10-year clinical study underlines safety and efficacy of Eurosilicone® implants

Surgeon holding breast implants

GC Aesthetics through its leading brands of Eurosilicone and Nagor is dedicated since more than 40 years to advance both the science and safety of medical aesthetics products around the world, and to deliver the highest quality products that meet the needs of our customers and their patients.

As part of the company’s commitment to provide long-term clinical safety data on its medical devices, GC Aesthetics initiated a 10-year post-marketing study involving over 500 women in 17 centers across France.

Largest published European study

The study looked at GC Aesthetics’ Eurosilicone’s Cristalline Paragel gel-filled mammary implants when used in breast augmentation and reconstructive surgery. Study participants received “Eurosilicone” textured mammary implants for primary (423 women) and revision (103 women) surgeries. Complications were recorded at 3 months and annually thereafter for 10 years.

The data from this largest published European study conducted to date on breast implants titled ‘Ten-Year Safety Data for Eurosilicone’s Round and Anatomical Silicone Gel Breast Implants,’ was published in April 2019 in the ‘Aesthetic Surgery Journal Open Forum’.

“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 the 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.”

Carlos Reis Pinto, Chief Executive Officer of GC Aesthetics, commented:

“As a leading global company with over 40 years of experience and dedicated to women’s aesthetic healthcare, we are proud about the outcome of this large scale European clinical study of our Eurosilicone breast implants. It demonstrates and reinforces our commitment to continually deliver safe and innovative solutions to our customers and their patients.”

The Key Findings*

Rupture: 4.9%

Rupture rates were low and significantly lower than the results obtained by competitor implants (9.3% and 9%).

Capsular Contracture: 13.8%

Capsular contracture (Baker Grades III and IV) rates were low and comparable to the results obtained by competitor implants (18.9% and 12%).

Re-Intervention: 13.3%

Re-intervention rates were low and significantly lower than the results obtained by competitor implants (18.6).

Conclusion

The results of this post-marketing 10-year study demonstrate the safety and efficacy of GC Aesthetics Eurosilicone® round and anatomical silicone gel breast implants. The rates of reintervention, rupture and capsular contracture were low, and significantly lower or comparable to competitor implants.

*According to the 10-year Kaplan-Meier risk estimates for patients in the primary augmentation cohort. A Kaplan-Meier survivorship estimate measures the statistical probability of a complication occurring in a particular patient cohort at a specific point in time during a clinical trial.

For more detailed results, please check the full 10-year clinical study.

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