After a decade-long wait, the U.S. Food and Drug Administration has approved Motiva Implants for breast augmentation and revision surgeries—the first new breast implant approval in the U.S. since 2013. Already widely used in over 70 countries, these implants underwent six years of meticulous clinical trials. To understand what sets them apart, we spoke with surgeons who participated in the trials and those now using Motiva, uncovering why this breakthrough is generating so much excitement in the world of breast surgery.
Featured Experts
- Dr. Caroline Glicksman is a board-certified plastic surgeon in Wall Township, NJ
- Dr. Steven Teitelbaum is a board-certified plastic surgeon in Santa Monica, CA
- Dr. Bradley Calobrace is a board-certified plastic surgeon in Louisville, KY
- Dr. Tracey N. Cook is a board-eligible plastic surgeon in Louisville, KY
What Makes Motiva Unique?
Motiva Implants are gaining attention for their advanced features, which surgeons say address long-standing challenges in breast augmentation. A key innovation is the SmoothSilk surface, which surgeons describe as reducing inflammation and minimizing the risk of capsular contracture, a common complication. “Based on the three-year data, there are very low rates of capsular contracture,” said Wall Township, NJ plastic surgeon Caroline Glicksman, MD, who served as the medical director of the U.S. IDE study. “Capsular contracture has been one of the most common reasons for implant revisions, and with Motiva, we’re seeing dramatically reduced rates.”
“Outside the U.S., Motiva implants have been utilized in over 85 countries since its first availability in 2010,” says Louisville, KY plastic surgeon Tracey N. Cook, MD. “The U.S. Food and Drug Approval comes after rigorous clinical studies, demonstrating the safety and efficacy of the Motiva breast implant, giving surgeons and patients additional options for breast augmentation.”
Clinical Trial Results
Clinical trials for Motiva’s FDA approval included more than 1,000 patients across primary augmentation and revision cohorts. At three years, the capsular contracture rate for primary augmentation patients was below 1 percent, rupture rates were 0.6 percent and patient satisfaction surpassed 95 percent.
The Motiva study stands out as a “modern clinical trial,” says Dr. Glicksman, because it went beyond evaluating the implants alone. It collected detailed data on factors like incision size, implant placement and surgical techniques, ensuring a comprehensive approach. “We didn’t just study the device; we studied how modern surgical practices impact outcomes,” she explains. “That’s what makes this trial so unique.”
Above or Behind the Muscle?
Most surgeons in the study placed implants behind the muscle, with more than 95 percent opting for a dual-plane approach to minimize rippling and capsular contracture. While sub-fascial placement (above the muscle) is gaining interest for benefits like easier recovery, Dr. Glicksman noted, “We have no data yet to fully support those claims. The company will need to continue collecting data as these techniques evolve.”
The ‘Softness’ Factor
One of the standout features surgeons consistently mention is the implants’ softness. “The implant’s feel is so similar to normal breast tissue that it’s nearly undetectable,” notes Dr. Teitelbaum. “Patients who were hesitant about implants feeling hard or unnatural are particularly enthusiastic about this option.”
Dr. Glicksman added that her patients often comment on how soft the implants feel. “Patients often tell me these are the softest implants they’ve ever felt. Many of them compare the feel to memory foam and they love how natural and comfortable they are. It’s one of the key reasons they choose Motiva,” she shared.
The implants come in two styles: the SmoothSilk Round implant, which maintains a rounded shape for upper pole fullness and the Ergonomix, which adjusts to body positioning for a more teardrop look. “These two styles allow surgeons to tailor the implant choice based on the patient’s goals and anatomy,” said Dr. Calobrace.
Who Should Consider Motiva Implants?
Motiva Implants are currently FDA-approved for primary augmentation and revision cases. While not yet approved for reconstruction, surgeons agree they are particularly well-suited for first-time augmentation patients or those replacing older implants.
“These implants are ideal for patients who have adequate soft tissue and want a natural look and feel,” said Dr. Glicksman. “It’s a wonderful revision implant because it’s so soft and comfortable. Many of my revision patients are amazed by how much better it feels compared to their previous implants,” she shared.
What’s Ahead
“This is an exciting time for both surgeons and patients,” remarked Dr. Glicksman. “It’s been over a decade since we’ve had a new option like this, and it shows that innovation is possible when rigorous data and collaboration come together.”
