FDA Panel Advises Agency to Deny Approval of Contraceptive Device

A Food and Drug Administration advisory panel recommended Monday against approval of a new contraceptive device similar to the cervical cap, saying it is unclear how well it prevents pregnancy.

Women’s advocates had pushed the FDA to approve Lea’s Shield quickly, arguing that the millions of unplanned pregnancies every year show how desperate women are for better contraceptive options.

“The appropriate response to the public health needs of women in the ‘90s is to expedite barrier controls,” said Lisa Cox of the National Women’s Health Network.

But manufacturer Yama Inc. managed to get only 55 women to complete a six-month study of the device. The study found a 9% pregnancy rate.

The company argued that was an acceptable rate, indicating that had the women used Lea’s Shield for a year, the maximum pregnancy would have been 18%, equivalent to most diaphragms.

But the FDA’s scientific advisors said no other contraceptive has ever been approved on the basis of such a small study. A test involving 55 women is not considered enough to determine the pregnancy rate reliably.

The FDA typically requires a study of 200 women before approving contraceptive devices.