February 2009 · Vol. 21, No. 02What’s the gist of a new FDA label for the LNG-IUS?
Important changes for practice affect insertion and use of the Mirena device, selection of candidates, contraindications, and adverse effects
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Fast Track
The new label downplays concerns over group A strep infection and the risk of pregnancy while using the LNG-IUS
Optimally, a cycling woman should have the LNG-IUS placed during the first 7 days of menses
An LNG-IUS device that settles in the lower uterine segment still maintains its effectiveness
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Anita
L.
Nelson,
MD;
Raquel
Arias,
MDDr. Nelson is Professor of ObGyn at the David Geffen School of Medicine at UCLA, Los Angeles, and Chief, Women’s Health Care Programs, at Harbor-UCLA Medical Center.
Dr. Arias is Associate Professor of ObGyn at the Keck School of Medicine of the University of Southern California, Los Angeles, and Associate Dean of Women at the Keck School of Medicine.
Dr. Nelson has received research grants from, and participated in a speaker’s bureau and an advisory council for, Bayer Health Care Pharmaceuticals for the LNG-IUS (Mirena) and derivative products. Dr. Arias has participated in a speaker’s bureau and an advisory board for Bayer Health Care Pharmaceuticals for the LNG-IUS (Mirena).
Since the levonorgestrel-releasing intrauterine system (LNG-IUS) (Mirena, Bayer Health Care Pharmaceuticals) (FIGURE 1) was introduced in the United States in 2001, more than 2 million devices have been used by women here. This use has contributed to a cumulative experience of 14 million women (36 million woman-years of experience) in 120 countries over the last 18 years.
Recent Food and Drug Administration (FDA)-approved labeling changes for the LNG-IUS1 expand the pool of women who are candidates for this convenient, reversible method of contraception. This article summarizes those labeling changes and answers questions that are often asked by clinicians who, more and more, insert the LNG-IUS for their patients.
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