Breast Implant-Associated Illness: Medicine by Belief, So Says Dr. Google

Recently, we observed that breast implant patients are more frequently calling our office with vague symptoms of fatigue, poor sleep, aches and pains, lymphadenopathy, and malaise. They seemingly have a common thread within their conversation of, “I know that my implants are making me sick, and I need an enbloc total capsulectomy in order to feel better.” The conversation appears almost scripted at times. Many of the callers are patients with excellent long-term clinical outcomes, who have been back for scheduled follow-up visits. Formerly, they expressed excellent satisfaction with regards to their clinical outcome and no reported complaints otherwise. Objective evidence from their medical records does not contain reference to vague symptoms. Occasionally, patients will reference a newspaper report or television program that mentions a specific study that links breast implants to systemic illness. One patient called the office, inquiring about an enbloc capsulectomy and implant removal, 6 months after a successful breast augmentation. She was a registered nurse and was convinced that the unilateral axillary lymphadenopathy and fatigue she was experiencing was caused by her silicone gel implants. The focus in her conversation was on the enbloc capsulectomy/removal because she had been on various internet sites and believed that her symptoms fit into what was described on these sites as “breast implant-related illness.” She had not been seen by her personal physician for an evaluation of her symptoms but went to the internet in search of answers. She was quite emotionally distressed from worries about having a systemic illness affecting her immune system that was caused by her breast implants. Our office surgical nurse over the course of several conversations helped her reorient her thinking and encouraged her to see her personal physician. Her symptoms were evaluated, and laboratory testing confirmed a case of mononucleosis from the Epstein Barr virus. To a patient, there seems to be the common thread of a Google search and time spent on internet sites and social media that promote a link between silicone breast implants and systemic illness. These sites advocate for enbloc capsulectomy to remove the capsule that contains “toxins” in addition to the implants. These sites also have a referral function to plastic surgeons throughout the world who are willing to perform implant removal with enbloc capsulectomy that is not covered by health insurance. Some patients go to extreme measures to have their implants and capsules removed through medical tourism to foreign clinics that can be found on the internet. A recent patient sought a second opinion about her misplaced mastopexy scars that were visible in her décolleté following enbloc capsulectomy/explant/mastopexy/AFT procedure. She also had a “cobra deformity” of her neck from overly aggressive sub mental liposuction that the surgeon upsold her on at the time of the breast procedure. Arguably, she was not better off from her medical tourism escapade because now she has visible deformities. Unfortunately, patients seem to be in the realm of belief-based medicine when they make associations between their breast implants and ill-defined symptom complexes.1 This appears to be magnified by fake medical advice on internet sites and social media that purports a link between silicone breast implants and ill-defined systemic illnesses. They then request an enbloc capsulectomy and implant removal that is proposed as a way to rid oneself of the problems allegedly caused by silicone implants. Patients seemingly are focused on surgical removal vs trying to determine what might be the cause of their malaise through a medical workup. Their anxiety and worry lead them to make irrational treatment choices. These patients are acting according to what is described as “medicine by belief,” where objective evidence and outcome data are discarded. According to some patients, any decision requiring a deliberative consideration of contested positions can and should be decided on just one thing: belief. Belief is sufficient. Nothing else matters. It is an inescapable irony that this standard—“I believe”—is being established inside the context of an implanted medical device that probably has been the most studied in history. This new standard for would be that linkage to alleged vague systematic complaints can be rendered in the absence of substantive scientific data or any medical standard relating to corroboration. To make matters worse, even the renowned New England Journal of Medicine published a recent article by Chang and Lee that promotes the concept of “interpersonal medicine.”2 In the opinion of the authors, what is needed is “interpersonal medicine,” a disciplined approach to delivering care that responds to patients’ circumstances, capabilities, and preferences that is outside of evidence-based medicine. Together, medicine by belief and interpersonal medicine appear to be a nice fit, especially when in relation to linking breast implants to vague systemic illness. Witness mercury amalgam tooth fillings, autism and thimerosal in vaccines, where there exist