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February 17, 2003

Lea's Shield

A while back you mentioned that the USFDA had approved the Lea's Shield vaginal contraceptive device. What is that?

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% effective in preventing pregnancy, which is comparable to other barrier contraceptive methods such as the cervical cap and diaphragm. The U.S. 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).

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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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