Silicone Gel Breast Implant Adverse Event Reports To The Food And Drug Administration, 1984-1995

November 09, 1998

SILICONE GEL BREAST IMPLANTS. Authors of a study reported in the November/December issue of Public Health Reports have characterized adverse event reports associated with silicone gel breast implants (SGBIs) submitted to the Food and Drug Administration (FDA).

Five scientists from the Center for Devices and Radiological Health in the FDA analyzed 94,120 mandatory and 4303 voluntary SGBI-related adverse events reported to the FDA from December 13, 1984 through December 31, 1995.

The study also compared reports submitted before and after the 1991-1992 barrage of media coverage about concerns regarding breast implants. The authors conclude that the number of adverse event reports had vastly increased after press coverage. The type of reports also changed and the complexity of the reports increased, signaled by the growing number of reports with multiple signs, symptoms and diagnoses reported.

The authors note that the number of mandatory reports remained fairly steady from 1984 to 1990 (729 SGBI reports in 1990 accounted for 2.6% of a total 28,248 reports for all medical devices). In 1992, however, the number of SGBI reports jumped to 20,160, or 30.3 % of the total 66,476 reports on all medical devices. Two years later, 32,884 SGBI reports made up 35.3% of all mandatory medical device-related adverse event reports entered in 1994.

In 1988, before media coverage, the authors report that 87% of all mandatory SGBI adverse event reports were related to implant leak or rupture, while 5.8% involved "reactions." By 1992, "reactions" accounted for 53% of all mandatory reports, superceding that year's 34.4% of reports for leak or rupture. Reaction reports ranged from allergies, alopecia, and arthritis to weight loss, wrinkling, and yellow fingers or toes.
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CONTACT: S. Lori Brown, PhD, MPH
tel 301-594-0610
fax 301-594-0050
email syb@cdrh.fda.gov.

Public Health Reports

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