The rule of perfection

IMAGINE A COUNTRY where anyone with a basic medical degree – say, your local GP – was allowed to perform complex, invasive surgery without any specialist training in that area. You’re probably picturing some tin-pot banana republic, but this is the situation in modern-day Ireland, at least when it comes to cosmetic procedures.

Whatever your view of cosmetic or aesthetic surgery, it is legal in this country. However successive governments have failed to tackle the gaping regulatory vacuum in this area, leaving consumers dangerously unprotected.

While there is a body of highly qualified plastic surgeons in Ireland, there is no regulation to stop people who are not suitably qualified from calling themselves a “cosmetic surgeon”.

“There is nothing which says a doctor has to have had supervision under a suitably qualified surgeon before they can do highly technical ,” says John McCarthy, a Cork solicitor who is representing a number of the 1,500 Irish women affected by the Poly Implant Prothese (PIP) breast implant scandal (where industrial-grade silicon was used in implants, leading to higher rupture rates).

A number of cautionary, sometimes tragic, cases have already arisen in Ireland. Last year, Dr Marco Loiacono was found guilty of misconduct over care he provided to a patient following breast-augmentation surgery – the woman developed severe infection and became seriously ill.

In 2007, mother-of-six Bernadette Reid died after an abandoned gastric banding procedure at the now-defunct Advanced Cosmetic Surgery clinic in Dublin.

So what needs to be done to protect consumers as patients? Over a year ago, Dr Labros Chatzis, medical director of the River Medical cosmetic surgery clinic, wrote a white paper on the need for regulation. He believes there should be an oversight body for the cosmetic surgery sector responsible for drawing up clear guidelines specifying who exactly is allowed to carry out surgery procedures. “At the moment any doctor can call themselves a cosmetic doctor . . . anyone with a medical degree from university, not even speciality training . . . We want the State to say who is allowed to do those procedures,” he says.

He points out that there is currently nothing to stop doctors from carrying out procedures in unsuitable environments. He says general anaesthetics and surgeries can be undertaken in establishments that are not even proper clinics, let alone hospitals, but the operators are not breaking the law as it stands.

There are stories of people being operated on on the top floor of buildings with no lifts, so if there’s an emergency, it’s not going to be possible to stretcher them out. There are fears too about the equipment being used by some companies, as well as outmoded methods of sterilising that equipment.

Concerns have also been raised about doctors who fly into Ireland once a month, operate for two days and have one day of consulting, and then fly on to somewhere else. “If something goes wrong, those people have no back-up,” says Dr Labros. “Those private clinics reassure there is back-up. Rubbish. There’s isn’t. The person involved is not there.” All of these areas have to be regulated and not left to the goodwill of the entrepreneur running the clinic, he says.

McCarthy highlights another problem: at the moment in Ireland there is no obligation on a clinician to notify any central authority or register if a breast implant ruptures. “The actual rupture rates relied on are anecdotal at best. There could be many, many situations . . . where ruptures are sorted out on the ‘QT’ without having to notify the Irish Medicines Board or any other authority. This is something that really comes out of the [Pip implants] scandal – we should have a central registrar of failed medical devices, a clear record of failure rates, so this isn’t happening silently.”

IN EUROPE, BREASTimplants are categorised as medical devices for regulation purposes, which means they can be marketed once they have the CE marking. This is in contrast to the situation in the US, where such products can't be brought to market without approval from the Food and Drug Administration (FDA), which sets much more stringent standards. "Europe doesn't have anything like that kind of rigour when it comes to [testing] medical devices," says McCarthy. He also believes that dermal fillers are "particularly egregious" and could be the next scandal waiting to happen.

Ireland’s cosmetic surgery industry has been described in the past as the Wild West for its lack of regulation, but some might argue that it’s down to the consumers to protect themselves and, if they’re determined to go through with a procedure, to ensure their surgeon is sufficiently experienced. However, a 2010 UK report by the National Confidential Enquiry into Patient Outcome and Death (a pretty damning review of cosmetic-surgery practices which makes for disturbing reading), rejects this premise out of hand: “It is trite to say the first line of protection must be with the patients themselves.”

The report recommends that prospective cosmetic surgery patients interrogate surgeons and their teams so that their questions are answered – for example, how often the procedure being contemplated is carried out by that surgeon. “Yet we must acknowledge that the essence of modern regulation is to protect those who are too trusting and fail to ask questions,” it says. The report goes on to say that consumers of medical services should not have to be auditors. “Just as we do not demand to check the hygiene in the kitchen and fridges before we sit down to eat in a strange restaurant, patients are entitled to suppose that clinics offering surgery in the High Street are properly regulated by those who are paid to do so. Thus the patients’ common sense must here be fortified by an enhanced role for the regulators.”

So what, if anything, is the Government doing to ensure patients in Ireland are adequately protected? It’s been a long time coming, but it seems the wheels of regulation may finally have been set in motion. The Department of Health is currently developing legislative proposals for the licensing of public and private healthcare providers. “Licensing of cosmetic surgery is being considered in this context,” a spokesman said. Public consultation will take place later this year on draft legislative proposals.

So in the meantime, what are people to do? The department recommends that if invasive procedures are being arranged, people would be strongly advised to check that the services are provided by a medical practitioner who is registered with the Medical Council. “Before agreeing to undergo any procedure, people should also ascertain the level of follow-up medical support which will be available to them after surgery.”

But how can this regulatory gap have

been allowed to continue for so long? Is it a case of the cosmetic surgery industry moving too quickly for Government to keep up? McCarthy thinks not. The industry here is hardly new. “There’s been quite a bit of lead-in time now. There have been sufficient examples of how things can go badly wrong due to lack of regulation. It should have been looked at before now . . . If we are a civilised society offering medical procedures, they should be properly regulated.”

At the moment any doctor can call themselves a cosmetic doctor . . . anyone with a medical degree from university, not even speciality training . . . We want the State to say who is allowed to do those procedures