Safety Of Silicone Breast Implants Research Articles

Optimizing Aesthetic Outcomes after Retroglandular Breast Implant Explantation.

The safety of silicone breast implants has been questioned due to concerns such as the risk of associated lymphoma, as well as rheumatological and systemic symptoms. This has resulted in an increased demand for explantation, posing the challenge of addressing stigmas related to implant removal. There is a dearth of literature on techniques for restoring breast contour postexplantation. After implant removal, the original breast anatomy is altered, and depressed areas may manifest in random locations. To reposition the breast tissue displaced by the implant, we enlarge the retroglandular pocket and subsequently use sutures for centripetal traction, relocating the tissue back to the footprint area but now in an improved position, delineating the breast contour. This maneuver enables us to restore the breast contour to an anatomical condition akin to preimplantation; diminish the final explantation defect, creating a more suitable pocket for delicate mastopexy flaps; recruit breast tissue, allowing internal sutures to conceal tissue irregularities; and redesign the breast contour area on the chest to achieve better symmetry.

Breast Implant Illness Through a Psychiatric Lens.

Since their introduction in the 1960's, the safety of silicone breast implants has remained contentious due to concerns regarding carcinogenicity as well as a growing array of adverse psychiatric symptoms, which have now been termed 'Breast Implant Illness.' This article aims to explore the merits of a psychiatric approach to treating Breast Implant Illness by outlining how it is defined by psychiatric symptoms and categorized alongside other psychiatric illnesses. Furthermore, it is unclear whether the pathology of Breast Implant Illness is purely medical or psychiatric. However, the efficacy of the medical approach to treatment through a process called explantation, which involves removal of the implant and surrounding scar tissue, or capsule, is not strongly supported by existing data. A psychiatric approach to treatment, in conjunction with explanation, thus holds potential in remedying the novel and poorly understood Breast Implant Illness.Level of Evidence V This journal requires that authors assign a level of evidence to each article. For a full description of these Evidence-Based Medicine ratings, please refer to the Table of Contents or the online Instructions to Authors www.springer.com/00266 .

Progressive sensory ataxia and breast implant rupture, an uncommon presentation of a debated concept: a case report

BackgroundAutoimmune Syndrome Induced by Adjuvants (ASIA) is a concept introduced by Shoenfeld to group various disease entities believed to be triggered by an infection, silicone exposure or other external stimuli. A causal link between the use of silicone and the development of autoimmune diseases and lymphoma has been suggested in the past. Sjögren’s Syndrome (SS) is one of the autoimmune diseases that has been postulated as an example of ASIA syndrome. Although typically characterized by sicca, SS can manifest as a ganglionopathy as the primary presenting symptom. To our knowledge, this is the first case report in which a ganglionopathy unveiled an underlying SS in the context of a possible ASIA syndrome.Case presentationWe describe a case of a 44-year-old woman who developed rapidly progressive sensory loss in the 4 limbs with a walking impairment due to the severe sensory ataxia. After extensive work-up, she was diagnosed with a ganglionopathy as the first symptom of SS, and the concurrent diagnosis of a bilateral breast implant leakage with severe inflammation due to silicone bleeding. After surgical removal of the prostheses and initiation of immunosuppressive therapy, stabilization of symptoms was achieved.ConclusionThis case report brings to attention the possibility of a sensory ganglionopathy as first and isolated symptom of SS. The occurrence of SS in the setting of ASIA stir up the discussion about the safety of silicone breast implants.

Assessing Long-Term Outcomes in Breast Implant Illness: The Missing Link? A Systematic Review.

