Breast Implant Safety
Learn How We Keep Motiva Implants® Safe for All Patients
Establishment Labs, the manufacturer of Motiva® products, is a women’s health company that is committed to achieving safety through innovation. As such, our focus has always been – and will always be – the safety and satisfaction of our patients.
Surrounded by competitors that still use relatively old technology in their implants (i.e. from the last five generations), we firmly believe patients deserve to reap the benefits of technological evolution – which is exactly what makes our sixth-generation implants stand out.
Over more than a decade, Establishment Labs has built a body of scientific research on breast implant surfaces and the human immune system response. A combination of this research, product development, and technological innovation has culminated in the creation of the Motiva® product line.
Safety and performance data collected through our robust Post-Market Surveillance System and other extensive clinical research confirm that our SmoothSilk® / SilkSurface® shell contributes to improved post-operative outcomes, with patients reporting fewer high- and low-risk complications.
In particular, the data demonstrated a very low (less than 1%) capsular contracture rate in patients with SmoothSilk®/SilkSurface®.
What Makes Motiva Implants® Unique?
By default, all Motiva Implants® are housed within our proprietary SmoothSilk®/SilkSurface® shell. With smooth, 360-degree uniform nanosurface technology, our post-market research proves they can:
- minimize inflammation and maximize biocompatibility (i.e. lower bacteria and biofilm formation);
- enable implant insertion via smaller incisions (thereby decreasing associated risks); and
- reduce the risk of double capsules and late seromas
Patients can rest assured that these implant shells do not pose the risks associated with macrotextured implants, as SmoothSilk®/SilkSurface® is classified as a smooth shell per the latest international standard (ISO-14607:2018).
Some of the other notable safety features of Motiva Implants® include:
- BluSeal®: This patented visual safety indicator is why all Motiva Implants® (aside from sizers) appear slightly blue – to allow surgeons to ensure the entire implant shell barrier layer (which reduces the risk of gel bleeding) is 100% intact before insertion
- TrueMonobloc®: Also present in all Motiva Implants®, this flexible, multilayer system links all implant components (gel, shell, and patch) to create a unified structure that allows for easier insertion, robust function, and a clinically proven safety profile
- Qid®/Q Inside® Safety Technology: Patients can choose to have their Motiva Implants® come with an optional, passive RFID microtransponder system that lets patients and doctors verify important implant information instantly, easily, and non-invasively
Read our complete position statement on breast implant safety here.