Female condom

Last updated
Female condom
Preservatif feminin.jpg
Polyurethane Female condom
Background
Type Barrier
First use1980s
Failure rates (first year)
Perfect use5% [1]
Typical use21% [1]
Usage
ReversibilityImmediate
User remindersTo avoid risk of incorrect use, read the instructions carefully prior to use.
Advantages and disadvantages
STI protectionYes
Weight gainNo
BenefitsNo external drugs or clinic visits required

A female condom (also known as an internal condom) is a barrier device that is used during sexual intercourse as a barrier contraceptive to reduce the probability of pregnancy or sexually transmitted infection (STI). It is inserted in the vagina (or anus) before intercourse to reduce the risk of exposure to semen or other body fluids. [2] [3] [4] The female condom was invented in 1990 by Danish MD Lasse Hessel, and approved for sale in the US by the FDA in 1993. [5] It was developed as an alternative to the older external condom, which is put on the man.

Contents

Description

The female condom is a thin, soft, loose-fitting sheath with a flexible ring/frame or ring/foam disc at the closed end. They typically come in various sizes. For most vaginas, a moderately sized condom is adequate; women who have recently given birth should try a large size first. The inner ring or foam disc at the closed end of the sheath is used to insert the condom inside the vagina and to hold it in place during intercourse. The rolled outer ring or poly frame at the open end of the sheath remains outside the vagina and covers part of the external genitalia.

The female condom was developed in the late 20th century (male condoms have been used for centuries). A primary motive for its creation is the refusal of some men to use a condom because of loss of sensation and the resulting impact on the hardness of the man's erection, and secondarily by its implication that the male could transmit an STI. [6] [7]

Versions and materials

An illustration of a female condom Female Condom.png
An illustration of a female condom

The FC1 female condom was first made from polyurethane. The second generation female condom is called the FC2 and is made from synthetic nitrile [8] (this material change was announced in September 2005, [9] and full transition of the product line to FC2 was done by October 2009 [10] ). The newer nitrile condoms are less likely to make potentially distracting crinkling noises. FC2 was developed to take the place of FC1, providing the same safety and efficacy during use, but at a significantly lower cost. [9] FC2 is manufactured by Veru Pharma. The World Health Organization (WHO) has cleared FC2 for purchase by U.N. agencies and the United Nations Population Fund has incorporated the female condom into national programming. [11] They are sold under many brand names, including Reality, Femidom, Dominique, Femy, Myfemy, Protectiv and Care.

FC2 is currently the only female condom with Food and Drug Administration (FDA) approval in the United States. It was initially available over the counter, but in 2018, Veru switched to a prescription model because of poor sales, so female condoms are no longer available OTC in American pharmacies. [12]

A recent version of the female condom is made from natural latex, the same material used in male condoms. This condom does not make the noises some experience with plastic condoms and fits snugly against the female anatomy. This type of female condom is manufactured by HLL Lifecare Ltd., India and IXu LLC of USA. It is sold under the brand name VA w.o.w Condom Feminine. One more clinical trial is required before it can be considered for FDA approval in the United States. [13]

The global health nonprofit PATH has also developed an female condom tailored for use in developing countries. The Woman's Condom is manufactured by Shanghai Dahua Medical Apparatus in China and is in early introduction. [14]

FC2 condoms

VA wow brand female condom ReddyFc.png
VA wow brand female condom

The FC2 female condom is a nitrile sheath or pouch 17 cm (6.7 in) in length. At each end there is a flexible ring. At the closed end of the sheath, the flexible ring is inserted into the vagina to hold the female condom in place. The other end of the sheath stays outside the vulva at the entrance to the vagina. This ring acts as a guide during penetration and stops the sheath from shifting during intercourse. There is a silicone-based lubricant on the inside of the condom, but additional lubrication can be used. The condom does not contain spermicide.

VA W.o.W.

