Commentary on: Understanding Breast Implant Illness

“In God we trust; all others bring data.”―W. Edwards Deming

The authors of this study should be commended for designing the first qualitative study intended to scientifically characterize the causes, course, risk factors, and treatment of women experiencing self-reported breast implant illness (BII) and compare this cohort with a control group of women who denied experiencing BII. Dr Newby is a specialist in illness anxiety disorder, a psychological disorder characterized by excessive fears of illness. Patients with this condition tend to worry about having or developing illness, and based on these fears, they seek medical care and Google their symptoms.

Although breast augmentation and the replacement of aging implants remains popular worldwide, increasingly physicians are seeing patients concerned that their systemic symptoms are related to their breast implants.¹ At this time, there are no diagnostic criteria or specific tests that specifically differentiate BII from other medical conditions that share over 100 reported symptoms. Most current studies have neglected to investigate the many complex psychological symptoms, the widespread use of social media, or any previous psychological therapy these women may have had. Also missing from previous published studies is a comparison of the experiences between women self-reporting BII and those who do not, nor has there been an evaluation of where, or how often, patients seek help for their symptoms or compare their experiences with each other. A discussion on the potential pathophysiology of BII was beyond the scope of this study. Instead, Newby and Adams focused on illness anxiety disorders, in particular the psychological and social factors that may contribute to stress, somatization, and the misattribution of unrelated symptoms to breast implants in certain women.²

In order to specifically address the multitude of symptoms most commonly reported by women with BII, Newby and Adams administered the validated Generic Assessment of Side Effects Measure (GASE).³ This questionnaire is structured to assess self-reported symptoms as compared to the general population and contains questions that are very closely aligned to the symptoms reported by women with BII. Further, it is recognized and used by the Food and Drug Administration (FDA) as tool to evaluate medical device and pharmacologic side effects.⁴ To specifically assess subjects’ anxiety and depression, the Hospital Anxiety and Depression Scales (HADS) were used. This questionnaire has been validated in patient populations suffering from various pathologies, including patients with medically unexplained symptoms and those with chronic physical conditions. HADS does not confound the symptoms of anxiety and depression with other physical symptoms, for example, fatigue, which may be reported in other chronic conditions.⁵ Physical health was assessed by the Self Rated Health questionnaires. Self-diagnosis of health has been shown to be powerfully linked to the emergence of new sources of health information, making patients perhaps more aware of conditions they may not have recognized before or making conditions they were aware of more personally salient.⁶ The authors took considerable measure to provide the simplest, shortest surveys on mental health that provided a validated cut-off between a clinical and nonclinical range, while being clear that they were not suggesting that all symptoms were psychological in nature.

The demographic data interestingly reveals that women with self-diagnosed BII tend to be older and less likely to have an advanced educational degree. They were also more likely to be out of work due to sickness than the non-BII group. More subjects had saline implants in the BII group and most were not sure on the surface type. Over 90% of BII group reported having been diagnosed with a medical condition, and 98% reported assessing online support including social media groups (90.1%). Based on Newby’s expertise in psychology, this paper is the first to demonstrate, with a significant degree of certainty, that women with BII who had their implants in place had significantly higher anxiety and depression than those explanted with BII, and even those who had been explanted had higher levels of anxiety and depression than those in the non-BII cohort. The data collected from this study sheds light on the significant level of clinical anxiety and depression experienced by women in the BII cohort and suggests that better screening of aesthetic patients prior to breast augmentation may be indicated. The temporal relationship between the diagnosis of anxiety and/or depression and the timing of the breast augmentation needs to be better documented. Although high rates of anxiety and depression were documented among women self-identified as having BII, fewer than 25% reported ever being under the care of a psychiatrist. The need to identify systemic symptoms and psychological illness before explantation and at periodic intervals after surgery is critical to our development of best practices for the surgical management of the capsule tissue. This data is essential essential to answer the question whether the type of capsulectomy performed—partial, complete, or en bloc—will have any significance on the long-term improvement of reported symptoms and how long these improvements last.

There are currently dozens, if not more, BII studies underway worldwide. Previous historical theories, including autoimmune inflammatory syndrome induced by adjuvants (ASIA) and silicone illness incompatibility syndrome (SIIS) lack a plausible biological mechanism, have no defined biochemical markers, and no temporal relationship between the stimuli and condition.⁷ Currently, one study, funded by Aesthetic Society Education and Research Foundation (ASERF) is enrolling subjects in the United States. This multisite biospecimen study is collecting data in 3 cohorts: women with breast implants undergoing an explantation who attribute their symptoms to their breast implants; women who are undergoing an implant explantation or revision without symptoms that they attribute to their implants; and an age-matched control of women undergoing a mastopexy with no previous exposure to any implanted device. In addition to the collection of capsular tissue and systemic blood, subjects complete both a systemic symptoms survey and the PROMIS National Institutes of Health–validated survey on anxiety and depression as well as a fibromyalgia scale preoperatively, and at 6 weeks, 6 months, and 1 year postoperatively. The 22-item symptom survey was designed around the top systemic symptoms reported by women in the largest BII social media groups. In a similarly structured study currently underway in Australia, investigators are collecting surgical, implant, and patient data, and are utilizing a similar systemic symptom questionnaire along with a modified Breast Q and the PROMIS survey.

The contributions of Newby and Adams bring up a very important issue concerning current and future BII research. The use of patient-reported outcome measures (PROMs) and quality-of-life measures have become increasing relevant to physicians, patients, and international regulatory bodies. Based on the need to classify the identifying symptoms reported by women who associate their implants with their illnesses, as well as the need to validate psychological and social measures, shouldn’t both the symptom surveys and the validated psychological tools used to collect data on these subjects be unified across all studies? Although there are ways to harmonize results directly across different measures, this does require a bit of statistical maneuvering. This is precisely why the FDA recommends that quality-of-life measures in breast implant trials be consistent, reflected by their requirement that all breast implant clinical trials use the Breast Q moving forward. Although an absolute consensus on symptoms may be difficult, a consensus on the use of specific validated anxiety and depression measures may make future collaboration and meta-analysis much more reliable and significant.

Disclosures

Dr Glicksman is the Medical Director of the Motiva Clinical Trial (Establishment Labs, Alejuela, Costa Rica).

Funding

The author received no financial support for the research, authorship, and publication of this article.

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