Important Breast Implant Update
January 1, 2022
Governor Ducey signed Arizona Revised Statute (A.R.S.) § 32-3228 into law and it becomes effective on January 1, 2022.
In summary, the requirements under the statute are as follows:
Beginning January 1, 2022, before performing breast implant surgery, the surgeon must provide the patient with the following – in print or electronic format:
1. A description of the risks of breast implants and the surgical procedures used in breast implant surgery;
2. Breast implant manufacturer patient information materials, in a hard copy or an electronic format, on the implants that will be used in the surgery, including warning requirements prescribed by the United States FDA (See links below).
3. The Arizona Breast Implant Patient Checklist
4. Information on how the patient can report adverse events associated with breast implants
5. A written informed consent for the procedure from the patient before performing the breast implant surgery.
Breast Implant Patient Checklists – Arizona and Allergan Natrelle Silicone Implants
This new Arizona Statute requires The Arizona Breast Implant Patient Checklist, prepared by the State, is to be provided to all patients before placement of breast implants. Although some of the information in the checklist is not currently supported by scientific or medical studies, we are required to make this available to you either electronically or in print. In addition, the FDA by way of the breast implant manufacturers, requires the physician to present the specific manufacturer’s checklist to you before proceeding with your breast implant surgery.
Arizona Breast Implant Patient Checklist – Click HERE to download
Allergan Natrelle Silicone Implant Patient Decision Checklist – Click HERE to download
Please place your initials and sign in the locations provided to indicate that you have read and understood each item. Please bring BOTH of the Patient Checklists (AZ and Natrelle) to your consultation or pre-op visit to go over any questions or concerns you may have.
Please Note: If we decide on a different manufacturer (Sientra or Mentor) then that specific checklist will be substituted at your pre-op appointment.
Patient Brochure: Please click on the link below to review the Breast Implant Patient Brochure that includes important information about your specific breast implant.
Allergan Natrelle Silicone Breast Implant Information Brochure – Click HERE to View
How do I report a breast implant problem?
To report, use MedWatch form 3500 (click link below to download), which may also be obtained through FDA’s website at https://www.fda.gov/Safety/MedWatch/.
A consumer-friendly version of the 3500 reporting form: Form FDA 3500B – Voluntary Reporting for Consumers
MORE LINKS TO IMPORTANT INFORMATION
Arizona Breast Implant Patient Checklist – Click HERE to download and Print.
Allergan Natrelle Silicone Breast Implant Information – Click HERE to View
Allergan Natrelle Saline Breast Implant Information – Click HERE to View
Sientra Silicone Breast Implant Patient Decision Checklist – Click HERE to download
Sientra Silicone Breast Implant Patient Brochure – Click HERE to View
Mentor Breast Implant Patient Decision Checklist – Click HERE to download
Mentor Breast Augmentation / Memory Gel Silicone Implant Brochure – Click HERE to View
Mentor Breast Augmentation / Saline Implant Brochure – Click HERE to View