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What You Need To Know About... Personal Lubricants

What You Need To Know About... Personal Lubricants

By Steph Auteri | From the May 2015 Issue

Liquid Silk. Uberlube. Astroglide. Sliquid. There seem to be just as many personal lubricants on the market as there are sex positions. But until recently, lubricant use wasn't a topic that was discussed openly or marketed quite so widely, though research shows that 65.5 percent of women and 70 percent of men have used commercial lubricants.

"Many folks have the attitude that if they need to use lube, they are somehow sexual[ly] deficient," sex educator Kate McCombs told Mic. "They erroneously assume that vaginal lubrication is in direct proportion to someone's arousal. This isn't always the case. Someone with a vagina can be super turned on, but not super wet. It's not always linear."

In fact, persistent dryness during intercourse can stem from any number of things. Yes, dryness can be an indication that partners might benefit from more foreplay. But lack of natural lubrication can also be caused by stress, dehydration, various health conditions and their treatments, menopause, and more.

And so, slowly, there has been an uptick the usage of personal lubricants. In a 2012 research article published in The Journal of Sexual Medicine, researchers found that "women generally feel positively about lubricants and lubricant use and prefer vaginal-penile intercourse to feel more wet."

But the question for consumers then becomes: which lubricants work best, and which are safest for my body with repeated use? This question is more difficult to answer.

One reason is that the results of research conducted on the effects of various lubricants on our bodies is limited to in vitro studies and sometimes conflicting.

In addition, the Food & Drug Administration (FDA), which oversees medical device safety, has only slowly evolved its oversight and classification of personal lubricants, and this system is still not perfect. Scott Geibel, a researcher with Population Council, has written about the "flexible regulatory environment" that exists when it comes to lubricants. Geibel points out in this article that, since 1976, the FDA has usually classified most personal lubricants as "medical devices," depending upon how the product itself was marketed.

"Under the 1976 FDA regulation 21 CFR 880.6375," he writes, "a lubricant is considered a 'medical device' when 'intended for medical purposes that is used to lubricate a body orifice to facilitate entry of a diagnostic or therapeutic device.'" Conversely, personal lubricants that were marketed as moisturizers or cleansers were classified by the FDA as "cosmetic."

And the FDA clearance of medical devices is not nearly as stringent as the approval process for drugs. According to a 2011 report from the Institute of Medicine, the Federal Food, Drug, and Cosmetic Act (FFDCA) requires a "reasonable assurance of safety and effectiveness" before a device can be marketed, and the FDA is responsible for enforcing this requirement. Devices considered to have a moderate risk to patients cannot go on the market until they are cleared through the 510(k) process. But some policymakers and patients feel this process is not sufficient to ensure that medical devices are safe and effective. Others, however, feel the process "has become too burdensome and time-consuming and ... is delaying important new medical devices from entering the market." The Institute of Medicine in particular recommended that the 510(k) process be overhauled, but the FDA disregarded this recommendation.

Still, "it is only recently that the FDA started enforcing the requirement that lubricants be registered as Class 2 medical devices," says Ellen Barnard, MSSW, sex educator and counselor, and co-owner of A Woman's Touch Sexuality Resource Center. Which is a small improvement, and hopefully provides greater incentive for researchers to look closely at the effects of personal lubricants on our bodies. But what do we already know? And how can we use this limited knowledge to answer questions about effectiveness, possible irritation, compatibility with condom usage, effects on fertility, and more?

Personal Lubricants and Skin Irritation

Barnard says one of the most common concerns she hears is whether or not a lubricant will cause irritation. Unfortunately, research findings have been heterogeneous. Illustrating this reality is an article published in Environmental Health Perspectives in 2014, in which author Nicole Wendee compares results from a variety of studies.

Wendee mentions, for example, programs taking place in the early '80s that "led to groundbreaking discoveries in animals and humans that certain chemicals—including glycerin (glycerol), a common base for personal lubricants—can damage or irritate vaginal and rectal epithelial cells, potentially increasing the transmission of STIs such as herpes and human immunodeficiency virus."

Then she looks at more recent studies. In 2012, Charlene Dezzutti, Ph.D. and a team of researchers studied how lubricants might affect mucosal safety – both cervical and rectal. During the course of this work, they discovered that many personal lubricants damage human epithelial cells from cervical and rectal tissue.

