Hindsight bias, Daubert, and the silicone breast implant litigation: Making the case for court-appointed experts in complex medical and scientific litigation.

Empirical research indicates that knowledge of the outcome in a given case influences juror deliberations. This bias is compounded when the jury must evaluate complex scientific evidence. Because jurors typically lack the background necessary to evaluate such evidence, they often use hindsight as a "cognitive shortcut." "Junk science" can exacerbate this tendency by offering a "scientific" link between the injury and the product. Daubert v. Merrell Dow Pharmaceuticals, Inc. (1993), properly applied, can defuse junk science testimony and mitigate its distorting effect on legal outcomes. The authors argue that judges carrying out Daubert's prerogatives should, where feasible, appoint independent experts and science panels to educate themselves and the jury, and thereby improve the likelihood that legal decisions will be based on sound scientific understanding. (PsycINFO Database Record (c) 2010 APA, all rights reserved)     

Silicone breast implant litigation (Part 1)

Silicone breast implant litigation has escalated in the past couple of years with the Food and Drug Administration (FDA) investigation of silicone gel implants which resulted in finally removing the silicone gel implants from the market. Plaintiffs have linked various medical problems to the presence of silicone in the body. The FDA has stated that there is no medical evidence that silicone causes autoimmune disease. Silicone has never been shown to cause breast cancer. Breast implants can result in complications such as capsule contracture, gel bleed, implant rupture, calcifications around the implants, and possibly interference with mammography in the diagnosis of breast cancer. Plaintiffs have claimed that the implant manufacturers knew of the defects in the silicone shell implant covering, and covered up the facts. The product liability action has become a class action, and a proposed settlement has been made in terms of which implant recipients with any problems will be reimbursed. Furthermore, there will be coverage for future implant problems over the next 30 years. There will still be some litigation by those patients who have opted out of the settlement agreement.     

Meeting the challenge of the "junk science" defense in domestic violence litigation.

Attorneys increasingly challenge the admissibility of expert testimony in domestic violence litigation on the ground that it is "junk science." This article discusses the standards courts apply when determining whether to admit "novel" scientific theory and methodology. It is recommended that psychologists offering testimony that may be subjected to this kind of challenge, critically evaluate the foundation for their opinions in light of the admissibility standards being applied in the pertinent jurisdiction, and that they directly address with the attorneys offering them as witnesses how best to present that foundation to the trial judge in their mutual effort to meet and overcome the junk science challenge. (PsycINFO Database Record (c) 2010 APA, all rights reserved)     

Depression in elderly spouse pairs

Men, women, and children are subject to a number of disease conditions that have been documented over many centuries. Among the most recently described and the least understood of these conditions are autoimmune diseases. As we unfortunately have seen in recent years, the obscure nature of autoimmune disorders has allowed scientific distortion by individuals who stand to profit by claiming a cause-and-effect relationship among some types of autoimmune conditions and a number of medical products, resulting in a rapidly expanding use of "junk science" in our courtrooms. Attempts have been made recently to implicate a number of environmental factors in the development of autoimmune disorders, most notably silicone gel-filled breast implants. The controversies surrounding these alleged relationships have proved to be among the most contentious, costly, and dangerous events ever to occur in women's health care.     

Silicone breast implants and connective tissue disease: an overview

Silicone breast implants have been implicated in the possible pathogenesis of various connective tissue diseases. These findings have had a major impact not only on the medical and legal communities, but also on the community at large. In this communication, we review the history of the breast implant controversy, and examine the medical evidence regarding the possible link of silicone gel implants with connective tissue disorders such as scleroderma, rheumatoid arthritis, and lupus. Finally, we give a broad overview of the topic and offer some general suggestions regarding the care of patients who have silicone breast implants.     

