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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)

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ClinicalTrials.gov Identifier: NCT00443274
Recruitment Status : Recruiting
First Posted : March 5, 2007
Last Update Posted : June 20, 2018
Sponsor:
Information provided by (Responsible Party):
Allergan

Brief 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.

Condition or disease Intervention/treatment
Breast Implant Other: NBIR Placeholder Device: 410 Arm Device: BIFs

Study Type : Observational
Estimated Enrollment : 57000 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Breast Implant Follow-up Study: A 10- Year Observational Study of the Safety of Allergan Silicone Gel-filled Breast Implants as Compared Both to Saline-Filled Breast Implants and to National Norms
Actual Study Start Date : November 1, 2006
Estimated Primary Completion Date : October 31, 2028
Estimated Study Completion Date : October 31, 2028

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
NBIR placeholder
Once the US National Breast Implant Registry is established, subjects will be transferred to this database for follow up
Other: NBIR Placeholder
410 Arm
Anatomically shaped silicone gel-filled breast implants.
Device: 410 Arm
BIFs
Round silicone gel-filled breast implants and saline-filled breast implants
Device: BIFs



Primary Outcome Measures :
  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 [ Time Frame: 10 Years ]
    Rates of reoperation reported by subjects and by investigators at office visits



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00443274


Contacts
Contact: Clinical Trials Registry Team 877‐277‐8566 IR-CTRegistration@allergan.com

  Show 1777 Study Locations
Sponsors and Collaborators
Allergan
Investigators
Study Director: Kenne Mountford, PhD Allergan

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
CMO-EPI-PLS-0536 ( Other Identifier: Allergan Study Number )
First Posted: March 5, 2007    Key Record Dates
Last Update Posted: June 20, 2018
Last Verified: June 2018

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No