Aquamid obtained CE marking in March 2001. This marking, which is granted by an independent notified body, certifies that the production of Aquamid takes place in compliance with European norms and that the product has proved to be harmless and efficient in human beings.

This is the number from the notifying body in Denmark (DGM) which is audited by MDA in London. A notified body is an institution that issues CE certificates, i.e. grants CE marking to products that have been approved for sale in the European Community. The CE mark indicates that Aquamid meets the requirements formulated in EU Directive 93/42.

Aquamid is made in Copenhagen, Denmark, at the pharmaceutical company Ferrosan NS. The production takes place in sterile surroundings. In addition the gel is sterilised by means of autoclave sterilisation in the syringe.

The manufacture and processing of Aquamid take place under aseptic conditions. The filled syringes are then sterilised by means of autoclave sterilisation (moist heat).

Because the components forms long chains that cannot be split by the human body. No enzyme or bacterium is able to metabolise the gel. This is the reason why it remains in place at the site of injection and remains as a part of that tissue.

Because it has been used for aesthetic correction for more than eight years. 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 Aquamid implants 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. Components of the gel 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 compared with reactions to other foreign bodies. This indicates that the polyacrylamide gel is well tolerated 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.

Aquamid should be injected into the subcutaneous tissue.

The result obtained immediately after the injection is the visible, definitive result. Aquamid requres neither undercorrection nor overcorrection.

Aquamid should NOT be used for:

• The area around the eyes
• Frontal horizontal lines
• Areas where another permanent filler has been used previously
• Patients who have been treated with absorbable fillers within the last six months
• Breast and genital areas

No. Aquamid is not indicated for treatment of fine lines

Aquamid should not be used in an area where a non absorbable filling product has been injected previously.

New injections can be performed after a minimum of two weeks. The swelling from the last injection must have completely subsided.

In the first days it is not unusual to see bruising, swelling or a light redness of the skin. This is the natural reaction after an injection and does not require treatment. If symptoms persist after a few days, the patient should return to their injecting physician.

The patient should not expose the injected area to intense heat (e.g. solarium, sunbathing or sauna) or extreme cold (e.g. wind, chill or ice), for four weeks after treatment. This is to avoid inflammation of the injected area. After this period of time normal habits can be resumed, however a high sun protection factor is recommended.

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