Commentary on: The Prevalence of Self-Reported Health Complaints and Health-Related Quality of Life in Women With Breast Implants Free

Since initial concerns arose in 1992 regarding a potential link between breast implants and systemic autoimmune disease, much attention has been given to researching and validating the safety of modern implantable devices for breast augmentation and reconstruction.^1-4 As new data emerged in the 1990s and early 2000s, federal regulation and monitoring of these devices significantly changed with regard to the utilization of saline vs silicone implants.^5-10 Unfortunately, a similar wave of concern has arisen more recently with the association of anaplastic large cell lymphoma (ALCL) in some women with textured shell breast implants. An entirely new body of research has arisen from these concerns in an attempt to better elucidate the underlying mechanisms and risk factors in breast implant-associated ALCL with an ultimate recall of textured implants from the United States device market by the FDA in 2019.^11-17 Though much of the existing literature supports the safety of saline and modern, cohesive, silicone implants, continued investigation and patient monitoring remain vital to ensure optimal patient care and informed decision-making.

The current study offers continued investigation regarding the prevalence of systemic health complaints, characterized as the autoimmune syndrome induced by adjuvants syndrome, in women who have undergone elective breast augmentation or reconstruction. Four groups of women were studied, with those in the Meldpunt Klackten Siliconen (Dutch Foundation of Women With Illness Due to Breast Implants) database group producing the most interesting findings. Specifically, the Meldpunt Klackten Siliconen database is a self-reported database that collects demographic and clinical information for women with breast-associated complaints. Patients within this group reported the highest rates of clinical autoimmune syndrome induced by adjuvants syndrome manifestations, surgical revision, chronic disease prevalence (irritable bowel syndrome [IBS] and fibromyalgia, in particular), allergies, myalgia, and fatigue. These findings represent an interesting subset of the population of women who underwent breast implant placement who may be at higher risk for development or worsening of symptoms of underlying preexisting medical comorbidities. We commend the authors on their endeavor to further identify and stratify those patients who may be at risk for adverse outcomes following breast implantation.

As mentioned in the article, it is important to note that many of the symptoms of the underlying disorders outlined in this study have significant overlap with the self-reported complaints of the women surveyed as well as multiple other diagnosable and non-diagnosable syndromes. For example, an internet query of diseases associated with allergies, myalgia, and fatigue yields numerous possibilities for a differential diagnosis, including but not limited to chronic fatigue syndrome, fibromyalgia, IBS, rheumatoid arthritis, multiple sclerosis, adrenal insufficiency, and depression. As such, any of the complaints reported by participants in this study could be attributable to a number of other pathologic entities. Further, given the retrospective nature of this study, it is unclear whether patient complaints were present prior to implant placement or arose postoperatively as new or worsening complaints that may have occurred regardless of breast implantation. It also warrants mention that there is a component of self-selection involved in this study, which the authors duly note. Self-reported patient databases are more likely to recruit responses from negatively affected or dissatisfied patients than those without complaint or complication. As such, the data are surely skewed secondary to this sampling bias. Lastly, the control group inevitably has implicit bias because these participants were selected via recruitment of friends and family members of participants in the silicone implant study group. The relationship of control group participants with study group participants results in an inherent opinion bias based on personal experience that may affect the data represented in this study. A control group comprised of random women without breast implants, who may or may not personally know someone who underwent breast implantation, would be considered more representative of the population at large.

Anecdotally in our practice, though we do see a small subset of patients who present with symptoms of systemic illness that may be attributable to the presence of breast implants, we do not find a notable trend of postoperative complications related to systemic complaints in women who underwent breast reconstruction or augmentation with breast implants, silicone or saline. For patients with breast implant-associated complaints, some do have substantial improvement in symptoms following explant. These findings may be the result of treating true symptoms caused by an unknown, underlying, physiologic response mechanism to the implanted device or perhaps may be a placebo effect vs psychological reassurance that a foreign body is no longer present. However, some women who do choose implant removal do not necessarily have significant improvement in symptoms after undergoing explantation. This finding not only suggests that the specific systemic complaints prompting implant removal are attributable to something other than breast implant illness but also often results in significant dissatisfaction in body image without anticipated symptomatic improvement following explant.

Further prospective research is warranted to better identify and characterize patients who may be at risk for complications following breast implant placement as well as aiding selection of patients for whom explant may be beneficial. This is an incredibly difficult problem to study, and we applaud the authors’ attempt at answering these complex questions. Nonetheless, the findings of this and future studies may assist in guiding preoperative discussions with patients with fibromyalgia, IBS, and other autoimmune or inflammatory disorders and possible postoperative outcomes, thus improving informed decision-making.

Disclosures

The authors declared no potential conflicts of interest with respect to the research, authorship, and publication of this article.

Funding

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

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