The Female Condom: A Product History

1937 Female Condom example

Figure 1: Example of a female condom from 1937

In researching the history of female condoms it is possible to find examples of products going back several decades, even as far back as 1937. Further, there is evidence of female condom patents being filed prior to the 1980s. However, it was only in this particular decade that the development of the female condom as widely-used dual-protection contraceptive really began. 

Lasse Hessel and the Modern Development of the Female Condom[1]

The modern forefather of the female condom is without doubt Lasse Hessel, a Danish physician, who in 1984 developed a prototype female condom, which would later evolve into the FC1 condom. In terms of design, the female condom had the following features:

Hessel collaborated with Wisconsin Pharmacal Co. Inc. (a company that primarily manufactured chemical products such as home cleaners and institutional health care products), to develop the design and to make a female condom that would meet U.S. Food and Drug Administration (FDA) requirements. As part of the collaboration, Hessel developed the manufacturing technology for the female condom and sought a U.S. patent for the female condom (issued in 1990).

FC2

Figure 2: FC2 female condom. The FC2 followed the same design as the FC1 but is made of Nitrile instead of polyurethane.

As the development of FC1 continued, Wisconsin Pharmacal Co., Inc. created a new division, the Female Health Company (FHC), to take responsibility for the female condom work. The company embarked on the studies required to gain FDA approval for the technology. However, in the late 1980, the FDA made a decision to use stricter criteria to evaluate all new condoms, based on a Citizen’s Petition filed by the National Women’s Health Network. Based on the Network’s petition and subsequent discussion within the FDA, the regulatory agency classified the female condom as a Class III medical device, requiring more extensive safety and efficacy studies for Wisconsin Pharmacal’s product than the company originally thought necessary. These studies would require more time and investment from Wisconsin Pharmacal. To raise capital for female condom development, the company went public in 1991.

Meanwhile, Hessel was experiencing financial and technical problems in his efforts to develop the manufacturing technology for the female condom. To solve these problems, he sold the female condom’s world rights (outside the United States) to a Dutch investor. In 1989, this investor established Chartex Resources, Ltd., a London-based company, to manufacture the female condom and market it outside of North America. With resources from the investor (millions of dollars) and also a non-profit Danish foundation, Chartex developed state of the art production processes for the technology and received permission to market the device in a number of countries outside the United States. The FDA approved Wisconsin Pharmacal’s application to market and distribute the female condom in the United States in 1993, and one year later, it approved the Chartex manufacturing facility.

In the early 1990s, the commercial introduction of the product gained significant attention. For instance, in the eight months preceding its launch in the UK (1992), it had generated 94 articles in the national press and 56 TV and radio features[2]. The large amount of publicity was however not matched in terms of sales and by 1995, Wisconsin Pharmacal had limited funds to market the product and the company decided to restructure its business. First, in 1995 it purchased Chartex, and the next year it split into two companies, with FHC relocating to Chicago and remaining public. These changes gave the Female Health Company full ownership of all intellectual property related to the female condom. Its subsidiary, Chartex, continued as the sole manufacturer of the technology. In order to increase the uptake of female condoms, in 1996 FHC began to build partnerships and alliances with global public health agencies and governments[3]. This strategy was built upon with FHC establishing a Global Public Sector (GPS) team in 2003. According to FHC this development was critical to developing a global market for the female condom[4].

FCShipments_2004_2012

Figure 3: Quantity of female condoms shipped per year as reported by  AccessRH's RH Interchange database.

 

Growing International Momentum and the Issue of Price

By the middle of the last decade, momentum behind the female condom has begun to gain pace. A landmark event in this growing momentum was the Global Consultation on the Female Condom organised by PATH in September 2005 which gathered 100 stakeholders from 15 countries to review current scientific and program evidence regarding female condoms and to develop plans to build support for increased promotion and distribution of female condoms. The Global Consultation on the Female Condom identified four key actions to increase access and use of female condoms[5]:

Since the consultation, a range of programmes and initiatives, including the UAFC Joint Programme have begun and, as Figure 3 shows, the quantity of female condoms shipped per year since 2004 has increased steadily. Critical to this growth has been the commitment of USAID and UNFPA (by far the largest procurers of female condoms[6]); the former through its USAID | Deliver programme and the latter through its Global Female Condom Initiative in which UNFPA works with various countries to scale up female condom programming.

In addition to a previous lack of female condom programming, a significant other market barrier for female condoms had traditionally been its relatively high unit price, especially compared to its male counterpart. Although it is recognised that the manufacturing of female condoms is more complex and thus more costly than the production of male condoms, a point of action has been to explore ways in which the cost of female condoms can be reduced.

FC1_FC2_UnitSales_1996_2012

Figure 4: Unit sales of the FC1 and female condom, 1996 – 2012. Between 2005 and 2010, FHC transferred production from FC1 to FC2.

