Federal Panel Withholds Approval of Breast Exam Device : Health: FDA’s outside experts call for studies that show the Sensor Pad works. The product has been at the center of a long legal battle.

A Food and Drug Administration advisory panel recommended Thursday that the agency not approve the Sensor Pad, an experimental device designed to help women better detect breast lumps during self-examination, until its manufacturer submits scientific studies that show the product works.

In doing so, the panel of outside experts sided with the agency in its nine-year dispute with the company that makes the device, a controversy that has involved FDA seizures of the product for illegal marketing to hospitals.

When placed over the breast, the pad--made of two latex-like sheets with a liquid silicone lubricant in-between--is supposed to enhance its tactile surface, much like using soap or body lotion, presumably making lumps easier to feel.

It is expected to cost about $15 and, if approved, likely would be available without a prescription.

It is available in Europe and Asia, but its status in the United States has been held up by the device industry as a case study of the FDA’s sluggishness in approving potentially lifesaving medical devices.

But the FDA, which in recent years has sought to achieve a balance between speeding promising products to the market and protecting the public from injury, has refused to approve the product until the manufacturer submits evidence that it is effective.

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.

The pad’s manufacturer, Inventive Products Inc., of Decatur, Ill., has argued that the pad is intended as an adjunct to--not a substitute for--traditional methods of breast cancer detection and that it is safe.

Therefore, the manufacturer has said, 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 deaths.

But agency officials fear, among other things, that the pad could either mask abnormalities or cause women to feel something that is not there, resulting in undue anxiety and unnecessary medical procedures. Also, they worry that women who use it might forgo conventional breast cancer detection methods, such as mammograms or physical exams by physicians.

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“Given the importance of early detection . . , the public health implications are obvious,” said Dr. Susan Alpert, director of the FDA’s Office of Device Evaluation. “Are our concerns warranted, or are we being overly cautious? If this device is safe and useful . . , we want it to reach the public.”

The company provided the panel and the agency with testimony from numerous clinicians and women praising the pad, but it never has conducted extensive clinical trials that compare breast examination with and without the pad.

“There is no good way to do a human trial (because) there are so many variables in breast self-examination” that “you can’t come out with good, clean science,” said Grant Wright, president of the company.

“We’re up here trying to do some good,” he added. “I lost an aunt to breast cancer and another aunt underwent a mastectomy. We want to work with you.”

Nevertheless, the FDA’s obstetrics and gynecology devices panel urged that studies be conducted in professional settings, such as hospitals and clinics, using both physicians and patients to compare breast examinations with and without the pad.

The committee also recommended behavioral studies to determine whether use of the product resulted in changes in women’s practices, either in self-examination or other detection methods.

Earl Wright, the product’s inventor and father of the company’s president, said he does not know whether the company will comply, but he expressed pessimism about the prospects.

“Each woman’s breast is unique and there’s no way trials could be set up using women that would be scientific,” he said. “For nine years we’ve heard the same arguments and we’ve never come up with a solution.”

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 it contained little information and was inadequate to determine safety and effectiveness.