Female sponge contraceptive re-approved for US market

Saturday, April 23, 2005

What was once the most widely sold contraceptive for millions of women, the Today® Sponge, has been re-approved by the Food and Drug Administration (FDA) to be brought back for sale to the American marketplace, as early as this summer.

The reintroduction of the sponge, demanded by many women for years, is noteworthy because it offers certain distinct advantages versus other forms of contraceptive:

It does not interfere with the natural sensations of intercourse, compared with male or female condoms.
It does not require multiple applications of contraceptive gel or cream, unlike the diaphragm.
It remains effective at preventing pregnancies for up to 24 hours after insertion, even with several acts of sexual intercourse.
It will legally be made available over-the-counter an estimated price of $7.49 to $8.99 for a package of 3.

The sponge does not, however, protect against sexually transmitted diseases, and it carries with it certain minor risks which should be noted by potential users.

There is a minor risk of Toxic Shock Syndrome, a risk also carried by certain other female hygiene products, such as tampons.
Product should not be inserted during menstruation, and should be removed after no more than 30 hours of continuous use.

The sponge has also been found less effective as a form of birth control than oral contraceptives, Depo-Provera injections or an intrauterine device (IUD), although similar in effectiveness to the male condom. A pregnancy rate of 13 to 16% is expected from a year of "typical use" as a standalone method of birth control. The product varies in effectiveness depending on if the woman forgets to insert the device before intercourse, uses the device incorrectly, or fails to wait at least 6 hours after intercourse before removing the device.

History of the Today Sponge

The sponge was invented by Bruce Vorhauer, PhD to combine a safe, widely used spermicide, nonoxynol-9 (N-9), and a barrier contraceptive, made from polyurethane. Since being brought to market in 1983, it quickly established itself as the best-selling contraceptive for women. More than 250 million Today Sponges were sold until March, 1994, when manufacturer American Home Products ceased making the sponge.

Some misconceptions have surrounded the product's withdrawal, such as the sponge was found to be unsafe by the FDA (false), or that the company making it went bankrupt (also false). What happened is that the FDA inspected the only plant where the sponge was manufactured, in Hammonton, New Jersey, and discovered bacterial contamination of the water supply and other concerns.

American Home Products, which today is known as Wyeth, decided to cease manufacture rather than undergo the potential cost and delay of upgrading their plant and meantime losing share to their competitors.

The passing of the sponge era was noted in the famous episode of the TV show Seinfeld (Season 7, Episode 119: "The Sponge"). Character Elaine Benes hoarded her sponges as the supply started to dwindle, and began to examine her potential lovers to see which one of them was truly "spongeworthy".

Reintroduced to Canada, US

The President and Chief Executive of Allen Pharmaceuticals, Gene Detroyer, bought the Today Sponge from Wyeth in 2000 for US$7 million and prepared new packaging to meet updated requirements. However, re-introduction of the product was delayed by several years, at least partly due to FDA inaction in inspecting the new manufacturing plant.

"I'm overwhelmed," said Detroyer to the Associated Press. "I am pleased both from a business point of view ... and from the point of view that we can add another contraceptive for women." The Today Sponge received FDA approval in March 2003 to be sold in Canada, and some women even in the US have been able to purchase it through Canadian websites. The FDA has in the past received criticism for its role in removing the Today Sponge from the market and it continues to receive criticism for the impact of its regulatory actions on women's health.

Despite its decade-long absence from public availability, "The product was found to be safe and effective," said FDA spokesperson Susan Cruzan about its recent re-approval.

Sources

"Update 9: Contraceptive Sponge to Return to Market" — Forbes/AP, April 22, 2005
Lisa Richwine. "Sponge contraceptive returning to U.S. market" — Reuters, April 22, 2005
Linda A. Johnson. "Contraceptive Sponge to Return to Market" — ABC News/AP, April 22, 2005

Press Releases

January 12, 1995: Today Sponge: FDA Talk Paper

External links

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