NCT00443274 (BIFS) is a clinical trial of NBIR - US National Breast Implant Registry in Breast Implant, sponsored by Allergan.

Who is sponsoring NCT00443274?

NCT00443274 is sponsored by Allergan.

What drugs are being tested in NCT00443274?

Interventions in NCT00443274: NBIR - US National Breast Implant Registry, 410 Arm, BIFs - Breast Implant Follow-Up Study.

What condition does NCT00443274 study?

NCT00443274 studies Breast Implant.

Is NCT00443274 still recruiting?

NCT00443274 is currently active, enrolled. Last updated 16 July 2025.

Last reviewed 2025-07-16 · How we verify

NCT00443274: BIFS

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

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

Active, enrolled Last updated 16 July 2025

What this trial tests

trial testing NBIR - US National Breast Implant Registry in Breast Implant in 56,460 participants. Participants enrolled and being followed up; not accepting new ones.

Timeline

1 November 2006

Primary endpoint
31 December 2029

31 December 2029

Quick facts

Lead sponsor	Allergan
Status	Active, enrolled
Study type	OBSERVATIONAL
Enrollment	56,460
Start date	1 November 2006
Primary completion	31 December 2029
Estimated completion	31 December 2029
Sites	1 location across United States

Drugs / interventions tested

NBIR - US National Breast Implant Registry
410 Arm
BIFs - Breast Implant Follow-Up Study

Conditions studied

Breast Implant — all drugs for Breast Implant →

Sponsor

Allergan — full company profile →

Who can join

Adults 18 to 99, female only, with Breast Implant. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

5 peer-reviewed publications reference this trial (live from Europe PMC):

Prospective Analysis of Primary Breast Augmentation on Body Image Using the BREAST-Q: Results from a Nationwide Study.
Alderman A, Pusic A, Murphy DK. · · 2016 · cited 44× · PMID 27219264 · DOI 10.1097/prs.0000000000002183
Lactation Outcomes in More Than 3500 Women Following Primary Augmentation: 5-Year Data From the Breast Implant Follow-Up Study.
Jewell ML, Edwards MC, Murphy DK, Schumacher A. · · 2019 · cited 8× · PMID 30165661 · DOI 10.1093/asj/sjy221
Natrelle Silicone Breast Implant Follow-Up Study: Demographics, Lifestyle, and Surgical Characteristics of More Than 50,000 Augmentation Subjects.
Singh N, Picha GJ, Murphy DK. · · 2016 · cited 8× · PMID 26710009 · DOI 10.1097/prs.0000000000001851
The Risk of Breast Implant-Associated Anaplastic Large Cell Lymphoma; A Systematic Review and Meta-Analysis.
Elameen AM, AlMarakby MA, Atta TI, Dahy AA. · · 2024 · cited 6× · PMID 38724638 · DOI 10.1007/s00266-024-03956-9
Natrelle Silicone Breast Implant Follow-up Study: Demographics, Lifestyle, and Surgical Characteristics of More Than 5000 Reconstruction Subjects.
Picha GJ, Singh N, Murphy DK. · · 2015 · cited 1× · PMID 26495202 · DOI 10.1097/gox.0000000000000406

Verify or expand the search:

Other recruiting trials for Breast Implant

Currently open trials in the same condition.

NCT06938399 — Motiva Implants® Post-Approval Study · NA · recruiting
NCT07059104 — Implant-based Breast Reconstruction in Post-bariatric Women - a Registry-based National Study · recruiting

Other Allergan trials

Trials by the same sponsor.

NCT04609020 — Study to Evaluate Subject Satisfaction With Facial Appearance and Impact of Combined Facial Treatment · Phase 4 · completed
NCT05452070 — A Study to Assess Adverse Events and Change in Disease Activity of HArmonyCa Lidocaine Injectable Gel for Mid Face Soft · Phase 3 · completed
NCT05393089 — Study of AGN-190584 Eye Drops to Assess Safety and Efficacy in Participants Aged 40-80 Years With Pseudophakic Presbyopi · Phase 2 · withdrawn
NCT05152576 — A Study To Assess the Adverse Effects and Change in Condition of OnabotulinumtoxinA X Injection in Adult Participants Wi · Phase 2 · completed
NCT05088980 — Study to Assess Effectiveness and Adverse Events of JUVEDERM VOLBELLA With Lidocaine Injection in Correcting Infraorbita · Phase 3 · completed

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT00443274 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Allergan
Last refreshed: 16 July 2025

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT00443274.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing