After a decade off the market, the FDA has reapproved public sales of the Today Sponge.
Allendale Pharmaceuticals, the marketers of the sponge, found that the demand for their product was still high even though it was removed from the market in 1995. The manufacturers determined that they had no choice but to improve the product and once again obtain FDA approval for their popular product.
According to the FDA's Web site, their spokeswoman, Susan Cruzan, confirmed the approval for the sponge. "They can re-enter the U.S. market," she said. "The product was found to be safe and effective."
The ease of application and the fact that it does not contain any hormones made it a very popular form of contraception. Between 1983 and 1995, there were an estimated 250 million sponges sold.
In 1993, shortly before it was removed from the market, news of contaminants from water that was being used to make the sponge surfaced, yielding debates as to whether this form of contraception was indeed as safe as it was expected to be. In the midst of the contamination scare, officials began to question whether the sterilization procedures were effective in the manufacturing process.
Despite these health regulation questions, the decision to remove the sponge from the market in 1995 rather than improve upon the design came as a blow to women. Even the media responded to the outcry of women discovering that their favorite contraceptive method had been removed from the market. In one Seinfeld episode, Elaine desperately scouted around pharmacies to stock up on remaining sponges to keep her supply. In 2003, the sponge was made available on the market through Canada and select internet providers.
The Today Sponge is a barrier form of contraception. It does not contain any form of hormone. The sponge is donut shaped with a dimpled center and it is made of polyurethane. The sponge itself acts as a trap for semen and will absorb the sperm from traveling further. There is a loop on the underside to facilitate easy removal. To ensure further effectiveness, the sponge also contains 1000 mg of a spermicide (nonoxynolÐ9) which is effective immediately upon insertion and provides a 24-hour window of protection. Not only does it contain immediately effective contraception and give a long period of effectiveness, it also is available over the counter.
The material used in the sponge is reported to be soft and mimics the feel of vaginal tissues; therefore, it is comfortable and unobtrusive for either partner during intercourse.
Proper use of the sponge will help facilitate a greater amount of protection. To activate its use, wet the sponge thoroughly with tap water. Gently squeezing the sponge will activate a considerable amount of suds, which activates the spermicidal ingredients. For insertion, fold the sponge in half, dimpled side up and insert it into the vagina -- deeply enough so that it covers the cervix. The dimpled side, upon correct insertion should face the cervix and the loop should face outwards. After intercourse, the sponge should be left in for about six hours for effective barrier control. Many women find that propping one leg up, squatting or lying down can promote a easier insertion of the sponge. Removal should be easy. Insertion of one finger in the vagina catches the loop and the sponge slides out easily.
If used correctly, the sponge has an 89 to 91percent effectiveness. These statistics are reported from Allendale Pharmaceuticals. If used inconsistently and with a margin of error, the sponge has an effectiveness of 84 to 87 percent.
The sponge provides many benefits. It is easy to use and is effective immediately. In addition, it is a relatively inexpensive form of contraception. The sponge does not require a medical exam or prescription. There are few drawbacks for using the sponge. First, the sponge does not provide protection against sexually transmitted diseases.
Second, a small percentage of women may be allergic to the preservative metabisulfate used in the Today Sponge. If either the woman or her partner is allergic to sulfa ingredients, she should consult a physician before attempting to use the sponge. Another health concern is Toxic Shock Syndrome (TSS). TSS is a severe and often fatal disease that can affect women after they have left a tampon in for too long. In order to prevent TSS, it is recommended to leave the sponge in for no longer than 30 hours at one time. Women who experience an extremely high fever, vomiting, diarrhea, a rash similar to sunburn, dizziness and muscular pain should seek medical help immediately. Also, if the woman has problems removing the sponge or only removes part of the sponge, she should consult a physician immediately.
"It's always a good thing when women have more choices about which contraceptive to use, because then there is a greater chance that they can find a method they can use correctly and consistently," said James Trussell, director of Princeton University's Office of Population Research in an interview on NBC.
Since the sponge has been recently reappoved by the FDA, it may not be available in all areas at first. The sponge will be available throughout the United States by this summer. For more information, please visit Allendale Pharmaceutical's webpage for the sponge, http://www.todaysponge.com.
