Safety Evaluation in Subjects With Silicone- and Saline- Breast Implants - Full Text View

Safety Evaluation in Subjects With Silicone- and Saline- Breast Implants (BIFS)

This study is currently recruiting participants.

Verified by Allergan Medical, December 2009

First Received: March 1, 2007 Last Updated: December 3, 2009 History of Changes

Sponsor:	Allergan Medical
Information provided by:	Allergan Medical
ClinicalTrials.gov Identifier:	NCT00443274

Purpose

Ten year safety study examining rates of rare adverse events, child bearing issues, optimal mammography, and detection of ruptures in subjects with silicone or saline breast implants.

Condition	Phase
Breast Implant	Phase IV

Study Type:	Observational
Study Design:	Case-Only, Prospective

Resource links provided by NLM:

MedlinePlus related topics: Breast Reconstruction

U.S. FDA Resources

Further study details as provided by Allergan Medical:

Biospecimen Retention: None Retained

Biospecimen Description:

Estimated Enrollment:	55000
Study Start Date:	November 2006
Estimated Study Completion Date:	November 2016

Eligibility

Ages Eligible for Study:	18 Years and older
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

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

Contacts

Contact: Allergan Medical

devicetrials@allergan.com

Locations

United States, Oregon
	Recruiting
Eugene, Oregon, United States

Sponsors and Collaborators

Allergan Medical

Investigators

Study Director:

Allergan Medical

More Information

No publications provided

Responsible Party:	Allergan ( Allergan Medical )
Study ID Numbers:	BIFS001
Study First Received:	March 1, 2007
Last Updated:	December 3, 2009
ClinicalTrials.gov Identifier:	NCT00443274 History of Changes
Health Authority:	United States: Institutional Review Board

ClinicalTrials.gov processed this record on February 08, 2010