ARIZONA STATE SENATE RESEARCH STAFF TO: MEMBERS OF THE SENATE HEALTH & HUMAN SERVICES COMMITTEE DATE: March 21, 2022 SUBJECT: Strike everything amendment to H.B. 2635, relating to breast implant surgery; informed consent Purpose Applies statutory informed consent requirements for cosmetic breast implant surgery to breast implant surgery for reconstructive purposes. Background Current statute requires licensed medical and osteopathic physicians to provide patients receiving breast implant surgery with the following information prior to surgery: 1) a description of the risks of breast implants and of the surgical procedures used in breast implant surgery; 2) manufacturer patient information materials on the implants that will be used in the surgery, including warning requirements prescribed by the U.S. Food and Drug Administration (FDA); 3) the informed consent checklist, including information on breast implant-associated anaplastic large cell lymphoma, breast implant illness and the National Breast Implant Registry; and 4) information on how the patient can report adverse events associated with breast implants through the FDA MedWatch Program or any similar program. A physician must obtain written informed consent for the procedure from the patient before performing the breast implant surgery. A physician who knowingly violates the informed consent requirement commits an act of unprofessional conduct and is subject to disciplinary action. Breast implant surgery is the surgical placement of a cosmetic breast implant (A.R.S. ยง 32-3228). There is no anticipated fiscal impact to the state General Fund associated with this legislation. Provisions 1. Applies statutory informed consent requirements for cosmetic breast implant surgery to breast implant surgery for reconstructive purposes. 2. Makes technical changes. 3. Becomes effective on the general effective date. MAELINN CHOW ASSISTANT RESEARCH ANALYST MICHAEL MADDEN LEGISLATIVE RESEARCH ANALYST HEALTH & HUMAN SERVICES COMMITTEE Telephone: (602) 926-3171