Silicone Gel-filled Breast Implants Research Articles

Testing Mechanical Properties of Silicone Gel-Filled Breast Implants and Their Degradation.

Breast augmentation procedures using silicone implants have become increasingly popular over the past six decades. This article addresses the concerns of patients regarding implant strength by providing clinicians with valuable information in addition to video and pictorial evidence to share, fostering reassurance. The article focuses on the structural integrity and stability of breast implants, which play a critical role in their long-term performance and patient satisfaction. Specifically, it examines the industry standards outlined by the International Organization for Standardization (ISO), with a particular emphasis on ISO14607-2018, which encompasses a range of mechanical and physio-mechanical tests, including the assessment of silicone gel-fill firmness, evaluation of shell integrity, and examination of the impact of environmental conditions on implant performance. Breast implants are not static devices and are subject to aging and fatigue-based degradation. This emphasizes the need for ongoing monitoring and evaluation to ensure the long-term safety and satisfaction of patients. By providing a comprehensive examination of breast implant structure and industry standards, this article equips clinicians with the necessary knowledge to address patient concerns and foster confidence in the safety and longevity of breast augmentation procedures using silicone implants.Level of Evidence III 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 .

Ultrasonographic Identification of Shell Surface Types in Commercially Available Silicone Gel-Filled Breast Implants.

Breast implant safety issues have resulted in the need for global product recalls and medical device tracing. Conventional methods of breast implant tracing, have to date proven to be unsuccessful. This study aims to evaluate the effectiveness of high-resolution ultrasound (HRUS) screening in identifying implanted breast devices. Data from 113 female patients undergoing preoperative ultrasound screening for secondary breast surgery between 2019 and 2022 was prospectively reviewed to evaluate the effectiveness of HRUS imaging with the aid of a sonographic surface catalog to identify the surface and brand type of implanted breast devices. To corroborate the findings and assess the reproducibility of the approach, further evaluations were replicated in New Zealand white rabbits and compared with the results found in humans. In the human recipients, implant surface and brand types were correctly identified by ultrasound imaging in 99% (112 of 113) and 96% (69 of 72) of the cases, either consultation-only or revision, respectively. This constituted an overall success rate of 98% (181 of 185). Furthermore, in a corroborating New Zealand white rabbit model where full-scale commercial implants were introduced and monitored over many months, from the total 28 analyzed, the surface was accurately identified in a total of 27 cases (the one failure being before generation of a sonograph surface catalogue), demonstrating an overall success rate of 96.4%. HRUS is, therefore, a valid and first-hand tool for breast implant imaging that can correctly evaluate both surface type and brand type alongside other variables such as implant placement, positioning, flipping, or rupture. HRUS is a valid and first-hand tool for the identification and traceability of breast implants that evaluates surface type and brand type. This low-cost, accessible, and reproducible practice provides patients with peace of mind and surgeons with a promising diagnostic tool.

Feasibility of Imaging Modalities Combined with a Silicone Gel-Filled Breast Implant in Korean Women.

With the occurrence of breast implant crises in Korea, it has become increasingly important to detect complications earlier in patients receiving a device. We have therefore combined imaging modalities with an implant-based augmentation mammaplasty. In this study, we assessed the short-term treatment outcomes and safety of the Motiva ErgonomixTM Round SilkSurface (Establishment Labs Holdings Inc., Alajuela, Costa Rica) in Korean women. A total of 87 women (n = 87) were included in the current study. We compared preoperative anthropometric measurements between the right side and the left side of the breast. Moreover, we also compared the thickness of the skin, subcutaneous tissue and the pectoralis major measured on a breast ultrasound preoperatively and 3 months postoperatively. Furthermore, we analyzed the incidences of postoperative complications and the cumulative complication-free survival. Preoperatively, there was a significant difference in the distance from the nipple to the midline between the left and right side of the breast (p = 0.000). Both sides of the breast showed significant differences in the thickness of the pectoralis major preoperatively and 3 months postoperatively (p = 0.000). A total of 11 cases (12.6%) of postoperative complications occurred; these included five cases (5.7%) of early seroma, two cases (2.3%) of infection, two cases (2.3%) of rippling, one case (1.1%) of hematoma and one case (1.1%) of capsular contracture. Time-to-events were estimated at 386.68 ± 27.79 days (95% CI 334.11-439.27). Here, we describe our experience with imaging modalities in combination with the Motiva ErgonomixTM Round SilkSurface in Korean women.

