In this chapter, the following terms have the meanings indicated. Terms Defined. “Breast implantation” means both: Breast augmentation, the procedure of surgically inserting breast implants beneath a woman's natural breasts; and The type of breast reconstruction that involves surgically inserting a breast implant in the chest area of a woman who has had a mastectomy. “Department” means the Maryland Department of Health. “Physician” means an individual who is authorized under the Medical Practice Act to practice medicine in Maryland and who performs breast implantation surgery in Maryland. The Department shall: Provide a standardized written summary in layperson's language that: Contains the information on breast implantation generally contained in the package inserts for breast implants, and Discloses side effects, warnings, and cautions for a breast implantation operation; Update as necessary the standardized written summary; Provide a statement indicating acknowledgment of receipt of the standardized written summary to be signed by the patient; Provide a waiver form describing the conditions under which the usual time requirements of the summary distribution may be waived; and Distribute copies of the standardized written summary, the acknowledgment of receipt statement, and the 5-day waiver form to all hospitals, clinics, other facilities, and physicians' offices where breast implantation is performed. The standardized written summary provided by the Department shall be provided to the woman by the physician as soon as possible but not later than 5 days before a physician performs a breast implantation operation. The physician may provide the standardized written summary less than 5 days before performing breast reconstruction with breast implants only when the following conditions have been met: The woman's breast cancer surgery is scheduled to take place within 5 days of the time she initially consults with a breast cancer surgeon; The woman decides to have breast implant reconstruction at the same time as the breast cancer surgery; At the time of the woman's initial visit with the physician who will perform the breast implant reconstruction, that physician: Gives the woman the Department's standardized written summary; Has the patient sign the statement provided by the Department acknowledging receipt of the summary; and Informs the woman of the relative advantages and disadvantages of having breast implant reconstruction at the same time as cancer treatment; The woman decides to waive the 5-day minimum waiting period and signs the waiver provided by the Department; and A copy of this signed waiver, along with a copy of the signed acknowledgment of receipt form, is placed in the patient's medical record which is used by the physician. A physician may not perform breast implantation until a patient has been given the standardized written summary described in Regulation .02A of this chapter. A physician who provides a patient with the written summary required under these regulations shall have: The patient sign a statement provided by the Department acknowledging receipt of the summary; and A copy of the signed acknowledgment pursuant to §D(1), of this regulation, placed in the patient's medical record which is used by the physician. This regulation is supplemental and additional to any other requirements established by other laws upon a physician and may not be regarded as in derogation or substitution of any requirements now existing upon a physician, such as the need to obtain informed consent for treatment. Health-General Article, §20-114, Annotated Code of Maryland Effective date: September 3, 1990 (17:17 Md. R. 2080)