ab2002

Study to determine the presence of antipolymer antibodies in a group of Dutch women with a silicone breast implant

W.H. De Jong¹, C.A. Goldhoorn², M. Kallewaard³, R.E. Geertsma³, H. Van Loveren¹, J.W.J. Bijlsma², J.S.A.G. Schouten⁴

¹Laboratory for Pathology and Immunobiology, National Institute of Public Health and the Environment (RIVM), Bilthoven; ²Department of Rheumatology and Clinical Immunology, University Medical Centre, Utrecht; ³Laboratory for Medicines and Medical Devices and ⁴Department for Public Health Forecasting, National Institute of Public Health and the Environment, Bilthoven, The Netherlands.

ABSTRACT
Objective
To determine whether there exists a population of Dutch women with a high prevalence of antipolymer antibodies (APA) and severe health complaints/symptoms, and exposure to a silicone breast implant (SBI). As the antigen-specific nature of the antipolymer antibody has not yet been established, we refer to the term polymer binding immunoglobulins.

Methods
The study population was selected from a voluntary registry of SBI recipients of a Dutch consumers organisation. The final selection was based on the severity of self-reported complaints in a questionnaire. A total of 42 SBI recipients were included in the study, clinically examined and blood samples were obtained.

Results
In 12 of 42 SBI recipients an increase in the level of polymer binding immunoglobulins was detected compared to a negative reference sample, 3 of these 12 showing a positive and 9 a weakly positive response. In 3 out of 12 non-SBI recipients, included for control on the performance of the APA assay, an increased level of polymer binding immunoglobulins was demonstrated, 2 of these 3 showing a positive and 1 a weakly positive response. The study population of SBI recipients was categorised in severity subgroups (limited, mild, moderate, advanced) based on the functional capacity and the physicians general assessment of pain and disease activity. Most (34 of 42) SBI recipients belonged to the limited severity subgroup.

Conclusion
Our methods failed to select a group of severely symptomatic Dutch SBI recipients reported to have a high prevalence of polymer binding antibodies. A discrepancy was present between the self reported severe complaints and the observed mild clinical symptoms. In the group of SBI recipients with self reported severe complaints recruited we did not find a high prevalence of polymer binding immunoglobulins. SBI exposure (mean 17 years) did not result in induction of polymer binding immunoglobulins in this minimal symptomatic study group.

Key words
Silicone breast implant, antipolymer antibodies (APA), polymer binding immunoglobulins.

Please address correspondence and reprint requests to: W.H. De Jong, Laboratory for Pathology and Immunobiology, National Institute of Public Health and the Environment (RIVM), P.O.Box 1, 3720 BA Bilthoven, The Netherlands.
E-mail: w.de.jong@rivm.nl