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Women who have undergone implantation of a breast prosthesis have been exposed to a variety of health risks, many of which were unknown to them at the time of surgery. Recognition of health hazards has prompted the Food and Drug Administration to restrict implantation of these devices while study of safety and efficacy are undertaken. Capsule contracture, or the contraction of the fibrous tissue surrounding the prosthesis, is the most frequently occurring complication. Exposure to an implant does not appear to heighten the risk for breast cancer, but the opacity of a prosthesis substantially reduces the diagnostic capability of mammography. Silicone, used in the manufacture of implants, is linked to immunologic changes that result in connective tissue disorders. Most often this condition is scleroderma. Damaging effects from toluenediamine, a disintegration product of the polyurethane coating, have been reported. Whether the concentration of this chemical reaches toxic levels in women with prostheses remains to be clarified by current investigations.
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Delores Schumann (1994) studied this question.
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