The VA w.o.w. Condom Feminine is manufactured by HLL Lifecare Ltd. and IXu LLC. This latex condom has a pouch attached to its rounded triangular opening and a sponge to secure it inside a woman's vagina. It is available through the distributor IXu LLC for the private and public sectors in several regions, including the EU, South Africa, Brazil, and India. The VA w.o.w. received the CE mark, a certification that it meets European Union consumer health requirements. It is also under review by the WHO. [15]

The Woman's Condom

The Woman's Condom, developed by PATH, through a user-centered design process, is a new female contraceptive designed for improved acceptability, ease of use, and good sensation. The Woman's Condom is a polyurethane pouch that is partially enclosed in a capsule to aid insertion. The capsule dissolves quickly after insertion in the vagina, which releases the pouch. The condom is then held stable in the woman by foam pads. The Woman's Condom is packaged dry and comes with a small sachet of water-based lubricant to be applied at point of use. PATH licensed manufacturing and distribution of the Woman's Condom to the Shanghai Dahua Medical Apparatus Company in 2008. Dahua has received the South Africa Bureau of Standards (SABS) certification marking (2013), Shanghai Food and Drug Administration Approval (2011), and the CE Mark approval (2010) for the Woman's Condom, which allows for marketing and distribution of the product in South Africa, China and Europe, respectively. The Woman's Condom is currently under review by the WHO/United Nations Population Fund Technical Review Committee; the committee's approval could lead to bulk public-sector purchase by United Nations agencies. [16]

Natural Sensation Female Condom

The Natural Sensation Panty Condom is distributed in the US exclusively by the ACME Condom Company. It is manufactured by Natural Sensation Compañia Ltda. (NS) based in Bogotá, Colombia. The product is made of a polyethylene resin, which is stronger and thinner than latex. Unlike latex, polyethylene is anti-allergenic, ultra sensitive, transparent and odorless. Natural Sensation's condoms are lubricated and may be used with either oil- or water-based lubricants.

Silk Parasol Female Condom

The Female Panty Condom is manufactured by Silk Parasol. It is made of biodegradable latex. It has not yet been approved by the FDA and is currently undergoing clinical trials.

The Phoenurse Female Condom

The Phoenurse is made of a dumbbell-shaped polyurethane sheath and comes with an insertion tool, a water- or silicone-based lubricant, sanitary towels, and disposal bags. It is manufactured by the Tianjin Condombao Medical Polyurethane Tech. Co. Ltd. and is approved for sale in the European Economic Area. The Phoenurse female condom is also available in Brazil, Sri Lanka, China, Kenya, and Mexico. It has not been approved by the FDA.

Cupid's Female Condom

The Cupid's Female Condom is made of natural latex rubber and manufactured in India by Cupid Ltd. It is approved for distribution in Europe and was prequalified for distribution by WHO in 2012. It is currently undergoing clinical trials to gain approval by the FDA.

Origami Female Condom

The ORIGAMI Female Condom (OFC) is fabricated in molded silicone for anatomical conformity. It was validated as 100% biocompatible and non-allergenic in independent pre-clinical lab testing. The condom is not yet approved for sale and must be reviewed by the WHO, the C-Mark (EU), and the FDA to meet regulatory safety requirements. The OFC is in clinical trials in San Francisco, California, in collaboration with the Women's Global Health Imperative at RTI, International. Large-scale clinical trials were to follow in 2014, to evaluate its performance and safety. It had been expected to reach the market in late 2015, pending regulatory pre-market approvals. As of January 2017, no results were available from initial feasibility studies. [17] A pending lawsuit involving allegations of embezzlement means that the Origami is, as of February 2017, suspended indefinitely from reaching the market. [18]

Costs and "reuse" of the original FC and FC2

The per unit price of female condoms is higher than male condoms but there is some evidence to suggest that polyurethane female condoms can be washed, disinfected, and reused.

Re-using the polyurethane female condom is not considered as safe as using a new one; however, the WHO says, [19]

Batches of new, unused female condoms were subjected to seven cycles of disinfection, washing, drying and re-lubrication, reflecting the steps and procedures in the draft protocol, but at considerably higher concentrations of bleach and for longer durations. All female condom batches met the manufacturing quality assessment specifications for structural integrity after the test cycles. ... Disinfection, washing, drying, re-lubrication and reuse of the device were not associated with penile discharge, symptomatic vaginal irritation or adverse colposcopic findings in study volunteers.

