Reoperation Rate After Primary Augmentation With Smooth, Textured, High Fill, Cohesive, Round Breast Implants (RANBI-I Study).

Background: Reoperation after primary breast augmentation remains an important clinical issue.

Objective: Evaluate incidence and causes of reoperation in patients who underwent primary augmentation.

Methods: This retrospective, noninterventional study conducted at 16 Canadian sites reviewed medical records and subject-completed questionnaires of women who underwent primary breast augmentation with smooth or textured Natrelle® Inspira® implants containing TruForm 1 or TruForm 2 gel. Subjects were aged ≥22 years, received implants via inframammary fold incision, and had follow-up at 2 to 4 years.

Results: A total of 319 women received Inspira implants (smooth TruForm 2, n=205; textured TruForm 2, n=99; smooth or textured TruForm 1, n=15). At follow-up, 30 women (9.4%) had undergone reoperation, including 19 (9.3%) in the smooth TruForm 2 subgroup and 9 (9.1%) in the textured TruForm 2 subgroup. The mean time to reoperation was 1.2 years; the risk rate for reoperation was 9.9% at 3 years. The most common reasons for reoperation were implant malposition (36.7%), capsular contracture (33.3%), and the patient's request for a change in implant size or style (20.0%). Most women were very or somewhat satisfied with the initial surgery (89.3% overall; 90.7% smooth TruForm 2; 86.9% textured TruForm 2). Thirty-four women (10.7%) reported adverse events, including 20 (9.8%) in the smooth TruForm 2 subgroup and 14 (14.1%) in the textured TruForm 2 subgroup.

Conclusions: This analysis suggests that Natrelle Inspira TruForm 2 implants are safe when used in primary breast augmentation, with low reoperation rates that are consistent with those for other breast implants.