The SILCS diaphragm is a silicone barrier contraceptive device which is inserted vaginally to cover the cervix. 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. USAID-supported Contraceptive Research and Development Program (CONRAD) supported product development and clinical trials.
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.
The designers of the device relied heavily on results from studies of current and former diaphragm users and clinicians to improve acceptability and satisfaction. Women are evaluating the new device for comfort and ease-of-use in studies, underway in the Dominican Republic, South Africa, Thailand, and the United States.
PATH licensed the SILCS design to Kessel medintim GmbH (Kessel) of Germany in late 2010 for commercialization. The SILCS Diaphragm achieved CE Mark approval in March 2013 and has since been launched in many European countries and Canada under the brand name Caya® contoured diaphragm.
The USFDA granted market clearance to the Caya® contoured diaphragm in late 2014, and Kessel is seeking a partner for US market introduction. Meanwhile, PATH is working with partners in developing countries to evaluate opportunities and challenges for future introduction in developing countries.
- SILCS diaphragm, by PATH