By VOICE-TRIBUNE • Photos by Matt Johnson
As the field of breast surgery enters a new era, Louisville’s own, Dr. Bradley Calobrace, stands at the forefront of innovation with the introduction of the newly FDA-approved Motiva® Breast Implants. On September 30, 2024, Dr. Calobrace became the first surgeon in the United States to place these groundbreaking implants, a mere few days after their FDA approval. Motiva Implants, already renowned internationally for their 15-year track record, bring to the U.S. market advanced features such as SmoothSilk surface technology, which significantly reduces complications like capsular contracture, boasting rates of less than one percent. With a low rupture rate and no reported cases of lymphoma, Motiva addresses critical safety concerns, offering women safer, more reliable options in breast augmentation and reconstruction.
A leader in breast surgery and a pioneer in clinical research, Dr. Calobrace played a pivotal role in the FDA trials and will serve as the medical director for Motiva’s post-approval study. Beyond his surgical expertise, he is committed to advancing education about this revolutionary technology, further cementing his role in shaping the future of women’s health. In this exclusive Q&A, Dr. Calobrace shares insights into the significance of Motiva Implants, the clinical advancements they represent, and what they mean for the future of breast surgery in the United States.
What was the most challenging part of the FDA clinical trials for Motiva® Breast Implants, and how did your role influence the approval process?
“The most challenging aspect is simply the coordination and implementation of such a challenging undertaking that was under the expert direction of Caroline Glicksman, MD. The study will take 10 years and includes aesthetic and reconstructive breast surgery. There is an enormous amount of data collection and follow-ups. My team was led by Keri Tomes and Nicole Beams, two of my long-term nurses, who know breast surgery well.“
What sets Motiva® Implants apart from other breast implants on the market, and why is their introduction to the U.S. so significant after a decade-long gap in new implants?
“There has not been a truly new breast implant approved in the US market in over a decade. All devices thus far have been some modifications of other implants already available. These implants are unique in that true scientific studies led to the development of many unique aspects… the smoothsilk surface (4-micron surface), the monobloc technology that links the shell to the gel creating one unified structure, and viscoelastic properties (the stretchability) that allows for softer implants placed through smaller incisions, and finally the ergonomic properties that allow these round implants to take on a more natural, anatomic appearance when the patient is upright. In other words, the implants tend to mimic the natural movements of breasts.”
Could you elaborate on the SmoothSilk surface technology and how it minimizes complications like capsular contracture and rupture?
“The 4-micron surface is generally a smooth surface with a very mild microtexture present on it… giving it the feel of very soft silk. This surface is unique in that it acts like a smooth implant with no association with lymphoma and a mobile, natural feel (not stuck or resistant to movement like textured implants) and yet unlike smooth implants, the smoothsilk surface is more biocompatible, meaning it has minimal inflammation, fibrosis or immune activation when placed in the body. The body does not react, and thus very little capsule is formed which is then associated with a much lower capsular contracture rate (less than 1%)”
Motiva® Implants have reported zero cases of lymphoma. How does this innovation address safety concerns associated with previous implants?
“Only textured implants are associated with lymphoma, especially the biocell texture which is no longer available anywhere in the world. Smooth implants are NOT associated with lymphoma at all… and likewise, the smoothsilk surface acts like a smooth implant and has no cases of lymphoma. I believe this is because of the biocompatible nature of these implants which tend to be non-immunogenic and non-inflammatory. Inflammation is felt to be one of the important contributors to the development of lymphoma associated with breast implants.”
With Motiva® Implants having a 15-year track record internationally, what lessons or insights from global use were most influential during the FDA trials?
“The most important experience is that these implants ACT like smooth implants, not textured. There are very thin capsules and thus one cannot depend upon capsules to keep these implants in place. Therefore, creating very tight pockets with a hand-in-glove fit is important. Tissue preservation has become a buzz phrase to describe doing less and preserving the natural supportive structures of the breasts during surgery. In the US, unlike the rest of the world, SMOOTH implants are used in the majority of cases. Outside the US, texture implants were used and the transition to Motiva was more challenging. In the US, the surgeons were able to master these implants much more readily as they function much more like the smooth implants surgeons have been used to using.”
