Natrelle Silicone Breast Implant Follow-Up Study: Demographics, Lifestyle, and Surgical Characteristics of More Than 50,000 Augmentation Subjects

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/m 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.

Trial registration: ClinicalTrials.gov NCT00443274.

Conflict of interest statement

Disclosure: This study was sponsored by Allergan, Inc., Irvine, Calif. Dr. Singh serves as the chair of the Data and Safety Monitoring Board (DSMB) for the Allergan BIFS-001 study. Dr. Picha is an employee of American Medical Technology, Applied Medical Technology, and Abeon Medical; serves as a consultant and advisory board member for Allergan, Inc.; is a member of the DSMB for BIFS-001; serves as an advisor for Intellirod and Mutual Capital Partners; and is an advisory board member for Intellirod. Ms. Murphy is an employee of Allergan, Inc., and holds stock and stock options in that company. Neither honoraria nor other forms of payment were made for authorship.

Figures

Fig. 1.

Age distribution for primary augmentation (above) and revision-augmentation (below) subjects. Percentages of women who selected silicone implants were higher than the percentages who selected saline implants in age groups 30 years and older for primary augmentation and in age groups 40 years and older for revision-augmentation (both p < 0.0001).

Fig. 2.

Implant size for primary augmentation (above) and revision-augmentation (below) subjects. Size distributions differed between the silicone and saline groups in both indications (both p < 0.0001).

Fig. 3.

Incision size for primary augmentation (above) and revision-augmentation (below) subjects. *Percentage was <0.1 percent.