The Dalkon Shield intrauterine device: a review of current status.
1975; National Institutes of Health; Volume: 14; Issue: 2 Linguagem: Inglês
Autores Tópico(s)
Reproductive Health and Contraception
ResumoThe current status of the Dalkon shield in nulliparous and multiparous patients is reviewed. Only published reports which have properly presented data and report loss-to-follow-up not greater than 10% are included. Pregnancy rates vary from 1.1% to 5.6% after 1 year. Poor insertion techniques or nonuse of an ancillary contraceptive for the first month are suggested factors. Expulsion and medical removal rates compare favorably with data for copper-bearing second generation devices. Most removals have been for bleeding or pain. Continuation rates are comparable to those of copper-bearing devices. Immediate postpartum insertion had a 48% expulsion rate in 1 series; insertion 4 weeks postpartum revealed a high failure rate. A 5% rate of clinical infection was reported in 1 series most successfully treated with device in situ. Perforations have been reported all occurring at time of insertion. Exacting insertion techniques have reduced the incidence of this complication. Since the writing of this paper the Gynecological Advisory Committee of the Food and Drug Administration (FDA) has held a series of hearings relative to the safety of intrauterine devices particularly the Dalkon shield. As a result the A. H. Robins Company withdrew the shield from the market. An editors note states the FDA has now lifted its 6-month ban on the shield but physicians using it must keep detailed records of patients experience with the device.
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