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09/18/2021 09:02 AM
Pennsylvania State Senate
https://www.legis.state.pa.us/cfdocs/Legis/CSM/showMemoPublic.cfm?chamber=S&SPick=20210&cosponId=35524
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Senate of Pennsylvania
Session of 2021 - 2022 Regular Session

MEMORANDUM

Posted: April 29, 2021 09:49 AM
From: Senator Judy Ward
To: All Senate members
Subject: Enhanced Information on Breast Implants
 
I plan to introduce legislation that would require doctors to provide patients with more detailed information on breast implants before consenting to surgery.
 
A constituent shared with me her story of getting ill after receiving reconstructive implants and experiencing an improvement in her health after having the implants removed. She believes that not enough information about the potential problems and issues with breast implants was shared with her when making the decision to undergo the procedure.
 
Every person undergoing breast implant surgery should be provided complete information about potential risks, symptoms, and complications involved before surgery. A survey of over 5,000 individuals who received breast implants found that 84 percent believed they were not given enough time and information to make an informed decision about the breast implant surgery. In October 2019, the U.S. Food and Drug Administration recommended a warning label on all breast implants.
 
My legislation would require physicians, starting on January 1, 2022, to provide patients at the first consultation with a checklist of information as part of informed consent to empower patients in making their own choices when it comes to any risks involved in a breast implant surgery. The checklist would include information on risks and illness of breast implants, systemic symptoms associated with breast implants, manufacturer patient information materials on the implants, including warning requirements, and information on breast implant-associated anaplastic large cell lymphoma. In addition, patients would need to be provided information on how to report adverse events to the FDA and information about the National Breast Implant Registry.
 
This proposal would help to ensure that women are fully informed about all the risks associated with breast implants before making an informed decision about surgery. A similar measure was recently signed into law in Arizona, which was supported by the American Society of Plastic Surgeons and the Arizona Society of Plastic Surgeons.
 
Please join me in cosponsoring this important legislation.
 



Introduced as SB762