet a patient undergoing cosmetic surgery may be operated upon by a doctor
with no surgical qualifications. Laser treatments of skin cancers have been
undertaken by beauty therapists with no medical or nursing training. This is a major
patient safety issue.
We are aware of patients being exposed to unsafe practices in both mainstream and
cosmetic medicine. It has become evident that both cosmetic and oncology conditions
are now "treated " by such a wide variety of practitioners including non-medically
trained individuals.
Example 1.
Groupon have had online discount deals, offering "laser removal " of moles in a
beauty salon. There was no mention of medical or nursing assessment, or any medical
training or supervision of those undertaking such mole examination or removal, or of
pathological analysis of the mole. Obviously, lasering off moles without medical
input could be potentially catastrophic if these moles were actually a melanoma (a
serious type of skin cancer).
Example 2
Two patients have attended a Plastic Surgeon in the past 3 months, having had a skin
cancers “treated” in beauty salons. This was ineffective and when the lesions
persisted, each patient sought proper surgical treatment. Worryingly, one of these
patients had already seen her GP about the lesion, and had been referred to a
Specialist, when the therapist offered to “zap” it for her.
Example 3
A 21 year old Beauty Therapist attended an optician with eye problems, after using
the glaucoma drug, bimatoprost, which she had bought on-line over the internet
without prescription. This drug which is used to treat glaucoma, has the known sideeffect of promoting eye-lash growth. She had done a “course” which explained this to
her.
Example 4
Doctors In Ireland are performing operations, such as breast augmentation, with no
post-graduate surgical qualifications, only a basic medical degree. There is no
oversight of such doctors, or of these clinics.
Example 5
An unproven laser treatment is being marketed for vaginal tightening, with no
medically-published clinical trials confirming its safety or effectiveness. Though
described as “safe”, this treatment can cause vaginal burns, as confirmed by a
Consultant Gynaecologist in Dublin who has treated such a patient. This treatment is
currently on offer on an on-line deals website for 199 euro reduced from 399 euro, or
“gift one to a friend”. Thus a medical treatment, described in the website as “used to
treat Urinary Stress Incontinence”, is being sold without any regard as to whether it is
a suitable, or necessary, treatment for the patient, and without any medical
examination or investigations of the other possible causes of the incontinence.
The experience in other countries
This is not just an Irish problem, and other countries have moved to bring in
regulation. Stringent changes were introduced in France and Denmark after the PIP
breast implant debacle, after the public became aware about the lack of regulation.
Strict regulation has been introduced, ensuring surgery is carried out only by those
trained to do so. These regulations include a ban on cosmetic surgery advertising, as
it is so often misleading and occasionally untruthful.
In the UK, Sir Bruce Keogh was charged with reviewing the situation2, also found
“widespread use of misleading advertising, inappropriate marketing and unsafe
practices right across the sector” , and he declared ”a person having a non-surgical
cosmetic intervention has no more protection and redress than someone buying a
ballpoint pen or a toothbrush”. Legislation3 is proposed in the UK, which would
include ban on advertising, a register of practitioners, and a Breast Implant Register.
What are the Surgery and Non-surgical Procedures
Cosmetic surgical treatments means operations such as breast augmentation, tummytuck, or liposuction. Cosmetic non-surgical (cosmetic medicine) procedures include
injection treatments such as botox or fillers, and laser treatments.
Cosmetic surgery represents only one part of the sector. Mintel in the UK estimates
that over 90% of cosmetic interventions are non-surgical, and that these amount to
74% of market value of the sector.
Key Concerns
The Patient Safety Diamond8 bases the concept of safe surgery on four factors: the
patient, the practitioner, the procedure and the premises. The patient should be a good
candidate for the requested surgery. The surgeon must be properly trained and
credentialed. The procedure should be appropriate for the patient. The surgical
facility should be an accredited and a proven safe venue with properly trained staff
and emergency preparedness.
