SB 1439 — breast implant surgery; informed consent

SB1439 - 542R - S-HealthS andVer Human  Services-Proposed    Fifty-fourthSenate Legislature                               Engrossed Health  and  Human  Services  State of Arizona Senate Fifty-fourth Legislature Second Regular Session                                                 Session S.B.    SENATE BILL 1439       AN ACT   Amending title 32, chapter 32, article 1, Arizona Revised Statutes, by adding section 32‑3228;

 relating PROPOSEDto SENATEhealth AMENDMENTScare TOprofessionals. S.B.

1439  (Reference  to(TEXT printedOF bill)BILL  BEGINS  ON NEXT PAGE)   PageBe 1,it lineenacted 5,by afterthe "conduct"Legislature insertof ";the State of Arizona:

workSection 1.  Title group"32, Linechapter 6,32, afterarticle "A." insert "Beginning January 1, 2021,"Arizona LineRevised 10,Statutes, strikeis "specializeamended in"by insertadding "perform"section Line32-3228, 13, after "2." strike remainder of line Line 14, strike "implants" insert "Manufacturer patient information materials, in a hard copy or electronic format, on the implants that are to beread: used in the surgery";

afterSTART_STATUTE32-3228.  Informed "including"consent; strike remainder of line Line 15, strike "effectiveness, implant product approval letters," Line 16, strike the second "and" insert a period Strike lines through 20, insert:

"3.  An informed consent checklist for physicians to discuss with the patient before breast implant surgerysurgery; that must include, at a minimum, information on:

requirements;

unprofessional conduct;

work group;

definition A.  Beginning January 1, 2021, 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 information, 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 a description of the surgical procedures used in breast implant surgery.

2.  Manufacturer patient information materials, in a hard copy or electronic format, on the implants that are to be used in the surgery, including warning requirements prescribed by the United States food and drug administration.

  3.  An informed consent checklist for physicians to discuss with the patient before breast implant surgery that must include, at a minimum, information on:

(c)  The national breast implant registry."registry. Line 23, after "program" insert "or any similar program" Line 28, after "to" insert "disciplinary action, including" After line 29, insert:

"D.  On4.  Information oron beforehow December 1, 2020, 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 advocatescan toreport jointlyadverse developevents anassociated informed consent checklist for physicians to discuss with patients before breast implantimplants surgery. through The informed consent checklist shall include the informationUnited prescribedStates infood subsectionand Adrug ofadministration's thismedwatch sectionprogram andor any othersimilar informationprogram. the boards and the work group decide is necessary.  The work group shall review the check list and provide updates as necessary." Amend title to conform     KATE BROPHY MCGEE   1439BROPHY MCGEE 02/14/2020 02:50 PM C:

MHB.  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, including license suspension or revocation pursuant to chapter 13 or 17 of this title.

D.  On or before December 1, 2020, 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 decide is necessary.  The work group shall review the check list and provide updates as necessary.

E.  For the purposes of this section, "breast implant surgery" means the surgical placement of a cosmetic breast implant.END_STATUTE