Unlocking Insights: Exclusive Q&A with Dr. Bradley Calobrace!
Images by Matt Johnson
Welcome to the future of breast surgery! Here in Louisville, Dr. Bradley Calobrace is breaking new ground with the launch of the revolutionary Motiva® Breast Implants—now officially FDA-approved! On September 30, 2024, Dr. Calobrace made history as the first surgeon in the U.S. to implant these cutting-edge devices, following their recent approval. With a stellar international reputation that spans 15 years, Motiva Implants are equipped with innovative features like the game-changing SmoothSilk surface technology, which slashes complications such as capsular contracture to less than one percent! Imagine the peace of mind that comes with a low rupture rate and zero reported cases of lymphoma. Motiva is here to transform breast augmentation and reconstruction into safer, more reliable choices for women everywhere.
As a trailblazer in the world of breast surgery and an advocate for clinical research, Dr. Calobrace has been instrumental in the FDA trials of Motiva and will take the helm as the medical director for the post-approval study. His commitment extends beyond the operating room; he is dedicated to educating others about this groundbreaking technology, solidifying his influence in shaping the future of women’s health. In this exclusive Q&A session, Dr. Calobrace reveals the monumental significance of Motiva Implants and what they represent for the future of breast surgery in America.
What challenges did you face during the FDA clinical trials for Motiva® Breast Implants, and how did your expertise contribute to their approval?
“The coordination and execution of such an extensive clinical trial were quite challenging, expertly managed by Dr. Caroline Glicksman. This monumental study spans ten years and encompasses both aesthetic and reconstructive breast surgeries. It involves a massive data collection effort and ongoing follow-ups. Thankfully, my team—led by my seasoned nurses, Keri Tomes and Nicole Beams—are well-versed in the intricacies of breast surgery.”
What distinguishes Motiva® Implants from other breast implants, and why is their arrival in the U.S. market after a decade of stagnation so vital?
“It’s been over ten years since a truly innovative breast implant has been approved in the U.S. Until now, all advancements have merely been tweaks to existing designs. Motiva Implants are a breath of fresh air, rooted in genuine scientific research that led to their unique characteristics. With features like the 4-micron SmoothSilk surface, monobloc technology that seamlessly integrates gel and shell, and viscoelastic properties allowing for softer implants through smaller incisions, these implants offer an ergonomic design that mimics the natural movement of breasts!”
Can you explain how SmoothSilk surface technology minimizes complications like capsular contracture and rupture?
“The SmoothSilk surface, with its incredibly soft feel, is designed to be smooth yet incorporates a mild microtexture. This unique surface functions like a traditional smooth implant—without the association with lymphoma—while providing a more natural and mobile feel than textured implants. Its biocompatibility minimizes inflammation and immune responses, resulting in less capsule formation. Consequently, the capsular contracture rate is impressively low, at less than 1%.”
With zero reported cases of lymphoma associated with Motiva® Implants, how does this advancement tackle safety concerns that have plagued previous models?
“Lymphoma has been primarily linked to textured implants, particularly the now-banned biocell texture. In contrast, smooth implants have no such association. Motiva’s SmoothSilk surface behaves like a smooth implant, maintaining this safety profile. This remarkable safety record is due to the implants’ biocompatibility, which reduces inflammation—a critical factor believed to contribute to lymphoma development.”
What lessons have been learned from the global use of Motiva® Implants that shaped the FDA trials?
“The most crucial insight is that Motiva Implants behave like smooth implants rather than textured ones. With very thin capsules, it’s essential to create a snug pocket for these implants. The concept of tissue preservation emphasizes minimizing surgical intervention and maintaining the natural structure of the breast during procedures. Unlike other markets, smooth implants dominate in the U.S. This familiarity allowed surgeons here to adapt to Motiva’s unique properties more readily.”
As a distinguished cosmetic surgeon, how has your expertise influenced the U.S. adoption of Motiva® Implants?
“I bring a wealth of experience in breast implant issues, having conducted numerous FDA trials and previously launched Sientra implants. As a co-author of the ten-year FDA summary for Sientra and Mentor implants, I’ve also shared my knowledge globally on breast surgery topics over the past 16 years. With the Motiva implants now FDA-approved in the U.S., I aim to translate my experience into optimal outcomes for patients. The approval is merely the beginning; effective use is crucial for achieving excellent results, and I am committed to leading this charge.”
In your role as medical director for the post-approval study, which aspects of implant performance and safety will you prioritize?
“The post-approval studies aim to assess implants in the real world, differing from the stringent protocols of initial FDA trials. Over the next ten years, I will ensure compliance among participating surgeons and facilitate crucial data collection. My prior work on a six-year review of the Sientra post-approval study equips me to lead this effort effectively. We will focus on capsular contracture, infection, ruptures, and the necessity for revision surgeries, among other aspects. Given that Motiva implants generate minimal capsules, we will closely monitor their stability and any potential malpositions or deformities.”
As you lead educational initiatives for Motiva’s U.S. launch, what will those efforts include, and how might they influence the plastic surgery community?
“Similar to the post-approval studies, my objective for the Motiva U.S. launch is to leverage nearly 15 years of international experience with these implants. This knowledge will help accelerate the learning curve for U.S. surgeons, enabling them to achieve optimal results right from the start. Many colleagues internationally have extensive experience with Motiva, and I will integrate their insights with those of FDA-participating surgeons in the U.S. to create educational programs aimed at maximizing outcomes with these implants.”
How will the introduction of Motiva® Implants reshape women’s health and aesthetic choices in the United States?
“Women can take comfort in knowing that the FDA carefully evaluates the safety and efficacy of new breast implants. The approval of Motiva signals that these devices meet the highest standards. With unique surface properties promoting a biocompatible environment, these implants lead to reduced inflammation and immune reactions. I believe this advancement will empower women to feel confident about their choices, knowing these implants will integrate more harmoniously with their bodies, minimizing the complications associated with previous models.”
What future advancements in implant technology or plastic surgery do you envision after introducing Motiva® Implants to the U.S.?
“Motiva implants are truly unique, setting a new standard among breast implants. Future developments will likely focus on creating new implant surfaces that provide optimal support while minimizing inflammation. We are also seeing advancements in tissue expanders that allow for MRI compatibility and improved radiation treatment options. The rise of fat grafting in breast surgery is another exciting frontier, with recent studies showing impressive retention rates. Additionally, the use of ‘internal bras’ or mesh for stabilizing and supporting implants is gaining traction, which I have implemented in my practice for the past eight years, yielding remarkable results for my patients.”