1. Patient
All patients considering cosmetic procedures, but particularly surgery, need to have
their suitability assessed. Certain medical conditions may increase the risks. There
may be psychological issues. Patient expectations need to be assessed as being
realistic.
2. Practitioner
There are a wide variety of practitioners working in the field of Cosmetic Surgery
and medicine, ranging from Specialist Plastic Surgeons who have spent 10 years
following qualification from medical school, to doctors, dentists and nurses with
basic degrees, to beauty therapists and others. There are some who are simply selftaught or have done weekend courses, and others who have travelled at their own
expense to attend courses. Many have no formal professional training. This is an
issue for both Surgical and Non-surgical treatments, which should be considered
separately.
A. Surgical treatments means operations such as breast augmentation, tummy-tuck,
or liposuction. The public would expect that these should be done by surgeons with
formal training and certification. But these are also are being done by doctors without
recognised/certified training as a surgeon.
Specialist training in Cosmetic Surgery is an intrinsic part of the Speciality of
“Plastic Reconstructive and Aesthetic Surgery”, and is recognised by the Medical
Council, and by the Royal College of Surgeons in Ireland. This training takes
approximately 10 years, after the 5-6 years in medical school, as this is how long the
RCSI and Medical Council consider it takes to train a Specialist surgeon in any
Speciality. Surgical Training Programmes not only include training in the technical
and academic aspects of surgery, but also the moral and ethical implications of
surgery, which is particularly important in cosmetic surgery.
The term cosmetic surgeon, or cosmetic doctor, is often used by non-accredited
doctors, as it is not a regulated term. Cosmetic surgery or cosmetic medicine is not a
specialty recognized by the Irish Medical Council. The correct term is Aesthetic
Surgery, which it is an integral part of the Specialty of Plastic Reconstructive and
Aesthetic Surgery, which is the term the Medical Council recognise. Unless one has
completed Specialist training, one cannot call oneself a Plastic Surgeon or an
Aesthetic Surgeon. There is no recognised training programme for those using this
title, and no requirement for Continuous Professional Development (CPD), in
cosmetic surgery or medicine,.
On many cosmetic surgery websites, a doctor is described as an “expert”. This is a
self-appointed title, and one which is not used by members of the Irish Association of
Plastic Surgeons, despite the fact that they would be considered the experts in the
area by virtue of their training research and experience. Some countries prohibit the
use of descriptive terms such as “leading”, “top”, “expert” from advertising and
websites.
Another term that is frequently used on websites is “fully registered with the
Medical Council”. However, it is mandatory for all doctors practising in Ireland to
be “fully registered”. This term includes those who are on the trainee register, the
general register or the specialist register. The distinction between those categories is
not clear to the general public, and on many websites the term “fully registered” is
placed in the context to suggest that the practitioner is actually a Specialist. Doctors
who have a basic medical degree, and do not complete Specialist training appear on
the Register under "General Registration”. A doctor without any post graduate
surgical qualifications described as “fully registered”, possibly masks the fact that he
is not a surgeon, nor on a Specialist Register.
It is not illegal for doctors to undertake whatever practice they want to, but it is
against regulations to misrepresent themselves. They cannot call themselves a cardiac
surgeon, for example, if they have not completed specialist cardiac training. Yet they
call themselves a cosmetic surgeon, without any specialist training.
B. A wide variety of practitioners offer Non-surgical procedures. Botulinum
toxins, fillers and laser treatments are being offered by doctors, nurses, beauty
therapists and possibly others. There is no register of practitioners. There is no
licence. Standards vary hugely. There are a vast number of treatments being offered,
many without any scientific proof of effect. "Non-surgical" or "non-invasive" does
not mean safe, many of these treatments may cause harm.
2. Procedures
Surgery
Done appropriately, cosmetic surgery procedures result in high levels of satisfaction
and improvement of a patients quality of life. These operations can be technically
challenging, and surgeons should be fully trained. As with all branches of surgery,
complications can occur and the surgeon should also be able to deal with these issues.
Careful selection of patients can help minimise risk.
