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Contraceptive Update: Contraceptive Pearls
(March 2003)
The "Contraceptive Pearls" offer answers to commonly asked questions about family planning. These "Pearls" were prepared by Dr. James D. Shelton, Senior Medical Scientist, Office of Population and Reproductive Health, United States Agency for International Development (USAID). They are reprinted with permission. To view archives of Jim Shelton's Pearls online, visit Jim Shelton's Pearls online
New Non-surgical Sterilization
Question: Can you tell me more about the non-surgical female contraceptive called "Essure" you mentioned in an earlier Pearl?
Answer: 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 followup 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..., 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.
Lea's Shield
Question: A while back you mentioned that the USFDA had approved the Lea's Shield vaginal contraceptive device. What is that?
Answer: Lea's Shield is a "one size fits most" cup-shaped vaginal barrier contraceptive made of silicone rubber. It works primarily by covering the cervix and, thus, blocking sperm access. Its unique design includes a valve and a loop. The valve helps with insertion by venting the air trapped between the cervix and the device, thus creating a good fit; the loop helps with removal of the device.
When used with spermicide, it is about 85 percent effective in preventing pregnancy, which is comparable to other barrier contraceptive methods such as the cervical cap and diaphragm. The US approval was made on a prescription basis. However, since the device does not require fitting by a doctor, in principle, it should be available over the counter. Both cost and marketing plans for the US are unclear for now. Research is ongoing to determine the effectiveness of female barrier methods in preventing cervical infections and HIV/AIDS.
The FDA approval was based largely on USAID-supported trials conducted by the Contraceptive Research and Development (CONRAD) Program and Family Health International (FHI).