FDA approves Lea's Shield.
In March 2002, the US Food and Drug Administration (FDA) approved a new female barrier contraceptive, Lea's Shield. Lea's Shield (YAMA, Inc.; Millburn, NJ) is a reusable, vaginal contraceptive made of medical-grade silicone rubber. The device is shaped like an elliptical bowl with an anterior loop that assists in removal. It is thicker at the posterior end, which fits into the posterior fornix of the vagina, helping to hold it in place and decrease rotation. Similar to the Prentif cervical cap (Cervical Cap Ltd.; Los Gatos, CA), Lea's Shield blocks the cervix. Unlike the cervical cap, however, Lea's Shield contains a centrally-located valve, which allows the passage of cervical secretions and air. The shape and size of the device help to create a snug fit over the cervix. In the United States, the device will be available by prescription only. The shield has been available over-the-counter since 1993 in Germany, Austria, Switzerland, and Canada. Lea's Shield comes in one size designed to fit most women. (excerpt)