Non-surgical
The three most popular non-surgical treatments are Botulinum toxins, dermal fillers
and laser treatments. New and unproven treatments are also being introduced on a
regular basis. While many of these may have therapeutic benefits, there is no need or
regulation for a practitioner to establish the bono fides of such treatments before
offering them to the public.
Botox is the registered trade mark of the original Botulinum Toxin, and used for the
reduction of forehead wrinkle lines. This is also available under different tradenames. It is scientifically proven to be effective, and has both FDA and HPRB
approval for the use in Glabellar (frown) lines. Botulinum Toxin is legally a "drug"
so has to be prescribed, or administered under the direction of, a doctor. Regulation
comes under the remit of the Health Products Regulatory Board.
A Beauty Therapist in Dublin was recently fined for importing the drug Botulinum
toxin over the internet and administering the agent to a client.4
Dermal fillers are a crisis waiting to happen, according to the recent UK review.
They are classified legally as a "medical device’, regulated by the Irish Medicines
Board, so they do not have to be administered by a doctor, despite being injected into
or under the skin. It is probably most appropriate to quote the UK Review of the
Regulation of Cosmetic Interventions which stated that “ Dermal fillers are a
particular cause for concern as anyone can set themselves up as a practitioner, with
no requirement for knowledge, training or previous experience. Nor are there
sufficient checks in place with regard to product quality – most dermal fillers have no
more controls than a bottle of floor cleaner. There has been explosive growth in this
market, driven by a combination of high demand and high profits in an era when all
other commercial income is stalling.”
We believe that same situation exists in Ireland.
Lasers - other than radiation protection legislation, there is no stipulation as to who
can buy/run them. All lasers can cause burns. Lasers are described as “non-invasive”
as the implement/handpiece does not penetrate the skin. However, the laser beam
does penetrate the skin, at a variable depth depending on the type of laser.
Lasers can be used very successfully, to treat a wide variety of conditions, ranging
from hair removal, to thread vein removal, to eradication of pigmented spots, to
reduction of wrinkles. Whilst many of these treatments are beneficial, there is a wide
variety of practitioners and premises. It is difficult for a member of the public to
know the difference between being treated by a beauty therapist, a nurse, or by a
specialist doctor, and which conditions are more appropriately treated by whom. The
number and variety of advertisements for laser treatments can only lead to confusion
at present. Without regulation, there is no guidance for the public.
Recent advertisements for ”mole removal” by laser are dangerous. Patients could
have a melanoma (a potentially fatal form of skin cancer) inappropriately treated in
such fashion. These mole removal services are offered in beauty salons and there is
no mention of a doctors input into the assessment or treatment. A mole which is
removed should be sent for analysis, but as laser effectively destroys the mole there
is no sample to send, compounding the danger as an accurate diagnosis is not made.
It is only when a melanoma will recur at a later date, which may be too late, that the
true danger will be apparent.
Burns can occur after laser treatments, resulting in permanent scarring. Members of
IAPS have seen many such patients, referred to them after inappropriate treatments.
Lasers have been advertised to treat Urinary Stress Incontinence by means inserting
the laser into the vagina, to achieve Vaginal tightening. They also claim to improve
the woman’s sex-life. However, any patient with symptoms of incontinence should be
carefully evaluated and investigated as to the cause. Even in Specialist hands this can
be a difficult problem to treat, and there can be many other causes contributing to
incontinence, such as a urinary infection. While it is possible that laser treatment
might play a role, this technique is not yet “evidence-based”. Such a treatment may
attract vulnerable people, and at an advertised cost of “from 1900 euro” and “4500
euro”, it must give rise for concern that neither the procedure, nor the treating
practitioners are reviewed.
Other treatments such as 'non-invasive" "fat-busting" machines. Minimal, if any,
evidence-based scientific studies showing that they are effective, or that effects are
prolonged.
