Safety and Effficacy | The Materials Involved | Programmatic
Concerns
I. Safety and Efficacy
Question: How effective is the female condom as a
contraceptive?
Answer: Its ability to prevent pregnancy is similar to other barrier methods,
such as the diaphragm and latex male condom (88 percent contraceptive effectiveness over
six months for the female condom in the United States). If used correctly and consistently
every time, the female condom is 95 percent effective.
As a group, the barrier methods are less effective than sterilization, injectables such as
DMPA, and the subdermal implant Norplant, all of which are close to perfect in terms of
preventing pregnancy. Oral contraceptives (the pill) also provide more effective
contraception than the female condom.
Question: How effective is the female condom at preventing
sexually transmitted diseases, including HIV?
Answer: The ability of the female condom to prevent the transmission of HIV and
other sexual diseases is speculative, but promising. Laboratory studies have found that
the female condom is impermeable to various STD organisms, including HIV.
Only one study involving human use has been done to evaluate its STD prevention
properties. Among 20 women with recurrent vaginal trichomoniasis, none of them experienced
reinfections while using the device consistently and correctly.
Question: Is it safe to use?
Answer: Like most barrier methods of contraception, the female condom is safe to
use. According to the manufacturer, no allergic reactions have been reported. The female
condom is a good option for the small number of people who are allergic to latex, the
material used in most male condoms.
Questions: What are the contraindications for use?
Answer: The female condom should not be used by people who are sensitive to
polyurethane or silicone.
II. The Materials
Involved
Question: What is the female condom made of?
Answer: The device is made of a thin, soft polyurethane sheath and two flexible
polyurethane rings. The inner ring is closed and helps with insertion and placement. The
outer ring and about an inch of the sheath remain outside the vagina during use. Each
condom is prelubricated with silicone, and a container of water-based lubricant is
supplied for those who prefer more lubrication.
Question: Does the female condom come in different sizes?
Does a woman need to be "fitted"?
Answer: There is one size only, no fitting is required. The female condom is
designed to fit most women.
Question: How long can this device be stored and still be
used effectively?
Answer: In the United States, the female condom called Reality is dated to
expire two years after manufacturing. However, its "shelf life" (how long it can
be stored and still be safe and effective during use) is believed to be longer. The
two-year expiration date may be extended if studies indicate a longer shelf life is
warranted.
Question: Is the female condom affected by heat, cold, air
pressure or humidity?
Answer: No. Unlike latex male condoms, the female condom is generally unaffected
by atmospheric conditions, including altitude, humidity or the normal temperature ranges
found in storage. However, the device should not be exposed to extreme heat or cold.
Question: Can this device rip or tear during use?
Answer: Any sharp object, including fingernails, rings or other jewelry, can rip
or tear the female condom. The rip and tear rate in one study, however, was less than 1
percent of the female condoms used.
III. Programmatic Concerns
Question: Can the female condom be used simultaneously with
other contraceptives?
Answer: It may be used with any nonbarrier contraceptive (such as oral
contraceptives) and with spermicidal cream or gel. However, it is not recommended for use
with a male latex condom, since friction between the two devices may displace them or
cause breakage.
Question: Can the female condom be used by women who have
recently given birth or undergone a pregnancy termination?
Answer: Yes, it may be used when contraception or STD protection is needed any
time following delivery.
Question: Can this device be used if a woman has a tampon
inserted?
Answer: No.
Question: Can it be used by pregnant or menstruating women?
Answer: Yes.
Question: Is this an appropriate method for young women
(under 20 years old)?
Answer: This method is safe and effective for any woman of any age, provided she
understands how to insert it correctly and how to avoid tearing or ripping the device.
Question: Can the female condom be inserted hours before
use?
Answer: Yes, although it may not be very comfortable to do so. It may be worn
under clothing for several hours prior to use. If this is done, re-lubrication will be
necessary for correct and comfortable use.
Question: Do people like to use the female condom?
Answer: In studies over six years among diverse populations, many women reported
that they liked the device and would recommend it to others. There were few complaints
about insertion, although some women said it took more than one attempt to get used to
inserting the condom. The most frequent complaints were not liking the inner ring and
movement of the device during use.
For more information, visit Family Health International's Website at www.fhi.org
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