IDEAL IMPLANT Structured Breast Implants

Core Study Results at 6 Years

Larry S. Nichter, M.D.; Robert A. Hardesty, M.D.; Gregg M. Anigian, M.D.

Disclosures

Plast Reconstr Surg. 2018;142(1):66-75. 

In This Article

Discussion

The IDEAL IMPLANT has been studied in a clinical trial conducted by plastic surgeons in private practice, the typical users of breast implants. Patient follow-up at 6 years exceeded that in any other breast implant Core study, demonstrating a well-executed clinical trial conducted at 35 private practice sites in the United States.

The nature, frequency, and severity of the adverse events observed in the clinical trial through 6 years are consistent with the 2-year follow-up data reported previously.[8] The most commonly reported adverse event was subsequent breast operation, and a common reason was dissatisfaction with implant size. The results from this clinical trial through 6 years show that the implant is safe and effective for primary and revision breast augmentation. This study will continue through 10-years of follow-up, providing additional clinical data.

Although Core clinical trials follow similar protocols established by the U.S. Food and Drug Administration,[9] there are differences in the patient populations and data collection methods. Nevertheless, it is useful to compare Core study data for two key adverse events, capsular contracture and implant failure (deflation/rupture). The IDEAL IMPLANT at 6 years had a substantially lower capsular contracture rate and lower failure rate than comparable round saline or silicone gel implants (Table 10 and Table 11).[6,7,10–12] The explanation for these favorable results is unknown but may be related to the unique technology of the structured implant compared with saline and silicone gel implants. Several theories to explain these results are offered here, but further studies are needed to evaluate each possibility.

The low capsular contracture rate may be because the multiple shell layers of the implant offer significantly greater resistance to compression than single-shell implants; thus, it may have greater resistance to the compressive forces of capsular contracture. Another possible explanation may be that this greater resistance to compression reduces repeated stretching of the implant during activities of daily living, thereby reducing microtrauma to the capsule that could stimulate contracture. Another possibility is that the low capsular contracture rate may result from the unique geometry of the implant, which has a favorable effect on the scar capsule. Because the implant surface is smooth, the low capsular contracture rate cannot be attributed to surface texturing.

The low deflation rate may be explained by the absence of crease folds of the shell. This could be attributable to the underlying baffle shell layers supporting the outer shell, which prevents it from folding onto itself. Another reason for the absence of crease folds could be related to the shell manufacturing process, which uses a robot to dip mandrels while spinning on the longitudinal axis. This manufacturing technology results in shells that are more consistent and uniform in thickness compared with those made by dipping mandrels by hand.

Now, women and plastic surgeons can choose from three different breast implant technologies: the saline implant with an unsupported shell, the silicone gel implant with a supported shell, or the structured implant with a supported shell. The cross-linked silicone gel and the internal structure of the IDEAL IMPLANT both support the shell to minimize collapse and wrinkling. Because the filler of the implant is only saline, women can look in the mirror and know their implants are intact, giving them peace of mind. In addition to a natural feel, the structured IDEAL IMPLANT has demonstrated clinical advantages over silicone gel implants through 6 years, such as a lower capsular contracture rate and lower rupture rate in primary augmentation.

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