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- Title
Implant complications reported.
- Authors
Klilsch, Michael
- Abstract
This article presents information on complication of the hormonal implant Norplant in the U.S. The complaint was made to the Food and Drug Administration between February 1991 and December 1993 by the more than 700,000 women who used the device during that period. Twenty-four women were hospitalized for treatment of infections at the insertion site, and 14 were hospitalized or required medical treatment because of removal difficulties resulting from deeply imbedded capsules. Thirty-nine women experienced benign or idiopathic intracranial hypertension; 16 of these women were report- ed to be obese, which is a risk factor for the condition. In addition, a total of 15 women experienced a stroke while using the implant; none of the strokes were fatal. Rates of stroke and intracranial hypertension among implant users were within the normal range for women of reproductive age, the investigators observe. They add, though, that given the expected level of underreporting, these rates were close enough to the expected rates, to suggest that Norplant users may be at increased risk of developing these disorders.
- Subjects
UNITED States; HORMONE therapy; INTRACRANIAL hypertension; HYPERTENSION; UNITED States. Food &; Drug Administration; WOMEN; OVERWEIGHT persons
- Publication
Family Planning Perspectives, 1995, Vol 27, Issue 3, p99
- ISSN
0014-7354
- Publication type
Article