Frequently Asked questions regarding safety of Aquamid.

How can you be sure that Aquamid injectable implants are not harmful in the long term?

Aquamid has been extensively tested in pre-clinical and clinical trials. The long-term effects have been studied in retrospective trials with an average observation period of six years (from two to nine years).

Are there any adverse events?

Temporary reactions typically connected with injections may appear, such as reddening, pain, oedema, itching at the site of injection.

Adverse events are seen in relation to less than 0.06% of all injections. In all cases, there were infections in connection with the procedure, and they were succesfully treated with proper antibiotics.

Can a person suffering from immune deficiency be treated with Aquamid?

In general, immune deficiency is not a contraindication for injection of Aquamid. However, special attention must be paid to patients with skin affecting diseases and patients under lasting or intermediate treatment. Therefore we advise to review each case carefully before injecting Aquamid.

Can a person suffering from autoimmune disorders be treated with Aquamid?

Aquamid should not be used in patients with autoimmune diseases affecting the skin area. Special attention should be paid to patients with autoimmune disorders receiving intermediate or lasting medical treatment with e.g. corticosteroids, NSAIDs etc., to evaluate if they are suitable for injection with Aquamid.

Can treatment of a patient with recurrent facial herpes with Aquamid provoke a new outbreak?

The very injection process constitutes a risk, since the injection of the needle into the skin may provoke an outbreak of facial herpes. Prevention of an outbreak of herpes by means of an oral antivirus drug is recommended.

Never use Aquamid when there is an outbreak of herpes labialis. Application of Aquamid is not recommended in persons with frequently recurrent herpes labialis.

Prescription of a prophylactic treatment with an oral antivirus drug is recommended in the case of patients suffering from recurrent facial herpes.

Can Aquamid cause hyper-pigmentation?

No hyper-pigmentation reaction has been recorded following injection of Aquamid.

How does the product react when the area is exposed to sunlight / UV rays?

The patient should not expose the treated zone to intense heat (sun bed, sunbathing, sauna) or extreme cold for four weeks following treatment. This is to avoid inflammation of the zone where the injection has been made.

Can Aquamid be used for pregnant or breast-feeding women?

There is no chemical or physiological reason why the use of Aquamid would be in any way harmful to pregnant and breast-feeding women. But since no clinical trials have been conducted concerning these groups, we advise against it.

Are there any known interactions with systemic treatments (antibiotics, etc.)?

There is no interaction between systemic treatment and Aquamid.

How does Aquamid react with the body tissue?

All pre-clinical studies show that the hydrogel will be surrounded by a thin connective tissue layer allowing water exchange with the surrounding tissue. There will be no hardening or capsular formation. The results are very soft and natural.

Can Aquamid be removed?

If immediate removal is necessary, always use an aseptic procedure. The needle must be changed. Put on a 21G or 18G needle and go directly to the area where hydrogel has been deposited and make an aspiration. If unsuccessful, make a small prick-incision and perform a small curettage. Clean up the stick channel.

Prescribe a prophylactic antibiotic treatment.