An actual use comparison of condoms meeting Australian and Swiss standards: results of a double-blind crossover trial.

The performance of condoms in actual use has been poorly researched in the past, especially in comparing condoms that met different quality control standards as indicated by laboratory testing. The present study used a double-blind crossover design to compare the performance of 2 types of condoms in actual use; one that met the Australian and International Organization for Standardization (ISO) standards for condom quality and one that met the more stringent Swiss Quality Seal requirements. Ninety-two men recruited from Metropolitan Melbourne completed a self-report diary sheet after each condom was used which assessed the performance of the condom and the conditions under which it was used. From a total of 1917 condom uses, there was an overall breakage risk of 2.7%. The breakage risk ratio (Australian/ISO:Swiss) for all types of use was 1.16 (95% confidence interval 0.68-1.99). When subanalyses by method of entry were performed, the condoms meeting the Swiss standard appeared to fare better than the Australian/ ISO standards for anal sex (RR = 4.84, 95% CI 1.07-21.8, P = 0.022), while the opposite was the case for vaginal sex (RR = 0.74, 95% CI 0.35-1.53, P = 0.41). The result for anal use was statistically significant at the 5% level, despite being based on fewer condom trials than that for vaginal use, but this result needs to be replicated. Although the participants appeared representative of the general male population in Melbourne in the age bracket 18-46 years, there was a significant history of condom usage reported. This may have influenced the risk of breakage.

[The condom: a badly known method in 1995]. / Le preservatif: un produit mal connu en 1995.

PIP: The only contraceptive product that remained legal under French legislation of 1920 was the condom, which kept its place in the market because of its efficacy against venereal disease. Legislation of November 1987 governs manufacture, importation, marketing, and free distribution of condoms in France. Condoms sold in France must meet specific conditions for size, form, strength, packaging, and labeling. With 110 million units distributed in 1992, France represents 3.9% of the world market. The 61 approved brands of condoms are all imported. Only natural latex condoms are currently approved. Measures to increase condom use in France for AIDS prevention may focus on increasing accessibility or increasing acceptability. During the 1980s the principal factors limiting condom use were reported to be interference with sensation, interruption of coitus, the association of condoms with prostitution, and the negative attitude of physicians. The increased use of oral contraceptives, which largely replaced condoms in France, allowed men to disengage themselves from contraception. The decline of condom use has probably increased the difficulty of its reacceptance. Condoms are used primarily by young persons and those with multiple partners, but even in these groups usage should be increased. The efficacy of condoms must be evaluated in different ways. Condoms are impermeable to sperm and apparently to the AIDS virus, although apparently some smaller viruses are not barred. Neither the efficacy in vivo of spermicides used with condoms nor the greater efficacy of condoms with reservoirs have been demonstrated. Failure rates for condoms are very difficult to evaluate and depend greatly on motivation. Two recent studies of couples with one HIV seropositive and one seronegative partner indicate that systematic and correct condom use prevents HIV transmission.^ieng

[Damage to condoms caused by vaginally administered drug]. / Beschadiging van condooms door vaginaal toegediende geneesmiddelen.

A 28-year-old woman who was treated for vaginal candidiasis with Gyno-Daktarin vaginal capsules (miconazole nitrate) became pregnant because a condom used during intercourse had ruptured. Incubation in vitro with 400 and 1200 mg miconazole nitrate vaginal capsules (Gyno-Daktarin 3 and Gyno-Daktarin I), but not miconazole nitrate vaginal cream (20 mg/g), was shown to damage rubber condoms. Patients using vaginal medicines should be aware of a possible adverse effect on rubber condoms or contraceptive diaphragms and a subsequent increased risk of pregnancy or contagious diseases such as AIDS. Fatty excipients such as glycerin, paraffin, petrolatum or Witepsol may be involved.

