2259.5. (a) A physician and surgeon shall give each patient a copy of the standardized written summary, as developed pursuant to subdivision (e), describing collagen injections 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 collagen injections, 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 the 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 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 intended for the layperson on collagen injections used in cosmetic, plastic, reconstructive, or similar surgery, the state department shall develop a standardized written summary to inform the patient of the risks and possible side effects of collagen injections as used in cosmetic, plastic, reconstructive, or similar surgery. In developing this summary, 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 procedure, nor does the state claim to provide an exhaustive analysis of all the potential benefits or risks associated with any procedure.
(3) Identify the type of animal used to produce the collagen and identify the situations where the federal Food and Drug Administration has given its approval for the procedure.
(4) 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 summary prepared pursuant to subdivision (e) and shall distribute copies of the summary, upon request, to physicians and surgeons. The Medical Board of California shall make the summary 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 summary. A physician and surgeon performing surgical procedures described in subdivision (a) shall purchase the summary from the Medical Board of California for distribution to his or her patients, as required in this section. Any person or entity may purchase the summary 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 summary 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.
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 collagen 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, “collagen” includes, but is not limited to, any substance derived from animal protein, or combined with animal protein, that is implanted into the body for purposes of cosmetic, plastic, reconstructive, or similar surgery. However, “collagen” does not include absorbable gelatin medical devices intended for application to bleeding surfaces as a hemostatic or any other medical device used for purposes other than beautifying, promoting attractiveness, or altering the appearance of any part of the human body.
(j) A physician and surgeon shall not be responsible for complying with this section until the written summary is published pursuant to subdivision (g).
(Added by Stats. 1992, Ch. 1140, Sec. 2. Effective January 1, 1993.)
Structure California Code