5-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 5 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*

 

Ruptures: 

  • Risk of rupture was 0.4% per patient within 5 years of implantation
  • Only 2 out of 1010 implants ruptured in this clinical trial

Capsular Contracture: 

  • Risk of capsular contracture was 13% on a per patient basis
  • Only 52 out of 534 women experienced capsular contracture within the 5 years

 

Eurosilicone’s 5-year results of removal for patient’s first implants (8.5%) were lower than the 5-year rates reported by Sientra (8.7%) and 4-year results for Allergan (9.6%).

Patients who had undergone reconstruction following cancer diagnosis also showed lower rates of removal when compared with competitor designs (14.7% vs 24.8% and 31% for Allergan and Sientra, respectively).

 

Conclusion

 

Based on the 5-year interim results, the complication profile of Eurosilicone gel–filled mammary implants until 10 years postimplantation are expected to demonstrate an excellent long-term safety and efficacy profile.

For more detailed results, please check the full 5-year clinical study.

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