SF 4 (LSB 1399XS (3) 90)

SENATE FILE 4

BY  ZAUN

A BILL FOR

An Act relating to the provision of informed consent prior to breast implant surgery, and providing for professional discipline.
BE IT ENACTED BY THE GENERAL ASSEMBLY OF THE STATE OF IOWA:

    Section 1.  NEW SECTION.  147.115  Prior informed consent —— breast implant surgery.
   1.  Prior to performing breast implant surgery, a physician who is licensed pursuant to chapter 148 shall provide the patient with the following, in writing or in an electronic format, based on information generally available at the time of the surgery to physicians who perform breast implant surgery:
   a.  A description of the risks of breast implants and of the surgical procedures used in breast implant surgery.
   b.  Manufacturer patient information materials, in a hard copy or an electronic format, for the implants that will be used in the surgery including warning requirements prescribed by the United States food and drug administration.
   c.  The informed consent checklist developed under this section that includes, at a minimum, information on all of the following:
   (1)  Breast implant-associated anaplastic large cell lymphoma.
   (2)  Breast implant illness.
   (3)  The national breast implant registry.
   (4)  Information for the patient to use in reporting adverse events associated with breast implants through the United States food and drug administration’s Medwatch program or any similar medical product safety reporting program for health professionals, patients, and consumers.
   2.  A physician shall obtain written certification from the patient that the patient has received the information required under subsection 1 prior to performing the breast implant surgery.
   3.  A physician who violates this section commits unprofessional conduct and is subject to professional disciplinary provisions.
   4.  The board of medicine shall convene a work group that includes physician representatives and patient advocates to jointly develop an informed consent checklist for physicians to discuss with patients prior to breast implant surgery. The informed consent checklist shall include, at a minimum, the information prescribed in subsection 1 and any other information the board of medicine and the work group determine necessary. The work group shall review the checklist and provide updates as necessary.
   5.  For the purposes of this section, “breast implant surgery” means the surgical placement of a breast implant for cosmetic or reconstructive purposes.
EXPLANATION
The inclusion of this explanation does not constitute agreement with
the explanation’s substance by the members of the general assembly.
   This bill requires the provision of informed consent prior to breast implant surgery.
   Under the bill, a licensed physician shall provide the patient, in writing or in an electronic format, based on information generally available at the time of the surgery to physicians who perform breast implant surgery: a description of the risks of breast implants and of the surgical procedures used in breast implant surgery; manufacturer patient information materials for the implants that will be used in the surgery including warning requirements prescribed by the United States food and drug administration (FDA); the informed consent checklist developed under the bill; and information for the patient to report adverse events to the FDA’s Medwatch program or any similar medical product safety reporting program for health professionals, patients, and consumers.
   A physician shall obtain written certification from the patient that the patient has received the information specified under the bill prior to performing the breast implant surgery.
   A physician who violates the bill commits unprofessional conduct and is subject to professional disciplinary provisions.
   The bill requires the board of medicine to convene a work group, including physician representatives and patient advocates, to jointly develop an informed consent checklist for physicians to discuss with patients prior to breast implant surgery. The work group shall review the checklist and provide updates as necessary.
   Under the bill, “breast implant surgery” means the surgical placement of a breast implant for cosmetic or reconstructive purposes.