Monday, December 20, 2010

Beauty and the Beast

During the boom years in Ireland, while many were indulging in a frenzy of empire expansion, an industry that specialised in nipping, tucking and tightening flourished. The cosmetic surgery business experienced a massive surge in clients eager to satisfy fantasies of designer bodies and ageless beauty.

In 2006, one Dublin clinic reported a 200 per cent leap in patient numbers over a 12-month period. That year, the cosmetic surgery market in Ireland was worth about €25 million. By the beginning of 2009, this extraordinary growth industry was estimated at almost €50 million. 
Despite a recent reversal of this trend as the economic belt tightens – one industry source tells Scope that the decrease in procedures could be more than 30 per cent in Ireland over the past 12 to 24 months – the market for cosmetic surgery remains high. And according to leading specialists in the field, the industry is badly in need of a facelift of its own.
Plastic and cosmetic surgeons in Ireland are concerned about the worrying lack of formal regulations to ensure uniform standards are maintained in facilities and practices throughout the country. Within this unregulated environment, unscrupulous opportunists are free to target vulnerable members of society, aggressively marketing their trade at deflated prices with no guarantee of adequate service or after-care.
However, this gravy train may be about to derail for disreputable cosmetic surgery clinics. After years of lobbying by members of the Irish Association of Plastic Surgeons (IAPS), the Medical Council and a small number of professionals and clinics, the Government is poised to clean up the unregulated mess that is the Irish cosmetic surgery market. 

Corrective work
While the majority of clinics operating in Ireland are reputable, and several have secured or are seeking international accreditation for their facilities, clinics offering cosmetic surgery are not regulated and practitioners may have neither adequate credentials nor training to carry out these invasive surgical procedures.
The Department of Health has just announced plans to push through a mandatory licensing system for public and private healthcare facilities, including cosmetic surgery clinics. Scope has learned that the Department aims to have these legislative proposals ready for the Health Minister’s consideration by the end of this year.
And not before time, according to the IAPS, which in 2007 submitted a document, The Regulation of Private Clinics, to the Government, the Medical Council, the RCSI and the Commission on Patient Safety and Quality Assurance. 
“People in Ireland, who, for one reason or another seek cosmetic surgery, have been left unprotected for far too long,” IAPS president Mr Michael Earley tells Scope. “Most of our members have seen patients who come to them for corrective work to repair badly done cosmetic surgery. 
Mr Michael Earley
“These patients were lured in by glossy advertisements promising unrealistic results and end up with bad or disfiguring surgery and, in some cases, complications that may risk their physical and mental well being.”
Under current Irish law, even a recently qualified doctor with a basic degree and no further training or specialisation is permitted to perform cosmetic surgical procedures, as long as they receive patient consent. 
A common practice in a small number of cosmetic surgery clinics in Ireland is to fly in ‘visiting surgeons’, who are then not around when the patient requires post-operative care.
“There are definitely a few clinics around which have what we call ‘FIFO’ – fly in, fly out – surgeons who come in to the country and operate and then leave the same day,” says Mr Kevin Cronin, a consultant plastic surgeon who shares a private aesthetic surgery practice with five colleagues, each a fully accredited and registered plastic surgeon living in Ireland. “The patients are then looked after in other hospitals by nursing staff. If there is a problem like haematoma, for example, or bleeding, that surgeon is not in the country to deal with the problem.”
Conversely, while doctors fly into Ireland to perform procedures, ‘cosmetic tourists’ continue to travel abroad for plastic surgery that costs a fraction of the price here. But this can also be a risky business.
“All of us have seen the fall-out from cosmetic tourism,” Mr Cronin remarks. “We don’t know how widespread this practice is or how many people are travelling abroad for cosmetic surgery, so we can’t say how much of it turns out badly, but we do know that we end up repairing the damage when the procedure goes awry. I would say 10 to 15 per cent of my work is corrective – repairing the bad work of others.”