A presentation at the 1998 International AIDS conference concluded that "washing, drying and re-lubricating the female condom up to ten times does not significantly alter the structural integrity of the device. Further microbiological and virological tests are required before re-use of the female condom can be recommended." [20]

Research suggests that the FC2 female condoms are a cost-effective method of HIV prevention even at low levels of use. The data shows that the cost-effectiveness would increase significantly at higher levels of use. A study conducted in 2005 by David Holtgrave, Chair of the Department of Health, Behavior and Society at Johns Hopkins University's Bloomberg School of Public Health, examined the projected public health impact that the FC2 female condom would have at different levels of use in two developing countries: South Africa and Brazil. The study concluded that FC2 use would generate significant cost savings at all levels of implementation by preventing thousands of HIV infections and saving millions of dollars in health care costs. [21] There is some evidence to suggest that the effectiveness of internal condoms in preventing transmission of HIV may be similar to that of male condoms. [22]

Lubrication

As with all barrier contraceptives, water or silicone-based lubricants are safe to use with any female condom. Oil should not be used with a female condom made of latex.

The FC2 Female Condom comes pre-lubricated with a non-spermicidal, silicone based lubricant. The FC2 is made of nitrile so oil-based (or water-based) lubricants can be added on the inside and outside of the FC2 Female Condom or on the penis.

Effectiveness

When used correctly, the female condom has a 5% failure rate. Inconsistent or incorrect usage has been shown to result in a 21% failure rate. [23]

Some benefits of female condoms over other methods of birth control include: [24]

Some disadvantages to the female condom include: [25]

Advantages

FC2 Female Condom gives women control and choice over their own sexual health; women can protect themselves when their partner does not want to use an male condom; female condoms may provide enhanced sensation for men as compared to male condoms; [26] [27] FC2 is hypo allergenic and is safe to use with people who are allergic to rubber latex; FC2 may be inserted hours before intercourse; female condoms are not dependent on the penis being erect for insertion and does not require immediate withdrawal after ejaculation; FC2 is not tight or constricting; FC2 is highly lubricated and the material warms to body temperature. [28]

The external genitals of the wearer and the base of the penis of the inserting partner may be better protected (from skin-to-skin transmitted STIs such as herpes and HPV) than when the male condom is used; however see studies below.[ citation needed ]

Worldwide use

Sales of female condoms have been low in developed countries, though developing countries are increasingly using them to complement already existing family planning and HIV/AIDS programming. [29] Probable causes for poor sales are that inserting the female condom is a skill that has to be learned and that female condoms can be significantly more expensive than male condoms (upwards of 2 or 3 times the cost). Also, reported "rustling" sounds from the original version of the female condom during intercourse turn off some potential users, as does the visibility of the outer ring which remains outside the vagina. [30] Regulatory issues have also limited interest in manufacturing female condoms. In the United States, the FDA historically categorized female condoms as Class III medical devices, a category with more stringent requirements than Class II, which includes external condoms. Following proposals to reclassify female condoms, [31] the FDA announced in 2018 that single-use female condoms would now be known as single-use female condoms, and moved to Class II. [32]

In November 2005, the World YWCA called on national health ministries and international donors to commit to purchasing 180 million female condoms for global distribution in 2006, stating that "Female condoms remain the only tool for HIV prevention that women can initiate and control," but that they remain virtually inaccessible to women in the developing world due to their high cost of 72¢ per piece. If 180 million female condoms were ordered, the price of a single female condom was projected to decline to 22¢. [33]

In 2005, 12 million female condoms were distributed to women in the developing world. By comparison, between 6 and 9 billion external (male) condoms were distributed that year. [33]

Awareness and access

Recently, a number of initiatives have been undertaken by international and intergovernmental organizations to expand access to the female condom. In 2012, the United Nations Commission for Lifesaving Commodities for Women and Children (UNCoLSC) endorsed female condoms as one of its 13 Life-Saving Commodities, catalyzing inter-organizational efforts to overcome several commodity-specific barriers currently inhibiting women in the developing world from benefiting from this product.

Price has been one of the key obstacles in expanding access to female condoms on an international level. female condoms cost, on average, US$2–4, depending on local market factors. At the 2012 Family Planning Summit in London, the Female Health Company pledged to increase access to the FC2 female condom for the world's poorest countries and announced a prospective pricing arrangement based on aggregate purchases and 5 percent free goods based on the prior year's purchases, together with a multiyear agreement to provide $14 million in training and education by FHC over the next six years.