PIP: A 28-year-old woman who was treated for vaginal candidiasis with Gyno-Daktarin vaginal capsules (1 capsule per day containing 400 mg miconazole nitrate for 3 days) became pregnant because a condom used during intercourse on the 3rd day had ruptured. The pregnancy was later was terminated by vacuum aspiration. With the collaboration of Janssen Pharmaceutica the TNO Plastics and Rubber Institute studied the effect of Gyno-Daktarin on the quality of condoms. Three different forms were investigated: Gyno-Daktarin cream (20 mg miconazole nitrate/g), Gyno-Daktarin in 1 vaginal capsule (1200 mg miconazole nitrate), and Gyno-Daktarin in 3 vaginal capsules (400 mg miconazole nitrate). Before the investigation six different types of condoms were selected from among the commonly sold types in the Netherlands. The condoms were brought into contact with the above three products. Then they were exposed for one hour to a temperature of 37 degrees Celsius and cooled off to room temperature. Among 450 condoms that were handled in this fashion (75 per brand) length changes, bursting volume, and bursting strength measured by means of ISO 4074, the valid standard of the International Standard Organization, were compared to the outcome of 600 condoms (100 per brand) that had not been exposed to Gyno-Daktarin. The three different combination forms of Gyno-Daktarin were each tested on 150 condoms (25 per brand). There was no change in the length of condoms that were brought into contact with the cream (20 mg/g), however, after incubation in vitro with both 400 and 1200 mg miconazole nitrate vaginal capsules (Gyno-Daktarin 3 and Gyno-Daktarin 1) the length was augmented by an average of 20%. After treatment with the two kinds of capsules the bursting pressure and the bursting volume were reduced by an average 35-44%. Patients using vaginal medicines should be aware of a possible adverse effect on rubber condoms or contraceptive diaphragms and a subsequent increased risk of pregnancy or contagious diseases such as AIDS.

Avanti overcomes safety concerns raised by FDA.

PIP: As an alternative to the latex condom, the Avanti polyurethane condom represents the first technological breakthrough in the condom industry in 70 years. The manufacturer, London International in Florida, claims to have spent $16 million developing this condom. Although the US Food and Drug Administration (FDA) determined that the condom is safe, it questioned test results showing that the polyurethane material did not biodegrade under relatively mild conditions. Therefore, the FDA required the company to perform additional animal toxicity studies, which showed that the product was safe for rabbits. This was necessary because certain polyurethanes when degrading in mild conditions release a known carcinogen and a potential toxin. Canadian officials are also reviewing Avanti for approval; Canada does not have standards for plastic condoms either. The co-inventor of the Avanti condom said in San Diego that the toxicity studies had been conducted to satisfy the FDA, and there were no indications that the polyurethane condom could cause cancer or other adverse reactions. However, one study was located in the literature linking asthma and contact dermatitis to substances released from polyurethane chemicals. Another issue was the silicone used as the lubricant for the condom. Long-term exposure to silicone is still debated, but moderate amounts are harmless, according a Canadian official. The manufacturers are also considering providing Avanti with the nonoxynol-9 spermicide, which would need FDA approval. The safety of the Avanti's retention ring was also questioned. It is a rubber-based elastomer used for nonallergenic gloves, safe for people with allergies. In addition, polyurethane is not susceptible to ozone and oxidation, and its shelf life is three years, although it remains stable up to five years, according to durability tests.^ieng

Special report: the truth about condoms. Restrictive label could impede plastic condom sales.

You walk into a drugstore to buy a package of plastic condoms. You happen to notice the label says that no one's sure how well they protect you from pregnancy or sexually transmitted diseases (STDs) like AIDS. Then, the label indirectly points you in the direction of latex condoms. What would you do? Some observers familiar with the condom industry speculate that the restrictive labeling carried on each package of the new plastic condoms for men will not interfere with consumers' purchasing decisions. Other predict an instant replay of the situation faced by makers of the polyurethane Reality female condom: A lack of data on pregnancy rates and STD rates resulted in a label touting latex as a superior product, which in turn caused an onslaught of negative press about the first plastic condom. The US Food and Drug Administration, finding itself in a similar position with approving plastic condoms for men, recently released interim labeling to be followed by all manufacturers who want to sell the new male condoms. Essentially, the manufacturers must point out on the front of the condom box that the product is "for latex-sensitive condom users," and on the back of the box must tell a potential buyer that risks for pregnancy and STDs are not known for the product. Upon reading this disclaimer, the consumer then reads that "latex condoms for men, if used correctly with every act of vaginal intercourse, are highly effective at preventing pregnancy, as well as STDs, including AIDS (HIV infection)."