Silicon analysis of breast and capsular tissue from patients with saline or silicone gel breast implants: II. Correlation with connective-tissue disease

The silicone breast implant controversy rages on. Recent work has demonstrated that normal or baseline breast tissue silicon levels in women who had had no prior exposure to any type of breast implant may be as high as 446 microg/gm of tissue. These data ranged from 4 to 446 microg/gm of tissue, with a median of 27.0 microg/gm of tissue. In addition, numerous other epidemiologic and rheumatologic studies have demonstrated no association between silicone breast implants and any connective-tissue diseases. Despite these reports, the use of silicone implants remains restricted. The present study measured breast and capsular tissue silicon levels from 23 breasts in 14 patients with saline implants, and from 42 breasts in 29 patients with silicone implants. No patient in the saline implant group presented with signs or symptoms of connective-tissue disease. Patients with silicone implants, however, were divided into three groups based on the presence or absence of signs or symptoms of connective-tissue disease: group I, no symptoms or signs; group II, + symptoms, no signs; and group III, + symptoms, + signs. Six patients in group III were diagnosed with a specific connective-tissue disease, including systemic lupus erythematosus, rheumatoid arthritis, or scleroderma. The most common indications for implant removal or exchange were capsular contracture and implant rupture, although 41 percent of patients with silicone implants expressed media-related concern over the implant issue. The most common symptoms described by patients in groups II and III were joint pain and stiffness, arm pain and numbness, and fatigue. In all groups, capsular tissue silicon levels were significantly greater than breast tissue levels. This finding may indicate that the capsule serves as a barrier to the distribution of silicone from the implant into adjacent breast tissue. Although breast tissue silicon levels in patients with silicone implants were not significantly greater than those in patients with saline implants (p = 0.48), capsular tissue levels in patients with silicone implants were, indeed, significantly greater than those in patients with saline implants (p < 0.001). However, no statistically significant differences in tissue silicon levels were observed with relation to the presence or absence of connective-tissue disease signs or symptoms in patients with silicone implants (groups I to III). Therefore, these data strengthen the conclusion that there is no association between tissue silicon levels and connective-tissue disease.     

Controversy over the silicone gel breast implant: current status and clinical implications

The silicone gel breast implant controversy has generated much confusion, making informed decision making for physicians and patients increasingly difficult. In order to better understand the controversy, we review the steps taken by the Food and Drug Administration and the resultant status of breast implants. The currently available scientific data are summarized with regard to cancer development and detection, implant rupture and gel migration, and autoimmune disorders. By reviewing the presently available information on silicone gel breast implants, we can better address the concerns of our patients.     

Rupture of silicone-gel breast implants: causes, sequelae, and diagnosis

Silicone-gel-filled breast implants have been widely used for breast augmentation and reconstruction after mastectomy. The rate of implant rupture and its sequelae are not known. We review the frequency, causes, sequelae, and detection of implant rupture. Materials testing of removed implants provides evidence that as implants age in vivo, they weaken and may rupture. Sequelae of rupture include migration of gel accompanied by inflammation and silicone granuloma formation. The role of free silicone gel in relation to idiopathic or atypical connective tissue disease is not clear. Magnetic resonance imaging is substantially more sensitive in the detection of rupture than is mammography or ultrasonography.     

Breast cancer risk among women using silicone gel breast implants

Since their introduction in 1962, silicone gel-filled breast implants have been used by an estimated one to two million women. Questions concerning an increased cancer risk to these women have been raised. A review of the medical literature, including case reports, case series, physician surveys, case-control studies, and cohort studies, failed to turn up any evidence which associated the use of silicone breast implants with either an increased risk of breast cancer or an increased risk of a more advanced stage of cancer at the time of cancer diagnosis. The available data do not indicate any significant difference between the characteristics of the breast cancers of women with breast implants and those of women in control populations.     

Children, psychiatrists and the courts: understanding the ambivalence of the legal profession. Part 1--General principles

Psychiatrists and other mental health professionals are frequently involved as expert witnesses in court proceedings related to children and adolescents. Their testimony may be based on a therapeutic relationship, but frequently arises because of an assessment conducted specifically for the court process. This two part paper discusses some of the issues that arise when child psychiatrists are involved as expert witnesses in litigation, with specific focus on their role in child custody, sexual abuse and young offender cases. It also offers some practical advice for those who may be called as witnesses. There is controversy in the legal profession about the role of mental health professionals in the court process. While there is recognition of their expertise, there is also a concern about not wanting to have experts usurp the role of the courts. Legal professionals also question the "objectivity" of experts, and the reliability of their opinions. Frequently the opinions of psychiatrists about children and adolescents involved in litigation have inherently speculative and value based dimensions, and not "scientific". Participation in the court process by mental health experts is nevertheless a vitally important role, providing information, analysis and recommendations about what are often very difficult societal decisions. Part two of this paper starts on page 531.     