One avenue explored to reduce costs was to reuse the product. In the early 21st Century, research was undertaken on the reuse of the FC1 condom[7] and the evidence suggested that the polyurethane FC1, due to its robust property, did have the potential for reuse if a strict disinfection and washing protocol is carried out[8]. However, after a consultation in 2002, the WHO decided not to recommend the reuse of female condoms[9]. Further, with the FHC transitioning to a non-polyurethane female condom (FC2), the subject of reuse has not since been revisited in such depth. Although the transition from FC1 to FC2 in effect stifled the reuse debate, it did however achieve an impact in terms of the female condom cost price.

The Female Company was for a long time a loss making operation[10] and was aware of the need to produce a less expensive product than the FC1. In 2003, FHC therefore began the development of the FC2. This new female condom is made from nitrile, a cheaper and easier-to-manufacture material than polyurethane[11]. In the period 2009-2010, the production of FC1 was phased out - see Figure 4[12] - and the manufacture of the FC2 transitioned to a facility in Malaysia which had previously produced nitrile surgical gloves. This facility enabled FHC to significantly scale-up production to meet growing demand and also to make cost savings from the resulting economies of scale. FHC previously announced that the FC2 costs 30% less to make than the FC1[13].

From a functional point of view, the FC2 is non-inferior to the FC1. Further, in gaining key regulatory approvals (CE–approved in 2005; WHO clearance in 2006; USFDA approval in 2009; and various national regulatory approvals including India and Brazil) FHC has developed a new product that, as per December 2013, is available in 143 countries[14] and can be procured by the largest bulk procurers of female condoms. The extent to which the FC2 has actually benefitted procurers in terms of lower prices is debatable. Already in 1996 FHC negotiated a public-sector pricing agreement, reducing the price for developing country governments to approximately $0.58 per (FC1) condom for bulk purchases[15]. Given that the current reported price of a FC2 female condom is $0.55, it is unclear the extent to which purchasers of FC1 and FC2 female condoms have benefitted from the reported cost savings resulting from the transition from the polyurethane to nitrile product.

MSH Female Condom Prices 2007-2012

Figure 5: Female condom prices reported by the MSH Price Indicator Guide since 2007. The guide collects the prices paid for medical products paid by pharmaceutical suppliers, international development organizations, and government agencies.

In summary, over recent years, relative advances have been made in the availability of female condoms with organisations such as UNFPA and USAID increasing the programming of female condoms. However, in the same period, the price of female condoms has remained relatively inelastic, especially for bulk purchasers of female condoms – see Figure 5 – even though FHC has reported cost savings of around 30% from moving from the FC1 to FC2 female condom. Due to these relatively modest decreases in female condom prices, it is unsurprising that UNFPA/WHO has encouraged other female condom producers to work towards the prequalification of their products, not only to increase competition but also to provide users a greater range of female condoms to choose from.

 Women's Condom

Figure 6: Woman's Condom, produced by PATH in collaboration with Dahua Medical Apparatus Company of Shanghai, China

A Growing Range of Female Condoms

Although the history of FHC and the FC1 and FC2 female condoms represent an important chapter in the broader history of female condoms, the development of other female condoms cannot not be overlooked. For instance, already in 1995, Dr. Reddy begun developing a female condom (which has since evolved into the present VA w.o.w. female condom). Further, in 1996, two PATH employees who were working together on new reproductive health technologies started exploring the development of a more ‘user-friendly’ female condom (which has since evolved into the Woman’s Condom)[16]. Currently FCMi is aware of over 10 female condoms either on the market or in development.

In order to support the establishment of other female condoms on the market, the UAFC Joint Programme funded a female condom functionality study in 2011-2012. This trial - carried out by MatCH (Maternal Adolescent and Child Health), University of The Witwatersrand, South Africa - aimed to assess the functional performance (breakage, slippage, invagination and misdirection) and safety of three new condom types — the Woman’s Condom, the VA worn-of-women (VA w.o.w.) Condom Feminine, and the Cupid female condom — against the WHO/UNFPA prequalified FC2. The results of the study were featured in the Lancet in 2013[17] and found that the functional performance (defined as the frequency of user-reported breakage or misplacement) of the three new products, which all differ fairly significantly in terms of shape, materials, and lubrication, was no worse than for the FC2 condom.

Cupid1

Figure 7: Cupid1 female condom, which gained WHO/UNFPA prequalification in mid-2012

This study formed a key part of the Cupid1 product dossier that was submitted for WHO/UNFPA pre-qualification (obtained in mid-2012 - the first latex female condom to obtain prequalification). The prequalification of the Cupid1 represents a landmark event in the diversification of the female condom supply base, as UNFPA, the largest bulk procurer of female condoms in 2012, and other WHO/UN affiliated organisations, can now procure and distribute an additional female condom to the FC2. Cupid Ltd. is currently preparing its application to USFDA which will potentially lead to USAID-funded programmes also having an additional female condom product to procure and supply.

