FemCAP method receives market approval from the Food and Drug Administration

Your next patient is a young married woman who is unable to use hormonal birth control and is not interested in using an intrauterine device. Because she wants to have more children, sterilization is not an option at the present time. What contraceptive methods are available to her?

Family planning providers now can offer the FemCap vaginal barrier contraceptive. The device, which has been approved by the Food and Drug Administration (FDA), already is available in Germany, Austria, Switzerland, and Great Britain. According to the device’s web site, www.femcap.com, a single FemCap with instructional video is $64.85, including shipping and handling; two FemCaps with video are $81.90. (See "Resource" section, at end of article, for contact information.) The device is available in the United States by prescription only.

"This is great news, and I am grateful for the tenacity Dr. Shihata [Alfred Shihata, MD, founder and president of FemCap of Del Mar, CA] demonstrated to gain approval for a new nonlatex barrier method for women," states Susan Wysocki, RNC, NP, president and chief executive officer of the Washington, DC-based National Association of Nurse Practitioners in Women’s Health.

The FemCap is a silicone rubber barrier contraceptive shaped like a sailor’s hat with a dome that covers the cervix, a rim that fits into the fornices, a brim that conforms to the vaginal walls around the cervix, and a removal strap.

The device comes in three sizes; the inner diameter of the rim determines its size. The smallest-rim diameter (22 mm) is intended for women who have never been pregnant, while the medium (26 mm) cap is intended for women who have been pregnant but have not had a vaginal delivery, such as those who have had an abortion or who have delivered via cesarean section. The largest (30 mm) is intended for women who have had a vaginal delivery of a full-term baby.

Providers must perform a clinical examination to see that there are no pathological or anatomical contraindications; the three most important contraindications are if the woman has a vaginal abnormality, a cervical abnormality, or has cancer of the cervix.

Each FemCap comes with an instructional video, which provides the woman all the necessary information for using the device. Women can review the instructional video in the office or at home to learn how to position the FemCap.

As with all barrier contraceptives, the FemCap must be used correctly and consistently to achieve pregnancy protection. Barrier methods are less effective in preventing pregnancy than hormonal methods with typical use.1 In a 2002 review that compared the contraceptive efficacy, safety, discontinuation, and acceptability of the cervical cap with that of the diaphragm, the Prentif cap was comparable to the diaphragm in preventing pregnancy, but the first-generation FemCap was not as effective in preventing pregnancy as its comparison diaphragm.2

In a clinical trial that looked at the first generation of the device, women were randomized to use the FemCap or a diaphragm, along with nonoxynol-9 spermicide, for 28 weeks. The six-month Kaplan-Meier cumulative unadjusted typical use pregnancy probabilities were 13.5% among FemCap users and 7.9% among diaphragm users. The adjusted risk of pregnancy among FemCap users was 1.96 times that among diaphragm users, with an upper 95% confidence limit of 3.01.3 The two devices were comparable with regard to safety and acceptability, but a six-point difference in the true six-month pregnancy probabilities of the two devices could not be ruled out.3

According to Shihata, the FDA approved only the second-generation FemCap, which has a removal strap to enhance its acceptability and increased dimensions of the brim to improve its stability. The product labeling recommends the use of emergency contraception in the event the woman does not use the FemCap or uses it incorrectly.

Data from an acceptability study reflect that that none of the study subjects or their partners reported any discomfort, trauma, or interference in sexual spontaneity with the cap.4 Vaginal irritation and infections were reported infrequently.4

Review use instructions

To use the FemCap, the woman should apply the bulk of spermicide in the storage groove facing the vaginal opening and then spread it in a thin layer all over the cap except for the spots where the finger and thumb are holding the cap. Squeezing and flattening the device, the woman should then insert the FemCap into the vagina with the bowl facing upward and the long brim entering first. The FemCap then should be pushed down toward the rectum and then downward and back as far as possible to make sure it completely covers the cervix. If the device is correctly placed, a woman may rarely be aware of its presence during her daily activities or during intercourse.

According to the product web site, women should check to make sure that the FemCap is not partway between the vaginal opening and the cervix. They may check the position of the FemCap and insert additional spermicide without removing the cap prior to each repeated intercourse within the next 48 hours.

Women must wait at least six hours after their last act of intercourse before removing the cap. To ease removal of the device, women should be instructed to squat and bear down, which will bring the cap closer to the finger. The device may then be rotated in any direction that is comfortable. By pushing the tip of the finger against the dome of device, the woman breaks the suction, allowing room to hook the removal strap with the tip of the finger. The device then can be slowly and gently pulled down and out of the vagina. The FemCap should be thoroughly washed with antibacterial hand soap, rinsed with tap water, then allowed to air dry or gently patted dry with a clean, soft towel before storing it in its provided plastic storage container.

Who would be successful in using the FemCap contraceptive? According to the product web site, this group would include those who are highly motivated and educated; cannot tolerate hormonal side effects; have contraindications to intrauterine device use; or who are allergic to latex rubber or do not rely on the male to use a condom. Women who may have a higher failure rate with the device would include those who do not plan or who want to have intercourse on the spur of the moment; have aversions to touching their genitalia; or lack motivation and/or planning, the product web site states.

"The FemCap offers women another contraceptive option, and its design makes FemCap use easier to insert and remove," says Sharon Schnare, RN, FNP, CNM, MSN, women’s health consultant and clinician with the Seattle King County Health Department in women’s and adolescent health care and the International District Community Health Center in Seattle. "I look forward to offering women in my practice this new option."

Resources

For more information on FemCap, contact:

FemCap, 14058 Mira Montana Drive, Del Mar, CA 92014. Fax: (858) 792-2624. E-mail: femcap@yahoo.com. Web: www.femcap.com.

References

1. Technical Guidance/Competence Working Group and World Health Organization/Family Planning and Population Group. Family planning methods: New guidance. Population Reports 1996; Series J(44):32.

2. Gallo MF, Grimes DA, Schulz KF. Cervical cap versus diaphragm for contraception. Cochrane Database Syst Rev 2002; 4:CD003551.

3. 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.

4. Shihata AA, Gollub E. Acceptability of a new intravaginal barrier contraceptive device (FemCap). Contraception 1992; 46:511-519.