Further study sought on breast device

September 02, 1994|By Los Angeles Times

WASHINGTON -- A Food and Drug Administration advisory panel yesterday recommended 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 in women 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, a controversy that has involved FDA seizures of the product for illegal marketing to hospitals, and court battles.

The pad is composed of two latex-like sheets with a liquid silicone lubricant in-between. When placed over the breast, it enhances its tactile surface, much like using soap or body lotion, presumably making lumps easier to feel. It is expected to cost about $15 and, once approved, likely would be available without a prescription.

It is available in Europe and Asia but not in the United States, and has been touted by the device industry as a case study of the agency's sluggishness in approving potentially life-saving 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.

The pad's manufacturer, Inventive Products Inc. of Decatur, Ill., has argued that the pad is intended as an adjunct to -- and not a substitute for -- traditional breast cancer detection methods, and is safe. Therefore, the FDA should not view it with the same regulatory scrutiny it does with such devices as heart valves or IUDS, 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 isn't 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 mammograms, or physical exams by physicians.

"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 has never 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.

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 use of the pad.

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