Collagen Replacement Therapy

Collagen Replacement Therapy, Restylane, Perlane and Other Cosmetic Augmentation Techniques

Collagen Replacement Therapy (CRT) is, as the name suggests, a technique whereby the body's natural collagen is replaced artificially. As part of the ageing process, collagen beneath the skin is lost, producing wrinkles and crease lines. In CRT, bovine collagen is injected subcutaneously with the aim of reducing or eliminating these wrinkles. Unfortunately, the injected collagen implant is itself resorbed (the rate varies from patient to patient) and the treatment usually needs to be repeated. The purpose of this statement is not to discuss the merits of the technique itself, but rather to consider its medico-legal implications.

The stated view of the General Dental Council is that CRT does not satisfy the requirement of being treatment "as is usually performed or given by dentists", and consequently it does not constitute the practice of dentistry as defined by Section 37 of the Dentists Act (1984). However, it is important for members to appreciate that the Council's stance is under continuing review. It is likely that a similar decision would be taken in relation to the use of Hyaluronic acid techniques such as Perlane and Restylane. Perlane and Restylane are non-animal hyaluronic acid gels used as fillers for soft tissue augmentation.

What are the Risks?
These techniques are relatively expensive and are used in elective procedures. The patients who request such treatment are a self-selecting group with high and perhaps unrealistic aesthetic expectations. Any one of these factors, alone, would make these techniques have an above average potential for litigation. Taken together, they represent a considerable potential risk.

The primary risk of the treatments themselves is hypersensitivity/allergic reactions. Anaphylaxis has been reported, albeit rarely, but transient side effects such as swelling, erythema, urticaria, and/or headaches, fever, muscle pain, neuralgia or paraesthesia can arise in up to 2% of cases. This is high for an elective procedure. Other undesirable consequences have been induration, abscess/cyst formation or sloughing/necrosis at the injection site, and permanent paraesthesia. Whilst the injection technique itself is relatively simple, and should not present any particular hazards for dental surgeons, great care must be taken to avoid deep subepithelial or sub-cutaneous injection. The best (and safest) results are achieved superficially.

Training
Any members contemplating the provision of any of these techniques are urged to approach them responsibly and professionally as they would any other procedure, ensuring that they fully understand the procedure and the risks before proceeding. They should first attend a recognised training course, and investigate the relevant research literature. These techniques are not ones to try, initially, without experienced supervision.

Careful pre-treatment counselling of potential patients is necessary, to exclude those who are psychologically unsuitable (including those with unrealistic expectations) or those for whom the treatment may be directly contra-indicated. This might include any history of anaphylaxis, multiple allergies (especially certain protein allergies), lignocaine hypersensitivity and various other conditions described in the literature. These techniques should be avoided during pregnancy.

As part of the process of obtaining the patient's informed consent to the procedure, operators should ensure that the patient:

1. Has been made fully aware of the possible risks and side effects.
2. Understands the nature of the procedure.
3. Accepts the short-term nature of the treatment and the likelihood that re-treatment (at further cost) will be necessary.
4. Has a realistic expectation of the results that can be achieved.

Contemporary techniques must be used and there should be a clear and comprehensive written record of the consent process. Patients should also be given written documentation underpinning the consent process preferably indicating their consent in writing.

Emergency Reactions
Practitioners undertaking such procedures should ensure that they and their staff are confident and competent to deal with any medical emergency that might arise.

Indemnity
In the light of the above advice, Dental Protection can indemnify members for these techniques undertaken in the lip and immediate peri-oral areas. An additional subscription is payable, (membership grade DC1) the relevant total subscription for the year commencing 1st April 2008 being £4,180.

Members wishing to carry out these techniques elsewhere in the face (eg "crows feet" around the eyes, "frown lines" in the glabella region and forehead) can similarly be indemnified. This requires an annual subscription of £5,570 (membership grade DC2) with effect from April 1st 2008.

These additional subscriptions reflect Dental Protection's view is that it would be unreasonable for subscription rates generally, for all members, to have to reflect the potential risk of these techniques in areas that do not amount to the practise of dentistry.

Last updated 1st June 2006