Tightening up on practices
Mr Jack Kelly, consultant plastic and reconstructive surgeon at the Galway Clinic and IAPS secretary, points out that he and his colleagues have met and operated on many cosmetic surgery patients who have been delighted with their outcome. 
Mr Jack Kelly
“There are certainly patients who have a poor result and who are dissatisfied with cosmetic surgery, as there are with any type of surgery, but the vast majority are happy and pleased as a consequence,” Mr Kelly adds.
While there are no official statistics available in Ireland to indicate the level of referrals to correct poor cosmetic surgery, a recent survey of 155 GPs in the UK found that over 60 per cent of them have been consulted by distraught patients following unsatisfactory invasive cosmetic procedures.
In 2009, nearly 40 per cent of surgeons in the UK said they had seen patients who had suffered complications from permanent filler operations, and over 25 per cent had to perform corrective surgery.
The Medical Defence Union, which provides indemnity cover to doctors in the UK and Ireland, issued a statement in 2006 estimating that £8.5 million had been paid out for claims over poor cosmetic surgery in the previous 10 years. Breast and facial surgery accounted for the most claims. The size of settlements ranged from £200 to £305,000.
“This area has a significant rate of litigation and this is attributable to both the high expectations of patients undergoing these procedures and the nature of the risks involved. 
“In light of all of these factors, there is a very high duty of care on surgeons performing cosmetic surgery and it is important that patients give fully informed consent. The unregulated landscape does not assist matters from the perspective of patient or doctor,” says Aoife Nally, a solicitor at Hayes Solicitors in Dublin.
However, as the concept of cosmetic surgery becomes increasingly mainstream, fuelled in part by the reality TV ‘make-over’ phenomenon, prospective ‘customers’ are being hit with a hard sell. Even a cursory shuffle through the many websites managed by Irish cosmetic surgery facilities reveals a forest of ‘leggy babes’ who have obviously never seen the sharp end of a surgeon’s knife. Images of perfect breasts and tight abs, plump lips and sculpted features are seducing the gullible into believing that improbable results are possible.
“It’s the age-old problem of advertising cosmetic surgery, showing people who have very definitely never had or needed to see a cosmetic surgeon. All of these perfect bodies are utterly misleading,” says Mr Earley. “In an ideal world, we would ban all advertising for cosmetic surgery but at the very least there should be no photographs or illustrations allowed and the ads should not be misleading and should carry health warnings because there is a risk involved in all surgery.”
The Medical Council’s Guide to Professional Conduct and Ethics recommends that doctors “avoid using photographic or other illustrations of the human body to promote cosmetic or plastic surgery procedures, as they may raise unrealistic expectations amongst potential patients”. But clearly, in some cases, these guidelines are being ignored. The IAPS’s 2007 report on the regulation of cosmetic surgery calls for the legal enforcement of these advertising restrictions.

A new code
The IAPS document also recommends the introduction of a ‘code of practice’ that would require the surgeon to meet with the patient for a private consultation prior to the procedure. During this meeting factual and not promotional information should be given. 
The issue of payment is also highlighted. It should be illegal for money to change hands prior to the patient’s consultation with the surgeon, and there should be a 14-day ‘cooling-off’ period between agreeing to undertake surgery and doing so.
Importantly, recognised specialist training in cosmetic surgery should be established and surgeons who have been suspended for clinical reasons should not be permitted to work in the private healthcare sector.
“There is no reason why the private sector should not be regulated in a similar fashion to the public in order to ensure fair standards for both private patients and public patients,” the report states. “We would recommend the establishment of a new regulatory body for the private healthcare sector. This body should be made up of individuals; half of whom should be elected by the professionals and half of whom should be recommended by the Department of Health.” 
This industry watchdog would be paid for by the private healthcare sector and would oversee all regulatory matters related to private clinics. 
Dr Labros Chatzis
Many of the association’s recommendations were echoed in a recent submission to the Department of Health by Dr Labros Chatzis, a consultant plastic surgeon and Medical Director of the River Medical cosmetic surgery clinic in Dublin.
He concurs that only a qualified surgeon on a specialist register with the Medical Council, permanently resident in Ireland with 24-hour, seven-day-a-week medical and nursing back-up and performing all operations in a regulated medical environment, should be allowed to practise here.
Dr Chatzis further recommends that all doctors seeking to perform specific non-surgical cosmetic procedures must first receive a certificate of competence from the Medical Council. This provision is also espoused by members of the Irish Association of Cosmetic Doctors, which has been lobbying since 2008 for proper regulation of the non-surgical cosmetic medicine business in Ireland.

UK findings
There is no clear picture of how many private cosmetic surgery businesses operate in Ireland, if their surgeons are suitably qualified and screened, or whether their facilities are adequately equipped.
UK authorities have addressed a similar information deficit there in a new nationwide review of the organisational structures surrounding the practice of cosmetic surgery. The findings, which were published in September this year, are truly alarming. 
Although there was a statutory obligation to take part in the review, a mere 20 per cent of cosmetic surgery clinics participated. Shockingly, more than one in 10 clinics “ceased to exist” between being identified and being approached by the National Confidential Enquiry into Patient Outcome and Death (NCEPOD), which conducted the review. The remaining 69 per cent of clinics either did not answer or refused to take part.
One would imagine that those clinics that complied with this investigation would have facilities ranking among the top in the industry. But the report authors discovered “an alarming lack of equipment in the theatre, in proper recovery facilities, in HDU facilities and in out-of-hours surgical cover”.
Less than half (44 per cent) of operating theatres were fully equipped to carry out cosmetic surgery and 30 per cent of sites performing cosmetic surgery did not have a Level 2 care unit. Almost 20 per cent had no emergency re-admission policy. 
Many cosmetic surgery sites were offering a menu of procedures, some of which were only performed infrequently, and surgical training was only available on 16 per cent of the sites. “In one sense this may be just as well: what sort of training can be offered in a centre that performs most of its procedures once a month?” the authors remarked.
Among its recommendations, the NCEPOD said that regulatory bodies should ensure national requirements for audit and scrutiny of sites under licence are adhered to. More formal training programmes must be established, leading to a certificate of competence. Cosmetic surgical practice should also be subject to the same level of regulation as any other branch of surgery. 
Mr Nigel Mercer
British Association of Aesthetic Plastic Surgery president, Mr Nigel Mercer, agrees: “These figures present a distressing picture, but one which is sadly not surprising to us as they only confirm what we have been saying for years – that there is an absolute need for statutory regulation in this sector.
“Aesthetic surgery needs to be recognised as the multi-million pound specialty it is and not just a fragmented cottage industry.”
Mr Earley says that the HSE should conduct a similar investigation into cosmetic surgery in Ireland. “If it’s anything similar to the UK, we have a lot of work to do,” he warns. 
The NCEPOD review may be informally discussed at the IAPS annual winter meeting in Dublin on November 25 and 26, as will the Department of Health’s drawn-out efforts to regulate private healthcare clinics in Ireland. This is a hugely complex, multi-layered issue and considerable uncertainty abounds. To what degree will any new legislation tackle the problems unique to the cosmetic surgery sector? Who will grasp the nettle in enforcing these regulations? When will this long-awaited legislation be introduced and will the Government get it right this time or will corrective work be required?    

