FemCap in Germany, seeking U.S. approval
American women who are interested in using a vaginal barrier device for contraception may have another option beside the diaphragm and cervical cap if a nonlatex device, FemCap, receives regulatory approval from the federal Food and Drug Administration (FDA).
The silicone rubber FemCap, which has been in development for over 10 years, is available in Germany, Austria, and Switzerland, and soon it will be marketed in Finland, according to Alfred Shihata, MD, who heads the Del Mar, CA-based FemCap Inc. An FDA ruling on the device should come by the end of the year, says Shihata.
The FemCap design resembles the shape of a sailor’s hat, with a dome that covers the cervix, a rim that fits into the cornices, and a brim that conforms to the shape of the cervix. According to the company, the brim forms a seal against the vaginal wall and acts as a funnel to direct ejaculate fluid into the groove. The groove serves as a reservoir for spermicide and a trap for sperm. The underside of the dome forms a bowl that covers the cervix completely, with a strap that provides ease of removal.
The FemCap comes in three sizes: the smallest diameter (22 mm) is intended for women who have never been pregnant, with the medium diameter (26 mm) developed for women who have been pregnant but have not had a vaginal delivery. The large diameter (30 mm) is for women who have had vaginal delivery. The three sizes offer a simple approach to device fitting and eliminate the need for measurement, says Shihata.
The device is undergoing testing through the Contraceptive Research and Development (CONRAD) Program in Arlington, VA, with clinical study data prepared for the FDA pre-marketing approval. (Contraceptive Technology Update reviewed information on FemCap and other nonlatex barriers in March 1998; see p. 40.)
An earlier model of the device, which did not have a removal strap, was used in a comparative study, with 841 women randomized to use the FemCap or a diaphragm. The research was designed to compare the two devices’ safety and acceptability and to determine whether the probability of pregnancy among FemCap users was no worse (more than 6%) than in those using the diaphragm.1
"We were hoping to see equivalence, and we didn’t see equivalence," says Christine Mauck, MD, CONRAD’s director of clinical trials, in discussing the pregnancy probability results. "While the FemCap did not perform as well as the diaphram in preventing pregnancy, they both performed in the range of most barrier methods."
The data in the published research is obsolete, contends Shihata, because the FemCap has been redesigned with a strap added for ease of removal. Two sites are now investigating the redesigned device to check the acceptability of the added strap, with results to be available within the next year, says Mauck. The redesigned model is the one now marketed in Europe, where it is being accepted by patients and providers, says Shihata.
As with such barrier devices as the diaphragm and cervical cap, the FemCap represents a woman-controlled method that almost every woman can use. Advantages of such barrier methods include:
• help in preventing some sexually transmitted diseases (STDs) and conditions caused by such STDs, such as pelvic inflammatory disease. They also may offer some protection against HIV and AIDS, although research is ongoing in that area;
• ability to provide contraception just when needed, with no daily action needed;
• no side effects from hormones;
• no effect on breast milk;
• can be stopped at any time;
• easy to use with a little practice.2
"FemCap clearly broadens the scope of available choices for women who choose to use a barrier method or for those who have either been using another method or not been using any method but who — because of the unique char acteristics of FemCap — find it best meets their needs," says Paul Blumenthal, MD, MPH, asso ciate professor in contraceptive research and programs in the OB/GYN department of Johns Hopkins Bayview Medical Center in Baltimore.
About half the women who become pregnant while using vaginal barriers report contraceptive failure has occurred in a context of imperfect use.3 To help with compliance, the FemCap is packaged with two devices so it is always available, whether at home or in a woman’s purse, says Shihata.
An instructional video is included to help users become proficient in proper placement of the device. Women are strongly instructed to use the FemCap with each act of intercourse, with the device inserted before sexual arousal to ensure it is correctly seated, Shihata says. Women also are told to check its position and add more spermicide before any repeated act of intercourse, he says. If those instructions aren’t followed, women are directed to use emergency contraception, he stresses.
With the increasing interest in use of microbicides as a form of woman-controlled protection against HIV/AIDS and other STDs, Shihata sees the FemCap as "designed for the future." With its unique design, the FemCap can serve as an effective carrier for such material now in the research pipeline, he says.
References
1. Mauck C, Callahan M, Weiner DH, et al. A comparative study of the safety and efficacy of FemCap, a new vaginal barrier contraceptive, and the Ortho All-Flex diaphragm. Contraception 1999; 60:71-80.
2. Hatcher RA, Rinehart W, Blackburn R, et al. The Essentials of Contraceptive Technology. Baltimore: Johns Hopkins School of Public Health, Population Information Program; 1997.
3. Hatcher RA, Trussell J, Stewart F, et al. Contraceptive Technology. 17th ed. New York City: Ardent Media; 1998.
• For more information on the FemCap, visit the company’s Web site at www.femcap.com, or e-mail the company at [email protected].
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