Coming Soon: New and Improved Female Condom

Wednesday, 16 Jul 2014 08:00 AM

 

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When Debby Herbenick met a friend and former colleague for lunch at the end of last year, it was only natural the conversation would turn to sex.
 
It is their job after all. Herbenick is a sexual health researcher and Frank Sadlo, her lunch date, a product developer with experience in the same field. So the pair got talking about new contraceptive design, exchanging ideas and eventually sketching hypothetical devices.
 
Last month, their plan for a new female condom moved closer to reality. The product was one of 11 contraceptive projects to win $1.1 million in exploration grants from billionaire Bill Gates’s philanthropic foundation, and one of three focused on women. The aim is to improve on earlier female condoms with a product that’s easy to use and enjoyable to help protect women, who are disproportionally affected by sexually transmitted infections in developing countries.
 
“We hope that women can feel empowered,” said Herbenick, a sexual health scientist at Indiana University. “Female condoms gives women a choice to say: ‘OK, if you don’t want to wear one, I will.’”
 
Existing condoms never really took off because they “just aren’t built for women’s bodies,” said Herbenick, who likened their fit to a “sandwich bag.”
 
The condoms are intended for use across the globe, from Chicago to Rio de Janeiro to Abidjan. But it’s developing countries where public health officials are intensifying their focus on the poor state of women’s health. The two biggest killers during reproductive years are AIDS and childbirth complications, according to the World Health Organization.
Though condoms can stop both HIV and unwanted pregnancies, women often depend on men to wear them. The WHO estimates adolescent girls and young women are twice as likely to risk HIV infection as young men.
 
Some Autonomy
India, where some of the condom product tests will take place next year, ranks second-worst in the world after Azerbaijan for the health and survival of women, according to the World Economic Forum’s Global Gender Gap Index. Only 48 percent of married couples there practice a form of modern birth control, compared with 73 percent in the U.S., judging from the latest comparable data from the United Nations Department of Economic and Social Affairs.
 
“The reality in India is that it’s hard to tell men what to do in any situation,” said Anjuli Pandit, a business development executive who lives in Mumbai and credits her U.S. education for a willingness to discuss sex and contraception. “I can imagine that for a lot of women it’s hard to tell even their husbands to use contraceptives. So here’s something that they can do.”
 
Productive Lunch
Herbenick has worked for more than a decade researching and teaching sexual health, with a focus on women’s genitals. But she says the day she met Sadlo over a grilled cheese sandwich and soup at Farm, a restaurant in Bloomington, Indiana, he was the one with a suggestion for women.
 
“When he told me his idea for a female condom, I told him mine for male condoms,” she recalled in a telephone interview. “We melded both. We’re both creative types and soon the conversation turned to sketching and to discussion about what was or wasn’t possible in terms of manufacturing.”
 
Herbenick and Sadlo’s prototype will be made with typical male condom material -- probably latex -- but will be shaped and sized to better fit the vaginal anatomy. It will likely come in foil packaging much like male ones, she said. Instead of gripping the penis, though, it would sheath the vaginal path, with a ribbed outside for better grip and texture.
A more popular female condom could stoke growth in the overall market, projected to reach $6.6 billion in 2020 from $4.5 billion this year, according to a report published by Global Industry Analysts Inc. in May. Much of the focus has been on men’s condoms so far. Of the condoms provided by the the Global Fund to Fight AIDS, Tuberculosis and Malaria, 95 percent were for men, according to a 2012 report.
 
Pumped Up
Mache Seibel, a gynecologist and editor of My Menopause magazine who’s working on the other female condom that just won a Gates Foundation Grand Challenges in Global Health grant, says his prototype could be put in place hours before intercourse to avoid any last-minute negotiations.
 
“In the heat of the moment, people want something that’s easy to use,” Seibel said. “Having it in place in anticipation will take away a lot of that angst.”
 
The product Seibel and his colleagues are working on is still in the early stages of development but it should be reasonably priced, disposable, pleasant to use and able to stay in place as long as necessary. To achieve that, it will be air-infused, adding pressure that should help stimulate both partners, and made of slippery material, according to Seibel.
 
Some prototypes have been tested, and the women who used them reported favorable results, he said. The product isn’t intended for use only in the developing world. Herbenick and her colleagues at Indiana University’s School of Public Health plan to test their own condom in the U.S. as well as India, and compare it to existing products.
 
Condom Applicator
“Very few people know about female condoms in India,” said G.S. Shreenivas, who works with prostitutes, truckers and other at-risk groups in the western state of Maharashtra to prevent HIV infection. “When sex workers have a problem of males not wearing condoms, they could wear these condoms discreetly. It is a tool of empowerment.”
 
The Bill & Melinda Gates Foundation launched Grand Challenges Explorations, a $100 million grant program tasked to “radically improve health in the developing world,” in 2008. They award money twice a year. Among other projects getting a $100,000 grant last month are: a re-usable applicator to insert women’s condoms; a disposable applicator for men’s; two male condoms made from materials that mimic the skin’s surface; and one product made of silicone, with anti-microbial properties, intended for anal intercourse.
 
Tests Needed
Condoms are crucial to public health because they can stop unwanted pregnancies as well as sexually transmitted infections, or STIs, said Papa Salif Sow, senior program officer on the HIV team at the Bill & Melinda Gates Foundation.
 
Laboratory studies show male latex condoms create an impermeable barrier for pathogens. The U.S. Centers for Disease Control and Prevention says they are “highly effective” in preventing the sexual transmission of HIV and can reduce the risk of infection by other diseases including the genital human papillomavirus and associated diseases such as cervical cancer.
 
The female condoms will need to undergo some tests. Typically, manufacturers must provide data on mechanical performance, viral penetration and contraceptive effectiveness. In the U.S., the Food and Drug Administration ranks female condoms as as a class III medical device: generally the highest risk devices requiring the highest level of regulatory control.
 
‘Beyond Exciting
“Wherever in the world you make it available, it’s a long process,” Herbenick said. “We need to prove that it protects against pregnancy and STIs. That it stays safe and doesn’t break or slip or get pushed inside the vagina. This initial grant of $100,000 is a wonderful introduction and gets us that early stage feedback from potential users, but it takes quite a lot more to get a contraceptive device on the market.”
 
Every year, an estimated 500 million people get infected with curable sexually transmitted diseases -- chlamydia, gonorrhea, syphilis and trichomoniasis, according to the World Health Organization. The largest proportion of new infections in people aged 15 to 49 occurs in south and southeast Asia.
 
In India, besides HIV, which caused 130,000 new infections in 2012, public health officials are grappling with high rates of cervical cancer. Caused by the human papillomavirus, it’s the second most-common malignancy found in Indian women, contributing about 20 percent of all cancers in the country. An estimated 122,844 new cases are diagnosed annually in the country, according to a report from the HPV Information Centre at the Institut Catala d’Oncologia.
 
Herbenick, who has worked on sex research for the past 15 years, says of the project:
“I’ve been very focused in my work on women’s sexual experience,” she said. “To be making a real thing you can hold in your hand, help save lives and manage people’s sexual experience is beyond exciting.”

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