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Jim Shelton's Pearls

January 27, 2003

New Non-surgical Sterilization

P:Can you tell me more about the non-surgical female contraceptive called "Essure" you mentioned in an earlier Pearl?

R:Yes. See press excerpt below. However, although the concept of non-surgical sterilization is certainly attractive in many ways, it seems unlikely this particular method will have wide application in the developing world anytime soon.

The method is fairly high-tech. It requires a hysteroscope (a device similar to a laparoscope,) to allow the provider to enter the uterine cavity through the cervix and to deliver the Essure device (or plug) to the tubes. Thus it requires a relatively skilled provider, equipment and support system. Correct tubal placement is still sometimes problematic and follow-up X-rays are needed to confirm placement. Notably, the projected price (including the insertion) in the US is about $2,500.

Excerpt from AP press report:
The USFDA has approved the first nonsurgical method of sterilizing women, a tiny device called Essure that could transform the way many women end their childbearing years. The device looks like a tiny spring. Doctors use a thin tube to thread one Essure device up the vagina, into the uterus and then into each fallopian tube. Flexible coils temporarily anchor it inside the tube. Dacron-like mesh embedded in those coils - material widely used in medical procedures - irritates the tube's lining to cause scar tissue to grow that eventually permanently plugs the tube. The catch: It takes three months for the scar tissue to grow.

So in approving Essure on Monday, the Food and Drug Administration cautioned that women must use another type of birth control during those three months, then return for testing to ensure the scar tissue has fully blocked her tubes. That's a crucial check, because not all women can be implanted successfully. In one study, doctors failed to block both tubes fully on the first try in about one of seven women, the FDA said. The test, performed at outpatient radiology clinics, consists of an injection of dye into the uterus followed by an X-ray to be sure the tubes are blocked.

In studies of more than 600 women, followed for a year, there so far have been no pregnancies in those whose Essure devices were implanted successfully. The FDA did, however, require Essure's maker, Conceptus Inc., to continue studying those women for five years to ensure no long-term problems crop up.

Conceptus, of San Carlos, Calif., expects to have enough physicians trained that Essure will be offered nationwide by March. It will cost about the same as traditional tubal ligation, about $2,500, a company spokeswoman said.

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The "Pearls" offer answers to commonly asked questions about family planning. These "Pearls" are prepared by Dr. James D. Shelton, Senior Medical Scientist, Office of Population, United States Agency for International Development (USAID)

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