breast implant surgery; informed consent
State of Arizona
First Regular Session
SENATE BILL 1001
Amending title 32, chapter 32, article 1, Arizona Revised Statutes, by adding section 32-3228; relating to health care professionals.
(TEXT OF BILL BEGINS ON NEXT PAGE)
Be it enacted by the Legislature of the State of Arizona:
Section 1. Title 32, chapter 32, article 1, Arizona Revised Statutes, is amended by adding section 32-3228, to read:
32-3228. Informed consent; breast implant surgery; requirements; unprofessional conduct; work group; definition
A. Beginning January 1, 2022, before performing breast implant surgery, a physician who is licensed pursuant to chapter 13 or 17 of this title must provide the patient with the following, in writing or in an electronic format, based on the information that is then generally available to physicians who perform breast implant surgery:
1. A description of the risks of breast implants and of the surgical procedures used in breast implant surgery.
2. 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 food and drug administration.
3. The informed consent checklist developed pursuant to subsection D of this section that includes, at a minimum, information on:
(a) Breast implant-associated anaplastic large cell lymphoma.
(b) Breast implant illness.
(c) The national breast implant registry.
4. Information on how the patient can report adverse events associated with breast implants through the United States food and drug administration's medwatch program or any similar program.
B. A physician must provide the information required by subsection A of this section and obtain written informed consent for the procedure from the patient before performing the breast implant surgery.
C. A physician who knowingly violates this section commits an act of unprofessional conduct and is subject to disciplinary action.
D. On or before December 1, 2021, the Arizona medical board and the Arizona board of osteopathic examiners in medicine and surgery shall convene a work group that includes licensee representatives and patient advocates to jointly develop an informed consent checklist for physicians to discuss with patients before breast implant surgery. The informed consent checklist shall include the information prescribed in subsection A of this section and any other information the boards and the work group determine to be necessary. The work group shall review the checklist and provide updates as necessary.