Safety and Performance of POLYTECH Mesmo Breast Implants: A 5-Year Post-market Surveillance Study on 919 Patients.

BackgroundIn 2007, POLYTECH Health & Aesthetics (POLYTECH, Dieburg, Germany) established an ongoing patient survey to improve the post-market surveillance of silicone gel-filled breast implants based on patient-reported outcomes in the context of the pioneering “Implants of Excellence” (IoE) program.ObjectivesTo disclose an update on safety and performance outcomes at 5 years for Mesmo breast implants.MethodsBetween January 2014 and October 2019, 919 patients (for a total of 1816 implants) who underwent breast augmentation and reconstruction with Mesmo implants were asked to participate in the IoE program. Data were collected by mean of 1320 questionnaires received. A survival analysis assessed the onset of different complications.ResultsEight patients (0.9%) experienced capsular contracture Baker grade III or IV with a cumulative rate at 5 years of 1.2% (95% CI = 0.6-2.4). The proportion of revisional surgery was 0.5% with a 5-year rate of 0.6% (95% CI = 0.2-1.5). Additional adverse events such as hematoma, seroma, malposition, open wounds, and other complications were carefully monitored. Questionnaires showed that 93.9% (95% CI = 92.2-95.4) of the patients were satisfied or very satisfied with their aesthetic results with Mesmo implants. ConclusionsPost-market clinical follow-up revealed that the overall complications rate reported was low. Data demonstrated an excellent safety property on a large cohort of patients. This result allows the rating of Mesmo breast implants as highly competitive and a very safe choice for both surgeons and patients.Level of Evidence: 3

A Preliminary Retrospective Study to Assess the Short-Term Safety of Traditional Smooth or Microtextured Silicone Gel-Filled Breast Implants in Korea.

Background and objectives: We conducted this preliminary retrospective study to assess the short-term safety of silicone gel-filled breast implants (SGBIs) that are commercially available in Korean women. Materials and methods :The current retrospective, observational study was conducted in a total of 2612 patients (n = 2612) who underwent augmentation mammaplasty using breast implants at our hospitals between 1 January 2017 and 31 August 2021. Results: Overall, there were a total of 248 cases (9.49%) of postoperative complications; these include 112 cases of early seroma, 52 cases of shape deformation, 32 cases of CC, 12 cases of early hematoma, 12 cases of rupture, 12 cases of infection, 12 cases of stretch deformities with skin excess and 4 cases of rippling. Overall complication-free survival of the breast implant was estimated at 1564.32 ± 75.52 days (95% CI 1416.39–1712.32). Then, the Motiva Ergonomix™ SilkSurface showed the longest survival (1528.00 ± 157.92 days [95% CI 1218.48–1837.56]), followed by the BellaGel® SmoothFine (1458.4 ± 65.76 days [95% CI 1329.56–1587.28]), the Sebbin® Sublimity (1322.00 ± 51.20 days [95% CI 1221.64–1422.32]), the BellaGel® Smooth (1138.72 ± 161.28 days [95% CI 822.6–1454.84), the Mentor® MemoryGel™ Xtra (698.4 ± 52.64 days [95% CI 595.28–801.52]) and the Natrelle® INSPIRA™ (380.00 ± 170.88 days [95% CI 45.04–714.96]) in the decreasing order. On subgroup analysis, both the Motiva ErgonomixTM and Mentor® MemoryGel™ Xtra showed no postoperative complications. However, the BellaGel® SmoothFine, Sebbin® Sublimity and BellaGel® Smooth showed incidences of 8.87%, 4.84% and 1.61%, respectively. A subgroup analysis also showed differences in incidences of postoperative complications between microtextured and smooth breast implants (15.18% vs. 16.67%). Conclusions: In conclusion, our results indicate that diverse types of an SGBI are commercially available and their safety profile varies according to the manufacturer. Plastic surgeons should consider the safety profile of each device in selecting the optimal types of the device for Korean women who are in need of an implant-based augmentation mammaplasty. However, this warrants a single-surgeon, single-center study with long periods of follow-up.

Breast Implants: A Historical Review With Implications for Diagnosis and Modern Surgical Planning.

