ARIZONA HOUSE OF REPRESENTATIVES Fifty-fourth Legislature Second Regular Session
	Senate: HHS DPA 8-0-0-0 │3^rd Read 30-0-0-0

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SB 1439: breast implant surgery; informed consent

Sponsor:  Senator Ugenti-Rita, LD 23

Committee on Health & Human Services

Overview

Requires a physician to obtain written informed consent from a patient before performing breast implant surgery.

History

The U.S. Food and Drug Administration (FDA) is in the process of updating guidance to ensure that patients know the benefits and risks of breast implants. New FDA recommendations include labeling materials with boxed warnings, implementing a patient decision checklist, providing material descriptions including types and quantities of chemicals and heavy metals found in breast implants, providing implant rupture screening recommendations and including certain information on patient device cards.

MedWatch is the FDA's medical product safety reporting system which publishes safety alerts for FDA-regulated products and allows health professionals and patients to report adverse medical events.

According to statute, a medical doctor or doctor of osteopathy suspected of unprofessional conduct may be investigated and disciplined if found guilty by their respective boards (A.R.S. §§ 32-1451, 32-1855).

Provisions

1. Beginning January 1, 2021 a physician prior to performing breast implant surgery, must provide a patient the following information, based on information that is then available to physicians:

a) A description of the risks of breast implants and a description of the surgical procedures used in breast implant survey;

b) Informational materials on the implants to be used in the surgery, including warning requirements prescribed by the FDA;

c) An informed consent checklist for physicians to discuss at least the following with a patient before breast implant surgery:

i. Breast implant-associated anaplastic large cell lymphoma;

ii. Breast implant illness; and

iii. The National Breast Implant Registry; and

d) Information on how to report adverse events associated with breast implants through the FDA MedWatch program or a similar program. (Sec. 1)

2. Mandates that a physician provide the required information and obtain written informed consent from a patient before performing breast implant surgery. (Sec. 1)

3. Specifies that a physician who violates these requirements commits unprofessional conduct and is subject to disciplinary action. (Sec. 1)

4. Requires the Arizona Medical Board and the Arizona Board of Osteopathic Examiners in Medicine and Surgery, by December 1, 2020, to convene a work group to develop an informed consent checklist for physicians to discuss with patients before breast implant surgery, including the information prescribed in this section and any other information deemed necessary. (Sec. 1)

5. Requires the work group to review and update the list as needed. (Sec. 1)

6. Defines breast implant surgery. (Sec. 1)

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10.                   SB 1439

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