Breast prostheses and their complications

In the past few years silicone breast implants have been a highly charged and controversial topic for psychologic, health and politico-legal reasons for patients and for surgical, medical and research concern for professionals. Both sides are interested in knowing about the complications encountered with these implants on one hand and to find the ideal device needed for mammary reconstruction on the other. Indeed silicone does not fulfill the characteristics initially expected for a synthetic soft-tissue substitute. The local cellular response leads to the formation of a capsule around the implant with frequently unsatisfying cosmetic results. The well described leakage occurring through the silicone envelope allows the silicone gel to diffuse to multiple anatomic areas in the body. Scientific works demonstrated that silicone gel acts as a potent immunologic adjuvant and can induce antibodies to silicone surface-associated antigens. Breast implanted women who present with systemic clinical symptoms can be included either in the group of well defined connective tissue diseases or in the atypical connective tissue disease-like syndrome. The largest epidemiologic studies have shown reassuring evidence against large hazards but have documented a low but statistically significant risk of connective-tissue diseases in women with silicone gel filled implants. Practitioners must manage these patients with the awareness that reliable objective tests to identify the useful problem are not yet available.     

Silicone breast implants: immunotoxic and epidemiologic issues

Silicone gel implants for breast augmentation and reconstruction have been in use since 1962. Significant local complications include capsular contracture, rupture, gel "bleed", and spread of the implant material to regional lymph nodes (1-7) as well as histologic findings of foreign body granulomas in the capsular tissue and in lymph nodes (7-9). Through magnetic resonance spectroscopy and atomic emission spectroscopy, silicon compounds were found in the blood of some women with silicone breast implants; silicone and silica have also been found in liver (10). Well-publicized case reports have raised significant concerns regarding an association between implants and systemic disease. However, despite the availability of silicone implants for over 30 years, controlled epidemiological studies were not carried out until 1992. Currently available epidemiologic data are extremely limited. In part, because the majority of implants were used after 1981, the incidence of long-term problems is not yet known. In 1992, due to the unavailability of studies demonstrating the safety of implants, the U.S. Food and Drug Administration advised that silicone breast implants should be used only in reconstructive surgery and as part of clinical trials (11). This decision spurred a wave of research on the bioreactivity of silicone and clinical observations of patients with implants. Herein, we review the adverse immune effects following contact with silicone as well as the epidemiologic data available.     

Silicone breast implants: an oncologic perspective

In 1992, the FDA decided that silicone gel-filled breast implants would be available only through controlled clinical studies, despite the fact that they had been used for mammoplasty in millions of women around the world for more than 30 years. The safety of silicone breast implants had been called into question after several reports of a possible association between the implants and the subsequent development of connective tissue diseases. Such reports led to general public concern fueled by popular media attention and multiple class-action lawsuits against the product's manufacturers. It was in this climate that the FDA was forced to make its decision. This article reviews current scientific evidence on the safety of silicone gel-filled breast implants. Issues pertinent to oncology are highlighted. These include the possible carcinogenic effect of silicone gel, the safety of irradiating breasts with silicone implants, and the ability to mammographically image the implanted breast.     

