Essure™ System - P020014
This is a brief overview of information related to FDA's approval to market this product. See the links below to the Summary of Safety and Effectiveness and product labeling for more complete information on this product, its indications for use, and the basis for FDA's approval.
Product Name: Essure™ System
Manufacturer: Conceptus, Inc.
Address: 1021 Howard Ave., San Carlos, CA 94070
Approval Date: November 4, 2002
Approval Letter: http://www.accessdata.fda.gov/cdrh_docs/pdf2/p020014a.pdf
What is it? A new method of permanent birth control (sterilization) for women. In this system, small metal coils are placed in a woman’s fallopian tubes. Unlike other sterilization procedures for women, this system does not require incisions or general anesthesia. Instead, a doctor implants the coils by threading them through the vaginal opening.
How does it work? The Essure™ System works by blocking the fallopian tubes so that sperm can not fertilize a woman’s eggs. To insert the coils, a doctor uses a special catheter that passes through the vagina and uterus into the fallopian tubes. After the catheter is removed, the coils remain in place permanently. Over time, scar tissue forms around the implants and blocks the fallopian tubes. General anesthesia is not required to perform the implantation procedure.
During the first three months, the woman cannot rely on the Essure™ system and must use another type of birth control. After three months, she will undergo an x-ray procedure to confirm that her fallopian tubes are blocked. If this shows successful blockage, she can stop using her back-up birth control.
When is it used? The Essure™ System is used by women who are sure that they will never want to bear children. This system should be used only by women who can rely on alternative forms of birth control for at least three months after the implant.
What will it accomplish? This system provides permanent female sterilization, without incisions or general anesthesia.
In two clinical studies of the Essure™ System, there were no pregnancies in women who relied on the device for one year (439 women) or for two years (193 women). In about one out of seven women, doctors could not place both Essure™ implants on the first attempt.
When should it not be used? Because this system permanently prevents a woman from conceiving, should not be used by those who might wish to become pregnant in the future. It should not be used by women who cannot use an alternative method of birth control for at least three months after implant.
Additional information: Summary of Safety and Effectiveness is available at: http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cftopic/pma/pma.cfm?num=p020014