Motiva Implants Obtain FDA Approval

After years of anticipation, the revolutionary Motiva breast implants have lastly acquired U.S. Meals and Drug Administration (FDA) approval. Institution Labs authorised two implants: Motiva SmoothSilk and Motiva Ergonomix. This marks the primary new breast implant pre-market approval authorization since 2013, and plastic surgeons are desirous to welcome this new choice.

Featured Specialists

• 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 International Success 

Whereas new to the U.S., Motiva implants launched in 2010 and have been distributed to plastic surgeons in over 80 nations. In a press launch, Wall Township, NJ plastic surgeon Caroline Glicksman, MD, who served because the medical director of the Motiva regulatory research said, “The Motiva U.S. IDE Research is essentially the most rigorous breast implant medical trial ever carried out below FDA tips and it reveals that Motiva implants are usually not solely secure and efficient but in addition that ladies had distinctive outcomes.”

New Expertise 

One of many key options of the Motiva Implants is their SmoothSilk floor, which is designed to cut back the danger of widespread issues akin to capsular contracture—a situation the place scar tissue varieties across the implant, inflicting it to harden. A 3-year medical trial revealed a capsular contracture and rupture price of lower than one %.

The implants additionally characteristic a delicate gel and an ergonomic design that retains them spherical when mendacity down and shifts to a teardrop form when standing up. “Motiva is the primary and solely implant purposefully designed for ladies and their existence,” mentioned Campbell, CA, plastic surgeon Kamakshi R. Zeidler, MD and member of Institution Labs’ Femtech Advisory Board. “These implants transfer and really feel like pure breast tissue. The charges of issues within the medical trial have been additionally a lot decrease than we’ve seen with some other implant in a U.S. PMA research. That is true Femtech. I couldn’t be happier that ladies in the US now have entry to this revolutionary expertise.”

Future Focus

With FDA approval now secured, many consultants consider that Motiva may reinvigorate breast aesthetics within the U.S. “There was an actual lack of innovation within the U.S. breast implant marketplace for properly over a decade,” added Louisville, KY plastic surgeon and research investigator M. Bradley Calobrace, MD. “Motiva ought to remodel breast augmentation, each in how we function and in what we will obtain for our sufferers. A safer, next-generation viscoelastic implant with a uniquely designed low inflammatory floor will undoubtedly enhance medical and aesthetic outcomes. I’m happy to lastly have the ability to supply Motiva implants to my sufferers in the US.”