March 08, 2022, Introduced by Reps. Calley, Whitsett and Yaroch and referred to the Committee on Health Policy.

A bill to amend 1978 PA 368, entitled

"Public health code,"

(MCL 333.1101 to 333.25211) by adding section 17019.

the people of the state of michigan enact:

Sec. 17019. (1) Beginning January 1, 2023, a physician shall not perform breast implant surgery on a patient without first providing the patient with and discussing all of the following and obtaining the patient's written, informed consent:

(a) A description of the risks associated with breast implants and a description of the surgical procedure used in breast implant surgery.

(b) Manufacturer patient information materials on the breast implant that will be used in the breast implant surgery, including, but not limited to, warning requirements prescribed by the United States Food and Drug Administration.

(c) The informed consent checklist described in subsection (3).

(d) Information on how the patient can report an adverse event associated with a breast implant through the United States Food and Drug Administration's medical product safety reporting program or a similar program approved by the board.

(2) The information described in subsection (1) may be provided to a patient in writing or in electronic form. The information described in subsection (1) must be based on information that is generally available to physicians who specialize in breast implant surgery at the time the information is provided to the patient.

(3) By December 1, 2022, the board, in consultation with the Michigan board of osteopathic medicine and surgery and patient advocacy groups, shall develop an informed consent checklist that includes information on breast implant-associated anaplastic large cell lymphoma, breast implant illness, the Plastic Surgery Foundation's National Breast Implant Registry or a similar registry approved by the boards described in this subsection, and any other information that is considered necessary. The board shall periodically review the checklist to determine whether an update to the checklist is necessary.

(4) As used in this section, "breast implant surgery" means the surgical placement of a cosmetic breast implant.

Enacting section 1. This amendatory act does not take effect unless Senate Bill No.____ or House Bill No. 5881 (request no. 03834'21) of the 101st Legislature is enacted into law.