Today the FDA Approved the NATRELLE® 410 Highly Cohesive Gel Implant, Under Study Since 2001. Dr. Bradley Bengtson of Grand Rapids, Mich. holds the Largest Single Surgeon Site with ~500 Augmentation Patients.
GRAND RAPIDS, Mich., February 20, 2013 ─ A rising star in the plastic surgery industry, shaped, form stable, highly cohesive breast implants have achieved FDA approval on February 20 following 11 years of study. In Europe the 410 implant has been the most popular implanted shaped device for many years, and that trend is poised to take root in the United States. Dr. Bradley Bengtson of the Bengtson Center for Aesthetics and Plastic Surgery in Grand Rapids, Michigan, currently holds the largest single surgeon augmentation patient series of NATRELLE® 410 Highly Cohesive Gel Implants in the U.S. with approximately 500 patients.
The NATRELLE 410 Implant contains a more highly cohesive, thicker, gel filler creating the ability for it to hold its shape and form. Some have likened it to a “Gummy Bear,” hence its common comparison. The implant is unique in its ability to hold shape and form without collapse of the shell, and it actually helps define the shape of the breast, unlike a standard gel implant. Thickness of the gel and its cohesiveness equips the device to hold its shape in all positions with no intrinsic wrinkling or rippling. Similarly, a highly textured surface pocket reduces the chance of rotation or spinning of the implant, which is reported less than two percent of the time.
Dr. Bengtson is one of the lead investigators for the NATRELLE 410, researching and writing extensively on his patient experience with the device. As a result of his role and holding the largest augmentation series using NATRELLE 410 in the U.S., Dr. Bengtson has traveled across the country and internationally, giving more than 20 presentations on the new implant. He’s also written published reviews of the implant’s three and six-year research data in peer reviewed journals and book chapters.1-3 Dr. Bengtson has helped lead the national education and curriculum development for the training of plastic surgeons in the nuances and use of the NATRELLE 410, and now following the launch will help lead the education of surgeons in multiple training venues.
“The NATRELLE 410 Gel Implant has many unique characteristics, and in order to set surgeons and patients up for success with the 410, it must first be looked at as a brand new device. Everything from patient selection and education to implant selection and meticulous surgery – all are different than using standard round implants. Along with the benefits of offering the 410 implant to patients, it has been an honor to help create the education and training curriculum for plastic surgeons and to help them incorporate these new shaped devices into their practices,” comments Dr. Bengtson.
Since 2001, Dr. Bengtson has played a key role as one of the lead surgeons in the investigational device pre-market approval study implemented by Allergen Medical, maker of the NATRELLE 410 Gel Implant. Initially, a total of 48 plastic surgeons across the U.S. performed implantation on 941 subjects. Each patient participating was enrolled in a 10 year study.
Results showed that the implant has relatively low complication rates and high patient satisfaction rates. In a study titled “Style 410 Cohesive Silicone Breast Implants: Safety and Effectiveness at 5 to 9 Years after Implantation,” authors concluded that overall 99 percent of implants studied within patients showed no evidence of rupture after three years. The 410 has the greatest degree of cohesivity of any implant, providing a less fluid filler and making it less likely that the gel will exude from the shell or into the surrounding tissue with no reports of gel outside the implant capsule reported.
“It has been a privilege to have such a great early experience with these next generation implants and offer them as an option to my patients over the past 12 years,” said Dr. Bengtson. “With nearly 500 patients experiencing the NATRELLE 410, this implant has helped me deliver some of the best long-term results I’ve ever seen in my breast augmentation and reconstruction practice.”
More information about Dr. Bengtson’s participation in the aforementioned studies and his use of the NATRELLE 410 may be found at www.bengtsoncenter.com. Video resources may be found at http://bit.ly/XqvjA7.
About Dr. Bradley Bengtson
Bradley Bengtson, MD FACS is a board certified plastic surgeon who has been named “Best Plastic Surgeon” by Grand Rapids Magazine for the past three years and for the last 17 consecutive years has been elected by his peers for inclusion in Best Doctors in America. He received his doctorate with honors from Indiana University School of Medicine and is board certified by the American Board of Plastic Surgery. Dr. Bengtson is a member of the American Society for Aesthetic Plastic Surgery, the American Society of Plastic Surgeons, and the Christian Medical Society among many others. He’s a leader in ground-breaking research in plastic surgery and has received numerous grants and awards, including two Tiffany Awards for best national research from the Aesthetic Society of Plastic Surgery. Recently he was presented the best research article award in North America from the Aesthetic Surgery Journal in 2012 for his research in Ultrasound applications to plastic surgery. He maintains expertise in breast and facial aesthetics, 3-D imaging, revision breast surgery, liposuction, abdominoplasty (tummy tuck), CoolSculpting, Ulthera and more. Outside of surgery, Dr. Bengtson is one of the most highly sought after, board certified national trainers for BOTOX® and Juvéderm®, breast augmentation and breast revision speaker, and he maintains the Symmetry Skin Care Center. The BengtsonCenter for Aesthetics and Plastic Surgery in the Women’s Health Center of West Michigan is Dr. Bengtson’s main practice. His sister practice can be found in Grandville at Design 1 Salon Spa.
1Bengtson BP, VanAtta B et al.. Style 410 Highly Cohesive Silicone Breast Implant Core Study Results at 3 Years. Plastic Reconstructive Surgery. 120: 7 Suppl 40-48S.
2Bengtson, BP, VanAtta B, Maxwell,GP. Style 410 Highly Cohesive Breast Implant Core Study Results at 6 Years. Aesthetic Surgery Journal, August, 2012.
3Bengtson BP. In Spear, S editor. The Natrelle 410 Highly Cohesive, Form-stable Gel Implant for Primary Breast Augmentation, Chapter 116, Surgery of the Breast , Principles and Art, 2010.
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Plastic Surgeons Dr. Bengtson and Dr. Alfonso, along with the team at the Bengtson Center for Aesthetics & Plastic Surgery, provide advanced surgical and cosmetic treatments for patients from Grand Rapids, Birmingham, Detroit, and Kalamazoo, Michigan.Fees & Financing