Single-sized, easier to use

Diaphragms offer reusable, inexpensive protection from pregnancy and some sexually transmitted infections (STIs), yet they are not widely promoted in family planning programs in either developed or developing countries. Why? Once methods such as the pill and injectable contraceptives became available, providers began to promote them instead, for their effectiveness and ease of provision.

Yet women have continued to ask for a method that they could initiate and that could offer dual protection from both pregnancy and STIs—the diaphragm.

What if a woman could choose a diaphragm that is comfortable, easy to use, and offers good barrier protection?

Traditional diaphragms can be slippery to handle and uncomfortable to use for some women. Plus, they come in multiple sizes and require a fitting by a trained health provider, something many women don’t have access to, further limiting their availability. What if a woman could choose a diaphragm that is comfortable, easy to use, and offers good barrier protection—and is made in one size to fit most bodies, without requiring a pelvic exam? PATH has created a diaphragm that meets this need.

More accessible protection

In collaboration with women in multiple sites, PATH developed the SILCS diaphragm—named for SILCS, Inc., a partner in the diaphragm’s development. The sleek device is designed to be more comfortable and easier to use than standard diaphragms.

The reusable, one-size-fits-most SILCS diaphragm is made of silicone, which is more durable than traditional latex diaphragms—it will hold up to extreme temperatures and poor storage conditions common in developing countries. Because clinical guidelines recommend a diaphragm be used with contraceptive gel for increased protection, new studies also are looking at the diaphragm as a delivery method for microbicide gel—a topical vaginal product that could protect women from HIV and other STIs.

The SILCS diaphragm could be approved by the US Food and Drug Administration as soon as 2010.

The device eventually could be available directly to women with less clinical interaction than is required for traditional diaphragms. This means the single-size SILCS diaphragm could be appropriate for use in health systems in many poor countries, where clinic time and resources are severely stretched.

User-focused design

Diaphragms are more discreet than condoms and have few side effects. Some women prefer diaphragms to hormonal contraception or intrauterine devices for medical reasons or because they prefer the freedom of using contraception only when they need protection.

Most contraceptive devices have been designed to allow for ease of manufacture or from the perspective of a single developer, without significant input from the women who rely on these contraceptives for protection. PATH, however, has actively sought feedback from women in designing the SILCS.

Since 1994, we’ve engaged women from four continents in evaluating and refining this contraceptive barrier. The result is a device that is acceptable to women and their partners in widely diverse regions, even in countries where women had no previous experience using diaphragms.

Primary design evaluations occurred in the United States. Later studies with couples in South Africa, Thailand, and the Dominican Republic confirmed that the SILCS diaphragm fits women from diverse regions, is easy to insert and use, and is acceptable to both partners.

Men in the Dominican Republic even reported enjoying the sensation of sex more when their partners used the SILCS diaphragm—a very positive finding that bodes well for the likelihood of couples using it for both protection and pleasure. Greater protection with greater sensation: why not?

Clinical studies of safety and effectiveness

Clinical studies have tested whether the SILCS diaphragm creates a good barrier to sperm. In the first phase of studies, it performed as well as the standard latex diaphragm in preventing sperm from reaching the cervix when both devices were used with the spermicide Nonoxynol-9. In these studies, the SILCS diaphragm was found to be as safe as a traditional diaphragm.

The next clinical study, which began in 2008, will test the effectiveness of the SILCS diaphragm among 450 women who will use it with a contraceptive gel to protect from pregnancy. If this study confirms that the SILCS diaphragm offers protection similar to the standard diaphragm, the contraceptive could be approved by the US Food and Drug Administration as soon as 2010. PATH will study how to make the diaphragm available through clinics and over the counter.

On the horizon

Once approved, the SILCS single-size diaphragm will offer women a new option for barrier contraception—one that can be used with little or no partner involvement and a fitting exam. Once a microbicide gel is approved, the SILCS diaphragm could also be used as a microbicide delivery system, thus increasing protection from STIs.

PATH and our collaborators will collect information during future studies to determine the kinds of information women want and need to feel comfortable and confident using this new barrier device. Our findings will support countries in making the SILCS available at pharmacies and in communities—giving women a powerful tool to protect their health.

Photo: PATH/Mike Wang.