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news.The FDA has accepted several revisions to the prescribing label for ParaGard, a intrauterine contraceptive device produced by FEI Women's Health.
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Until recently, intrauterine devices (IUD) were only recommended for women in mutually monogamous relationships with at least one child. Now, the FDA has approved the hormone-free ParaGard as the only IUD indicated for women in all stages of reproductive life who are in stable relationships and therefore not at high risk of sexually transmitted diseases.
Approved by the FDA since 1984, the ParaGard IUD is more than 99% effective according to FEI. The company reports that more than 75 million women worldwide use ParaGard.
“The FDA’s approval of the changes to ParaGard’s label is important progress in contraceptive practice and in the prevention of unplanned pregnancies,” said Dr Laura MacIsaac, director of family planning at Albert Einstein Medical College and chief medical officer at FEI Women’s Health.
Like most popular forms of contraception, ParaGard (copper T 380A intrauterine contraceptive) does not protect against sexually transmitted diseases. Women who engage in sexual behavior suggesting a high risk for pelvic inflammatory disease should not use ParaGard.