Compulsory estimate
and informed consent
Compulsory estimate
It was under pressure from Consumer Associations and with the help of Plastic Surgeons that the decree of 17 October 1996 relating to the publication of the price of the aesthetic medical and surgical procedures has been drafted.
OFFICIAL JOURNAL OF THE REPUBLIC OF FRANCE Nº253 of 10/28/1996
Finance and Foreign Trade Decree of October 17 1996 concerning the publicity of prices of aesthetic medical and surgical acts.
The Deputy Minister for Finance and Foreign Trade, having regard to the Consumer Code in particular Article L.113-3; having regard to the Decree No. 86-1309 of 29 December 1986 laying down the implementation regulations relating to Ordinance No. 86-1243 1 December 1986 relating to freedom of pricing and competition; having regard to the decree of October 3, 1983 concerning the advertising of prices for all services; having regard to the decree of 3 December 1987 concerning consumer information on prices;
Having consulted the National Consumer Council
Hereby decrees as follows:
Art. 1 - For any act for aesthetic purposes, the estimated cost of which is greater than or equal to euros 150, or for general anaesthesia, the practitioner shall provide a detailed estimate. Other aesthetic assistances must also give rise to an estimate when the person examined so requests.
Art. 2. - All estimates must include the following:
1. Date of drafting;
2. The name, address, departmental council registration number of the Association of Doctors, qualification in a specialisation (including general medicine) and / or exclusive competence in Plastic, Reconstructive and Aesthetic Surgery issued by the National Council of the Order of Physicians and the existence or not of a professional civil liability insurance of the practitioner, providing the doctor concerned with a warranty in respect of the planned procedure;
3. The name, surname, date of birth and address of the patient applying for treatment;
4. The location where the service will be provided, specifying for private health facilities, the approval number issued by the Department of Health and Social Affairs;
5. The precise nature of the foreseen act and, if necessary, the anaesthesia, the proposed date; medical information on the intended procedure may be given on a separate document;
6. A detailed statement, in quantity and price of each product and service necessary for the procedure envisaged: denomination, unit price and quantity covered, save in the case of pre-operative of preoperative examinations and the period for which postoperative care is to be provided, the total amount payable, inclusive, and the period for which the estimate is to remain valid of the offer;
7. The expected number of days off work and the nature of any necessary preoperative examinations;
8. The requirement for the practitioner to provide a report on the operation to the medical practitioner nominated by the person to be treated;
9. The sentences: « When medical devices or injectable products for aesthetic purposes are used, they must be officially authorized. The references will be detailed on the invoice (brand, manufacturer, batch number...). « If it is an act solely for aesthetic purposes, examinations, surgery, prescriptions and the time off work will not be covered by health insurance. « It is agreed that should be respected a minimum of 15 days should elapse between the provision of this documen and any procedure taking place. This is a period of reflection before any decision for the practitioner and the examined person. During this period, no consideration or commitment of any kind may be demanded or obtained, directly or indirectly, from the person examined, in any capacity or in any manner whatsoever, save for the price of this consultation. « This period may however be reduced to seven days, at the express request of the person examined, who shall enter this request on the estimate in writing and sign it. In all cases, the estimate, drawn up in duplicate and signed for the practitioner must also include a manuscript indication, dated and signed by the consumer: « estimate received before the carrying out of the service ».
After such period of reflection, the examined person who accepts the estimate must write on the practitioner’s handwritten copy, dated and signed: « estimate accepted after reflection ».
When the practitioner provides medical information mentioned in paragraph 5 on a separate document, the document must include the same handwritten, signed entry as the estimate. The practitioner shall retain the duplicate of the estimates under the same conditions as are prescribed by the decree of October 3, 1983.
Art. 3. - For all procedures, the objective of which is solely aesthetic and which are not referred to in Article 1, the person examined shall be given an information sheet containing the information referred to at paragraphs 1 to 5 of Article 2.
Art. 4. - This order shall be published in the Official Journal of the French Republic and shall enter into force on January 1st, 1997.
Drawn up in Paris, October 17, 1996
YVES GALLAND
Informed Consent in Plastic, Reconstructive and Aesthetic Surgery
The Code of Professional Conduct specifies that no surgery should be carried out without the person concerned being informed.
According to current practice, the practitioner is obliged to provide full information to patients, but also has the obligation to prove he/she has fully delivered this information.
The obligation to inform
In the particular field of Plastic, Reconstructive and Aesthetic Surgery, the surgeon qualified in aesthetic surgery shall deliver complete information to the patient before surgery.
Read on
Informed Consent
In practice, courts require that the surgeon qualified in aesthetic surgery obtains fully informed free consent from the patient, which requires him to point out not only the normal, common risks, but also the exceptional risks, as well as minor and major risks.
Information on risks and techniques must be accessible and understandable to the patient; the surgeon qualified in aesthetic surgery should adapt this explanations to the capacity of the individual concerned to understand them.
This information should be more rigorous where the patient is psychologically fragile.
The information must be recent or repeated and thus the information given a few years or months previously is not sufficient to obtain an informed consent.
The information must be issued "at a distance from the operation": the surgeon qualified in aesthetic surgery should indeed observe a period of reflection between consultation and intervention; in the field of cosmetic surgery, the precipitation is regarded as a fault.
Finally, the information must exceed the strictly surgical and because the information must be complete, it must be expanded by the same particular anaesthetic risk inseparable from any surgery.
Proof of information
It should be noted that if the surgeon qualified in plastic surgery must prove that he/she has given a full information, there is no specified form to give that evidence.
In practice, one can distinguish two types of evidence:
• The written evidence: the surgeon qualified in aesthetic surgery can pre-constitute proof of its information by making the patient sign a document stating that he/she had received full information on the unfolding of the intervention, the location of scars, the usual result, the uncertainties and risks and complications, which should include, as we have seen, the exceptional risks.
• The bundle of presumptions
The proof of the information may be made "by all means", including a set of presumptions.
This bundle of presumptions may be of the following elements:
- One or more consultations at a distance from the operation allow the surgeon qualified in aesthetic surgery to issue information and the patient to ask any questions he/she deems desirable.
- The length of consultations.
- The quality of medical records (complete, easy to access and transmit, updated).
- The period of reflection of several weeks between the first consultation and the date of surgery.
- Sending a letter to the patient giving an account of the consultation with the use of an adapted vocabulary and summarizing the unfolding of the intervention, its benefits and possible risks.
- Sending a letter to the patient’s doctor.
In total, to obtain the informed consent of his/her patient, the surgeon qualified in aesthetic surgery must provide complete, simple, understandable and fair information, it must also be able to demonstrate the proper implementation of this notification requirement.
