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Contura, Leading Permanent Filler Company, Responds to Survey by the British Association of Aesthetic Plastic Surgeons

London, June 15 – Information released last week by the British Association of Aesthetic Plastic Surgeons (BAAPS) highlighted their concerns regarding complications due to cosmetic fillers. Contura International, a Danish medical technology company that markets the permanent filler Aquamid®, has the following comments to the findings of the Survey:

Since Aquamid was approved in Europe in 2001, more than 350,000 injections have been performed and safety surveillance shows an incidence of complications of less than 0.1%. Moreover the safety has been documented in numerous clinical trials published in peer-reviewed journals. A European multicentre clinical study showed more than 90% patient and physician satisfaction 5 years after the treatment with Aquamid without reinjection.

Aquamid is a soft hydrogel which in contrast to most other lasting fillers does not contain microparticles. Therefore, the filling effect is due solely to the injected volume and the product does not elicit tissue hardening. Similar to other fillers, infections can occur rarely at the injection site due to bacterial contamination and are treated with broad-spectra antibiotics.

In Contura’s view, the top three reasons BAAPS surgeons feel complications occur with temporary and permanent fillers, are in line with the experience from other countries:

o Unqualified practitioners are administering the fillers incorrectly

o Patients are unaware of the risks and side effects involved with the procedure

o Lack of regulation has allowed unproven substances to be used

To minimize the risk to patients of any filler treatment, the procedure should always be performed by properly trained and qualified practitioners. This is of particular importance when injecting a permanent filler.

Contura’s Chief Medical Officer, Dr. Ieva Ankorina-Stark says ”Aquamid is a very well-documented, and safe product. However, as with all injectable procedures there are risks. To minimize these risks, physicians who use Aquamid should be trained and use correct aseptic injection techniques, while adhering to post-treatment instructions and careful selection of patients and indications.”

Notes to Editors:

About Aquamid®

Aquamid® is a soft tissue filler that gives a natural look and feel. Aquamid® was approved in Europe in 2001 and is now available in 40 countries worldwide. Over 350,000 Aquamid® injections have been successfully performed to date. Aquamid® is currently being studied in a double-blind, randomized, multi-center, 2-arm parallel study involving 315 patients in 13 centers in the United States comparing the effectiveness of Aquamid® and Restylane® for the aesthetic treatment of facial wrinkles/folds. Data from this trial will support a PMA application with the FDA.

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 40 countries. Ethicon Inc., a Johnson & Johnson company, holds the exclusive worldwide distribution rights for Bulkamid which is currently available in most European countries. 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.

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