[U.S. Food and Drug
Administration]

This article was published in FDA Consumer magazine several years ago. It is no longer being maintained and may contain information that is out of date. You may find more current information on this topic in more recent issues of FDA Consumer or elsewhere on the FDA Website, by checking the site index or home page, or by searching the site.
Latex Condoms Lessen Risks of STDs

With sexually transmitted diseases, infection is not always apparent. If
you're not sure about yourself or your partner, the wisest course is not to 
have sex. But if you do, be sure to use a latex condom labeled for disease
prevention from start to finish. And remember that the condom must cover the
entire penis to reduce the risk of infection. 

Condoms, one of the oldest forms of birth control, have for decades also been 
used to prevent sexually transmitted diseases (STDs) even though little 
scientific information to endorse this practice was then available. In this 
instance, "street smarts" turned out to be right. 

With the discovery in the 1980s that the AIDS virus can be transmitted during 
sexual activity, the condom, which the Food and Drug Administration regulates 
as a medical device, was scrutinized more closely. Laboratory studies showed
that condoms can block passage of the AIDS virus as well as agents
responsible for other STDs. 

The only sure ways to avoid sexual transmission of diseases (including AIDS,
chlamydia, genital herpes, genital warts, gonorrhea, hepatitis B, and 
syphilis) are not to have sex at all or to limit sex to one uninfected
partner who is also monogamous. Short of this, condoms (also called rubbers,
safes or prophylactics), though not 100 percent effective, may reduce the 
risk of STDs if properly used.

About two-thirds of people with AIDS in the United States got the disease 
through sexual intercourse with an infected partner. Experts believe that 
many of these people could have avoided the disease by using condoms. 

The condom is a sheath that covers the entire penis. It protects against STDs 
by acting as a barrier, or wall, to keep semen, blood, and vaginal fluids 
from passing from one person to another. These fluids can harbor organisms
such as HIV (human immunodeficiency virus), the virus that causes AIDS. If no 
condom is used, HIV or other disease-causing germs can pass easily from the 
infected partner to the uninfected partner. 

Only Latex Effective Against STDs 

Condoms currently marketed in the United States are made of either latex
(rubber) or natural membrane (lambskin). Natural membrane condoms have
different permeability characteristics and less uniformity than those made of 
latex and may allow HIV, which is tinier than sperm or bacteria, to pass
through. For this reason, lambskin condoms are not considered as effective as 
latex condoms in reducing the risk of STDs, including AIDS. 

Only latex condoms labeled for protection against STDs should be used for 
disease protection. In the future, manufacturers may offer condoms of other 
materials and designs for disease prevention. As with all new products that 
make medical claims, these new condoms would have to be reviewed by FDA 
before they could be sold.

For many years, condoms have been labeled for the prevention of bacterially 
transmitted STDs, such as syphilis and gonorrhea. In 1987, however, FDA began 
allowing condom labeling to contain claims for the prevention of viral STDs 
such as HIV and herpes. The agency also reviewed the available medical
literature showing that latex condoms offered some protection against the HIV 
virus, which is about 1/25th the size of sperm. 

At that time, FDA revised its strategy for regulating condoms by stepping up
its inspections of manufacturers and repackers, and its sampling and
inspection of condoms in commercial distribution. It also made sure that
imported condoms were tested before being allowed through U.S. Customs. 

The agency also provided guidance on the labeling of condoms for use in 
disease prevention. In a letter to condom manufacturers, FDA suggested that 
the labeling language of condoms intended for disease protection include the
following information, adapted by the manufacturer: 

"When used properly, the latex condom may prevent the transmission of many
sexually transmitted diseases (STDs) such as syphilis, gonorrhea, chlamydial
infections, genital herpes, and AIDS. It cannot eliminate the risk. For 
maximum protection, it is important to follow the accompanying instructions.
Failure to do so may result in loss of protection. During intimate contact, 
lesions and various body fluids can transmit STDs. Therefore, the condom
should be applied before any such contact." 

The agency also provided a sample set of instructions for using the condom, 
and requested that all condoms, whether or not they are labeled for STDs, 
include adequate instructions for use.

Leakage Standards 

In strengthening its sampling and inspection of condoms, FDA adopted the
voluntary standard established by the American Society for Testing Materials
already being used by many manufacturers. Under this procedure, a sample of 
condoms is collected and then tested according to a statistically derived 
sample schedule. The standard requires that no more than an average of 4
condoms per 1,000 examined leak. If that level is exceeded, FDA can recommend 
recall or seizure of the substandard lots. In the instance of imported
condoms, it can re-fuse entry to the United States. 