4 Premises / Facility
Lack of care has been an issue for patients in Ireland with the closure of some highprofile commercial clinics, particularly those who had PIP implants. The clinic which
used most of the PIP implants in Ireland (Harley Medical Group) has gone into
liquidation. Patients have not been able to access medical records or gain satisfactory
follow-up, despite contacting the parent company which still appears to offer services
in Ireland.
After the PIP implant debacle, this company confirmed with the Irish Medicines
Board (now the Health Products Regulatory Board, HPRB) that they had contacted
the patients involved, in writing5. It subsequently was found that they did not do so. It
is reported that the Harley Medical Group refused to meet the Joint Committee on
Health and Children in the past.
In addition to ensuring the people who carry out such procedures have the necessary
skills and qualifications, they and their organisations should have the systems in place
to look after their patients both during their treatment and afterwards, particularly in
the event of a complication or adverse event.
This includes issues such as data protection, disposal of clinical waste, selection of
approved medical devices, recording and storage of drugs, etc.
Marketing and advertising by commercial clinics are a concern as they may target
vulnerable people. Incentives to encourage surgery, such as 2-for-1 deals, or “buybefore (date) to avail of discount” are often offered by sales staff in the clinic. Such
staff are asked to reach sales targets, and therefore may pressurise people into making
a choice which may not be in the patients best interest.
5 Regulation
There is no overall regulation, bringing together the individual agencies involved in
separate aspects of cosmetic surgery and non-surgical practice. The Health Products
Regulatory Board (HPRB, formerly the Irish Medicines Board) deals with the
regulation of drugs and devices, but not the premises in which they are used. The
Medical Council deals with professional standards and competence of doctors, but
not the extent of their practice. The Irish Nursing and Midwifery Board deals with
professional standards and competence of nurses, but do not have a training module
for cosmetic procedures. HIQA have a remit to the public health system and private
nursing homes, do not regulate the private cosmetic sector. The Royal College of
Surgeons in Ireland (RCSI) who deal with professional training of surgeons, but other
doctors who decide to perform cosmetic surgery or medicine, do not come under their
remit.
There is no overall umbrella agency tying all these strands together. Thus, one can
have non-accredited doctors, or nurses, or beauty therapists, offering non-approved
treatments in a non-accredited institution.
Even those areas that are regulated are routinely flouted, and there are few instances
of enforcement on the public record. Each agency works independently and unlike
the Law Society, which have stated that they actively assess for breaches of their
advertising regulations, medical agencies are generally dependent on complaints from
the public before investigating. Many patients feel embarrassed to complain to a
public body, about cosmetic treatments as there is an element of guilt in seeking such
treatments, or a concern that they won’t be taken seriously. Problems are underreported officially, but regularly referred to members of IAPS.
6 National Implant Registry
No breast implant registry exists in Ireland. This caused difficulty at the time of the
PIP implant problem, and many of those patients have still not been able to access
their records as Clinics have gone out of business, or re-opened as a different legal
entity.
Possible Solutions
1. Practitioners
a. A Register of Practitioners should be implemented
b.Such practitioners should be identified by their professional training, eg Plastic
surgeon, general doctor, nurse, beauty therapist, dentist, etc
c. Consideration be given to declaring whether the practitioner is giving medical
treatment (which should be “in the best interest of the patient”) or commercial
treatment (in which case “buyer beware”)
d. Describing and defning the levels of expertise would provide clarity and
transparency for the patient. In France, the authorities have defined what operations
can be done by which specialty surgeons, for example, rhinoplasty (nose-jobs) can be
done by qualified plastic surgeons, or qualified ENT surgeons, but not by general
doctors.
2. Procedures
Practitioners and their organisations should have the systems in place to look after
their patients both during their treatment and afterwards, particularly in the event of a
complication or adverse event.
Medical devices, including fillers and breast implants, should be FDA and/or CE
approved.
Patients considering cosmetic surgery should receive information about their
procedure, and the alternatives, as for any branch of surgery, and time for reflection
to make an informed choice.
A cooling-off period is recommended.
