Three-Year Clinical Trial Results with the IDEAL IMPLANT¨ Saline-filled Breast Implant
Goals/Purpose:
There is a need for a saline-filled implant that gives a natural result, since many women are more comfortable having saline in their breast implants than silicone gel. To address the well-known problems of current single-lumen saline implants, a new implant design was developed. It is a double-lumen with a baffle structure in the outer lumen that controls fluid movement to prevent bouncing, supports the upper pole to prevent collapse and the edges to minimize wrinkling.
Methods/Technique:
An FDA clinical trial began February 2009, with 502 women enrolled by February 2010: 399 for primary augmentation and 103 for replacement of existing saline or silicone gel implants. Investigators were 45 ABPS certified plastic surgeons at 35 sites. A total of 472 patients completed 2-year follow-up visits, arate of 94%. It is anticipated that the 3-year follow-up visit rate will also be higher than for that for previous breast implant clinical trials, providing complete clinical data for analysis.
Results/Complications:
For the 472 patients with 2-year follow-up, patient satisfaction with the outcome was 94.3% for primary and 92.3% for replacement augmentations; surgeon satisfaction was 96.5% for primary and 93.4% for replacement augmentations. Adverse events were tabulated by Kaplan-Meier risk rates of first occurrence: Baker class 3 or 4 capsule contracture - 3.8% for primary, 8.2% for replacement augmentations; moderate to severe wrinkling - 3.8% for primary, 12.0% for replacement augmentations; deflation - 4.8% for primary, 3.3% for replacement augmentations. One deflation was from a surgical needle puncture and one was indeterminate because the implant was damaged after removal. All other deflations were due to early manufacturing defects that were identified and corrected.
The 3-year follow-up data from the clinical trial will be available by April 2013. The "Results" section will be updated with the 3-year data in time for the presentation of this paper.
Conclusion:
Two-year data from 472 women indicates this new technology implant has a high rate of patient and surgeon satisfaction, with a low rate of wrinkling and capsule contracture. It seems to offer women an alternative to current single-lumen saline and silicone gel implants (Figures 1 & 2). The 3-year data presentation will clearly define the place for this new technology implant relative to current single-lumen saline-filled implants and the various silicone gel-filled implants.
