Safety Follow-up Study in Subjects With Silicone Gel-filled Breast Implants as Compared Both to Saline-filled Breast Implants and to National Norms (BIFS)

Breast Implant Follow-up Study: A Long-term Observational Study of the Safety of Allergan Silicone Gel-filled Breast Implants as Compared Both to Saline-filled Breast Implants and to National Norms (410-arm)

Ten year safety study examining rates of rare adverse events, child bearing issues, effects of mammography, MRI compliance and results, and long-term benefit of silicone-filled breast implants.

Study Overview

• Status: Active, not recruiting
• Conditions: Breast Implant
• Intervention / Treatment: Other: NBIR - US National Breast Implant Registry; Device: 410 Arm; Device: BIFs - Breast Implant Follow-Up Study

• Study Type: Observational
• Enrollment (Actual): 56460

Contacts and Locations

Study Locations

• United States
  • Texas
    • El Paso, Texas, United States, 79925-7618
      • Southwest Plastic Surgery /ID# 240510

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 95 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Women with breast implants for augmentation, reconstruction, or revision of augmentation or reconstruction

Description

Inclusion Criteria:

Screening Criteria

1. Female

   1. age 18 years or older who is a candidate for breast reconstruction (primary or revision) with Allergan silicone implants or saline breast implants (controls) OR
   2. age 22 or older who is a candidate for breast augmentation (primary or revision) with Allergan silicone implants or saline breast implants (controls)
2. Exhibit fluency and literacy in English or Spanish

Enrollment Criteria

1. Have satisfied all the inclusion and none of the exclusion criteria
2. Have completed the implant surgery
3. Have only one breast implant or have matching breast implants (i.e., both Round Responsive, both Style 410, or both saline) following their qualifying surgery. In the case of silicone, the device(s) must be manufactured by Allergan.
4. Are free of all target diseases at baseline (410 arm only)
5. Have signed the informed consent form, documenting agreement to participate in all required follow-up interviews by internet, phone, or mail and authorizing health care providers to release medical records to study personnel, and have completed the baseline questionnaire prior to implant surgery (prospectively enrolled subjects)

For retrospectively enrolled subjects into the 410 arm, in addition to the above, these criteria also apply:

1. Received 1 or 2 Style 410 implants between 2015 and 2019
2. Willing to complete baseline questionnaire at time of enrollment

Continuation Criteria (BIFS Arm Only)

1. Have completed baseline and years 1, 2, 3 and 4 follow-up questionnaires available (including the Satisfaction with Breasts and Psychosocial Well-Being modules of the BREAST-Q)
2. Met all enrollment criteria, specifically the minimum age requirements for silicone implants (18 or older for reconstruction subjects and 22 or older for augmentation subjects), and were free of all target diseases at baseline
3. Were enrolled at a site that was selected in the cluster sampling to continue in the BIFS arm

Exclusion Criteria:

1. Are transgender
2. If a saline implant subject, have a current or past unilateral or bilateral silicone gelfilled breast implant
3. Investigator decision that subject is not a suitable candidate for a long-term observational study

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Risk rates of adverse events of high clinical interest (eg, cancers, neurological diseases, connective tissue diseases) assessed by the investigator		10 Years
Risk rates of common complications of breast surgery (eg, capsular contracture, implant rupture/deflation) assessed by the subject and investigator		10 Years
Re-operations	Rates of reoperation reported by subjects and by investigators at office visits	10 Years

Collaborators and Investigators

• Sponsor: Allergan
• Investigators: Study Director: ALLERGAN INC., Allergan

Publications and helpful links

General Publications

• Singh N, Picha GJ, Murphy DK. Natrelle Silicone Breast Implant Follow-Up Study: Demographics, Lifestyle, and Surgical Characteristics of More Than 50,000 Augmentation Subjects. Plast Reconstr Surg. 2016 Jan;137(1):70-81. doi: 10.1097/PRS.0000000000001851.

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2006
• Primary Completion (Estimated): December 31, 2029
• Study Completion (Estimated): December 31, 2029

Study Registration Dates

• First Submitted: March 1, 2007
• First Submitted That Met QC Criteria: March 2, 2007
• First Posted (Estimated): March 5, 2007

Study Record Updates

• Last Update Posted (Actual): July 16, 2025
• Last Update Submitted That Met QC Criteria: July 14, 2025
• Last Verified: July 1, 2025

More Information

Terms related to this study

• Other Study ID Numbers: BIFS001; CMO-EPI-PLS-0536 (Other Identifier: AbbVie)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No