Quality is a necessity, not a luxury.

Our history speaks for itself. Mentor has been manufacturing breast implants for more than 30 years. Those three decades have not only given us enormous experience, but a global reputation for integrity and continuity. Choosing gel implants from a certified company with a strong history of technological excellence, and safety is in the long run an absolutely critical investment for the physician and patient.

We are commited to go through a three stage testing process for optimal quality and product safety.

Safety:

• Biocompatibility Trials
• Toxicity
• Endotoxins
• Sensitisation
• Implantation
• Carcinogenicity/Chronic Toxicity

Shell/Device Physical Properties:

• Elongation
• Tension Set
• Fatigue
• Impact
• Static Rupture

Device Testing:

• Chemical Analysis
• Gel Cohesion
• Packaging
• Sterility
• Endotoxins

Certification

• All our products are 100% latex free.
• All our manufacturing sites are certified to ISO 13485 by TÜV Product Service.
• All our products made in the U.S. comply with the U.S. FDA requirements.
• All our breast implants comply with EN 12180 regulations and have CE-marking.
• All our breast implants have been issued EC Certificates by TÜV Product Service.
• All our breast implants are re-classified from Class II to Class III per European Directive effective March, 2004. This Class III certification is the most rigorous level of review and approval by the European regulatory authorities and provides further evidence of the safety and effectiveness of our full range of breast implant products.