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Q): How does the FemCap work?
A): It prevents sperm from entering the cervix. The FemCap
should be used with a small amount of 2% Nonoxynol-9 spermicide
to reinforce the mechanical barrier of the FemCap with a
chemical sperm-killing agent. About ¾ teaspoon is
plenty.
Q): What are the side effects
of the FemCap?
A): There are no known local or systemic side effects.
Q): How about the irritation
caused by the spermicide?
A): The currently available spermicide has been sold over
the counter for more than thirty years with an excellent
safety record. It is true that spermicide can cause irritation
when used very frequently and in very high doses. To minimize
the irritation caused by spermicide, the FemCap is designed
with a unique groove facing the vagina. This groove stores
the bulk of the spermicide and minimizes leakage. The
storage of the bulk of spermicide in this groove ensures
immediate and prolonged exposure of sperm to the spermicide
as soon as it is deposited into the vagina.
Q): Is it easy to use?
A): Yes, it is easy to use. The average woman can learn
how to insert and remove the FemCap on her own
in a few minutes and master its use in a few days.
Q): What is the effectiveness
rate of the FemCap?
A): Effectiveness depends on the motivation of the user
and whether she uses the FemCap consistently and properly
every time she has sex. There is a wide range of effectiveness
among users. One pregnancy occurred among the 85 women who
completed eight weeks of the study to test the second-generation
FemCap. Due to the small number of participants and the
relatively shorter duration, the confidence interval would
be wide. Based on this study, the typical failure rate (Pearl
index) of the second generations FemCap was estimated to
be 7.6 per hundred women per year. It is estimated that
the FemCap may achieve a much higher rate if it used properly
and consistently. It is estimated that the FemCap may achieve
up to 96-98% success in preventing pregnancy if used PERFECTLY.
The perfect use estimation is based on the fact that if
emergency contraception (plan-B) is used alone, it would
be 95% effective if used within 24 hours and 89% effective
if used within 72 hours in preventing pregnancy.
The seven requirements for
perfect use are:
1. The woman should be motivated to use the FemCap every
time before having sex.
2. The woman should watch the instructional DVD carefully
before using the FemCap.
3. A backup contraceptive method should be used during the
learning phase; (few days) e.g. use the condom, or finish
the pack of birth control pills.
4. The FemCap must be inserted before any sexual
arousal.
5. For repeated intercourse, the woman should apply a small
amount of spermicide on the tip of her finger, insert it
deep into her vagina and check the position of the FemCap
without removing it prior to each repeated intercourse within
the span of 48 hours. The FemCap is designed to rotate to
conform to the vaginal anatomy.
6. The FemCap must be left in place at least six hours after
the last act of intercourse.
7. Emergency contraception should
be taken ASAP if the woman did not use the FemCap at all
or used it incorrectly.
In the worst-case scenario, the FemCap (first-generation,
obsolete now and not approved by the FDA) was 86.5% successful
in preventing pregnancy in the six-month pivotal clinical
trials. All women who volunteered and participated in the
clinical trials were novices and selected at random to cover
the entire socioeconomic spectrum. Women in these clinical
trials were prohibited from using any back-up method during
the learning phase, and were not even allowed to watch the
instructional videotape. Women in these trials were also
prohibited from using emergency contraception even if they
admitted to having forgotten to use the FemCap.
Q): Can the FemCap be used
during menstruation?
A): No, the FemCap can not be used during menstruation,
as it would impede the natural flow of menstrual fluid.
Q): Will the FemCap be available
over the counter in the pharmacies?
A): No, at this time, the FemCap should be prescribed and
provided by a nurse practitioner, nurse midwife, physician's
assistant, or a doctor. Future availability in Pharmacies
is pending and would be by prescription from a health care
professional.
Q): How is the FemCap cleaned
between uses? How often should it be replaced?
A): The FemCap should be washed thoroughly with antibacterial
hand soap and rinsed with tap water, then dried and stored
in its container. It is recommended that the FemCap be replaced
every year or sooner if it shows any signs of deterioration.
Q): Does the FemCap need measurement
and custom fitting?
A): No, the fit of the FemCap is determined by obstetrical
history of the woman. Women who have never been pregnant
will use the 22mm FemCap; women who miscarried, even
after two week of pregnancy, or had caesarian section
will use the 26mm; if in doubt it
is safer to use the 26 mm FemCap. Women who have
had a vaginal delivery will use the 30mm FemCap.
Q): Does the FemCap interrupt
spontaneity or interfere with natural intercourse?
A): No, the FemCap does not interrupt spontaneity or reduce
sexual pleasure to either partner because it must be inserted
before any sexual arousal. The male partner may rarely have
even a sense of awareness.
Q): How well has the FemCap
been accepted?
A): The FemCap is highly accepted by women and their partners.
In the clinical trials, seventy-five percent of women who
have had prior experience with the diaphragm preferred the
FemCap.
Q): How much does the FemCap
cost?
A): The retail price is $80.00-90.00 for a single FemCap
kit. A kit contains an instructional DVD.
Q):Does health insurance cover
the cost of the FemCap?
A): Yes, if your health insurance covers birth control.
FemCap Inc. will provide you with proof of payment to submit
it to your insurance.
FemCap has been added to the California state Family PACT
formulary. Use the following NDC Codes for reimbursement:
NDC 08454-0001- 22 FemCap 22mm
NDC 08454-0002- 26 FemCap 26mm
NDC 08454-0003- 30 FemCap 30mm
For Clinicians use the following CPT codes for services:
Initial Office Visit, Annual Examination CPT Code...............................
99243
Follow up visit.............................................................................................
99214
Diagnostic ICD9 Code for Other Contraception…...............................
V25.49
Cervical Cap fitting CPT Code is.............................................................
57170
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