Breast ImplantBIFSNCT00443274
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 of Breast Implant, run by Allergan at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 99 years, women only
- Conditions the study is for
- Breast Implant
- What is being tested?
- NBIR - US National Breast Implant Registry, 410 Arm and BIFs - Breast Implant Follow-Up Study
- Type of treatment
- Medical device
- How many people
- 56,460 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Nov 2006to 31 Dec 2029
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Women with breast implants for augmentation, reconstruction, or revision of augmentation or reconstruction
Who may be able to join
- 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
Show all 18Show fewer
- Have satisfied all the inclusion and none of the exclusion criteria
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Southwest Plastic Surgery /ID# 240510
El Paso, Texas, 79925-7618
About this study
Official title: 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.
- Conditions
- Breast Implant
- Being tested
- NBIR - US National Breast Implant Registry, 410 Arm, BIFs - Breast Implant Follow-Up Study
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NBIR - US National Breast Implant RegistryOther
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 ArmDevice
Anatomically shaped silicone gel-filled breast implants.
BIFs - Breast Implant Follow-Up StudyDevice
Round silicone gel-filled breast implants and saline-filled breast implants
What is being measured
The primary outcome is the main question the study is designed to answer.
Risk rates of adverse events of high clinical interest (eg, cancers, neurological diseases, connective tissue diseases) assessed by the investigator
Measured: 10 Years
Risk rates of common complications of breast surgery (eg, capsular contracture, implant rupture/deflation) assessed by the subject and investigator
Measured: 10 Years
Re-operations
Rates of reoperation reported by subjects and by investigators at office visits
Measured: 10 Years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2007 (estimated)
- Study start1 Nov 2006
- Primary completion31 Dec 2029 (estimated)
- Study completion31 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Breast ImplantStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 56,460 participants (actual)
Sponsor and investigators
- Lead sponsor
- Allergan
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- ALLERGAN INC., Study director, Allergan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00443274
- Sponsor's protocol ID
- BIFS001
- Other IDs
- CMO-EPI-PLS-0536
- Acronym
- BIFS
- Status last verified
- Jul 2025
- First submitted
- 1 Mar 2007
- Last updated
- 16 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
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
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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)
- ClinicalTrials.gov ID
- NCT00443274
- Acronym / sponsor ID
- BIFS / BIFS001
- Conditions
- Breast Implant
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 56,460 participants (actual)
- Lead sponsor
- AllerganIndustry (pharma, biotech, devices)
- Study start
- 1 Nov 2006 (actual)
- Primary completion
- 31 Dec 2029 (estimated)
- Study completion
- 31 Dec 2029 (estimated)
- First posted
- 5 Mar 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 99 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Women with breast implants for augmentation, reconstruction, or revision of augmentation or reconstruction
Key inclusion criteria (18 listed)
- Screening Criteria
- Female
- Exhibit fluency and literacy in English or Spanish
- Enrollment Criteria
- Have satisfied all the inclusion and none of the exclusion criteria
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NBIR - US National Breast Implant RegistryNBIR 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.. | Other | – |
| 410 ArmAnatomically shaped silicone gel-filled breast implants. | Device | – |
| BIFs - Breast Implant Follow-Up StudyRound silicone gel-filled breast implants and saline-filled breast implants | Device | – |
Primary outcome
Risk rates of adverse events of high clinical interest (eg, cancers, neurological diseases, connective tissue diseases) assessed by the investigator
Time frame: 10 Years
Risk rates of common complications of breast surgery (eg, capsular contracture, implant rupture/deflation) assessed by the subject and investigator
Time frame: 10 Years
Re-operations
Time frame: 10 Years
Rates of reoperation reported by subjects and by investigators at office visits
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2025.
- Derived from this study: PubMed 26710009Singh 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.
- Individual participant dataSharing planned: Undecided
Related trials for Breast Implant
RecruitingPhase 1/2
Study of ORIC-114 in Patients With Advanced Solid Tumors Harboring an EGFR or HER2 Alteration
Solid Tumors
RecruitingObservational study
The Study is an Observational Post-market Follow-up Program to Evaluate Long Term (5 Years) Safety of Mentor Breast Implants in Chinese Population
Breast Augmentation, Mammaplasty
Active, not recruiting
A Study of the Safety and Effectiveness of the Mentor Larger Size MemoryGel Ultra High Profile Breast Implants in Subjects Who Are Undergoing Primary Breast Reconstruction or Revision Reconstruction
Breast Reconstruction, Revision Breast Reconstruction
Active, not recruiting
Memory Gel and Shape Combined Cohort
Primary Breast Augmentation, Primary Breast Reconstruction
Not yet recruiting
Impact of Intraoperative Neurotization on Sensory Recovery of the Nipple and Breast Skin in Patients Undergoing Nipple Sparing Mastectomy With Immediate Implant-Based Reconstruction: NERSENSE, Prospective Randomized Control Study
Breast Cancer
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
ALLERGAN INC. study director
Allergan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Implant, run by Allergan at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 18 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 16 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Risk rates of adverse events of high clinical interest (eg, cancers, neurological diseases, connective tissue diseases) assessed by the investigator (time frame: 10 Years). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00443274, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jul 2025.