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. |
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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.
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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. |
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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). |
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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. |
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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. |
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HOW DEEP INTO THE TISSUE SHOULD CONTURA'S LTF BE INJECTED?
Contura's LTF should be injected into the subcutaneous tissue. |
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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. |
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