One-Year Follow-up Results for 478 Women with A New Design Saline Breast Implant
In spite of the limitations of current single-lumen saline implants and the availability of silicone gel, ASAPS statistics for 2010 show that 38% of US women chose saline implants for breast augmentation. To correct some of the shortfalls of available saline implants, a new design saline breast implant was developed. It is a double-lumen implant with a baffle structure in the outer lumen that controls fluid movement and supports the implant edge and upper pole.
An FDA-approved, US clinical trial was begun in February 2009 to investigate the safety and effectiveness of this new design saline implant. By February 2010, 502 women had been enrolled, of which 399 had primary breast augmentation and 103 had replacement of their existing augmentation implants. Breast reconstruction was not included.
Methods/Technique:
Clinical trial data was collected by 45 ABPS certified plastic surgeon investigators at 35 sites. Through March 31, 2011, a total of 478 out of 502 women completed 1-year follow-up visits, for a follow-up rate of 95.2%. The data was tabulated by an independent Clinical Research Organization (CRO) and reported as a percent of the women in each cohort: 382 primary augmentations and 96 replacement augmentations. (The 2-year follow-up visit data is being collected through March 31, 2012, and will be included in the presentation.)
Results/Complications:
Patient reported satisfaction with the outcome was 95.5% for primary and 87.5% for replacement augmentations; surgeon reported satisfaction was 96.3% for primary and 89.6% for replacement augmentations. Baker class 3 or 4 capsule contracture was reported in 1.0% of primary and 3.1% of replacement augmentations. Wrinkling was reported as either “none” or “negligible” in 86.4% of primary and 77.1% of replacement augmentations. Deflations occurred in 2.6% of primary and 3.1% of replacement augmentations. No deflation was due to shell failure caused by shell folding. One deflation was due to iatrogenic puncture by a surgical needle. The other deflations were all due to an inadequate bond of the posterior valve to the patch or damage to the posterior valve during assembly. These early manufacturing problems have been identified and corrected.
Conclusion:
The 1-year clinical data from 478 women indicates that this double-lumen saline implant containing a baffle has a lower rate of wrinkling, capsule contracture and deflation from shell failure than the current single-lumen saline implants. Satisfaction with the outcome was very high for both patients and surgeons.