Europe’s largest silicone implant manufacturer has published safety data from a five-year review in Plastic and Reconstructive Surgery (PRS), the first ever study on European women.
The multi-centre study monitored 1,010 devices made by Eurosilicone implanted in 535 women undergoing either augmentation or reconstructive surgery. Each patient was followed up three months post-surgery, and annually thereafter.
Owned by GC Aesthetics also the parent company of the UK’s only implant manufacturer Nagor; the study’s results demonstrate a reassuringly low rupture rate and excellent safety profile for Eurosilicone’s products.
In June, Eurosilicone joined its sister brand to triple the variety of implants available to British women. Combined, both companies produce 300,000 implants annually exported to over 80 countries.
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, Eurosilicone’s results show 50% fewer removals than its nearest competitor.
Implant removal may be required for a number of reasons and figures relating to this form part of the study. Most re-operations were performed for cosmetic reasons – but capsular contracture (an abnormal reaction of the body where the breast tissue hardens) was just 1.9%, while the most frequent reason for re-operation was mastopexy at 10.7%, followed by scarring (3.6%). Out of the 365 women having a 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. None were found during the 35 re-operations and the total risk of rupture was assessed at just 0.4%.
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 news to women and surgeons worldwide, who can select their implants with confidence. At GC Aesthetics we’re proud to produce 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 aesthetic possibilities to British patients.”