More Research Is What We Need Now for Breast Implant Illness

See the Original Article here.

Breast implant illness (BII) or “symptoms related to breast implants” is a challenging topic that has been debated for decades without any substantial scientific data to advance the discussion. Recognizing this, the authors of the recently published articles in Aesthetic Surgery Journal, “Heavy Metals in Breast Implant Capsules and Breast Tissue: Findings from the Systemic Symptoms in Women–Biospecimen Analysis Study: Part 2” ¹ and “Impact of Capsulectomy Type on Post-explantation Systemic Symptom Improvement: Findings from the ASERF Systemic Symptoms in Women—Biospecimen Analysis Study” ² are to be commended. These are truly groundbreaking studies and go a long way in furthering discussions surrounding the type of capsulectomy that needs to be performed, what is present in these implant capsules, and perhaps, whether BII is indeed a real entity and process. These are extremely well-designed clinical studies that expand the dialogue on this important topic. The authors are to be held in esteem for their scientific rigor and willingness to undertake such painstaking detail in their methods.

The study looks at 3 cohorts of patients: women with breast implants and systemic symptoms, women with breast implants requesting removal who do not have symptoms, and women undergoing mastopexy who have never had an implanted device. Part 1 looks at improvement in patient symptoms in relation to the type of capsulectomy performed. Based on their data, the authors conclude that “The findings show that patients who self-report BII demonstrate a statistically significant improvement in their symptoms after explantation and that this improvement persists for at least 6 months. This improvement in self-reported systemic was seen regardless of the type of capsulectomy performed.” ² The conclusion that the type of capsulectomy has no relationship to symptom relief is not only a first for this type of study, but also an incredibly impactful statement pointing toward the potential delineation of care for these patients. However, the authors downplay the truly meaningful finding that patients with symptoms seen preoperatively (Cohort A) have at least partial relief of these symptoms in 94% of cases. Not only is this a statistically significant finding but one that goes to the heart of the BII discussion. One might reasonably conclude that the authors have indeed established that BII or “symptoms related to breast implants” is a real entity.² Some who have read these findings have dismissed this as a placebo effect. Although the placebo effect is considered a scientific reality, it is difficult to dismiss findings of this magnitude as simply that. In fact, studies have shown that this phenomenon is only affected in about 1 in 3 individuals (mean, 21%-40%).^3,4 Given this known finding, it would suggest, in this study, that at least 62.7% of patients have indeed seen a statistically significant improvement in their symptoms simply by removing their implants. This is a major finding in the discussion around BII and seems to bolster the argument that BII is a real medical and surgical entity.

In Part 2, the authors look at the presence of heavy metals in breast implant capsules and whether there is a difference between the capsules of those with symptoms and those without. They state, “The data reveal patients in Cohort A (those with breast implants and symptoms) had a statistically significant increase in only 2 of the 22 metals tested, arsenic and zinc.” They dismiss the findings by stating “Confounding variables such as cigarette smoking, gluten-free diets, dietary supplements, and the presence of tattoos were all identified as statistically significant potential contributory sources of arsenic and zinc in Cohort A.” ¹ However, the findings that arsenic and zinc are indeed present in statistically significant elevated levels in those with symptoms warrants further investigation because the non–breast implant cohort does not show these elevated levels. Furthermore, the authors ignore the findings that aluminum, barium, chromium, copper, iron, lead, mercury, nickel, tin, and zinc are all found in statistically significantly elevated levels in all patients with breast implants (Cohorts A and B) and their capsules vs a breast tissue sampling from those who have never had a device in place (Cohort C). What these findings demonstrate is still unclear and needs to be investigated further. Given their significance, however, these results should be conveyed in some manner to maintain transparency.

As a specialty, we need to continue the work that these studies have revealed and remain open to the possibility and concept that there is a subset of patients who may have symptoms related to their breast implants. Recognition of this, which may actually be supported by these studies, should not be thought of as a failing, but rather a willingness to understand the needs of patients that the plastic surgery community has implanted with these devices. No matter how small or large that number may be, these patients deserve our understanding and care. The overarching ask is for the continuation of further research in an area that is still only minimally understood.

Disclosures

Dr Glasberg is a consultant for Allergan Inc. (Irvine, CA).

Funding

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

REFERENCES

Author notes