Technologies for Reproductive Health

SILCS Diaphragm

Innovation to increase contraceptive options

Light from window shining on smiling woman.

Photo: PATH/Eric Becker.

Providing women and couples with a range of contraceptive options allows them to find the methods that fit their needs to prevent unwanted pregnancies. Some women cannot or do not want to use hormonal products. Other women do not have frequent sex and want to have a method that can be easily started and stopped. And other women want a back-up option in case their existing method is inaccessible. Through a user-centered product development process, PATH and its partners responded to the needs of these women to design a reusable contraceptive barrier device, the SILCS Diaphragm.

SILCS is a type of diaphragm that is single-sized and was designed to be easy to insert and use as well as provide good comfort for women and their partners. The single-size device should be easier to supply and provide than traditional diaphragms that come in multiples sizes; women will not need a fitting exam to determine diaphragm size. The single-size device should simplify procurement as well. This will be beneficial to providers and clinics in both developed and developing countries.

In low-resource settings where there is a shortage of health care providers and the health system is over stretched, these simplified procedures could encourage family planning programs to begin including diaphragms as part of their program.

SILCS user-centered design

SILCS held in hands.

SILCS Diaphragm. Photo: PATH/Patrick McKern.

The design features of SILCS, like the contoured shape and patented spring technology, allow for one size of diaphragm to fit most women. Incorporating suggestions from women and men through a user-centered design process led to features that make the device easy to use and comfortable to wear. For example, the grip dimples on the rim of the device offer a cue where to squeeze SILCS for insertion, and a removal dome helps users remove the device. SILCS is made of silicone which is more durable than diaphragms made from latex. It has a shelf life of five years and a use life of up to two years. Read More >>

Safe, effective, and acceptable option

Over the past decade, numerous studies in developing countries show that women can use diaphragms and find them acceptable. Results from five countries studied show that women find SILCS acceptable, even when women had no previous diaphragm experience. In comparative studies, women have preferred SILCS over the traditional diaphragm. A recently completed contraceptive effectiveness study, implemented by CONRAD, confirmed SILCS used with contraceptive gel has effectiveness similar to a traditional multisize diaphragm used with contraceptive gel. Read More >>

Moving towards introduction

SILCS is the first new female barrier method to receive regulatory approval and enter the market in more than a decade. PATH licensed the SILCS design to Kessel medintim GmbH (Kessel) of Germany in late 2010 for commercialization. The SILCS Diaphragm achieved regulatory approval in 2013 and has since been launched in more than 20 countries under the brand name Caya® contoured diaphragm. The US Food and Drug Administration granted market clearance to the Caya® contoured diaphragm in late 2014 and in June 2015, Kessel launched the Caya® diaphragm in the U.S. SILCS will initially be introduced in developed countries where women have expressed interest and diaphragms are still available and included in family planning programs. This will help build experience providing the diaphragm in a variety of markets. Additional work is needed to prepare for diaphragm introduction in developing countries. PATH has been conducting health system assessments to identify countries where a single-size diaphragm could be introduced and integrated into existing family planning channels. Read More >>

Evaluating alternative contraceptive gels

Clinical guidelines recommend diaphragms be used with a conceptive gel to increase effectiveness. The most commonly available contraceptive gel products contain nonoxynol-9 (N-9) which is no longer recommended for use by women who are at risk of HIV or who have frequent sex. PATH and our research partners are evaluating contraceptive gels that could be used with the SILCS device in both developed- and developing-country markets.

PATH and our research partner are also evaluating SILCS as a reusable delivery system for microbicide gel, which would make this a multipurpose prevention technology that could simultaneously protect from HIV (and other sexually transmitted infections) and unintended pregnancy. Read more >>