"A lot of the aqueous-based lubricants are hyperosmolar," she told Wendee, "[which means] they tend to pull water out of your cells, and that causes the cells to shrink and shrivel. When we looked at human tissue, the cervical epithelium fractured off, and the rectal mucosa came off as well." This same study also showed that lubricants containing highly osmolar glycerin have also been linked to bacterial vaginosis and changes in the vaginal flora.

However, in looking at another study, researchers found no obvious damage to the vaginal flora of rhesus monkeys from the use of K-Y Warming gel, despite the product's high glycerin content.

In fact, Debby Herbenick, M.P.H., Ph.D., a sex educator and researcher with the Kinsey Institute, says that over the course of her own research—in which she and her colleagues looked at participants' reports of genital irritation both with and without the use of lubricant—she's found very few incidents of genital irritation. "When we tested lubricants with glycerin and propylene glycol, there just wasn't an issue," she says. "In fact, as you can see in our study, some women report more genital symptoms when they have sex without a lubricant." Herbenick credits this to the fact that lubricants decrease friction and, thus, decrease pain, discomfort,  and tearing for many people. "Sex is not a "no risk" game to the body," says Herbenick, "but, fortunately, most risks are pretty small, and most can be managed." Whether one chooses to have sex with or without lubricant, she feels that what's important is educating people about the choices they have.

Personal Lubricants and Condom Compatibility

Another concern among those using personal lubricants is how compatible different types of lube are with condoms. In 2013, Geibel published a report on condom and lubricant usage in developing countries, which was published in the Journal of the International AIDS Society. In this paper, Geibel writes of two different ways to measure the effects of lubricants on latex condoms. "One method," he writes, "is to apply lubricants in a laboratory setting and conduct precisely measured mechanical strength or burst tests. The other is to recruit actual condom users and measure lubrication use and condom breakages, either within a prospective cohort or retrospectively among a cross-sectional sample."

According to Geibel, it seems that the most commonly cited information on condom breakage when used with oil-based substances comes from a 1989 paper published in Contraception. For the purposes of their research, the authors conducted burst testing with various substances and concluded that mineral oil-based lubrications, such as baby oil or body lotion, had a significant degrading effect on latex.

Meanwhile, a study conducted that same year (Pugh B, Englert M. An evaluation of the effects of various lubricants on latex condoms. Fifth International Conference on AIDS; Jun 4–9; Montreal. 1989. p. 135) claimed that similar testing methods found that petroleum jelly also has a significant weakening effect on latex condoms. And yet another study in 1999 reported that products containing vegetable oil weaken latex condoms. There are also two more recent studies (both published in 2008) showing that users of oil-based lubricants were significantly more likely to have experienced condom breakage.

But there have also been other studies showing more favorable results for those in search of the best lubricant to use with a condom. A 1993 assessment of men who have sex with men, for example, showed lower condom failure rates among users of water-based lubricants (1.7 percent) versus those who used oil-based lubricants (10.3 percent) or saliva/no lubricant (5.7 percent). And a 1999 study showed that lubricants can, in fact, have a protective effect against condom breakage, though the types of lubricant being tested were not described. Geibel's report mentions several other studies showing similar results. Which results are we to follow?

Personal Lubricants and Anal Sex

And Population Council has studied more than just condom compatibility. Researchers within the organization have also studied the efficacy of various personal lubricants during anal sex. In a brief they released in 2011, the authors write that water-based lubricants have historically been championed as the best choice for use during anal sex, especially in the case of reducing the risk of STIs.

"The theory behind this advice," they write, "is that lubricants reduce the friction that occurs during vaginal or rectal intercourse. Friction can cause small tears in the fragile vaginal and rectal lining, through which disease-causing microorganisms can enter. Lubricants might prevent these tears from forming and thus reduce the transmission of STIs."

Herbenick mentions that her own findings were similar but, in the end, all six lubricants tested had high ratings when it came to anal sex, highlighting the fact that personal preference matters.

The authors of the Population Council brief also discuss the Council's newer research, which has shown that many lubricants can themselves damage rectal epithelial cells, though the researchers are quick to emphasize that their findings were from in vitro studies. "What happens in the laboratory environment does not always happen in the human body," says Jose Fernandez-Romero.

Still, the discrepancies between research results only highlight how far there it to go when it comes to the science of personal lubricants.

