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Conceptus, permanent birth controlFrom: ainsron@sbcglobal.netTue Jul 30 18:24:30 2002
FDA Panel Backs Conceptus System for Permanent Birth Control WASHINGTON (Reuters Health) Jul 23 - An advisory panel to the US Food and Drug Administration (FDA) voted on Monday to recommend that the agency approve Conceptus Inc.'s Essure, a micro-insert designed for permanent birth control. The FDA's Obstetrics and Gynecology Devices Panel voted 8 to 0 to back the system, with one abstention for religious reasons. The flexible insert creates scar tissue that blocks the fallopian tubes, offering a less-invasive alternative to tubal ligation. The Essure device can be placed with a catheter using local anesthesia. Panel members said Essure appeared to offer a major benefit. "It has a great chance for improving healthcare in the United States," observed Dr. Kenneth L. Noller from the Department of Obstetrics & Gynecology at Tufts University Medical School in Boston. The panel's decision was based on a review of three clinical trials in which the device was more than 99% effective in preventing pregnancy. A total of 854 women participated in the clinical trials. There were no reported pregnancies following placement, although four women were later found to have been pregnant prior to the insertion. Common side effects included cramps, pain and nausea. There were no device-related adverse events requiring major follow-up surgery and most recipients were discharged within 45 minutes. But the panel's support was not unconditional. Among its concerns was whether physicians would be able to correctly insert the device and to confirm that it was properly placed. In the pivotal trial of about 500 women, physicians failed to properly place the system in about 12% of the women. The panel also expressed concern about the lack of long-term data, since trial participants were followed for only 2 years. To address this concern and others, the panel recommended that the FDA approve the device with certain stipulations, including that the company conduct a post-marketing surveillance program. Conceptus already had submitted a proposed follow-up program and an educational program for physicians. The FDA generally follows its committees' recommendations, although it is not bound by their advice. The agency, which has granted Essure an expedited review, expects to make a final decision on the product in early 2003. The system already is approved for sale in Europe, Canada and Australia. The US marketing application was filed in April.
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