ENGROSSED SUBSTITUTE SENATE BILL 5050
State of Washington 68th Legislature 2023 Regular Session
By Senate Health & Long Term Care (originally sponsored by Senators
Wellman, Hunt, Keiser, Kuderer, McCune, Nobles, Rolfes, Wagoner, and
C. Wilson)
READ FIRST TIME 02/10/23.
1 AN ACT Relating to informed consent for breast implant surgery;
2 adding a new section to chapter 18.130 RCW; and creating a new
3 section.
4 BE IT ENACTED BY THE LEGISLATURE OF THE STATE OF WASHINGTON:
5 NEW SECTION. Sec. 1. (1) The legislature finds that every
6 person undergoing breast implant surgery should be provided complete
7 information about potential risks, symptoms, and complications
8 involved before the surgery.
9 (2) A survey of over 5,000 individuals who received breast
10 implants found that 84 percent believed they were not given enough
11 time and information to make an informed decision about the breast
12 implant surgery.
13 (3) In October 2019, the food and drug administration recommended
14 a warning label on all breast implants.
15 (4) Therefore, the legislature intends to require physicians to
16 provide patients with a checklist of information and receive informed
17 consent to empower patients to make their own choices when it comes
18 to any risks involved in a breast implant surgery.
19 NEW SECTION. Sec. 2. A new section is added to chapter 18.130
20 RCW to read as follows:
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 1 (1) Beginning January 1, 2024, during the first consultation
2 before breast implant surgery is performed, a physician licensed
3 under chapter 18.71 RCW or an osteopathic physician licensed under
4 chapter 18.57 RCW must provide the patient with the following
5 information in writing or in electronic format:
6 (a) A description of the risks of breast implants and a
7 description of the surgical procedures used in breast implant
8 surgery;
9 (b) Notice that breast implants are not considered lifetime
10 devices, the chance of developing complications increases over time,
11 and some complications will require more surgery;
12 (c) Manufacturer patient information materials on the implants
13 that are to be used in the surgery, including warning requirements
14 prescribed by the United States food and drug administration;
15 (d) Information on any surgical mesh used during breast implant
16 surgery including, but not limited to, mesh made of nondegradable
17 synthetic materials, biodegradable synthetic materials, or animal or
18 human derived tissues. This information must include a warning that
19 no surgical mesh has been approved by the food and drug
20 administration for use with breast implants;
21 (e) Information on breast implant-associated anaplastic large
22 cell lymphoma, including notice that breast implant-associated
23 anaplastic large cell lymphoma occurs more commonly in patients with
24 textured breast implants than smooth implants, and deaths have
25 occurred;
26 (f) Information on breast implant illness;
27 (g) Information on the systemic symptoms association with breast
28 implants;
29 (h) Information on the national breast implant registry; and
30 (i) Information on how a patient can report adverse events
31 associated with breast implants through the United States food and
32 drug administration's medwatch program or any similar program.
33 (2) The information provided must be based on the information
34 that is generally available to physicians who specialize in breast
35 implant surgery.
36 (3) After providing the information required by subsection (1) of
37 this section, a physician or osteopathic physician must obtain
38 written informed consent for the procedure from the patient before
39 performing the breast implant surgery.
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1 (4) A violation of this section constitutes unprofessional
2 conduct under this chapter.
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