Incentives to have surgery, such as 2-for-1 deals, or “buy-before (date) to avail of
discount” should be avoided as they may not be in the patients best interest.
3. Regulation
An umbrella body, overseeing cosmetic surgery practices, would be welcomed. This
would complement the existing bodies, but bring together the expertise of such bodes
in a seamless fashion. Active assessment of advertising claims, and enforcement of
breaches would be welcomed.
4. Public Information Campaign
The Department of Health, with IAPS, have issued "Guidelines for patients
considering cosmetic procedures" which advises what to look
for http://www.dohc.ie/issues/cosmetic_procedures/
The Medical Council also have a page on their website with
advice http://www.medicalcouncil.ie/Public-Information/Surgical-CosmeticProcedures/
Despite these webpages, the public remain largely unaware of these guidelines.
Publicly funded advertising or information booklets or social media campaigns would
be beneficial.
5. Advertising
The Advertising Authority of Ireland is currently reviewing their guidelines for
Medical Advertising. This presents an opportunity to explore the best practice for
Ireland. The experience of other EU countries could be considered.
6. National Implant Registry
No breast implant registry exists in Ireland. This would have been useful at the time
of the PIP implant problem. Many of those patients have still not been able to access
their records as Clinics have gone out of business. They remain unaware of the
implants which were used, but could have accessed this information from a National
Registry, if it were instigated. The Australian Breast Implant Registry has offered its
database on an international goodwill basis. The opportunity exists to access this.
7. European Standards in Aesthetic Surgery Services
A European Standard has been developed, aimed at producing a minimum Standard
of Care for patients undergoing undergoing aesthetic surgery, and non surgical
procedures. The final draft of the surgical document and the working draft of the nonsurgical document are attached. This has been co-ordinated by the National
Standards Authority in each european country, with the National Standards Authority
in Ireland (NSAI), co-ordinating it here.
After 5 years in development, this European Standards in Aesthetic Surgery Services
was passed this year. As a European Standard, it is voluntary. It’s recommendations
represent an agreed minimum standard of care, and these can be exceeded. Some
countries have legislation demanding higher standards of care than contained in this
document. In Ireland, legislation would be required to make some, or all of it,
mandatory.
These Standards include such things as avoiding misleading advertising, avoiding
misrepresentation, maintaining accurate records, adherence to Data protection,
appropriate training of practitioners, adherence to standards for disposal of clinical
waste, etc. Public and Private hospitals would be familiar with these principles
through accreditation processes, but there is no requirement for commercial clinics to
adhere to such practices.
This European Standard is the first of two documents. This particular
document relates mostly to cosmetic surgery, and has been passed. The second refers
to non-surgical treatments such as lasers, fillers and Botox which is in draft format,
and soon to be put to final vote.
There are some who reject these European Standards. These include some nonspecialist doctors, some nurses in Independant practice (despite there being no Bord
Altranais approved training for those in Cosmetic practice) and others. It must be
stressed that such Standards do not aim to prevent anyone working in this area, but
would allow the public choose between those practitioners and clinics which comply
with the Standards, and which do not. Support for these Standards has been obtained
from from the Irish Association of Plastic Surgeons, Irish College of Ophthalmology,
Irish Association of Dermatology, Irish Otolaryngology, Head and Neck Society,
Association of Oral & Maxillofacial Surgeons in Ireland, Royal College of Surgeons
in Ireland, ENT, Irish Medicines Board, Irish Nursing & Midwifery Board. This is a
major opportunity to co-ordinate these agencies and others, to introduce these
standards, and to improve patient care.
