Breast implant illness: diagnosis and management

Introduction

Breast implant illness (BII) is a condition that is not well understood. It is represented by a cluster of symptoms that do not fit into any other classic disease diagnosis. It is not associated with abnormal physical or laboratory findings and is therefore looked on skeptically by some individuals. Recently, the US Food and Drug Administration (FDA), the major plastic surgery societies, and other health authorities have been devoting more attention to BII than they did in the past. In May 2019, the FDA released a statement noting that the agency’s officials are “taking steps to better characterize BII and its risk factors, and are considering ways to help to ensure women have all of the information they need to make informed decisions about whether to obtain breast implants or to remove existing breast implants in an effort to reverse systemic symptoms”. Several syndromes have been described which have met with varying degrees of support for their hypotheses.

ASIA syndrome and other silicone incompatibility syndromes

Controversies have surrounded the use of breast implants for breast augmentation and reconstruction for close to 50 years. “Human adjuvant disease” was first described to arise after the injection of paraffin and processed petroleum and silicone. In 2011 a new syndrome was described by Shoenfeld, the so-called ASIA syndrome (autoimmune syndrome induced by adjuvants). Since its first publication, close to 100 papers have been written on ASIA syndrome. Interestingly, it is a syndrome without a clearly defined causative agent or precise resulting symptoms. Of the numerous papers written on this and similar syndromes, the majority are opinions, reviews, or editorials, most often with broad definitions of the potential external stimuli and resulting clinical manifestations. Early quantitative laboratory studies in animal models were undertaken by Shoenfeld and others who postulated that there may be a direct link between adjuvants and autoimmune disease. Most of the research focused on two agents, aluminum hydroxide, used in vaccines to enhance the response to an antigen, and Complete Freund's adjuvant (CFA), which is used to stimulate cell-mediated immunity. CFA is currently not permitted for use in humans by regulatory authorities and all studies included doses of aluminum hydroxide that were far more than what could be reasonably injected in humans during vaccination. Studies on CFA were also inconclusive with large variations between the studies, absence of clear experimental protocols, and the use of high dosages of aluminum hydroxide, which led to the increased mortality of experimental animals.

A similar syndrome, called “Sjogren-like syndrome” or silicone-related disorder (SRD), was described in 1994 by Freundlich. After reviewing the development of collagen vascular disease-like symptoms in Japanese women injected with raw silicone, he evaluated 50 patients with silicone gel implants who presented with a range of self-reported complaints. While these women did not meet the criteria for a specific diagnosis, the author postulated that capsular contracture (75% of the patients reported significant breast pain) was linked to leaking silicone implants and further postulated that symptoms such as fatigue and generalized achiness were a direct result. Additional work-up of these patients revealed positive ANA, low thyroid levels, Raynaud phenomenon, RA, and Sjögren syndrome.

Researchers in the Netherlands reported on a perceived association between silicone breast implants and systemic symptoms they term SIIS or silicone implant incompatibility syndrome. Patients may be classified as having SIIS if they had symptoms or signs of silicone allergy, capsular contracture, and/or systemic manifestations such as chronic fatigue, arthralgia, myalgias, asthenia, and/or fever. Using similar self-reported diagnostic criteria as used in ASIA, the diagnostic criteria include broad and varying self-reported symptoms, which may manifest anywhere from 2 to 20 years after implantation. Unlike BII, which includes women with both saline-filled and silicone-filled devices, patients with these syndromes only have silicone gel implants.

Despite growing concerns about autoimmune conditions and systemic symptoms to date, ASIA syndrome, SIIS and SRD all remain poorly supported hypotheses. Although there have been numerous publications and presentations on ASIA, some that even tout the syndrome as scientifically valid, more research is necessary to determine whether there are biologic mechanisms, a defined dose response, or a temporal relationship between the possible adjuvants and systemic disease. In addition to the necessary clinical and laboratory studies that are greatly needed, research should include a closer look at which of the self-reported physical and mental health symptoms improve after the removal of the adjuvant and for how long.

Science on trial: changing sources of medical information

There is no question that social media strongly influences the current perception of breast implant safety. The internet has a profound impact on the opinions, emotions, and behavior of women seeking information about their breast implants. In the late 1980s and early 1990s however, it was the mass media that reported on the events surrounding silicone implant litigation as well as the FDA silicone breast implant moratorium. Newspapers and television served as the primary influencers in the late twentieth century. In 1990, a one-sided attack on breast implants aired on the Connie Chung show. The media followed with a flood of articles and headline news, but within a few months the breast implant news cycle was over. Scientific issues concerning implants also permeated into the law. Legal disputes and growing class action litigation increasingly involved complicated medicine, statistics, toxicology, and engineering. In 1993, to reflect sound science, the courts imposed the Daubert requirement that, “an expert in the courtroom employ the same level of intellectual rigor that characterized the practice of an expert in the relevant field”. In 1996, Judge Sam Pointer Jr. of Alabama appointed a “neutral science panel” of four scientists to prepare testimony on the scientific basis of claims against silicone breast implants. This judicial decision turned the tide of breast implant litigation. Later that same year, Judge Jones ruled that the plaintiff's theory of causation, that silicone leaked from breast implants causes signs and symptoms such as muscle and joint pain, headaches, rashes and the inability to concentrate (brain fog), must meet rigorous scientific conclusions in the fields of epidemiology, rheumatology, immunology/toxicology, and polymer chemistry.

The Institute of Medicine report published in 1999 further fortified the robust research on all breast implants (saline and silicone, textured and smooth) that were available at the time. Because of the polarized and controversial nature of the issue, the Institute of Medicine (IOM) report was highly regarded in part due to the committee's make up with half of the members women, including medical experts in rheumatology, radiology, family medicine, and breast cancer. Further, the IOM is a non-government entity that was tasked to carry out an independent scientific review. They recognized information provided by the implant manufacturers, scientists, patient medical histories, and personal submissions. In grading the evidence, anecdotal reports and expert opinion were not given equal weight to well-designed cohort or case-controlled studies and randomized clinical trials, including over 1200 citations from the peer-reviewed literature.

Self-described symptoms in women with breast implants-BII

Breast implant illness (BII) refers to a variety of non-specific symptoms reported by women with implants. These patients have no abnormal lab or physical finding to explain their symptoms. Between 2008 and 2019, 3577 reports were made to the FDA MAUDE database including the terms BII, breast implant illness, and systemic symptoms in relation to breast implants.

Over 100 symptoms have been reported to the FDA by women with self-described BII. The most common symptoms reported are fatigue, brain fog, joint pain, anxiety, hair loss, depression, and rash ( Box 10.1 ). There is no specific configuration of symptoms and most of the described systemic symptoms are common in women with and without breast implants. There are currently no diagnostic criteria for BII; it is a diagnosis of exclusion.