When are Motiva Ergonomix2 implants expected to be approved by the FDA?

Question

When are Motiva breast expected to be approved by the FDA (understanding of course that this is all conjecture). I’d like to get primary breast augmentation, but I really want the Motiva Ergonomix2 implants. Ideally would want my surgeon local to me, but if the timeline is too long, am considering traveling for surgery. Thank you for your thoughts!

Gerald Minniti, MD, FACS · Answer

I am one of 22 American surgeons in the US who is participating in the FDA approval study for Motiva. Enrollment ended in the spring of 2018 and follow up has been ongoing though the last 4 years. According to study organizers, the data being generated is very good, as would be expected from their track record outside the US over the last decade. In 2021 we had a Motiva meeting at the national ASPS meeting in New Orleans, and at that time the FDA indicated that Establishment Labs (EL), the parent company of Motiva, could submit a requisition for limited use of the implants by study surgeons. Unfortunately, that was only a tease; as of now EL has yet to produce and submit the paperwork to the FDA required to go forward. This represents a disappointment for many of us, as we are all anxious and hopeful to begin using these implants in a less restricted fashion. Although no surgeon has any privileged knowledge at this point, we are all hopeful that either approval, or expanded use in the meantime, is coming soon.

Andrew Wolfe, MD · Answer

Thank you for your question.  As you porbably know, Motiva's Ergonomix and Round implants were finally approved in the U.S. in October.  I am a Primary Investigator in the FDA trials and am in close contact with the Establishement Labs/Motiva team.  Based on recent conversations, It's unlikely that we will see the Ergo 2 sooner than 18 months from now.  The Ergo 1 implants we have now are excellent and quite natural feeling.  The Ergo 2 gel was designed, in part, to flow a little better through very small incisions and the gel was necessary to develop the Diamond implant that is used with the Mia system, which uses a a small axillary incision, a balloon dissector to create the pocket, and an implant injection device. I've seen it in use in Costa Rica and it's pretty nifty.  We are hopeful that the Mia might make it to the US in the next few years.
Hope this helps!

Elizabeth Kiwanuka, MD, PhD · Answer

As of September 27, 2024, Motiva Ergonomix2 implants have received FDA approval, making them a viable option for your primary breast augmentation. This new development means you can now consider these implants, known for their ergonomic design and natural feel, as part of your enhancement journey.
The Motiva Ergonomix2 implants are specifically engineered to adapt to your body's movements, providing a more natural aesthetic and comfort. With their approval, you can look forward to the possibility of achieving your desired silhouette with confidence, knowing that these implants have met rigorous safety and effectiveness standards.

When are Motiva Ergonomix2 implants expected to be approved by the FDA?

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