SILCS diaphragm

We’ve engaged women from four continents in developing the SILCS diaphragm. Photo: PATH/Mike Wang.

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 contraceptive method that doesn’t contain hormones, has few side effects, and that they themselves control.

Diaphragms fit this description, but for some women, there are drawbacks. Some find that traditional diaphragms can be slippery to handle and uncomfortable to use. Plus, traditional diaphragms come in multiple sizes and require a fitting by a trained health care provider, something many women don’t have access to, further limiting 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.

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

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. PATH and its partners designed this sleek device keeping the needs of couples and the requirements of developing-county health systems in mind.

The 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. The single size means that the product could require less clinical interaction than traditional diaphragms. The SILCS diaphragm could be appropriate for use in health systems in many poor countries, where clinic time and resources are severely stretched.

In late 2010, PATH licensed the SILCS diaphragm design to Kessel Marketing & Vertriebs GmbH of Frankfurt, Germany—a company that has manufactured and distributed contraceptive and sexual health products for 24 years. Kessel will manufacture and distribute the device in select markets. SILCS has achieved approval allowing for sales in Europe, and regulatory applications for the US Food and Drug Administration are under way. Through a phased approach, Kessel and PATH aim to introduce the product in both developed and developing countries and are working with local partners and governments to provide a new, affordable family planning option to women globally.

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 diaphragm.

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 SILCS 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 study determined the effectiveness of the SILCS diaphragm as a contraceptive barrier. CONRAD, our research partner and collaborator, implemented the SILCS contraceptive effectiveness study from 2008–2009, with funding from the United States Agency for International Development. Six clinical sites in the United States recruited 450 women who used the SILCS Diaphragm with BufferGel®, a contraceptive gel, to protect from pregnancy. This study confirmed that SILCS and the standard diaphragm offer similar protection. These data will provide the basis for an application to the US Food and Drug Administration for regulatory approval in the United States.

On the horizon

PATH and our partners are conducting health system assessments in Uganda, India, and South Africa to understand how the SILCS diaphragm could be successfully integrated into existing family planning or commercial channels. The assessments also will help us understand how women want to obtain this new diaphragm—whether through clinics or outside the clinic system. These results could support countries in making the SILCS diaphragm available, giving women a powerful tool to protect their health.

PATH is working to provide couples not only with contraception, but also protection from STIs. Because clinical guidelines recommend using a diaphragm with contraceptive gel for increased protection, new studies are looking at the SILCS diaphragm as a delivery method for microbicide gel—a topical vaginal product that could help protect women from HIV and other STIs. Once a microbicide gel is approved, the SILCS diaphragm could be used as a microbicide delivery system, allowing dual protection from pregnancy and STIs.