Understanding Breast Implant–Associated Illness

A Delphi Survey Defining Most Frequently Associated Symptoms

Claire E. E. de Vries, M.D.; Manraj N. Kaur, Ph.D.; Anne F. Klassen, D.Phil.; Katie Sommers, M.P.H.; Keith M. Hume, M.A.; Andrea L. Pusic, M.D.

Disclosures

Plast Reconstr Surg. 2022;149(6):1056e-1061e. 

In This Article

Abstract and Introduction

Abstract

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.

Introduction

Over 400,000 breast implant operations are performed annually in the United States: approximately 75 percent for cosmetic augmentation and 25 percent for postmastectomy reconstruction.[1] Breast augmentation is the top cosmetic surgical procedure performed.[1] Given that breast implants are classified as high-risk devices by the U.S. Food and Drug Administration, they have been studied closely for safety and adverse outcomes since they were first approved in 1962.[2] However, there continues to be inquiry into the safety of these devices and whether the breast implants could be associated with specific diseases and conditions.[3]

In recent years, there has been an increase in women with breast implants presenting with a constellation of systemic symptoms, including fatigue, depression, anxiety, joint pain, skin rashes, brain fog, and hair loss, thought to be caused by their implants. These symptoms have been collectively referred to as breast implant illness. The pathophysiology of breast implant–associated illness is unknown, and no diagnostic tests currently exist.[4–14] The few existing epidemiologic studies of women with suspected breast implant–associated illness have been limited because of cross-sectional study design, risk of biases, potential confounders, or inconsistencies in study results.[15–21] Furthermore, researchers have lacked a rigorous, validated, patient-reported outcome measure to assess the systemic symptoms these women with breast implants have been experiencing.

Increased understanding of breast implant–associated illness is necessary to address patients' concerns, fully inform patients preoperatively about the risks associated with breast implants, and advance evidence-based care. The aim of this study was to establish a list of symptoms most frequently associated with breast implant–associated illness with consensus from patient research partners, surgeons, researchers, and regulators. The results of this study will inform the development of long and short forms of a breast implant-associated illness–specific patient-reported outcome measure for use among women with breast implants. We anticipate that this new patient-reported outcome measure will support future research to improve safety and inform patient-centered treatment decision-making for women undergoing breast implant surgery.

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