FemCap™ - P020041
This is a brief overview of information related to FDA's approval to market this product. See the links below to the Summary of Safety and Effectiveness and product labeling for more complete information on this product, its indications for use, and the basis for FDA's approval.
Product Name: FemCap™
Manufacturer: FemCap, Inc.
Address: 14058 Mira Montana Drive, Del Mar, CA 92014, USA
Approval date: March 28, 2003
Approval letter: http://www.accessdata.fda.gov/cdrh_docs/pdf2/P020041a.pdf
What is it and who uses it? The FemCap™ (Fig. 1) is prescribed for women of childbearing age who wish to prevent or postpone pregnancy. FemCap™ is made of medical grade silicone rubber and comes in three sizes to fit most women. Before a woman inserts the device, she puts some nonoxynol-9 spermicide on the inside and outside of it. The device should remain in place for at least 6 hours after sexual intercourse, but no longer than 48 hours total. It may be washed and reused but only by the woman for whom it was prescribed.
How does it work? The FemCap™ device is designed to prevent sperm from entering the cervix and the uterus (womb). The dome of the device covers the cervix, the rim covers the vaginal vault, and the brim covers the vaginal walls surrounding the cervix (Fig. 2). The brim helps direct sperm to the groove between the dome and brim where it is exposed to spermicide. A removal strap helps in removing the device after use.
What will it accomplish? Based on a clinical effectiveness study of 355 women who used the FemCap™ for up to six months, on average 23 women out of 100 who use FemCap™ for one year can expect to become pregnant. For women who have had babies by vaginal delivery, and who use the large size FemCap, 29 of 100 can expect to become pregnant in a year’s use. For women who have never been pregnant or who have never delivered vaginally, and who use the small or medium sized FemCap, 14 out of 100 can expect to become pregnant in a year’s use.
There was no serious side effect reported in this study for either the woman or her partner. A woman uses nonoxynol-9 spermicide with FemCap™, however, and this spermicide can irritate her vagina.
When shouldn’t a woman use it? A woman should not use FemCap™ if she has an infection in her vagina, cervix, or pelvic area or a cut or tear in her vagina or cervix.
Additional information: Summary of safety and effectiveness is available at: http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cftopic/pma/pma.cfm?num=p020041