Ms Margaret O'Donnell:

We thank the committee for inviting us to discuss what we believe is a widespread patient safety issue. Patients are being harmed. If one gets into a taxi, one expects the driver to have passed a driving test, and to hold a licence. Yet a patient undergoing cosmetic surgery may be operated upon by a doctor with no professional surgical qualifications.

Perhaps I should begin by clarifying what is surgery and what is non-surgery. Surgery means operations, such as breast implants, tummy tucks or liposuction. Non-surgery usually means injection treatment, such as botox, fillers and laser treatments. Done properly, these treatments can give a very high quality of satisfaction to the patient and improvement in their quality of life. These treatments are offered by a wide variety of practitioners - not just surgeons and doctors, but also nurses, beauty therapists and possibly others - but there is no register of practitioners, there is no licence and standards vary hugely. A vast number of treatments are being offered, many without any scientific proof that they work. Non-surgical and non-invasive does not mean safe. Many of these treatments can and do cause harm.

We have been asked to give some examples. Groupon has had an online discount deal offering "laser removal" of moles in a beauty salon. There was no mention of medical assessment and lasering of moles could be potentially fatal if a melanoma, a type of skin cancer, were inadvertently removed. The normal practice is that any mole that is removed should be analysed in a laboratory, but if one removes or destroys a mole by laser, there is nothing to analyse. Other laser treatments are being offered to patients at huge cost, with no proof that they work. They are being offered to under-age patients. Recently a 15 year old was offered something at the cost of €850, despite being under the age of consent. Plastic surgeons are seeing patients who have had treatments in beauty salons. I have had two patients in recent months who have had skin cancers treated in beauty salons. Having said that, there are some excellent beauty therapists who pick up on things and send people to their GP or other practitioners.

We are concerned that the incidence of purchasing prescription medication online for use on the purchaser or on others is rising. We are also concerned that doctors with no postgraduate surgical qualifications and only a basic medical degree are operating on patients. We are also concerned about misleading and false advertising. There are many examples of this, including the use of unrealistic models in ads - these are not patients who have had any surgery - photos that are airbrushed, stock photos being used as examples of a practitioner's own practice, prices stated as "from" when there is no realistic expectation of that price being offered, and so on. We are also concerned about doctors who describe themselves as "qualified surgeons" or "leading experts".

In one specific case, a doctor who is described as a qualified surgeon is not on any specialist register as a surgeon and appears on a general register only in both the United Kingdom and Ireland.

The use of the terms "cosmetic doctor" and "cosmetic surgeon" is also a matter of concern as these are unregulated terms that are not recognised by the Medical Council. There is no syllabus, training or examinations in place for persons who describe themselves as cosmetic doctors or surgeons.

The use of the term "fully registered" is misleading. Practitioners often describe themselves as being fully registered with the Medical Council to suggest that they are specialists. Every doctor practising in Ireland must be fully registered. The issue is one of breaking down the register to determine whether he or she is a trainee doctor, doctor on the general register or specialist.

Many other countries have legislated in this area. The PIP implant case in France, which affected approximately 100,000 women, caused a major public outcry about the lack of regulation in this area. France and Denmark subsequently introduced legislation to ensure surgery is carried out only by those who are trained to do so. Consumer groups have called for a ban on cosmetic surgery advertising on the basis that it is often misleading. Legislation proposed in the United Kingdom includes measures to ban such advertising and provide for a register of practitioners.

Safety is a key concern of the Irish Association of Plastic Surgeons and could be addressed in the areas of patients, practitioners, procedures and premises. The patient should be a good candidate, be informed and have realistic expectations. The practitioner must be properly trained. Surgeons, for example, must be trained and possess the appropriate credentials, and non-surgical practitioners must be trained and possess credentials for the level at which they work. The procedures should be appropriate for the patient and of proven effectiveness. The premises should be an accredited and safe venue, with properly trained staff and provision for emergency treatment should such be necessary.

The Irish Association of Plastic Surgeons calls for the implementation of a number of solutions, which are detailed in the document we have circulated. Some or all of the European standard developed and passed this year should be implemented in legislation. The standard is currently voluntary and will only become mandatory if it is implemented in legislation. Some countries have already done so. A regulatory or umbrella body should be established to oversee and co-ordinate the activities of bodies such as the Medical Council, the Irish Medicines Board, the Irish Nurses and Midwives Organisation and the Royal College of Surgeons in Ireland. These are all very good organisations but they act in isolation and without an overarching body to co-ordinate their activities in this area.

A register of practitioners should be established for those working in this field. The register should contain divisions indicating the level at which each practitioner operates, for example, whether he or she is a therapist, nurse, dentist, specialist doctor, etc. Members of the public must have confidence that surgery will be carried out by a surgeon who is trained to perform the procedures in question. In addition, procedures must be assessed and medical devices should be only FDA or CE approved. Consideration should also be given to introducing a national breast implant registry. Many of those affected in the PIP case still find it difficult to determine if they had PIP implants.

Premises should be fit for purpose and accredited and systems should be in place to look after patients during surgery and afterwards, particularly in the event of an emergency. Cooling off periods should be recommended and good data protection measures followed. It should be mandatory to follow what would be considered normal guidelines.

We are aware that the Advertising Standards Authority of Ireland is reviewing its guidelines for medical advertising. This review presents an opportunity to examine specifically cosmetic surgery advertising, as has been done in other countries. It is necessary to strike a balance between providing information and avoiding manipulation of those who are vulnerable. The experience of other European Union countries should be considered, for example, steps to prohibit practices such as advertising to those aged under 18 years, placing advertisements in public places, including radio and television, and using incentives such as two-for-one deals or discounts where purchases are made before a certain date. These practices have been shown not to be in the best interests of patients.

While I have tried to keep the presentation brief, I will be pleased to provide details of cases, without naming individuals, involving the types of treatments about which we are concerned.