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ARIZONA STATE SENATE
Fifty-Fourth Legislature, Second Regular Session
breast implant surgery; informed consent
Purpose
Requires a physician to provide a patient with breast implant surgery information as outlined and obtain informed consent from the patient prior to surgery.
Background
The U.S. Congress passed the federal Food, Drug and Cosmetic Act in 1976 granting the Food and Drug Administration (FDA) regulatory authority over breast implants which were previously unregulated. In the 1980s, breast implants were classified as Class III medical devices, and as such are required obtain pre-market approval (PMA) and be reviewed by the FDA for safety and effectiveness. According to the FDA, Class III medical devices have the most stringent regulatory controls and are generally devices that support or sustain human life, prevent the impairment of human health or present a potential unreasonable risk of illness or injury to the patient. Typically, a PMA submission to the FDA is required to obtain approval to market a Class III medical device; however, a few Class III medical devices are required to only have a 510(k) cleared by the FDA to be marketed. Examples of Class III devices that require a PMA are replacement heart valves, silicone gel-filled breast implants and implanted cerebella stimulators (FDA).
Breast implant-associated anaplastic large cell lymphoma (ALCL) was first identified in 1997. Other countries, including France and Australia, have additionally experienced reports citing a correlation between breast implants and ALCL. In 2011, the FDA issued a warning on ALCL in women with these medical devices, stating that such women are believed to have a small but increased risk of developing ALCL (FDA warning).
Currently, the Plastic Surgery Foundation, in collaboration with the FDA and breast implant device manufacturers, has developed the National Breast Implant Registry (NBIR) to strengthen national surveillance for breast implant devices in the United States. The purpose of the NBIR is to create a database that collects information on breast implant procedures and devices and to identify trends and other data that can be used to improve patient safety (NBIR).
There is no anticipated fiscal impact to the state General Fund associated with this legislation.
Provisions
1. Requires, prior to a breast implant surgery, a licensed physician to provide a patient with the following breast implant surgery information accepted by physicians who specialize in breast implant surgery, either in writing or electronically, that contains:
a) a description of the risks of breast implants and a description of the surgical procedures used in breast implant surgery;
b) information on saline-filled and silicone gel-filled breast implants, including data supporting a reasonable assurance of safety and effectiveness, implant product approval letters, FDA warning requirements and information on breast implant product studies conducted after federal approval;
c) information on breast implant-associated anaplastic large cell lymphoma in women with breast implants; and
d) information on how a patient can report adverse events associated with breast implants through the FDA MedWatch Program.
2. Stipulates that, in addition to the breast implant surgery information requirements, a physician must obtain written informed consent from the patient before performing the surgery.
3. Classifies, as unprofessional conduct, knowingly violating the breast implant surgery information and informed consent requirements and subjects the physician to license suspension or revocation.
4. Becomes effective on the general effective date.
Prepared by Senate Research
February 17, 2020
CRS/kja