H.B. 229

1

BREAST IMPLANT SURGERY
2 2000 GENERAL SESSION
3 STATE OF UTAH
4 Sponsor: David Ure
5 AN ACT RELATING TO HEALTH; DEFINING TERMS; IMPOSING DUTIES ON THE
6 DEPARTMENT OF HEALTH TO PREPARE AN INFORMED CONSENT FORM FOR
7 BREAST IMPLANT SURGERY, A POST-SURGERY REPORT, AND A POST-SURGERY
8 SURVEY; REQUIRING HEALTH CARE PROVIDERS TO PROVIDE INFORMED CONSENT
9 BEFORE PERFORMING A BREAST IMPLANT SURGERY; REQUIRING HEALTH CARE
10 FACILITIES TO SUBMIT A POST-SURGERY REPORT TO THE DEPARTMENT OF
11 HEALTH; AND MAKING CONFORMING AMENDMENTS.
12 This act affects sections of Utah Code Annotated 1953 as follows:
13 AMENDS:
14 26-21-11, as last amended by Chapter 209, Laws of Utah 1997
15 26-21a-101, as enacted by Chapter 126, Laws of Utah 1991
16 58-67-502, as enacted by Chapter 248, Laws of Utah 1996
17 58-68-502, as enacted by Chapter 248, Laws of Utah 1996
18 ENACTS:
19 26-21a-401, Utah Code Annotated 1953
20 26-21a-402, Utah Code Annotated 1953
21 26-21a-403, Utah Code Annotated 1953
22 26-21a-404, Utah Code Annotated 1953
23 Be it enacted by the Legislature of the state of Utah:
24 Section 1. Section 26-21-11 is amended to read:
25 26-21-11. Violations -- Denial or revocation of license -- Restricting or prohibiting
26 new admissions -- Monitor.
27 If the department finds a violation of this chapter, Section 26-21a-403 , or any rules adopted

28 pursuant to this chapter the department may take one or more of the following actions:
29 (1) serve a written statement of violation requiring corrective action, which shall include
30 time frames for correction of all violations;
31 (2) deny or revoke a license if it finds:
32 (a) there has been a failure to comply with the rules established pursuant to this chapter;
33 (b) evidence of aiding, abetting, or permitting the commission of any illegal act; or
34 (c) conduct adverse to the public health, morals, welfare, and safety of the people of the
35 state;
36 (3) restrict or prohibit new admissions to a health care facility or revoke the license of a
37 health care facility for:
38 (a) violation of any rule adopted under this chapter; or
39 (b) permitting, aiding, or abetting the commission of any illegal act in the health care
40 facility;
41 (4) place a department representative as a monitor in the facility until corrective action is
42 completed;
43 (5) assess to the facility the cost incurred by the department in placing a monitor;
44 (6) assess an administrative penalty as allowed by Subsection 26-23-6 (1)(a); or
45 (7) issue a cease and desist order to the facility.
46 Section 2. Section 26-21a-101 is amended to read:
47 CHAPTER 21a. WOMEN'S HEALTH
48 Part 1. Definitions
49 26-21a-101. Definitions.
50 As used in this chapter:
51 (1) "Breast implant surgery" means a medical procedure designed to reconstruct or
52 augment the size of a patient's breast by means of an implant.
53 [(1)] (2) "Breast cancer screening mammography" means a standard two-view per breast,
54 low-dose as defined by the National Cancer Institute, radiographic examination of the breasts to
55 detect unsuspected breast cancer using equipment designed and dedicated specifically for
56 mammography.
57 [(2)] (3) "Diagnostic mammography" means mammography performed on a woman having
58 suspected breast cancer.

59 [(3)] (4) "Facility" means a facility that provides screening or diagnostic breast
60 mammography services.
61 (5) "Implant" means any object or substance that:
62 (a) is foreign to the patient's body;
63 (b) is purposefully left in a patient's chest cavity in connection with a breast implant
64 surgery; and
65 (c) is not intended or designed to be absorbed into the patient's body.
66 (6) "Patient" means a person who is considering or undergoes a breast implant surgery.
67 Section 3. Section 26-21a-401 is enacted to read:
68 Part 4. Breast Implant Surgery Act
69 26-21a-401. Title.
70 This part is known as the "Breast Implant Surgery Act."
71 Section 4. Section 26-21a-402 is enacted to read:
72 26-21a-402. Duties of the department.
73 (1) The department shall prepare:
74 (a) an informed consent form for breast implant surgery;
75 (b) a post-breast implant surgery report; and
76 (c) a post-breast implant survey.
77 (2) (a) The informed consent form for breast implant surgery shall require that the
78 following information be given to a patient:
79 (i) the chemical make up of any implant to be used;
80 (ii) the name of the manufacturer and any bin, lot number, and other related identifying
81 information associated with any implant to be used;
82 (iii) the potential risks of breast implant surgery based on:
83 (A) the best, available research;
84 (B) state-specific health data; and
85 (C) information regarding breast implants published by the federal Food and Drug
86 Administration;
87 (iv) the statistical chances of an adverse result;
88 (v) the potential warning signs associated with an adverse result; and
89 (vi) a telephone number to call in the event the patient believes that an adverse result may