similar parallels to silicone breast implants in terms of unfounded health concerns. Oddly, if there was a benefit from enbloc capsulectomy surgery for the treatment of “breast implant illness,” someone would have published an outcome series of this in an indexed peer-reviewed scientific journal somewhere in the world during the last 25 years. Scientific evidence just does not exist to prove benefit. It cannot be found in a PubMed Search (Figure 1). Unfortunately, patients who believe that they have “breast implant illness” become prey of unscrupulous surgeons and are exposed to risk of surgical complications and poor aesthetic outcome from implant and capsule removal surgery, such as the recent patient we saw for a second opinion. A PubMed search using the term “Enbloc Capsulectomy” yields no results. There are a variety of high-quality, peer-reviewed, scientific studies and meta-analysis of the outcome data from breast implant studies that fail to show an association between systemic illness and silicone breast implants. Notable is the meta-analysis of 32 separate studies summarized by Evans in the Annals of Internal Medicine and the Institute of Medicine report of 1999.3,4 Local events such as capsular contracture and rupture seem to be the most common adverse events. Despite the preponderance of evidence in these studies, a poorly written study with unfounded conclusions is highlighted within the media/internet as shining new light on medical conditions alleged to be caused by breast implants. Such a study becomes the most credible rally point for anti-implant groups on the internet. No medical device is without risk both during implantation and afterwards. Even in situations where long-term studies and postmarket approval protocols are used, events can occur such as the breast implant-associated anaplastic large cell lymphoma (BIA-ALCL). BIA-ALCL appears related to biofilm contamination of the textured surface, chronic inflammation, and malignant transformation of lymphocytes.5 There is good awareness of this disorder and how to manage late-term periprosthetic fluid and the BIA-ALCL disorder, both surgically and oncologically. Our current understanding of BIA-ALCL is the result of various professional societies, plastic surgeons, the FDA, and device manufacturers working together, including establishing protocols to evaluate late-term periprosthetic fluid occurrence and oncologic capsulectomy if BIA-ALCL is encountered.6 Textured surface breast implants are widely used throughout the world in a variety of configurations. These devices offer patients specific clinical benefits yet have the potential to trap bacteria in their surfaces that produces biofilm linked to capsular contracture, double capsules, and BIA-ALCL. Despite concerns about biofilm contamination and BIA-ALCL, the results of surgeons who used similar surgical techniques to mitigate biofilm during macrotextured breast implant surgery show progress in managing this problem. Their results indicate that no BIA-ALCL incidence was encountered in 42,000 implants during a mean follow-up of 11.5 years.7 The FDA has removed the restriction on the use of povidone iodine during implant surgery as an anti-infective agent.8 Povidone iodine appears effective against a wide variety of gram-positive and gram-negative bacteria, including Ralstonia picketti, which has been linked to BIA-ALCL. With or without media attention, patients who received breast implants will always continue to have questions and concerns. A recent announcement by the French Agence Nationale de Sécurité du Médicament that textured surface implants from one manufacturer were being withdrawn from the European market becomes a source of concern for patients that must be addressed scientifically. According to the current knowledge, patients who have textured implants and no symptoms have no reason to panic or have their textured implants removed as a precaution. We counsel all of our breast implant patients to continue with their personal breast care, including monthly breast self-examination, mammograms as recommended, and annual visit. If they experience sudden swelling and pain after years after implantation, they should immediately contact us for an evaluation. The plastic surgeon remains the best source of information and clinical judgment for these patients. When a patient calls, inquiring about her implants, this represents an opportunity to address her concerns and provide scientific education and treatment if a problem exists. Help her understand that it is about science, not fake medical advice and belief-based medicine from Dr. Google and social media. Dr. Google is a bad physician and continues to spew disinformation about medical devices and unproven treatments such as the enbloc capsulectomy for “breast implant illness.” There is no reason that medicine by belief and interpersonal medicine should trump science and safety when it comes to medical devices. Dr Jewell is a consultant for Allergan and Solta. Ms Jewell declared no potential conflicts of interest with respect to the research, authorship, and publication of this article. The authors received no financial support for the research, authorship, and publication of this article.