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Clinical Trial
, 142 (1), 66-75

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

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Clinical Trial

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

Larry S Nichter et al. Plast Reconstr Surg.

Abstract

Background: The structured breast implant uses different technology than saline or silicone gel implants, making it a third type of implant. The U.S. Food and Drug Administration and Health Canada granted approval in November of 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. As with saline, the filler is only saline, which women like for peace of mind in case of rupture/deflation. As with silicone gel, it has a natural feel, but without the risk of silent rupture and U.S. Food and Drug Administration-recommended magnetic resonance imaging scans-women can simply look in the mirror and know their implants are intact.

Methods: This U.S. trial enrolled 502 women: 399 primary augmentations and 103 replacements of existing augmentation implants. Investigators were 45 American Board of Plastic Surgery-certified plastic surgeons at 35 sites. Of the 502 women enrolled, 438 (87.3 percent) completed 6-year follow-up visits, a higher percentage than other Core breast implant trials.

Results: At 6 years, patient satisfaction was 89.7 percent for primary and 91.6 percent for replacement augmentations; surgeon satisfaction was 92.6 percent for primary and 94.0 percent for replacement augmentation. Kaplan-Meier adverse event rates were as follows: Baker grade III and IV capsular contracture, 5.7 percent for primary and 11.5 percent for replacement augmentation; and rupture/deflation, 1.8 percent for primary and 4.7 percent for replacement augmentation.

Conclusion: Six-year results from 438 women show that the structured breast 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.

Trial registration: ClinicalTrials.gov NCT00858052.

Figures

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Fig. 1.
Fig. 1.
(Above, left) Mentor Moderate Plus 325 cc saline implant at minimum fill volume (total implant volume, 345 cc from 325-cc fill volume plus 20-cc empty implant volume). (Above, center) Allergan Moderate style 15 silicone gel implant (total implant volume, 339 cc). (Above, right) Allergan Inspira style SRF silicone gel implant (total implant volume, 365 cc). (Center, left) Allergan Inspira style SSF silicone gel implant (total implant volume, 365 cc). (Center, center) Allergan Inspira style SCF silicone gel implant (total implant volume, 365 cc). (Center, right) IDEAL IMPLANT 335-cc structured implant at minimum fill volume (total implant volume, 335 cc). (Below) A 335-cc structured IDEAL IMPLANT at maximum fill volume (total implant volume, 375 cc). Standardized oblique photographs were taken perpendicular to the surface of a curved form with a 10-inch diameter that simulates the convexity of the chest wall. The form was tilted 45 degrees up from the horizontal; a 2-cm lip at the bottom of the form kept the implant from sliding off and simulates support from the inferior capsule. (Photographs courtesy of Ideal Implant Incorporated.)
Fig. 2.
Fig. 2.
Cutaway of IDEAL implant (335- to 555-cc) to show internal structure. (Drawing courtesy of IDEAL IMPLANT Incorporated.)
Fig. 3.
Fig. 3.
IDEAL implant on a curved surface simulating the convexity of the chest wall. (Photograph courtesy of IDEAL IMPLANT Incorporated.)

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References

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