10 Year Data Shows Long-Term Safety and Efficacy of GC Aesthetics Implants
Monday, May 20, 2019 2:00 AM
DUBLIN, IRELAND / ACCESSWIRE / May 20, 2019 / GC Aesthetics (GCA) announced today that data from a European clinical study of over 500 women implanted with the GC Aesthetics' Eurosilicone breast implants was published online on the April 27, 2019 in Aesthetic Surgery Journal
Open Forum. The study, titled "Ten-Year Safety Data for Eurosilicone's Round and Anatomical Silicone Gel Breast Implants," looked at Eurosilicone's Cristalline Paragel gel-filled mammary implants when used in breast augmentation and reconstructive surgery and is the largest long-term European study conducted to date on breast implants.
"The results of this long-term study are among the best in the industry," said Professor Franck Duteille, MD, Plastic Reconstructive and Aesthetic Surgery at University Hospital in Nantes and Principle Investigator of the study. "The endpoints were achieved and can be observed through the low complication rates for capsular contracture and rupture, as well as through the low number of patients who experienced local complications such as haematoma, seroma and infection."
Study participants received GC Aesthetics' Eurosilicone textured mammary implants for primary (423 women) and revision (103 women) surgeries in 17 centers throughout France. Complications were recorded at 3 months and annually thereafter for 10 years.
The 10-year outcomes show Kaplan-Meier risk estimates for patients in the primary augmentation cohort as:
- 4.9% rupture
- 13.8% capsular contracture (Baker Grade III & IV)
"The results obtained from this large scale European clinical study of our textured breast implants confirms GC Aesthetics' 30-year commitment to continually delivering safe, innovative technologies to our customers, demonstrated through independent clinical research and daily support provided by our dedicated employees," commented Carlos Reis Pinto, Chief Executive Officer of GC Aesthetics. "In addition to this exciting data, we are awaiting approval to start another long-term European clinical study on our smooth breast implants. We are working collaboratively with partners across the industry as we remain focused on patient safety and care."
About GC Aesthetics
GC Aesthetics (GCA) is an established global medical technology company that develops, manufactures in-house and markets a comprehensive range of proprietary aesthetic products that empower patients to feel safe and confident on their personal journey. Through 30 years of commercial presence, GCA has been dedicated to advancing the science of medical aesthetics and delivering high-quality products under its premium Nagor and Eurosilicone brands, primarily for breast augmentation and breast reconstructive surgery. More than 3 million women and men across 70 countries have trusted GCA products, which are supported by published 10-year clinical data demonstrating compelling safety and clinical effectiveness. The Company's vertically-integrated strategy enables exceptional clinical, operational and commercial performance, which allows GCA to provide competitively differentiated products to physicians and patients. Through a culture of continuous innovation and dedication to customer-responsiveness, GCA has established itself as a leading provider of medical aesthetics solutions and the partner-of-choice for patients seeking to improve their lives.
SOURCE: GC Aesthetics