Update on the Female Condom - The Journal of Family Practice

CONTRACEPTION
UPDATE
<strong>Update</strong> on the Female Condom
Jill Schwartz, MD
FOCUSPOINT
A less expensive version of the female
condom (FC) was recently approved by
the FDA. Will this increase the use of
this contraceptive form, which offers
several important benefits for women?
Male condoms have played an important
role in global HIV prevention
over the past few decades. In recent
years, women have become increasingly
vulnerable to HIV, especially in highly
afflicted sub-Saharan Africa. Since women are
not always able to insist on the use of male condoms,
there is a great global need for affordable
and accessible woman-controlled barrier methods
that provide dual protection against unintended
pregnancy and the transmission of
sexually transmitted infections (STIs), including
HIV/AIDS.
FC1/FC2 FEMALE CONDOMS
The Reality Female Condom
(Female Health Company
The FC2 was
[FHC], Chicago, Ill), was
recently developed approved by the FDA in 1993 as
to replace the FC1, the first barrier contraceptive
for women that offered some
and is made of synthetic
latex (nitrile), currently sold as the FC Female
protection against STIs. It is
a newer material that Condom (FC1). 1,2 The failure
rates for this first-generation
allows for a significant
reduction in
Table 1. 3 FC1 has been mar-
polyurethane FC are listed in
FC pricing.
keted or available under a variety
of brand names through
various channels in more than
100 countries and has the features
described in Table 2. The FC2 was
recently developed to replace the FC1, and is
made of synthetic latex (nitrile), a newer material
that allows for a significant reduction in FC
Jill Schwartz, MD, is Medical Director and Research Associate
Professor, CONRAD/Eastern Virginia Medical School,
Arlington, VA.
TABLE 1. Pregnancy Rates of FC1 3
Pregnancy Rates (12 Months)
Typical Use a
Perfect Use b
FC1 Female Condom 21% 5%
Male Latex Condom 15% 3%
3
Hatcher HA, Trussell J, Nelson AL, Cates W, Stewart F, Kowal D.
Contraceptive Technology. 19 th ed. New York, NY: Ardent Media,
Inc.; 2007.
a
Typical use rates indicate the method may have been used incorrectly,
may not have been used with every act of sex, or may have
failed during use.
b
Perfect use rates indicate the method was used correctly in
every act of sex, but failed anyway.
pricing (Figure 1). The FC2 has been approved
by the World Health Organization and, as of
March 11, 2009, the FDA. In a comparative
study of the FC1 to the FC2 with respect to the 4
FC failure modes (breakage, invagination, slippage,
and misdirection), the risk of failure of
the FC2 during use was equivalent to FC1 and
both were found to be acceptable in overall
experience, ease of insertion, and comfort
(Table 3). 4-6
Despite a global need for a female initiated
barrier device, sales of FCs have been
disappointing in developed countries such
as the United States, although donor agencies
TABLE 2. FC1 and FC2 Features
• Woman can use the FC if her partner refuses to
use a male condom
• Provides dual protection against STIs and
pregnancy, if used correctly
• Most women insert FC1 between 2 to 20 minutes
before sex, but it can be inserted up to 8 hours
before sex
• A new FC should be used with each sex act
• Additional lubricant is provided and should be
used as needed
• The FC should be removed after sex
26 The Female Patient | VOL 34 JUNE 2009 www.femalepatient.com

