<?xml version='1.0' encoding='utf-8'?>
<regulation prefix="Regulation" num=".02" citation="COMAR 10.12.05.02" title_num="10" subtitle_num="12" chapter_num="05" heading="Requirements for the Maryland Department of Health.">
  <text>The Department shall:</text>
  <paragraph num="A.">
    <text>Provide a standardized written summary in layperson's language that:</text>
    <paragraph num="(1)">
      <text>Contains the information on breast implantation generally contained in the package inserts for breast implants, and</text>
    </paragraph>
    <paragraph num="(2)">
      <text>Discloses side effects, warnings, and cautions for a breast implantation operation;</text>
    </paragraph>
  </paragraph>
  <paragraph num="B.">
    <text>Update as necessary the standardized written summary;</text>
  </paragraph>
  <paragraph num="C.">
    <text>Provide a statement indicating acknowledgment of receipt of the standardized written summary to be signed by the patient;</text>
  </paragraph>
  <paragraph num="D.">
    <text>Provide a waiver form describing the conditions under which the usual time requirements of the summary distribution may be waived; and</text>
  </paragraph>
  <paragraph num="E.">
    <text>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.</text>
  </paragraph>
</regulation>