Not without complications

Several prominent cases in recent years have highlighted the dangers of the lucrative but unregulated cosmetic surgery industry. Plastic surgeon Marco Loiacono, 34, was found guilty earlier this year of six out of 12 counts of misconduct by the Medical Council. In June, the High Court confirmed the Council’s decision to suspend Mr Loiacono for six months and he was ordered to undergo further education. However, an Irish national newspaper recently revealed that despite this ban, he has since returned to his native Italy where he is still working in plastic surgery.
In May this year, a Co Limerick man was awarded $3.1 million in compensation over the death of his wife following cosmetic surgery in the US in 2005. The cosmetic surgeon at the core of the case, Dr Michael Sachs, settled without admission of liability for $2.1 million.
Dr Jerome Manuceau
In 2007, Bernadette Reid, a mother of six, died from a cardiac problem after an aborted procedure to have a gastric band fitted at the now defunct Advanced Cosmetic Surgery (ACS) clinic in Dublin. Paris-based surgeon Jerome Manuceau did not complete the operation after he discovered a tumour in Mrs Reid’s stomach. The Arklow woman died the next day. The coroner recorded a verdict of death by natural causes. 
Dr Manuceau has since been struck off the register of medical practitioners following a Medical Council inquiry. It said the surgeon was guilty of “professional misconduct”, a claim confirmed by the High Court on September 10, 2008.
Mr Michael Earley, consultant plastic surgeon at the Mater Misericordiae Hospital and president of the IAPS, has been called on as an expert witness in a number of court cases when legal action is being taken against cosmetic surgeons. 
“That is not rare in Ireland. Usually the examples revolve around the post-operative care and lack of it. Unfortunately you also come across errors of judgment on the part of the surgeon, they would usually revolve around breast implants and basically taking the easy option,” he says.
“I can only say that these patients are very traumatised by their surgery experience. If someone is willing to chase after a surgeon from a legal viewpoint they certainly are filled with both dissatisfaction and anger. It is often quite difficult to secure a finding against a surgeon because you have to prove that someone is actually negligent. And proving negligence is quite different to saying ‘that wasn’t a very good job’.”

The long road to legislation

It’s hard to blame the sceptics when they scoff at news that the Government is poised to introduce new legislation to regulate all healthcare facilities, including cosmetic surgery clinics. It has been a lengthy journey and there is no definite end in sight.
The task to devise these tighter controls began in earnest in 2007 when Health Minister Mary Harney established the Commission on Patient Safety and Quality Assurance to make recommendations ensuring quality and safety of patients. 
Nineteen months later, in August 2008, the recommendations were published. Most notably they called for the introduction of a licensing system for public and private health services. Indeed, the Commission singled out cosmetic surgery clinics in its list of facilities that urgently require mandatory licensing and audit.
The Government deliberated on these recommendations for a further six months before finally announcing in February 2009 that they had decided to draw up legislation for the licensing of healthcare providers.
To facilitate this, the Government approved “the immediate establishment” of a steering group to drive implementation of the Commission’s recommendations. This group was launched four months later, in June 2009, and set about dividing the 134 recommendations into 13 separate projects, including legislation, standards, education and training, and clinical audit. 
In its September 2009 progress report – the only one published to date – the group stated that legislative provisions regarding open disclosure, adverse event reporting and clinical audit were to be included in heads for the Health Information Bill. This Bill was enacted in July this year. It is concerned with the transfer of information from the HSE to the Health Minister; it does not relate to private facilities and makes no mention of clinical audit. The Commission also recommended that the Health Information and Quality Authority (HIQA) “progress urgently” the development of safety and quality standards to be applied to hospitals and all future licensed healthcare facilities, in advance of the introduction of licensing legislation.
In September 2010, HIQA launched a six-week public consultation process on draft national standards for better, safer healthcare. “It is proposed that these national standards will provide the basis of a mandatory licensing system for private and independent healthcare facilities, including cosmetic surgery clinics,” a Department spokesperson told Scope. 
He added that the Department “is now developing legislative proposals for a mandatory licensing system covering both public and private healthcare facilities in line with the Commission’s recommendations. The Department aims to have these legislative proposals ready for the Minister’s consideration by the end of this year.”


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