Implant Firm’s Memos Linked to Full FDA Ban
Until two days before he called for a temporary halt to the use of silicone gel breast implants, Food and Drug Administration Commissioner David A. Kessler was planning to allow certain exceptions, including breast cancer patients seeking reconstruction after mastectomies, according to knowledgeable sources.
But he changed his mind after reviewing hundreds of internal documents from Dow Corning Wright, the leading manufacturer of the controversial devices, the sources said.
“He was headed toward some limited availability” for several different categories of women, sources said. These would have included--in addition to breast cancer patients--women seeking a replacement for a ruptured implant, burn and trauma patients and those suffering from congenital abnormalities, such as the absence of a breast, sources said.
But the FDA chief experienced real concern after “seeing the whole picture” portrayed in the memos, said the sources, who requested anonymity.
He was so disturbed “that he just said: ‘timeout.’ ” for everyone, the sources said.
The moratorium on the sales and the use of the devices was announced Jan. 6.
“The ban may not necessarily be permanent and these exceptions may come back,” the sources added. “He certainly is very sympathetic to the breast cancer patients and believes that, for mastectomy patients, this option should be part of the treatment. But when he saw that, despite all of the concerns (expressed in the memos), they (the company) went ahead and implanted them in women, he just said: ‘timeout.’ ”
Kessler refused to comment and said it is unlikely that he will publicly discuss any aspect of the controversy until a special FDA advisory committee has evaluated these and other documents related to the issue. The panel is expected to meet within the next six weeks. A final decision from the agency on the future of the implants is expected after the panel makes its recommendation.
Kessler also has refused to make public any of the documents, despite repeated requests from Dow and from plastic surgeons, saying that the papers are subject to a protective order issued by a federal judge in San Francisco. Most are associated with a lawsuit that recently resulted in a $7.3-million judgment against the company.
Dow officials have insisted that the devices are safe and have characterized the memos as “a printed record of one side of a two-way conversation.” Bob Grupp, a company spokesman said Thursday that “we’re very disappointed that the FDA won’t refocus this whole discussion on science. If the commissioner is so focused--or so persuaded--by some 10- to 20-year-old internal correspondence, that only goes to show the sad state of the process.”
Sharon Green, executive director of Y-ME?, a national information and support network for breast cancer patients, said Thursday that it is “unfortunate that women are held hostage based on memoranda.”
“Is this science or is this business judgments within a company?” she asked. “I happen to know someone who runs an independent testing lab who says that memos are exchanged all the time that show a difference of opinion. If he (Kessler) has science that proves these devices are unusually dangerous, then let’s have it. The delay has been emotionally draining on women--and compromises their ability to make a free choice.”
But Rep. Ted Weiss (D-N.Y.), chairman of a House subcommittee that has been investigating the safety of breast implants for more than a year, said Thursday that he agrees with Kessler’s decision. “The FDA would not be doing breast cancer patients any favor by continuing to expose them to a product when serious doubts have been raised about it’s safety,” he said.
The memos, which were made available to The Times, depict a company under intense self-imposed pressure to meet a marketing deadline for a new line of implants--despite doubts expressed by their own scientists about the devices’ safety.
In fact, every weekly memo of Dow’s “mammary task force” conveys the company’s sense of urgency up front: Each begins with a countdown listing the number of weeks, days, hours--and even minutes--remaining until the product must be on the market.
“17 weeks, 121 days, 2,904 hours, 174,240 minutes” reads the beginning of a Jan. 31, 1975, memo of the minutes of the second meeting of the task force. The timing refers to a June 1 target date for introducing its new Silastic implant with “flo-gel”--at the time a new, thinner formulation of silicone gel that was supposed to feel more like the tissue of a natural breast.
During that period--and even years later--memos written by various company officials raised concerns numerous times about the health and safety consequences of gel “bleed,” or leakage of silicone from the implant and the lack of research to assure their safety.
On June 6, 1976, for example--months after the new line of devices already had been implanted into women--Arthur H. Rathjen, a senior clinical research specialist and chairman of the task force, wrote in a memo: “I have proposed again and again that we must begin an in-depth study of our gel, envelope and bleed phenomenon. . . . Time is going to run out for us if we don’t get under way.”
As late as 1983, company official William Boley warned in a Sept. 15 memo: “. . . we have no valid long-term implant data to substantiate the safety of gels for long-term implant use.”
Numerous women have claimed that silicone leaking from the implants was responsible for the development of autoimmune diseases, such as arthritis, lupus and other conditions. There are currently several hundred lawsuits pending against the company.
Even sales officials were aware of the bleed problem. In a May 12, 1975, memo, officials complained that the surface of the implants “became oily” during trade shows promoting the product and “were bleeding on the velvet in the showcase.”
A memo several days later proposed “a range of solutions” from “reformulating the gel to eliminating salesmen’s abuse of the product during demonstrations.” The salesmen were advised in another memo to periodically wash off the implants in the nearest restroom and dry them with a hand towel.