The purpose of this special topic article is to explore the current state of outcomes-based literature related to breast implant illness and summarize the key understandings that emerge from the summation of existing studies. While implanted silicone devices are some of the most ubiquitous products in modern medicine, the safety of silicone breast implants has long remained under scientific scrutiny. In the era of social media and with breast implants once again under public scrutiny with the recent connection of texture silicone implants to breast implant-associated anaplastic large-cell lymphoma, the borders between breast implant illness and other implant-related diseases are becoming clouded in the public eye. The surgical management options for breast implant illness range from simple implant explantation alone to complete en bloc capsulectomies, or even secondary exploratory operations for additional capsulectomy in persistently symptomatic patients. In this review of outcomes-based studies related to breast implant illness, the authors found that a subset of patients improves with surgical intervention but limited evidence to inform most current surgical management practices. Further, the nature of this illness renders it difficult to study. A carefully designed, large, prospective, outcomes-based study is still required if an evidence-based and sound treatment approach for this condition is to be established.

Self-Reported Health Complaints in Women Undergoing Explantation of Breast Implants.

BackgroundConcerns about the safety of silicone breast implants (SBIs) have existed for years, but a causal relation between systemic complaints and SBIs has not been proven. Nevertheless, some women are worried and even request explantation. ObjectivesThis study aimed to review the explantation procedures performed, focusing on patient-reported symptoms preoperatively, the effect of explantation, and the effect of breast reconstruction on these symptoms.MethodsA retrospective chart review was performed for patients who had undergone explantation between 2010 and 2020 at Maastricht University Medical Center. Patients who had undergone tissue expander removal, tissue expander–implant exchange, or direct implant exchange were excluded.ResultsMore than half of the patients undergoing explantation reported complaints, mostly pain. Some 15% reported systemic complaints they believed were implant related. Breast implant illness (BII) was found to be the fifth most common indication for explantation (11.2%). A history of either allergies or implant rupture resulted in higher odds ratios of having BII (odd ratios, 2.1 and 2.1, respectively). Subjective improvement of BII after explantation was reported by about 60% of patients. ConclusionsA relatively low prevalence of suggested BII exists among women undergoing explantation; 1 in 9 procedures were performed for this reason. Allergy and implant rupture may increase the likelihood of having BII. About 60% of BII patients experienced an improvement in their complaints after implant removal. Autologous breast reconstruction appears a good alternative. Prospective studies into health complaints and quality of life should be performed to confirm the effectiveness of explantation as a therapy for BII.Level of Evidence: 4

Controvérsia sobre a Doença do Implante de Silicone Mamário: Uma revisão sistemática sobre o tema


 
 
 
 Introdução: Atualmente, existem evidências esmagadoras para apoiar a segurança dos implantes mamários de silicone. A decisão obter, manter ou remover os implantes mamários é escolha da paciente. Se uma paciente optar por remover os implantes mamários, é importante encontrar um cirurgião plástico certificado pela Sociedade Brasileira de Cirurgia Plástica.
 Objetivos: O objetivo deste artigo é apresentar o estado atual das evidências científicas relacionadas à segurança dos implantes mamários de silicone. Os estudos em andamento são fortemente incentivados em todas as áreas, da detecção do câncer à doença auto-imune, cabendo ao profissional cirurgião plástico (a), o esforço necessário para melhorar a segurança, a conscientização e a educação do paciente.
 Metodologia: Foi pesquisado o termo “Silicone Implant Illness” nos portais de indexação Google Acadêmico, Scopus e Web of Sciences e foram selecionados 102 artigos com maior fator de impacto e citações.
 Conclusão: Até o presente momento, não existem estudos concretos ou baseados em evidências ou dados revisados ​​por pares sobre a formação de uma nova síndrome.
 
 
 
 

Silicone Implant Illness: Science versus Myth?