Condoms: a wider range needed.

PIP: In England, 281 men attending a genitourinary clinic in south London completed a questionnaire designed to allow researchers to better understand condom failure. This area has one of the highest incidences in the UK of HIV seropositive pregnant women. 25% (70) faced difficulties putting on condoms. 52 of these men (19% of all men) said the condoms were too tight. These men were more likely to have condoms slip off than those who did not find condoms to be too tight (73% vs. 52%). Some men frequently had condoms coming off (8% for Blacks, 2% for Whites, and 21% for Asians). Condom splitting occurred sometimes for 18% of Blacks and 7% of Whites, but not for Asians. During the last year, 56% of all men, especially Black men (70% vs. 53% for Whites and 36% for Asians) had had intercourse with at least two partners. 22% of all men always used condoms. Black men were less likely to always use condoms than Whites and Asians (9% vs. 27% and 36%, respectively). These results indicate that many men may have penises too large for condoms to be placed on with ease. These men tend to experience the condom slipping off or splitting. These difficulties may affect their acceptability of condoms. Condom failure linked to tightness reinforces negative images of condoms. WHO's guidelines show that more than 33% of penises are larger than the British Standard Institute's standard dimensions for condoms (a flat width of 52 [SD 2] mm). Thus, the standard limits the production of an appropriate range of condom sizes. Further research is needed in condom design. The findings suggest that Blacks are at particular risk of HIV infection and that condom promotion efforts should target them.^ieng

Efficacy of thermoplastic elastomer and latex condoms as viral barriers.

The barrier efficacy of a thermoplastic elastomer (TPE) and three brands of latex condoms was compared in a passive-leak test and in a dynamic model of simulated intercourse. Fifteen replicates of each of the condoms were challenged with bacteriophage T7 (100 nm) and the polio virus Type 1 (PV-1, 27 nm). In the passive test, no condom leaked either virus. In the dynamic model, no TPE condoms leaked either virus and no latex condoms leaked T7. Two samples of one commercially available latex condom leaked T7 but not PV-1. These data support that intact latex condoms are effective in vivo viral barriers and extend the finding to TPE condoms as well. Given its substantial equivalence to latex as a viral barrier, TPE condoms are an alternative choice for individuals with latex allergies. The TPE material is also more resistant to common environmental conditions that affect latex adversely and should therefore be a superior choice if condoms must be stored for extended periods in suboptimal conditions.

PIP: A microbiologist at Loma Linda University in California used T7 (100 nm), a virulent bacteriophage of Escherichia coli, and the poliovirus type 1 (PC-1) (27 nm) to compare the efficacy of the viral barrier of latex and new thermoplastic elastomer (TPE) condoms. The scientist used a passive test and a simulated intercourse model to compare the 2 condom types. The simulation consisted of a condom-covered disposable centrifuge tube with 4 ml of virus which was inserted into an outer condom with 2 ml of virus-free medium. This apparatus was withdrawn and inserted 30 times within 30 seconds into a commercially produced latex vagina. The tests with T7 used 15 condoms of each brand. The tests with PV-1 used 14 condoms of each brand. The only TPE condom brand was Tactylon. Latex condom brands were Shiek, Trojan-Enz, and Lifestyles. No virus passed through the barrier during the passive test. T7 leaked through 2 latex condoms (13.3%) of the same brand (Trojan-Enz) during the simulated intercourse test. On the other hand, PV-1 did not leak through any of the condoms. Tactylon effectively prevented the passage of both T7 and PV-1. These findings confirmed that latex condoms tend to block passage of both small and large viruses. They indicated that TPE condoms also block passage of small and large viruses. Thus, the effective maximum pore size in all of the TPE condoms and in all but 2 of the latex condoms was too small to let HIV (80-120 nm) and hepatitis B virus (about 42 nm) filter through. Clinical trials have indicated the breakage rate of TPE condoms is not significantly different from that of latex condoms. Advantages of the TPE condom are its ability to resist environmental effects, e.g., ultraviolet light and heat, which deteriorate the latex condom and it does not have antioxidants and accelerators the latex condom has which cause allergic reactions, e.g., dermatitis.

