Assessing Long-term Outcomes in Breast Implant Illness

The Missing Link? A Systematic Review

Rod J. Rohrich, M.D.; Justin L. Bellamy, M.D.; Brendan Alleyne, M.D.


Plast Reconstr Surg. 2022;149(4):638e-645e. 

In This Article

Abstract and Introduction


Summary: The purpose of this special topic article is to explore the current state of outcomes-based literature related to breast implant illness and summarize the key understandings that emerge from the summation of existing studies. While implanted silicone devices are some of the most ubiquitous products in modern medicine, the safety of silicone breast implants has long remained under scientific scrutiny. In the era of social media and with breast implants once again under public scrutiny with the recent connection of texture silicone implants to breast implant–associated anaplastic large-cell lymphoma, the borders between breast implant illness and other implant-related diseases are becoming clouded in the public eye. The surgical management options for breast implant illness range from simple implant explantation alone to complete en bloc capsulectomies, or even secondary exploratory operations for additional capsulectomy in persistently symptomatic patients. In this review of outcomes-based studies related to breast implant illness, the authors found that a subset of patients improves with surgical intervention but limited evidence to inform most current surgical management practices. Further, the nature of this illness renders it difficult to study. A carefully designed, large, prospective, outcomes-based study is still required if an evidence-based and sound treatment approach for this condition is to be established.


Breast implant illness remains a poorly understood entity. Concerns that breast implants may be linked to autoimmune diseases ultimately fueled the U.S. Food and Drug Administration–issued moratorium on silicone breast implants in January of 1992. Multiple comprehensive studies have since been done in the subsequent years, but no definitive causal link between autoimmune disease and silicone breast implants could be established.[1–5] The Food and Drug Administration moratorium was subsequently lifted in 2006, with widespread resumption of silicone breast implant use across the United States for both cosmetic and reconstructive breast surgery. However, concern regarding the safety of silicone and silicone-coated saline breast implants did not entirely abate. In part stirred by the growing impact of social media, there has been a recent resurgence of interest in what has been termed "breast implant illness" to describe this variable and ill-defined constellation of systemic symptoms associated with breast implants.[6,7] Our goal as physicians and plastic surgeons is to continue to learn about this complex multifactorial illness and advocate for more and improved outcomes-based research to elucidate how we can optimally help these patients.

Women continue to seek surgical explantation of their silicone breast implants, either out of concern for potential future health risk or out of suspicion that the silicone implants are actively contributing to the systemic health complaints associated with breast implant illness (Figure 1). These trends have attracted the attention of several research groups, from both the industry as mandated by the U.S. Food and Drug Administration and independent investigators, in an attempt to clarify the safety profile of silicone breast implants.[2–5,8–15] Several related terms to describe the constellation of systemic complaints in this population emerged: breast implant illness, silicone implant illness syndrome, and adjuvant breast disease. In addition, relevant reports in the rheumatology literature surfaced as a subset of a larger classification of diseases termed "autoimmune syndrome induced by adjuvants," wherein silicone is the theorized adjuvant that facilitates or exacerbates an autoimmune or proinflammatory condition.[16] Other published theories as to breast implant illness etiology include psychologic somatization, wherein a psychological fixation of nonspecific symptoms to a foreign body causes elevated anxiety, with cathartic psychological relief with explantation of the offending foreign body.[17,18] However, these psychologically based theories inadequately explain some of the more objective or rheumatic symptoms related to breast implant illness.

Figure 1.

Breast implant illness.

Although breast implant illness is its own entirely distinct and unrelated condition, there has been some anxiety and confusion related to the rare cancer termed breast implant–associated anaplastic large-cell lymphoma (BIA-ALCL), seen almost exclusively in textured silicone implants.[19–22] This has reignited fears about the general safety of all breast implants. Social media have further amplified the public response[6,7] and clouded the borders between distinct disease entities related to breast implants. Plastic surgeons are tasked with providing this growing body of patients with well-informed data and evidence-based care regarding the safety of breast implants. Yet, with an unknown and undefined denominator, little is known about the true prevalence of breast implant illness, let alone the best course of treatment. Thus, many surgeons have empirically turned to management strategies borrowed from the BIA-ALCL literature, including implant explantation with en bloc capsulectomy, despite the paucity of evidence at this time to support this aggressive means of breast implant illness management.

The aim of this article is to specifically review the present state of outcomes studies related to breast implant illness management strategies. Key principles related to this study population are highlighted.