FDA Approves Next Generation Female Condom

Kimberly Whipkey

Yesterday the FDA approved the second-generation female condom, expanding the "prevention toolkit" and offering women a less expensive contraceptive and STI prevention option.

Prevention advocates rejoice! Yesterday  the U.S. Food and Drug Administration (FDA) approved the FC2 female
condom – a second generation product manufactured by the Female Health
Company.   

There are many reasons to celebrate. 
First and foremost, the "prevention toolkit" is expanding – women
and men now have another option to prevent HIV infection. And women
in particular now have another safe and effective method designed for
them to initiate (even though men
can initiate female condom use too
!). 
The FC2 is designed to overcome some of the reported barriers faced
by its predecessor, the FC1 – it is apparently less noisy to use during
sex – and yet shares all the benefits of the FC1, such as the ability
to use water and oil-based lubricants or to insert the condom up to
eight hours before intercourse.  But the reason that is grabbing
the most headlines is the FC2 is cheaper to produce than the FC1, which
means that cost-savings will be passed on to the consumer.  In
fact, the FC2 will sell for about 30% less than the FC1. 

This of course has positive
implications for the affordability and accessibility of female condoms
in the U.S. and internationally.  For instance, the United States
Agency for International Development plans to phase out procurement
of the FC1 upon FDA approval of the FC2 according to Saving Lives
Now
, a report
by the Center for Health and Gender Equity.  This means that potentially
more female condoms can be procured, distributed and programmed overseas
due to lower costs.   

Cheers are definitely in order
for the decrease in manufacturing costs.  But it’s also important
to recognize that lower cost to the consumer is not a silver bullet
to rapid female condom uptake and use in the U.S. or internationally. 
Without adequate investments in technical support and programming, how
will women in men learn about the female condom-about how to insert
it and use it correctly and consistently, and how to negotiate and communicate
with their partners?   

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With the drop in cost for the
new female condom, we also need a surge in education and advocacy, at
the local, national and international level.  Local service providers
and departments of health, ministries of health and other decision makers
need to hear from advocates that increased investment in female condom
procurement, distribution and programming is essential. 

We encourage you to join the Prevention Now!
Campaign
– a
global campaign to dramatically increase donor and government funding
for the purchase, distribution and program support needed to expand
access to female and male condoms and other existing prevention options
for women and men.  Let’s build on this momentum together to
make universal access to female condoms a reality!   

News Contraception

FDA Approves New IUD Designed To Be More Affordable

Martha Kempner

Liletta, an IUD just approved by the FDA, is being marketed in the United States through a unique partnership between manufacturers who hope to bring the device to more people at a lower cost. However, it is still unclear whether those savings will be felt by all women.

On March 2, the Food and Drug Administration (FDA) approved a new intrauterine device (IUD) that, among other things, was designed with affordability in mind. Liletta, which is already available in Europe, is being marketed in the United States through a unique partnership between manufacturers who hope to bring the device to more people at a lower cost. However, it is still unclear whether those savings will be felt by all women.

When released, Liletta will be the fourth IUD currently available in the United States. It joins ParaGard (also called the Copper-T), which began being sold to women in the United States in 1988; Mirena, a hormonal IUD introduced in 2000; and Skyla, a smaller version of that hormonal IUD which was released just last year with younger users in mind.

All IUDs are small T-shaped devices that are inserted into the uterus by a health-care professional and serve to block sperm from moving through the uterus toward the egg. ParaGard also releases copper, which some experts believe creates a substance toxic to sperm. In addition, Mirena, Skyla, and now Liletta all release levonorgestrel, a hormone similar to those found in birth control pills. This means that they also thicken cervical mucus (creating a barrier to sperm) and may suppress ovulation in some women. ParaGard lasts for ten years, Mirena for five, and Skyla and Liletta for three—but all can be removed by a health-care provider at any point if a woman decides she wants to become pregnant or switch methods.

Some of the primary benefits of IUDs are their ease of use and efficacy in preventing pregnancy. Unlike condoms, the pill, or other hormonal methods such as the patch or ring, once in place an IUD works for years without any thought or action on the part of the user. This doesn’t just take pressure off the user to remember their birth control; it takes user error out of the efficacy equation altogether. It’s not surprising, therefore, that IUDs have among the lowest failure rates of any contraceptive method. In clinical trials, Mirena had a failure rate of 0.2 percent; Skyla had a failure rate of 0.9 percent; and ParaGard had a failure rate ranging from 0.6 to 1.0 percent.  Liletta has a failure rate of 0.55 percent. For comparison, the pill has similar failure rates under perfect conditions, but the possibility of user error makes the typical-use failure rate a much higher 9 percent.

