Establishment Labs Holdings Inc. (NASDAQ: ESTA) has secured FDA approval for its Motiva SmoothSilk Ergonomix and Motiva SmoothSilk Round breast implants, marking a significant advancement in breast aesthetics and reconstruction. The approval allows for the use of these implants in both primary and revision breast augmentation procedures.
Innovative Design and Technology
The Motiva implants incorporate the patented SmoothSilk surface, engineered to enhance biocompatibility and minimize inflammation. The Ergonomix design adapts to the body's position, mimicking the natural movement and feel of breast tissue. According to Establishment Labs, the Ergonomix implants maintain a round shape when lying down and a teardrop shape when standing, offering a natural aesthetic in various positions.
Clinical Trial Results
The FDA's approval was supported by data from the Motiva U.S. IDE Study, conducted across 32 centers in the U.S. and three in Western Europe. The study demonstrated high patient compliance, with 92.4% of patients in the primary augmentation cohort completing the three-year follow-up. Key findings from the study include:
- Capsular Contracture: 0.5%
- Rupture (Confirmed or Suspected): 0.6% (MRI Cohort N=176)
- Breast Pain: 0.7%
- Infection: 0.9%
Any reoperation, including implant size changes, was reported in 6.1% of patients, while the overall complication rate, including reoperations, was 8.4%.
Expert Opinions
"Today’s approval is transformative for breast aesthetics in the United States," said Juan José Chacón-Quirós, Founder and CEO of Establishment Labs. "Motiva implants have changed the paradigm by proving that women do not have to compromise when it comes to their aesthetic goals."
Dr. Caroline A. Glicksman, Medical Director of the Motiva study, highlighted the rigorous nature of the clinical trial, stating, "The Motiva U.S. IDE Study is the most rigorous breast implant clinical trial ever performed under FDA guidelines and it shows that Motiva implants are not only safe and effective but also that women had exceptional results."
Market Impact
Since their initial commercial availability in 2010, nearly four million Motiva devices have been distributed to plastic and reconstructive surgeons in over 85 countries. This FDA approval marks the first new breast implant PMA approval in the U.S. since 2013, potentially reshaping the U.S. breast implant market.
Dr. M. Bradley Calobrace, a study investigator, noted, "There has been a real lack of innovation in the U.S. breast implant market for well over a decade. Motiva should transform breast augmentation, both in how we operate and in what we can achieve for our patients."
