Ideal Implant Structured Breast Implants: Core Study Results through 10 Years

Area of Science:

• Plastic Surgery
• Biomaterials Science
• Medical Devices

Background:

• The Ideal Implant is a novel structured saline breast implant approved in 2014.
• Its internal structure provides a natural feel and supports the upper pole.
• Unlike silicone gel implants, women can visually confirm the integrity of Ideal Implants, reducing anxiety about silent ruptures.

Purpose of the Study:

• To evaluate the 10-year safety and efficacy of the Ideal Implant in breast augmentation.
• To compare complication rates and satisfaction levels with existing breast implant technologies.

Main Methods:

• A U.S. trial enrolled 502 women (399 primary, 103 revision augmentation) with 45 surgeons at 35 sites.
• High follow-up rate of 84.9% (426 women) at 10 years.
• Kaplan-Meier analysis was used to assess cumulative risk rates for adverse events.

Main Results:

• High surgeon satisfaction (94.8% primary, 87.4% revision) and patient satisfaction (92.7% primary, 82.3% revision) at 10 years.
• Low cumulative risk rates for Baker class III/IV capsular contracture (6.6% primary, 11.5% revision).
• Low cumulative risk rates for rupture/deflation (3.7% primary, 4.7% revision), significantly lower than silicone gel implant trials.

Conclusions:

• The Ideal Implant demonstrates high patient and surgeon satisfaction over a 10-year period.
• It exhibits a low incidence of major adverse events, including capsular contracture and rupture/deflation.
• These findings support the Ideal Implant as a safe and effective option for breast augmentation.