The Today Sponge
The Today Sponge
The sponge often was used as an interim method while withdrawing from or beginning use of the birth control pill. It also provided some protection against the spread of sexually transmitted diseases. About 400,000 women used the Today Sponge. As a contraceptive, Today's failure rate was relatively high, but the FDA ruled the sponge both safe and effective. It was certainly a lot more effective than using nothing.
The sponge was invented by Bruce Ward Vorhauer, who struggled for seven years to get the device approved and on the market. The Today Sponge was the first new contraceptive method to appear in decades and, for more than 10 years it was the most popular female, over-the-counter birth-control method around. Five years after its release, 75 million sponges had been sold. During its initial 12 years on the market, it is estimated that 6.4 million women (11 percent of all women using contraceptives at the time), had tried the sponge at least once.
The sponge is one of the few over-the-counter, non-hormonal, woman-controlled contraceptives approved for use in the United States. It was widely available in the United States for 12 years before its discontinuation in 1995. The Today Sponge was released to sell in Canada in 2003. Canadian pharmacies do not regulate the contraceptive as a drug and American women went on sponge-buying sprees there until its re-release in June 2005.
Description and Ingredients
The Today Sponge is constructed of soft polyurethane foam containing 1000 mg of nonoxynol-9, a locally acting, non-systemic spermicide. Women like the sponge--a small, doughnut-shaped device containing spermicide--because it is comfortable and about as effective as a diaphragm. The sponge works to prevent pregnancy by releasing the spermicide nonoxynol-9 for a period of 24 hours. It is 90-90.8% effective at preventing pregnancy, offering more protection than condoms but less than most birth control pills. It is not considered a reliable defense against sexually transmitted diseases. Women say they like the sponge for a variety of reasons: It is sold over the counter, can be inserted as long as 24 hours before sex and, unlike condoms, it can be left in place for multiple rounds of intercourse. At a half-inch thick and three-quarters of an inch in diameter, it was both discreet and portable.
The sponge was the second-most popular form of over-the-counter birth control in the U.S. before production stopped in 1995. Some people are allergic to the spermicide and some women reported irritation as well as difficulty removing it.
"I noticed it inside her because I knew her well. You can feel it. It's not like you're running into a hubcap; it's a soft object." For a small number of male and female users, the sponge was more painful than pleasurable. One former male user described the sensation he experienced using the sponge as "the flaming urethra." The sponge may be even less effective for women who've already had children, because their vaginas and cervical openings are larger.
Effectiveness
A 1998 survey found failure rates of 20 percent among women who had already had a child and 9 percent among those who had not. Women who used the device correctly and consistently for a full year, compared with a failure rate of less than 1 percent for women using birth-control pills.
Prices
While still on the market initially, the Today Sponge costed about $1.50 or less per sponge. Now that the Today Sponge is back on the market, it is selling for $2.50-$3.00 per sponge. The Today Sponge is usually sold in boxes of three.
Taken off the Market
Drug giant American Home Products (AHP) took the contraceptive device off the market in 1995 after the Food and Drug Administration found too much bacteria in its factory's water. AHP withdrew the sponge because it wasn't enough of a cash cow to justify refurbishing the contaminated factory or restarting production.
Production of the Sponge ceased in March 1994. In the year before being taken off the market, it was the single most used form of over-the-counter birth control. The Today Sponge was pulled from the market in 1995.
FDA investigators also established that the firm had neglected to validate its microbiological test methods, there by raising questions about their reliability. Still other problems were found in the firm's equipment sanitization. There's no evidence that the bacteria ever contaminated the sponge.
Delays
Allendale Pharmaceuticals announced that it was bringing back the device in 1999. Government regulators requested significant packaging changes, including the addition of warnings about Toxic Shock Syndrome (TSS).
Unfortunately, although Allendale met the packaging requirements in 2000, the FDA lagged on inspecting the plant. The FDA scheduled and cancelled two appointments by July 2000 to inspect the Allendale plant in Mainland, PA. Despite the fact that Allendale had met all the requirements of the Canadian government, the FDA refused to allow the company to ship to Canada until 2003.
Early in 2000, the FDA demanded that the company run three six-month stability studies instead of the 90-day stability study that officials had originally requested to determine the safety and stability of the device. A stability study test is used to make sure that a product remains in the same form for a certain period of time following manufacturing. Proponents believed that this ban on sale was based on politics, not science.
The Return of the Today Sponge in the United States
In April 2005, Allendale Pharmaceuticals reported that the Today Sponge would be available for sale and distribution via their website by June and in drug stores nation-wide by August 2005. Nothing at all has changed about the Today Sponge except for the prices. The Today Sponge does not protect from HIV/AIDS but may provide some protection against STD's. Women are to not use the Today Sponge while they are on their period because of risks of TSS.
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