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Active, not recruitingNCT00443274BIFSUpdated Jul 16, 2025

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

An observational study in Breast Implant, sponsored by Allergan. Active, not recruiting at 1 site in United States. Open to female participants aged 18 Years to 99 Years. Per ClinicalTrials.gov, last updated 2025-07-16.

Sponsored by Allergan (part of AbbVie) · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
56,460
Ages
18 Years to 99 Years
Sex
Female
01

Study 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.

02

Conditions studied

  • Breast Implant
03

In context

Lead sponsor

Allergan is the lead sponsor of 505 studies on the registry; none are open to participants now.

Of its 93 completed or terminated interventional studies of FDA-regulated products, 91 (98%) have results posted.

First submitted before Allergan became part of AbbVie.

Browse Allergan studies →All AbbVie studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 99 Years
Sexes eligible
Female
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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 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

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
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
56,460 participants (actual)

Interventions

  • OtherNBIR - US National Breast Implant Registry

    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..

  • Device410 Arm

    Anatomically shaped silicone gel-filled breast implants.

  • DeviceBIFs - Breast Implant Follow-Up Study

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

06

What researchers measure

Primary outcomes

  1. Risk rates of adverse events of high clinical interest (eg, cancers, neurological diseases, connective tissue diseases) assessed by the investigator

    Time frame: 10 Years

  2. Risk rates of common complications of breast surgery (eg, capsular contracture, implant rupture/deflation) assessed by the subject and investigator

    Time frame: 10 Years

  3. Re-operations

    Rates of reoperation reported by subjects and by investigators at office visits

    Time frame: 10 Years

07

Study locations

1 site
08

References and documents

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. PubMed 26710009 ↗

Individual participant data

Plan to share: Undecided

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Started Nov 2006 (actual). Primary completion is estimated for Dec 2029, 277 months after the start.

How these figures are worked out, and which studies are left out of them.

Registered
Mar 1, 2007
First posted
Mar 5, 2007
StartActual
Nov 1, 2006
Primary completionEst.
Dec 31, 2029
CompletionEst.
Dec 31, 2029
Last update
Jul 16, 2025
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jul 16, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00443274
Lead sponsor
Allergan
Responsible party
Sponsor
First posted
Mar 5, 2007
Start date
Nov 1, 2006
Primary completion
Dec 31, 2029 (estimated)
Completion
Dec 31, 2029 (estimated)
Last update
Jul 16, 2025

Study contacts

ALLERGAN INC.
study director · Allergan

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Jul 2025. You cannot join it, but the record below documents what was studied.

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Discussion

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