Distribution of organosilicon polymers in augmentation mammaplasties at autopsy

Silicone-containing breast implants have been used since 1963 for cosmetic augmentation and breast reconstruction. Currently, there is intense debate regarding the extent and mechanism of migration of silicone from the area of implant. The current study compares tissue distribution of organosilicon polymers between women with and without silicone breast implants to determine the extent of silicone migration from breast implants. Samples were collected at autopsy from 15 individuals with bilateral breast implants with no known history of chest trauma and from 14 age- and sex-matched controls. Capsule, breast, axillary lymph nodes, abdominal fat, liver, lung, and spleen were collected for analysis of organosilicon polymers by atomic absorption spectrometry and for examination by light microscopy. Blood was collected for analysis of rheumatoid factor and antinuclear antibodies. Silicone was observed microscopically in at least one capsule section from all implant cases and in at least one lymph node in 8 of 15 implant cases. Silicone was not observed in lymph nodes from control cases. Organosilicon polymers were extracted from tissue using heptane, and the silicon content of the extract was quantitated by atomic absorption spectrometry. Silicon was detected in all capsules; statistically significant increases of organosilicon polymers were measured in axillary lymph nodes, breast, and abdominal fat from individuals with silicone breast implants when compared with the nonimplant group. Measurable amounts of organosilicon polymers were found in tissues from the nonimplant group. Suitable blood specimens were analyzed for the presence of rheumatoid factor and antinuclear antibodies. All nine implant cases tested were negative for the presence of antinuclear antibodies. Three implant cases which were tested for rheumatoid factor also were negative. We conclude that organosilicon polymers routinely migrate from the site of breast implantation to regional tissues near the implant site. Tissues from nonimplant cases often contained measurable amounts of organosilicon polymers, and tissue distribution was variable within any single individual: this is consistent with the wide-spread use and form of organosilicon polymers.     

Breast implants and their history

The controversy concerning breast implants has led to a profound change in our surgical practice. Four years after the moratorium suspending the use of silicone implants, the situation still remains confused. Polyurethane implants, incriminated as being dangerous at the start of the anti-implant campaign, were cleared by the FDA in 1995, but have not been re-released onto the market. Silicone implants, the subject of a great many international studies on carcinogenicity and immunological risks which failed to confirm these risks, are now being used again throughout the world except in the USA, Canada and France. Hydrogel implants, victims of the bad reputation of the other implants, were suspended for dubious insurance reasons concerning the French Huriet law, although they satisfy the clinical and laboratory criteria required for breast implants. Only normal saline implants are currently used in France, although their safety is only relative, as the reoperation rate for deflation is not negligible. In our opinion, the Cronin type of bladder implant is obsolete and the new available technologies must be used, although they raise an economic problem following the overpublicized silicone implant catastrophe.     

Ruptured or intact: what can linear echoes within silicone breast implants tell us?

OBJECTIVE: During sonographic evaluation of silicone breast implants for possible rupture, we have frequently encountered several patterns of linear echoes within the implants. To our knowledge, the significance of this finding has not been established in the literature. The purpose of this study was to determine whether internal echoes are significant in predicting implant rupture. SUBJECTS AND METHODS: Thirty-three patients with 64 silicone implants were prospectively entered into a study that included gray-scale sonography of the implants and subsequent surgical removal. Echo patterns within the implants were retrospectively evaluated on hard-copy films and compared with the integrity of the implant at surgery. RESULTS: Three categories of internal echo patterns were identified: "thick linear echoes." "thin linear echoes," and "commas." One or more of these echo patterns were seen in 57 (89%) of the 64 implants. Thick linear echoes were seen in 23 (36%) of the 64 implants, thin linear echoes were seen in 33 (52%) of the 64 implants, and commas were seen in 47 (73%) of the 64 implants. All echo patterns were seen in intact and ruptured implants with nearly equal frequency. We found no statistical significance for any echo pattern in predicting whether an implant was ruptured or intact. Of the 64 implants, four were entirely free of internal echoes. All four implants were intact. CONCLUSION: A variety of linear echoes can be seen in most silicone breast implants on gray-scale sonography. The presence or absence of linear echoes is not useful in predicting implant rupture. Complete absence of internal echoes, while highly predictive of an intact implant, is infrequently seen.     

Capillary electrophoresis in court: the landmark decision of the People of Tennessee versus Ware

Capillary electrophoresis is a versatile and emerging technique. In the fields of law and science, history has been made with the admissibility of CE as a method to evaluate evidence. The extremely low sample requirements, high separation efficiencies, and excellent resolution allow for quantitative techniques from extracted and amplified mitochondrial DNA (mtDNA), which was presented as evidence from hair shafts in the case of The People of Tennessee versus Paul Ware (Tennessee v. Ware). This paper discusses the history of the admissibility of scientific evidence. In 1993, the United States Supreme Court Justices rewrote the rules for admission of scientific evidence under the Federal Rules of Evidence (FRE) in Daubert v. Merrell Dow Pharmaceuticals, Inc. (Daubert) (509 U.S. 597). After rejecting the longstanding requirements under Frye v. United States (Frye), 293 F.1013 (1923), which focused on the conclusions obtained rather than the methodologies employed, Daubert went further in establishing a liberal policy in the FRE favoring the District Court judges to act as gatekeepers, thus admitting well-grounded scientific evidence. Later this year, the Supreme Court will once again review the issue of how the decisions reached in trial courts should be treated by reviewing courts. CE has demonstrated its ability to meet the requisite scientific standards in the court system. The CE evidence presented in Ware led to a felony conviction.     

