ABSTRACT
Pathological material was collected from 4 patients involved in post-surgical complications with polyurethane foam-coated mammary prostheses. This material included: prosthesis and capsule removed at prosthesis explantation for medical reasons (first and second patient), capsule removed following prosthesis implantation and prosthesis and capsule removed at prosthesis explantation (third patient), and lump excised two years after prosthesis explantation (fourth patient).
Evidence of deterioration processes and tissue interaction was evident as early as 12 days after the operation. In this short time, the polyurethane foam and the silicone-based adhesive that was used to bond it to the prosthesis surface became partly detached from the prosthesis core. Over longer time intervals, the tissue growth continued and a connective tissue layer was generated between the original foam cover and the surrounding fatty tissue. Then, larger solid entities dispersed in the tissue over a period of at least two years, suggesting that the half-life of prosthesis debris may be very long.
Our study emphasizes that it is of paramount importance to investigate mammary prostheses in three directions:
A sound epidemiological study is needed to establish the in vivo durability of the prostheses, the success rate and the nature of major evolutive complications.
A basic bench study is needed to characterize the prostheses and identify the degradation products, if any, and the kinetic of the reactions.
An advisory board should be set up at the provincial or federal level to advise doctors and patients of the most appropriate forms of treatment in case of major complications.
