Response to: More Research Is What We Need Now for Breast Implant Illness

See the Original Article here.

Overall, we thank Dr Glasberg for providing us with some very positive feedback about our study and the impact of its findings.¹ It is important to note, however, that we have not downplayed the finding that 94% of subjects in the breast implant illness (BII) cohort who underwent explantation experienced at least partial symptom relief of their systemic symptoms. In fact, the first line in the Conclusions states this, so this finding was hardly downplayed. We believe it is unhelpful to go back and forth about whether this is a “real entity.” The symptoms, suffering, and impairment experienced by women who self-report BII are real. We agree with the author that “these patients deserve our understanding and care,” ¹ and that there is a need for further research on this poorly understood area. To establish an actual medical diagnosis would require specific diagnostic criteria and, to date, BII remains a diagnosis of exclusion with no specific symptoms or abnormal laboratory results. Our study is not the first to show symptom improvement after implant removal for patients with systemic symptoms they attribute to their implants. What differentiates our first paper is the demonstration that symptom improvement is independent of the type of capsulectomy performed. This is crucial information for patients choosing whether to remove their implants, and determining whether a capsulectomy is necessary.

The author argues that our results are unlikely to be caused by placebo effect because so many women were positively affected. It is unclear where the cited placebo response rate of 21% to 40% came from because the citation is a website, not an original peer-reviewed publication. To our knowledge there is no established “placebo response rate” and evidence shows that placebo effects are largely influenced by context, including patient-practitioner interactions, the severity and strength and treatment, and expectations of benefit. Although it remains unclear how much of the postsurgery improvement can be attributed to a placebo effect, vs biological, physiological, or another explanation, this does not matter. What matters is that these data guide patient decisions about the benefits they can anticipate if they choose to remove their implants. In addition, we believe that there is also likely to be a positive effect of surgery through the removal of a nocebo.² A previous study coauthored by Dr Newby, one of authors for our papers, showed that women with self-reported BII believe their implants are toxic, and therefore a major threat to their health. The removal of this threat is likely to alleviate at least some patient suffering and anxiety.³

Regarding the heavy metals portion of the study, all of the heavy metals findings were transparently presented without any attempt to dismiss any results. The most important finding addressing the potential causation of symptoms experienced by the BII patients was that no metals were detected at levels of toxicologic concern in any of the 3 cohorts. Furthermore, contrary to the commenter’s remarks, the level of arsenic in the tissue from non–breast-implant patient controls (who were not reporting significant symptoms) was higher than that observed in the BII cohort patients. With respect to zinc, in addition to being present at recognized safe levels, the effects of various levels of exposure to zinc are very well understood and would not account for the range of symptoms experienced in the BII cohort. The primary focus of our study from the start has been to better understand systemic signs and symptoms in these patients, and although there have been several interesting observations which arose that might be of academic interest to explore further, our initial aim remains our focus going forward. Lastly, we thank the author for his thoughts and comments on our paper and encourage further collection of data on this topic from controlled studies.

Disclosures

Dr McGuire is a clinical investigator and consultant for the Motiva US Clinical Trial (Establishment Labs, Alejuela, Costa Rica). Dr Glicksman is the medical director, Motiva US Clinical Trial (Establishment Labs, Alejuela, Costa Rica). Dr Wixtrom is a consultant for Mentor (Mentor Worldwide LLC, Irvine, CA) and PhaseOne Health (Nashville, TN). The remaining author declared no potential conflicts of interest with respect to the research, authorship, and publication of this article.

Funding

All funding for this study was provided by a grant from the Aesthetic Surgery Research and Education Foundation (ASERF).

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