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.

Tags: Sexually Transmitted Diseases (STDs), Birth Control

About the Author

www.fda.gov
FDA is A United States government body that oversees medical devices, including contact lenses, intraocular lenses, excimer lasers and eyedrops. In the US, these products must be approved by the FDA before they can be marketed.