FDA Objects to 19-Year Delay in Release of Implant Study : Health: Dow Corning failed to tell agency of research into adverse effect on mice of compound in silicone gel.
The head of the federal Food and Drug Administration on Thursday expressed serious concerns about Dow Corning Corp.’s 19-year-delay in disclosing a study indicating that a component of the silicone gel in breast implants harmed the immune system of mice.
“The agency has significant concerns both about the findings and the manner in which they became available to us,” FDA Commissioner David Kessler said.
The FDA first obtained the study last week from lawyers representing women suing Dow Corning and other companies, alleging that they were injured by silicone gel breast implants.
“The report seems to suggest that one of the compounds that is present in breast implants and that we were concerned about does have adverse impacts,” Kessler said in a statement.
FDA spokesman James O’Hara said Kessler was referring to the fact that Dow failed to provide the study during 1991 and 1992 FDA hearings on implant safety. At those hearings, O’Hara said, “there was considerable discussion about the significance” of the material Dow studied in 1975.
Robert LeVier, Dow Corning’s director of bioscience research, one of the co-authors of the 1975 study, participated in the FDA hearings in 1991. At the time of the hearings, LeVier said that the company had not seen any “immunologic events” from the material, which is called D4.
LeVier made a brief reference to the 1975 study in a March, 1993, letter to the FDA, a year after the agency had restricted the use of implants. But the company did not provide the study at the time, according to FDA officials.
The controversy over the new study arose as thousands of women around the country are trying to decide whether to join a pending $3.75-billion settlement of implant cases that could bring individual women awards ranging from $105,000 to $1.4 million.
Gary Anderson, Dow Corning executive vice president, contended that the study revealed no significant hazard and had not been disclosed because of that. He also expressed concern that publicity about the study might cause women to opt out of the settlement, believing that they could fare better in court because their lawyers could argue that Dow suppressed evidence of safety hazards.
Several plaintiffs’ lawyers said they did not think the 1975 study alone would prompt a woman to choose not to join the settlement. “I think very few decisions will be made on the basis of this study,” said Ernie Hornsby, a Dothan, Ala., lawyer who represents several hundred women in implant cases. However, Hornsby and other attorneys said the study could be quite useful to a woman who decided to take her case to court because it might help her win punitive damages.
The attorneys who gave the study to the FDA said they found it last month while reviewing millions of documents turned over to them by court order last May.
“The overall significance of the study” is that it belies contentions “by the implant manufacturers, primarily Dow, that there is no immune response elicited by a silicone gel breast implant,” Hornsby said. “This study shows there was an immune response and they were aware of it in 1975. The D4 material in the implant had a suppressive effect on the immune system of the mice. While the study is not conclusive, it put Dow on notice” of possible dangers, Hornsby said.
“I think the study is shocking,” said Frederic L. Ellis, a Boston lawyer who represents numerous women suing Dow and who came upon the study last month. “It’s unconscionable that Dow knew this material, called D4, could stimulate the immune system and they didn’t tell the FDA, plastic surgeons or the women, and they kept implants on the market.”
But Anderson, Dow’s executive vice president, said the plaintiffs’ lawyers had mischaracterized the significance of the study.
“Had we seen a negative health effect . . . we would have submitted the report to the FDA and probably have withdrawn the product from the market,” Anderson said. “The results indicated there was no need to be concerned, so we didn’t submit the report.”
Barbara S. Carmichael, Dow’s chief spokeswoman, offered a more detailed explanation.
“When this material was tested in its pure form at an extremely high dose level, it showed no effect on the immune system of mice,” Carmichael said. She said that only when the D4 material was mixed with a foreign substance that does not appear in implants did it show “a marginal and short-lived (48-hour) effect on the immune system of the mice.”
Ellis said that plaintiffs also had discovered references to other Dow studies dating to 1971 during the discovery process and that the company had failed to turn over these documents.
This week, Ellis and other plaintiffs lawyers filed papers with U.S. District Judge Sam C. Pointer Jr. in Birmingham, Ala., who is presiding over 6,000 implant lawsuits, requesting that he compel Dow to turn over the other studies. Ellis said he believed the judge would rule on the motion this month.
There has been considerable debate in the scientific community on whether breast implants have a negative impact on the immune system or cause other medical problems, such as tissue problems, aching joints and short-term memory loss.
On Thursday, at least two knowledgeable researchers differed on the study’s significance.
“The results from the 1975 study seriously challenge statements that silicone is inert,” said Dr. Nir Kossovsky, associate professor of pathology at UCLA, who has done considerable research on women with implants and testified for plaintiffs in implant lawsuits. That is significant because women contend they have been injured by silicone leaking out of the implant pouch and migrating throughout their systems.
Kossovsky also said the study shows that silicone can account for numerous symptoms described by implant recipients, including fevers, joint aches, chills and general malaise.
On the other hand, John Naim, an immunologist at Rochester, N.Y., General Hospital, said he concurred with Dow’s position on the study. “At the time, from their point of view, it was not relevant.”
Meanwhile, negotiations continued between 3M and other breast implant manufacturers who thus far have not joined the settlement. If 3M and the other companies join the settlement, it could add up to $1 billion to the fund.
