INNOVATION FOR ENHANCED SAFETY

With more than 30 years of advanced breast implant manufacturing experience, building quality breast implants has always been a natural outcome for Establishment Labs’ founders and top executives. As a result, Motiva Implants® has established a level of product innovation that always results in safety. And while we respect our past, we´re more focused on the present and the future, one that´s innovative, safe and progressive.

We believe that these goals can be achieved by incorporating the current needs and preferences of plastic surgeons and patients into our product design. From our comprehensive range of breast implant shapes and sizes for outstanding breast aesthetic results, all the way to our new ProgressiveGel Ultima™ performance characteristics and innovative Q Inside Safety Technology™, our patients and surgeons have come to expect only the best from us. Utilizing the most advanced, state-of-the-art design and manufacturing technologies, Establishment Labs assures that Motiva Implants® Silicone Breast Implants are the best choice for the most discerning patients and surgeons worldwide.

INNOVATION FOR ENHANCED SAFETY

With more than 30 years of advanced breast implant manufacturing experience, building quality breast implants has always been a natural outcome for Establishment Labs’ founders and top executives. As a result, Motiva Implants® has established a level of product innovation that always results in safety. And while we respect our past, we´re more focused on the present and the future, one that´s innovative, safe and progressive. We believe that these goals can be achieved by incorporating the current needs and preferences of plastic surgeons and patients into our product design. From our comprehensive range of breast implant shapes and sizes for outstanding breast aesthetic results, all the way to our new ProgressiveGel Ultima™ performance characteristics and innovative Q Inside Safety Technology™, our patients and surgeons have come to expect only the best from us. Utilizing the most advanced, state-of-the-art design and manufacturing technologies, Establishment Labs assures that Motiva Implants® Silicone Breast Implants are the best choice for the most discerning patients and surgeons worldwide.

Q INSIDE SAFETY TECHNOLOGY™

Q Inside Safety Technology™, a passive radio frequency identification (RFID) transponder, is the world’s first FDA cleared micro-transponder for use in humans and the only one with a CE-Mark when used in a breast implant. The inclusion of Q Inside Safety Technology™ allows healthcare providers to securely and accurately identify breast implant information from outside of the body, at the point of care. Q Inside Safety Technology™ consists of a biocompatible micro-transponder, programmed with a unique numeric sequence (15 digits) that is accessed by a proprietary handheld reader when waved over the breast area. The 15-digit number delivered to the reader corresponds with a secure, online database that can be accessed via the internet and by authorized persons only.

By utilizing Q Inside Safety Technology™, physicians and patients have access to secure, non-invasive verification of implant-specific data. Unlike product and warranty cards that are typically provided to a patient undergoing breast augmentation or reconstruction, Q Inside Safety Technology™ can never be lost or misplaced. Providing your patients the option of breast implants with Q Inside Safety Technology™ can give them increased peace of mind in the event of a safety issue or device recall, thereby helping to ensure their safety and well-being.

 

Q INSIDE SAFETY TECHNOLOGY™

Q Inside Safety Technology™, a passive radio frequency identification (RFID) transponder, is the world’s first FDA cleared micro-transponder for use in humans and the only one with a CE-Mark when used in a breast implant. The inclusion of Q Inside Safety Technology™ allows healthcare providers to securely and accurately identify breast implant information from outside of the body, at the point of care. Q Inside Safety Technology™ consists of a biocompatible micro-transponder, programmed with a unique numeric sequence (15 digits) that is accessed by a proprietary handheld reader when waved over the breast area. The 15-digit number delivered to the reader corresponds with a secure, online database that can be accessed via the internet and by authorized persons only.

By utilizing Q Inside Safety Technology™, physicians and patients have access to secure, non-invasive verification of implant-specific data. Unlike product and warranty cards that are typically provided to a patient undergoing breast augmentation or reconstruction, Q Inside Safety Technology™ can never be lost or misplaced. Providing your patients the option of breast implants with Q Inside Safety Technology™ can give them increased peace of mind in the event of a safety issue or device recall, thereby helping to ensure their safety and well-being.

 

HIGHEST SAFETY PROFILE

  • Medical grade, long-term implantable silicones with extensive chemical, physical and biological testing, filed with the FDA.
  • Raw materials provided by the largest and most reputed silicone manufacturer in the US, with a safety record of more than 30 years in the medical industry.
  • Enhanced safety profile, as demonstrated by the biological testing results, in accordance to the US Pharmacopeia (USP), 31st Revision and the European Pharmacopeia (Ph.Eur.) 7th Edition for Endotoxin LAL, as well as ISO 11737-1:2006.
  • The level tested of in-process Endotoxin Units (EU) per ml in Motiva Implants® samples before sterilization was only 1% of the maximum value required by the Standard (US and European Pharmacopeias), which is evidence of the cleanliness and control of the process.

HIGHEST SAFETY PROFILE

  • Medical grade, long-term implantable silicones with extensive chemical, physical and biological testing, filed with the FDA.
  • Raw materials provided by the largest and most reputed silicone manufacturer in the US, with a safety record of more than 30 years in the medical industry.
  • Enhanced safety profile, as demonstrated by the biological testing results, in accordance to the US Pharmacopeia (USP), 31st Revision and the European Pharmacopeia (Ph.Eur.) 7th Edition for Endotoxin LAL, as well as ISO 11737-1:2006.
  • he level tested of in-process Endotoxin Units (EU) per ml in Motiva Implants® samples before sterilization was only 1% of the maximum value required by the Standard (US and European Pharmacopeias), which is evidence of the cleanliness and control of the process.