Barrier Methods

When Margaret Sanger was arrested in 1916 for "obscenity" (which is to say, advocating birth control), diaphragms were a revolutionary way for women to take control of their bodies. What do most women think of diaphragms today? Yawn. So quaint, so old-fashioned, so ... Margaret Sanger. The number of women using the diaphragm has fallen steeply since highly effective hormonal methods were introduced in the United States in the 1960s. What was once the country's most common contraceptive device is now used by less than 2 percent of couples nationwide, according to the Centers for Disease Control and Prevention.

A small but growing number of researchers and advocates think that the oldest contraceptive on the market -- a latex or silicone cup with a firm, flexible rim and a shallow dome -- could be re-imagined for the 21st century. A Seattle-based international nonprofit organization, Program for Appropriate Technology in Health (PATH), is working on a diaphragm redesign, the first ever in the device's 120-year history. Not only could it offer American women yet another contraceptive option, but it could prove a powerful tool in reducing HIV infection rates both at home and abroad. In a large-scale clinical trial that's the first of its kind, researchers are currently testing the impact that diaphragm use has on HIV infection rates in Africa -- where methods of protection that women can initiate without requiring their partners' consent are badly needed.

The new diaphragm, known as SILCS, tested well in early trials and is poised to enter the market before the end of the decade. Unlike the Ortho All-Flex, currently the most commonly prescribed diaphragm, which comes in nine sizes and requires a woman to undergo a specialized pelvic exam to be fitted with the correct size, SILCS is a "one size fits most" silicone device. "Providers look at [the Ortho All-Flex] as a hassle because of the fitting requirements," said Dan Grossman, a San Francisco-based gynecologist and senior associate at the nonprofit research and advocacy organization Ibis Reproductive Health. In a recent article in the American Journal of Public Heath, Grossman argued that there is no evidence for utility of the fitting requirement, and that a diaphragm in the most commonly-prescribed size may be just as effective as a fitted one.

"Manufacturing processes have changed, materials have been updated, we know a lot more about vaginal anatomy now, so this is a good, simple technology that we could make significant improvements in," said PATH program officer Maggie Kilbourne-Brook. If all goes according to plan, SILCS will gain FDA approval and be available to American women by late 2009 or early 2010. The initial approval will likely require some sort of prescription, though once the product is on the market, PATH plans to submit a second round of applications to allow for over-the-counter access, according to Kilbourne-Brook.

It remains to be seen whether even the most high-tech barrier method will become popular among a generation of American women who are far more comfortable using hormonal methods of contraception. The pill prevents pregnancy more effectively, and for many women it is more convenient. "Many women are likely to see the diaphragm as outdated, messy, unreliable, and generally inconvenient," wrote women's health researcher S. Marie Harvey in the journal Perspectives on Sexual and Reproductive Health.

"The problem with the diaphragm was that it has to be 'in place' to work, and didn't work if it lay in its case in the drawer," said Dr. Diane Merritt, Professor of Obstetrics and Gynecology at Washington University in St. Louis and a member of the FDA's Advisory Committee on Reproductive Health Drugs. "It required planning, and as anyone will tell you, sex isn't always planned. Removing the act of contraception from the act of intercourse led to the popularity of the pill."

Still, there's a reason the diaphragm has endured; when used correctly and consistently, it can prevent unintended pregnancy for upwards of 90 percent of users. (Researchers differentiate between "typical use" and "perfect use"; the diaphragm's typical use effectiveness is more like 85 percent, as opposed to 92 percent for hormonal birth-control pills). Unlike the pill and the vast array of other hormonal methods, including the patch, the Nuva-Ring, implantable rods, and Depo-Provera injections, a diaphragm is not systemic, has no side-effects, and can be immediately reversed by simply taking it out. It is a woman-controlled barrier method, meaning women can use it without the need for their partners' consent or approval.

Perhaps most importantly, the newly redesigned diaphragm could prevent more than pregnancy. Scientists already know that the device provides some protection from gonorrhea, pelvic inflammatory disease, and abnormal cell growth. Why not HIV? Particularly among sex workers and other women in vulnerable situations, who may be unable to negotiate condom use given uneven power dynamics, the fact that diaphragms are woman-controlled and can be used without a partner's knowledge could make them a critical tool in the fight against AIDS.

In 2002, PATH convened with virologists and immunologists to determine if cervical barrier methods, such as the diaphragm, might offer some protection against HIV. Inside and around the cervical os (the passage through the cervix into the uterus) is a single layer of delicate, easily ruptured, tissue. This area is packed with HIV receptor cells, and thus is thought to be particularly vulnerable to STIs. Conversely, the vaginal walls are lined with some 30 layers of tougher, more durable cells that are less susceptible to infection.

But the vagina itself does contain HIV receptors, and lesions from other STIs, like herpes, can make even tough cells vulnerable to infection. Clearly a cervical barrier would only provide partial protection. However, in places like sub-Saharan Africa, where 2.4 million people are infected with HIV each year, even partial protection could potentially make a huge difference.

PATH's research caught the attention of the Bill and Melinda Gates Foundation, which gave $28 million to the Women's Global Health Imperative program at the University of California, San Francisco medical school to further investigate whether diaphragms might be a part of the HIV prevention puzzle. The result is a large-scale randomized, controlled trial of 4,500 women in Zimbabwe and South Africa, examining whether diaphragm use may provide them with some protection against HIV. Preliminary results are expected this summer.

"The world is waiting for the results," said Kilbourne-Brook. Unlike brand-new methods of HIV prevention which are still in the research and development phase, diaphragms are already widely available, cheap to manufacture, and relatively easy to distribute. "If it turns out that something as simple as a diaphragm, this old-fashioned technology, could actually offer some protection from HIV, that's something that could get into women's hands very easily."

Beth Schwartzapfel is a freelance journalist and MFA student in creative nonfiction at the New School. She lives in Brooklyn, NY.

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