1. Introduction
2. Getting Approval for Reality
3. What did the FDA not like about the female condom?
4. What is a female condom?
5. How do you use it?
6. What is it made of?
7. What do women like about the female condom?
8. What do women dislike about the female condom?
9. How effective is the female condom?

Introduction

Contraception has come a long way. Many methods and forms have been invented. Condoms, however, are the most recommended form. Condoms, which are made of a soft latex, not only offers prevention to unwanted pregnancies, it also offers protection against STD's and the deadly AIDS virus. There are great numbers of people infected with this untreatable disease, all precautions should be taken when one decides to have intercourse with a new partner. The only form of protection that is available for this disease is

1)Condoms 
2)Abstinence.

When it comes to contraception, both parties involved are responsible. However, this is not always the case. Women are most often placed with the burden. This might be true because of the variety of methods offered to women versus men. Women can use Diaphragms, sponges, IUD's, Norplant, and the Pill. Men are only given one method, the condom. This is the safest form offered in today's market and it's the only barrier method that can prevent the spread of STDs and AIDS. This however, is a thing of the past.

Getting Approval for Reality

Wiscoinson Pharmacal Company (WPC) has gotten approval from the FDA on December 10, 1992, for Reality the FEMALE CONDOM. The FDA placed a few conditions that WPC must agree to before a final approval was given. These conditions were:

the female condoms are available in stores now.

What did the FDA not like about the female condom?

The FDA was most concerned about the high rate of pregnancy resulting from improper use of the female condom. The agency gave the product an expedited review bacause it saw an urgent need for a means whereby women can protect themeselves without depending on the cooperation of their partners. FDA had reservations about the limited data available on protection the female condom offered against STDs, as well as about the high pregnancy rate among users, the small number of women in the clinical studies and the short duration of the studies, which lasted less than a year. Eventually, the agency decided to approve the female condom as the only product of its kind ready for marketing. Wisconsin Pharmacal Co. was the first to have a product that was ready to market and was given the marketing rights for the female condom under the product name Reality, in the U.S.and Canada.

What is a female condom?

How do you use it?

The female condom can be inserted in minutes before intercourse, or several hours in advance. Click below for an illustrative diagram of how the female condom is use. How to use Reality

What is it Made of?

Reality is made of polyurethane, a material stronger and thinner than latex. Polyurethane is used medically for many purposes, including surgical implants, bandages and certain prosthetic units. The type of polyurethane used is soft and easy to handle. It transfers heat, so it warms to body temperature soon after insertion.

What do women like about the female condom?

• Of 147 women who used it in a study, most found it was easy to insert and comfortable.
• The female condom is not disruptive to sex because the woman can insert it minutes or hours before intercourse. But like the male condom, it can only be used once.
• Most women report that the female condom gives either the same sexual sensations or better!
• It is sold over the counter and does not require a doctor to fit you for the device. It's a one-size-fits-all device.
Women who like the device include:
• Women who are ready to stop using birth control pills and want to try a barrier method;
• Women who are allergic to latex, but want to use a barrier method;
• Women who want the option of using both a male condom and female condom so each partner is sharing the responsibilty for protection against diseases and pregnancy.
• Men reported that they liked the female condom because it was not as constricting as the male condom.

What do women dislike about the female condom?

• they do not like to use tampons or barrier methods of birth control;
• they do not like having anything hanging outside of their vagina.
Other complaints include:
• The biggest complaint is that the device is just not aesthetically pleasing.
• Women reported that it squeaks when not adequately lubricated. It comes prelubricated and extra lubricant is supplied.
• The cost. A female condom will cost approximately $2.50 each, compare to about a dollar for a male condom.
• 14% of the men who tested it said they did not like it. If this is the case, then going back a condom is the best solution. Look to see which brand of condom scored the highest.

  • How effective is the Female Condom?

    The maufacturer, Wisconsin Pharmacal Co., studied 200 women who used the device for six months. In the study, the six-month pregnancy rate among U.S. women was approximately 12.5 percent, or an estimated 26 percent per year. This high rate is believed to have been the result of improper use of the device. It compares to an expected rate of 85 percent among women not using any contraceptive method. Women who use the device correctly each and every time they have intercourse can expect a much lower pregnancy rate.

    In laboratory tests done by WPC, studies have established that the AIDS virus (HIV) and the hepatitis B virus, the smallest virus known to cause an STD, do not penetrate the Reality sheath.

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