GCA committed to ensure Breast Implant Safety

A position statement regarding our silicone gel and manufacturing processes

GC Aesthetics® is focused on safety, quality and reliability. With more than 40 years in the market and over 3 million implants sold during the last 10 years1, GCA is fully committed with surgeons and patients worldwide with systems in place to ensure the safety of our products through pre-clinical testing, clinical studies and excellent global post-market surveillance, as well as continuous audits in our manufacturing sites: quality, technical, operational, microbiological and regulatory functions inspected.

We work to make sure our breast implants not only comply strictly but exceed safety standards required by regulatory authorities across the globe.

Our manufacturing sites:

  • Both manufacturing sites: Cumbernauld, Scotland and Apt France are externally certified and inspected facilities.
  • Continuous Audits >10 audits per site across manufacturing facilities in last 3-years from multiple agencies.
  • ISO Classified and validated Clean rooms

Our medical grade silicone materials:

  • Our breast implants are manufactured in accordance with the internationally recognized Quality Management System Standard ISO 13485.
  • Implants are manufactured with high purity long-term implantable medical grade silicone supplied from the only worldwide certified source, designed to meet FDA and ISO 10993 biocompatibility requirements within GMP-based manufacturing and an ISO 13485 certified quality system.
  • All Nusil® silicone materials are designed, manufactured and purified to meet the strictest requirements of the healthcare industry and supported by Master files with the US FDA

Our clinical data:

We are proud of our 5, 8 and 10 year clinical data2, which we have confirmed:

  • GCA re-intervention and rupture rates are low and significantly lower than competitors3
  • GCA capsular contracture rates are low and comparable to results obtained by competitors4

GCA is able to support our safety claims with the only two large scale prospective European studies of both textured and smooth breast implants, with 10-years of patient follow up.  Furthermore, with over 3 million implants sold over the last 10 years across 70 countries, the rate of BIA-ALCL incidence for GCA textured implants is less than 0.0009%5, and it is 0%6, for GCA smooth implants over the same period.

“The proven and long-standing safety record of GCA’s products has enabled us to provide a platform for continuous investment into our robust research and development activities. These activities have allowed GCA to ensure that our products are safe and highly effective in achieving the needs of our doctors and patients”

Carlos Pinto

CEO, GC Aesthetics

GCA continues to invest in research to better understand the interaction between breast implant surfaces and the body. Data from recent research we supported was presented by the investigator, Michail Sorotos, MD PhD (University of Salerno, Italy) in the 2nd World Consensus Conference on BIA-ALCL on November 2020.

We also recently launched on October 1st, our new round smooth opaque breast implant PERLE™ under the Directive 93/42/EEC on medical devices in Italy, Spain, France and Germany. We are currently working on registering with Health Authority regulators so our new revolutionary product can be present in the rest of the world in 2021.

“GC Aesthetics is committed to the safety and efficacy of each product that is produced within of our manufacturing facilities.  Each product is hand crafted using the highest purity of medical grade materials and individually inspected to ensure that it exceeds Global Quality Management specifications.  This attention to quality and detail has been the foundation which GC Aesthetics has built our 40 history on.  This is simply one reason that GC Aesthetics products are a “Confident Choice for Life” for over 3,000,000 patients around the world.”

Ron Cosmas

CCO, GC Aesthetics

Regulatory Licensing Documentation7:

  • CE marks according to Applicable European directives/Regulations
  • Global products registration in the markets we serve
  • Biocompatibility ISO10993
  • Implant Testing ISO14607
  • Manufactured to certified Quality Management Systems
  • Clinical Investigation of Medical Devices ISO14155 & ISO14791 (Application of Risk Management to Medical Devices).

“For over 40 years at GC Aesthetics through our Nagor and Eurosilicone brands we are proud to design, manufacture and distribute our products made from high purity medical grade materials in compliance with applicable state of the art standards to assure product safety and performance

Chris Brotherston

Head of Medical Affairs, GC Aesthetics

We continue to stand behind the long term proven safety of our products, collaborate with all Regulatory Authorities, commit to full transparency and care about patient safety and product innovation.

  1. Duteille F, et al. Aesthet Surg J Open Forum 2019;1. (2) 1-10;
  2. Duteille F, et al. Aesthet Surg J Open Forum. 2019; 1(2): 1–10.
  3. Duteille F, et al. Aesthet Surg J Open Forum. 2019; 1(2): 1–10.
  4. Duteille F, et al. Aesthet Surg J Open Forum. 2019; 1(2): 1–10.
  5. Global latest validated annual post market surveillance data for all smooth mammary implants based on total sales since launch
  6. Global latest validated annual post market surveillance data for all smooth mammary implants based on total sales since launch.
  7. Duteille F, et al. Aesthet Surg J Open Forum 2019;1. (2) 1-10;

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