Dr Marie Louise von Sperling discusses lessons on cosmetic regulatory requirements in Denmark
In 2014, one in four Danes is considering undertaking a cosmetic procedure.1 The number is increasing, along with the demand for, and the availability of, a wider variety of cosmetic procedures performed by doctors. As a consequence, more focus has been placed on side effects, complications, or simply failure to achieve expected results – with requirements coming from patients, doctors and health authorities. Across borders plastic surgery has developed rapidly during the twentieth century. New types of injuries resulting from fire damages and disfigured victims of the first and second world wars, led to an increased need for surgery that could reconstruct appearance. The surgical methods became increasingly advanced, and these techniques were transferred to corrections in healthy patients for beautification purposes. This was the beginning of cosmetic surgery, which started in Hollywood in the early 1920s. It really took hold in the 1960s when Texan Timmie Jean Lindsey became the first woman in the world to receive breast implants.2,3
In Denmark – with its 5.6 million inhabitants – the number of both surgical and nonsurgical procedures is increasing by 30% a year. In 2013, 4,000 purely cosmetic surgical procedures were performed in private clinics.4 The number of injections with botulinum toxin and non-permanent fillers was 110,000. To perform plastic surgery, there are approximately 80 specialists in Denmark,5,6 placed mainly in eight public hospitals and fewer in private clinics. It takes six years of surgical training to specialise in plastic surgery.
At the start of the twenty-first century, cases of malpractice became more visible to the public with an increasing number of enquiries made to the Danish National Board of Health on cosmetic procedures.7 These originated both from patients seeking to complain about their treatment, who were then referred to the Patient’s Board of Complaint, and from doctors reporting serious complications. Furthermore, stories about malpractice, serious complications and unsatisfactory results accumulated in the media. We heard about the 23 year-old woman who received a liposuction of 6.5 litres on her abdomen and developed large skin necrosis. Another patient received a liposuction of 16 litres and also developed skin necrosis. A long list of men consulted a specific plastic surgeon for penis enlargements, and came out with chronic nerve issues. In my own experience, I have seen a patient who required removal of her implants after she asked for an augmentation of 400cc on each side, but received four implants, two 200cc on each side.8,9,10,11,12
As a reaction to these reports the Ministry of the Interior and Health in 2004 asked the National Board of Health to set up a working group to look at cosmetic procedures performed by doctors in Denmark. In 2007 this led to a new set of rules and regulations on cosmetic practice. The National Board of Health stated in 2007, that only surgeons with relevant specialist training are permitted to perform cosmetic surgery in Denmark.13 Other than plastic surgeons, only surgeons with relevant training are allowed to perform specific cosmetic procedures, such as ENT surgeons, gynecologists and urologists, in the respective organs. The doctor and all assistants who perform any non-surgical cosmetic procedure have to be registered to a central register. The doctor pays a fee of 15,000 DKR (£1,600) once a year to be on the register. The National Board of Health routinely oversees all cosmetic clinics on the register every third year, in surgical as well as non-surgical clinics. Only specialists in plastic surgery, dermatology and neurology, as well as some with special permission, are allowed to prescribe toxins. Registered assistants may inject toxins after the doctor´s indication, and are allowed to inject fillers, do superficial peels and conduct laser procedures after special laser-certification. For all interventions, both surgical and non-surgical, it is mandatory to keep a before-picture in the medical record. Physicians who are registered, must publish their latest control review report made by the health officer on the clinic's website and have it readily available in the office.
To avoid quick and poorly thought-through decisions in connection with cosmetic surgery, the patient is to have a week’s time for consideration from the time the oral information is received until written consent is given. All preliminary examinations before operations, and information provided before a cosmetic procedure, must be done by the surgeon and cannot be delegated to an assistant. To receive an injection with filler of toxin, the patient is to have a consideration time of 48 hours before the first treatment. Written consent is also mandatory for these types of cosmetic improvements.
In Denmark regulations on cosmetic practice are strong regarding “who, where and when” procedures are allowed to be performed. The “Danish model” may be useful for other countries to replicate as part of a standardisation process. But did outcomes in cosmetic practice in Denmark improve since 2007? Unfortunately we do not yet have a register with mandatory reporting on complications, outcomes and patient satisfaction. This means that we do not have precise figures on the extent of these parameters. For developing yet higher standards for our patients, the next step would be for cosmetic health professionals to share and report experience and outcomes in a central register. This would hopefully create an honest picture of reality for our patients, colleagues and the public.