PRINTER'S NO. 916
THE GENERAL ASSEMBLY OF PENNSYLVANIA
SENATE BILL
No.
762
Session of
2021
INTRODUCED BY J. WARD, COSTA, YUDICHAK, MENSCH AND MUTH,
JUNE 16, 2021
REFERRED TO CONSUMER PROTECTION AND PROFESSIONAL LICENSURE,
JUNE 16, 2021
AN ACT
Amending the act of March 20, 2002 (P.L.154, No.13), entitled
"An act reforming the law on medical professional liability;
providing for patient safety and reporting; establishing the
Patient Safety Authority and the Patient Safety Trust Fund;
abrogating regulations; providing for medical professional
liability informed consent, damages, expert qualifications,
limitations of actions and medical records; establishing the
Interbranch Commission on Venue; providing for medical
professional liability insurance; establishing the Medical
Care Availability and Reduction of Error Fund; providing for
medical professional liability claims; establishing the Joint
Underwriting Association; regulating medical professional
liability insurance; providing for medical licensure
regulation; providing for administration; imposing penalties;
and making repeals," in medical professional liability,
providing for enhanced information on breast implants.
The General Assembly of the Commonwealth of Pennsylvania
hereby enacts as follows:
Section 1. The act of March 20, 2002 (P.L.154, No.13), known
as the Medical Care Availability and Reduction of Error (Mcare)
Act, is amended by adding a section to read:
Section 504.1. Enhanced information on breast implants.
(a) Physician duty.--During the first consultation between a
physician and patient before breast implant surgery is
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performed, the physician shall provide the patient with the
following information in writing or in an electronic format:
(1) A description of the risks of breast implants and a
description of the surgical procedures used in breast implant
surgery.
(2) Notice that breast implants are not considered
lifetime devices, the chance of developing complications
increases over time and some complications will require more
surgery.
(3) Manufacturer patient information materials on the
implants that are to be used in the surgery, including
warning requirements prescribed by the Food and Drug
Administration.
(4) Information on surgical mesh used during breast
implant surgery including mesh made of nondegradable
synthetic materials, biodegradable synthetic materials or
animal or human derived tissues. The information shall
include a warning that no surgical mesh has been approved by
the Food and Drug Administration for use with breast
implants.
(5) Information on breast implant-associated anaplastic
large cell lymphoma, including notice that breast implant-
associated anaplastic large cell lymphoma occurs more
commonly in patients with textured breast implants than
smooth implants and that deaths have occurred.
(6) Information on breast implant illness, with the use
of the breast implant patient checklist described in
subsection (d).
(7) Information on the systemic symptoms associated with
breast implants.
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(8) Information on the national breast implant registry.
(9) Information on how a patient can report adverse
events associated with breast implants through the Food and
Drug Administration's MedWatch program or similar program.
(b) Breast implant information.--The information provided
under subsection (a) shall be based on the information that is
generally available to physicians who specialize in breast
implant surgery.
(c) Informed consent.--After providing the information
required under subsection (a), a physician shall obtain written
informed consent for the procedure from the patient before
performing the breast implant surgery.
(d) Breast implant patient checklist.--The department shall
transmit notice to the Legislative Reference Bureau for
publication in the Pennsylvania Bulletin of the breast implant
patient checklist, and any change to the breast implant patient
checklist shall be transmitted by the department separately as a
notice to the Legislative Reference Bureau for publication in
the Pennsylvania Bulletin. The department shall publish and
maintain the complete breast implant patient checklist on the
department's publicly accessible Internet website.
(e) Violation.--A violation of this section constitutes
unprofessional conduct under the the act of October 5, 1978
(P.L.1109, No.261), known as the Osteopathic Medical Practice
Act, and the act of December 20, 1985 (P.L.457, No.112), known
as the Medical Practice Act of 1985.
(f) Definitions.--As used in this section, the following
words and phrases shall have the meanings given to them in this
subsection unless the context clearly indicates otherwise:
"Breast implant patient checklist." A standardized informed
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consent checklist developed by an international group of
professional societies and patient advocacy organizations, based
on recommendations by the Food and Drug Administration's
guidance on breast implants, that includes information relating
to:
(1) Breast implant-associated anaplastic large cell
lymphoma.
(2) Breast implant illness.
(3) The systematic symptoms associated with breast
implants.
(4) The national breast implant registry.
"Breast implant surgery." The surgical placement of a
cosmetic breast implant.
"Department." The Department of State of the Commonwealth.
"National breast implant registry." A database established
by a national organization of plastic surgeons in the United
States, in collaboration with the Food and Drug Administration,
patients and breast implant manufacturers that:
(1) is designed to strengthen the postmarket
surveillance infrastructure for current and future breast
implant devices in the United States; and
(2) is a quality improvement initiative and safety
surveillance registry that collects clinical, procedural and
outcomes data at the time of operation and subsequent
reoperations for patients receiving breast implants in the
United States.
"Physician." An individual who is licensed to practice
medicine and perform breast implant surgery in this
Commonwealth.
Section 2. This act shall take effect January 1, 2022, or
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immediately, whichever is later.
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