About the Breast Implant Follow-up Study (BIFS)
Power of One, Strength of Many
BIFS is an important research study. As a participant in BIFS, you agree to complete a questionnaire once a year. By fulfilling that commitment, you and the other 2,700 women who are a part of the BIFS community are contributing to the health and safety of all women with breast implants.
We’re in this together.
BIFS STUDY INFORMATION
Annual Questionnaire for 10 Years
The BIFS study is a large, multicenter study being conducted to evaluate the long-term safety and performance of NATRELLE® silicone gel-filled breast implants compared with saline-filled implants. Participants are asked to complete an online health questionnaire annually for 10 years.
The information obtained in the questionnaires from women with silicone gel-filled breast implants will be compared to women with saline implants (or national norms) regarding health concerns such as:
- Adverse events, implant complication rates, pregnancy outcomes, problems related ot lactation, effects on mammography, and effects on satisfaction with breasts and psychosocial well-being
By completing your Annual Questionnaires, you provide valuable safety information that helps all women with breast implants.
What Is the Purpose of the BIFS Study?
This large, 10-year observational study is being conducted to compare the long-term safety and performance of NATRELLE® silicone gel-filled breast implants with saline implants or national norms.
Who Is the BIFS Study For?
Women who received NATRELLE® silicone gel-filled breast implants or saline implants for augmentation, reconstruction, or revision of augmentation or reconstruction.
Yearly Online Questionnaire
Study participants are asked to complete a questionnaire regarding their health and the status of their implants once a year for 10 years through a secure online portal (or by telephone when necessary).
About Study Participants
Over 2,700 women age 18 years or older (reconstruction) or age 22 or older (augmentation) who received NATRELLE® silicone gel-filled implants or saline implants have enrolled in BIFS.
UPDATEDInformed Consent Form
This is the document you sign when you enroll in BIFS that explains the purpose of the study, what your role is, and how your information will be kept private.
