Contura

SINCE WHEN HAS CONTURA'S LTF BEEN USED IN EUROPE?

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

WHAT DOES THE CE 0543 MARK MEAN?

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 indi- cates that Contura's LTF meets the requirements formulated in EU Directive 93/42.

WHY ARE CERTAIN POLYACRYLAMIDE GELS SAID TO BE NON-PERMANENT?

We suggest that you submit this question directly to other manufacturers. Studies have shown that the polyacrylamide gel Contura's LTF is stable, that it does not migrate, and that Contura's LTF implants are well tolerated over long periods of time without biodegradation.

HOW IS CONTURA'S LTF MADE?

Contura's LTF 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.

HOW IS CONTURA'S LTF STERILISED?

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

WHAT IS CPM?

The Essential Beauty with CPM Filler is manufactured using Cohesive Polydensified Matrix (CPM) technology. This dynamic cross linking process is unique to the product and gives it its unusual elasticity and suppleness.

HOW LONG HAS THE ESSENTIAL BEAUTY WITH CPM FILLER BEEN USED?

The filler was launched in 2005 and has already taken the European and New Zealand markets by storm. The Essential Beauty with CPM Filler has been administered to 150,000 patients worldwide.

WHAT CAN THE ESSENTIAL BEAUTY WITH CPM FILLER BE USED TO TREAT?

The filler provides an aesthetic solution for: treating moderate to deep wrinkles; treating furrows; treating scars; adding volume to facial contours such as cheeks and chins and lip enhancement.

HOW LONG DO RESULTS LAST?

The gel integrates homogenously into the skin for immediate and long-term results that last between 9 to12 months.

HOW LONG DOES A TREATMENT TAKE?

One session usually takes just 20 minutes. There have been few reported incidences of swelling after treatment with the Essential Beauty with CPM Filler, allowing the patient to return immediately to their daily activities.

WHY IS CONTURA'S LTF GEL PERMANENT?

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.

WHAT IS CONTURA'S LTF'S MODE OF ACTION?

The Contura's LTF gel is homogeneous and does not contain any particles (microballs, microcrystals). Contura's LTF's effect is clearly linked to the volume injected. Contura's LTF does not migrate; it is stable and inactive at the site of injection.

HOW LONG DOES TREATMENT WITH CONTURA'S LTF LAST?

The effect of the injection of Contura's LTF is permanent. Since the ageing of the skin continues, it may be necessary to carry out follow-up injections after a certain period of time, depending on a number of factors (skin structure, age,...).

FOR WHAT PURPOSES IS POLYACRYLAMIDE USED?

Polyacrylamides are used in the production of drinking water. They are used as a floculant and coagulant to remove particles from the water. Polyacrylamides are used to wash fruits for peeling as well as certain vegetables. Polyacrylamides are also used as a floculant in the production of cane sugar. Polyacrylamides are used in medical products: soft contact lenses, implant materials,... They are also used in the cosmetics industry (hair colouring products, creams, lotions,...) and in paper production.

HOW CAN YOU BE SURE THAT CONTURA'S LTF 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 Contura LTF gel 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 Contura's LTF 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. Contura's LTF does not cause any allergic reaction or any other immunological effect either in animals or in humans. Contura's LTF does not migrate. In fact, its high molecular weight makes migration impossible.

HOW DEEP INTO THE TISSUE SHOULD CONTURA'S LTF BE INJECTED?

Contura's LTF should be injected into the subcutaneous tissue.

WHAT SIZE OF NEEDLE SHOULD BE USED?

For injection of Contura's LTF 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. Contura's LTF requres neither undercorrection nor overcorrection.

WHAT IS THE DIFFERENCE BETWEEN CONTURA'S LTF AND OTHER PRODUCTS CONTAINING A SIMILAR FORMULA?

The difference lies in the origin and manufacture of the gel. Contura's LTF is made in Denmark in compliance with the ISO standards. Another difference is the structure of the gel. Contura's LTF 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). Contura's LTF is patented in the United States, Europe and Brazil.

WHAT WILL HAPPEN IF CONTURA'S LTF 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 CONTURA'S LTF BE INJECTED TO ELIMINATE FINE WRINKLES?

Contura's LTF 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 CONTURA'S LTF BE ASSOCIATED WITH OTHER TYPES OF INJECTABLE IMPLANTS?

Contura's LTF 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 Contura's LTF should not be made until the soluble product has disappeared completely.

