Bill

Bill > S385


NJ S385

NJ S385
Requires informed consent for breast implant surgery.


summary

Introduced
01/09/2024
In Committee
01/09/2024
Crossed Over
Passed
Dead
01/12/2026

Introduced Session

2024-2025 Regular Session

Bill Summary

This bill requires a physician to provide information about breast implant surgery to a patient and to obtain written informed consent for the procedure from the patient before performing breast implant surgery. The information will be provided to the patient in writing or in an in electronic format, and will include, but is not limited to: a description of the risks of breast implants and of the surgical procedures used in breast implant surgery; manufacturer patient information materials on the implants that will be used in the surgery including warning requirements prescribed by the United States Food and Drug Administration; a Global Patient Advocacy Coalition standardized informed consent checklist based on recommendations by the United States Food and Drug Administration's guidance on breast implants; and information on how the patient can report adverse events associated with breast implants. A physician who knowingly violates the requirements of this bill commits an act of unprofessional conduct and will be subject to disciplinary action, which may include license suspension or revocation.

AI Summary

This bill requires physicians performing breast implant surgery, defined as the surgical placement of a cosmetic breast implant, to provide patients with comprehensive information before the procedure and obtain their written informed consent. This information must be delivered in writing or electronically and include details about the risks of implants and surgery, manufacturer-provided materials with warnings from the U.S. Food and Drug Administration (FDA), a standardized checklist from the Global Patient Advocacy Coalition based on FDA guidance covering topics like implant-associated lymphoma and breast implant illness, and instructions on how to report adverse events through programs like the FDA's MedWatch. Physicians who knowingly fail to comply will be considered to have engaged in unprofessional conduct, potentially leading to disciplinary actions such as license suspension or revocation. The Commissioner of Health is tasked with creating rules and regulations to implement these provisions, and the act takes effect immediately.

Committee Categories

Health and Social Services

Sponsors (1)

Last Action

Introduced in the Senate, Referred to Senate Health, Human Services and Senior Citizens Committee (on 01/09/2024)

bill text


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