What is the difference between AQUAMID and other products containing polyacrylamide?
The difference lies in the origin and manufacture of the gel. AQUAMID is a polyacrylamide gel that is made in Denmark in compliance with the ISO standards. Another difference is the structure of the gel. AQUAMID is made on the basis of a new patented technology (lLX TechnologyTM) which makes it possible to control the viscosity and elasticity of the gel while preserving a watery, stable concentration. The monomer content is below 5 ppm (approx. equal to two day's consumption of drinking water). AQUAMID is patented in the United States, Europe and Brazil.
Why is AQUAMID gel permanent?
Because the polyacrylamide forms long chains that cannot be split by the human body. No enzyme or bacterium is able to metabolise the polyacrylamide. This is the reason why the gel remains in place at the site of injection and remains as a part of that tissue.
How can you be sure that AQUAMID is not harmful in the long term?
Because it has been used for aesthetic correction for more than ten years in 30,000 patients. Restrospective studies have not shown any long-term side effects, clinically and histologically. Numerous toxicological studies have been carried out on animals. They have shown that implants of polyacrylamide gel are tolerated for long periods of time without biodegradation. Preclinical studies have not shown any cytotoxic effects, any systemic or pyrogenic effect, any effect on the blood or on enzyme activity. Polyacrylamides have been used for many years in the United States and Europe for treatment of drinking water. Injection of AQUAMID causes only mild reaction in the surrounding tissue which is minimal com- pared with reactions to other foreign bodies. This indicates that the polyacrylamide gel is well toler- ated by the human body. There is no calcification, no carcinogenic effect, no inflammation and no local allergic reaction. The gel is not found in the lymph nodes. AQUAMID does not cause any allergic reaction or any other immunological effect either in animals or in humans. AQUAMID does not migrate. In fact, its high molecular weight makes migration impossible.
How deep into the tissue should AQUAMID be injected?
AQUAMID should be injected into the subcutaneous tissue.
What size of needle should be used?
For injection of AQUAMID a fine gauge 27G needle is recommended.
Does the material grow in size after injection?
The result obtained immediately after the injection is the visible, definitive result. AQUAMID requjres neither undercorrection nor overcorrection.
What will happen if AQUAMID is not injected at the subcutaneous level?
The gel must be injected subcutaneously. It should not be injected into the superficial dermis or the intermediate dermis, since the consequences of such injections are not known. If an injection is too superficial, the aesthetic result may not be as desired, since the surface will not be smooth. If necessary, the gel can be withdrawn with a 19G needle inserted into the gel. The gel can be diluted by means of a solution of sodium chloride or anaesthesia, which will facilitate the removal of the gel.
Can AQUAMID be injected to eliminate fine wrinkles?
AQUAMID is not indicated for treatment of fine wrinkles.
Are there any side effects or adverse reactions?
Temporary reactions typically connected with injection may appear, for example reddening, pain, oedema, itching at the site of injection. Adverse effects are seen in relation to 1-2% of injections. They are mainly due to the quality of the injection and of hygienic standard and sterility.
Can AQUAMID be associated with other types of injectable implants?
AQUAMID should not be used in a site where a non-soluble filling product has previously been injected. In sites previously treated with a soluble filling product, an injection of AQUAMID should not be made until the soluble product has disappeared completely.
Can AQUAMID be injected if other filling products have already been used?
It is a contraindication for the use of AQUAMID if the site in question has already been treated with injections of a permanent filling product. If other filling products have been used, injection of AQUAMID should wait until the first product has disappeared.
Can AQUAMID be used between the eyebrows?
Treatment of the area between the eyebrows is one of the indications for AQUAMID.
Can a person suffering from an autoimmune disorder be treated with AQUAMID?
Autoimmune disorders are not a contraindication for injection of AQUAMID.
Can a person suffering from immune deficiency be treated with AQUAMID?
Immune deficiency is not a contraindication for injection of 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 contribute to provoking an outbreak of facial herpes. Prevention of an outbreak of herpes by means of an oral antivirus drug is recommended. Never use AQUAMID when having an outbreak of herpes labialis.
Should a prophylactic treatment be prescribed for patients suffering from recurrent herpes?
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 hyperpigmentation?
No hyperpigmentation reaction has been registered 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) or extreme cold in the first days following treatment. The purpose of this is to avoid inflammation of the zone where the injection has been made.
Can AQUAMID be used for pregnant or breastfeeding women?
Since there is no clinical evidence of AQUAMID in pregnant and breastfeeding women it is advisable not to use AQUAMID for pregnant or breastfeeding women.
Are there any known interactions with systemic treatments (antibiotics, etc.)?
There is no interaction between systemic treatment and AQUAMID, since AQUAMID is stable, inactive and bio- compatible and does not migrate.
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