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PRESS STATEMENT: Health Care Providers Applaud FDA Approval of Mirena to Treat Heavy Menstrual Bleeding
Important Action Offers Women Who Suffer this Condition a Non-Surgical Option and Reflects FDA’s Renewed Commitment to Evidence-Based Science
For Immediate Release
October 2, 2009
Wayne C. Shields
President & CEO, Association of Reproductive Health Professionals
On behalf of the more than 11,000 members of the Association of Reproductive Health Professionals (ARHP), ARHP applauds the Food and Drug Administration's (FDA) approval of Mirena (levonorgestrel intrauterine system) to treat heavy menstrual bleeding in women who use intrauterine contraception as their method of pregnancy prevention.
Mirena was approved as a contraceptive by the FDA in 2000. It is a small, flexible hormone-releasing device inserted into the uterus to prevent pregnancy. The device is inserted by a trained health care professional.
Recent studies show a statistically significant reduction in menstrual blood loss in women using Mirena. Participants in the most recent clinical trial had excessive menstrual blood loss prior to treatment and did not have any medical conditions that are known to cause heavy menstrual bleeding, except for small uterine fibroids in some cases.
Many women suffer from excessive menstrual bleeding and, until now, have had limited options for treatment other than surgery, often times hysterectomy. This indication allows exploration of a non-surgical intervention and gives women with this condition a less invasive option.
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The Association of Reproductive Health Professionals (ARHP) is the leading
source for trusted medical education and information on reproductive and sexual
health. ARHP educates health care providers, informs consumers, and helps shape
public policy. ARHP is a non-profit membership association composed of highly
qualified and committed experts in reproductive health. ARHP members are health
professionals in clinical practice, education, research, and advocacy and they
include physicians, nurse practitioners, physician assistants, nurse midwives,
researchers, educators, pharmacists, and other professionals in reproductive
health. To learn more, visit: http://www.arhp.org.
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