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

Area of Science:

• Plastic Surgery
• Biomaterials
• Medical Devices

Background:

• Structured breast implants represent a third type, distinct from saline and silicone gel implants, approved in 2014.
• These implants feature an internal structure supporting the upper pole and controlling fluid, combining benefits of saline (peace of mind) and silicone (natural feel) without silent rupture risks.

Purpose of the Study:

• To evaluate the long-term safety and efficacy of structured breast implants.
• To assess patient and surgeon satisfaction and adverse event rates at 6 years post-implantation.

Main Methods:

• A U.S. trial enrolled 502 women for primary augmentation (399) or implant replacement (103).
• Data collected by 45 board-certified plastic surgeons at 35 sites, with 87.3% completing 6-year follow-up.

Main Results:

• High patient satisfaction (89.7% primary, 91.6% replacement) and surgeon satisfaction (92.6% primary, 94.0% replacement) at 6 years.
• Low Kaplan-Meier adverse event rates: capsular contracture (5.7% primary, 11.5% replacement) and rupture/deflation (1.8% primary, 4.7% replacement).

Conclusions:

• Structured breast implants demonstrate high patient and surgeon satisfaction at the 6-year mark.
• The study confirms a low incidence of capsular contracture and rupture/deflation for this implant type.