Health Canada, the Canadian regulatory authority, has approved a new single-size diaphragm for over-the-counter sale, giving women a nonhormonal option for contraception.
The SILCS diaphragm, developed by PATH and partners including CONRAD and research groups in multiple sites, is marketed under the name Caya® contoured diaphragm. Caya® will be launched in Canada today by the diaphragm's Canadian supplier, TriMedic Supply Network Ltd. of Toronto, at the Primary Health Today Toronto trade show. The launch represents another step toward expanding contraceptive options for women, especially nonhormonal options like diaphragms that have been limited both in Canada and worldwide in recent years.
Canada's approval follows European regulatory approval of the SILCS diaphragm last year, which opened the way for its commercial debut.
In 2010, PATH licensed the single-sized diaphragm design to Kessel medintim GmbH (Kessel) for manufacturing and marketing. Kessel is a privately held German company that manufactures and distributes sexual and reproductive health products. After gaining regulatory approval, Kessel began marketing the Caya® diaphragm in April 2013, and to date it has reached 14 European countries via family planning providers, pharmacies, and online shops. Additional approvals and product launches are planned for 2014.
Expanding sale of this new barrier contraceptive to Canada will continue to raise awareness and help inform future introduction in low-resource settings where diaphragms have not been available in recent decades.
A recent analysis of the unmet need for family planning in developing countries suggests that many women want access to a method that has few side effects, can be used when the woman needs it, and is safe and effective. The SILCS diaphragm addresses these needs for many women.
While Kessel and its distribution partners are focused on early introduction in developed countries, PATH has worked with research partners in Uganda, India, and South Africa to assess opportunities and challenges for introducing the diaphragm in low-resource settings over the next few years. Kessel is planning for additional market registrations and a regulatory submission to the US Food and Drug Administration for clearance to market the diaphragm in the United States is currently under review.
The SILCS diaphragm was designed through a unique collaboration between PATH; CONRAD, a reproductive health product development organization operated through the Eastern Virginia Medical School in Norfolk, Virginia; the US Agency for International Development; and partners in multiple countries. It was developed through a user-centered development process to address issues that have limited access to traditional diaphragms.