The manufacturers and FDA inspectors determine condom leakage by filling the
devices with water. However, consumers should never use the "water test" on 
condoms they plan to use because filling a condom with any liquid weakens it. 

(FDA has recently developed an advanced system for testing condoms under
conditions simulating actual use.)

All latex condoms sold in the United States, whether manufactured here or 
abroad, are subject to the same standards for leakage. At present, about 18 
to 20 foreign manufacturers ship condoms to this country. FDA samples these 
condoms at ports of entry. The agency automatically detains condoms from
companies whose products have previously failed entry criteria at a high
rate. The condoms are not allowed into the United States until they are 
proven acceptable by results from an independent lab. 

Although regulatory requirements and surveillance can go a long way towards 
ensuring the effectiveness of the product, how well condoms protect also
depends a great deal on which condoms are chosen and how they are stored, 
handled and used. 

Choosing a Condom 

The first step in choosing a condom is to read the label and look 
particularly for the following: 

* The condoms should be made of latex (rubber). 
* The package should say that the condoms are to prevent disease. 

If the package doesn't say anything about preventing disease, the condoms may 
not provide the protection you want even though they may be the most
expensive ones you can buy. 

Novelty condoms, for example, will not be labeled for either disease- or
pregnancy-prevention. Condoms that don't cover the entire penis are not 
labeled for disease prevention and should not be used for this purpose. For 
proper protection, a condom must unroll to cover the entire penis.

Some condom packages bear the words "DATE MFG." This is the date when the 
condoms were made, not an expiration date. FDA requires that all condoms to 
which a spermicide has been added be labeled with the expiration date of the
spermicide. New York state requires an expiration date on all condoms sold in 
that state. To gain access to the New York market, therefore, most of the 
five domestic manufacturers of condoms will now include this date on all
their packages, usually abbreviated "EXP." The condom should not be purchased 
or used after that date.

Condoms are available in almost all pharmacies; many supermarkets and other 
stores also carry them. They are also available from vending machines. When 
purchasing condoms from vending machines, as from any source, be sure they
are latex, labeled for disease prevention, and are not outdated. Do not 
purchase condoms from a vending machine located where it may be subject to
extreme temperatures or direct sunlight. Extreme temperatures--especially 
heat--can make latex brittle or gummy.

Condoms should be stored in a cool, dry place out of direct sunlight. Closets 
or drawers usually make good storage places.  Condoms should not be kept in a 
pocket, wallet or purse for more than a few hours at a time because they may
be  exposed to extreme temperatures. Places that may get very hot, such as
car glove compartments, are particularly poor storage areas.

When opening a condom, handle the package gently. Don't use teeth, sharp
fingernails, scissors, or other sharp instruments as these may damage the 
condom. And make sure you can see what you're doing!

After you open the package, inspect the condom. If the material sticks to 
itself or is gummy, the condom is no good. Check the condom top for other 
obvious damage such as brittleness, tears and holes, but don't unroll the 
condom to check it because this could damage it.

Spermicides  


Some experts think that even if a condom with spermicide is used, additional
spermicide in the form of a jelly, cream or foam should be added. These are 
sold over the counter in pharmacies and some supermarkets. (Although
swallowing small amounts of spermicide has not proven harmful in animal 
tests, it is not known if this is true for humans. For that reason, and 
because spermicides have a bitter taste, for oral sex it may be best to use a 
condom without spermicide.) 

Spermicide should be added to the condom in the following way:

* Before placing it on the penis, put a small amount of spermicide inside the 
condom at its tip.
* After the condom is on the penis, apply more spermicide to the outside of 
the condom. 
* Spermicide can also be placed inside the vagina. Directions for this are
included in the spermicide package. Spermicides are required to carry 
expiration dates and should not be used after this date.

Lubricants

Lubricants may help prevent condoms from breaking during use and may prevent
irritation that might increase the chance of infection. Some condoms already
are lubricated with dry silicone, jelly or cream. If those you buy are not
already lubricated, you can add water-based lubricants specifically made for
this purpose (for example, K-Y Lubricating Jelly).

If you use a separate lubricant, never use a product that contains oils, fats 
or greases such as a petroleum-based jelly (for example, Vaseline), baby oil
or lotion, hand or body lotions, cooking shortenings, or oily cosmetics such
as cold creams. These can seriously weaken latex, causing a condom to tear
easily. If you are not sure which product to use, ask your pharmacist.

If you use a spermicide, you do not need to use a lubricant because 
spermicide acts as a lubricant. 