Effectiveness of latex condoms as a barrier to human immunodeficiency virus-sized particles under conditions of simulated use.

Condoms were tested in an in vitro system simulating key physical conditions that can influence viral particle leakage through condoms during actual coitus. The system quantitatively addresses pressure, pH, temperature, surfactant properties, and anatomical geometry. A suspension of fluorescence-labeled, 110-nm polystyrene microspheres models free human immunodeficiency virus (HIV) in semen, and condom leakage is detected spectrofluorometrically. Leakage of HIV-sized particles through latex condoms was detectable (P less than 0.03) for as many as 29 of the 89 condoms tested. Worst-case condom barrier effectiveness (fluid transfer prevention), however, is shown to be at least 10(4) times better than not using a condom at all, suggesting that condom use substantially reduces but does not eliminate the risk of HIV transmission.

PIP: Physical science researchers tested the ability of 89 undamaged latex condoms manufactured in the US to prevent passage of HIV=size particles under simulated physiologic conditions at their Food and Drug Administration laboratory in Rockville, Maryland. The design of the test system considered particle size, pH, surface tension, and time. A suspension of polystyrene 110 nm microspheres labeled with fluorescent dye served as the HIV-sized particle model in semen. They challenged each condom with this suspension for 30 minutes. The test did not include motion since stretching over the penis accounts for most pore stretching. Leakage of fluorescent dye occurred in 29 condoms (p .03). 21 condoms leaked at minimum leak rates 1 nl/s, 7 at 1-6 nl/s, and 1 at around 10 nl/s. Assuming the leakage occurred through the only pore in each condom, the pore diameters ranged from 2 to 7 mcm. Also assuming an even more conservative criterion, the qualitative results were the same: 11 condoms with leak rates were nl/s vs. 6 condoms with leak rates 1-9 nl/s (p .002). The widely used 300 ml water test did not indicate any pores in any of the condoms. In the extreme and highly unlikely scenario of all the fluid being pumped out of the condom, the transfer rate would be about 0.1 mcl after 10 minutes of thrusting after ejaculation filled the condom with semen (i.e., 0.01% of a typical 3 ml ejaculate). Thus proper use of latex condoms would result in exposure reduction from HIV of at least 4 orders of magnitude. These findings demonstrated that use of latex condoms can significantly reduce the risk of HIV transmission, but it does not eliminate that risk.

Selected legal developments in reproductive health in 1991.

PIP: Because of American preoccupation with abortion, worldwide reproductive health issues in 1991 received scant attention, despite many important changes. With the fall of Communism, Eastern European governments struggle in the legislatures and the courts to regulate abortion, particularly Poland, Czechoslovakia, Hungary, and the newly unified Federal Republic of Germany. Two international tribunals ruled narrowly on the restrictive Irish abortion law and international treaties ratified by Ireland protecting freedom of speech, leaving the Irish law intact. Spain's Supreme Court relaxed restrictions on abortion and for the 1st time allowed abortions for social reasons. Frances' highest administrative court ruled that the French government exceeded its authority in ordering the distribution of RU 497 (mifepristone), but ruled that French abortion law, allowing abortions in the 1st 10 weeks in "situations of distress," did not violate international treaties guaranteeing the "right to life." England approved use of RU 486 under English abortion law, with medical restrictions. The Canadian Supreme Court agreed to review a province's legislation that had the effect of limiting access to abortions via medical and hospital regulations. The Islamic, developing countries of Pakistan and the Sudan replaced colonial laws with more liberal abortion rules tailored to Islamic law. Pakistan decriminalized early abortions when given to provide (undefined) "necessary treatment" the Sudan allows abortions during the 1st 90 days. Peru reduced the penalties for some abortions. In Latin America, only Cuba allows abortions on request in early pregnancy. Iran, China, and the former USSR tightened and encouraged compliance with their family planning regulations. Fear of AIDS prompted several countries to tighten condom regulations. Artificial insemination, embryo research and surrogate motherhood also received attention.^ieng

