8-year clinical study underlines safety and efficacy of Eurosilicone® 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. Here are the Key finding after 8 years conducting the study.

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*

 

Implant Removals: 0.1%

Implant removal rate was low, only 0.1%, with 57 out of 526 patients who underwent reoperations.

Ruptures: 

Of 995 implants, only 8 had ruptured within 8 years postimplantation.

Capsular Contracture: 

Capsular contracture (Baker Grades III and IV) rates were low with only a 15.7% within the first 8 years postimplantation.

 

Conclusion

 

The results presented here in the ongoing Eurosilicone postmarket clinical study illustrate the low level of complications and the high degree of performance associated with long-term implantation of Eurosilicone Cristalline Paragel breast implants.

For more detailed results, please check the full 8-year clinical study.

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