Breast Implant Illness: Identifying Patients Concerns from Public Comments on Regulation.gov

Abstract

INTRODUCTION: Breast Implant Illness is an evolving syndrome that has been gaining traction from the public and the medical community. Patients are experiencing negative emotions towards BII and are dissatisfied with the quality of patient education, as expressed in the public comments submitted in response to the 24OCT2019 FDA draft guidance on breast implant labeling recommendations. To better gauge the patient experience, this study aims to further examine these comments for frequently encountered concerns and themes. METHODS: The comments under the 24OCT2019 Regulations.gov docket were extracted. A team of 14 researchers examined them to detect recurring themes. The comments were then equally and randomly allocated to two independent reviewers to code for the presence of the identified themes, and to a third reviewer for conflict reconciliation. Microsoft Excel was used to quantify theme frequencies. RESULTS: The docket contained 1321 comments, of which 4 were not in English, 10 were duplicates and 449 represented repetitions of a template expressing dissatisfaction with the guidelines. Amongst the remaining 758 comments, we identified the following recurrent concerns and themes: 1) insufficiency of FDA guidelines (present in 37% of the 758 comments), 2) feelings of betrayal by doctors, implant manufacturers and/or insurance companies (29.7%), 3) requesting a complete list of ingredients and metals (18.6%), 4) requesting a patient checklist (15%), 5) surgeons, other physicians, or nurses not being able to explain the patient’s symptoms (13.5%), 6) requesting all breast implants to be banned (10.4%), 7) doctors not acknowledging patients’ BII concerns (8.6%), 8) concern about gel bleed/migration (6.2%), 9) explant not covered by insurance (5.7%), 10) patients recognizing they have BII only after coming across a social media group discussing it, or a friend who has it or read about it (4.2%), 11) requesting advocacy for recognition of BII by insurance companies (3.1%), 12) requesting only silicone breast implants to be banned (2.9%), 13) mention/discussion of the previous silicone implant ban (2.1%). CONCLUSION: Patients are expressing several concerns about the safety of breast implants, the FDA guidelines, breast implant illness, and patient education. Notably, the trust towards the medical community is being questioned as patients feel betrayed and dismissed. Breast implants represent one of the mainstay treatments for post-mastectomy breast reconstruction, and their condemnation may compromise the quality of patient outcomes. Therefore, further research is needed to characterize breast implant illness and improve patient advocacy. Interestingly, the FDA updated their labeling recommendation for improved patient communication to include a patient decision checklist which is also reflected by our findings (15% of comments). Our results can serve as a springboard to proactively address patients concerns for optimized patient-physician relationship and restore the trust that qualified plastic surgeons will always have the patients best-interest in mind.