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

The US FDA in response to concerns that patients undergoing breast implant surgery were not adequately informed about the risks of receiving an implanted medical device mandated a patient decision checklist (PDC) in October 2021. Breast implant manufactures communicated with plastic surgeons in 2022 regarding the use of the PDC as a condition for the sale of breast implants. Plastic surgeons voiced concerns over the accuracy of content in the PDC and its confusing statements about risk of adverse events associated with breast surgery. In April 2022, the Aesthetic Society developed a survey that was sent to its members regarding their experiences with the PDC. This was a 5-question survey and one additional place for comments. The purpose for this survey was to develop data on the six-month experience of plastic surgeons using the PDC. A total of 206 Aesthetic Society members (9%) participated in the survey (1849 total active members in the United States). Patients deserve appropriate information prior to breast implant surgery to make an informed decision after reviewing the potential risks and benefits. The authors believe that there is still more work to be done on an ideal PDC will make it fair and balanced and that it scientifically describes risk incidence in a way that patients understand and can be updated.