Roanoke Times
Copyright (c) 1995, Landmark Communications, Inc.
DATE: TUESDAY, February 11, 1992 TAG: 9202110261
SECTION: NATIONAL/INTERNATIONAL PAGE: A1 EDITION: METRO
SOURCE: From The Associated Press and the Los Angeles Times
DATELINE: WASHINGTON LENGTH: Medium
IMPLANT CONCERNS REVEALED MAKER RELEASES MEMOS, REPLACES ITS CHAIRMAN
Dow Corning on Monday released hundreds of internal memos, letters and other documents revealing it had received complaints for decades that its silicone-gel breast implants had caused medical problems. Late in the day, the company said its chairman was stepping down.John S. Ludington was replaced and will become chairman emeritus of Dow Corning, according to an announcement at the company's headquarters in Michigan. The implant issue was cited as a reason for the change.
The company has repeatedly told doctors and the government that the implants are safe, and it reiterated that assurance on Monday. But the documents show concern within Dow Corning as well.
In one 1985 memo, Bill Boley, a company scientist, warned that more testing was needed to determine whether a particular formula of the silicone gel caused cancer. He wrote, "Without this testing, I think we have excessive personal and corporate liability exposure."
Boley's note is in a 4 1/2-pound book of internal documents the company released at the demand of the Food and Drug Administration, which is re-examining the safety of the implants. At the FDA's request last month the manufacturer and surgeons agreed not to use any more implants until the agency decides on their safety.
An FDA advisory committee is to consider the safety issue next week; the agency had demanded release of the documents to give the panel time to consider them.
People filing lawsuits, as well as consumer groups, have alleged that the breast implants can cause a host of medical problems, including cancer and damage to the immune system, if they break open and spill the silicone gel inside someone's body.
A quick examination of the documents does not show that the company's studies confirmed those allegations. But the papers do show a long history of complaints, leaky implants, production problems, and concern for public relations.
Some of the internal company memos released by Dow Corning raised new concerns over whether exercises routinely recommended to keep the devices supple actually may contribute to their rupture.
Patients who receive breast implants are instructed by their plastic surgeons to massage their breasts regularly to prevent capsular contracture, a hardening of the breast that results after scar tissue has formed around the device. But massage, some of the memos suggested, could cause some implants to break, leaking silicone gel into the surrounding tissues.
The new material about ruptures is connected to a Michigan case against Dow Corning Wright that has not yet gone to trial.