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Condoms: Barriers to Bad News

March/April 1998

What do condoms have in common with toothpaste and toilet paper?

Not enough, according to Adam Glickman, owner of the Condomania stores in New York and Los Angeles. Glickman, who has sold condoms by the millions to individuals and organizations such as the Peace Corps and Planned Parenthood, says condoms should be viewed as ordinary, like toothpaste and toilet paper. "People have gotten past asking, 'Isn't brushing my teeth every morning a hassle?' Given the world we live in, wearing condoms is something you just have to do, like brushing your teeth. The stakes are too high."

Luis Lopez knows first-hand what's at stake. About 10 years ago, Lopez, now 31 and a health educator with the People With AIDS Coalition of New York, became infected with the HIV virus, which causes AIDS, during a casual sexual encounter.

"I thought people with AIDS had purple spots or looked really skinny," Lopez says. "I thought by being discriminating about who I slept with, I could keep myself safe. We know now that makes no sense."

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We know now that abstaining from sex is the only foolproof protection from the sexual passage of HIV and other sexually transmitted diseases (STDs). We know, too, that for those who choose to have sex with someone who has any chance of being infected, using a latex condom during every sexual encounter can significantly reduce the risk of HIV and other sexually transmitted diseases, while protecting against pregnancy.

For those who can't or won't use latex condoms, the Food and Drug Administration has cleared two alternative barrier methods of birth control, a male condom made of polyurethane and a condom that is worn by the woman. Both help protect against pregnancy and may provide some level of protection from STDs.


A Life-Saving Barrier

HIV and spermA male condom, sometimes called a "rubber" or "prophylactic," is a sheath that fits snugly over a man's erect penis, with a closed end to catch the sperm and stop them from entering the woman's vagina. No prescription is needed to buy a condom.

Data show that if a condom is used correctly with every act of sexual intercourse for one year, about three out of every 100 women are expected to get pregnant.

Besides sperm, latex condoms act as a barrier to a wide variety of viruses, bacteria, and other infectious particles. By preventing contact with many sores and minimizing the exchange of infectious fluids, condoms can help prevent the transmission of sexually transmitted diseases, including HIV, gonorrhea, chlamydia, syphilis, herpes infection, and genital ulcers. Even though sperm are enormous compared to HIV (see illustration), both are much too small to see. But even HIV, which is among the tiniest of STD organisms, cannot pass through a latex condom.

Millions of Americans are infected with these diseases each year, and hundreds of thousands of them become seriously ill or die as a result. According to the Centers for Disease Control and Prevention, in the United States, someone is infected with HIV every 13 minutes. CDC estimates that 65 percent of these AIDS cases can be attributed to sexual contact.

The best protection from such diseases is to not have sex or to have a mutually monogamous relationship with someone who is known to be uninfected. However, for those who are sexually active, studies have shown that proper and consistent use of latex condoms is the best defense.

A 1994 European study published in the New England Journal of Medicine looked at HIV transmission rates of heterosexual couples with one HIV-infected partner. The study compared the transmission rates for couples who used condoms consistently to those who didn't. Of the 123 couples who consistently used condoms, none of the HIV-free partners became infected during the study, whereas 12 of the 122 partners who didn't consistently use condoms became infected.

"The scientific evidence is compelling," says Herbert Peterson, M.D., chief of CDC's women's health and fertility branch. "We're not guessing about this."

The spermicide nonoxynol-9, used in some condoms, has been shown to be effective as a contraceptive, and may reduce the risk of transmitting certain STDs. But the spermicide has not been proven to prevent sexual transmission of HIV.

Similarly, lambskin (or natural membrane) condoms, while effective for contraception, should not be used for disease protection because the naturally occurring pores in lambskin are large enough to allow some viruses to pass through.


Hole Check

Since 1976, FDA has regulated condoms to ensure their safety and effectiveness. Currently, manufacturers of American-made and imported condoms electronically test each condom for holes and other defects. Also, before distributing the condoms to retailers, manufacturers perform additional testing on random condoms from each batch, usually involving a "water leak" test to find holes and an "air burst" test to check condom strength.

FDA oversees the testing procedures by periodically inspecting the manufacturing facilities, and the agency tests some condoms in its own laboratories to confirm their quality.

Condoms are sold in various colors, shapes or packaging to suit different personal preferences. But, whether they glow in the dark or taste like strawberries, products that sufficiently resemble a condom must comply with FDA's requirements, even if they are labeled as "novelties." The only condom-like products that need not comply are those that can't be used like condoms. For example, some novelty products have the closed end removed or are sealed so they can't be unrolled.