Schwartz
latex, and when unstretched, it is much shorter
than the FC1 or FC2, measuring only 9 cm (3.5
inches) in length. It consists of a latex pouch
with a triangular polyethylene frame at the
open end and a polyurethane sponge inside
the closed end to anchor the device inside the
vagina. The Natural Sensation Panty Condom,
a reusable thong panty with replaceable condoms,
has been marketed in Latin America, but
has not gained momentum among large private
or public procurers.
FIGURE 1. Comparison of FC1 and FC2 female condoms.
Image courtesy of The Female Health Company.
such as US Agency for International Development
and United Nations Population Fund
have increasingly purchased them for use in
family planning and HIV/AIDS programs in
developing countries. Worldwide sales in 2008
were 34.7 million units. Differing acceptability
ratings have been reported in short-term FC
studies and problems identified include insertion
difficulty, discomfort, and suboptimal performance
during intercourse. 6-9
As the price per unit of female condoms is
higher than male condoms, it is hoped that
the reduction in cost of the FC2 might lead
to greater accessibility and wider popularity
than the original female condom. Efforts to
develop new and improved female condoms
are ongoing.
AVAILABLE BUT NOT FDA APPROVED
FEMALE CONDOMS
The Reddy Condom (Medtech Products, Ltd.,
Chennai, India) and the Natural Sensation
Panty Condom (Natural Sensations, Columbia)
are available but have not been approved for
use by the FDA as contraceptives or HIV/STI
prevention methods. The Reddy FC has received
the CE mark for distribution in the European
Union and is sold primarily through the private
sector in several countries as the VA w.o.w. condom
(Figure 2). It is made from highly elastic
FEMALE CONDOM PRODUCTS
IN DEVELOPMENT
Several additional novel FC products are in various
stages of development but it will take several
years for any of them to be available. PATH,
a nonprofit organization, has used an iterative
user-driven development process to produce a
novel FC product. The PATH Woman’s Condom
(WC) has a 23-cm (9-inch) pliable polyurethane
pouch, a flexible soft outer ring, and 4 oblong
foam pieces on the outside of the pouch that
cling to the vagina to stabilize the device. The
distal end of the pouch and foam pieces are
packaged in a capsule that serves as an insertion
aid and dissolves quickly after insertion
TABLE 3. Acceptability of FC1 and FC2 6
OVERALL EXPERIENCE
FC1 (n=218)
% %
Good 51 55
Satisfactory 45 39
Neutral 2 5
Unsatisfactory 2 1
EASE OF INSERTION
Easy 59 58
Moderate 10 13
Difficult 5 3
Easier with practice 27 27
COMFORT
Comfortable 89 90
Neutral 6 8
Uncomfortable 5 2
FC2 (n=214)
The Female Patient | VOL 34 JUNE 2009 27

CONTRACEPTIONUPDATE
<strong>Update</strong> on the Female Condom
FIGURE 3. PATH Women’s Condom.
Image courtesy of PATH/Glenn Austin.
FOCUSPOINT
Despite a global
need for a female
initiated barrier
device, sales of FCs
have been disappointing
in developed
countries such as
the United States.
FIGURE 2. VA w.o.w. female condom.
Image courtesy of Medtech Products Ltd.
(Figure 3). The WC performed
well in a short-term acceptability
study and in a comparative
crossover study with the
FC1. 10,11 PATH has identified a
manufacturer for the WC
(Shanghai Dahua Medical
Apparatus Company, Shanghai,
China), and anticipates
the device will be marketed
first in China.
Other designs include the
Belgium Female Condom
(Mediteam, Brussels, Belgium),
made of natural latex and
designed to cover the entire
vulva and base of the penis,
and the Silk Parasol Panty Condom (Silk Parasol
Corporation, Bodega, Ca), a reusable panty
with refill condoms.
To obtain comparative information on the
acceptability of the 3 FCs working toward
FDA review (the FC2, Reddy, and PATH WC), a
novel acceptability study was funded by
USAID and conducted by Family Health
International in Durban, South Africa. In
this study, the 3 FCs were tested by 180
women in a crossover design measuring
functionality, safety, and acceptability outcomes.
A subset of 130 women participated
in a simulated market study to determine
preference. Results from this study are
expected soon.
CLINICIAN’S ROLE IN FEMALE
CONDOM SUCCESS
The clinician may play a pivotal role in helping
women make decisions about the benefits of
FCs, and other barrier method use based on
their individual risk of unintended pregnancy
and STI exposure. A woman who has frequent
intercourse, is young, or has had previous
unintended pregnancies with barrier methods
may not be an ideal candidate for exclusive use
of an FC. However, a woman at high risk for STI
exposure and unable to use male condoms
might benefit from the dual method use of
effective contraceptives, such as hormonal
contraceptives and FCs. Although FCs are
available over the counter, the clinician can
play an important role in helping women use
these products successfully.
CONCLUSIONS
Despite the many potential benefits of FCs
in maintaining reproductive health, they
have not yet achieved their full potential. It
is hoped that the upcoming availability of the
less costly FC2 will help galvanize its acceptability
and use in appropriate populations.
Efforts are ongoing to develop more userfriendly
products with unique insertion and
anchoring mechanisms, but much greater
efforts are needed to promote the FC and help it
achieve its full dual prevention potential.
28 The Female Patient | VOL 34 JUNE 2009 www.femalepatient.com

The author reports no actual or potential
conflicts of interest in relation to this article.
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