[Improvement of quality standards for condoms]. / Amelioration des normes de qualite des preservatifs.

PIP: The worldwide spread of AIDS has led officials of family planning and AIDS prevention programs to question whether the condoms they dispense are of the highest possible quality. Quality standards for condoms are based on laboratory tests, which may not always reflect the actual stresses condoms are under in use. 3 key quality tests for condoms measure elasticity, permeability, and inflation. A basic knowledge of the manufacture of condoms and quality tests could help family planning and public health officials understand questions about the reliability of condoms. Almost all condoms are made of latex, a rubber derivative. The latex is said to 'mature' for several months after manufacture. But after maturation, the strength of the condom progressively declines with age. For this reason, Family Health International recommends that condoms over 5 years old not be used even if they have been stored under optimal conditions. The major manufacturers electronically monitor all their condoms to verify that they haven't been perforated and are of uniform thickness. Some 20 countries and the major donor organizations have established norms regarding the size and strength of condoms. Testing usually involves random sampling of a few hundred condoms from lots ranging from 35,000 to 500,000. US Agency for International Development standards specify acceptable limits for condom size and results of tests for leakage, elasticity, and inflation, as well as for lubricants and packaging. The other major donors require the factories themselves to carry out quality tests because of the high costs involved. But in 1990, the US Agency for International Development began having a certain proportion of condoms tested at the Family Health International laboratory in North Carolina. The permeability of condoms is usually tested by filling them with a certain quantity of water. Any leakage constitutes failure. This test is often considered to measure strength as well as permeability. The test of elasticity consists of cutting out a piece of the condom and stretching it until it ruptures. Some researchers consider this test less reliable because it examines only a small section. Some research groups have concluded that condoms that break during use are of comparable elasticity to those that don't break. The test of inflation involves filling condoms with air until they burst. This test permits testing of the strength of the condom. Recent studies suggest that it is the best indicator of risk of rupture in usage. Pressures are multiplying for development of new quality tests that will better predict condom failure. In the meantime, users of recently manufactured condoms meeting US Agency for International Development standards can be assured that the products are reliable, as long as they are properly stored and used.^ieng

Condom breakage studied.

4 specific reasons why condoms--even those of high quality--break have been identified following a series of studies in 8 countries among 1700 people. According to the studies, breakage falls into 4 general categories: incorrect methods of putting on condoms, use of oil-based lubricants, reuse of condoms, and duration or intensity of coitus. The studies, conducted by Family Health International, a North Carolina based contraceptive research and AIDS prevention organization, was the 1st large scale effort to examine condom breakage. Used properly and consistently, condoms are considered to be highly reliable for prevention of pregnancy and sexually transmitted diseases. An estimated 40 million couples worldwide currently use condoms for pregnancy prevention. The studies found that human factors caused condoms to break at rates that ranged up to 13%, with a 4-5% average breakage rate reported at most sites. Preliminary research data indicate that the vast majority of condom users very seldom experienced condom failure. Past condom "failure," as defined by the number of accidental pregnancies among US couples who used condoms for contraception, was estimated at 12% (12 of 100 couples using condoms for 1 year will experience a pregnancy). But the 12% failure rate was attributable primarily to nonuse or inconsistent use of condoms, not breakage. "W now have some guideposts as to what types of behavior lead to breakage," said Dr. Nancy Williamson, director of Family Health International's program evaluation division, which directed the studies. "We need to inform condom users and providers about which errors users make." The studies provide an important cross-cultural data base on condom use. "The causes of condom breakage were usually associated with individual behavior, not with culturally based practices," said Dr. Williamson. the 8 countries where the studies were conducted are: Ghana, Kenya, Mali, Sri Lanka, the Dominican Republic, Jamaica and Mexico.

