Motiva Implants
Quite simply, the safest breast implant ever designed.
Real-World Clinical Results Demonstrate
Extremely Low Complication Rates
- Low rates of capsular contracture (<1%)
- Overall complication rates of less than 1% reported through 8 years of Post-Market Surveillance of Motiva Implants.
- Overall Complication Rate (0.36%)
- 3 year retrospective clinical data in 5,813 patients with 16 plastic surgeons at 1 study site.
- Implant Related Events (6 year report on prospective safety outcomes – 0%)
- No implant rupture, capsular contracture, double capsule or late seroma at 6 years following 35 patients in a 10-year follow-up study with MRI assessment.
Comparative Study
Every Attribute of the Breast Implant Has Been Reengineered
Motiva Implants® are brought to you by Establishment Lab®, a global breast implant and medical technology company that partners with the best minds in the industry, invests significantly in research and development — including the commencement of a US clinical investigation program — and delivers superior6 products through:
- Innovative, proprietary technologies
- Impactful performance — as a result of advanced manufacturing practices
- Impressive safety — unmatched safety statistics
Controlled Surfaces (SmoothSilk®/SilkSurface®)
Characteristics:
- A uniform shell surface developed through 3D nanotechnology imprinting
- Manufactured with no foreign materials (such as salt or sugar crystals)
- Hierarchical micro-nano-surface arrangement
Designed to:
- Improve biocompatibility
- Minimize inflammation
- Enable implant insertion through smaller incisions
- Reduce risk of double capsule and late seroma
Next-Generation Silicone Gel
Mastered rheological (relating to the physics of fluid) properties of silicone gels with controlled viscosity and elasticity
Provides optimum performance:
- Designed to prevent gel fracture
- Designed to mimic the look and feel of natural breasts
TrueMonobloc® Shell Configuration
Characteristics:
Creates uniform strength between shell, gel and patch
Mechanical performance meets or exceeds regulatory standards in all shell testing dimensions:
Elongation
- Break force
- Tear resistance
- Tensile set
- Patch joint integrity
Designed for:
- Ease of insertion and smaller incisions
- Durability through improved implant mechanical qualities under stress
BluSeal® Barrier-Layer
Characteristics:
- Provides visualization of shell barrier integrity
- Patented visual safety indicator to improve quality control — only available with Motiva Implants®
Designed to:
- Assure the presence of a barrier-layer technology, which prevent silicone gel diffusion into the body
- Provide surgeons with assurance of implant quality
Advanced Technology
- World’s first FDA-cleared RFID microtransponder for unique identification (UDI) that can be accessed externally
- Offers increased peace of mind in the unlikely event of a safety issue or device recall
- Helps ensure active patient information through MotivaImagine® App
Establishment Labs® Commitment to Safety
Always Confident Warranty® and Product Replacement Policy
- Establishment Labs® provides a limited warranty — covering the Motiva Implants® product family — providing a replacement product in the event of rupture for the lifetime of the implant
- Establishment Labs® provides assistance in cases of capsular contracture Baker Grades III and IV through its Product Replacement Policy for a period of 10 years
2-Year Motiva® Extended Warranty
For all Motiva Implants®, without Qid® our 2Y Motiva® Program, in addition to the replacement product, your patient may also receive up to $1,000 of financial assistance for each affected implant, applicable to the cost of the revision surgery in the case of a warranty claim for rupture or capsular contracture grades III and IV
5-Year Motiva® Extended Warranty
For Motiva Implants® with Q Inside® Safety Technology, with our 5Y Motiva® Program, in addition to the replacement product your patient may also receive up to $2,500 of financial assistance for each affected implant, applicable to the cost of the revision surgery in the case of a warranty claim for rupture or capsular contracture grades III and IV