The Food and Drug Administration on Friday gave limited marketing approval to a controversial breast self-examination device that has become a symbol of overzealous government regulation for FDA critics.
The "sensor pad," made of two latex-like sheets with a liquid silicone lubricant in between, is designed to enhance the tactile surface of the breast, presumably making lumps easier to feel. It was approved for distribution only through health care providers, clinics and other facilities where women can be taught how to use it.
Breast cancer, the second-leading cancer killer of women, results in about 46,000 deaths annually. There are about 182,000 new cases every year. Early detection of the disease is considered critical.
Inventive Products Inc. of Decatur, Ill., the pad's manufacturer, has been trying to obtain approval for a decade but had sought to have the device available for over-the-counter purchase.
"This is an embarrassment to American women to say they don't know how to read instructions and do a breast exam," said Val Mullens, a spokeswoman for the company.
The dispute over the pad has been cited by the device industry and congressional critics as a case study of the FDA's sluggishness in approving potentially lifesaving medical devices.
Rep. Richard M. Burr (R-N.C.), one of several House members seeking to reform the FDA, called the agency's action "an insult to women."
Burr said that he has carried a sensor pad in his coat pocket for the last 10 months "and I use it every time I give a speech, because it's the clearest tool I've used to show that common sense doesn't play in the bureaucracy up here."
Burr said that Friday's action was the FDA's "way of trying to call off the dogs," which is not going to happen, he said.
The agency, which in recent years has sought to achieve a balance between speeding promising products to the market and protecting the public from injury, had refused to approve the product until the manufacturer submitted evidence that it was effective.
In September 1994, an FDA advisory committee recommended that the device not be approved until clinical studies had been submitted.
Agency officials were concerned that the device could mask breast abnormalities or changes in breast tissue, or that women would abandon other detection methods--such as mammography or clinical exams by physicians--in favor of using only the pad.
FDA's decision to approve the device was based on two clinical studies submitted last month by the manufacturer.
One of the studies, conducted in the United States, examined the impact of different educational strategies on the skill and frequency of breast self-examinations. The other study was conducted as part of a breast self-exam screening program in Japan.
The Japanese study of 832 women showed that women who had been properly instructed in the pad's use detected their own breast lumps almost as frequently as they were found by trained nurses using the pad.
Nurses were able to detect lumps in each of the 72 women identified with breast cancer. Of the women who participated, only one missed her own breast lumps when self-examining with the pad.
During its long and contentious battle with the FDA, the company argued that the device was intended as a supplement to traditional breast cancer detection methods, not a substitute for them, and that it is safe.
Therefore, the company maintained, the FDA should not view it with the same regulatory scrutiny as devices such as heart valves or intrauterine devices, which in some cases have resulted in injury and death. The FDA disagreed.
In 1987, the firm began selling the pad to hospitals illegally, which led to a series of seizures by the FDA. When the firm contested the original seizure, a federal court upheld the FDA actions. The company appealed the ruling, contending that the product was not a medical device.
In 1991, a federal appeals court affirmed the original ruling that the pad was a medical device and that it could not be sold until it was licensed.
Following the initial seizure and throughout the legal process, the firm continued to distribute the device, and the agency continued to seize it.
The firm first sought marketing approval in 1985, saying that the device was essentially equivalent to products that were already legally on the market, in effect seeking to bypass agency requirements that it submit proof of safety and effectiveness.
The FDA concluded that the device was not like anything on the market and that a full pre-market approval application, including evidence of safety and effectiveness, was required.
The company submitted such an application in 1989, but the FDA said that it contained little information and was inadequate to determine safety and effectiveness.