Frequently Asked Questions

ABOUT AQUAMID® – SOFT VOLUME FILLER

Aquamid®

Aquamid® is a soft volume filler, which integrates with your patient’s body tissue. It is a biocompatible, non-allergenic and non-absorbable hydrogel. Nominal proportions of the hydrogel are approximately 97.5% non-pyrogenic water and 2.5% cross-linked polyacrylamide.

Aquamid® is homogeneous.

The water component is in dynamic equilibrium with the surrounding tissues. Aquamid® becomes totally integrated with body tissue and hence cannot be distinguished from tissue by touch and feel.
It is pH neutral.

Aquamid® is uniquely suited to replace lost tissue volume due to aging, or add extra volume where needed, to achieve optimal facial contours.

Aquamid® Reconstruction

Aquamid® Reconstruction is a soft volume filler, which integrates with your patient’s body tissue. It is a biocompatible, non-allergenic and non-absorbable hydrogel. Nominal proportions of the hydrogel are approximately 97.5% non-pyrogenic water and 2.5% cross-linked polyacrylamide.

Aquamid® Reconstruction has a higher viscosity than Aquamid® making it ideal for filling larger areas and for reconstructive purposes.

Aquamid® Reconstruction is homogeneous.

The water component is in dynamic equilibrium with the surrounding tissues. Aquamid® Reconstruction becomes totally integrated with body tissue and hence cannot be distinguished from tissue by touch and feel.
It is pH neutral.

Aquamid® Reconstruction is especially designed for reconstructive or aesthetic corrections of the body and the face. Aquamid® Reconstruction is uniquely suited to replace lost tissue volume due to aging, or add extra volume where needed, to achieve optimal facial contours.

Aquamid® Reconstruction can be used for corrections of facial fat loss (lipoatrophy), e.g. in people receiving treatment for human immunodeficiency virus (HIV).
The full effect is obtained immediately. Results are predictable and natural looking. The volume obtained with the Aquamid® product range is equal to the amount injected.
Prospective, multicentre clinical studies with the Aquamid® product range have shown that the aesthetic results last at least for five years. A prospective, multicentre clinical study conducted in six European countries show patient satisfaction levels above 90% after five years while investigators assessed the aesthetic results as very good or good in more than 90% of patients. Continuous loss of facial tissue fat is part of the natural aging process, possibly requiring additional Aquamid® injections with time after the initial treatment.

The actual durability of the treatment depends on the aging process of the individual patient. Since Aquamid® gets completely integrated with the tissue and moves undisturbed with the skin, the look is natural.
The Aquamid® product range consists of stable, firmly cross-linked polymer gels, which do not degrade under normal environmental conditions. It gets fully integrated with the body tissue and therefore does not migrate from the injection site.
The Aquamid® product range aesthetic effect is due to the injected volume only. Other fillers which provide results lasting more than 12 months are typically composed of micro particles suspended in a carrier gel. With these fillers the desired tissue enhancement is achieved through intended foreign body response. This bears a risk of tissue hardening and firm nodule formation.

The Aquamid® product range does not get absorbed in the body, and the results last for many years without need for re-treatments. With hyaluronic acid and collagen fillers, aesthetic correction usually lasts from 3 to 12 months.
“Polyacrylamide” is a name for a large group of substances having the same basic synthesis materials but being different in characteristics. Polyacrylamides can vary substantially in their properties and hence are not identical.

The Aquamid® product range is manufactured in Denmark based on patented cross-linking technology. Extensive work has been done on developing the molecular structure to manufacture the gel tailored especially for soft tissue augmentation. The Aquamid® product range contains the highest water content – 97.5% – and less dry matter – 2.5% – compared to other polyacrylamide hydrogel.
Aquamid® obtained CE marking in March 2001 from the Danish Notified Body. It has been marketed throughout the world since then.
The Aquamid® product range is developed and manufactured in Denmark in compliance with the European Medical Devices Directive.

