Breast Implant
Conditions
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.
Interventions
OTHERNBIR - 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..
DEVICE410 Arm
Anatomically shaped silicone gel-filled breast implants.
DEVICEBIFs - Breast Implant Follow-Up Study
Round silicone gel-filled breast implants and saline-filled breast implants
Sponsors
Allergan
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 99 Years
Healthy volunteers
No
Inclusion criteria
Screening Criteria 1. Female 1. 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 2. age 22 or older who is a candidate for breast augmentation (primary or revision) with Allergan silicone implants or saline breast implants (controls) 2. Exhibit fluency and literacy in English or Spanish Enrollment Criteria 1. Have satisfied all the inclusion and none of the
Exclusion criteria
2. Have completed the implant surgery 3. 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. 4. Are free of all target diseases at baseline (410 arm only) 5. 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: 1. Received 1 or 2 Style 410 implants between 2015 and 2019 2. Willing to complete baseline questionnaire at time of enrollment Continuation Criteria (BIFS Arm Only) 1. 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) 2. 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 3. Were enrolled at a site that was selected in the cluster sampling to continue in the BIFS arm
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Risk rates of adverse events of high clinical interest (eg, cancers, neurological diseases, connective tissue diseases) assessed by the investigator | 10 Years | — |
| Risk rates of common complications of breast surgery (eg, capsular contracture, implant rupture/deflation) assessed by the subject and investigator | 10 Years | — |
| Re-operations | 10 Years | Rates of reoperation reported by subjects and by investigators at office visits |
Countries
United States
Outcome results
None listed