Less than 1 percent of the women interested in having larger breasts elect to have surgical augmentation mammaplasty with insertion of breast implants. The purpose of this report is to describe and test the efficacy of a nonsurgical method for breast enlargement that is based on the ability of tissues to grow when subjected to controlled distractive mechanical forces. Seventeen healthy women (aged 18 to 40 years) who were motivated to achieve breast enlargement were enrolled in a single-group study. The participants were asked to wear a brassiere-like system that applies a 20-mmHg vacuum distraction force to each breast for 10 to 12 hours/day over a 10-week period. Breast size was measured by three separate methods at regular intervals during and after treatment. Breast tissue water density and architecture were visualized before and after treatment by magnetic resonance imaging scans obtained in the same phase of the menstrual cycle. Twelve subjects completed the study; five withdrawals occurred due to protocol noncompliance. Breast size increased in all women over the 10-week treatment course and peaked at week 10 (final treatment); the average increase per woman was 98 +/- 67 percent over starting size. Partial recoil was seen in the first week after terminating treatment, with no significant further size reduction after up to 30 weeks of follow-up. The stable long-term increase in breast size was 55 percent (range, 15 to 115 percent). Magnetic resonance images showed no edema and confirmed the proportionate enlargement of both adipose and fibroglandular tissue components. A statistically significant decrease in body weight occurred during the course of the study, and scores on the self-esteem questionnaire improved significantly. All participants were very pleased with the outcome and reported that the device was comfortable to wear. No adverse events were recorded during the use of the device or after treatment. We conclude that true breast enlargement can be achieved with the daily use of an appropriately designed external expansion system. This nonsurgical and noninvasive alternative for breast enlargement is effective and well tolerated.