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 breast implants with saline implants or national norms. Participants in the study are contributing to the health and safety of all women with breast implants. The FDA required Allergan to perform the BIFS study in response to safety concerns about silicone breast implants, and updates regarding study status are reported annually to the FDA.

What should I do if I have moved and need to transfer to a new study site?

Please contact the BIFS Support Team at bifs410@syneoshealth.com or 1-866-619-BIFS (2437) and we will attempt to transfer you to a local study site.

Will I receive compensation for my participation in BIFS?

You will receive $50 for each annual questionnaire you complete and $100 as compensation for your time in attending each physical exam at years 1, 4, and 10.

How will my personal information, which may include my health information and protected health information (PHI), be used and disclosed?

As a participant in BIFS, you signed an Informed Consent Form and HIPAA release form that outline the manner in which your PHI (protected health information) may be used and disclosed. Please refer to those documents for more information. If you have any questions, please contact the BIFS Support Team at bifs410@syneoshealth.com or 1-866-619-BIFS (2437).

Will I be reimbursed if I have my breast implants removed due to the BIOCELL® recall?

If you have any questions about reimbursement in relation to the BIOCELL® recall, please contact Allergan Medical Information at 1-800-678-1605, option #2, or email IR-Medcom@allergan.com. For additional information, including what assistance may be available to you through the NATRELLE ConfidencePlus® and BIOCELL® Replacement Warranties from Allergan, please visit www.BIOCELLinformation.com.

Where do I report any new breast implant complications, reoperations, or new diagnoses of connective tissue disease, neurological disease, or cancer?

Please contact the BIFS Support Team at bifs410@syneoshealth.com or 1-866-619-2437 (BIFS), and include the information when you complete your next annual questionnaire.

Can you provide information about my breast implants from when I used to be in BIFS?

For details about your implants, please provide your name and your Registration Code. If you no longer have your Registration Code, the call center should be able to provide you with your initial surgery implant details. If you have any further questions about the BIOCELL® recall, please contact Allergan Medical Information at 1-800-678-1605, option #2. Visit https://www.biocellinformation.com for more information.

Where can I get more information about BIFS?

For more information please contact the BIFS Support Team at 1-866-619-2437 (BIFS) or email bifs410@syneoshealth.com.

Is there special guidance for breast cancer screening for women with breast implants?

If you have breast implants, you should still have regular mammograms. Knowing and monitoring your breast implants is important. In general, follow your surgeon’s instructions on how to monitor your implants. Read more.

Where can I access more information about my Natrelle 410 Shaped Gel breast implant?

If you've received the Natrelle 410 Shaped Gel breast implant, there are important factors to consider. Get a refresher by reviewing the Natrelle 410 brochure, available here.