Plastic
& Reconstructive Surgery:
January 2016 -
Volume 137 - Issue 1 - p 70–81
Singh, N, Picha, G, Murphy, D
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.
