WASHINGTON -- Dow Corning Corp.'s chairman and chief executive has stepped down following the company's release of documents showing it knew of potential problems with its silicone gel breast implants as early as 1971.
The Food and Drug Administration said its January call for a moratorium on implant use was based in part on information contained in these studies and internal memos from one of the leading makers of the devices.
Dow Corning, headquartered in Midland, Mich., announced Monday its board had named Keith R. McKennon to replace John S. Ludington as chairman and chief executive. McKennon, a former executive vice president of Dow Chemical, has been on the board of Dow Corning since 1987.
The board also elected Lawrence A. Reed, who is president, to the additional post of chief operating officer to oversee the silicone breast implant controvery.
'It is clear to the board, the company must focus full-time top executive attention to both the complex issues related to silicone breast implants as well as the ongoing operations of the company,' Ludington said in a statement. He will continue as a director and become chairman emeritus.
The papers released by Dow Corning before the management shakeup was revealed included reports from physicians of leakage or other complications involving different versions of silicone gel-filled implants.
One memo nearly 21 years ago said a New Orleans plastic surgeon removed an imlant from a woman who suffered repeated breast irritation. The surgeon found the implant 'partially empty of gel and what gel was there was extremely fluid and oozed out of the prosthesis and the surrounding tissue.'
A March 2, 1978, memo titled 'Excessive Mammary Ruptures' came from Frank Lewis, a company representative from Detroit. 'I have experienced what I consider to be an excessive number of ruptures in my area over the past six months,' Lewis's memo said.
It also referred to a December 1977 memo 'pertaining to the same problem.'
An April 20, 1983, internal memo suggested rejecting a particular lot of implants as 'unsuitable for sale.'
'Gel fell en masse from the envelopes, a condition which has not been previously noted,' the memo said. 'On the basis of the risk which would be posed to a patient having one of these units implanted, prudence requires their rejection,' the memo said.
'It is prudent at this point to make a more detailed study of internal mammary gel, its chemical and physical characterizations and parameters affecting its performance,' it said.
At a news conference, Robert Rylee, chairman of health related business for Dow Corning, said the overall rupture rate was low. 'There's never been more than 0.5 percent reported post-operative ruptures. The cumulative total to date does not exceed 0.5 percent,' he said.
Rylee also denied the company had tried to keep the documents from public scrutiny but said he was concerned they would be judged out of context.
'Typically we would prefer not to have put those memos out in the public domain because they do raise the kinds of questions that are non- scientific and you know, they need to be put in perspective,' he said.
The company said it supports continued study of the implants but added that until such studies indicate otherwise, 'Dow Corning, along with many practitioners and surgeons within the medical community -- assured by the clinical evidence gathered during decades of use -- support the continued use of silicones in breast implants.'
Hundreds of pages of documents, including scientific studies and internal correspondence, were released by the implant maker under pressure from the FDA, which wanted to provide the information they contained to doctors, patients and other governments.
An FDA advisory panel in November determined that studies to date failed to prove silicone gel-filled implants were safe. However, the panel recommended that the products continue to be available while further studies were conducted.
The panel criticized Dow and other implant makers for having failed to conduct long-term studies of the devices to determine the consequences of leakage or other adverse reactions.
A physician's group, the American Society for Aesthetic Plastic Surgery, said the documents from Dow should be viewed carefully.
'There is a real danger that statements from these documents will be taken out of context by the media and their meaning or scientific implications misinterpreted. The scientific issues involved are extremely complex,' said Dr. Edward Truppman, the group's president.