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The FDA approval of Liletta is based on a U.S. efficacy trial of 1,751 women, which the manufacturers say is the largest study of a hormonal method conducted in this country. The results of the study to date show that Liletta is 99.45 percent effective at preventing pregnancy for three years, and that it is safe for women regardless of their body mass index or whether or not they have had children. The study is ongoing, in part, to determine whether Liletta could continue working past its currently approved three-year lifespan.

Liletta’s manufacturers say that their partnership will make the device affordable to women of all income levels. One of the main complaints about IUDs today is their high cost. Between the price of the device itself and the provider’s fee for insertion, an IUD can cost as much as $1,000. While this is actually more cost-effective than other methods paid for on a monthly basis—a woman who uses ParaGard for its full ten-year lifespan, for example, could pay less than 30 cents a day—having to come up with the money up front is prohibitive for many women.

As Rewire recently reported, IUDs can even be difficult for Medicaid patients to access, as reimbursement rules in many states are problematic in different ways. In some states, for example, Medicaid reimbursement rates are less than the cost of the actual device, which means providers inevitably lose money. The high cost of the device also means that many providers and clinics can’t stock them in advance, so women who want IUDs will have to come back at least a second time for the insertion. Moreover, some states’ rules mean Medicaid will only pay for a device prescribed to a specific woman. This doesn’t just prevent providers from stocking them in advance of a patient request; it means if that specific patient does not return for insertion, the device can’t be used for anyone else. A number of states are working to fix this issue by loosening rules and increasing reimbursement.

Liletta may also be part of that solution, as it was designed with access in mind. Medicine 360, one of the companies marketing this new device, is a nonprofit pharmaceutical company. It will make Liletta available at a reduced price to clinics enrolled in the 340B Drug Pricing program. The 340B program is run by the U.S. Department of Health and Human Services and is available to entities that typically serve low-income women such as Title X family planning clinics, STD clinics, and Federally Qualified Health Centers. The exact pricing to these organizations will not be available until the device is actually released. It is likely—though not guaranteed—that savings will trickle down to patients who get their care at these locations.

However, for those obtaining Liletta through private providers, it is unclear whether Liletta will be cheaper than the three IUDs already on the market. Elle.com wrote that we should “expect it to be markedly more wallet-friendly than the existing IUDs on the market when it launches this spring.” But when Rewire reached out to Actavis, the Dublin-based pharmaceutical company that will be handling the commercial sales of Liletta, the company gave no specifics. In an email, a spokesperson said: “Actavis is committed to providing access to IUDs in the private sector. More information on patient programs will be provided when LILETTA is available.” She added: “Information about pricing will be provided when LILETTA is commercially available.”

After their near-extinction in the 1980sIUDs continue to increase in popularity—the latest National Survey of Family Growth shows that 6.4 percent of women ages 15-to-44 are relying on this method of contraception. These numbers may very well go up when Liletta becomes available and helps at least some women overcome the price barrier to accessing this safe and effective form of contraception.

CORRECTION: This piece has been updated to reflect the correct daily price of an IUD when used for ten years.

Commentary Contraception

Cigarettes Cause Cancer; Condoms Don’t

Melissa White

A new petition calls on the FDA to “Get Carcinogens Out of Condoms.” But there is no scientific evidence linking condoms to cancer—and to claim otherwise has the potential to unravel decades of committed work focused on saving lives through encouraging condom use and education.

Last month, a new condom brand called Sustain began promoting a petition through email and social media calling on the FDA to “Get Carcinogens Out of Condoms.” Obviously, the possibility of carcinogens in condoms is a frightening thought. But the reality is that there is no scientific evidence linking condoms to cancer—and to claim otherwise has the potential to unravel decades of committed work focused on saving lives through encouraging condom use and education. Those of us who support and advocate for sexual wellness and reproductive health need to take notice and work to combat misinformation like this.

As the petition notes, most of us are exposed daily to nitrosamines, chemicals which are indeed classified as carcinogens. They are found in our drinking water, in the food we eat, and the air we breathe—at doses 1,000– to 10,000-fold higher than can ever be expected from condom use.

Condom manufacturers have worked diligently to keep these levels as low as possible. Nitrosamine residues are largely removed during manufacturing by a thorough washing or leaching process. Even so, based on the findings of the leading toxicological study evaluating nitrosamines in condoms, in order for condoms to cause cancer, they would have to contain a million times more nitrosamines than they actually do. Furthermore, a person would have to use more than 1,500 of such hypothetical condoms spanning decades.

