April 27, 1995

These are answers from the Centers for Disease Control and Prevention (CDC) and the Food and Drug Administration (FDA) to questions submitted by the CDC National AIDS Hotline concerning an article on condoms in Consumer Reports magazine in April of 1995.

1. Some condom boxes specifically indicate they are designed for vaginal sex only. Are they not effective for anal sex? Which condoms should be used for anal sex?
For the most part, FDA has only evaluated data on condoms tested in vaginal sex. There have been several published studies and surveys which indicate condom breakage and slippage rates may be higher during anal sex. However, these studies are only retrospective. Whatever the breakage rate, it may be reduced by use of a water-based or silicone- based lubricant.

2. In the discussion of condoms' failure rate, the article indicates that the rate can be further reduced by combining condoms with a vaginal spermicide. Does this relate to pregnancy, STDs, both?
Spermicides have been shown to be effective as a contraceptive. While they can reduce the risk of transmitting certain STDs, their effectiveness in preventing transmission of HIV infection has not been shown.

3. Since the FDA has only recently begun to use the air inflation test, does that mean condoms sold in the United States years ago might not have been reliable?
Condoms produced before this standard was introduced have been shown in actual practice to be highly effective in preventing the transmission of STDs, including HIV, when used consistently and correctly. This standard provides added assurance of the high quality of condoms manufactured in the United States.

4. Since "Trojans" and "Lifestyles" failed Consumer Reports A-1 test, are they not good to use?
While testing will always show some variation between different brands of condoms, it is important to recognize that every condom manufactured in the United States is electronically tested for holes and weak spots before it is released for sale. In addition, sample condoms from every manufacturing batch are removed for further standardized testing for leaks and breakage. And if these sample condoms fail the tests, the entire batch is thrown out. FDA has an ongoing inspection program that ensures that the quality control tests are done~and done right~by the manufacturer. And FDA itself tests both American and imported condoms. In the average batch of condoms, more than 99.7% of them passed the standard water leak test.

With respect to the Consumer Reports findings on condoms, it is important to understand how the type of testing affected the results. In its testing, Consumer Reports used the air- burst test, in which condoms are inflated with air and their resistance to breakage is measured. However, it wasn~t until last year that U.S. manufacturers were required by the FDA to adopt this test. Prior to that, they used the water leak test, in which the condoms are filled with water and checked for leakage. Unfortunately, as acknowledged in the article, many of the condoms used in the Consumer Reports study were manufactured prior to adoption of the air-burst test. If more recently manufactured condoms had been used in the study, the results might have been different.

5. The graphic on page 1 indicates men are less likely to get HIV/STDs from women than vice-versa? Does CDC still maintain that men are as likely to catch diseases as women?
For most STDs, the chances of a man transmitting infection to a woman is greater than vice-versa. Several studies have looked at the efficiency of heterosexual transmission of HIV (some are summarized in Holmberg, S., et al., Biologic Factors in the Sexual Transmission of Human Immunodeficiency Virus. J. Inf. Dis. 1989;160;116-125). Compilation of these studies appears to show that differences in rates of male- to-female versus female-to-male sexual transmission of HIV may not be very great. However, this conclusion is based on many assumptions concerning biologic factors of the virus itself, such as viral infectiousness, the number of infectious sex partners, and the presence of genital ulcers. All of these factors are known or suspected to influence transmission and may explain the observed differences in sexual transmission in different parts of the world. Other risk factors in women, including estrogen use and menstrual bleeding, have been suggested, but not confirmed. In the United States, most heterosexual transmission of HIV has occurred from men to women, but this results from the larger proportion of men in HIV-infected populations (bisexual men, injecting drug users, and persons with hemophilia).

6. The article tells us the FDA also tests imports. Is this process the same as for domestic condoms? In other words, are imports purchased in the United States as safe as domestics?
Imported condoms are required to pass the same tests as domestic condoms, so they should be equally safe.

7. Can consumers test condoms on their own?
No. Testing damages the condoms. Consumers should carefully examine the condom package before it is opened. The condom should not be unrolled and examined before it is used, because this could damage it. However, the condom should be checked as it is unrolled on the penis. Don~t use the condom if it sticks to itself, is gummy or brittle, is discolored, or has tears or holes.

8. How can consumers check the age of their condoms? Do all condoms have expiration dates?
All condoms have either an expiration date or manufacturing date on the package. Condoms should not be used beyond their expiration date or more than 5 years after their manufacturing date.

9. The article indicates that an intense dose of birth control pills can block pregnancy if used within 72 hours of intercourse. Is this true? Is it recommended, or not?
Callers should consult with their physician or family planning provider for further information. Oral contraceptives have not been approved for this use, and there are many different contraceptives with varying doses of different hormones.

