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

NCT00443274 | Active Not Recruiting FDA Device

• 2 other identifiers: BIFS001CMO-EPI-PLS-0536
• Study Type: observational
• Target: 56,460
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Breast Implant

Outcome Measures

Primary Outcomes (3)

• 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

Interventions

NBIR - US National Breast Implant Registry OTHER

NBIR is intended to be a surveillance tool to track patient safety and real-world outcomes associated with breast implants used for aesthetic or reconstructive purposes..

410 Arm DEVICE

Anatomically shaped silicone gel-filled breast implants.

BIFs - Breast Implant Follow-Up Study DEVICE

Round silicone gel-filled breast implants and saline-filled breast implants

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• Screening Criteria
• Female
• 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
• age 22 or older who is a candidate for breast augmentation (primary or revision) with Allergan silicone implants or saline breast implants (controls)
• Exhibit fluency and literacy in English or Spanish
• Enrollment Criteria

You may not qualify if:

• Have completed the implant surgery
• 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.
• Are free of all target diseases at baseline (410 arm only)
• 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:
• Received 1 or 2 Style 410 implants between 2015 and 2019
• Willing to complete baseline questionnaire at time of enrollment
• Continuation Criteria (BIFS Arm Only)
• 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)
• 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
• Were enrolled at a site that was selected in the cluster sampling to continue in the BIFS arm
• Are transgender
• If a saline implant subject, have a current or past unilateral or bilateral silicone gelfilled breast implant
• Investigator decision that subject is not a suitable candidate for a long-term observational study

Sponsors & Collaborators

• Allergan: lead

Study Sites (1)

Southwest Plastic Surgery /ID# 240510

El Paso, Texas, 79925-7618, United States

Location

Related Publications (1)

• 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.

  PMID: 26710009 DERIVED

Study Officials

• ALLERGAN INC.

  Allergan

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 1, 2007
• First Posted: March 5, 2007
• Study Start: November 1, 2006
• Primary Completion (Estimated): December 31, 2029
• Study Completion (Estimated): December 31, 2029
• Last Updated: July 16, 2025

Record last verified: 2025-07

Locations

US (1)