Cervical Cap Gets Final Federal OK

The cervical cap, a birth-control device similar to the diaphragm but said to be more convenient to use, was approved for nationwide sale Monday by the U.S. Food and Drug Administration--bringing to a close a decade-long effort to introduce it in this country.

Developed in England, the cap is a flexible plastic cup-like device fitted by a doctor so that it covers the base of the cervix. Like the diaphragm, the cervical cap is used in conjunction with spermicidal gel or cream.

The cap can be left in place, according to the FDA’s Monday marketing approval, as long as 48 hours--though some women’s health advocacy groups maintain it can safely remain as long as three days. The cap can be left undisturbed during repeated episodes of intercourse while the diaphragm must be removed after 12 hours or one episode. Both are 85% effective.

Monday’s announcement pertains to a cervical cap called the Prentis Cavity-Rim, manufactured by the British firm of Lamberts Dalston Ltd. The company’s American technical representative said it was uncertain when caps would be shipped to American physicians.

However, the National Women’s Health Network, which has advocated approval of the cap since 1978, said about 100 U.S. physicians and other health workers are already qualified to fit the cap and have supplies available that were acquired during the product’s nationwide pre-market testing program. The price is expected to be between $25 and $100. Other testing is continuing, including a trial that may eventually lead to marketing of disposable cervical caps.