Ever had a second thought about that latex condom you were preparing to use? A moment's doubt, perhaps, along the lines of--OK, I know when and how to put this on and take it off, but will it really protect me? How likely is it to leak, or break, or slip off?

U.S. regulation by the FDA

Since 1976, the U.S. Food and Drug Administration (FDA) has regulated the import, manufacture, quality control, and marketing of condoms in this country, much in the same way it regulates prescription drugs. And since 1987, amid mounting public concern about the HIV/AIDS epidemic, the FDA has increased its vigilance regarding condom manufacturing standards and quality control. All condoms marketed in the U.S are subject to random inspection, sampling, and testing.

Standards are especially high for condoms made in this country. Each condom is electronically screened for tiny "pinholes" and weak spots before it is packaged. In addition, each finished, packaged lot of condoms is randomly sampled and inspected by an independent laboratory to identify batches of condoms that may have manufacturing flaws. In this independent check, condoms are tested for holes that would allow body fluids and germs to pass through the barrier. The test is done by filling the condom with water and looking for leaks. If more than 1 in 400 tested condoms fails this test, the entire lot from this manufacturer is rejected.

Additional tests are done to assure adequate strength. These include filling sample condoms with air until they burst, and stretching cross-sectional bands of condoms until they break. The air volume and tensile strength break points must remain above a prescribed minimum that far exceeds the stresses of sexual intercourse. Dimension testing measures length, width, and thickness.

If condoms are not packaged in airtight wrappers they will dry out and loose strength. Package stability and shelf life (the predicted length of time that the condom will stay in good condition if the package is not damaged) are assured by storing sample condoms in two types of environments: (1) conditions of temperature and humidity similar to those found in a modern household, and (2) at higher temperatures that accelerate deterioration.

Your Mileage May Vary

So with all this testing and all these quality control steps, how well do condoms perform in actual use?

Breakage--According to the authoritative text Contraceptive Technology, 17th edition, condom breakage during heterosexual vaginal intercourse is a rare event. Breakage rates in prospective studies range from 0% to 6.7%, but most studies report breakage rates of less than 2%. Comparatively little research has been done on condom integrity during anal sex, but four prospective studies report breakage rates from 0.5% to 12%; in three of those studies, the rate was less than 2%. Between 24% and 65% of condom breaks (tears) happen before intercourse--while opening the package, for instance.

Slippage--Condoms slip off the penis in 0.6% to 5.4% acts of vaginal intercourse; partial slippage down the shaft of the penis occurs in 3.4% to 13.1% acts of vaginal intercourse. Slippage rates for anal intercourse range from 2% to 15%.

Note: Proper use of a condom requires withdrawal after intercourse while the penis is still erect; the condom should be held firmly at the base of the penis during withdrawal to prevent slippage or leaking of contents. Regular users of condoms are less likely to have problems with breakage or slippage than novice users. Practice, in this case, doesn't make perfect, but it does help.

A Note on Lubricants

Condom lubrication serves two general purposes: to prevent damage to the condom during the manufacturing process and to prevent breakage during use. During manufacture, formed condoms are washed with a water/powder mix; the powder is usually cornstarch. The condoms are then dried in a machine similar to a clothes dryer, leaving a residue of powder that serves as a dry lubricant to facilitate further processing. Wet lubricants applied to latex condoms just before packaging are either liquid silicone or a water-based lubricant. These help prevent breakage during use and improve user satisfaction. (Oil-based lubricants destroy latex condoms; never use an oil-based lubricant, e.g., Vaseline, with a latex condom.)

A number of condoms also include a spermicide in their lubricant, but there is no evidence that this increases the contraceptive effectiveness of the condom. On the other hand, spermicides can be irritating to vaginal tissues and may actually increase a woman's risk of acquiring a sexually transmitted disease (STD).

Government Condom Report: The last word?

Along with three other federal agencies, the National Institutes of Health (NIH) recently published a review of the medical literature on latex condoms and STD prevention. The summary finding on the male condom itself follows: "Natural rubber latex condoms for men are manufactured to conform to limits specified within consensus standards, including water leakage. Laboratory studies show that manufactured condoms meet these specifications. Other studies, based on viral penetration assays, have demonstrated that condoms provide a highly effective barrier to transmission of particles of similar size to those of the smallest STD viruses. These data also provide a strong probability of condom effectiveness when used correctly, where the cause of STD transmission is linked to containment of pre-ejaculate and seminal fluids or barrier coverage of lesions on the penis and there is no slippage or breakage."

The report emphasized the well-documented evidence that the male latex condom can prevent HIV infection with approximately 85% effectiveness. However, it also highlighted a lack of published studies documenting the protective effect of condoms against several common sexually transmitted diseases (STDs). There is a push for more and better studies that would measure how much protection condoms offer against these STDs. Experts say such studies are difficult to organize and it may be years before they are implemented. As far as the device itself, however, there appears to be little reason to doubt condoms are well-made. Today's condoms--especially those brands manufactured in the U.S.--are everything but road-tested.