Personal Lubricants and Fertility

Another concern among those using personal lubricants is what effects it may have on their fertility. Unfortunately, as a result of conflicting in vitro and clinical data, this issue is still unresolved. Or at least that was the verdict in a 2014 paper published in Current Opinion in Obstetrics and Gynecology. For instance, an in vitro analysis conducted in 2014 showed that, among nine lubricants:

"the lubricant which had the best results in terms of vitality, at 92%, was Pre-seed® and the worst was Forelife™ with 28% vitality. In terms of motility, Pre-seed® resulted in the highest percentage of spermatozoa with progressive motility at 86% and Sylk™ resulted in the lowest percentage of progressively motile cells in the sample with 31% of sperm progressively motile. There were no significant effects on DNA integrity."

Which would seem to indicate that there are some lubricants available on the market that don't have much of a detrimental effect at all. And there were a number of other studies indicating similar findings. There are older studies, however, that have shown quite the opposite.

Because of the lack of any sort of consensus thus far, some, like Barnard, have had to approach client concerns in a more roundabout way. "It is possible," says Barnard, "to reason your way through a topic, especially one where there are plenty of pieces of research to apply to the analysis. A lot of the therapy-related social science is not definitive either, but we still talk about a variety of ways to address sexual dysfunction through different therapeutic and educational modalities. Even medicine does a lot of off-label recommending of things, based on health care providers' own experiences or case experience that does not make it into the published journals."

As an example, Barnard refers to the question of which personal lubricants might be more likely to irritate the skin. "There's no research," she says, "but if you look up complaints on the FDA site, or even on Amazon or other sales sites, you'll see a long list of reactions that people have."

As another example, she explains why she might recommend specific lubricants for anal sex. Barnard references a 2012 study on lubricant use and rectal STIs that was published  in Sexually Transmitted Diseases. "Based on that information," says Barnard, "we would trend toward products that do not shift the osmolar balance and draw moisture out of the skin... We also want lubricants used for anal penetration to be long-lasting and protective, and silicone is known to be derma-protective (that is, it seals the surface of the skin) by the dermatology researchers."

While one shouldn't necessarily rely solely on the contents of Amazon reviews, for example, in formulating a theory about how lubricants compare to one another in terms of safety, Barnard's approach to her work highlights the shifting ways in which clinicians are tackling issues like these. While some clinicians choose to practice evidence-based medicine (make decisions purely based on research findings), others are starting to take a more evidence-informed approach, formulating opinions and making decisions based on research findings and clinical experience.

Using this approach, there are some lessons we can glean as we attempt to figure out how to answer questions about various lubricants:

  • For one, oil-based products are not compatible with latex condoms (and even with some non-latex condoms that "behave" like latex).
  • Silicone lubricants should not be used with silicone products, including adult toys, pessaries, certain dilators, and certain vaginal estrogen rings.
  • But silicone-based lubricants do tend to stay on the skin longer, even when exposed to water, making them a better choice for sex in the bath or shower.
  • Dezzutti also recommends looking at the ingredient lists when choosing your lubricant. While the FDA is not required to list the amount of each product component, ingredients are typically listed in order of quantity, from highest to lowest. "The less ingredients, the better," she says.

Still, "since lubricants are under the FDA medical device category as opposed to the drug category," says Lynn Wang, MD, who works at Main Line Gynecologic Oncology, "'generic' lubricants do not have the same requirements as 'generic medications.' They don't have to have the same ingredients," she explains, "nor the same bioavailability. So when we recommend that someone use a water-based lubricant, generic version, it does not reflect the equivalent levels of safety and efficacy as when we tell patients to use a generic medication."

At the moment, our knowledge of lubricant safety and efficacy is still limited. "We can only encourage more research in this area," says Wang, "and, as an organization, rally together to demand more transparency and product safety."

Other conference programs containing information on personal lubricants include:

Thursday, June 4:

8:30 a.m. - 12:30 p.m.: Pre-conference workshop from Debby Herbenick, Ph.D., MPH, CSE, Sexual Enhancement Products: An Update on Condom, Lubricant & Vibrator Use

Friday, June 5:

5 p.m. - 6 p.m.: Workshop from Sarah Mueller, LUBE! An In-depth Look at Personal Lubricants

(image: Doug McCaughan)