Summary: The purpose of this Special Topic article is to present the current state of scientific evidence related to the safety of silicone breast implants. There is presently overwhelming evidence to support the safety of silicone breast implants. Ultimately, the decision to obtain, keep, or remove breast implants is the choice of the patient. If a patient chooses to have her breast implants removed, it is important to find a board-certified plastic surgeon with expertise in breast surgery. Ongoing studies are strongly encouraged in all areas, from cancer detection to autoimmune disease, as we strive for improved patient safety, patient awareness, and patient education. To the best of our body of scientific knowledge to date, there have not been any concrete or evidence-based studies or peer-reviewed data concerning the formation of a new syndrome: “silicone implant illness.” Silicone breast implants are used in nearly 300,000 breast augmentation and 100,000 breast reconstruction operations annually in the United States. 1 Silicone gel–filled implants were first approved by the U.S. Food and Drug Administration in 1962. Since that time, few medical devices have been studied as closely for their safety and associated adverse outcomes. Despite multiple generations of implant shells and gel fillers, the basic components remain as originally designed. 2,3

US FDA Breast Implant Postapproval Studies: Long-term Outcomes in 99,993 Patients.

To analyze the long-term safety and efficacy outcomes of patients with breast implants. Research is ongoing regarding the safety of silicone breast implants. Despite the number of patients with breast implants followed by United States Food and Drug Administration large postapproval studies (LPAS), this database has not been thoroughly analyzed or reported. This is a multicentered, cohort study. LPAS prospectively monitor long-term implant-related outcomes and systemic harms for silicone/saline implants from 2 manufacturers (Allergan and Mentor) placed for primary/revision augmentation/reconstruction. Systemic harms, self-harm, and reproductive outcomes are compared with normative data. Implant-related complications are analyzed by implant composition and operative indication in the short and long terms. LPAS data includes 99,993 patients, 56% of implants were silicone for primary augmentation. Long-term magnetic resonance imaging surveillance is under 5%. Compared with normative data, silicone implants are associated with higher rates of Sjogren syndrome (Standardized incidence ratio [SIR]8.14), scleroderma (SIR 7.00), rheumatoid arthritis (SIR5.96), stillbirth (SIR4.50), and melanoma (SIR3.71). One case of BI-ALCL is reported. There is no association with suicide. In the short term, rupture is higher for saline (2.5% vs. 0.5%, P < 0.001), and capsular contracture higher for silicone (5.0% vs. 2.8%, P < 0.001). At 7 years, reoperation rate is 11.7% for primary augmentation, and 25% for primary/revision reconstruction. Capsular contracture (III/IV) occurs in 7.2% of primary augmentations, 12.7% primary reconstructions, and is the most common reason for reoperation among augmentations. This is the largest study of breast implant outcomes. Silicone implants are associated with an increased risk of certain rare harms; associations need to be further analyzed with patient-level data to provide conclusive evidence. Long-term safety and implant-related outcomes should inform patient and surgeon decision-making when selecting implants.

Biological Matrices and Synthetic Meshes Used in Implant-based Breast Reconstruction - a Review of Products Available in Germany.

While autologous breast reconstruction was considered the procedure of choice for immediate breast reconstruction, there has been a shift towards implant-based breast reconstruction (IBBR) in recent years. The proven safety of silicone breast implants and the development of biological matrices and synthetic meshes have contributed to the growing popularity of this approach. Although these different products are widely used, only limited clinical data are available with regard to breast surgery. The aim of this review was to give an overview of available biological matrices and synthetic meshes and discuss their use in clinical practice.

