Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
Randomized Controlled Trial
. 2016 Jan;137(1):70-81.
doi: 10.1097/PRS.0000000000001851.

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

Navin Singh  1 , George J Picha, Diane K Murphy
Affiliations
Randomized Controlled Trial

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

Navin Singh et al. Plast Reconstr Surg. 2016 Jan.

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.

PubMed Disclaimer

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.
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.
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.
Fig. 3.
Incision size for primary augmentation (above) and revision-augmentation (below) subjects. *Percentage was <0.1 percent.
None
See this image and copyright information in PMC

Similar articles

See all similar articles

Cited by

References

    1. American Society of Plastic Surgeons. 2013 Plastic Surgery Statistics Report. Available at: http://www.plasticsurgery.org/Documents/news-resources/statistics/2013-s.... Accessed November 9, 2015.
    1. Jewell ML. Silicone gel breast implants at 50: The state of the science. Aesthet Surg J. 2012;32:1031–1034. - PubMed
    1. Centers for Devices and Radiological Health; U.S. Food and Drug Administration. FDA update on the safety of silicone gel-filled breast implants; June 2011. Available at: http://www.fda.gov/downloads/MedicalDevices/ProductsandMedicalProcedures.... Accessed November 9, 2015.
    1. Allergan, Inc. Irvine, Calif.: Allergan, Inc.; 2009. Natrelle Silicone-Filled Breast Implants [directions for use].
    1. Reece EM, Ghavami A, Hoxworth RE, et al. Primary breast augmentation today: A survey of current breast augmentation practice patterns. Aesthet Surg J. 2009;29:116–121. - PubMed

MeSH terms

Associated data