
                         Roanoke Times
                 Copyright (c) 1995, Landmark Communications, Inc.

DATE: FRIDAY, September 2, 1994                   TAG: 9409020078
SECTION: NATIONAL/INTERNATIONAL                    PAGE: B11   EDITION: METRO 
SOURCE: THE WASHINGTON POST
DATELINE: WASHINGTON                                 LENGTH: Short

MORE TESTING URGED FOR BREAST-EXAM PAD

An advisory panel to the Food and Drug Administration recommended Thursday that a Decatur, Ill., company conduct further tests on its controversial breast-cancer self-examination aid before the FDA approves the device for sale.

The company, Inventive Products Inc., had become something of a poster child for FDA critics, who point to the firm's nine-year fight to get the relatively simple product approved as an example of an overprotective government bureaucracy stifling innovation and damaging public health.

Breast self-examination to detect lumps is made more difficult by the friction of fingers on dry skin - which is why many women examine their breasts in the bathtub or shower. Inventive Products designed its Sensor Pad - a 9.5-inch sandwich of latex-like plastic filled with liquid silicone - as a ``dry lubricant'' device to overcome the friction problem.

Members of the advisory panel said the company, which in 1988 tried to circumvent the FDA process by selling the product directly to hospitals, never proved that the device is any more effective at enhancing users' sense of touch than using lotion, oil or soapy water.

Speakers and panelists questioned whether the device actually might diminish sensation, thus giving users a false sense of security, leading them to skip mammography tests, which catch more cancers than the self-exam does. Others noted that it had been tested by only 45 women who tried the device on plastic breast models.

by CNB