A Descriptive Analysis of Physical Complaints From Women With Silicone Breast Implants

Abstract

The scarcity of documented problems over the past 30 years use of silicone breast implants has been cited as evidence of their safety. Letters received by the Food and Drug Administration (FDA) cast doubt on the claim that 30 years of silence is equivalent to safety. During the publicity of the regulation of silicone gel breast implants in 1991 and 1992, the FDA received letters from women who described health problems that they felt were related to the silicone gel breast implants. Two hundred and seventy-one of these letters were reviewed and the physical complaints were coded for a computer search program. These physical complaints were categorized as local reactions, systemic symptoms, or diagnoses. The complaints were then summarized and rank ordered by a data base management system computer program. The most common complaints were breast pain (40%), rupture (31%), capsular contracture (29%), joint pain (39%), and fatigue (35%). The most common diagnoses were arthritis (19%), autoimmune disease (7%), Raynaud's disease (5%), and connective tissue disorder (4%). These same complaints were used as keywords for a computerized search of two FDA systems of reported problems with silicone gel breast implants. These letters and two systems of reports show similarities in physical complaints that are consistent with published case reports of physical complaints of women with silicone gel breast implants.