FDA tells implant maker to release data

January 21, 1992|By New York Times News Service

WASHINGTON -- The Food and Drug Administration has told Dow Corning Corp. to make public approximately 90 documents on silicone gel breast implants, but company officials said yesterday that the company might not comply.

Dr. James S. Benson, the chief FDA official in charge of medical devices, told the company that the agency would disclose the documents if the company did not do so by tomorrow.

Based on the documents and new information, Dr. David A. Kessler, the FDA commissioner, called for a moratorium Jan. 6 on the sale and use of silicone gel implants.

In a letter to Lawrence A. Reed, president of Dow Corning, the largest maker of breast implants, Dr. Benson said the company should immediately release the data so that women and doctors can consider company documents on safety.

"These memoranda reflect a lack of appropriate safety and performance data for the Silastic I device and reinforce concerns about the safety and performance of all currently marketed devices," Dr. Benson wrote. "We believe that disclosure of this information is warranted in light of Dow Corning's previous statements about the safety of its devices" and the company's previous "representation that it has put all relevant evidence on the record."

Dow Corning officials said they will release scientific information but are "inclined to withhold" documents in which company officials debated the adequacy of safety studies.

Robert T. Rylee, chief of Dow's health care businesses, said that releasing all of the documents would paint an inaccurate, one-sided picture.

The memos, some of which have been disclosed by the New York Times and other newspapers, show top company officials rushing to push a new soft gel implant onto the market before basic safety studies were carried out.

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