According to that study, nitrosamine occurrence in condoms is, in fact, so low that they are measured in ppb—parts per billion. Yes, billion.

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Simply put, condoms have been proven exceedingly safe.

The petition being promoted by Sustain bases its claims on a study: Making a Good Thing Even Better: Removing NITROSAMINES from CONDOMS produced by the Reproductive Health Technologies Project (RHTP) and the Center for Environmental Health. But this research, which was funded in part by Sustain co-founder Jeffrey Hollender, is plagued by questionable methodology.

Based on the white paper released by RHTP, researchers in the study compared the nitrosamine levels of condoms of varying expiration dates procured from various unsecure locations, such as retail stores or online. Of the 24 condoms tested, ten were manufactured by Trojan, three by LifeStyles, and two by Durex; the other nine were an eclectic blend of brands and styles that included a female (internal) condom, flavored and colored condoms, arousal condoms, and textured condoms. This does not accurately represent the consumer market, because the authors of the study did not test the most popular styles and brands available, or test the same style among a variety of different brands. Furthermore, the methodology section of the study reported that all 24 condoms were latex. In reality, two—Lifestyles SKYN and the FC2—are actually non-latex.

The study was also not published in a medical or scientific journal, suggesting that it was not peer-reviewed by the academic community. In September, it was simply promoted via a press release and Twitter.

Additionally, documentation from the world’s leading independent testing lab proved that contrary to RHTP’s results, the styles it tested from three brands—ONE, Sir Richard’s, and GLYDE—have effectively non-detectable amounts of nitrosamines.

The authors of the study acknowledged that nitrosamines do exist throughout our environment. But their conclusion that “it is possible to manufacture quality condoms on a large scale with little to no nitrosamines” still effectively positions condoms that don’t contain nitrosamines—like Sustain—as superior. In turn, the public could easily interpret their results—that two-thirds of the condoms they tested contained nitrosamines—as an implication that the condom industry in general is negligent. Faulty methodology aside, this is incredibly misleading, and possibly dangerous.

And former Surgeon General Joycelyn Elders seems to agree. In September, Salon quoted Elders as saying:

Any public statement calling into question the safety of latex condoms, given the mountain of evidence supporting their safe and effective use, simply is not credible. Consumers should continue using condoms to prevent unintended pregnancies, HIV, and other sexually transmitted infections —and they should remain confident that condoms are safe and effective.

The RHTP study itself warns that any condom use is better than none. Its authors also “recognize that some people with […] a sensationalist bent may seek to distort the results of this study and erroneously claim that condoms cause cancer. Anyone who does so—be it the media, politicians, or advocates—is acting irresponsibly and not in the best interests of public health.”

Even so, Sustain’s leaders have continued to lean on nitrosamines as a danger. Jeffrey Hollender recently told the Portland Tribune that “Nitrosamines are known to cause cervical cancer.” Meika, his daughter and co-founder of Sustain, added, “And penile cancer.”

Again, there has been no research showing that condom-based nitrosamines cause cervical or penile cancer.

Neither Hollender nor Jessica Arons, the head of RHTP, would comment for this article on the study’s methodology, the evidence that several brands targeted in their study had undetectable nitrosamines, or on the implications of publicizing or promoting the “condoms contain carcinogens” argument.

With selling condoms comes an undeniable level of responsibility. My work, like many others’, is leading people to a better relationship with condoms, thereby increasing consistent and correct use. Misleading marketing, scare tactics, and irresponsible messaging is doing a disservice to all of us, especially to the millions of people who depend on condoms to protect their health.

According to the Kaiser Family Foundation, one-third of U.S. teens believe condoms are “not too” or “not at all” effective at preventing pregnancy. In fact, if consistently and correctly used, condoms are 98 percent effective. The longevity of these falsehoods demonstrates how difficult it’s been to promote consistent condom use. Hence, it is essential that the information used to promote condoms is accurate and easy to understand.

Fear campaigns, by their nature, are compelling. Tweets and top-level messages are often the only takeaways needed to shift opinion. People who don’t have the time, inclination, or interest to research the claims behind petitions may simply opt out of using condoms altogether. And that is definitely far more dangerous than the negligible levels of nitrosamine in condoms.

As health educators, teachers, parents, and communities, we must act. This kind of misinformation cannot—and must not—unravel the dedicated work we have accomplished across the globe, for decades, to educate consistent and correct condom use, shift attitudes around condoms, and stop the stigma, shame, and myths that often prevent consistent condom use.