Long-term exposure to silicone breast implants does not induce antipolymer antibodies

The focus of our studies was to determine whether the antipolymer antibody assay (APA) as an objective laboratory assay could contribute to the diagnosis in women with a silicone breast implant (SBI) and complaints/symptomatic disease. We investigated whether a population of symptomatic SBI recipients exists with a high prevalence of APA in the Netherlands. The study participants were selected based on self-reported complaints. In one study their physician was approached for additional information on their disease status. Two groups of 42 women were included in the studies, with a mean SBI exposure of 17 and 16 years, respectively. The participants were clinically examined, and the APA level in serum samples determined. The study population of SBI recipients was categorised in severity subgroups based on the functional capacity, and the study physicians general assessment of pain and disease activity. Positive APA levels were found in 10% of the SBI recipients. Also in control groups 8% showed a positive APA response. After categorisation most (65 of 84) SBI recipients belonged to the limited severity subgroup on an increasing scale of limited, mild, moderate and advanced. Eight were categorised in the mild, four in the moderate, and seven in the advanced severity subgroup. None of the APA positive women were found to belong to the moderate or advanced severity subgroup. Seven of the APA positive women belonged to the limited, and one woman to the mild severity subgroup. In conclusion, we were unable to include a large proportion of severely symptomatic SBI recipients in our study populations. So, we cannot confirm the results of Tenenbaum et al. [1] on the presence of APA in symptomatic SBI recipients. However, our failure in two separate studies to recruit symptomatic SBI recipients suggests that the population of severely symptomatic SBI recipients in the Netherlands is rather small. The number of APA positive responses in our study population was low. In addition, also in the normal population a similar low percentage of positively reacting women were observed. Hence, we cannot recommend the use of the APA assay for diagnostic purposes in the clinical evaluation of SBI recipients with severe complaints/symptoms.