Abstract
Dr Alain Fogli is a member of the ISAPS Specialty Promotion Committee and ISAPS National Secretary for France. Dr Fogli has been Chairman of the Board of Directors of the Syndicate of Plastic Surgery in France for over five years. The National Syndicate is a National Union whose purpose is to protect the specialty and the Syndicate has an official spokesperson for the Government. Members of the Board of Directors are elected by French plastic surgeons. The changes initiated in France were in response to extensive publicity about cosmetic surgery that drew attention to the lack of traditional safeguards for patients. It became necessary for the Government to learn more about the field of cosmetic surgery, including its financial and safety aspects. The Government initiated an inquiry and the Syndicate was subsequently invited to participate in the writing new regulations. Dr Fogli and Dr Hepner met with the Health Minister to assist in formulating the regulations and the final proposition was put to Parliament and passed into Law.
The regulations are also designed to monitor the practice of cosmetic surgery and to avoid possible abuse.
Introduction
The changes initiated in France were in response to extensive publicity about cosmetic surgery that drew attention to the lack of traditional safeguards for patients. It became necessary for the French Government to learn more about the field of cosmetic surgery, including its financial and safety aspects, and they initiated an inquiry. The French National Syndicate of Plastic, Reconstructive and Cosmetic Surgery was subsequently invited to participate in the writing new regulations.
These regulations were intended to:
Regulate the facilities where cosmetic surgery is performed; Explain the specific skills and training required to perform cosmetic surgery procedures so that the patient can be assured of the surgeon's competence to perform the surgical procedure appropriate to their condition; Explain the information that must be provided to patients about procedures, including the costs and associated medical risks.
As a result of this close collaboration, The French National Syndicate of Plastic, Reconstructive and Cosmetic Surgery has now become a world leader in setting standards for patient safety in cosmetic surgery.
Defined surgical procedures
French Law now defines the most frequently performed cosmetic surgery procedures and that they must only be performed by qualified surgeons. The following have also been classified as cosmetic surgery procedures and are not covered by French health insurance:
All forms of liposuction on any part of the body, including fat harvesting for lipofilling; All treatments for baldness; Dermabrasion of the lips; Injection of non-absorbable materials. Injection of botulinum toxin; Injections of non-permanent fillers.
The following procedures are not included as cosmetic surgical procedures:
Practitioner qualification
The following principles were enshrined:
Surgical procedures, which take place in authorized facilities, can only be undertaken by surgeons who are registered specialists and deemed competent. Possession of a general medical degree, and the fact that the practitioner is ‘experienced’ are not sufficient qualifications; Plastic surgeons registered under the Law are entitled to perform all reconstructive and aesthetic surgery procedures; Other specialists registered with the Medical Council of France are only permitted to perform cosmetic surgery in the anatomic areas in which they are qualified. For example, ENT specialists are qualified to perform cosmetic surgery in the face and neck, whereas maxillofacial surgeons can perform surgery of the face, neck and oral cavity.
Patient information
Details of procedures and associated risks
The Law defines the information, which must be conveyed to patients, about cosmetic surgery:
It places certain obligations regarding the provision of information and strict control of surgical methods on the practice of cosmetic surgery; The law is clear with regard to the necessity for imparting to the patient comprehensive information about the procedure at the first consultation. The surgical methods must be fully explained to the patient and must not be modified without the agreement of the patient. The risks involved and the potential complications must be explained to the patient, no matter how minor or rare. The action required to correct the complications must also be explained.
Information about surgical fees and services
A detailed quotation is to be given to the patient and a mandatory waiting period of 15 days must be respected so that the patient can reach a decision without feeling pressurized. The 15-day period may not be shortened. The quotation must be signed by the surgeon (or surgeons, if a joint procedure is planned) and given to the patient before any part of the proposed treatment/operation is undertaken.
Regulation of surgical facilities
The Regulations define the facilities, organization, personnel and equipment used, specify conditions in which cosmetic surgery can be practised, and the levels of patient care that must be adhered to. The Regulations vary depending on whether the installation is within a medical facility.
For cosmetic surgery performed within a medical facility, the law designates that a ‘Commission’ deals with patient relations and ensures that quality standards are met in the facility; For cosmetic surgery performed outside a medical facility, the law provides for a committee to be installed for the same purpose. These authorities oversee the information given to patients as well as addressing patient complaints; The law prohibits commercial patient accommodation from being part of, or attached to, a doctor's house. The entrances of surgical facilities and any commercial accommodation must be clearly separated; The presence of paramedic personnel is obligatory for the entire period during which the patient is undergoing the procedure and the period of hospitalization.
Advertising and publicity restrictions
All forms and methods of publicity and advertising, direct or indirect, in whatever form, including the Internet, are forbidden. This is also applicable to all French doctors involved in healthcare.
Positive and negative aspects of new regulations
The significance of these regulations for the practice of cosmetic surgery in France is below.
Positive aspects
There has been a progressive reduction in the surgical activity of non-qualified physicians;
Because of the prohibition on advertising, business groups no longer have an interest in developing commercial cosmetic surgery clinics or hospitals.
