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The aim of this prospective, controlled clinical investigation was to compare the capsular contracture rate between silicone implants with a smooth and those with a textured surface. The implants were otherwise identical. Twenty-five women with bilateral mammary hypoplasia underwent augmentation mammoplasty. All received a textured implant on one side and a smooth implant on the other. Before surgery the patients were told that they could have the implants changed if the study showed that one type was better than the other. The investigation was conducted with the double-blind technique, with the code broken 1 year after surgery. At 1-year follow-up (reported previously) three parameters were used to estimate the tendency to capsular contracture: (1) the patient's opinion on differences in hardness of the breasts, (2) the investigators' classification of capsular contracture, and (3) applanation tonometry. All parameters showed unequivocally that the breasts augmented with textured implants had a lower tendency to develop capsular contracture than those with smooth implants. Five years after surgery 17 patients had had their smooth implant changed to a textured one because of hardness. Only one of the textured implants had been removed. A comparison between the 1-year and 5-year tonometric results of the 24 breasts that still had the original textured implants showed that after 5 years, a small but statistically significant increase in hardness had occurred compared with that after 1 year.
Hakelius et al. (Sat,) studied this question.