Silsesquioxane Nanocomposites as Tissue Implants

Sir: We read with interest and would like an opportunity to comment on the article by Kannan et al. entitled “Silsesquioxane Nanocomposites as Tissue Implants” (Plast. Reconstr. Surg. 119: 1653, 2007). The article describes the implantation of two test materials—one containing silsesquioxane nanocomposites and the other ostensibly a “siloxane control”—into sheep for 3 years. After explantation, the material with nanocomposites appeared significantly less degraded than did the “siloxane controls.” In the context of breast implants, the word “siloxane” usually refers to the material generally called silicone, which is often described with the chemical term polydimethylsiloxane.1 Unless one very carefully reads the details in the Polymer Synthesis section of the article and is somewhat familiar with urethane chemistry, one might come to the incorrect conclusion that the control material described in this article is a silicone, when in fact it is polyurethane that happens to have some integrated siloxane content. In fact, the chemical stability associated with silicones is so well established that siloxane has been formulated into other less stable biomaterials, such as polyurethanes, to enhance their biodurability.2 Attenuated total reflectance/Fourier transform infrared spectra are shown in Figure 5. The authors assign the peak at 1109 cm–1 to silicon monoxide structure in both the nanocage and the siloxane control, and attribute loss of intensity between the preimplantation and postimplantation spectra to degradation of this silicon monoxide structure. However, the intensity of the 1109 cm–1 band in the nanocage sample is abnormally intense for a component that is only 2 percent of the overall composition. Because this spectral area is a common location for absorbances associated with other oxygenated species, carbon monoxide being a common example, we feel that the data support assignment of the large 1109 cm–1 band in the nanocage sample to something other than silicon monoxide. We assume that the authors’ use of siloxane in referring to the control sample implies a polydimethylsiloxane type structure. The infrared spectrum of polydimethylsiloxane shows large absorbance bands with comparable intensities near 1260 cm–1, a doublet between 1100 and 1000 cm–1, and near 800 cm–1. The depicted spectra do not extend to 800 cm–1, but the expected band near 1260 cm–1 is not seen. This suggests that the band at 1109 cm–1 was misassigned in the siloxane control and that the spectral changes observed are not indicative of silicon monoxide degradation.3 Finally, we are also puzzled by the authors’ mention of “silicone-osis,” a controversial alleged disease not generally accepted by the medical community, and their reference to a study that in fact “did not confirm the existence of a new disease entity ‘silicone-osis’ uniquely and causally associated with silicone exposure.”4 Furthermore, this alleged disease was considered and dismissed in the most extensive independent review of the scientific evidence, the report on the safety of silicone breast implants from the prestigious Institute of Medicine. The Institute of Medicine report affirmed that “[T]here does not appear to be even suggestive evidence for the existence of a novel syndrome in women with breast implants. In fact, epidemiological evidence suggests that there is no novel syndrome.”5 James M. Curtis, M.E. Elmer D. Lipp, Ph.D. Dow Corning Corp. Midland, Mich. DISCLOSURE James M. Curtis and Elmer D. Lipp are employees of Dow Corning Corporation, a silicone material supplier to numerous industries including the life sciences.

A Review of Psychological Outcomes and Suicide in Aesthetic Breast Augmentation

Aesthetic surgery is an essential component of plastic surgery and has become increasingly popular in American society. In 2002, 1.8 million surgical cosmetic procedures were performed in the United States, representing a 294 percent increase from 1992. The 1992 U.S. Food and Drug Administration moratorium on silicone breast implants arose in response to numerous reports of connective tissue disease associated with silicone gel breast augmentation and has led to a decade-long battle over the safety of silicone breast implants that continues today. Numerous scientific and epidemiologic studies of the past decade have established that there is no association between silicone breast prostheses and systemic disease. Recently, a new front has opened in the conflict regarding the safety of breast augmentation: the psychological impact of breast augmentation. Quality studies assessing the psychological characteristics of breast augmentation patients and the psychological impact of breast augmentation surgery are few and most studies are flawed in their methods. Recent reports have provided corroborating evidence to support the psychological benefits of cosmetic surgery and breast augmentation. New reports citing an increased risk for suicide among women with breast implants have brought renewed concerns but are unable to demonstrate a cause-and-effect relationship between breast implants and suicide. The present challenge is to determine whether the increased risk reported in epidemiologic studies is falsely associated with breast implants or whether it represents underlying risk factors or psychopathology in women undergoing breast augmentation that puts them at increased risk for suicide. The purpose of this article is to review the literature regarding the psychological impact of breast augmentation and assesses current scientific findings, with emphasis on the validity of suicide risk in breast augmentation patients.