Modern breast surgery was first introduced in the United States in 1962 with the use of silicone gel-filled breast implants. Over the past 6 decades, development of breast implants has been challenged by a variety of influencers including aesthetic appeal in shape, texture, and material; challenges in managing outcomes such as contracture, disease, and rupture; and public perception of risks associated with implants. In 1992, silicone breast prostheses were banned by the US Food and Drug Administration with exception for use in breast reconstruction, congenital deformities, or to replace existing implants.The ban led to heightened concerns about implants and possible disease manifestations. Knowledge of the historical evolution of breast prostheses is useful for understanding the associated risks and outcomes unique to each breast implant era. This article aimed to explore characteristics of breast implants by generation, with implications for diagnosis and assistance to modern surgical planning for novice plastic surgeons.

The Value of Ultrasound in the Evaluation of the Integrity of Silicone Breast Implants.

Background and Objective: Breast implant surgery for cosmetic purposes is the most popular plastic surgery and it has been performed for over 100 years. Rupture of silicone gel-filled breast implants usually is asymptomatic and is one of the more dangerous complications due to free silicone migration. The aim of our study was to evaluate the diagnostic value of ultrasound (US) in the evaluation of the integrity of silicone breast implants and identify the main sign of intact and ruptured breast implants. Patients and Methods: In this retrospective study, the medical documentation of women who underwent breast implant surgery and US checkups at Tautrimas Aštrauskas Clinic in Kaunas, Lithuania, during 2015–2020 was analyzed. The patients were divided into two groups: patients with intact and ruptured breast implants. The accuracy, sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV) as well as the signs of implant integrity of US examination were evaluated. Results: In this study, 76 women with bilateral breast implants (n = 152) were reviewed. On a US examination, ruptured implants were found in 41.1% (n = 61) of the cases; of them, 78.7% (n = 48) of the cases had ≥2 US signs of a ruptured implant, and in all these cases, implant rupture was confirmed at surgery. Overall, one US sign of a ruptured implant was found in 21.3% (n = 13) of the cases. Of them, inhomogeneous content in all cases (n = 3) was found in the intact implant group, and an abnormal implant shell was documented more often in the ruptured implant group, not intact one (n = 9, 90% vs. n = 1, 10%). US had a diagnostic accuracy of 94.7%, sensitivity of 98.3%, specificity of 89.2%, PPV of 93.4%, and NPV of 97.1% in the evaluation of implant integrity. Conclusions: Our results show that US is a very reliable alternative in evaluating breast implant integrity and could be the investigation of choice for implant rupture, while MRI could be advocated only in inconclusive cases. Uneven implant shell was found to be the most important US sign of breast implant rupture. Based on the findings, we recommend performing US examination after breast augmentation surgery with silicone gel-filled implants annually.

Short-term treatment outcomes and safety of two representative brands of the fifth-generation silicone gel-filled breast implants in Korea

It is allegedly reported that the BellaGel® SmoothFine (HansBiomed Co. Ltd., Seoul, Korea) and Motiva ErgonomixTM (Establishment Labs Holdings Inc., Alajuela, Costa Rica) are representative brands of a microtextured breast implant in Korea. We compared short-term safety outcomes between them. We evaluated the patients who received breast augmentation using the BellaGel® SmoothFine (n = 264) or the Motiva Ergonomix™ (n = 76) for aesthetic purposes and those with available medical records. They were followed up during a mean period of 122.11 ± 95.37 (4–477) and 126.80 ± 116.29 (13–534) days in the corresponding order. Early seroma occurred at an incidence of 1.89 and 5.26% following breast augmentation using the BellaGel® SmoothFine and the Motiva ErgonomixTM, respectively. This difference reached statistical significance (p < 0.05). Of note, CC occurred at an incidence of 2.27 and 0.00% in the corresponding order. Cumulative incidences of postoperative complications depending on the type of breast implants showed no significant difference; statistical significance was analyzed using the log-rank test (χ2 = 1.71, df = 1, p = 0.19). Cumulative survival of the breast implant is shown in Table 3; the Motiva Ergonomix™ showed a longer survival as compared with the BellaGel® SmoothFine (130.13 ± 13.70 vs. 120.45 ± 5.76 days). In conclusion, we describe short-term treatment outcomes and safety of an implant-based breast augmentation using two representative brands of the fifth-generation silicone gel-filled breast implants in Korean women.

Safety and Effectiveness of Silicone Gel-Filled Breast Implants in Primary Augmentation Patients.

