Largest European Study on Breast Implants Published

First-Ever Study on European Women: Over 1,000 Devices Monitored

London – 9 June, 2014 – Europe’s largest silicone implant manufacturer has published safety data from a five-year review* in the prestigious journal Plastic and Reconstructive Surgery (PRS), the first ever study on European women. The multi-centre study monitored 1,010 ‘Cristalline Paragel’ devices made by Eurosilicone (www.eurosilicone.com) implanted in 535 women undergoing either augmentation or reconstructive surgery.  Each patient was followed up at three months post-surgery, and then annually thereafter.

Owned by Dublin-based GC Aesthetics (www.gcaesthetics.com) which is also the parent company of the UK’s only implant manufacturer Nagor (www.nagor.com), the study’s results demonstrate a reassuringly low rupture rate and an excellent safety profile for Eurosilicone’s products. This month, Eurosilicone joins its sister brand to effectively triple the variety of implant profiles and combinations available to British women, backed by the biggest cache of positive data ever researched and released.  Combined, both companies produce 300,000 implants annually exported to more than 80 countries, enjoying over 60 years of history in the market.

Whilst the results don’t allow for direct comparison with competitors, the dramatically lower removal rates of implants for breast augmentation experienced by the Eurosilicone patients compared with other brands is reassuringly positive.  Where implants are used in reconstructive surgery following a cancer diagnosis, Eurosilicone’s results are impressive – 50% fewer removals than its nearest competitor.

Implant removal may be required for a number of reasons and figures relating to this form a large part of the study.  Most re-operations were performed for cosmetic reasons rather than reconstructive – but capsular contracture (an abnormal reaction of the body where the breast tissue forms a ‘capsule’ and hardens) was just 1.9%, while the most frequent reason for re-operation was women wanting a boob lift (mastopexy)  at 10.7%, followed by scarring (3.6%).  Most of the devices that were removed were associated with patients having a breast reconstruction. Out of the 365 women having a boob job – ie primary augmentation – just 4.4% had their implants removed during the five year period.

Rupture rates were exceptionally low with just one of the 1,010 implants found to be ruptured on examination. No ruptures were found during the 35 re-operations and the total risk of rupture was assessed at just 0.4% per patient.

According to GC Aesthetics’ Chief Executive Ayse Kocak, who is also the industry’s first-ever female CEO;

“This study – the largest ever published in Europe – provides very positive and reassuring news to women and surgeons worldwide, who know they can select their implants with confidence.  At GC Aesthetics we are proud to be producing some of the highest quality products available, alongside the most comprehensive warranty on the market. We are thrilled to be introducing Eurosilicone to the UK, which will provide hundreds of new and reliable aesthetic possibilities to British patients.”

Eurosilicone’s product lines include the bestselling ‘Round Collection’ spanning 219 variations, as well as the ‘Matrix’ offering 9 types with 102 variations.  GC Aesthetics products also offer the most comprehensive warranty on the market: free and valid for the entirety of the patients’ lifetime, rather than just the product’s lifetime.

About GC Aesthetics

GC Aesthetics, which stands for Global Consolidated Aesthetics, was founded in 2007 and is the umbrella company for two leading implant manufacturers: Nagor and Eurosilicone.  The Dublin-based privately owned company has more than 60 years of combined experience and excellence in implant development, manufacture and innovation and currently manufacture and sell breast implants in 90 countries, offering a wide product range with nearly 600 types of implant. The company manufactures their products at their own facilities based in Scotland, England and France and produce to the highest European standards. GC Aesthetics is committed to the continuous improvement and evolution of the Eurosilicone and Nagor product lines and to educating consumers by providing clear information on implants.

GC Aesthetics directs group operations from their corporate headquarters in Dublin, Ireland. To contact them, please email info@gcaesthetics.com and to visit the GCA website please go to www.gcaesthetics.com 

About Nagor

Nagor (www.nagor.com) is the only British manufacturer of silicone breast implants with facilities situated in Cumbernauld in Scotland and Ashby De La Zouch in central England, employing 125 highly skilled and dedicated people. They have been selling implants since 1979 and offer a lifetime patient guarantee on all breast implants.

All Nagor products are designed, developed and manufactured in facilities compliant with the ISO 13485 standards and requirements demanded for class III sterile breast implant medical devices. They are manufactured under a quality management system in accordance with ISO and EN requirements and have CE mark certification.

About Eurosilicone

Eurosilicone (www.eurosilicone.com) is a leading manufacturer in the global plastic surgery community. They are an innovative developer and manufacturer of a complete range of quality surgical implants and tissue expanders. Their extensive product line provides surgeons with a wide range of breast augmentation, aesthetic and reconstructive options.

Eurosilicone products are manufactured in state-of-the-art facilities in Apt, France. Their implants are manufactured in full compliance with ISO and EU requirements and are CE certified according to the requirements of the Medical Device Directive 93/42/EEC.