RESUMEN
BACKGROUND: The Ideal Implant structured breast implant uses different technology than unstructured saline or silicone gel implants, making it a third type of implant. U.S. Food and Drug Administration (FDA) and Health Canada granted approval in November of 2014. This saline-filled implant has an internal structure consisting of a series of nested shells that support the upper pole when upright and control movement of the saline to provide a natural feel. Because women can look in the mirror to know their implants are intact, they have peace of mind. In contrast, most women are concerned about silicone gel implant ruptures, which are silent and require FDA-recommended magnetic resonance imaging or ultrasound scans for detection. METHODS: This U.S. trial enrolled 502 women: 399 for primary and 103 for revision augmentation. Investigators were 45 American Board of Plastic Surgery-certified plastic surgeons at 35 sites. Of the 502 women enrolled, 426 (84.9%) completed 10-year follow-up visits, a higher percentage than all other FDA breast implant trials. RESULTS: Through 10 years of follow-up, surgeon satisfaction was 94.8% for primary and 87.4% for revision augmentation; and patient satisfaction was 92.7% for primary and 82.3% for revision augmentation. Cumulative Kaplan-Meier risk rates for two major adverse events were lower than in the silicone gel implant trials: Baker class III and IV capsular contracture was 6.6% for primary and 11.5% for revision augmentation; and rupture/deflation was 3.7% for primary and 4.7% for revision augmentation. CONCLUSION: Ten-year results from 426 women show the Ideal Implant has high patient and surgeon satisfaction, a low rate of capsular contracture, and a low rate of rupture/deflation. CLINICAL QUESTION/LEVEL OF EVIDENCE: Therapeutic, IV.
