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Breast Implant Patient Informed Consent Checklist and Black Box Warnings

By The Breast Implant Working Group



This black box warning was developed by the Breast Implant Working Group, which consists of Dr. Diana Zuckerman (National Center for Health Research), Dr. Scot Glasberg (American Society of Plastic Surgeons), Dr, Alan Matarasso (also ASPS), Jamee Cook (Breast Implant Victim Advocacy), Raylene Hollrah (Just Call me Ray), and Karuna Jaggar (Breast Cancer Action).   As individuals, we are urging the FDA to include a black box warning about the risks of cancer and other serious health problems for women considering breast implants.


Black Box Warning

Breast implants can cause a type of cancer of the immune system called BIA-ALCL (Breast Implant Associated Anaplastic Large Cell Lymphoma).  People with silicone or saline breast implants have developed this rare disease, which can be deadly if not treated early. Almost all women who have developed BIA-ALCL have had textured breast implants or expanders at some point.


Several studies also suggest that women with breast implants have a small but significant increase in their chances of developing certain autoimmune or connective tissue diseases. Women with silicone gel or saline breast implants have reported symptoms that are sometimes serious, such as joint or muscle pain, fibromyalgia, mental confusion, and painful skin conditions.  Many of these symptoms improve partially or completely when their breast implants are removed and not replaced.


The Breast Implant Working Group’s Patient Informed Consent Checklist

This checklist was developed by the Breast Implant Working Group, which consists of Dr. Diana Zuckerman (National Center for Health Research), Dr. Scot Glasberg (American Society of Plastic Surgeons), Dr, Alan Matarasso (also ASPS), Jamee Cook (Breast Implant Victim Advocacy), Raylene Hollrah (Just Call me Ray), and Karuna Jaggar (Breast Cancer Action).  The checklist has been endorsed by their organizations, as a requirement to be read and signed by all potential breast implant patients.





All posts are intended strictly for educational purposes. It is not intended to make any representations or warranties about the outcome of any procedure. It is not a substitute for a thorough in-person consultation with a medical professional. If you have questions about your personal medical situation, please call your healthcare provider.

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