nagor-breast-implants

Short history

  • 1979 Nagor (Isle of Man) established to distribute silicone implants
  • 1990 Biosil, Ashby-de-la-Zouch (England) set up to design and manufacture silicone devices for Nagor
  • 1995 2nd facility (Cumbernauld) established to design and manufacture silicone devices
  • 2008 Nagor and Biosil acquired by Global Consolidated Aesthetics (Ireland)

Gel

There are two gel suppliers of medical grade silicone gel around the world: Nusil Technologies and Applied Corporation. Both are designed to meet FDA and ISO 10993 biocompatibility requirements. Both of them are also offering form stable Gel.

Nagor purchases silicone gel from Applied Corporation and has a large choice of breast implants in terms of gel.

 

Regulatory environment

All our implants are CE marked Class III medical devices

Europe – Medical Devices Directive (93/42/EEC)

International standards – ISO 14607 and ISO 13485

Worldwide requirements:

Australia, Argentina, Brazil, Mexico & China

Site Inspections (4 annually)

Materials – Long-term implantable medical grade silicone

Vigilance and post marketing surveillance

 

Since PIP scandal

  • Increased inspections (9 in 2012) – UK, French & Brazil authorities
  • Increased review of safety data – new implants approved
  • Product testing by authorities
  • New European regulations – more scrutiny & unannounced inspections

CGA Comfort Guarantee

  • As a company, we are very proud of our market-leading safety record and boast a low capsular contracture rate and one of the lowest rupture rates in the industry.
  •  We will replace one or both (if your physician recommends it) of your implants free of charge in rare cases of rupture.
  • We will replace one or both (if your physician recommends it) of your implants free of charge if you suffer capsular contracture at grade III of IV in the Baker Scale.

 

This guarantee is valid during patient lifetime.