Senate File 4 - Introduced SENATE FILE 4 BY ZAUN A BILL FOR An Act relating to the provision of informed consent prior 1 to breast implant surgery, and providing for professional 2 discipline. 3 BE IT ENACTED BY THE GENERAL ASSEMBLY OF THE STATE OF IOWA: 4 TLSB 1399XS (3) 90 pf/rh

S.F. 4 Section 1. NEW SECTION . 147.115 Prior informed consent —— 1 breast implant surgery. 2 1. Prior to performing breast implant surgery, a physician 3 who is licensed pursuant to chapter 148 shall provide the 4 patient with the following, in writing or in an electronic 5 format, based on information generally available at the time of 6 the surgery to physicians who perform breast implant surgery: 7 a. A description of the risks of breast implants and of the 8 surgical procedures used in breast implant surgery. 9 b. Manufacturer patient information materials, in a hard 10 copy or an electronic format, for the implants that will be 11 used in the surgery including warning requirements prescribed 12 by the United States food and drug administration. 13 c. The informed consent checklist developed under this 14 section that includes, at a minimum, information on all of the 15 following: 16 (1) Breast implant-associated anaplastic large cell 17 lymphoma. 18 (2) Breast implant illness. 19 (3) The national breast implant registry. 20 (4) Information for the patient to use in reporting adverse 21 events associated with breast implants through the United 22 States food and drug administration’s Medwatch program or any 23 similar medical product safety reporting program for health 24 professionals, patients, and consumers. 25 2. A physician shall obtain written certification from the 26 patient that the patient has received the information required 27 under subsection 1 prior to performing the breast implant 28 surgery. 29 3. A physician who violates this section commits 30 unprofessional conduct and is subject to professional 31 disciplinary provisions. 32 4. The board of medicine shall convene a work group that 33 includes physician representatives and patient advocates to 34 jointly develop an informed consent checklist for physicians 35 -1- LSB 1399XS (3) 90 pf/rh 1/ 3

S.F. 4 to discuss with patients prior to breast implant surgery. 1 The informed consent checklist shall include, at a minimum, 2 the information prescribed in subsection 1 and any other 3 information the board of medicine and the work group determine 4 necessary. The work group shall review the checklist and 5 provide updates as necessary. 6 5. For the purposes of this section, “breast implant 7 surgery” means the surgical placement of a breast implant for 8 cosmetic or reconstructive purposes. 9 EXPLANATION 10 The inclusion of this explanation does not constitute agreement with 11 the explanation’s substance by the members of the general assembly. 12 This bill requires the provision of informed consent prior 13 to breast implant surgery. 14 Under the bill, a licensed physician shall provide the 15 patient, in writing or in an electronic format, based on 16 information generally available at the time of the surgery to 17 physicians who perform breast implant surgery: a description 18 of the risks of breast implants and of the surgical procedures 19 used in breast implant surgery; manufacturer patient 20 information materials for the implants that will be used in the 21 surgery including warning requirements prescribed by the United 22 States food and drug administration (FDA); the informed consent 23 checklist developed under the bill; and information for the 24 patient to report adverse events to the FDA’s Medwatch program 25 or any similar medical product safety reporting program for 26 health professionals, patients, and consumers. 27 A physician shall obtain written certification from the 28 patient that the patient has received the information specified 29 under the bill prior to performing the breast implant surgery. 30 A physician who violates the bill commits unprofessional 31 conduct and is subject to professional disciplinary provisions. 32 The bill requires the board of medicine to convene a 33 work group, including physician representatives and patient 34 advocates, to jointly develop an informed consent checklist for 35 -2- LSB 1399XS (3) 90 pf/rh 2/ 3

S.F. 4 physicians to discuss with patients prior to breast implant 1 surgery. The work group shall review the checklist and provide 2 updates as necessary. 3 Under the bill, “breast implant surgery” means the surgical 4 placement of a breast implant for cosmetic or reconstructive 5 purposes. 6 -3- LSB 1399XS (3) 90 pf/rh 3/ 3