The Cupid female condoms have been sold in Kyrgyz Republic through UNFPA for their public distribution system. The Woman's Condom has been sold to the public sector in China. Globally, it is acknowledged that further price reductions are necessary to achieve universal access to female condoms. Based on market analysis it is expected that sustainable price reductions are feasible. [34]

Campaigns

Prevention Now!

The Center for Health and Gender Equity's Prevention Now! Campaign promotes the use of external and female condoms as a means of preventing the spread of HIV/AIDS; reducing instances of unintended pregnancy, unsafe abortion, and other unsafe outcomes of unprotected sexual intercourse; promote the sexual and reproductive health and rights of all persons; and expand choices for those living with HIV/AIDS.

Put a Ring on It!

The Chicago Female Condom Campaign is a coalition of HIV/AIDS, reproductive justice, women's health, and gay men's health organizations dedicated to increasing access, affordability, availability, awareness, and utilization of female condoms. Lead partners include the AIDS Foundation of Chicago, Chicago Women's AIDS Project, Illinois Caucus for Adolescent Health, Pediatric AIDS Chicago Prevention Initiative, Mujeres Latinas en Accion, and Planned Parenthood of Illinois.

See also

Related Research Articles

<span class="mw-page-title-main">Condom</span> Device for birth control and STI prevention

A condom is a sheath-shaped barrier device used during sexual intercourse to reduce the probability of pregnancy or a sexually transmitted infection (STI). There are both external condoms, also called male condoms, and internal (female) condoms.

<span class="mw-page-title-main">Safe sex</span> Ways to reduce the risk of acquiring STIs

Safe sex is sexual activity using methods or contraceptive devices to reduce the risk of transmitting or acquiring sexually transmitted infections (STIs), especially HIV. "Safe sex" is also sometimes referred to as safer sex or protected sex to indicate that some safe sex practices do not eliminate STI risks. It is also sometimes used colloquially to describe methods aimed at preventing pregnancy that may or may not also lower STI risks.

<span class="mw-page-title-main">Diaphragm (birth control)</span> Cervical barrier type of birth control

The diaphragm is a barrier method of birth control. It is moderately effective, with a one-year failure rate of around 12% with typical use. It is placed over the cervix with spermicide before sex and left in place for at least six hours after sex. Fitting by a healthcare provider is generally required.

<span class="mw-page-title-main">Nonoxynol-9</span> Chemical compound

Nonoxynol-9, sometimes abbreviated as N-9, is an organic compound that is used as a surfactant. It is a member of the nonoxynol family of nonionic surfactants. N-9 and related compounds are ingredients in various cleaning and cosmetic products. It is widely used in contraceptives for its spermicidal properties.

Spermicide is a contraceptive substance that destroys sperm, inserted vaginally prior to intercourse to prevent pregnancy. As a contraceptive, spermicide may be used alone. However, the pregnancy rate experienced by couples using only spermicide is higher than that of couples using other methods. Usually, spermicides are combined with contraceptive barrier methods such as diaphragms, condoms, cervical caps, and sponges. Combined methods are believed to result in lower pregnancy rates than either method alone.

<span class="mw-page-title-main">Cervical cap</span> Form of barrier contraception

The cervical cap is a form of barrier contraception. A cervical cap fits over the cervix and blocks sperm from entering the uterus through the external orifice of the uterus, called the os.

<span class="mw-page-title-main">Microbicides for sexually transmitted infections</span> Pharmacologic agents and chemical substances

Microbicides for sexually transmitted infections are pharmacologic agents and chemical substances that are capable of killing or destroying certain microorganisms that commonly cause sexually transmitted infection.

<span class="mw-page-title-main">Vaginal lubrication</span> Natural lubrication of the vagina during sexual arousal

Vaginal lubrication is a naturally produced fluid that lubricates the vagina. Vaginal lubrication is always present, but production increases significantly near ovulation and during sexual arousal in anticipation of sexual intercourse. Vaginal dryness is the condition in which this lubrication is insufficient, and sometimes artificial lubricants are used to augment it. Without sufficient lubrication, sexual intercourse can be painful. The vaginal lining has no glands, and therefore the vagina must rely on other methods of lubrication. Plasma from the vaginal walls due to vascular engorgement is considered to be the chief lubrication source, and the Bartholin's glands, located slightly below and to the left and right of the introitus, also secrete mucus to augment vaginal wall secretions. Near ovulation, cervical mucus provides additional lubrication.

