[2][3][4] The female condom was invented in 1990 by Danish physician Lasse Hessel, and approved for sale in the United States by the FDA in 1993.
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.
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.
The second generation female condom is called the FC2 and is made from nitrile synthetic rubber[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]).
At the closed end of the sheath, the flexible ring is inserted into the vagina to hold the female condom in place.
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.
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 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.
The OFC is in clinical trials in San Francisco, California, in collaboration with the Women's Global Health Imperative at RTI, International.
[17] A pending lawsuit involving allegations of embezzlement means that the Origami is, as of February 2017, suspended indefinitely from reaching the market.
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.
[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.
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.
[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.
[33] Recently, a number of initiatives have been undertaken by international and intergovernmental organizations to expand access to the female condom.
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.
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.