In 2018, I was asked to be one of twenty two U.S. surgeons to serve as Primary Investigators in the US Motiva FDA Clinical Trial. What this meant was that I was brought up to speed on the Motiva implant and its technology, and then permitted to enroll subjects in the study. The subjects were women desiring cosmetic breast augmentation in which Motiva breast implants were utilized. These women were followed annually with examinations, questionnaires, 2D and 3D photography and annual MRIs to check for rupture.
What I Have Observed With Motiva Breast Implants
Throughout my experience with Motiva, my patients have consistently reported high levels of satisfaction. I have also been impressed by the aesthetic qualities of these implants.
The breasts can feel remarkably soft and natural, and in some patients, it can be difficult to detect the presence of an implant by feel alone. Motiva implants can also provide attractive breast contours and appropriate upper breast fullness when the implant is carefully selected for the patient.
What I found was that my Motiva patients almost uniformly rated their satisfaction at the highest level. Complications and adverse events were no more than with other breast implants. What I found most fascinating was when I recently compared the photographic images from before, 4 months, 1 and 6 years. I noticed that the shape of the breasts was incredibly stable from 1 to 6 years.
My experience with Motiva® breast implants began well before they became commercially available in the United States. In 2018, I was selected as one of 22 U.S. surgeons to serve as a Primary Investigator in the Motiva FDA Clinical Trial.
As part of the study, I was trained extensively on Motiva implant technology and permitted to enroll women seeking cosmetic breast augmentation with Motiva implants. Participants were followed annually with examinations, questionnaires, 2D and 3D photography, and MRI imaging to evaluate their implants over time.
Motiva Implant Safety
Motiva SmoothSilk® Round and SmoothSilk Round Ergonomix® silicone gel-filled breast implants received FDA approval in September 2024 for breast augmentation in women age 22 and older, including primary and revision augmentation. A prospective clinical study involving hundreds of patients supported the approval.
FDA approval does not mean that breast implants are risk-free. Potential complications of breast augmentation can include capsular contracture, implant rupture, changes in sensation, infection, pain, asymmetry, additional surgery, and other implant- or surgery-related complications. Patients should review the FDA-approved patient labeling and discuss the potential benefits and risks with their surgeon before deciding on surgery.
Long-term monitoring also remains important. The FDA required post-approval studies for Motiva implants, including continued follow-up of premarket clinical-trial participants and a new prospective study designed to collect data through 10 years. These studies remain ongoing.
Aesthetically speaking, the contours of the breasts were as good if not better than seen with other breast implants. The breasts felt extremely soft and natural, and in some cases, it was very hard to detect the presence of the implant at all! There was adequate upper breast fullness as well.
Eight Years of Experience With Motiva
Selecting and using Motiva Round and Motiva Ergonomix implants involves important nuances. Having performed Motiva breast implant surgery for approximately eight years, placed approximately 140 implants, and followed these patients over time has given me extensive firsthand experience with this technology.
This experience helps me evaluate implant selection, breast shape, movement, softness, and long-term appearance when planning breast augmentation for each patient.
There are nuances to using the Motiva Round and Motiva Ergonomix breast implants. Having been performing Motiva breast implant surgeries (approximately 140 implants placed) and following my patients for eight years has helped me immensely and has given me quite a head start in utilizing this new and amazing breast implant technology!
Long-Term Motiva Results
One of the most interesting parts of participating in the clinical trial has been the opportunity to observe how patients’ results evolve over several years.
When I compared photographs taken before surgery and at approximately four months, one year, and six years after augmentation, I was particularly impressed by the stability of breast shape between the one-year and six-year images.
These observations reflect my experience with my own patients and should not be interpreted as a guarantee that every patient will have the same result. Breast appearance can change over time because of aging, pregnancy, weight fluctuations, changes in breast tissue, and other factors.
Seeing patients over many years has also given me valuable insight into the nuances of choosing and working with both Motiva Round and Motiva Ergonomix® implants.
Disclosure: Dr. Epstein is a paid investigator in the Motiva U.S. FDA clinical trial and is compensated by Establishment Labs to train surgeons on the Preservé technique. Dr. Epstein owns stock in Establishment Labs.
Sections - Motiva Breast Implants
- What is the Motiva Breast Implant?
- Are Motiva Implants Safe? FDA Data Explained by a Trial Investigator
- Motiva Ergonomix vs. Round: A Surgeon's Guide to Choosing
- Ergonomix vs Round: Breast Shape and Movement
- Dr. Epstein’s Eight Year Motiva Experience
- What Makes the Motiva Implant Different?
- Motiva – Is it Smooth or Textured?
- Motiva vs Other Implants
- How Motiva Implants Are Different from Allergan Natrelle, Mentor and Sientra Implants
- MOTIVA Warranty Information
- MOTIVA US Clinical FDA Trial
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Chapters – Breast Augmentation Guide
- Intro to Breast Augmentation
- Preservation Breast Augmentation – A New Era!
- Motiva Implants – What You Need to Know
- Five key decisions you need to make
- One-Day Recovery Breast Augmentation
- Anesthesia – General, Sedation or Local?
- Breast Lift (Mastopexy) with/without Implants or Fat
- What else should I know about breast augmentation?
- Important Things to Consider When You Decide to Move Forward With Breast Augmentation
- Revision of breast augmentation
- ALCL and Breast Implant Illness