90 have occurred.
91 (b) In addition to the requirements of Subsection (2)(a), an informed consent form for
92 breast implant surgery shall request the permission of the patient to forward the patient's name to
93 the department for future follow-up on the patient's health status.
94 (3) The post-breast implant surgery report shall record the following information for a
95 patient who has undergone a breast implant surgery:
96 (a) the date on which informed consent was given, explained, and signed;
97 (b) the date on which the surgery was performed;
98 (c) the name of the manufacturer of any implant left in the body of the patient;
99 (d) the lot number, bin number, and other related identifying information associated with
100 any implant left in the body of the patient; and
101 (e) the name and address of the patient if the patient consented to follow-up contact by the
102 department.
103 (4) The post-breast implant survey shall be designed as a follow-up tool for determining
104 the ongoing health status of patients who have undergone breast implant surgery.
105 (5) (a) The department shall distribute informed consent forms for breast implant surgery
106 and post-breast implant reports to health care providers and facilities.
107 (b) The department shall, in its discretion, distribute post-breast implant surveys to
108 patients.
109 (6) The department shall use the information produced from the post-implant surveys:
110 (a) in preparing the informed consent form for breast implant surgery;
111 (b) to inform women generally regarding the health issues associated with breast implant
112 surgery;
113 (c) to track the long-term health status of women who have undergone breast implant
114 surgery; and
115 (d) for other health-related purposes identified by the department.
116 (7) In preparing the forms, reports, and surveys required by Subsection (1), the department
117 shall seek the input of:
118 (a) the Utah Medical Association;
119 (b) the Utah Hospital Association;
120 (c) one or more women who have undergone breast implant surgery; and

121 (d) others who, in the opinion of the department, may be able and willing to provide
122 helpful information or insight on breast implant surgery.
123 Section 5. Section 26-21a-403 is enacted to read:
124 26-21a-403. Duties of health care providers and facilities.
125 (1) At the initial consultation for breast implant surgery, and in no event less than 72 hours
126 before the surgery is performed, the patient's health care provider shall:
127 (a) give the patient the informed consent form for breast implant surgery prepared by the
128 department; and
129 (b) thoroughly explain the provisions of the informed consent form.
130 (2) Before a breast implant surgery may be performed within a health care facility, the
131 facility shall verify that:
132 (a) the informed consent has been obtained from the patient in accordance with Subsection
133 (1); and
134 (b) the patient has signed the form.
135 (3) After a breast implant surgery has been performed, the health care facility shall:
136 (a) fill out the post-breast augmentation surgery report; and
137 (b) send the report and a copy of the patient's signed informed consent to the department
138 within 30 days of the surgery unless an extension of time is requested.
139 (4) The health care provider that obtained the patient's informed consent and performed
140 the surgery shall cooperate with the health care facility in filling out the post-breast augmentation
141 surgery report.
142 Section 6. Section 26-21a-404 is enacted to read:
143 26-21a-404. Failure to comply.
144 The failure of a health care provider or health care facility to comply with the provisions
145 of this chapter may be grounds for disciplinary action for unprofessional conduct against the
146 license of the provider pursuant to Title 58, Occupations and Professions, or facility pursuant to
147 Chapter 21, Health Care Facility Licensing and Inspection Act.
148 Section 7. Section 58-67-502 is amended to read:
149 58-67-502. Unprofessional conduct.
150 "Unprofessional conduct" includes, in addition to the definition in Section 58-1-501 and
151 a violation of the informed consent requirement of Section 26-21a-403 , using or employing the

152 services of any individual to assist a licensee in any manner not in accordance with the generally
153 recognized practices, standards, or ethics of the profession, state law, or division rule.
154 Section 8. Section 58-68-502 is amended to read:
155 58-68-502. Unprofessional conduct.
156 "Unprofessional conduct" includes, in addition to the definition in Section 58-1-501 and
157 a violation of the informed consent requirement of Section 26-21a-403 , using or employing the
158 services of any individual to assist a licensee in any manner not in accordance with the generally
159 recognized practices, standards, or ethics of the profession, state law, or division rule.




Legislative Review Note
as of 1-14-00 7:15 AM

A limited legal review of this legislation raises no obvious constitutional or statutory concerns.

Office of Legislative Research and General Counsel