The Danish Registry for Plastic Surgery of the Breast: establishment of a nationwide registry for prospective follow-up, quality assessment, and investigation of breast surgery.

Although numerous epidemiologic studies have examined the long-term safety of silicone breast implants during the past decade, there is a relative lack of surveillance data on short-term health effects and complications following cosmetic surgery of the breast. The Danish Registry for Plastic Surgery of the Breast, established in May of 1999, provides plastic surgeons with a nationwide system for the collection of preoperative, perioperative, and postoperative data on women undergoing breast implantation, breast reduction, or mastopexy. The purpose of the Registry is to examine short-term and, eventually, long-term local complications and possible health effects, and to contribute to an ongoing evaluation of surgical results and surveillance of the products. Furthermore, the Registry will allow the identification of new areas for research into cosmetic and reconstructive breast surgery. Women accepting registration in the Danish Registry for Plastic Surgery of the Breast complete a self-administered questionnaire focusing on medical history and demographic and behavioral factors. Preoperative blood samples are drawn for storage. Surgical data, postoperative results, and complications are registered following surgery and at postoperative visits. Currently, registration has been initiated at 24 private and public clinics, representing more than 80 percent of the plastic surgery clinics in Denmark. As of November of 2001, a total of 1472 women with breast implants and 560 women with breast reduction were included in the Registry. These figures are expected to increase annually by 1000 women undergoing breast implantation and 500 women undergoing breast reduction or mastopexy. The authors present their experience of establishing the first nationwide comprehensive clinical-epidemiologic database and biological bank for cosmetic and reconstructive surgery procedures.

Safety of Silicone Breast Implants: Scientific Validation/Vindication at Last

Safety of Silicone Breast Implants: Scientific Validation/Vindication at Last

SEEKING CLARITY ON BREAST IMPLANTS

During a break at last month's meeting of the Institute of Medicine's (IOM) Committee on the Safety of Silicone Breast Implants, a shaking woman buttonholed committee members and loudly denounced manufacturers of the breast implants she said had ruined her life. Just minutes before her emotional outburst, this reporter heard her discussing with a companion in another room her planned crazy act. Was it real or just a performance? Is she ill, and did her breast implants cause her condition? Such incidents cloud even further this murky, complex, litigation-spawning issue. The committee met in Washington, D.C., to try to gain some perspective on previous and ongoing studies on the possible link between silicone breast implants and disease. The panel is preparing a review of research on this potential link, the nature and strength of the association, possible biological mechanisms, the quality and limitations of the previous research, and suggestions for future research. The study also ...

Silicone Breast Implants, Breast Cancer and Specific Connective Tissue Diseases: A Systematic Review of the Data in the Epidemiological Literature

Unanswered concerns about the systemic safety of silicone breast implants (BI) underlay the Food and Drug Administration's moratorium pronouncement in 1992. Since then, many epidemiological studies have been reported that examined either the association between BI and cancer, particularly breast cancer, or the association between BI and connective tissue diseases (CTD), particularly scleroderma. These studies are reviewed, and their data are synthesized. Three breast cancer easel control studies that examine BI as a risk factor show no association between BI and breast cancer. Nor do four BI cohort studies. The data appear to show a reduced risk. No association has been seen between Bl and either breast sarcomas or total cancers. Case-control studies do not show an association between BI and scleroderma (four studies), rheumatoid arthritis (three studies), systemic lupus erythematosus (two studies), or other connective tissue diseases. Eight cohort studies of women with breast implants sought an association between BI and CTD. Seven had negative results. One found a statistically significant risk of self-reported CTD of 1.24 (upper confidence limit = 1.41), but medical record review for diagnostic confirmation has not yet been performed. In toto, the epidemiological studies do not indicate an association between breast implants and breast cancer, though they suggest possibly a negative association. In toto, the epidemiological studies do not indicate an association between breast implants and specific connective tissue diseases, though one study's current results present a small statistically significant association with self-reported CTD.