As a leading cosmetic surgeon, how has your expertise shaped the adoption of Motiva® Implants in the United States?
“I have a long history of significant expertise in issues related to breast implants. I have conducted many FDA trials related to implants and led the launch of Sientra breast implants. I likewise co-authored the 10-year FDA summary paper for Sientra and Mentor implants and have traveled the world over the past 16 years lecturing on issues related to breast surgery. With the recent FDA approval of the Motiva implants in the US, and as a part of the FDA study, I will take my years of experience and expertise to help surgeons achieve optimal outcomes for their patients. FDA approval is just the start. It is imperative that these implants are used effectively to achieve the very best outcomes for their patients. It is my job to help provide leadership in achieving this goal.”
As the medical director for the post-approval study, what specific aspects of the implants’ performance and safety will you be focusing on?
“The post approval studies are designed to continue the evaluation of breast implants in the “real-world” with many surgeons using them… which is a bit different than the rigorous protocols and limitations placed on the initial FDA trials. The post-approval studies will last 10 years, and I will work with the company to ensure compliance from surgeons that participate in the study and ensure collection of this very important data. I was the primary author on a 6-year review of the Sientra post approval study on their implants, so I bring experience and expertise which will be helpful in leading this study. These implants will be evaluated for capsular contracture, infection, ruptures and need for revisional procedures, as well as many other aspects. Uniquely, as these implants produce minimal capsules, we will be looking closely at the stability of the implants and whether malpositions or stretch deformities are more problematic with these implants. Capsules can be problems… but they also stabilize the implants. We will evaluate these issues and whether such issues could lead to additional revisional surgeries.”
You’ll be leading educational efforts for Motiva’s U.S. launch. What will these efforts entail, and how will they impact the plastic surgery community?
“Like the post approval studies, my goal in leading the Motiva US launch is simply to assimilate the knowledge we have with nearly a 15-year experience with Motiva implants internationally and using that knowledge to speed up the learning curve and help surgeons achieve optimal outcomes immediately. So many of my colleagues internationally have been using Motiva for years… and I am using that experience plus the experience of the FDA-participating surgeons in the US to develop educational programs that optimize the outcomes with these implants. Many US surgeons have a large experience as part of the FDA trials, and their experience will be invaluable. My job is to coordinate and structure the education, but what will be taught will be from the great experience and talents of my US and International plastic surgery colleagues.”
How do you see the introduction of Motiva® Implants transforming the landscape of women’s health and aesthetic options in the United States?
“Well, I believe women can feel assured the FDA is very careful to evaluate completely the safety and efficacy of new breast implants and that FDA-approval signals that these implants have met these rigorous requirements. I do believe the unique properties of the surface of these implants provide a biocompatible environment that leads to way less inflammation and immune reaction. I believe this may help women feel more confident that these implants can be used and that the implants will live more “quietly” with their bodies not creating the capsular contractures, fibrosis, and immune responses that we have seen with other implants placed in the body.”
What advancements in implant technology or plastic surgery do you envision following the introduction of Motiva® Implants to the U.S. market?
“Motiva implants are very unique and quite different from other breast implants available. I believe development will always look for new implant surfaces that provide the optimal support without the detriment of inflammation. Additionally, tissue expanders are being developed that allow for MRI studies (which has been a problem in the past) and radiation treatments. The most recent advancements have been in the increased use of fat grafting in breast surgery and achieving predictable outcomes. We participated in a one year study of fat grafting showing the Viality system achieved 79% retention of fat at one year. Also, the use of “internal bras” with scaffolds or mesh are increasingly used to stabilize and support implants. I have used internal mesh bras for the last 8 years and now I use these internal bras every day to achieve way more predictable, outstanding results for our patients.”
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