CAN CONTURA'S LTF BE INJECTED IF OTHER FILLING PRODUCTS HAVE ALREADY BEEN USED?

It is a contraindication for the use of Contura's LTF 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 Contura's LTF should wait until the first product has disappeared.

CAN CONTURA'S LTF BE USED BETWEEN THE EYEBROWS?

Treatment of the area between the eyebrows is one of the indications for Contura's LTF.

CAN A PERSON SUFFERING FROM AN AUTOIMMUNE DISORDER BE TREATED WITH CONTURA'S LTF?

Autoimmune disorders are not a contraindication for injection of Contura's LTF.

CAN A PERSON SUFFERING FROM IMMUNE DEFICIENCY BE TREATED WITH CONTURA'S LTF?

Immune deficiency is not a contraindication for injection of Contura's LTF.

CAN TREATMENT OF A PATIENT WITH RECURRENT FACIAL HERPES WITH CONTURA'S LTF 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 Contura's LTF 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 CONTURA'S LTF CAUSE HYPERPIGMENTATION?

No hyperpigmentation reaction has been registered following injection of Contura's LTF.

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 CONTURA'S LTF BE USED FOR PREGNANT OR BREASTFEEDING WOMEN?

Since there is no clinical evidence of Contura's LTF in pregnant and breastfeeding women it is advisable not to use Contura's LTF for pregnant or breastfeeding women.

ARE THERE ANY KNOWN INTERACTIONS WITH SYSTEMIC TREATMENTS (ANTIBIOTICS, ETC.)?

There is no interaction between systemic treatment and Contura's LTF, since Contura's LTF is stable, inactive and bio- compatible and does not migrate.

HOW LONG CAN THE PRODUCT BE STORED?

At present Contura's LTF can be stored until the expiring date. Stability studies are being carried out with a view to prolonging the approved storage period.

UNDER WHAT CONDITIONS SHOULD CONTURA'S LTF BE STORED?

Contura's LTF should be stored at room temperature (25°C) protected from direct sunlight. Do not freeze Contura's LTF.

WHAT ARE AQUAMID® INJECTABLE IMPLANTS?

Aquamid® is a sterile, transparant injectable hydrogel. Aquamid® is made from a homogeneous (no microspheres or particles) polyacrylamide hydrogel. Aquamid® contains 97.5% apyrogenic water and 2.5% cross-linked polyacrylamide. Aquamid® is stable, and biologically inactive, non-toxic, non-biodegradable. It cannot pass through biological membranes because of the large molecular size and its hydrophere nature of the cross-linked polyacrylamide. It is pH neutral (7.5 in average) and insoluble in all known solvents. Aquamid® indicated for facial and body contour correction and reconstruction.

HOW SOON DO RESULTS APPEAR?

The results obtained with Aquamid® are immediate. The volume obtained with Aquamid® is equal to the amount injected (1:1).

HOW LONG DO RESULTS LAST?

Aquamid® is non-resorbable and does not disappear. Retrospective studies have shown the long-lasting results of patients who are satisfied with their treatment for up to a period of 9 years. However, since the ageing of the skin continues, it may be necessary to carry out follow-up injections after a certain period of time, depending on a number of factors (skin structure, age, etc).

WHY IS AQUAMID® LONG-LASTING?

The polyacrylamide used in Aquamid® is chemically stable; its cross-linked structure and big molecular size mean it cannot migrate. Moreover, no enzyme or bacterium can metabolise the polyacrylamide used. As a result, the implants remain at the site of injection as part of the soft tissue.

DOES AQUAMID® MOVE FROM THE SITE OF INJECTION?

Aquamid® is migration resistant and becomes an integrated part of the body's own tissue.

WHAT OTHER USES DO POLYACRYLAMIDES HAVE?

• Polyacrylamides are used in medical products such as soft contact lenses & implant materials. • Polyacrylamides are used in the production of drinking water. They are used as a flocculent and coagulant to remove particles from the water. • Polyacrylamides are used to wash fruits for peeling as well as certain vegetables. • Polyacrylamides are used as a flocculent in the production of cane sugar. • Polyacrylamides are used in the cosmetics industry (e.g. hair colouring products, creams, and lotions) and in paper production.

WHAT IS THE DIFFERENCE BETWEEN AQUAMID® AND OTHER PRODUCTS CONTAINING POLYACRYLAMIDE?

