NCT00443274

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

About the study

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.

Who can take part

You may be eligible to participate in the study if you meet the following criteria:

INCLUSION CRITERIA

Inclusion Criteria:

Screening Criteria

Female

age 18 years or older who is a candidate for breast reconstruction (primary or revision) with Allergan silicone implants or saline breast implants (controls) OR
age 22 or older who is a candidate for breast augmentation (primary or revision) with Allergan silicone implants or saline breast implants (controls)
Exhibit fluency and literacy in English or Spanish

Enrollment Criteria

EXCLUSION CRITERIA

Have satisfied all the inclusion and none of the exclusion criteria

Have completed the implant surgery

Have only one breast implant or have matching breast implants (i.e., both Round Responsive, both Style 410, or both saline) following their qualifying surgery. In the case of silicone, the device(s) must be manufactured by Allergan.

Are free of all target diseases at baseline (410 arm only)

Have signed the informed consent form, documenting agreement to participate in all required follow-up interviews by internet, phone, or mail and authorizing health care providers to release medical records to study personnel, and have completed the baseline questionnaire prior to implant surgery (prospectively enrolled subjects)

For retrospectively enrolled subjects into the 410 arm, in addition to the above, these criteria also apply:

Received 1 or 2 Style 410 implants between 2015 and 2019
Willing to complete baseline questionnaire at time of enrollment

Continuation Criteria (BIFS Arm Only)

Have completed baseline and years 1, 2, 3 and 4 follow-up questionnaires available (including the Satisfaction with Breasts and Psychosocial Well-Being modules of the BREAST-Q)
Met all enrollment criteria, specifically the minimum age requirements for silicone implants (18 or older for reconstruction subjects and 22 or older for augmentation subjects), and were free of all target diseases at baseline
Were enrolled at a site that was selected in the cluster sampling to continue in the BIFS arm

Exclusion Criteria:

Are transgender
If a saline implant subject, have a current or past unilateral or bilateral silicone gelfilled breast implant
Investigator decision that subject is not a suitable candidate for a long-term observational study

Study Locations

Enter your ZIP code/Postal code/PIN code to locate study sites near you:

How to Apply

Contact the study center to learn if this study is a good match for you.

Study’s details

Contition

Breast Implant

Age (in years)

18 - 99

Participants needed

56460

Est. Completion Date

Dec 31, 2029

Treatment type

Observational

Sponsor

Allergan

ClinicalTrials.gov identifier

NCT00443274

Study number

BIFS-001

Understanding Clinical Trials

Get answers to your questions about clinical trials.What is a clinical research?What does taking part in clinical trials involve?What should I ask the trial doctor?