Correct and Consistent

Although condoms are generally expected to break less than 2 percent of the time -- with more than half of the breakages occurring before ejaculation -- real-life pregnancy rates over a year of condom use may be as high as 15 percent.

Inconsistent or incorrect use of condoms explains the discrepancy, according to Lillian Yin, director of the division in FDA that regulates condoms and other reproductive devices. One national survey of heterosexual adults with multiple sex partners found that only 17 percent used a condom every time they had sex.

"People say they use condoms," Yin says, "but do they use them each and every time and use them correctly? That's another ballgame. We hear it all the time -- 'We tried to use it, but ....'"

But what? Partner trust was the most-cited reason for not wearing condoms in a recent study sponsored by the National Institutes of Health. But be careful, CDC cautions, because even a trustworthy partner could unknowingly have a sexually transmitted disease.

Many participants in the NIH study said they didn't always wear a condom because sex feels better without them. Lopez responds, "If you don't use them, you run the risk of something that feels much worse."

Sometimes a couple can't use a latex condom because one partner is allergic to latex. For these people, FDA has approved condoms made from polyurethane.

If a man objects to wearing a condom for some other reason, Planned Parenthood suggests possible replies. For example, to the partner who says, "I guess you don't really love me," the organization suggests responding, "I do, but I'm not risking my future to prove it." If the man still chooses not to wear a condom, the Reality female condom cleared by FDA in 1993 offers an alternative. (See "For the Female.")

Using condoms consistently is a start, but using them correctly is another key to protecting oneself. User error, not poor condom quality, leads to most breakages. But a few simple rules can minimize breaks and leaks. (See "Handle with Care.")

Even when used correctly, condoms aren't perfect, CDC acknowledges, comparing them to other important safety-enhancing behaviors like wearing seatbelts and bicycle helmets. Imperfect as they are, condoms can significantly reduce the rates of unintended pregnancies and sexually transmitted diseases.

"Correct and consistent condom use," says CDC's Peterson, "could break the back of the AIDS epidemic."


Tamar Nordenberg is a staff writer for FDA Consumer.


Handle with Care

To get the maximum protection against pregnancy and sexually transmitted diseases, remember the following things when using condoms:

  • Store condoms in a cool, dry place out of direct sunlight. Don't make the common mistake of storing them in a glove compartment, wallet or purse.
  • Don't use a condom if the package is damaged or the rubber material is sticky, brittle, discolored, or otherwise deteriorated. Don't use a condom after the expiration date or more than five years after the manufacturing date.
  • Never reuse a condom. Use a new condom with each sexual act that involves contact with the penis.
  • Handle a condom carefully to avoid damaging it with fingernails, teeth, or other sharp objects.
  • Put on the condom after the penis is erect and before intimate contact. Place the condom on the head of the penis and unroll it all the way to the base. Leave an empty space at the end of the condom to collect semen. Remove any air remaining in the tip by gently pressing the air out toward the base of the penis.
  • Ensure adequate lubrication during intercourse. When needed with latex condoms, use only water-based lubricants such as K-Y jelly or glycerin. Don't use oil-based lubricants such as baby oil, petroleum jelly, massage oil, body lotion, or cooking oil because they can weaken the latex. Oil-based lubricants may be used with polyurethane, however, without damaging the material.
  • After ejaculation, hold onto the rim of the condom and carefully withdraw the penis while it is still erect.

-- T.N.


For the Female

The pouch-shaped Reality female condom enables women to protect themselves against pregnancy and AIDS and other sexually transmitted diseases.

The female condom is made from polyurethane and, like the male condom, is a nonprescription barrier method of birth control. The device has a closed end that is inserted deep inside the vagina to catch the sperm and an open end that remains outside the body. A female condom should not be used with a male condom because the devices will not stay in place.

Over the course of a year, between 5 percent and 21 percent of women who use the female condom are expected to get pregnant, depending on whether the condom is used correctly with every act of vaginal intercourse. The female condom also provides some level of protection against STDs.

As with other condoms, follow label directions carefully to ensure that the material is not deteriorated or torn.

-- T.N.


More Safer Sex Information

CDC National AIDS Hotline 1-800-CDC-INFO (800-232-4636) http://www.cdcnac.org/

CDC National STDs Hotline 1-800-227-8922

Planned Parenthood Federation of America 1-800-230-7526 http://www.ppfa.org/ppfa/



  
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This article was provided by U.S. Food and Drug Administration. It is a part of the publication FDA Consumer. Visit the FDA's website to find out more about their activities and publications.
 
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