We’re constantly pursuing safer sex solutions to meet the evolving needs of our public health customers. In 2022, we enhanced our offering by proudly becoming the exclusive distributor of the FC2 Female Condom® (internal condom) to the US public sector. The partnership allowed us to bring this innovative product in bulk to non-profit customers across the country.
FC2, now under the ownership of Clear Future, Inc., is a powerful tool in the safer sex toolkit with proven efficacy. But unlike external condoms, the product is not widely known in the US. From a public health perspective, education can go a long way in raising awareness and helping communities realize the benefits of these internal condoms. We’re excited to partner with Clear Future to help our customers expand the reach of FC2 in their advocacy efforts.
What is FC2, you may ask – and many still do. But first, a little history. As a company with our own founder story, we have a soft spot for mission-driven entrepreneurs. FC1, the predecessor to FC2, was initially brought to market over thirty years ago by Mary Ann Leeper, a vanguard and passionate advocate for female sexual health. The product was met with muted demand in the US, but found enthusiastic response internationally – especially in developing countries where women have fewer choices and limited power negotiating safer sex with partners.
From that inspired start to today, FC2 continues to provide an essential solution for more empowered sexual health.
FC2 is the Only FDA Approved Internal Condom Proven Safe and Effective
FC2 provides effective protection against unintended pregnancy and sexually transmitted infections (STIs), including HIV, when used as directed:
- STI protection controlled by the wearer (receiving partner)
- Non-hormonal birth control method, so no hormonal side effects
- No medical procedure necessary
- Latex-free, great alternative for those with latex sensitivities
- Compatible with water, silicone, and oil-based lubricants
- May be a source of pleasure for users (Dias et al. 2006) due to qualities such as the material, outer and inner rings, and being less constrictive for penises versus external condom
- Can be inserted in advance, so there is no interruption during intimacy
FC2 internal condoms come in one inclusive size and are inserted into the vagina or anus prior to penetrative sex. They are similar in length to standard external condoms, but much wider. For those who find external condoms uncomfortable, FC2 internal condoms are a great option.
FC2 is available to individuals via Rx and in bulk to the public sector through Global Protection. Our non-profit customers can sign in to their accounts to view details for a bag of 100, a case of 500, a case of 1000, and the O-Cube internal condom demonstrator.
Access and Education are Key to Increasing Awareness and Facilitating Usage Familiarity
The case for expanding access to internal condoms is strong. A recent cost-effectiveness analysis by Total Impact Capital quantified a significant return on investment and highlighted additional layers of impact through a comprehensive literature review.
Based on the analysis of data from four counties in Africa, the findings indicate a return on investment of $4.22 to $8.48 for every one dollar spent on internal condoms. The assessment focused on the health impact of providing one million internal condoms per country:
- # of unintended pregnancies averted
- # of HIV infections averted
- # of maternal deaths averted
- # of child deaths averted
- # of unsafe abortions averted
The analysis also featured a review of published global literature, including the US, and cited considerable impact when internal condoms are available in addition to external condoms:
- After the introduction of internal condoms, unprotected sex decreased by between 27% – 81%
- Internal condoms reach women who are less likely to use other dual protection methods (to prevent both pregnancies and STIs)
- “Lack of availability and access” was the most commonly cited contributing factor for internal condom non-use or discontinuation
- Internal condoms often compare favorably to external condoms – users cite advantages over external condom such as comfort, increased sense of power for safer sex negotiation, etc.
- Internal condoms can prevent non-consensual condom removal (an act that is more likely to occur with external condoms), in which a sexual partner removes a condom without permission during sex or initiates condomless sex despite having been asked to wear a condom
Despite these societal benefits, internal condoms lack both awareness and familiarity amongst the US general public. There are clear advantages to including FC2 in the public health toolkit and providing the related safer sex education. This can ensure vulnerable communities have both the access and confidence necessary to drive adoption.
We understand that education is key to advocacy. That’s why we offer a range of FC2 bulk options along with the O-Cube demonstrator. Optimizing impact will happen one demo at a time.
Customers Can Count on Stringent Quality Control and Committed Product Support
As a medical device manufacturer with our own brands, master distribution relationships and private label partnerships, we adhere to Good Manufacturing Practices and meet the highest safety standards worldwide. Our customers can feel confident that Clear Future, Inc. is similarly committed to the quality of FC2.
While external condoms are globally ubiquitous and have standard testing protocols, Clear Future follows stringent quality controls that had to be established from the ground up for FC2, the only FDA approved internal condom. Supporting protocols for a singular product is obviously more costly and complex.
FC2 is manufactured with a strong emphasis on quality at every stage, from raw materials to end product. Every condom undergoes individual electronic pinhole testing; additionally, random sampling from every production lot is put through the following stringent quality assurance process:
- Dimensional testing for acceptable length, width and thickness standards (Clear Future adheres to a zero-defect approach)
- Airburst testing for compliance to acceptable air pressure and volume at the burst point
- Sachet integrity testing to detect any seal air leaks when the condom package is immersed in water
- Freedom-from-holes testing to verify the results of individual electronic pinhole testing by filling condoms with water and inspecting them for leaks
- Retention feature testing to ensure the outer ring of the condom resists the pulling force when forces that may occur during invagination are simulated
In partnership with Clear Future, we’re proud to exclusively distribute this innovative product in bulk and make FC2 internal condoms available to our customers and their communities.
To enhance service and support, we were recently joined at the US Conference on HIV/AIDS by a leading FC2 trainer who provided expert O-Cube demonstrations. And we fielded a customer survey to capture FC2 feedback and ensure our efforts include this essential input. You can learn more about these initiatives here.
We’re also developing educational materials in various formats to facilitate awareness and learning. And Clear Future will soon introduce a redesigned wrapper for FC2.
If you have questions or would like to connect, please reach out. We love to hear from you!
