The Breast Surgeon’s To-do List Just Got Longer

The FDA issued an order for breast surgeons that will add to their required responsibilities for informed consent from patients.

The US Food and Drug Administration (FDA) added an item to the list of physicians’ informed consent responsibilities by issuing an order requiring breast surgeons to provide specific information to patients considering breast implants and surgery and use a 16-page consent form.1 Breast surgeons can check informed consent off their to-do list after complying with state law requirements and the FDA’s new requirements.

New Federal Requirements

In October 2021, the FDA restricted the sale and distribution of breast implants to health care professionals and facilities utilizing the FDA’s new Patient Decision Checklist.2 In addition to complying with the state’s informed consent requirements, physicians must also do the following:

  • Review the FDA’s 16-page checklist information with the patient,
  • Give the patient the opportunity to initial and sign the checklist,
  • Sign or ensure the implanting physician signs the checklist, and
  • Provide the FDA sub guidance documents and information referred to in the checklist.3

The FDA’s Patient Decision Checklist alleviated many patients’, physicians’, and patient advocates’ concerns regarding previously approved patient information booklets, which were often 40 pages or more. The Checklist could prevent failure-to-warn claims against implant manufacturers, but the sufficiency of an FDA-required checklist has not been tested in product liability litigation.

Implications for Medical Professional Liability

Most courts have not rendered a decision on the use of a statutorily required checklist in a medical professional liability (MPL) lawsuit. The amount of information in the approved checklist, and the requirements for the patient’s initials and signature, may protect physicians against allegations of failure to obtain informed consent if they also provide the standard of care information that will be the subject of expert witness testimony in a MPL suit. Physicians should continue to document the patient’s informed consent in the medical record and answer any questions patients may have regarding breast implantation.

1 The FDA’s announcement for breast implant safety requirements also addresses the labeling requirements for saline and silicone gel-filled implants, which include a boxed warning; the checklist; materials and device descriptions, rupture screening guidelines, and patient device cards.

2 The Patient Decision Checklist is in Appendix B, on page 10, of FDA’s guidance document, available for downloading, Breast Implants – Certain Labeling Recommendations to Improve Patient Communication.

3 The sub guidance forms are Considerations for a Candidate for Successful Breast Implantation, Risks of Breast Implant Surgery, Risk of Cancer-Breast Implant-Associated Anaplastic Large Cell Lymphoma (BIA-ALCL), Systemic Symptoms, Breast Implant Specific Risks, Recommended Follow-Up, Questions for My Physician, Options Following Mastectomy, and Breast Augmentation Options. The forms are part of the FDA’s original breast implant recommendations and are incorporated into the Patient Decision Checklist.

The content of this publication or presentation is intended for educational purposes only; is not an official position statement of Mutual Insurance Company of Arizona (MICA); and should not be considered or relied upon as professional, medical, or legal advice or as a substitute for your professional judgment. Consult your attorney about your individual situation and the applicable laws. The authors, presenters, and editors made a reasonable effort to ensure the accuracy of the information at the time of publication or presentation but do not warrant or guarantee accuracy, completeness, or currency of such information. As medical and legal information is constantly changing and evolving, check for updated information and consult your attorney before making decisions.

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