Test method for evaluating the permeability of intact prophylactics to viral-size microspheres under simulated physiologic conditions.

The alarming number of AIDS cases has increased the attention given to barrier devices such as condoms. The authors describe a new test method that evaluates the permeability of the intact condom when subjected to simulated physiologic conditions. Fluorescent-labelled polystyrene microspheres (110 nm diameter) are used to model cell-free virus. Physical and chemical conditions that are present during coitus, such as pressure, pH, and temperature, are considered in the design of the method. The testing chamber is designed to be continuously monitored for changes in fluorescence due to leakage across the condom surface. The sensitivity of the system is 1 x 10(-5) of the original concentration of microsphere solution (3.4 x 10(11) particles/mL), which corresponds to leak rates as small as .001 microL/sec. The test provides an in vitro test of barrier material permeability relevant to actual use.

A study of the relationship between tensile testing of condoms and breakage in use.

The ability of the condom wall to maintain its integrity throughout sexual intercourse is critical to its role in halting the spread of major sexually transmissible pathogens including the human immunodeficiency virus. There are three principal in vitro performance tests applied to condoms: a test for freedom from holes, an inflation test, and tensile testing. In this study we subjected condoms that had broken in use to tensile tests in order to determine any correlation between their in vivo and in vitro performance. Condoms which had broken in use showed similar tensile properties to those which had not. All passed all tensile test criteria. Thus, the inclusion of tensile testing in National Standards for condoms is not sufficient to insure strong products.

Latex condom deterioration accelerated by environmental factors: I. Ozone.

Commercial non-lubricated latex condoms were unpackaged and exposed in an environmental chamber to ozone levels (0.3 ppm) commonly present in urban smog conditions. Deterioration was observed by scanning electron microscopy after 18 hours exposure. Loss of mechanical strength was quantitated by measurement of the air pressures necessary to burst the condom and volumes at burst. After 24 hours exposure to ozone the latex surface was covered with craters and after 48 hours the pressure required to burst the condom was 44% that of control samples. Data suggest the need for study of the effectiveness of lubrication and packaging in protecting condoms from environmental factors which may accelerate deterioration.

PIP: Although condoms are subject to tests of strength and leakage, these tests do not predict dependability nor do they consider environmental factors that may increase the probability of breakage. A study of latex condom deterioration was conducted with commercial non-lubricated condoms exposed to ozone levels commonly present in urban smog conditions. Environmental conditions during transport and storage may weaken the latex and contribute to its corrosive effects. In this study, commercial non-lubricated latex condoms were exposed to ozone in an environmental chamber. Deterioration was assessed by scanning electron microscopy after 18 hours of exposure. Condom air burst test protocols from the International Organization for Standardization were used to assess mechanical strength. Results revealed that there was marked deterioration of the condom wall after exposure to ozone after 6-48 hours. Mechanical strength was also decreased after 24 hours' exposure according to air burst test criteria. 3 different brands were tested to ensure that the effects were not limited to 1 brand. The condoms were non-lubricated and unpackaged when exposed, which is important in the interpretation of these results because most condoms marketed in the U.S. are pre-lubricated. Packaging may also provide additional protection. But the study did reveal a fundamental ozone-latex reaction. Anti-ozonant treatments, used in tires and other rubber products, could be an option for the prevention of deterioration in latex condoms. Careful transport and storage of condoms is important to protect them from environmentally accelerated deterioration.

Deliberation No. 88-176 AT authorizing the sale of only those condoms conforming to certain standards.

