Navigating Food and Drug Administration Mandated Breast Implant Patient Literature

Abstract

Objectives In October 2021, the US Food and Drug Administration mandated patient decision checklists and new labeling for breast implants with the goal of improving the informed decision-making process for patients considering breast implantation. Given growing concerns over breast implant–associated anaplastic large cell lymphoma, breast implant–associated squamous cell carcinoma, and breast implant illness, patients should be able to easily review these resources to make a fully informed decision when considering surgery. This study seeks to elucidate the accessibility, and therefore the utility of the newly mandated literature for the average breast implant patient. Methods Patient decision checklists and breast implant boxed warnings were obtained from the most used breast implant manufacturers in the United States—Allergan, Mentor, and Sientra. Readability analysis of all Food and Drug Administration required documents was performed using the Flesch Reading Ease Score, Flesch Kincaid Grade Level, Gunning-Fog Index, Coleman-Liau Index, Simplified Measure of Gobbledygook, and Automated Readability Index. Results The overall readability of all Allergan, Mentor, and Sientra patient materials correlates with a college reading level. Documents from all 3 implant manufacturers were of a statistically significantly higher reading level than that recommended by the American Medical Association and US Department of Health and Human Services. No materials were found to be at or below the recommended sixth-grade level. Conclusions The newly mandated breast implant patient decision guides are written at a college reading level. These materials should be simplified to improve health literacy shared decision making.

Artificial Intelligence as a Triage Tool during the Perioperative Period: Pilot Study of Accuracy and Accessibility for Clinical Application

“…30 Taking such concerns into consideration, the American Medical Association and the United States Department of Health and Human Services recommend that medical information intended for patients be written at the sixth grade level. 31 The reading level of the ChatGPT outputs in this study were substantially higher (at the college level) than this recommendation, posing a limitation to the accessibility of the AI-generated outputs to the general public of the United States. Educational materials with a higher than recommended reading level is a well-described issue within the plastic surgery literature.…”