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Kaiser Daily Women's Health Policy
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Contraception & Family Planning | FDA Grants Conceptus Approval To Extend Pregnancy Prevention Data on Essure to Five Years
[Jul 20, 2005]

      The San Carlos, Calif.-based pharmaceutical company Conceptus on Monday announced it has received FDA approval to update the stated effectiveness of its non-incisional female sterilization device Essure from three years to five years, the AP/Forbes.com reports (AP/Forbes.com, 7/19). Previously, the information included in the packaging for Essure stated that the device is 99.8% effective at preventing pregnancy for up three years after implantation. In the future, the packaging will state that the device is 99.8% effective at preventing pregnancy up to four years after implantation and 99.74% effective up to five years after implantation (Dow Jones News Service, 7/18). FDA in November 2002 approved Essure, which consists of small metal coils that are implanted in the fallopian tubes, prompting scar tissue to grow and permanently "plug" the tube. Sterilization is not immediate following the procedure, as the scar tissue might need to grow for up to three months before the fallopian tubes are completely blocked. After three months, patients must return for testing to ensure that the tubes have been completely blocked (Kaiser Daily Reproductive Health Report, 11/5/02). "Essure has reached an important long-term milestone with an exceptionally high effectiveness rating that has remained consistent over time," Mark Sieczkarek, president and CEO of Conceptus, said (Conceptus release, 7/18).

For current women's health policy news, visit the National Partnership for Women & Families' website.


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