Assigned to HHS

AS PASSED BY COMMITTEE

ARIZONA STATE SENATE
Fifty-Fourth Legislature, Second Regular Session

AMENDED
FACT SHEET FOR S.B. 1439
breast implant surgery; informed consent
Purpose
Beginning January 1, 2021, requires a physician to provide a patient with breast implant
surgery information as outlined and to obtain informed consent from the patient prior to surgery.
Directs the Arizona Medical Board (AMB) and the Arizona Board of Osteopathic Examiners in
Medicine and Surgery (ABOE) to convene a workgroup to develop an informed consent checklist
by December 1, 2020.
Background
The U.S. Congress passed the federal Food, Drug and Cosmetic Act in 1976 granting the
Food and Drug Administration (FDA) regulatory authority over breast implants which were
previously unregulated. In the 1980s, breast implants were classified as Class III medical devices,
and as such are required to obtain pre-market approval (PMA) and to be reviewed by the FDA for
safety and effectiveness. According to the FDA, Class III medical devices have the most stringent
regulatory controls and are generally devices that support or sustain human life, prevent the
impairment of human health or present a potential unreasonable risk of illness or injury to the
patient. Typically, a PMA submission to the FDA is required to obtain approval to market a Class
III medical device; however, a few Class III medical devices are required to only have a 510(k)
cleared by the FDA to be marketed. Examples of Class III medical devices that require a PMA are
replacement heart valves, silicone gel-filled breast implants and implanted cerebella stimulators
(FDA).
Breast implant-associated anaplastic large cell lymphoma (ALCL) was first identified in
1997. Other countries, including France and Australia, have additionally experienced reports citing
a correlation between breast implants and ALCL. In 2011, the FDA issued a warning regarding
ALCL in women with these medical devices, stating that such women are believed to have a small
but increased risk of developing ALCL (FDA warning).
Currently, the Plastic Surgery Foundation, in collaboration with the FDA and breast
implant device manufacturers, has developed the National Breast Implant Registry (NBIR) to
strengthen national surveillance for breast implant devices in the United States. The purpose of the
NBIR is to create a database that collects information on breast implant procedures and devices
and to identify trends and other data that can be used to improve patient safety (NBIR).
There is no anticipated fiscal impact to the state General Fund associated with this
legislation.

 FACT SHEET – Amended
S.B. 1439
Page 2

Provisions
1. Requires, beginning January 1, 2021, specified licensed physicians to provide a patient with
the following breast implant surgery information prior to a breast implant surgery, either in
writing or electronically, that contains:
a) a description of the risks of breast implants and a description of the surgical procedures
used in breast implant surgery;
b) manufacturer patient information materials on the implants to be used in the surgery,
including FDA warning requirements;
c) an informed consent checklist for physicians to review with the patient prior to surgery that
must include information on breast implant associated ALCL, breast implant illness and
the NBIR; and
d) information on how a patient can report adverse effects associated with breast implants
through the FDA MedWatch Program.
2. Stipulates that, in addition to the breast implant surgery information requirements, a physician
must obtain written informed consent from the patient before performing the surgery.
3. Directs the AMB and ABOE, by December 1, 2020, to convene a workgroup that includes
licensees and patient advocates to develop an informed consent checklist and requires the
workgroup to review and update the checklist as necessary.
4. Classifies, as unprofessional conduct, knowingly violating the breast implant surgery
information and informed consent requirements and subjects the physician to license
suspension or revocation.
5. Becomes effective on the general effective date.
Amendments Adopted by Committee
1. Applies informed consent requirements beginning January 1, 2021.
2. Requires the AMB and ABOE to convene a workgroup to develop an informed consent
checklist by December 1, 2020.
3. Modifies specified information that must be provided to a patient prior to breast implant
surgery.
Senate Action
HHS

2/19/20

DPA

Prepared by Senate Research
February 21, 2020
CRS/kja

8-0-0