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  • Title: [Ombrelle 250: a new contraceptive intrauterine device].
    Author: Audebert AJ.
    Journal: Contracept Fertil Sex (Paris); 1986 Oct; 14(10):885-7. PubMed ID: 12269090.
    Abstract:
    The umbrella 250 is a new IUD developed in France to minimize rigidity and penetration of the uterine wall so as to lessen side effects of local pain and bleeding. The flexible, supple vactor has the characteristics of a spring to ensure that it remains in place in the fundal position required for efficacy. The device is in the shape of a T whose vertical branch is coated with copper threads containing 250 sq mm of copper. The umbrella 250 comes in 1 size, 31.5 mm long, and is adaptable to any uterine cavity. The cumulative rates of events per 100 women after 12, 24, and 36 months respectively were .2, .9, and .9 for pregnancy; .6, .6, and .6 for expulsion; 1.9, 3.7, and 4.0 for removal for pain or bleeding; .8, 1.7, and 2.8 for removal for other medical reason; 1.7, 5.7, and 7.0 for removal to become pregnant; and .2, 1.2, and 1.4 for removal for personal reasons. The continuation rates were 95.1, 87.0, and 83.9 after 12, 24, and 36 months. There were 461, 373, and 149 insertions and 5755, 10,813, and 13,768 women-months of use in each of the 3 years. A multicenter study covering 925 insertions after 12 months showed 2 accidental pregnancies, 4 expulsions, 27 removals for pain and bleeding, 6 removals for infection, 10 removals for other medical reasons, and 16 removals to become pregnant. 89 patients were lost to follow-up. The continuation rate was 92, and the experience covered 9054 women-months of use. The patients were selected according to the usual criteria for IUD use. Most patients had at least 1 child and were at least 30 years old. The rates of expulsion and removal for pain and bleeding appear to be low, but a true comparative study has not been completed.
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