The Department shall:

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

   1. (1) Contains the information on breast implantation generally contained in the package inserts for breast implants, and
   2. (2) Discloses side effects, warnings, and cautions for a breast implantation operation;
2. B. Update as necessary the standardized written summary;
3. C. Provide a statement indicating acknowledgment of receipt of the standardized written summary to be signed by the patient;
4. D. Provide a waiver form describing the conditions under which the usual time requirements of the summary distribution may be waived; and
5. 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.

Authority: Health-General Article, §20-114, Annotated Code of Maryland

Effective date: September 3, 1990 (17:17 Md. R. 2080)