FDA Tells Firm to Open Data on Breast Implants

The U.S. Food and Drug Administration has told the leading manufacturer of silicone gel breast implants to agree by Wednesday to allow the government to make public the confidential new information that contributed to the FDA’s voluntary moratorium on the sale and use of the implants.

In a three-page letter sent Friday to Lawrence A. Reed, president of the Dow Corning Corp., a top FDA official said that the agency had determined that 90 key studies and memorandums “should be made publicly available” and is prepared “to take other steps” to allow their release if the company does not cooperate. The letter did not specify what these “other steps” were.

The FDA letter to Dow Corning, of Midland, Mich., which has not been made public, is the latest escalation in the acrimonious debate over the safety of the widely used implants.

James S. Benson, director of the FDA’s Center for Devices and Radiological Health, acknowledged that some of the documents would normally be treated as confidential commercial information.

Nevertheless, Benson wrote that “disclosure of this information is warranted in light of Dow Corning’s previous statements about the safety of its devices, widespread publication of summaries of certain safety and effectiveness data, and Dow Corning’s public representations that it has put all relevant evidence on the record.”

Barbara Carmichael, a spokeswoman for Dow Corning, said Saturday that the company will release to the public all “scientific evidence” about the implants but not internal correspondence or memorandums. She said Dow Corning is still considering its formal response to the FDA request.

“We are glad that the FDA has finally informed us of what they consider to be the new information,” said Dan M. Hayes Jr., president of Dow Corning Wright of Arlington, Tenn., the Dow Corning subsidiary that manufactures the implants. “We believe millions of women have been unduly alarmed by the FDA’s announcement of a moratorium.”

The contentious dispute has pitted the manufacturers of breast implants and plastic surgeons against the FDA, consumer advocates and other physicians. It has also deeply divided women, many of whom have spoken of the improvements the implants have made in their lives and others who have condemned them as a source of pain and suffering.

About 10 of the 90 documents are scientific studies, which Dow Corning did not initially submit to the FDA with its application to market the implants, the agency said. The other 80 are internal company memorandums, primarily from the period of 1975 to 1985, which discuss the marketing of a predecessor of the current version of the implants. The company says the memorandums are misleading because they present only one side of a two-sided conversation. Critics have seized upon the memorandums because they appear to demonstrate that the company did not pay sufficient attention to safety concerns.

Last week, both Dow Corning and the American Society of Plastic and Reconstructive Surgeons called upon David A. Kessler, the FDA commissioner, to provide doctors with the medical and scientific evidence behind his decision.

Up until now, the FDA has refused to release the information, saying that it was bound by protective orders issued in federal court cases against Dow Corning in San Francisco and Michigan. The majority of the documents are connected with these cases.

The FDA has said that it is up to Dow Corning, which sought the protective orders, to initiate steps that would allow the agency to make the material public. But the letter indicates that the FDA is prepared to take action on its own to ensure that the documents are released.

The FDA’s voluntary moratorium on the sale and use of the implants, announced Jan. 6, will continue into February if not longer, while the FDA and its advisory committee on general and plastics surgery devices reconsider their long-term status.

In the letter to Dow Corning, the FDA’s Benson said the studies and memorandums would “present a more complete record” of the marketing of the breast implants and “the known problems with these devices” than the information that Dow Corning has already released.

Benson said that Dow Corning memorandums “reflect a lack of appropriate safety and performance data” for the previously marketed implant and “reinforce concerns about the safety and performance of all currently marketed devices.”

Over the last 30 years, about 2 million of the silicone gel breast devices have been implanted in American woman. About 80% have been implanted for cosmetic reasons and the rest for breast reconstruction.

Times staff writer Marlene Cimons in Washington contributed to this story.