Public Release: 

FDA approves expanded patient profile for non-hormonal intrauterine device

ParaGard® T 380A now approved for nulliparous women in stable relationships from age 16 through menopause

Porter Novelli

Los Angeles, CA, September 13, 2005- FEI Women's Health announced today that the U.S. Food and Drug Administration (FDA) has approved an updated label for its intrauterine device (IUD), ParaGard® T 380A Intrauterine Copper Contraceptive.

The new prescribing information for ParaGard excludes nulliparity as a contraindication, confirming that the risk of pelvic infection is more related to a patient's sexual behavior than her contraceptive choice. Hormone-free ParaGard is also no longer contraindicated for women with a history of sexually transmitted diseases or pelvic inflammatory disease unless a patient currently has acute PID or engages in sexual behavior suggesting a high risk for PID. Finally, mutual monogamy is no longer a user requirement, although use by women is a stable relationship is encouraged.

"The FDA's approval of a less restrictive patient profile for ParaGard confirms what many health care providers have known for years," said Dr. Laura MacIsaac, director of family planning at Albert Einstein Medical College and chief medical officer at FEI Women's Health. "ParaGard is safe, effective and the most appropriate contraceptive for many women to use throughout their reproductive lives - from age 16 through menopause."

ParaGard is the only IUD available with no hormonal side effects, potentially making it a great choice for women who cannot - or prefer not - to take hormones. Also due to ParaGard's hormone-free mechanism of action, it is the recommended contraceptive choice by the American College of Obstetricians and Gynecologists, as well as the World Health Organization, for breastfeeding women and patients who prefer a predictable menstrual pattern. The most common side effects of ParaGard are heavier and longer periods for a few months after placement; some women have spotting between periods. For most women, these side effects typically subside after a few months.

ParaGard may also be appropriate for women who have a hard time with contraceptive methods that require highly compliant behavior. Because ParaGard does not require daily, weekly or monthly administration, user compliance becomes minimal in achieving efficacy. In addition, the largest study to date reports that 96 percent of patients who use intrauterine contraception are satisfied with their choice.

"For over 20 years, ParaGard® has provided reliable efficacy without the side effects associated with hormones," explains Dr. MacIsaac. "Now physicians are free to comfortably modernize their current IUD practice and better address the contraceptive needs of their patients." ParaGard does not protect against HIV/AIDS or other sexually transmitted diseases. Women who currently have acute Pelvic Inflammatory Disease (PID) or engage in sexual behavior suggesting a high risk for PID should not use ParaGard. It is also not an option for women who might be pregnant, have had a post-pregnancy or post-abortion uterine infection in the past 3 months, have cancer of the uterus or cervix, an infection in the cervix, an allergy to any component of ParaGard, or have Wilson's disease.

FEI offers a diverse tool kit of programs for health care professionals, providing accurate and easy-to-understand information to advance the usage of IUDs in their practice. Programs include insertion training and an "Ask the Nurse" hotline to provide answers to questions about IUD's and ParaGard. It is important to know that, while reimbursement for contraceptives can be complicated and time-consuming, most insurance companies fully cover ParaGard at a minimal patient expense. For assistance in providing patients with accurate and timely reimbursement information - or for information about any of the tools FEI offers - health care providers are urged to call 800-322-4966 or visit www.ParaGard.com.

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About ParaGard
ParaGard, the Copper T 380A, is an intrauterine device (IUD) that has been FDA approved for more than 20 years and has been used by millions of women worldwide. Shaped like a "T" and about 1 ¼ inches wide by 1 3/8 inches long, ParaGard consists of soft, flexible plastic and copper and is designed to fit comfortably inside the uterus. ParaGard is non-hormonal and over 99 percent effective in preventing pregnancy. Once placed in the uterus, ParaGard requires no daily or weekly routine and is the longest-lasting method of reversible contraception available. ParaGard is an effective option for women who choose not to use hormonal contraception or who are considering tubal ligation. Please see the full prescribing information available at www.paragard.com.

About FEI
FEI (FEI Women's Health and FEI Products LLC) is a women's healthcare company specializing in the manufacture and marketing of intrauterine contraception and has offices in El Segundo, CA; North Tonawanda, NY; and New York, NY. FEI has been the exclusive U.S. manufacturer of the Copper T 380A since 1984.

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