Executive Summary
With clearance from the Food and Drug Administration in hand, the German company licensed to market the Caya contoured diaphragm is seeking distribution and marketing partners to introduce the device in the United States.
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The device, called the SILCS diaphragm in its design and clinical validation stages, was designed through a unique collaboration between the global health nonprofit PATH, the reproductive health product development organization CONRAD, the United States Agency for International Development, and other partners. The device was licensed in 2010 to Kessel medintim GmbH to accelerate women’s access to the technology.
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As a one-size-fits-most product, a fitting exam is not required to determine diaphragm size. The Caya diaphragm represents an important move forward in diaphragm access in the United States.
With market clearance from the Food and Drug Administration (FDA) in hand, the German company licensed to market the Caya contoured diaphragm is seeking distribution and marketing partners to introduce the device in the United States.
Women in Europe and Canada already are familiar with the single size device. It received European regulatory approval in June 2013, with Canadian access granted in early 2014. It was designed through a unique collaboration between Seattle-based PATH (a global health nonprofit), Norfolk-based CONRAD (a nonprofit entity that operates as a Division of the Department of Obstetrics and Gynecology at Eastern Virginia Medical School), the United States Agency for International Development, and other partners. The device, called the SILCS diaphragm in its design and clinical validation stages, was licensed in 2010 to Frankfurt, Germany-based Kessel medintim GmbH (Kessel) to accelerate women’s access to the technology. (To read more about the device, see the Contraceptive Technology Update article "Diaphragm: update on this barrier contraceptive," June 2014, p. 66.)
Caya is the first new cervical barrier method to enter the market in more than 10 years, says Kate Grindlay, MSPH, executive director of the Cervical Barriers Advancement Society (CBAS) and senior project manager at Ibis Reproductive Health. As a one-size-fits-most product, the Caya diaphragm should be easier to provide than diaphragms in multiple sizes since a clinician fitting to determine size is not required. Thus, the Caya diaphragm represents an important move forward in diaphragm access, with the potential to reinvigorate interest in and use of the method, and to expand women’s contraceptive options, she says.
"Diaphragms are a good option for women who want a safe, effective, non-hormonal birth control method, They are also beneficial for women who have intermittent sex and may want a method they can use as needed rather than continuously," observes Grindlay. "Finally, new multipurpose prevention technologies that protect against both pregnancy and HIV and other sexually transmitted infections are greatly needed, and diaphragms are a promising delivery system for new microbicides under development."
How does it work?
How does the device work? In documentation submitted to the FDA, the device’s function is described as a mechanical barrier that prevents sperm from entering the cervical canal. The spring within its perimeter causes the device to create a seal against the vaginal wall, covering the cervix and preventing sperm from entering the cervical canal. The silicone cup-shaped device also serves as a repository for contraceptive gel.1
The historical control for the SILCS diaphragm pivotal study was a multi-center contraceptive study conducted by the National Institute for Child Health and Human Development (NICHD), according to the FDA. The design of the SILCS pivotal study was modeled after the NICHD study. It used a historical control analysis to compare the contraceptive effectiveness and safety of SILCS used with a contraceptive gel to the Ortho diaphragm used with contraceptive gel. In the SILCS pivotal study, the six-month Kaplan-Meier cumulative typical-use pregnancy probabilities per 100 women (with 95% confidence intervals) was 10.4 (6.9, 14.0) for all SILCS users.1 Results of the device’s contraceptive effectiveness study were presented at the 2011 Reproductive Health Conference3 and have been submitted for publication by CONRAD, which implemented the study, says Maggie Kilbourne-Brook, PATH program officer and team leader of the SILCS project.
Stay tuned for launch
Kessel is evaluating potential marketing and distribution partners in the United States, says Kilbourne-Brook. Because Kessel doesn’t currently market any products in the United States, it is reviewing potential partners for those who are best positioned to take on a new nonhormonal barrier method that will be available by prescription, she states. The company’s goal is to offer U.S. distribution in 2015, says Kilbourne-Brook.
With the discontinuation of the Ortho All-Flex diaphragm in December 2013, which had been the most popular diaphragm prescribed in the United States, women are left with few diaphragm options, says Grindlay.
"There is only one diaphragm currently available on the U.S. market, the Milex Wide Seal, and anecdotal information suggests that some women may face barriers when trying to access that product," states Grindlay. "Women need a variety of contraceptive options to be able to choose the one that is best for them."
REFERENCES
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Department of Health and Human Services. Food and Drug Administration. Letter to Martin Kessel. July 28, 2014. Accessed at http://1.usa.gov/1sjC4SU.
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Barnhart KT, Rosenberg MJ, MacKay HT, et al. Contraceptive efficacy of a novel spermicidal microbicide used with a diaphragm: a randomized controlled trial. Obstet Gynecol 2007; 110(3):577-586.
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Schwartz J. SILCS pivotal data: implications for MPTs. Presented at the 2011 Reproductive Health conference. Las Vegas; September 2011.
