Textured surface, nonsilicone gel breast implants: four years' clinical outcome

Since the development of smooth silicone breast implants in 1962, more than 1 million women throughout the world have opted for breast augmentation surgery. Although initially successful, smooth implants are prone to develop surrounding scar capsules that may harden and contract, resulting in discomfort, weakening of the shell with rupture, asymmetry, and patient dissatisfaction. This phenomenon has been shown to occur in as many as 70 percent of implanted patients over time. We have reviewed all of our patients and the Medical Device Reporting System for Bioplasty, Inc. (Minneapolis, Minn.) for the history of this device. At 18 months, more textured implants remain soft than the smooth group. After an additional 30 months of follow-up, for a total of 48 months maximum and 18 months minimum, most textured implants still remain soft. Since 1990 we have used AU24K, bio-oncotic hydrogel filling material in molecular impact surface textured implants (MISTI) that is similar to breast tissue in color, radiodensity, and viscosity. Complications have been late leaks, infection, and capsular contracture. Several asymptomatic implants were removed because of anxiety over the FDA controversy. Our experience so far indicates that such a breast implant is a reasonable alternative to the prior art. The longer-term performance of these implants must await the availability of further clinical outcome data.