Negative aspects
There has been a significant, added administrative burden for registered plastic surgeons;
In response to the regulations, non-specialist practitioners have formed a lobby group, which campaigns to promote the use of fillers and other non-surgical techniques, which lie outside the scope of the regulations. They have also given the public the impression that cosmetic surgery is dangerous;
Foreign countries can still advertise in France and so ‘medical tourism’ falls outside these regulations. The only positive approach to the problem of surgical tourism so far is limited to patient education. Hopefully, ISAPS (the International Society of Aesthetic Plastic Surgery) will be able to more effectively influence public education on the subject of cosmetic surgery tourism.
Evolution and current trends in France
In France, as in many other countries, there is an increasing desire in all social classes and age groups to improve one's physical image. Longer lifetimes have provided more time for this seduction of self-improvement. Young adults and, fortunately to a lesser degree, teenagers are also aware of the emphasis on looking younger and are seeking ‘preventive’ techniques. Society and the media's fascination with plastic surgery are intense. Magazines and TV programs regularly run pieces on aesthetic surgery. This strong media coverage favours the penetration and acceptance of cosmetic surgery in people's daily lives. Nevertheless, sensational stories are often preferred to factual information and this influences the public perception.
Current procedures performed in France
The demand for breast surgery (augmentation, reduction and mastopexy) is very strong. At the time of writing, there is much ethical and scientific debate about autologous fat transplantation for breast augmentation. There are also growing numbers of abdominoplasties, medial thigh and arm lifts, as well as body lifts following bariatric surgery. The demand for liposuction appears to be increasing, in large part because its practice by unqualified physicians is now forbidden.
The care and maintenance of one's face is becoming a greater concern for both women and men. While the number of rhinoplasties and chin augmentation or reduction procedures remains stable, periorbital surgery is increasingly replacing simple blepharoplasty. The surgical indications for this surgery are full of nuances, requiring diverse associated medico-surgical techniques such as temporal lifting, blepharoplasty, lipofilling and injections of botulinum toxin or hyaluronic acid. The same is true for the face, with cervico-facial or centro-facial lifting. The trend is towards less invasive surgery that enables rapid social re-integration and additional procedures that are even less invasive.
Few plastic surgeons perform hair transplantation, but patients regularly request this procedure.
Changes in aesthetic practice
French law, which many foreign plastic surgeons would like to have adopted in their own countries, has in large part protected patients. However, such legislative control of aesthetic surgery in France has placed very heavy constraints on surgeons. The advantage is that the laws ensure qualified surgeons have a requisite level of skill and must operate in centres that maintain equipment and facilities of the highest standard. The disadvantage is that free legal assistance and appeals to the Commissions enable patients to engage in frivolous lawsuits against surgeons. At the same time, surgeons from other countries are advertising lower prices for aesthetic procedures, creating an increase in medical tourism from France. Such advertising by French professionals is forbidden, while French laws cannot be applied to foreign institutions and professionals. Furthermore, wealthy patients, with ever-greater mobility, often travel abroad in search of famous surgeons.
Aesthetic medicine has presented challenges as a result of very powerful lobbying, claiming that aesthetic surgical procedure are dangerous, especially since ‘cosmetic’ doctors are forbidden to perform such procedures. As defined by the French Academy of Medicine, a surgical procedure is any procedure where the body is entered by cutting through the skin, as opposed to an invasive procedure such as endoscopy.
Creation of a teaching module
The American Society for Aesthetic Plastic Surgery (ASAPS) has shown that the market for aesthetic surgery has reached maturity and that only aesthetic medicine has potential for major growth. France has a long tradition of reconstructive surgery, dating back to World War I, and French plastic surgeons have had difficulty in accepting non-surgical techniques. Young plastic surgeons have reported that their qualifications, obtained after very difficult studies, are only a label for selection by patients. Given this new situation, the French Society of Aesthetic, Reconstructive and Plastic Surgery (SOFCPRE) and the National Union of Esthetic, Reconstructive and Plastic Surgery (SNCPRE) have decided to organize courses in aesthetic medicine by adding a teaching module by the College of Esthetic, Reconstructive and Plastic Surgery (CNCPRE), leading to a qualification exam. From this perspective, the plastic surgeon will become the main player in anything that concerns aesthetic intervention by applying the same rigor to adjuvant treatments as they do for complex surgery. They must therefore gain credibility and become the absolute reference point.
Conclusion
The French Government has intervened to regulate the cosmetic surgical sector to protect the patient. French Law now defines practitioners' qualifications, range of practice and the facilities they work in. Advertising medical and surgical cosmetic procedures is outlawed in France.
Notes about French Law
Anglo-Saxon and French Law are very different.
There are three different Laws.
The Law (March 2002) is called a ‘Frame’ Law, the second Law is called ‘Decrets’ (July 2005 and December 2005) and the third Law is called a ‘Circulaire’ which gave details concerning the application of the ‘Frame Law’.
Law dated 17 October 1996 – This law regulates publicity for medical and surgical procedures concerning aesthetic appearance; Law No. 2002-303, 4 March 2002; Decree No. 2005-776, 11 July 2005 relates to Law No. 2002-303; Newsletter No. DGS/SD2B/DHOS/04/2005-576 23 December 2005 defines the Decree mentioned above; Law No. 2002-203, and the associated decree and newsletter, outline patient rights and establish a framework for the practice of cosmetic surgery in hospitals, clinics and medical practices.