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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 · Status: ACTIVE_NOT_RECRUITING · Type: OBSERVATIONAL · Enrollment: 56460

Last updated 2025-07-16

No results posted yet for this 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.

Conditions

  • Breast Implant

Interventions

OTHER

NBIR - 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..

DEVICE

410 Arm

Anatomically shaped silicone gel-filled breast implants.

DEVICE

BIFs - Breast Implant Follow-Up Study

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

Sponsors & Collaborators

  • Allergan

    lead INDUSTRY

Principal Investigators

  • ALLERGAN INC. · Allergan

Eligibility

Min Age
18 Years
Max Age
99 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-11-01
Primary Completion
2029-12-31
Completion
2029-12-31
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00443274 on ClinicalTrials.gov