Florida Breast Implant Informed Consent Bill

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:

One comment

  1. Greg Penglis says:

    I wanted to save the first version of the bill so folks know where this version came from. This is for our legislative record.

    FLORIDA BREAST IMPLANT INFORMED CONSENT BILL

    April 21, 2021 Anne Ziegenhorn 0 Citizen Bill Ideas, Proposed Laws,

    Bill Rationale:

    I’m 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). We have been trying for over 3 years to get Informed Consent Laws passed here in Florida, but with elections and all the election fraud, our legislation felt it was not a good time, yet AZ who has active Voter Fraud issues with the 2020
    election manged to get it passed spring 2021.

    Here is what AZ Bill states and I believe FL can mirror it.

    1 Be it enacted by the Legislature of the State of Arizona:
    2 Section 1. Title 32, chapter 32, article 1, Arizona Revised
    3 Statutes, is amended by adding section 32-3228, to read:
    4 32-3228. Informed consent; breast implant surgery;
    5 requirements; unprofessional conduct; work group;
    6 definition
    7 A. BEGINNING JANUARY 1, 2021, BEFORE PERFORMING BREAST IMPLANT
    8 SURGERY, A PHYSICIAN WHO IS LICENSED PURSUANT TO CHAPTER 13 OR 17 OF THIS
    9 TITLE MUST PROVIDE THE PATIENT WITH THE FOLLOWING INFORMATION, IN WRITING
    10 OR IN AN ELECTRONIC FORMAT, BASED ON THE INFORMATION THAT IS THEN
    11 GENERALLY AVAILABLE TO PHYSICIANS WHO PERFORM BREAST IMPLANT SURGERY:
    12 1. A DESCRIPTION OF THE RISKS OF BREAST IMPLANTS AND A DESCRIPTION
    13 OF THE SURGICAL PROCEDURES USED IN BREAST IMPLANT SURGERY.
    14 2. MANUFACTURER PATIENT INFORMATION MATERIALS, IN A HARD COPY OR
    15 ELECTRONIC FORMAT, ON THE IMPLANTS THAT ARE TO BE USED IN THE SURGERY,
    16 INCLUDING WARNING REQUIREMENTS PRESCRIBED BY THE UNITED STATES FOOD AND
    17 DRUG ADMINISTRATION.
    18 3. AN INFORMED CONSENT CHECKLIST FOR PHYSICIANS TO DISCUSS WITH THE
    19 PATIENT BEFORE BREAST IMPLANT SURGERY THAT MUST INCLUDE, AT A MINIMUM,
    20 INFORMATION ON:
    21 (a) BREAST IMPLANT-ASSOCIATED ANAPLASTIC LARGE CELL LYMPHOMA.
    22 (b) BREAST IMPLANT ILLNESS.
    23 (c) THE NATIONAL BREAST IMPLANT REGISTRY.
    24 4. INFORMATION ON HOW A PATIENT CAN REPORT ADVERSE EVENTS
    25 ASSOCIATED WITH BREAST IMPLANTS THROUGH THE UNITED STATES FOOD AND DRUG
    26 ADMINISTRATION’S MEDWATCH PROGRAM OR ANY SIMILAR PROGRAM.
    27 B. A PHYSICIAN MUST PROVIDE THE INFORMATION REQUIRED BY SUBSECTION
    28 A OF THIS SECTION AND OBTAIN WRITTEN INFORMED CONSENT FOR THE PROCEDURE
    29 FROM THE PATIENT BEFORE PERFORMING THE BREAST IMPLANT SURGERY.
    30 C. A PHYSICIAN WHO KNOWINGLY VIOLATES THIS SECTION COMMITS AN ACT
    31 OF UNPROFESSIONAL CONDUCT AND IS SUBJECT TO DISCIPLINARY ACTION, INCLUDING
    32 LICENSE SUSPENSION OR REVOCATION PURSUANT TO CHAPTER 13 OR 17 OF THIS
    33 TITLE.
    34 D. ON OR BEFORE DECEMBER 1, 2020, THE ARIZONA MEDICAL BOARD AND THE
    35 ARIZONA BOARD OF OSTEOPATHIC EXAMINERS IN MEDICINE AND SURGERY SHALL
    36 CONVENE A WORK GROUP THAT INCLUDES LICENSEE REPRESENTATIVES AND PATIENT
    37 ADVOCATES TO JOINTLY DEVELOP AN INFORMED CONSENT CHECKLIST FOR PHYSICIANS
    38 TO DISCUSS WITH PATIENTS BEFORE BREAST IMPLANT SURGERY. THE INFORMED
    39 CONSENT CHECKLIST SHALL INCLUDE THE INFORMATION PRESCRIBED IN SUBSECTION A
    40 OF THIS SECTION AND ANY OTHER INFORMATION THE BOARDS AND THE WORK GROUP
    41 DECIDE IS NECESSARY. THE WORK GROUP SHALL REVIEW THE CHECK LIST AND
    42 PROVIDE UPDATES AS NECESSARY.
    43 E. FOR THE PURPOSES OF THIS SECTION, “BREAST IMPLANT SURGERY” MEANS
    44 THE SURGICAL PLACEMENT OF A COSMETIC BREAST IMPLANT.

    Our organization has 3 Plastic Surgeons willing to help any Legislative Representative willing to help us move forward. We are ready to move forward!

    Anne Ziegenhorn
    Breast Explant Specialist & Insurance Consultant
    Co-Founder The Implant Truth Survivors Committee 501c3
    OCREC Precinct Committeewoman

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