Silicone breast implant litigation has become a legal Hydra, with two heads replacing every one that is cut off. The scientific evidence is overwhelming: implants do not cause disease. Yet, the trial bar persists in squeezing damages from a largely bankrupt industry, and now threatens to twist scientific research to advance its case.
Silicone breast implants have been accused of causing a number of different diseases. Yet, reported the Institute of Medicine after a comprehensive review: "There is no evidence that silicone implants are responsible for any major diseases of the whole body." An expert panel appointed by U.S. District Court Judge Samuel Pointer, who is coordinating numerous implant suits, reached a similar conclusion last December.
Earlier in 1998, two foreign panels, the European Committee on Quality Assurance and Medical Devices in Plastic Surgery and the Independent Review Group from Great Britain, issued comparable reports.
Said the Committee: "There is no scientific evidence that such things as silicone allergy, silicone intoxication, a typical disease or a 'new silicone disease' exist."
Over the years, a score of peer-reviewed studies from such leading institutions as Harvard University, Johns Hopkins University and the Mayo Clinic have found no, or only a negligible, connection.
Unfortunately, the fact that their evidence is what the Institute of Medicine last June called "insufficient or flawed" hasn't stopped lawyers from winning enough big judgments and settlements to ruin the industry.
Some implant critics also charge that the product ruptures frequently, harming their recipients. Yet, observes Dr. Marcia Angell, executive editor of the New England Journal of Medicine,
"the consensus among physicians puts the rate at 4 percent to 6 percent."
Similarly, the Institute of Medicine concluded in June that "the chances are great that most women will outlast their implants."
Nevertheless, Dr. Lori Brown, a researcher at the Food and Drug Administration, is said to have conducted a study showing a higher rupture rate. The possibility naturally excites a trial bar placed on the defensive by the steady stream of adverse scientific findings.
Obviously, there is always a chance that new research will overturn past findings. But Brown's study apparently has been undermined by significant design flaws.
For instance, outside experts say her definition of "rupture," ranging from pinhole leaks to major tears, is too broad. Brown has admitted using a definition different from that employed by the College of American Pathologists.
The research combines MRI tests of women with implants and examination of medical records of women who had their implants removed.
Unfortunately, the study reportedly does not adequately distinguish between implants that rupture in the body and those that rupture during removal.
The participants were not representative, being drawn from just two surgical practices in Birmingham, Ala., which hosts massive, multi-district federal implant litigation that has been subject to heavy local press coverage. The response rate of those contacted was low, with no evaluation of those who failed to participate.
Even worse, Brown apparently relied on subjects provided by plaintiffs' attorneys and medical records developed by doctors who had testified as plaintiffs' experts. Such a biased selection process is almost certain to lead to biased results.
Moreover, Brown enlisted Dr. Michael Middleton to read the MRIs of women who still have their implants in place. Middleton has regularly assisted plaintiffs' attorneys. He claims to distinguish silicone fluid and gel when no one else can through use of a testing protocol followed by no other radiologist.
This same Dr. Middleton trained the MRI technician who performed the scans on study subjects.
Finally, Brown's project is part a larger National Cancer Institute study that has raised serious questions of bias. Research head Dr. Louise Brinton has worked with trial lawyers and breast implant "advocates," who assume that implants cause disease, to develop the study and find participants.
She sounds like a partisan, having referred to "silicone victims" and "breast implant victims" in internal National Institutes of Health documents and agreed to consult with a San Francisco trial attorney in 1995. She also sought to use the database from a class-action lawsuit, before being rebuffed by an NIH institutional review board.
Of the Brinton study, warns Institute of Medicine President Kenneth Shine, recruiting materials may have "encouraged women with symptoms and problems to enroll." Since the participants of Brown's study were selected from those who participated in Brinton's research, any bias in the latter would filter down to the former.
The trial bar has long subverted the legal process to enrich their clients and themselves in the name of justice. It is important not to allow liability lawyers to subvert government research in the name of science.