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medpundit |
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Tuesday, November 05, 2002The 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. I'd worry about the risk of tubal pregnancy after a procedure like that, too. Scarring isn't as trustworthy for blocking up passages as cutting and destroying is. Also, why go through an uncomfortable procedure twice - the placement of the implants and then the follow-up tests to check out the patency of the tubes - when you can go through a tubal ligation once for the same price? (To check for patency of the fallopian tubes, you generally have to inject die into the uterus and then follow its path up the fallopian tubes with x-rays. I've never had it done, but those who have tell me it's an uncomfortable procedure.) posted by Sydney on 11/05/2002 07:52:00 AM 0 comments 0 Comments: |
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