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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 (BIFS)

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2016 by Allergan
Sponsor:
Information provided by (Responsible Party):
Allergan
ClinicalTrials.gov Identifier:
NCT00443274
First received: March 1, 2007
Last updated: March 7, 2016
Last verified: March 2016
  Purpose
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.

Condition
Breast Implant

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective

Resource links provided by NLM:


Further study details as provided by Allergan:

Primary Outcome Measures:
  • Risk rates of adverse events of high clinical interest (eg, cancers, neurological diseases, connective tissue diseases) assessed by the investigator [ Time Frame: 10 Years ] [ Designated as safety issue: Yes ]
  • Risk rates of common complications of breast surgery (eg, capsular contracture, implant rupture/deflation) assessed by the subject and investigator [ Time Frame: 10 Years ] [ Designated as safety issue: Yes ]
  • Re-operations [ Time Frame: 10 Years ] [ Designated as safety issue: Yes ]
    Rates of reoperation reported by subjects and by investigators at office visits


Estimated Enrollment: 57000
Study Start Date: November 2006
Estimated Study Completion Date: October 2026
Estimated Primary Completion Date: October 2026 (Final data collection date for primary outcome measure)
Groups/Cohorts
NBIR placeholder
Once the US National Breast Implant Registry is established, subjects will be transferred to this database for follow up
410 Arm
Anatomically shaped silicone gel-filled breast implants.
BIFs
Round silicone gel-filled breast implants and saline-filled breast implants

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Women with breast implants for augmentation, reconstruction, or revision of augmentation or reconstruction
Criteria

Inclusion Criteria:

  • Female, age 18 years or older (22 or older for breast augmentation patients)
  • Fluency and literacy in English or Spanish

Exclusion Criteria:

  • Are transgender
  • If a saline implant patient, have a current or past unilateral or bilateral silicone breast implant
  • Investigator decision that patient is not a suitable candidate for a long-term observational study
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00443274

Contacts
Contact: Allergan Inc. clinicaltrials@allergan.com

  Show 1722 Study Locations
Sponsors and Collaborators
Allergan
Investigators
Study Director: Therapeutic Area Head Allergan
  More Information

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Allergan
ClinicalTrials.gov Identifier: NCT00443274     History of Changes
Other Study ID Numbers: BIFS001 
Study First Received: March 1, 2007
Last Updated: March 7, 2016
Health Authority: United States: Institutional Review Board

ClinicalTrials.gov processed this record on July 28, 2016