Aquamid® contains more water - 97.5% - and less polymer - 2.5% - than any other polyacrylamide hydrogel. This means that Aquamid®: • Is highly biocompatible • Allows maximum water exchange with tissue • Requires only a 27G needle • Is easy to inject • Is pH neutral (7.5 in average) Aquamid® is manufactured in Denmark in compliance with the European Medical Devices Directive 93/42/EEC.

HOW IS IT POSSIBLE THAT OTHER POLYACRYLAMIDES APPEAR IN THE MARKET?

Contura has the right to produce and sell this specific formulation of polyacrylamide, but we cannot avoid that other companies use polyacrylamide with different formulations.

WHY ARE CERTAIN POLYACRYLAMIDE GELS SAID TO BE RESORBABLE?

Some polyacrylamides are resorbable because they have a different molecular structure. The polyacrylamide in Aquamid® is cross-linked and is therefore non-resorbable.

HOW LONG HAVE AQUAMID® BEEN USED IN EUROPE?

Aquamid® obtained CE marking in March 2001 from the Danish Notified Body DGM. It has been sold throughout the world since then.

WHAT DOES THE CE 0543 MARK MEAN?

The CE-mark indicates that Aquamid® meets the requirements formulated in the European Medical Devices Directive 93/42/EEC. The 0543 number indicates the Notified Body. Studies have shown that the polyacrylamide gel used for Aquamid® is stable, migration resistant, and that Aquamid® is well tolerated over long periods of time without biodegradation.

WHERE IS AQUAMID® MADE?

Aquamid® is made in Copenhagen, Denmark, by the healthcare company Ferrosan A/S. The production takes place in clean room surroundings according to GMP rules.

HOW IS AQUAMID® STERILISED?

Aquamid® is made and processed in clean room conditions (class 100,000). The filled syringes are then sterilised by means of autoclave sterilisation (moist heat) at 121° for 60 minutes.

HOW MANY AQUAMID® PRODUCTS ARE AVAILABLE?

The range of Aquamid® consists of: • Aquamid® • Aquamid® Reconstruction

WHAT CAN AQUAMID® INJECTABLE IMPLANTS BE USED FOR?

Aquamid® is designed for lasting aesthetic correction and reconstruction of soft tissues in the face and body. The implants add volume to the subcutaneous tissue, thereby restoring or augmenting skin contours. Aquamid® injectable implants are indicated for: • Lip augmentation and contouring • Cheek remodelling • Chin augmentation • Smoothing of naso labial folds • Smoothing of mento labial folds • Glabellar frowns • Smoothing of deep wrinkles • Nasal correction / Rhinoplasty • Mandibular augmentation • Facial lipoatrophy • Aesthetic/reconstructive augmentation due to congenital, post-traumatic, post-surgical tissue insufficiency • Post-liposuction filling • Scar revision • Other types of facial and body contouring

CAN AQUAMID® BE INJECTED TO ELIMINATE FINE LINES?

Aquamid® is not indicated for treatment of fine lines.

CAN AQUAMID® BE USED FOR BREAST OR GENITAL ENHANCEMENT?

At this time, Aquamid® is not approved for breast or genital enhancement.

WHAT IS THE PERIOD OF TIME BETWEEN TWO INJECTIONS IN THE SAME PATIENT?

New injections can be performed after at least 2 weeks (swelling from the last injection must completely subside). There is no maximum interval.

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 needle is recommended, not thinner than 27G.

DOES AQUAMID® GROW IN SIZE AFTER INJECTION?

The result obtained is equal to the amount injected (1:1) and is visible immediately after the injection. Under-correction is recommended as Aquamid® is non-absorbable. Some swelling after injection might occur.

CAN AQUAMID® BE ASSOCIATED WITH OTHER TYPES OF INJECTABLE IMPLANTS?

Aquamid® should not be used in a site where a non-reabsorbable filling product has previously been injected. In sites previously treated with a resorbable filling product, Aquamid® should not be injected until the resorbable product has disappeared completely (minimum 6-12 months).

WHAT WILL HAPPEN IF AQUAMID® IS NOT INJECTED AT THE SUBCUTANEOUS LEVEL?

HOW LONG AND UNDER WHAT CONDITIONS SHOULD AQUAMID® BE STORED?

Aquamid® can be stored until the expiry date. We are conducting stability studies to learn if the approved storage period can be extended. Aquamid® should be stored at room temperature, and protected from direct sunlight. Do not freeze.

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). Read more in the article entitled \\\"Long term Effects of Polyacrylamide Hydrogel on Human Breast Tissue\\\" (Long-term histology study) which was published in Reconstructive Plastic Surgery, May 2003.

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.