FDA gives green light to Berlex’s Mirena intrauterine system
First new IUD in 12 years will be available by the end of March
American women enter the first year of the 21st century with a new contraceptive option in hand: the Mirena intrauterine system (IUS) from Berlex Laboratories of Montville, NJ.
The Dec. 6 approval by the Food and Drug Administration makes the Mirena the first such intrauterine device (IUD) to gain regulatory consent since the 1988 introduction of the copper T380A IUD, which is marketed in the United States as the ParaGard by Ortho-McNeil Pharmaceutical of Raritan, NJ.
Look for the IUS to be available by the end of the first quarter of this year, says Don Atkinson, director of marketing for Berlex Laboratories. Cost of the Mirena IUS has not been determined. Company officials say it will be comparable with other methods of long-acting hormonal contraception.
The Mirena is considered an intrauterine system due to its steroid reservoir around the vertical arm of the T-shaped device. (See illustration.) The reservoir contains 52 mg of the progestin levonorgestrel and offers a slow daily 20-mcg release of the hormone. It has been approved in the United States for five years’ use as a contraceptive.
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Mirena Intrauterine System |
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Source: Used with permission of Berlex Laboratories Inc.,
Montville, NJ. |
With 10 years of use in European markets, the Mirena represents a highly effective and safe form of contraception, states Marie Foegh, MD, director of clinical research and development for female health care at Berlex Laboratories. Berlex Laboratories is marketing the device under a license from The Population Council, a New York City-based research organization that initially developed the IUS.
The introduction of the Mirena might indeed begin a new chapter in the use of IUDs in the United States. David Grimes, MD, vice president of biomedical affairs at Family Health International, a reproductive health research firm based in Research Triangle Park, NC, and clinical professor in the department of obstetrics and gynecology at the University of North Carolina- Chapel Hill, says he plans to present Mirena to his patients in this fashion: "It is a new product. It is not your mother’s IUD."
More choices for women
News of the pre-Christmas regulatory approval was welcomed by U.S. providers, who have long eyed the use of the levonorgestrel IUS in international settings.
"That the FDA has approved the Mirena progestin-releasing intrauterine system is good news for U.S. women and their clinicians, who now have access to yet another safe, convenient, and highly effective contraceptive method," says Andrew Kaunitz, MD, professor and assistant chair of the department of obstetrics and gynecology at the University of Florida Health Science Center in Jacksonville. "My British colleagues have consistently sung the praises of this contraceptive, which, although as effective as sterilization, is fully and quickly reversible." The Mirena IUS, along with the Copper T380A, are equal in effectiveness to female sterilization procedures, are totally reversible, have few side effects, and do not increase the risk of infection or of infertility when used by women not at risk of sexually transmitted diseases, states Allan Rosenfield, MD, dean of the Mailman School of Public Health and DeLamar Professor of Public Health and obstetrics/gynecology at Columbia University in New York City. In looking at the percentage of women who experience an accidental pregnancy within the first year of use, the typical use rate for the levonorgestrel IUS is 0.1%, and the perfect use rate is 0.1%. The copper T 380A offers a typical use rate of 0.8%, and a perfect use rate of 0.6%.1
"IUDs are widely used in other countries and, with proper education of both women and their physicians, should become a popular [U.S.] contraception option," notes Rosenfield.
ARHP to offer training
The Washington, DC-based Association of Reproductive Health Professionals (ARHP) and the Ithaca Center for Post-Graduate Medical Education are cosponsoring a new continuing medical education (CME) program titled New Developments in Contraception, which will focus on Mirena and other new family-planning methods. The program will feature more than 200 accredited CME courses and hands-on insertion training sessions during 2001, according to Wayne Shields, association president. (See resources for more information on the CME program.)
ARHP also is developing patient education materials, a clinical handbook, and a special issue of its CME monograph, Clinical Proceedings, which will focus on the levonorgestrel IUS, says Shields.
The proprietary inserter used with the Mirena is designed for easy and safe delivery of the IUS, says Foegh. The Mirena insertion represents a one-handed technique, according to Anita Nelson, MD, professor in the obstetrics and gynecology department at the University of California in Los Angeles (UCLA) and medical director of the women’s health care clinic and nurse practitioner training program at Harbor-UCLA Medical Center in Torrance. Nelson is an investigator in the company’s Phase IIIB study of the device. (See Contraceptive Technology Update, January 2001, for more information on the study.)
"It is going to be so easy for providers to do, but because it is different from other IUD insertion techniques that have been used in the past, I think we’re all recommending that providers get hands-on, formal training before they enter into providing the device," says Nelson. "That is not a reflection that it is difficult. It is just a reflection that it is different."
Kaunitz, who also is part of the ongoing clinical trial, says he has recently inserted Mirena in six study participants in Jacksonville. Each insertion proceeded smoothly; none have required use of local anesthesia or cervical dilation, he notes.
Appropriate candidates for the Mirena IUS are women in stable, mutually monogamous relationships with at least one child, according to Foegh. They should have no recent history of pelvic inflammatory disease and have no history of ectopic pregnancy or a condition that would predispose to ectopic pregnancy, she says. (For patient information, click here.)
"Overall, if we are looking at who Mirena would be ideal for, most certainly it would be busy women who don’t want to worry about taking birth control pills, who don’t want to get pregnant, and who value their spontaneity," says Nelson. "They may not want to take time out to do barrier methods before they engage in coital activity."
In clinical studies, side effects of Mirena were most common during the first months after insertion and subsided during prolonged use. Side effects include acne, back pain, breast tenderness, headaches, mood changes, and nausea. Like many contraceptives, the levonorgestrel IUS does not protect against HIV infection and other sexually transmitted diseases.
Mirena, which provides birth control for at least five years, will complement the ParaGard copper IUD, which provides at least one decade of effective contraception, notes Kaunitz. Whereas the ParaGard IUS may increase flow and cramps in some users who continue to experience regular menses, Mirena has the opposite effect, he notes. One quarter of those women using Mirena will experience amenorrhea, while reduced flow will occur in the remainder, some of whom will experience unpredictable spotting or light bleeding.
"Therefore, it is important that clinicians discuss duration of action and menstrual issues in detail as part of contraceptive decision making," states Kaunitz.
Reference
1. Hatcher RA, Trussell J, Stewart F, et al. Contraceptive Technology. 17th ed. New York City: Ardent Media; 1998.
Resources
For more information on Mirena, contact:
• Berlex Laboratories, 340 Changebridge Road, P.O. Box 1000, Montville, NJ 07045-1000. Telephone: (800) 237-5392 (800-BERLEX2) Web site: www.mirena-us.com.
The Association of Reproductive Health Professionals (ARHP) and the Ithaca Center for Post-Graduate Medical Education are co-sponsoring New Developments in Contraception, which will offer counseling and insertion training for the Mirena levonorgestrel intrauterine system. For more information, call the toll-free number, (866) 564-4871, or visit the ARHP Web site, www.arhp.org.
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