Safety

The choice of indication or recognition of a contraindication is within the sole competence of the doctor who will adapt the following advice according to the indication, patient and techniques used.

The following list of exclusion criteria is not exhaustive, it serves as a reminder for the doctor; it does not represent any formal obligation for exclusion nor is it an exhaustive list.

1. Children, prepubescent teenagers, pregnant or breast-feeding women.
2. Chronic diseases or immunodefiency disorders. Insulin-dependent diabetes, connective tissue disorders, preexisting cardiac rhythm disorders.
3. Infectious skin diseases active in or close to the area to be treated.
4. Keloid or hypertrophic scars.
5. Surgical operation in the same area less than 6 months.
6. Any prior treatment that might affect skin permeability: laser, abrasion, isotretinoin, retinoic acid, fruit acids, benzoyl peroxide, other peelings, hair removal, face or body scrubs, etc.
7. Any prior treatment that might affect the skin’s capacity to regenerate: ionizing radiation, local corticosteroid injections, etc.
8. For deeper peelings: skin phototype 5/6
9. The body skin (except the facial skin) is a particular contraindication for deep peels application.
10. Allergy or hypersensitivity to one of the components of the medical device.
11. Smoking can affect skin regeneration and impede healthy healing of scars in case of deep peelings. Smoking promotes the re-appearance of wrinkles.
12. Long hystory of smokiing or “serious smoker”.

It is imperative to read the instructions for use for medical device Class IIa peels as they may include important information specific to that particular practitioner / procedure.

 

Patient Selection

CHOOSING THE RIGHT PATIENT IS A KEY SAFETY FACTOR

Choosing the right patient is one of the main rules of safety and involves taking account of the indications, contraindications, and results from a number of essential preliminary clinical tests. A phenol peel should not be applied if there is any doubt or if the hoped-for result is impossible to achieve.

 

Patients with Mental or Behavioral Risks
The patient has to understand the peel procedure and the limits of a deep peel. The patient must agree to comply with the strict rules of the procedure before, during, and after the peel. Any cosmetic procedure in which the patient is required to take an active part, and especially a deep peel, is strictly contraindicated for patients who do not have a minimum level of understanding. The patient has to be capable of understanding and accepting the necessity to wear sunblock and makeup after the peel and be aware of the time needed for the skin to regenerate completely. Squeamish patients will overwhelm the doctor with complaints, worries, questions, and reproaches. It is better to test a patient’s mental and physical resistance by first suggesting a painless peel without complications and then progressing to a medium-depth peel before considering a phenol peel. Individual tolerance can be tested in this way, and the patients themselves gradually learn what a peel is and what it can do for them.

Patients should be shown a series of photographs that illustrate what the face looks like day by day during the first week after a peel. Ideally, the patient’s family should also see these photographs. Without this precaution, paranoid patients, friends, and family may not believe it when the doctor tells them that everything is proceeding as normal.

 

ISOLATED PATIENTS
Being alone is not in itself a contraindication for a phenol peeling, but patient safety requires a few rules. Today’s phenol peelings are formulated to allow outpatient treatment: the patient can go home soon after the phenol peeling. However, a phenol peeling triggers significant swelling that can sometimes make it difficult for patients to open their eyes during the first night or the day after the peeling. It is therefore out of the question to allow a patient living alone to go home after the peeling. The patient has to be helped in all aspects of daily life for the first three days after the peeling. Clinics with hospital beds can also keep patients on-site for the first few days.

 

NOTE: Phenol is absorbed rapidly by the skin and mucous membranes. It is also eliminated immediately by the lungs and kidneys (in free form, as sulphate or glucuronide conjugates). Detoxification begins immediately in the liver, after application. A perfect aeration and ventilation of the treatment room will prevent respiratory absorption by a patient already under transcutaneous absorption. Phenol vapors enter the pulmonary circulation very quickly, and it is recommended that the doctor applying the phenol wear a mask to avoid breathing them in.

Summary of safety rules

RELATED TO THE PRACTITIONER:

• Doctors should inform their professional insurers that they perform this type of peel.
• The doctor must be aware of all potential complications. monitor for them, be able to treat them, and have the necessary equipment to deal with them.
• The risks of general anesthesia and products that could irritate the myocardium can be avoided by using local nerve blocks or deep sedation.
• Doctors should use phenol extremely carefully and in accordance with all the safety rules (equipment, skill), by using the proper application technique
• Doctors must inform patient about post treatment period and specific care, control patient understanding

 

IMPORTANT FOR ALL USERS:

• Do not leave phenol vial with the top off: if the vial is open, the solution will evaporate, changing the concentration of the active product with potentially serious consequences.
• Phenol can be applied only on a surface equal or less than 4% of the body surface (the face, for example).
• All contact between phenol and the eyes should be avoided. in case of contact, flush with saline and consult a specialist.
• The product should only be applied to the face. There are a large number of pilosebaceous units in the face that help the epidermis regenerate properly.
• When applied to the full face, phenol should be applied slowly, over a minimum of 1 hour, on healthy patients with normal liver and kidney function who can be expected to achieve good aesthetic results.
• It is better not to treat the neck with phenol.
• Occlusive masks must be applied carefully to prevent air bubbles or pools of phenol from forming. Occlusion slows down the absorption rate of phenol and reduces its toxicity.
• Before phenol application control the patients hydration. Treated area should be ventilated, and monitored (pulse oximeter and electrocardiogram). A venous drip should be set up beforehand, and if necessary glucose serum can be administered to avoid hypoglycemia.
• A phenol solution needs CE certification.

CONSENT FORM:

Download the consent form here.