PIP: This Order provides that only those condoms that conform to standards set by order of the Council of Ministers can be sold in French Polynesia. Order No. 202 CM of 8 February 1989 (Journal officiel de la Polynesie francaise, No. 7, 16 February 1989, p. 264) provides that the packaging of condoms offered for sale in French Polynesia must be stamped "NF" and carry a date of expiration of effectiveness.^ieng

Condoms for prevention of sexually transmitted diseases.

PIP: This set of recommendations for condom use in efforts to prevent sexually transmitted disease (STD) covers efficacy of condoms based on laboratory or epidemiologic evidence, quality control standards used in the U.S., and 10 recommendations for proper use of condoms. Condoms will reduce the risk of acquiring infections from exposure to cervical, vaginal, vulvar or rectal secretions or lesions, or from transmitting infections via semen, urethral discharged or penile lesions, but will not protect skin areas from lesions not covered by condoms. Latex condoms have been shown to prevent bacterial and viral exposure, while natural "skin" condoms may not prevent transmission of viral agents. Neither oral nor anal use of condoms has been studied. Use of vaginal spermicide is suggested to decrease risks in case of leakage or breakage. The U.S. Food and Drug Agency has tested 430 batches of domestic and foreign condoms as of 1988, and rejects all shipments with a failure rate, in the water test, of 4/1000 or more, a standard known as the Acceptable Quality Level (AQL). So far, 4 domestic and 7 foreign producers have had their products detained. A set of recommendations on storage and practical use of condoms is presented, with details such as use of water-based lubricants, and allowance of room at the tip without an air space.^ieng

High condom quality essential to reduce HIV spread.

PIP: As condoms are an important defense against the spread of Acquired Immune Deficiency Syndrome (AIDS), their quality is an important public health concern. Condom storage, manufacturing techniques, and national condom quality standards all are factors that affect condom quality and, consequently, their prophylactic capability. Under optimal storage conditions, condoms can be expected to last about 5 years, but optimal standards are not realistic in many countries. Condoms can be impaired during their display in retail outlets by mechanical damage from handling and exposure to ultraviolet (UV) light from sunlight or fluorescent lamps. UV can reduce significantly the strength of condoms in transparent packages in only a few hours. Opaque packaging prevents this form of deterioration. Condom deterioration also can be caused by prolonged condom storage in wallets or tight pockets. Several studies indicate that condom deterioration is likely to result in breakage during use. Dr. Michael Free, director of Path, determined in a recent study that the longer condoms were exposed to UV light, the more prone they were to breaking during use. Due to the fact that available data suggest that environmental factors in many developing countries may reduce the effectiveness of condoms as prophylactics against sexually transmitted diseases, the World Health Organization (WHO) is developing new guidelines for condoms specifically intended to slow the spread of AIDS in these countries. FHI is conducting research to develop a more effective condom. Improved condom storage conditions, higher condom quality, and strict condom quality standards will help ensure that all condom users will be better protected against human immunodeficiency virus and other sexually transmitted diseases.^ieng

Condom makers struggle to handle increased demand.

PIP: Growing public concern about AIDS has led to an increase in demand and importation of condoms. The increased demand, which has put pressure on manufacturers and distributors, has also led to increased scrutiny of condom quality. The public, as well as the FDA, are concerned about the quality standards of U.S. made and foreign-manufactured condoms. U.S. manufacturers welcome the FDA attention because of its potential to keep marginal producers out of the market. 3 U.S. manufacturers issued voluntary recalls of their products in 1987, and there is particular concern about foreign condoms. Many foreign shipments of condoms have been confiscated at the border because they failed the FDA's leakage test. With the demand for condoms up 20% or more, new ways of distribution are surfacing. Vending machines are a new means of distribution, but there are limited packaging plants (only 1 in 1987) to fill the demand. As AIDS continues to escalate, the importance of strict quality standards and efficient distribution and manufacture of condoms cannot be overemphasized.^ieng