(a) A physician and surgeon shall give each patient a copy of the standardized written summary, as developed pursuant to subdivision (e), describing silicone implants used in cosmetic, plastic, reconstructive, or similar surgery, before the physician and surgeon performs the surgery. A physician and surgeon may substitute, in place of the standardized written summary for silicone implants, written information authorized for use by the federal Food and Drug Administration prepared by the manufacturer based upon the physician package insert. The furnishing of a copy of the standardized written summary or written information shall constitute compliance with the requirements of this section.
(b) Prior to performance of surgery, the physician and surgeon shall note on the patient’s chart that he or she has given the patient the standardized written summary or written information required by this section.
(c) The failure of a physician and surgeon to comply with this section constitutes unprofessional conduct. The provision of the standardized written summary or written information shall not alter, diminish, or modify existing duties of physicians and surgeons, including duties relating to informed consent. However, no physician and surgeon shall be liable as a distributor of a standardized written summary or written information alleged to contain erroneous or incomplete information.
(d) The facility where the surgery is performed shall not be responsible for enforcement of, or verification of, compliance with the requirements of this section.
(e) If the State Department of Health Services determines that the federal Food and Drug Administration has not authorized written information on silicone implants intended for the layperson, the state department shall develop a standardized written summary to inform the patient of the risks and possible side effects of silicone implants as used in cosmetic, plastic, reconstructive, or similar surgery. In developing these summaries, the state department shall do all of the following:
(1) Use only language that is simple and readily understood by a layperson.
(2) Include a disclaimer that the state in no way endorses any procedures, nor does the state claim to provide an exhaustive analysis of all the potential benefits or risks associated with any procedure.
(3) Provide only information approved by the federal Food and Drug Administration.
(f) The State Department of Health Services shall update the written summary described in subdivision (e) as determined necessary by the state department to protect the public health and safety.
(g) The Medical Board of California shall publish the standardized written summaries prepared pursuant to subdivision (e), and shall distribute copies of the summaries, upon request, to physicians and surgeons. The Medical Board of California shall make the summaries available for a fee not exceeding, in the aggregate, the actual costs to the State Department of Health Services and the Medical Board of California for developing, updating, publishing, and distributing the summaries. Physicians and surgeons performing surgical procedures described in subdivision (a) shall purchase the summaries from the Medical Board of California for distribution to their patients, as required in this section. Any person or entity may purchase the summaries if he, she, or it desires. The Medical Board of California shall fund the State Department of Health Services for the actual cost of developing and updating the summaries incurred by the State Department of Health Services, through an interagency agreement entered into between the Medical Board of California and the State Department of Health Services for that purpose.
The Medical Board of California and the State Department of Health Services may distribute the written information described in subdivision (a) if a manufacturer of silicone implants provides the board and state department with a sufficient number of copies of this information, as determined by the state department.
(h) Section 2314 shall not apply to this section.
(i) For purposes of this section, “silicone implant” means any implant containing silicone, including implants using a silicone gel or silicone shell. This definition includes implants using a saline solution with a silicone shell.
(j) A physician and surgeon shall not be responsible for complying with this section until the written summaries are published pursuant to subdivision (g).
(Added by Stats. 1992, Ch. 1140, Sec. 1. Effective January 1, 1993.)
Last modified: October 25, 2018