Publications referred to in text
1. Review of the Regulation of Cosmetic Interventions, Call for Evidence. Sir Bruce
Keogh. 2012
https://www.gov.uk/government/uploads/system/uploads/attachment_data/file/21690
6/Call-for-evidence-cosmetic-procedures.pdf
2. UK Review of the Regulation of Cosmetic Interventions. Sir Bruce Keogh. 2014.
https://www.gov.uk/government/uploads/system/uploads/attachment_data/file/19202
8/Review_of_the_Regulation_of_Cosmetic_Interventions.pdf
3. Cosmetic Surgery (Minimum Standards) Bill (HC Bill 60)
http://www.publications.parliament.uk/pa/bills/cbill/2012-2013/0060/cbill_201220130060_en_2.htm
4 Approved Training Pathway for Basic Surgical Training, and Higher Surgical
Specialist Training in Plastic Surgery. http://www.plasticsurgery.ie/professionalcompetence .
5. Irish Times. 27 January 2014. Vaginal Tightening
6. Beautician fined €6,000 over illegal Botox treatments. Irish Times September 1,
2014. http://www.irishtimes.com/news/crime-and-law/courts/beautician-fined-6-000over-illegal-botox-treatments-1.1914502
7. Report from Health Products Regulatory Board. 6 January 2012, 5:25pm
https://www.hpra.ie/homepage/medical-devices/special-topics/poly-implantprosthese-(pip)-breast-implant-updates
8. The Patient Safety Diamond devised by then ISAPS President, Dr. Foad Nahai
(US), and presented at the ISAPS Congress in 2010. http://www.isaps.org/medicaltravel-guide/safety-considerations
9. European Standard in Aesthetic Surgery Services. CEN/TC 403. FprEN
16372:2014 (E)
CEN European Committee for Standardisation
10. Draft European Standard in Aesthetic Non-Surgery Services CEN/TC 403 CEN
European Committee for Standardisation
Appendix 1
Training Pathway for Basic Surgical Training, and Higher Surgical Specialist
Training in Plastic Surgery.
Typically, a doctor completes medical school with a basic MB BCh BAO degree,
before entering a Basic Surgery Training (BST) Programme for 2-3 years. Having
successfully completed this programme by gaining satisfactory competence reports
and passing an examination, the trainee surgeon may undertake a period of research
(leading to a MCh or MD degree) before applying for a position on a Higher Surgical
Training (HST) Programme in Plastic Surgery. This HST Programme is of 6 years
duration and will involve training in a number of different Hospitals, to gain different
areas of expertise in all fields of Plastic surgery. Towards the end of this programme,
the Trainee surgeon must pass the Intercollegiate Examination in Plastic Surgery,
which is run by the Royal Colleges of Surgeons.
This examination covers all aspects of plastic surgery, including Aesthetic (Cosmetic)
Surgery.Use of the letters FRCS(Plast) after a surgeons name denotes they have
passed this examination. The surgeon must also receive satisfactory competency
reports from their 6 years of HST training and only then may apply to the Medical
Council for a Certificate of Completion of Specialist Training (CCST). They are then
eligible to have their name entered on the Specialist Register Of Plastic,
Reconstructive and Aesthetic Surgery of the Medical Council.
A new training pathway has commenced , omitting the Research module. This is not
relevant to those who already completed training and already in practice.
The term Cosmetic Surgeon is not a qualification used by the Medical Council or by
The Royal College Of Surgeons. Unfortunately, there are a number of doctors using
the term Cosmetic Surgeon without holding any surgical qualifications. These doctors
may be entered on the General Register of the Medical Council (rather than Specialist
Register). In Ireland, The only recognized formal training for Cosmetic Surgery in
Ireland and the UK, is the FRCS(Plast) as described above, and members of the
public should check their plastic surgeon is suitably qualified.
What the letters mean
To clarify what the relevant letters mean, the letters MB BCh BAO are the basic
medical degree conferred on doctors when they qualify from Medical School.
The letters FRCSI mean Fellow of The Royal College Of Surgeons in Ireland, and
denote a General Surgical Qualification.
FRCS(Plast) means Specialist Fellowship in Plastic Surgery from The Royal College
of Surgeons. Many Plastic Surgeons also hold a FRCS qualification in General
Surgery which was obtained before they embarked on the Specialist Plastic Surgery
Training, at the end of which they will also obtain the FRCS(Plast).