<span class="mw-page-title-main">Personal lubricant</span> Substance to reduce friction, usually during sexual acts

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Dry sex is the sexual practice of having sexual intercourse without vaginal lubrication. Vaginal lubrication can be removed by using herbal aphrodisiacs, household detergents, antiseptics, by wiping out the vagina, or by placing leaves in the vagina besides other methods. Dry sex is associated with increased health risks.

<span class="mw-page-title-main">Vaginal ring</span>

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<span class="mw-page-title-main">Comparison of birth control methods</span>

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<span class="mw-page-title-main">Condom effectiveness</span>

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The history of condoms goes back at least several centuries, and perhaps beyond. For most of their history, condoms have been used both as a method of birth control, and as a protective measure against sexually transmitted infections such as syphilis, gonorrhea, chlamydia, hepatitis B and more recently HIV/AIDS. Condoms have been made from a variety of materials; prior to the 19th century, chemically treated linen and animal tissue are the best documented varieties. Rubber condoms gained popularity in the mid-19th century, and in the early 20th century major advances were made in manufacturing techniques. Prior to the introduction of the combined oral contraceptive pill, condoms were the most popular birth control method in the Western world. In the second half of the 20th century, the low cost of condoms contributed to their importance in family planning programs throughout the developing world. Condoms have also become increasingly important in efforts to fight the AIDS pandemic.

<span class="mw-page-title-main">Artificial vagina</span> Device designed to imitate the female sex organs

An artificial vagina is a device designed to imitate the vagina as well as sometimes the vulva. To achieve this, it will generally be made of a soft material, lubricated, and occasionally heated.

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<span class="mw-page-title-main">CONRAD (organization)</span> Nonprofit organization in Arlington, United States

CONRAD is a non-profit scientific research organization that works to improve global and reproductive health, particularly in women in developing countries. CONRAD was established in 1986 under a cooperative agreement between Eastern Virginia Medical School (EVMS) and the United States Agency for International Development (USAID). CONRAD’s products are developed primarily for women in low-resource settings, in that they are designed to be safe, affordable and user-friendly. CONRAD is led by Scientific and Executive Director Gustavo F. Doncel, M.D., Ph.D. Primary funding for CONRAD comes from the U.S. President's Emergency Plan for AIDS Relief (PEPFAR) through the U.S. Agency for International Development (USAID), with additional funding from The Bill & Melinda Gates Foundation and the National Institutes of Health (NIH).

Mary Ann Leeper is the founder of the Female Health Foundation (1994) where she became the chair and board member. She was president and COO for ten plus years before retiring in 2013. Leeper also co-founded another organization called the Business Woman's Initiative against HIV/AIDS. With Leeper's aid, the newest version of the female condom will be introduced to women in locations with high rates of HIV/AIDS. The launch of this new female condom is cheaper and will reach more women. Leeper gives lectures and presentations in colleges and universities across the world. Her main goal is to “help millions of women protect themselves against the spread of HIV and AIDS”. She also stated, “It is not a simple goal, but it is one I am determined to do everything possible to achieve.”

Multipurpose prevention technologies (MPTs) are a class of products designed to address at least two health issues simultaneously, often focusing on sexual and reproductive health which includes contraception, human immunodeficiency virus (HIV) prevention, other sexually transmitted infection (STI) preventions, such as genital infection by human simplex virus (HSV) infection and human papillomavirus (HPV) infection. For example, MPTs can combine contraception and HIV prevention, contraception and other STI prevention, or the prevention of multiple STIs. Since the simultaneous use of multiple products with a single indication against each specific sexual and reproductive health issue is inconvenient, this method may affect adherence. As a result, the goal of developing a MPT as an all-in-one product is to combat this issue.

One Male Condom is a natural rubber latex condom product specifically intended, evaluated and marketed for use during anal sex, as well as being approved for use as a contraceptive and to reduce the risk of sexually transmitted infections (STIs) by vaginal sex. It received US Food and Drug Administration (FDA) approval to be marketed for anal sex use on February 23, 2022. All previous FDA condom approvals were specifically only approvals for use with vaginal sex, and thus their use was off-label for anal sex. When used for anal sex, the One Male Condom product is intended to be used with a compatible water-based personal lubricant.

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