Breast implants and risk of neurologic disease: a population-based cohort study in Sweden

OBJECTIVE: To examine the risk of neurologic disorders among women with breast implants. BACKGROUND: Case reports in the literature have raised concern about a possible link between silicone breast implants and some types of neurologic disorders, but there is a dearth of epidemiologic studies in this area. METHODS: Through the nationwide Swedish hospital discharge register, we identified a population-based cohort of 7433 women with breast implants. A similarly identified cohort of 3351 women who underwent breast reduction surgery served as a comparison. The women were followed from 1972 (or date of breast surgery if it occurred later) through 1993 by means of record linkages and review of inpatient medical records. Ratios of observed to expected numbers, and relative risks (RR) with 95% confidence intervals (CI), were calculated as measures of the risk of neurologic diseases among women with implants. RESULTS: A direct comparison of the exposed (implant) versus comparison (breast reduction) groups, after exclusion of patients with pre-existing disease or incorrect neurologic diagnoses, showed no excess risk among implant patients (RR = 0.8; 95% CI = 0.5 to 1.4). When external rates derived from the background population were used as comparison, we found a small, statistically nonsignificant excess of neurologic disorders both in the breast implant (RR = 1.3; 95% CI = 0.9 to 1.9) and the breast reduction (RR = 1.5; 95% CI = 0.9 to 2.4) cohorts. CONCLUSION: Our results provide no support for the conjecture that breast implants cause neurologic disease.     

Silicone breast prosthesis and rheumatoid arthritis: a new systemic disease: siliconosis. A case report and a critical review of the literature

Today the number of women receiving breast implants of silicone gel, for augmentation or reconstruction of the breast, is increasing. Silicon implants may cause local complications (such as capsular contracture, rupture, closed capsulotomy, gel "bleed", nodular foreign body granulomas in the capsular tissue and lymph nodes) or general symptoms. An adverse immune reaction with signs and symptoms of rheumatoid disorders is also possible, although an increased frequency of true autoimmune systemic connective tissue diseases is controversial. The US Food and Drug Administration advised that these silicone implants should be used only in reconstructive surgery and as part of clinical trials. Silicone is not an inert substance and silicone compounds were found in the blood and liver of women with silicone breast implants. The development of disease related to silicone implants would depend on genetic factors, so that only a very few women are potentially at risk. HLA-DR53 may be a marker of predisposed subjects. Breast-feeding by women with silicone implants should not be recommended for possible autoimmune disorders in the children. We report the case of an adult female patient with silicone breast implantation for bilateral mastectomy (performed 12 months before) and a unique syndrome characterized by low-grade fever, chronic fatigue, arthralgias of the hands, dysphagia, dry eye, increased level of rheumatoid factor and decreased value of complement C3 and C4. No increased erythrocyte sedimentation rate occurred, and no ANA, nDNA, ENA and AAT autoantibodies were evidence. A critical review of literature (source: MEDLINE 1980-1997) was performed and our case seems to be the first one reported in Italy. The internist should become familiar with the immunological disorders related to silicone breast implants, often so marked to require the explantation of the prostheses to improve symptomatology. However, perhaps due to the leak and spreading of silicone, the progression to a severe systemic involvement may remain despite the implant removal.     

Breast capsule persistence after breast implant removal

Breast implant capsules are a foreign body immune response to breast implants. It has been proposed that capsulectomy after breast implant removal was unnecessary, as the body resorbs the capsule when the implant, the impetus for the foreign body response, is removed. We report eight women with persistent capsules 10 months to 17 years after silicone breast implant removal.