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Contraception. 2014 Feb;89(2):139-41. doi: 10.1016/j.contraception.2013.10.017. Epub 2013 Nov 7.

The IUB, a newly invented IUD: a brief report.

Author information

1
OCON Medical, Modiin 7171801, Israel.
2
Office of Population Research, Princeton University, Princeton, NJ 08544, USA; The Hull York Medical School, HU6 7RX Hull, England, UK. Electronic address: trussell@princeton.edu.

Abstract

OBJECTIVE:

To evaluate the initial safety and effectiveness of the intrauterine ball (IUB), a copper intrauterine device that, upon insertion in the uterus, takes a three-dimensional spherical form.

STUDY DESIGN:

Fifteen women were followed for 1 year, with follow-up visits at 1, 3, 6, 9 and 12 months.

RESULTS:

The physician reported that all devices were very easy to insert. One subject discontinued before the 6-month visit (at 119 days after insertion) for a reason not related to the device. There were no perforations, expulsions, malpositions or complications, or pregnancies.

CONCLUSION:

No safety or efficacy concerns were raised.

IMPLICATIONS:

Due to its form and deployment process the IUB is expected to ease insertion and reduce perforation, malposition and expulsion rates and may also reduce dysmenorrhea and menorrhagia.

TRIAL REGISTRATION:

ClinicalTrials.gov NCT01590563.

KEYWORDS:

Discontinuation; Ease of insertion; Efficacy; Expulsion; Safety; Satisfaction

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