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The Return of the Sponge: Women Are Still Waiting


WebMD Health News

Oct. 19, 2000 -- It's been five years since the contraceptive sponge, the popular over-the-counter birth-control device that once inspired a routine on the TV show Seinfeld, stopped being manufactured in the U.S.

And ever since Seinfeld character Elaine debated whether to dip into her precious stash of sponges when planning encounters with boyfriends who were potentially "sponge-worthy," doctors, researchers and government agencies have continued to investigate the effectiveness and safety of this barrier method of birth control. Though the device is still controversial among some, its FDA approval has never been withdrawn, and a small pharmaceutical company has now started manufacturing the polyurethane foam device.

But devotees of the sponge shouldn't get too excited just yet. Although Allendale Pharmaceuticals has begun production -- and has a long list of women asking when they can buy the sponges -- the company is still waiting for the FDA to inspect its plant for adherence to health regulations before it can market the device. And health officials are evaluating the spermicide the sponge contains, called nonoxynol-9 or N-9, in light of new findings that appeared to show that it increased the risk of transmission of the HIV virus.

"We hope we're getting close," to actually marketing the Today Sponge, says Allendale Pharmaceuticals president and CEO Gene Detroyer. The sponges produced so far are for Canadian buyers but won't actually ship to any consumers until the FDA gives a clean bill of health to the plant, located 30 miles north of Philadelphia.

"The sponge will be the same; it has to be, in order to keep FDA approval," says Detroyer. "Part of the inspection is to check the plant, and part is to make sure that it is exactly the same product." The FDA originally planned the plant inspection for April, but it has been postponed. An FDA spokesperson did not respond to WebMD's request for information about why the inspection has been delayed.

Bacterial contamination of water used to make the Today Sponge led the former manufacturers, the American Home Products subsidiary Whitehall-Robins Healthcare, to halt production. The company said that the cost of repairing its equipment would outweigh the amount realized from sales of the contraceptive.

In response to public demand, the FDA even issued a statement in January 1995, shortly after production of the sponge ceased, that said: "The agency did not object to continued production of 'Today Sponge' under appropriate manufacturing and hygienic conditions. Longstanding public health standards, however, do not allow the marketing of contaminated products that present a potential risk of disease transmission."

But a small group of scientists called Associated Pharmacologists and Toxicologists has raised concerns about possible health risks of the sponge ever since the device was introduced in 1983. The organization submitted its latest petition to the FDA last April, asking that approval of the device be withdrawn. The group's members say that the amount of N-9 found in the sponge promotes the survival of disease-causing organisms in the vagina and leads to vaginal irritation and tissue damage.

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