Q): How much does the FemCap cost?
A): The suggested retail price is $68.95 for a single FemCap and
$88.95 for the two-FemCap kit. Each kit contains the instructional
videotape.
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 its 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
generation FemCap was estimated to be 7.6 per hundred women per year.
It is estimated that the FemCap may achieve 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 ideal Women should be motivated to use the FemCap and wants to
avoid the
use of hormones.
2. Women should watch the instructional video very carefully before
using the FemCap.
3. A back-up contraceptive method should be used during the learning
phase;
4. The FemCap should be inserted before any sexual arousal.
5. A small amount of spermicide should be applied to the FemCap and
its position should be checked before each repeated
intercourse, within a span of 48 hours without removing the FemCap.
6. The FemCap must be left in place at least six hours after the last
act of intercourse.
7. Emergency contraception should be employed
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 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 the moment, the FemCap should be prescribed and provided
by a nurse practitioner, nurse midwife, physician’s assistant,
or a doctor. Future availability in the Pharmacist 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 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 the obstetrical
history of the woman. Women who have never been pregnant will
use the 22mm FemCap; women who miscarried or had caesarian section
will take the 26mm; and women who have vaginally delivered a full-term
baby will take the 30mm FemCap.
Q): Does the FemCap interrupt spontaneity
or interfere with natural intercourse?
A): The FemCap does not interrupt spontaneity or reduce sexual
pleasure to either partner. The male partner may, rarely, have
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 had
had prior experience with the diaphragm preferred the FemCap.
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 to
your insurance.
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
FemCap has been added to the California State
Family PACT formulary. Use the following NDC codes for reimbursement:
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