How to Use a Condom 

The following guidelines are suggested to insure that the condom is used
properly for disease protection:

* Use a new condom for every act of intercourse and oral sex. 
* If the penis is uncircumcised, pull the foreskin back before putting on the 
condom. 
* Put the condom on after the penis is erect and before any contact is made 
between the penis and any part of the partner's body. 
* If using a spermicide, put some inside the condom tip.
* If the condom does not have a reservoir top, pinch the tip enough to leave
a half-inch space for semen to collect. 
* While pinching the half-inch tip, place the condom against the penis and
unroll it all the way to the base. If you are using spermicide or lubricant,
put more on the outside of the condom.
* If you feel the condom break during intercourse, stop immediately and 
withdraw. Do not continue until you put on a new condom and, if using 
spermicide, apply more. 
* After ejaculation and before the penis gets soft, grip the rim of the 
condom and carefully withdraw.
* To remove the condom, gently pull it off the penis, being careful the semen 
doesn't spill out.
* Wrap the used condom in a tissue and throw it in the trash where others 
won't handle it. Because condoms may cause problems in sewers, don't flush
them down the toilet. Afterwards, wash your hands with soap and water.
* Be aware that drugs and alcohol may affect your judgment and your ability 
to use a condom properly. 

Although condoms afford good protection for vaginal and oral sex (where the 
penis is in contact with the mouth), the protection they give for anal sex is 
questionable. The Surgeon General of the Public Health Service has said,
"Condoms provide some protection, but anal intercourse is simply too
dangerous a practice."

Condoms may be more likely to break during anal intercourse than during other 
types of sex because of the greater amount of friction and other stresses 
involved. Even if the condom doesn't break, anal intercourse is very risky
because it can cause rectal tissue to tear and bleed, allowing disease germs
to pass more easily from one partner to another.

Because condoms are used for both birth control and reducing the risk of
disease, some people think that other forms of birth control will also
protect them against disease. This is not true. Even if you use another form
of birth control, you need a condom to reduce the risk of getting STDs. 

Condoms do not make sex 100 percent safe, but, if properly used, they can 
reduce the chance of contracting STDs, including AIDS. This can mean
protection not only for you and your partner, but also for any children you 
may have in the future. n 

--Judith Levine Willis


Who Should Use a Condom?

To lessen the chance of being infected with AIDS or other STDs, people who
take part in risky sexual behavior should always use a condom. High-risk
behaviors include having sex--vaginal, anal or oral--with:

* a person who has an STD. This is the riskiest behavior. If you know your
partner is infected, the best rule is to avoid intercourse (including oral
sex). If you do decide to have sex with an infected person, always be sure to 
use a condom from start to finish, every time.
* someone who has shared needles to inject drugs with an infected person. 
* someone whose past partner(s) was infected. Because the AIDS virus can be 
in the body a long time before a person gets sick, if your partner had
intercourse with a person infected with HIV, he or she could pass it on to
you even if the sexual contact was a long time ago--even as long as 10
years--and even if your partner seems perfectly healthy.
  Use of a condom is also important for an uninfected pregnant woman because
it can help protect her and her unborn child from STDs. n 


STD Facts 

* Sexually transmitted diseases affect more than 12 million men and women in
the United States each year.
* Anyone can become infected through sexual intercourse with an infected
person. 
* Many of those infected are teenagers or young adults. 
* Changing sexual partners adds to the risk of becoming infected. 
* Sometimes, early in the infection, there may be no symptoms, or symptoms
may be easily confused with other illnesses.

Sexually transmitted diseases can cause:

* tubal pregnancies, sometimes fatal to the mother and always fatal to the
fetus 
* death or severe damage to a baby born to an infected woman
* sterility 
* cancer of the cervix in women 
* damage to other parts of the body, including the heart, kidneys and brain 
* death to infected individuals 

See a doctor if you have any of these STD symptoms: 

* discharge from the vagina, penis or rectum
* pain or burning during urination or intercourse 
* pain in the abdomen (women), testicles (men), and buttocks and legs (both)
* blisters, open sores, warts, rash, or swelling in the genital area, sex 
organs, or mouth
* flu-like symptoms--including fever, headache, aching muscles, or swollen
glands--which may accompany or precede STD symptoms. n


Some of the material in this article was taken from the FDA pamphlet Condoms
and Sexually Transmitted Diseases . . . Especially AIDS. Copies of the
pamphlet and other information about condoms and STDs are available from the
National AIDS Hotline 24 hours a day. The phone numbers are:
* 1-800-342-2437 (English)
* 1-800-344-7432 (Spanish)
* 1-800-2437-TTY (deaf access)
  Information is also available from the National STD Hotline:
* 1-800-227-8922

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