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What you need to know as an Investigator in the BIFS Program...

As an investigator for BIFS, you play an essential role in the health and safety of your patients — a critical part of our program's goals. Although enrollment has closed, this is a 10-year study and patient follow-up is ongoing.

As you continue to be responsible for the care of your patient enrolled in BIFS, you are required to maintain Institutional Review Board (IRB) approval. This helps us ensure that BIFS is both safe and scientifically sound in accordance with FDA regulations and policies of IRB Company, Inc. (www.irbco.com), the national IRB selected for the BIFS program.

It is possible that your participation in this study is covered by a local IRB. If that is the case, renewal of your site status will be covered by their policies.

Questions about your IRB status? Contact the BIFS Clinical Team at 1-800-862-4426.

Helpful resources
  • Investigator Follow Up Visit
    Data Entry Worksheet

    For scheduled silicone or
    unscheduled visits
  • BIFS Protocol
  • BIFS Informed Consent Form
  • Natrelle® Breast Implant Labeling
  • To complete data entry or to view
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