USING AQUAMID®

Aquamid® adds volume to the subcutaneous tissue, thereby restoring or augmenting skin contours.

The indications are:
Lip augmentation and contouring
Cheek remodelling
Chin augmentation
Naso-labial folds
Mento-labial folds
Glabella lines

Aquamid® Reconstruction
Aquamid® Reconstruction can be used for corrections of the body and the face:
Aesthetic and reconstructive augmentation due to congenital, traumatic, and aging tissue insufficiency:
– Deep folds and large depressions
– Nasal correction / Rhinoplasty
– Mandibular augmentation
– Cheeks and chin augmentation
Correction of facial lipoatrophy e.g. in people receiving treatment for human immunodeficiency virus (HIV)
The Aquamid® product range is not indicated for treatment of fine lines, because injection is done subcutaneously.
The Aquamid® product range is not approved for breast or genital augmentation.
New injections can be performed after at least two weeks (swelling from the last injection must completely subside). There is no maximum interval.
TheAquamid® products should always be injected into the subcutaneous tissue.
For injection of Aquamid® a fine gauge needle (27G) is recommended.
For injection of Aquamid® Reconstruction a fine gauge needle either 25G or 27G is recommended.
The Aquamid® product range must not be used in the site where a non-absorbable filler has previously been injected.
If the injection site has previously been treated with absorbable injectable soft tissue fillers, absorption of this filler must be completed prior to the injection of the Aquamid® product range (minimum six months).

Injection of absorbable filler in sites already treated with the Aquamid® product range must follow the instruction for use for the absorbable filler.
The Aquamid® product range must be injected subcutaneously. If injected too superficially, the aesthetic appearance is impaired.
The gel must be stored protected from direct sunlight.
Do not freeze.
Keep out of reach of children.
Do not store unsealed syringes for later use.
The Aquamid® product range has a shelf-life of two years.
The Aquamid® product range is for single patient, single use only.
The patient should avoid laser, peeling, skin resurfacing, pigmentation or aesthetic treatments in the area injected for at least six months before and after injection with the Aquamid® product range.

SAFETY

The efficacy and safety have been documented in several clinical trials, involving more than a 5,000 patients. These studies have been published in peer-reviewed journals 2, 4-5, 11-12, 15-17, 18-24. The data from a 2-year pivotal clinical trial in the United States has been used to support an FDA application.
To date more than 575,000 injections have been performed world wide.
As with any filler, adverse events related to treatment were mostly mild transient local reactions. In rare cases, local infections have occurred and have been resolved with antibiotic treatment.
The recommended treatment for infection is with a broad-spectrum antibiotic. Steroids or NSAIDs should never be used, as these may seriously prolong the treatment.
In general, immune deficiency is not a contraindication for injection of the Aquamid® product range.
Avoid the use of NSAIDs. Special attention should be paid to patients with chronic diseases receiving intermediate or lasting treatment with, e.g. corticosteroids. Application of the Aquamid® product range should not be used in patients with recurring herpes labialis or acne. Outbreaks of herpes labialis or active acne are contraindications.
Anamnesis data on ongoing infections, concomitant medication, surgery, dental work etc. must be secured prior to injection in order to prevent possible infections.

Therefore, we advise to evaluate each patient carefully before injecting with the Aquamid® product range.
The Aquamid® product range should not be used in patients with autoimmune disorders.
Special attention should be paid to patients with autoimmune disorders receiving intermediate or lasting medical treatment with e.g. corticosteroids, NSAIDs.
The Aquamid® product range should not be injected during pregnancy or lactation.
Initially the gel can be removed easily by aspiration through a puncture/incision with a large bore needle attached to an empty sterile syringe. Always use aseptic procedures.
After the Aquamid® product range has integrated with the tissue, curettage can be performed to remove the hydrogel.

The hydrogel cannot be removed completely, however an aesthetic experience can be altered if desired.