IDEAL IMPLANT® Structured Breast Implants: Core Study Results at 6 Years

Background: The structured breast implant utilizes different technology than saline or silicone gel implants, making it a third type of implant. FDA and Health Canada granted approval in November 2014. This implant is filled with saline, but has an internal structure consisting of a series of nested shells that support the upper pole when upright and control fluid movement. It combines certain key features and benefits of saline and silicone gel implants. Like saline, the filler is only saline, which women like for peace of mind in case of rupture/deflation. Like silicone gel, it has a natural feel, but without risk of silent rupture and FDA-recommended MRI scans - women can simply look in the mirror and know their implants are intact. Methods: This US trial enrolled 502 women: 399 primary augmentations and 103 replacements of existing augmentation implants. Investigators were 45 ABPS certified plastic surgeons at 35 sites. Of the 502 women enrolled, 438 (87.3%) completed 6-year follow-up visits, a higher percentage than other Core breast implant trials. Results: At 6 years, patient satisfaction was 89.7% for primary and 91.6% for replacement augmentations; surgeon satisfaction was 92.6% for primary and 94.0% for replacement. Kaplan-Meier adverse event rates were: Baker class III & IV capsule contracture – 5.7% for primary, 11.5% for replacement; rupture/deflation – 1.8% for primary, 4.7% for replacement. Conclusion: 6-year results from 438 women show the structured breast implant has high patient and surgeon satisfaction, a low rate of capsule contracture and a low rate of rupture/deflation. Financial Disclosure Statement: Ideal Implant Incorporated designed and funded the study. The authors received research support for conducting this study. Gregg Anigian is an Ideal Implant Incorporated stockholder. Presented in part at: Plastic Surgery The Meeting (ASPS) 2017 in Orlando, Florida. This trial is registered under the name "Core Study of the Safety and Effectiveness of IDEAL IMPLANT® Saline-filled Breast Implants," ClinicalTrials.gov identification number NCT00858052 (http://ift.tt/2oFzXR1) The study was approved by a central investigational review board (RCRC IRB, now Salus IRB, Austin, TX). Corresponding author: Larry S. Nichter, M.D., Pacific Center for Plastic Surgery, 3991 MacArthur Boulevard Suite 320, Newport Beach, CA 92660 USA lnichter@gmail.com ©2018American Society of Plastic Surgeons

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