Two hundreds cases of ASIA syndrome following silicone implants: a comparative study of 30 years and a review of current literature

Abstract

In this study, we compared one hundred patients with autoimmune/inflammatory syndrome induced by adjuvants (ASIA) due to silicone implant incompatibility syndrome diagnosed in 2014 in Maastricht, the Netherlands, with one hundred historical patients with adjuvant breast disease diagnosed in the Baylor College of Medicine, Houston, USA, between 1985 and 1992. Similarities and differences between these two cohorts were identified to determine whether the spectrum of silicone-related disease changed during the last 30 years. Patients with complaints possibly due to silicone-filled breast implants were prospectively examined in the Reinaert Clinic, Maastricht, the Netherlands between January 2014 and October 2014. All patients were evaluated for the fulfilment of ASIA criteria. Results were compared to results of the Baylor College cohort and 18 other reviewed historical cohorts. Clinical manifestations between the Maastricht and Baylor College cohorts were comparable. Fatigue was observed in 98 current patients and in 95 historical patients. Arthralgia was observed in 91 versus 81 historical patients. Myalgia was observed in 54 versus 91 patients. Cognitive impairment was observed in 78 versus 81 patients, pyrexia was observed in 64 versus 52 patients, sicca complaints in 73 versus 72 patients and severe neurological manifestations in 20 versus 32 patients. From the 54 patients who underwent removal of their silicone breast implant, 50 % (n = 27) of the patients experienced improvement of complaints after explantation of the implant. Also, in the 18 reviewed historical cohorts, similar clinical manifestations were described. Our findings suggest that no major changes were present in the observed clinical manifestations between the Maastricht and Baylor College cohorts. Also, despite changes in the principal constituents of the silicone implants during the past fifty years, silicone remained an adjuvant that may ‘bleed’ and subsequently may be a chronic stimulus to the immune system resulting in similar clinical manifestations as observed in the Maastricht cohort, the Baylor College cohort and 18 other large cohorts of patients. We therefore conclude that silicone-related disease has not changed during the last 30 years.

Mechanisms of Breast Implant Toxicity: Will the Real Ringmaster Please Stand Up

“…Heavy metals adversely affect enzymes, DNA, and leukocyte respiration; can be toxic to muscle, brain, lungs, kidneys, liver, blood, and nerves; and when present in excess amounts can mimic multiple sclerosis, Parkinson's, Alzheimer's, and muscular dystrophy (21) . Clinical correlates reported in implant recipients include (but are not limited to) hair loss, recurrent infections in a variety of sites, weakness, fatigue, muscle twitching, nail cracking and splitting, cognitive dysfunction, a multitude of other nervous system disorders (e.g., paresthesias; dysesthesias; dizziness; gait imbalance); and abdominal pain, nausea, constipation, and loose stools from dysfunction of the myenteric plexus) (1,2,3,4,5,6,7,12,16,20,22) . i.…”

“…Numerous publications in the past five years have supported the assertion that silicone gel-filled breast implants are genuinely capable of causing a novel systemic illness (1,2,3,4,5,6,7) . Prior claims of a similar nature existed in the 1990's when the controversy first swirled around this issue, but legitimacy at that time was elusive due to faulty methodologies utilized by many investigators (1,4) .…”

“…Silicone-induced autoimmune theories have recently been resurrected in the form of ASIA (autoinflammatory syndrome induced by adjuvants, or Shoenfeld's syndrome), which promotes the concept of multi-organ inflammatory responses to silicone gel (3,5,6,7,9) . The deficiencies of ASIA and the failure of its proponents to consider multiple other mechanisms of disease causation have been outlined in a recent letter to the editor (10) .…”

Is Silicone Breast Implant Toxicity an Extreme Form of a More Generalized Toxicity Adversely Affecting the Population as a Whole?

“…An example of in vivo exposure to organosiloxanes occurs following implantation of silicone gel-filled breast implants. In the past five years these devices have been implicated by many researchers as the cause of a genuinely novel illness (3,4,10,11,12) . Identical causation claims in the early 1990's created a great deal of controversy back then because of faulty autoimmune theories, one of many factors contributing to the inevitable current repetition of this avoidable public health debacle (5,10) .…”

“…Identical causation claims in the early 1990's created a great deal of controversy back then because of faulty autoimmune theories, one of many factors contributing to the inevitable current repetition of this avoidable public health debacle (5,10) . Some investigators have proposed that breast implant illness is nothing more than spontaneous fibromyalgia, and others have proposed that this is an autoinflammatory disorder (12) . Both of these concepts are a gross oversimplification of what is clearly a much more complicated process (1,3) .…”