Hybrid Nonwomen and Corporate Violence

Unlike many issues relating to women's health, the recent controversy concerning the safety of silicone breast implants created a great deal of public interest. Despite growing public concern, corporate violence against women has received insufficient empirical and theoretical study. Using a feminist gaze, this article places the silicone breast implant dispute within the larger theoretical framework of corporate violence. A case study of the historical development of the silicone breast implant debate illustrates duplicity in the chemical industry, the power of special interest groups, the impotence/complicity of governmental regulatory agencies, and the vital impact of cultural prescriptions of beauty on women. The study also points to the force of the media in contested social issues, in addition to the increased power of ordinary people to affect change through collective action that fights governmental and corporate crime and cultural myths of beauty on behalf of women.

Women’s Reports of Breast Implant Problems and Silicone-Related Illness

The safety of silicone breast implants recently has been questioned. Increasing numbers of women have reported a variety of health problems that they attribute to their implants. The purpose of this descriptive study was to explicate the phenomenon of silicone-related illness as reported by women who have had breast implants. A qualitative design was grounded in the theoretical framework proposed by McBride and McBride (1981), the core of which is the first-person, lived experiences of women as interpreted and explained by the women themselves. Participants were recruited through Command Trust Network, an international support group for women with breast implant problems. The sample consisted of 55 women from 19 states and Canada who experienced health problems they attributed to their implants. Eighteen percent labeled themselves as disabled. Themes emerging from responses to 10 questions are discussed in terms of circumstances leading to initial implantation, understanding risks and benefits, health problems and symptoms, physician response, choices made about implant removal, and psychosocial and emotional consequences. Findings included dissatisfaction with implants, similarity of health problems, and recurrent surgical and nonsurgical procedures. Dominant themes included lack of informed consent, physician denial of health problems, and the decision to remove implants. Further research should be directed at recipients of implants who report silicone-related illness to determine the number of women affected and the nature of their problems.

Pregnancy, lactation and the use of silicone breast implants

In the United States alone, an estimated 1-2 million women have used silicone breast implants. Many of these women are of reproductive age. Given the current controversy over the safety of silicone breast implants, medical care providers should be able to advise women if use of these implants affects the use of any of the available contraceptive methods, whether pregnancy is in any way contraindicated and/or might be associated with special complications, whether there are potential risks to the fetus and neonate, and whether breast feeding might be compromised. A review of the literature on these topics yielded very little useful information.

Rheumatic Disease Among 1167 Women Reporting Local Implant and Systemic Problems After Breast Implant Surgery

Concerns about the safety of silicone breast implants have grown since 1988, when the Food and Drug Administration (FDA) designated silicone gel-filled breast implants as devices posing a risk to public safety. Potential risks include the development of connective tissue diseaselike syndromes and rheumatic disease, as suggested by numerous case reports. This study describes the frequencies of physician diagnoses and symptoms of the rheumatic diseases, systemic sclerosis (scleroderma), systemic lupus erythematosus, and rheumatoid arthritis, in 1167 women who have had breast implant surgery and who have reported local implant or systemic problems to the FDA. The investigators used a telephone survey of 820 respondents who were from all of the contiguous United States except Vermont. Among the 820 women, 232 (28%) reported a diagnosis of one of these three diseases after breast implant surgery. Many more met epidemiologic criteria for scleroderma, systemic lupus erythematosus, and rheumatoid arthritis after breast implant surgery. Statistically significant associations (p < 0.05) were breast implant type with scleroderma, breast implant manufacturer with systemic lupus erythematosus, geographic area with rheumatoid arthritis, and breast implant leakage or rupture and reason for implant surgery with each of the three rheumatic diseases. Analysis using a subgroup of women who had implant surgery at least 10 years before the interview and reported a physician diagnosis of or met epidemiologic criteria for at least one of the diseases revealed a higher percentage for scleroderma in the first year after implant surgery and for systemic lupus erythematosus in years 8 through 10. These findings warrant further study.