Natrelle Silicone Breast Implant Follow-Up Study

Abstract

Background:A large, multicenter, 10-year observational study is being conducted to compare the long-term safety and effectiveness of Natrelle silicone breast implants with saline implants or national norms. Study baseline data and surgical characteristics are reported here.Methods:Women seeking primary augmentation, revision-augmentation, primary reconstruction, or revision-reconstruction participated. Eligible subjects had completed surgery and received one implant or matching implants. Baseline demographics, health, lifestyle, and surgical characteristics were recorded. Data are presented here for subjects (≥22 years old) who underwent primary augmentation or revision-augmentation.Results:Of 50,979 subjects who underwent augmentation procedures, 35,756 received silicone implants and 15,223 received saline implants. Of these, 86.3 percent underwent primary augmentation, and 13.7 percent underwent revision-augmentation; nearly all subjects (99.3 percent) received bilateral implants. In the primary augmentation group, 67.6 percent of subjects received silicone implants versus 86.1 percent in the revision-augmentation group. Median age was lower in the primary augmentation group compared with the revision-augmentation group (33 versus 42 years old, respectively). Most subjects were white nonsmokers and had attended college. Hispanic subjects and subjects with a body mass index of 25 kg/m2 or greater were more likely to receive saline versus silicone implants. Across groups, the most common characteristics by procedure or implant type included inframammary incision site (54.6 percent), partial (58.2 percent) or complete (31.9 percent) submuscular placement, smooth surface implants (93.1 percent), and implant size of 300 to 399 cc. Incision size was larger for silicone versus saline implants.Conclusion:These data add to the body of knowledge on women undergoing augmentation procedures by providing an unprecedented look at a large number of subjects.

Validation of the Vectra XT three-dimensional imaging system for measuring breast volume and symmetry following oncological reconstruction

“…However, 3D-SI has not hitherto been exploited in a breast cancer population. In these patients, where body mass index is higher [ 5 ] compared to the slim build of the aesthetic breast augmentation population [ 6 ], 3D-SI may not give accurate volume measurements as it requires an assumption about the depth and curvature of the underlying chest wall. Thus, the validity of the volume and symmetry measurements in this population remains unknown and its use as a clinical tool is not established.…”

Lactation Outcomes in More Than 3500 Women Following Primary Augmentation: 5-Year Data From the Breast Implant Follow-Up Study

“…Compared with the primary augmentation population in the overall study in both the silicone and saline groups, the women in the current study were younger (median, 27 years vs 32-34 years) and had a smaller proportion of individuals with BMI ≥25 kg/m 2 (9-12% vs 14-19%). 13 The median duration of follow-up after breast augmentation to the last date of data collection was 3.6 years (range, 0.85-8.3 years) for the silicone group and 3.8 years (range, 0.88-8.5 years) for the saline group.…”

“…Inclusion and exclusion criteria for BIFS-001 have been published previously. 12,13 This subanalysis of BIFS-001 included only women who experienced live births after undergoing primary augmentation surgery with unilateral or bilateral silicone implants or saline implants. Eligible patients were women aged 22 years or older who were fluent in English or Spanish.…”