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 controversy.
"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 implant 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' 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.