Furthermore, Anteis regrets the confusion created by this scandal that aims to associate the inadmissible practices of the PIP Company (according to the facts reported in the press) with all manufacturers of injectable wrinkle fillers. In particular, unfounded concerns have appeared regarding the safety of resorbable products made from hyaluronic acid. In reply, certain sources of misunderstanding need clarification.
Resorbable products made from hyaluronic acid have nothing in common with the substances used in breast implants.
While silicone is the raw material used in PIP implants, Anteis injectable aesthetic products are developed from hyaluronic acid.
Silicone, a basic inorganic compound used in the manufacture of breast prostheses (notably) is an exogenous compound that is not present in the human body. On the contrary, hyaluronic acid, the basic compound in Anteis’s injectable products, is identical to endogenous hyaluronic acid. It is an entirely natural and completely biocompatible product that is naturally present in the body. Therefore, it is one of the safest and most effective means of filling wrinkles.
Anteis pays constant attention to conformity and quality in the production of its injectable aesthetic products made from hyaluronic acid.
Anteis conducts biocompatibility studies, clinical studies and stability studies, in order to assure constant quality, performance and clinical safety of its products throughout their period of validity.
Anteis aims to comply scrupulously with current standards. Consequently, the Group’s two production plants located in Geneva, Switzerland and Lonay (near Lausanne) respectively, operate strictly on the basis of Good Manufacturing Practice (GMP).
Anteis has its own quality control laboratory, and also sub-contracts inspections to external laboratories in the interests of independence. Our production process is strictly monitored and controlled, and the production conditions and methods employed are those applicable in the injectable pharmaceutical solutions sector.
Anteis gets its raw materials and components from renowned suppliers, mostly in Europe and Japan, systematically rejecting any raw materials or components that do not comply with applicable standards or internal specifications.
Anteis, thanks to its commitment to satisfy its customers by means of permanent monitoring of all its processes and products, has not experienced any serious incident in materiovigilance since its creation in 2003.
Injectable aesthetic products made from hyaluronic acid are subject to strict directives and external control from their development to their distribution including the production phase.
The entire range of injectable aesthetic products made from hyaluronic acid grouped under the following brand names: Esthélis, Fortélis, Modélis, Mesolis and Jolidermis are subject to strict directives and numerous internal and external controls in order to assure constant quality, performance and clinical safety throughout their period of validity.
They are registered and approved for sale in the 90 countries in which they are distributed.
All injectable products made from hyaluronic acid are class III medical devices certified CE by the SGS, under the delegated authority of Swissmedic, the Swiss body responsible for monitoring healthcare products attached to the Swiss Ministry of Health.
SGS is the world leader in inspection, control, analysis and certification. Accepted as the global reference in terms of quality and integrity, it is the notified body of Anteis, which issues CE certifications under the control of the English health authority (MHRA - Medicines and Healthcare Products Regulatory Agency). SGS is one of the most competent notifying bodies in Europe for products made from hyaluronic acid and the most renowned with health authorities outside Europe.
Anteis has been certified ISO 13485 since 2005. The last audit by SGS was successfully passed at the end of 2011.
The conformity of the quality management system has been certified by numerous inspections carried out by SGS, and also by some of the most exacting health authorities including the Australian regulatory authority (Therapeutic Goods Administration, TGA) and the American regulatory authority (Food and Drug Administration, FDA), and lastly by its customers, mainly pharmaceutical laboratory partners. These inspections have been successfully passed on every occasion.
The production site located in Geneva has been approved by the FDA since 2009, and Anteis is one of the rare companies worldwide authorised to market its wrinkle fillers* on the U.S. market, proving the seriousness and professionalism that Anteis applies to systematically guarantee the quality of its products and the safety of its patients.
*Marketed on the U.S. market under the Belotero brand name by the Merz Aesthetics Company
Anteis thus wishes to reassure the medical profession and its patients as to the utmost and constant quality and safety of its injectable products made from hyaluronic acid.
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