SILCS Launches in Early Markets

Publication date: 2015

S I L C S D I A P H R A G M THE HEALTH NEED Worldwide, women experience significant health consequences of unintended pregnancy. More than 200 million women—mostly in developing countries—have an unmet need for contraception.1 While some women lack access to safe and effective methods, many women with an unmet need cite issues related to methods (such as concern about side effects), infrequent sex, being postpartum, or breastfeeding as reasons for their nonuse. Expanding access to nonhormonal barrier contraception—like the SILCS diaphragm—could help address the needs for many of these women. WOMEN AS CO-DESIGNERS The SILCS diaphragm is a single-size contraceptive barrier designed to fit a broad range of women. PATH led a user- centered design process involving input from women, their partners, and providers. This feedback resulted in an innovative design that is easy and comfortable to use. PATH developed SILCS to expand women’s options for nonhormonal protection. This is especially important in low-resource settings where women have a limited range of methods, and access to health care providers is limited. SILCS may also be relevant for women in developed countries who are interested in a nonhormonal, user- initiated method with no side effects. CLINICALLY PROVEN SAFETY, ACCEPTABILITY, AND COMFORT In multiple studies, SILCS has achieved high marks for safety, acceptability, ease of use, and comfort among women and men, even women with no previous diaphragm experience.2-5 CONRAD, the clinical and regulatory partner for this design, implemented a multisite contraceptive effectiveness study in the United States from 2008–2010. Data from this study confirm that SILCS provides protection similar to a traditional diaphragm when both are used with a contraceptive gel.6 Data from this study supported a 510(k) regulatory application to the United States Food and Drug Administration (USFDA). EASY TO PROVIDE The SILCS diaphragm was designed to be easy for women to use as well as for health care personnel, clinics, and suppliers to provide. The single- size design reduces the complexity of ordering and stocking multiple sizes. Where approved by regulatory authorities, SILCS can be provided over- the-counter since a fit exam to determine what size diaphragm a woman can wear is no longer needed. In low-resource settings where there is inconsistent access to contraceptive methods, SILCS could be a valuable choice; it can be used for up to two years, which means that women would be less reliant on the health care system to meet their contraceptive needs. USER-FRIENDLY FEATURES Grip dimples Orient the woman’s fingers and provide a tactile cue for where to hold and squeeze the rim. Removal dome Allows for easy removal; a woman can hook her finger under or over the dome to remove the device. Cervical cup Accommodates a range of sizes of cervices, yet is pliable enough to collapse when there is unused space. Rim Provides stability and helps guide the SILCS diaphragm deep into the vagina as the woman pushes on the anterior edge. SILCS launches in early markets Grip dimples Rim Cervical cup Removal dome Photo: Kessel Marketing, CAYA® contoured diaphragm PATH is the leader in global health innovation. An international nonprofit organization, we save lives and improve health, especially among women and children. We accelerate innovation across five platforms—vaccines, drugs, diagnostics, devices, and system and service innovations—that harness our entrepreneurial insight, scientific and public health expertise, and passion for health equity. By mobilizing partners around the world, we take innovation to scale, working alongside countries primarily in Africa and Asia to tackle their greatest health needs. Together, we deliver measurable results that disrupt the cycle of poor health. Learn more at www.path.org. street address 2201 Westlake Avenue Suite 200 Seattle, WA 98121 USA mailing address PO Box 900922 Seattle, WA 98109 USA www.path.org MARKET INTRODUCTION PATH licensed the SILCS design to Kessel medintim GmbH (Kessel) of Germany in late 2010 for commercialization. This company has manufactured and distributed contraceptive and sexual health products for over 24 years. The SILCS diaphragm achieved regulatory approval and has since been launched in more than 20 countries under the brand name Caya® contoured diaphragm. The USFDA granted market clearance to the Caya® contoured diaphragm in late 2014 and in June 2015, Kessel launched the Caya® diaphragm in the U.S. Meanwhile, PATH is working with partners in developing countries to evaluate opportunities and challenges for future introduction in developing countries. EVALUATING ALTERNATIVE CONTRACEPTIVE GELS Diaphragms are used with a contraceptive gel to increase effectiveness. The most commonly available contraceptive gels contain nonoxynol-9, which is no longer recommended for use by women who are at risk of acquiring HIV. PATH is evaluating contraceptive gels in development or on the market that could be used with the SILCS device. PATH and CONRAD are also looking at SILCS as a delivery method for microbicide gel—a topical vaginal product that could protect women from HIV and other sexually transmitted infections (STIs). PRODUCT INQUIRES For more information regarding SILCS, please contact: Maggie Kilbourne-Brook, SILCS team leader PATH PO Box 900922, Seattle, WA 98109, USA mkilbou@path.org sites.path.org/rhtech/silcs-diaphragm/ For commercial inquiries, please contact: Martin Kessel Kessel medintim GmbH Kelsterbacher Str. 28, D 64546 M., Moerfelden-Walldorf, Frankfurt, Germany kessel@medintim.de www.medintim.de/ ACKNOWLEDGMENTS SILCS was developed in collaboration with research partners at CONRAD with support from the United States Agency for International Development (USAID) and the Bill & Melinda Gates Foundation. Support for this project is made possible by the generous support of the American people through the USAID under the terms of the HealthTech Cooperative Agreement # AID-OAA-A-11-00051. The contents are the responsibility of PATH and do not necessarily reflect the views of USAID or the US Government. References 1 Singh S, Darroch JE. Adding It Up: Costs and Benefits of Contraceptive Services— Estimates for 2012. New York: Guttmacher Institute and United Nations Population Fund; 2012. 2 Schwartz J, Ballagh S, Creinin M, et al. SILCS diaphragm: postcoital testing of a new single-size contraceptive device. Contraception. 2008;78:237–244. 3 Coffey P, Kilbourne-Brook M, Beksinska M, et al. Short-term acceptability of a single-size diaphragm among couples in South Africa and Thailand. Journal of Family Planning and Reproductive Health Care. 2008;34(4):233–236. 4 Coffey P, Kilbourne-Brook M, Brache V. Comparative acceptability of the SILCS and Ortho ALL-FLEX® diaphragms among couples in the Dominican Republic. Contraception. 2008;78:418–423. 5 van der Straten A, Sahin-Hodoglugil N, Clouse K, et al. Feasibility and potential acceptability of three cervical barriers among vulnerable young women in Zimbabwe. Journal of Family Planning and Reproductive Health Care. 2010;36(1):13–19. 6 Schwartz J, Weiner D, Lai J, Frezieres R, Creinin M, et al. Contraceptive efficacy, safety, fit, and acceptability of a single-size diaphragm developed with end-user input. Obstetrics and Gynecology. 2015;125(4):895-903. June 2015 C O N R A D Leaders in Reproductive Health and HIV Prevention

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