Commentary on: US FDA Patient Decision Checklist for Breast Implants: Results of a Survey to Members of The Aesthetic Society, April 2022 Free

See the Original Article here.

The authors of the article titled “US FDA Patient Decision Checklist for Breast Implants: Results of a Survey to Members of Tthe Aesthetic Society, April 2022” report the results of a questionnaire sent to The Aesthetic Society membership that solicited their opinion regarding utilization of the Patient Decision Checklists.¹ A total of 206 Aesthetic Society members (9%) responded. This response rate is low but sufficient to gauge the opinion of the membership.

The US Food and Drug Administration (FDA) convened the General and Plastic Surgery Devices Advisory Panel in 2019.² The aim of the public discussions was to get a better understanding of the patient's perspective and the risks associated with breast implants. Presentations included input from patients, manufacturers, and physicians. In September 2020 the FDA issued final guidance for breast implant utilization that recommended labeling updates, including a patient decision checklist, screening recommendations for ruptures, information about breast implant materials, and a patient device card.³ The FDA was concerned that despite the 2020 guidance, patients were still not being adequately informed of the risks associated with breast implants. In October 2021 they put teeth into the 2020 guidance by restricting the sale and distribution of breast implants to companies that required physicians to utilize their Patient Decision Checklist (PDC).⁴ The companies were also required to update their product labelling. Breast implant manufacturers communicated with plastic surgeons in 2022, making utilization of the PDC a condition for the sale of their implants.

The survey asked 6 questions:

• Question 1: Do you currently use breast implants?

• Question 2: What best describes your experience when discussing the PDC with your patients? (5 possible responses)

• Question 3: The risks of breast implants, including potential adverse events, are accurately represented in the PDC (5 response choices from strongly agree to strongly disagree)

• Question 4: The current version of the PDC should be modified to include scientific descriptions and/or risks of adverse events based on the latest peer-reviewed scientific data, such as the incidence of patients claiming systemic symptoms from their breast implants. (5 response choices from strongly agree to strongly disagree)

• Question 5: The PDC, as written, is fair and balanced. (5 response choices from strongly agree to strongly disagree)

• Question 6: Please share any additional comments you may have about this topic (text box for comments)

The responses reflected 3 main concerns. First, that the data presented in the PDC were inaccurate; second, that the information was not based on peer reviewed literature; and third, that the PDC was not “fair and balanced.”

Before elaborating on the concerns elicited by the responses to the questionnaire, it is worth understanding the makeup of the PDCs. Firstly, each company produces its own PDC.^5–8

Surgeons are required to discuss the risks with patients under the following common headings:

• 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

• Breast Augmentation Options

It must be noted that data with percentages are reported under only 3 of these headings.

Under the risks of the Cancer—BIA-ALCL heading, the data presented are the same for each company and come from the articles by Clemens et al, Loch-Wilkinson et al, and De Boer et al.^9–11

Under the Risks of Breast Implant Surgery and Breast-Implant Specific Risks, the companys quote data specific to their implants derived from their specific pre-market approval and post approval studies. These numbers vary considerably; for example, the percentages for breast pain are 5.2% (Mentor Memory Gel [Irvine, CA]), 11.7% (Allergan Natrelle [Irvine, CA]), 2.6% (Sientra [Santa Barbara, CA]), and 1.1% (Ideal Implant [Dallas, TX]). Seromas are reported occurring in 2.1% (Mentor Memory Gel), 6.7% (Allergan Natrelle), 2.4% (Sientra), and 2.9% (Ideal Implant).^5–8

Questions 2 and 3 revealed that most respondents expressed concerns with the accuracy of the data in the PDC and felt the risks were too high and not reflected by their own experience. Understanding that the data are specific to and supplied by each company should help the treating physician in their discussion with their patients. The physician can point out that these are the individual companies' figures. Even if the individual surgeon feels the risk is overstated, the discussion will satisfy the need to inform the patient and will also give the surgeon “cover” having completed the obligation.

Question 4 proposed that “the current version of the PDC should be modified to include scientific descriptions and/or risks of adverse events based on the latest peer-reviewed scientific data.” Once again, the figures are those reported by each company and are company specific. These data are arguably the most accurate data for each implant on the market.

The criticism that the incidence of systemic symptoms was not reported is true, but there are no reliable data available. The wording in this section of each PDC is, I believe, appropriate. We do have to acknowledge that this topic has generated a lot of concern among patient advocate groups. Instead of ignoring these concerns the wording that “some patients report” the various symptoms and that “some patients have reported relief of these symptoms with removal of their implants” does so without implicating implants as the causative agent. The section also includes wording that “researchers are working to better understand the possible link between breast implants and these symptoms.” This should facilitate a meaningful discussion with our patients.

The fifth question as to whether the PDC is “fair and balanced” demonstrates a misunderstanding of the role of the FDA in this situation. As stated on the FDA website, “The Food and Drug Administration is responsible for protecting the public health by ensuring the safety, efficacy, and security of human and veterinary drugs, biological products, and medical devices….” and the “FDA is responsible for advancing the public health by helping to speed innovations that make medical products more effective, safer, and more affordable and by helping the public get the accurate, science-based information they need to use medical products and foods to maintain and improve their health.”¹² The PDC fulfills this responsibility. The fact that the FDA has approved breast implants ensures the public that implants are effective at enlarging and reconstructing the human breast. Treating surgeons and breast implant companies also do a great job of communicating the benefits of implants to our patients. Adding these benefits to the PDC will only serve to make it more unwieldy.

There will always be some confusion where each company must produce their own PDC. Ideally, we should have a single PDC with input from the companies, The Aesthetic Society, the American Society of Plastic Surgeons (ASPS), and the FDA and where data on the risks would be presented as a range. In summary, I believe this FDA ruling is in keeping with its mandate to inform the public of the risks associated with breast implants.

Disclosures

The author declared no potential conflicts of interest with respect to the research, authorship, and publication of this article.

Funding

The author received no financial support for the research, authorship, and publication of this article.

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