A New Concept Breast Implant - Two-Year Follow-up Results In 472 Patients

Purpose –To address the problems of current saline implants, a new implant design was developed. It is a double-lumen and contains an internal baffle structure that controls fluid movement to prevent bouncing, supports the upper pole to prevent collapse and supports the edges to minimize wrinkling. Two-year outcomes in 472 patients are reported here.

Methods and Materials – An FDA clinical trial began February 2009, with 502 women enrolled by February 2010: 399 for primary augmentation and 103 for replacement of existing implants. There were 45 ABPS certified plastic surgeons at 35 sites in the US. A protocol for Upright MRI scans was developed that visualized breast implant shape, contour to the chest wall and edge wrinkling, both laterally and inferiorly.

Experience – A total of 472 patients completed 2-year follow-up visits, a rate of 94%. Five patients had Upright MRI scans before and 1-year after replacing current saline implants with these new design saline implants. 

Results – For the 472 patients with 2-year follow-up, patient satisfaction with the outcome was 93.1% for primary and 88.3% for replacement augmentations; surgeon satisfaction was 95.0% for primary and 89.4% for replacement augmentations. Baker class 3 or 4 capsule contracture occurred in 1.9% of primary and 4.3% of replacement augmentations. Wrinkling was moderate to severe in 6.6% of primary and 11.9% of replacement augmentations. Deflation occurred in 4.8% of primary and 6.4% of replacement augmentations, all from early manufacturing problems that were identified and corrected, except for two from surgical needle punctures. There were no deflations from a fold-flaw of the shell, the usual cause of implant failures. In five patients, contour to the chest wall was improved and edge wrinkling eliminated when current single-lumen saline implants were replaced with these double-lumen saline implants.

Conclusion – Two-year clinical data from 472 women indicates that this new design saline implant has a high rate of patient and surgeon satisfaction, with a low rate of wrinkling and capsule contracture. In the future, it may offer women an alternative to current saline and silicone gel implants.