Sec. 10.12.05.02. Requirements for the Maryland Department of Health  


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  • The Department shall:

    A. Provide a standardized written summary in layperson's language that:

    (1) Contains the information on breast implantation generally contained in the package inserts for breast implants, and

    (2) Discloses side effects, warnings, and cautions for a breast implantation operation;

    B. Update as necessary the standardized written summary;

    C. Provide a statement indicating acknowledgment of receipt of the standardized written summary to be signed by the patient;

    D. Provide a waiver form describing the conditions under which the usual time requirements of the summary distribution may be waived; and

    E. 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.