With other female condoms producers displaying their intention to gain WHO/UNFPA prequalification (Woman’s Condom and VA w.o.w, for instance), there is the potential for even further diversification of the female condom supply base for bulk procurers of female condoms.

Moving towards a New Female Condom Market

As explained above, the modern history of the female condom, has for a long time been closely linked to the development of the FC1 and FC2 condoms by FHC. FCMi and UAFC anticipate that the current chapter in the history of female condoms will in future be viewed as one in which the availability, variety and affordability of female condoms significantly increased.

With regard to availability and variety, important steps have certainly already been made, particularly with the WHO/UNFPA prequalification of the Cupid1 female condom in 2012. In terms of affordability, it is acknowledged that significant steps still need to be made beyond the savings made by FHC in the transition from FC1 to FC2. Indeed, the lowest priced female condom still costs over 20 times more than its male equivalent[18]. However, it is expected that as more female condom products come onto the market, especially onto the market for bulk procurement, that the increased competition will drive down prices and help female condoms become an increasingly affordable dual protection contraceptive method.


[1] This section is largely adapted from Access: How do Good Health Technologies get to Poor People in Poor Countries? Laura J. Frost & Michael R. Reich, 2008, Chapter 8: Female Condoms: Access to Dual Protection Technologies (with Beth Anne Pratt)

[2] Whatever happened to the Femidom?, Guardian website, 23 August 2005

[3] Important Milestones in the Development of the Female Condom, The Female Health Company website

[4] Ibid

[5] Female Condom: A Powerful Tool for Protection, PATH, June 2006

[6] According to the Access RH database, UNFPA supplied over 14 million female condoms in 2012 and USAID over 10 million female condoms.

[7] Structural integrity of the female condom after multiple uses, washing, drying and re-lubrication, Beksinska, M.E., Rees, H.V., Dickson-Tetteh, K.E., Mqoqi, N., Kleinschmidt, I., McIntyre, J. Contraception 63 (1):33-36. 2001; Structural integrity of the female condom after a single use, washing, and disinfection, Joanis, C., Latka, M., Glover, L.H., Hamel, S. Contraception 62 (2):63-72. 2000: ); Structural integrity of the polyurethane female condom after multiple cycles of disinfection, washing, drying and relubrication, Potter, B., Gerofi, J., Pope, M., Farley, T. Contraception 67 (1):65-72. 2003

[8] Structural integrity of the polyurethane female condom after multiple cycles of disinfection, washing, drying and relubrication, Potter, B., Gerofi, J., Pope, M., Farley, T. Contraception 67 (1):65-72. 2003.

[9] The safety and feasibility of female condom reuse: Report of a WHO Consultation. WHO, Jan. 2002; WHO information update: Considerations regarding the use of female condoms. WHO, Jul. 2002

[10] FHC experienced its first profitable year in 2006. Important Milestones in the Development of the Female Condom, The Female Health Company website

[11] FC2 Timeline, FC2 website

[12] FC1 and FC2 sales figures compiled from various sources including: Access: How do Good Health Technologies get to Poor People in Poor Countries? Laura J. Frost & Michael R. Reich, 2008, Chapter 8: Female Condoms: Access to Dual Protection Technologies (with Beth Anne Pratt); Research Profile, Female Health Company, RJ Falkner and Company; and market intelligence gathered by UAFC Joint Programme

[13] Information about FC2 Female Condom and Its Use, Factsheet prepared by the Female Health Company (accessible at God's House International)

[14] The Female Health Company Reports Fourth Quarter and FY2013 Operating Results, Dec. 3, 2013: The Female Health Company website

[15] Access: How do Good Health Technologies get to Poor People in Poor Countries? Laura J. Frost & Michael R. Reich, 2008, Chapter 8: Female Condoms: Access to Dual Protection Technologies (with Beth Anne Pratt), p.173

[16] A unique kind of condom, Woman's Condom expands choices for protection, PATH website

[17] Performance and safety of the second-generation female condom (FC2) versus the Woman’s, the VA worn-of-women, and the Cupid female condoms: a randomised controlled non-inferiority crossover trial, Mags E Beksinska, Gilda Piaggio, Jennifer A Smit, Junqing Wu, Yufeng Zhang, Jacqueline Pienaar, Ross Greener, Ying Zhou, Carol Joanis, Lancet Glob Health 2013; 1: e146–52

[18] Calculated using the MSH Price Indicator. Lowest reported price for a male condom in 2012 US$ 0.0245 (UNFPA); lowest reported price for a female condom in 2012 US$ 0.5600 (UNFPA).