New innovations in breast implants that address the current risks associated with breast augmentations are providing a safer alternative to currently available implants. We recently discussed the commencement of CollPlant Biotechnologies and Stratasys Ltd. pre-clinical study with 200cc commercial-sized regenerative implants printed on a Stratasys Origin 3D printer and its impact on improving the safety of breast augmentation procedures. A new development in the innovation of safer, as well as more aesthetically pleasing, breast implants recently emerged in the form of the newly FDA approved Motiva Breast Implants.
Motiva Implants
Establishment Labs Holdings Inc., an international medical technology company, specializing in breast aesthetics and reconstruction, recently announced that the first successful breast augmentations were performed on US patients using the new FDA approved Motiva Implants. The newly approved Motiva Implants provide a safer option for breast augmentations, with significantly lower complication rates compared to other currently available breast implants, as well as enhanced results and aesthetic appearance.
“With the FDA approval last week, we are experiencing high demand for Motiva Implants — both from surgeons and patients,” said Juan José Chacón-Quirós, Founder and Chief Executive Officer of Establishment Labs. “The FDA approval came as we were attending the annual conference of the American Society of Plastic Surgeons. The response was overwhelming, and our team has already talked to more than 400 plastic surgeons post announcement. Since approval, we have already doubled our team to 25 sales reps across the United States, and our story of real innovation, backed by science and data, is resonating strongly. Everything we are seeing suggests that we can be the implant of choice in the United States.”
First Successful Motiva Implant Breast Augmentation Procedures in US
After the FDA approval of Motiva SmoothSilk Ergonomix and Motiva SmoothSilk Round breast implants for primary and reconstructive breast augmentation, M. Bradley Calobrace, MD, Kentucky-based board-certified plastic surgeon, and Caroline A. Glicksman, MD, New Jersey-based board-certified plastic surgeon, are the first surgeons to perform the breast augmentation surgeries in the country.
“I have many patients that have been waiting a long time for Motiva approval, in some cases, for years,” said Dr. Calobrace. “I was delighted to perform one of the first Motiva breast augmentations in the United States. The innovation in these devices not only enhances aesthetics outcomes, but also significantly lowers the rates of the complications we see with other devices. Motiva implants are a game changer.”
Breast Augmentation Risks
Current statistics for complication and mortality rates following breast augmentation surgery show that the overall mortality rate for breast augmentation surgery is 0.13%, with the mortality rate for breast augmentation surgery in the US being 20.7 deaths per 100,000 procedures. In addition roughly 1 in 7,392 women die within 30 days after breast augmentation surgery, and the mortality rate for breast augmentation surgery complications requiring hospital readmission is approximately 0.22%.
3 Most Common Causes of Death Following Breast Augmentation
- The most common causes of death after breast augmentation surgery are pulmonary embolism and infection.
- Death related to breast augmentation surgery is more likely to occur in patients with untreated infections.
- Death related to breast augmentation surgery is more likely to occur in patients with delayed wound healing.
Motiva Implants Enhanced Safety & Superior Biocompatibility
The SmoothSilk surface featured in Motiva Implants is proven to encourage low inflammation post-surgery and provides superior biocompatibility. The Motiva Implants increased safety aspects that help lower inflammation post-surgery and increase biocompatibility help address these problems associated with current breast implant options. This is a major advancement in the need for safer options for breast augmentation, and one that will help mitigate the dangers associated with the procedure.
“The plastic surgery community has waited more than a decade to offer breast augmentation patients in the United States something truly new,” said Dr. Glicksman, Medical Director of the Motiva U.S. IDE Study and a clinical trial investigator. “Now, we can confidently offer our patients implants that have consistently shown low complication rates and high patient satisfaction.”
The implants are available in two implant styles. Motiva SmoothSilk Ergonomix is designed to feel, act and move like natural breast tissue, utilizing a unique ergonomic shape that is able to adapt to the movements of the body and maintain a teardrop shape when standing and a round shape when lying down. The Motiva SmoothSilk Round Implants provide greater upper breast fullness and softness as they maintain a full round form no matter the body’s position.
