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. 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 $100 for enrolling or reconsenting in the study. You will receive $275 for completing the Baseline Questionnaire and $275 for each Annual Questionnaire you complete.

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).

What if I no longer have NATRELLE® Style 410 breast implants (Allergan® anatomical, teardrop breast implants)?

If you no longer have your Natrelle® 410 Shaped Gel breast implants (Allergan® anatomical, teardrop breast implants) then you are no longer eligible to participate in the study and after completing your Annual Questionnaire you are no longer required to complete future questionnaires. For additional information please contact the BIFS call center at 1-866-619-BIFS (2437) or bifs410@syneoshealth.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® Style 410 breast implants (Allergan anatomical, teardrop breast implants)?

If you received the NATRELLE® Style 410 breast implants (Allergan anatomical, teardrop breast implants), there are important factors to consider. Get a refresher by reviewing the NATRELLE® Style 410 breast implants brochure, available here.

Where can I find my NATRELLE® serial number?

You can locate the serial number for your implant(s) on the Natrelle® Serial Identification Card you received at the time of your implant surgery. Click here to see an example. If you are unable to locate your serial number, please email us at AbbVieBIFS410@ubc.com or call 1-855-210-5157.

The BIFS study is shifting to a fully remote model. As a result, many study sites are closing local participation. Below are answers to frequently asked questions for participants in the Breast Implant Follow-up Study (BIFS) who are being transferred to the new BIFS virtual site.

Why is my BIFS study site location changing?

The surgeon who originally enrolled you in BIFS is closing their site for the study and will not be able to provide oversight for your continued participation for the full 10-year follow-up period. With the latest study protocol update, we have been moving towards a fully remote study model. Therefore, to ensure your seamless continuation on the study, we are transferring you to a virtual site, overseen by Principal Investigator Jaclyn Bosco, PhD. Patients can continue to see their enrolling surgeon at any time if they have issues with their implants.

What is a virtual site?

A virtual site allows both the patients and the study investigators to participate in clinical trials remotely. The goal is to make participation in research more convenient and to provide clinical trial access to people everywhere. All of the study data will be collected and maintained at the virtual site and overseen by the virtual study investigator and their team. However, if you have any concerns related to your implants, you can visit any physician of your choosing.

What does this change mean for me?

This change will not impact any activities or requirements associated with the study. You will continue to simply complete your annual questionnaires online every year and receive compensation. However, changing your study site means that your study data will be transferred to the virtual site and any future data you contribute will be overseen by the virtual study investigator and their team.

How do I complete the transfer process?

You will receive a phone call from the virtual site to help you complete the transfer process. You will be asked to reconsent to the study under your new study investigator at the virtual site and complete a Medical Release form. If your site is closing and you are being transferred, the process will also be described in detail in the transfer letter that will be emailed to you.

How do I reconsent to the study?

If you are being transferred, a copy of the informed consent form will be included in the participant transfer email communication that will be sent to you. A member of the virtual site team will reach out to you regarding reconsent and walk you through the updated consent form for the study. During this call, you will be sent a link to complete the consent form online and will have the opportunity to ask any questions.

You also have the option to sign the blank informed consent form that will be emailed to you and email it to the virtual site directly at AbbVieBIFS@iqvia.com.

Why do I have to complete a new Medical Release form?

Because the virtual site is not the site that originally enrolled you in the study, you will be asked to complete a medical records release form. This form will allow the virtual study site to gather information from your medical records for the purposes of the study, if required.

How do I complete a new Medical Release form?

A copy of the Medical Release form was included in the participant transfer email communication that was sent to you. You have the option to sign the blank form and email it to the virtual site directly at AbbVieBIFS@iqvia.com. This process can also be completed via a web link. When the virtual site calls you to complete the consent process, they will also guide you through the process of completing the medical records release form.

The Web link I received for reconsent from the virtual site has expired, how do I get a new one?

You can call or email the virtual site to receive a new, active consent link when you are ready to complete the documents if the one previously sent to you has expired. Please note that the virtual site working hours are from 9am – 9pm ET Monday to Friday (1-833-276-5304). If you would like to complete your consent over the weekend or after hours, you can always fill out the PDF documents sent to you in the transfer letter and email the completed documents to the virtual site at AbbVieBIFS@iqvia.com.

Do I have to transfer to the virtual site if my enrolling site is closing?

Because we are required to have qualified personnel oversee the collection and maintenance of your study data throughout the entire term of the study, participants at sites that are closing their participation in BIFS must be transferred in order to continue participation in the study. You are able to opt out of the transfer by contacting the BIFS support team (bifs410@syneoshealth.com or 1-866-619-2437). However, this may result in your withdrawal from the study.

What if I am interested in transferring to the virtual site, but did not receive a transfer letter?

If you are interested in transferring to the virtual site but have not received a transfer letter from the study team indicating your site is closing, you can contact the BIFS support team at bifs410@syneoshealth.com or 1-866-619-2437 (BIFS) to discuss transferring your participation.

What should I do if I have concerns or complications with my implants?

For any concerns related to your implants, you can visit any physician of your choosing. Any new breast implant complications, reoperations, or new diagnoses of connective tissue disease, neurological disease or cancer should be reported to the virtual site at 1-833-276-5304 or to the BIFS Support Team at bifs410@syneoshealth.com or 1-866-619-2437 (BIFS). You should also include the information when you complete your next Annual Questionnaire.

What were the study changes in the most recent BIFS protocol update?

If you have not yet reconsented to the study for the most recent protocol update in 2021, this transfer reconsent process will also include an overview of these changes, which include:

  • In-person visits, previously required at years 1, 4, and 10 post your implant date, have been removed
  • New safety information regarding Breast Implant Associated Anaplastic Large Cell Lymphoma (BIA-ALCL)
  • Compensation for Annual Questionnaire completion increased from $100 to $275
  • New compensation of $100 for participants who complete their transfer by reconsenting to the study
How will I complete my Annual Questionnaire?

You will continue to complete your Annual Questionnaire in one of the following ways:

  1. Through our online ENGAGE portal, which can be accessed through our website (bifs.us). If you have not previously used the ENGAGE portal and do not yet have a username/password, it is easy to get started with your patient ID number: 000-XXX or XXXX-XXX and your date of birth from the study website.
  2. Via telephone with the BIFS Support Team 1-866-619-2437 (BIFS)
What should I do if my contact information changes?

If your contact information changes, please contact the BIFS Support Team at bifs410@syneoshealth.com or 1-866-619-2437 (BIFS).

What is the Virtual Site contact information?

Site number: 7777
Principal Investigator: Jaclyn Bosco, PhD
Address: IQVIA
4820 Emperor Boulevard 7th Floor
Durham, NC 27703
Telephone: 1-833-276-5304; Monday – Friday 9am-9pm EST
Email: AbbVieBIFS@iqvia.com

If you have any questions regarding your participation in the BIFS Study, this transfer process, or if you would like to opt out of this transfer, please contact the BIFS Support Team at bifs410@syneoshealth.com or 1-866-619-2437 (BIFS) Monday through Friday from 8:30 AM – 5:30 PM ET. Messages received after business hours will be returned on the next business day.

If you have any questions regarding your participation in the BIFS Study, this transfer process, or if you would like to opt out of this transfer, please contact the BIFS Support Team at bifs410@syneoshealth.com or 1-866-619-2437 (BIFS) Monday through Friday from 8:30 AM – 5:30 PM ET. Messages received after business hours will be returned on the next business day.