20-11-2009 - Aquamid’s long-term safety and efficacy confirmed in follow-up study with 4800 Orientals

A new study published in Journal of Plastic, Reconstructive and Aesthetic Surgery confirms the long-term safety and efficacy data of Aquamid. In the study Aquamid was administered to 5676 Oriental patients in the period December 2002 to June 2007 with the follow-up including 4,822 patients. The follow-up period was up to four years with 55% of patients exceeding one year.

The article states that “Aquamid is very useful and safe, and has a long-lasting effect as a filler, if one pays particular attention to the rules and criteria […].We have not experienced any allergic reaction to Aquamid and no granuloma lesions as compared with hyaluronic acid treatment. Complications manly consisted of infectious lesions […]. Granulomatous reactions, which are generally seen in foreign-body operations, were never seen in our treatments. So, higher biocompatibility is expected to be guaranteed and complications are rare [less than 0.082%]. In addition, nonpermanent fillers are expensive for patients because they must be injected many times.”

Michael Peytz, Chief Executive Officer, Contura International A/S, said “The positive clinical experience in this Japanese study confirms the safety and efficacy of Aquamid in Orientals, which in previous studies have already been established in Caucasian subjects.”

Click here to download the press release.

About Aquamid®
Aquamid® is a soft volume filler that gives a natural look and feel. Produced using Contura’s patented hydrogel technology, Aquamid® is composed of 97.5% sterile water and 2.5% cross-linked polyacrylamide. The Aquamid® hydrogel is homogeneous: it contains no microparticles; hence its filling effect is due solely to the injected volume. Unlike particle-based fillers, the hydrogel does not rely on an intended foreign body reaction to achieve the desired augmentation. Therefore, the filling effect is immediate and predictable. Moreover, the hydrogel does not cause tissue hardening or fibrosis. No skin test is needed before treatment. The hydrogel integrates completely into the tissue and does not migrate from the injection site. It stays soft, feels like a natural part of the tissue and follows tissue movements. Because the hydrogel does not degrade over time, it provides augmentation that lasts for years. Aquamid® was approved in Europe in 2001 for facial augmentation and minor body contouring and is available in several countries in Europe, Asia, the Middle East and South America. Aquamid® is used mainly for treating nasolabial folds, lip augmentation, cheek contouring, nose enhancement and for treating facial lipoatrophy. Over 350,000 Aquamid® injections have been performed to date. A Pre-Marketing Application (PMA) for Aquamid® for mid-to-deep sub-dermal implantation for the aesthetic treatment of moderate to severe facial wrinkles and folds, such as nasolabial folds, is expected to be submitted to the U.S. Food and Drug Administration (FDA) in Q1 of 2010. Aquamid® is not approved for sale in the United States.

About Contura
Contura is a medical technology company based in Denmark that develops and commercializes soft tissue fillers. Contura’s products – Aquamid® for facial contouring and Bulkamid® for the treatment of female urinary incontinence – are manufactured using the company’s patented polyacrylamide hydrogel technology. Aquamid® is sold through a network of local distributors in several countries in Europe, Asia, the Middle East and South America.  Ethicon Inc., a Johnson & Johnson company, holds the exclusive worldwide distribution rights for Bulkamid and has started to sell the product in Europe. Clinical trials evaluating Aquamid® and Bulkamid® are ongoing in the United States. Data from these trials will be used to support PMA applications for these products. Contura’s products are developed, manufactured and tested in Denmark in compliance with the European regulatory requirements for medical devices.  

Reference: Yagi Y. et al. Use of Aquamid as a filler for facial rejuvenation in Orientals. Plast. Reconstr. Aesthet. Surg. (2009), 62: 1245-1249