10. CDC and FDA indicate that all condoms manufactured in the United States are safe and effective when used consistently and correctly. But the Consumer Reports article implies that some brands are clearly better than others. Why don't CDC and FDA acknowledge this? Why don't they provide the public with more complete information about differences so that the public can make more informed choices when purchasing condoms?
Government regulatory agencies set standards for product safety and make sure that manufacturers comply with these standards. As explained above (see the answer to question #4), any batch of condoms that does not meet these standards, is discarded by the manufacturer. Beyond this, the government does not test and ~rate~ condoms.

11. What type of condom does CDC/FDA think is the best?
Any condom labeled for disease prevention and sold in the United States should be effective in reducing the risk of transmitting an STD, including HIV, if it is used correctly and consistently.

12. The article includes % of chance of transmission from a single act of intercourse. Is this % range accurate, what affects it, and how is this information gathered?
There is limited scientific data supporting these estimates of chance of transmission. In a few studies, investigators have recorded the number of genital-genital exposures between HIV-infected persons and their uninfected sex partners. See the response to question #5 for more information about the other factors that are probably involved with transmission of HIV. Percentages of risk from sexual encounters are not really helpful to give callers. Information specialists should caution callers not to use any risk percentages to underestimate or inaccurately assess their own personal risks of HIV transmission. AIDS- knowledgeable callers should already be aware that single sexual encounters without the proper use of condoms have led to HIV infection in both men and women. All sexually active callers should be informed of this risk.

13. If the smallest hole that the water test can find is 100 times bigger than HIV, why is the test used to evaluate condoms?
The water leak test has been used to evaluate condoms for holes because the test is simple and fast and has shown itself through decades of use to be an effective tool for testing the quality of the manufacturing process. The test cannot detect holes as small as HIV. However, for those holes that go undetected, the amount of fluid which passes during use is so small that exposure to virus is unlikely. Sophisticated tests in FDA~s laboratories have confirmed this conclusion.

Note: another laboratory test has been developed to test condom materials for virus penetration. While the test is too complicated to be useful in quality control (i.e., on a batch-to-batch basis), it is used by all manufacturers to test new materials.

14. Inset on using condoms wisely-recommendation on washing with soap and water if a condom breaks, and possibly inserting a spermicide etc. This may be a statement callers question as we do not tell people anything of the sort except "if you are going to continue having sex, put on a new condom." Should we be recommending that people wash, etc?
There is no data to indicate that washing with soap and water can reduce the risk of acquiring an STD, including HIV.

15. On the final table, it states that the lubricant on a number of latex condoms feels oily. Does this mean these condoms came with an oil-based lubricant?
This only refers to the ~feel~ of the lubricant, not the type. Only water-based and silicone-based lubricants should be used with latex condoms.

16. What is a silicone-based lubricant? Is it new? Is it safe to use with latex condoms?
Silicone is a semi-inorganic polymer characterized by wide- range thermal stability, high lubricity, extreme water repellence, and physiological inertness; it is used in adhesives, lubricants, protective coatings, paints, electrical insulation, synthetic rubber, and prosthetic replacements for bodily parts. Because silicone does not deteriorate latex, it can be safely used as a lubricant for latex condoms.

17. Is there a correlation between breakage during condom use and failure during air burst testing?
There appears to be a correlation between condom breakage in use and air burst test results. However, we do not know what that correlation is. It should be recognized that once a condom is in the hands of a consumer, there are many individual factors that may contribute to condom breakage such as how carefully they are handled and used.

18. The article says condoms differ significantly in their resistance to the air-burst test. What are the risks of STD/HIV transmission with one of those ~risky~ condoms?
The risk of pregnancy or STD/HIV transmission is related far more to sexual practices than variations among condoms. It is critical that a condom be put on before there is any sexual contact (penis to vagina/mouth/anus), and that the penis be withdrawn immediately after orgasm, before losing an erection. If a condom tears or slips, the penis should immediately be withdrawn, and the used condom replaced with a new one.

19. Condoms produced before the air burst standard was introduced have been shown in actual practice to be highly effective in preventing the transmission of STDs, including HIV. Have studies been done to support this statement?
There have been numerous studies which have shown that latex condoms work. See the 1988 MMWR on condoms (CDC. Condoms for the Prevention of Sexually Transmitted Diseases. 1988; 37; 133-137.)

20. Is the air-burst test a FDA requirement or recommendation?
This is a guidance to manufacturers with which they have all complied.

21. What can we say about using a spermicide if the condom breaks?
If the condom breaks and you have not already used a vaginal spermicide, you can immediately use this product. However, we do not know how effective this use of spermicide may be in preventing pregnancy, STDs, or HIV. Do not douche. Douching after a condom breakage has occurred may cause harm by forcing any germs that may be present further into the vagina (or anus). This may increase your risk of infection. Call your doctor or family planning provider as soon as you can to discuss your family planning concerns and testing for STDs and HIV.

[email protected] (Sat Jun 24 22:03:57 1995)