April 21, 2021 Anne Ziegenhorn
Bill Rationale:
I’m Anne Ziegenhorn, a former plastic surgeon scrub tech who preached the safety of implants in the 90’s because I was deceived by the FDA & Manufacturers of these products. Breast implants almost killed me and have been harming women for well over 40 years; many who have Breast Implants due to Breast Cancer. A large number of women like me now advocate and we have joined together online to bring awareness to this issue. I run Non-Profit, The Implant Truth Survivors Committee 501c3 (aka TITS Committee 50). Five other states are moving in this direction to give women the full disclosure they need to make good medical decisions for themselves, and this model legislation from New Jersey is the best so far. Please consider this bill for Florida, this session of the State Legislature if at all possible.
AN ACT concerning informed consent for breast implant surgery BE IT ENACTED by the state legislature of the state of Florida: 1. a. As used in this section:
“Breast implant surgery” means the surgical placement of a cosmetic breast implant or any other implanted medical device or medical material (human, animal or synthetic) including mesh, acelleular dermal matrix, surgical screws, plates, or any other materials/devices that will be used in breast surgery for augmentation or reconstruction.
“Physician” means an individual licensed to practice medicine and to perform breast implant surgery in this State.
b. Before performing breast implant surgery, a physician shall provide complete information about potential risks, symptoms, and complications involved prior to having surgery. This information shall be given to a patient during the first consultation appointment, in writing or in an electronic format, which includes, but is not limited to:
(1) a description of the risks of breast implants and of the surgical procedures used in breast implant surgery;
(2) manufacturer patient information materials, in written or electronic format, on the implants that will be used in the surgery including warning requirements prescribed by the United States Food and Drug Administration;
(3) GPAC (Global Patient Advocacy Coalition) standardized informed consent checklist based on recommendations by the United States Food and Drug Administration’s guidance on breast implants, which includes, at a minimum:
(a) information on breast implant-associated anaplastic large cell lymphoma;
(b) information on breast implant illness;
(c) information on the systematic symptoms associated with breast implants;
(d) information on the national breast implant registry; and
(e) information on any surgical mesh used during breast implant surgery including, but not limited to, mesh made of nondegradable synthetic materials, biodegradable synthetic materials, or animal or human derived tissues. This information must include a warning that no surgical mesh has been approved by the food and drug administration for use with breast implants
(4) information on how the patient can report adverse events associated with breast implants through the United States Food and Drug Administration’s MedWatch program or any other similar medical product safety reporting program.
c. A physician shall furnish the information required by subsection b. of this section to the patient and obtain written informed consent for the procedure from the patient before performing the breast implant surgery.
d. A physician who knowingly violates the requirements of this section commits an act of unprofessional conduct and shall be subject to disciplinary action, which may include license suspension or revocation.
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 Dr 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.
Anne Ziegenhorn
Breast Explant Specialist & Insurance Consultant
Co-Founder The Implant Truth Survivors Committee 501c3
OCREC Precinct Committeewoman
Contact information:
Tags: breast implants, disclosure, health, laws, product liability, woman’s health
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