Understanding Breast Implant-Associated Illness: A Delphi Survey Defining Most Frequently Associated Symptoms.

Background: Increased understanding of the constellation of symptoms referred to as breast implant illness is necessary to better address patient concerns, provide evidence-based care, and inform prospective patients about potential risks. The aim of this study was to reach consensus on the symptoms most frequently associated with breast implant illness, which will subsequently inform the development of a symptom severity scale.

Methods: A literature search of peer-reviewed and gray literature was performed to identify a comprehensive list of symptoms associated with breast implant illness. This was followed by an online, three-round, modified Delphi survey where the list of symptoms was reviewed by an international panel to determine the top 20, 10, and five symptoms associated with breast implant illness. A virtual meeting of panelists was held to reach consensus on the symptoms to be included in a symptom severity scale.

Results: A total of 44 symptoms were identified through the literature search. The modified Delphi survey panel consisted of patient research partners [n = 9 (34.6 percent)], plastic surgeons [n = 10 (38.5 percent)], researchers [n = 6 (23.1 percent)], and a member of the U.S. Food and Drug Administration [n = 1 (3.8 percent)]. The response rates of round 1, 2, and 3 were 85, 96, and 100 percent, respectively. Consensus was reached on the top 19 and top six symptoms to be included in long and short forms of a symptom severity scale.

Conclusions: There was a high level of agreement on the symptoms to be included in a symptom severity scale. The next steps include conducting in-depth qualitative interviews with women with these symptoms and breast implants to understand the experience and impact of these symptoms and develop the preliminary scale.