After years of anticipation, the innovative Motiva breast implants have finally received U.S. Food and Drug Administration (FDA) approval. Establishment Labs approved two implants: Motiva SmoothSilk and Motiva Ergonomix. This marks the first new breast implant pre-market approval authorization since 2013, and plastic surgeons are eager to welcome this new option.
Featured Experts
- Dr. Caroline Glicksman is a board-certified plastic surgeon in Wall Township, NJ
- Dr. M. Bradley Calobrace is a board-certified plastic surgeon in Louisville, KY
- Dr. Kamakshi R. Zeidler is a board-certified plastic surgeon in Campbell, CA
A Global Success
While new to the U.S., Motiva implants launched in 2010 and have been distributed to plastic surgeons in over 80 countries. In a press release, Wall Township, NJ plastic surgeon Caroline Glicksman, MD, who served as the medical director of the Motiva regulatory study stated, “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.”
New Technology
One of the key features of the Motiva Implants is their SmoothSilk surface, which is designed to reduce the risk of common complications such as capsular contracture—a condition where scar tissue forms around the implant, causing it to harden. A three-year clinical trial revealed a capsular contracture and rupture rate of less than one percent.
The implants also feature a soft gel and an ergonomic design that keeps them round when lying down and shifts to a teardrop shape when standing up. “Motiva is the first and only implant purposefully designed for women and their lifestyles,” said Campbell, CA, plastic surgeon Kamakshi R. Zeidler, MD and member of Establishment Labs’ Femtech Advisory Board. “These implants move and feel like natural breast tissue. The rates of complications in the clinical trial were also much lower than we have seen with any other implant in a U.S. PMA study. This is true Femtech. I could not be happier that women in the United States now have access to this revolutionary technology.”
Future Focus
With FDA approval now secured, many experts believe that Motiva could reinvigorate breast aesthetics in the U.S. “There has been a real lack of innovation in the U.S. breast implant market for well over a decade,” added Louisville, KY plastic surgeon and study investigator M. Bradley Calobrace, MD. “Motiva should transform breast augmentation, both in how we operate and in what we can achieve for our patients. A safer, next-generation viscoelastic implant with a uniquely designed low inflammatory surface will undoubtedly improve clinical and aesthetic outcomes. I am pleased to finally be able to offer Motiva implants to my patients in the United States.”