BackgroundResults from the MemoryGel Breast Implants Core Clinical Study suggest these devices are safe and effective at 10 years after implantation. Although clinical trials are essential for measuring the safety and effectiveness of a device, real-world evidence can supplement clinical trials by providing information on outcomes observed in diverse clinical settings for a more heterogeneous population, without fixed treatment patterns, and without continuous patient monitoring, such that follow-up is more representative of normal clinical practice.ObjectivesThe aim of this study was to measure real-world outcomes, including safety and effectiveness, in patients who underwent primary breast augmentation with smooth MemoryGel implants.MethodsThis was a case series looking at patients, age 22 years and older, who underwent primary breast augmentation at a single site between December 2006 and December 2016 and who had a minimum of 2 years of follow-up. Descriptive statistics were used to summarize baseline characteristics and outcomes. Kaplan-Meier models were used to estimate safety outcomes for capsular contracture (Baker grade III/IV), infection, and rupture.ResultsA total of 50/777 (6.4%) patients reported a complication, with an average time to complication of 3.9 years (range, 19 days-11.8 years) postprocedure. Kaplan-Meier estimates of the 10-year cumulative incidence of capsular contracture (Baker grade III/IV), infection, and rupture were 4.7%, 0.1%, and 1.6%, respectively.ConclusionsAnalyses of a large population from a single site provide further support for the long-term safety and effectiveness of MemoryGel breast implants in a primary augmentation cohort.Level of Evidence: 4

Low molecular weight silicones induce cell death in cultured cells

Women with silicone gel-filled breast implants are exposed to organosilicon compounds, in particular methylsiloxanes, as a result of ‘gel bleed’ and implant rupture. Although these silicones were originally considered to be inert, increasing evidence indicates that they can cause serious health problems. Here, we have analyzed the effects of microdroplets of the methylcyclosiloxanes, in particular D4, on the viability of cultured human cells. The exposure of Jurkat suspension and HeLa monolayer cells to D4 resulted in morphological changes of the cells. The analysis of molecular markers for apoptotic and necrotic processes not only demonstrated that caspases were activated and DNA was fragmented in Jurkat cells exposed to D4, but that also the permeability of the plasma membrane was altered. The induction of apoptotic pathways by D4 was substantiated by the inhibition of caspase activation in cells overexpressing Bcl-2. Cleavage of the caspase-3 substrate U1-70K appeared to be dependent on the D4 content and the efficiency of cleavage decreased with increasing size of the methylcyclosiloxanes (D4, D5 and D6). In addition to Jurkat cells, D4-induced U1-70K cleavage was also observed in HeLa cells, but not in HEp-2 cells. Taken together, these results indicate that D4 and, to a lesser extent, D5 can activate cell-death-related pathways in a cell type-specific fashion and suggest that this phenomenon may contribute to the development of Breast Implant Illness.

Short-term Safety of a Silicone Gel-filled Breast Implant: A Manufacturer-sponsored, Retrospective Study.

Background:Currently, 8 different brands of a silicone gel–filled breast implant are commercially available in Korea. But the superiority of short-term safety has not been established.Methods:A total of 709 patients (1,418 breasts) received an implant-based augmentation mammaplasty. We compared a 1-year incidence of complications and complication-free survival among the breast implants. Moreover, we performed a subgroup analysis of the patient cohorts by excluding cases associated with a periareolar incision, revision or reoperation, and anatomic implants.Results:In our series, 1-year incidences of complications were 0.55% (1/182), 3.14% (5/159), 5.19% (7/135), and 6.58% (10/152) in patients receiving the BellaGel/BellaGel SmoothFine, the Mentor CPG, the Matrix, and the Motiva Ergonomix, respectively. Moreover, the incidence of capsular contracture was 0.55%, 0.63%, 1.32%, and 3.70% in patients receiving the BellaGel/BellaGel SmoothFine, the Mentor CPG, the Motiva Ergonomix, and the Matrix, respectively. Furthermore, a complication-free survival was 24.82 ± 0.18, 22.23 ± 1.09, 22.15 ± 0.77, and 22.12 ± 1.07 months in patients receiving the BellaGel/BellaGel SmoothFine, the Motiva Ergonomix, the Mentor CPG, and the Matrix, respectively, except for the 2 other remaining products used for a smaller number of patients. However, a subgroup analysis showed no significant differences in a 1-year incidence of complication and complication-free survival among the BellaGel SmoothFine, the Motiva Ergonomix, and the Naturgel.Conclusion:It is impossible to draw a definite conclusion about the superiority of the short-term safety among the silicone gel–filled breast implants that are commercially available in Korea.

Silicone Gel Breast Implants: Past, Present, and Future.

The authors have provided an in-depth review of the history of saline and silicone gel-filled breast implants. In the history of medicine, no devices have been more scrutinized and thoroughly studied than breast implants. Although we as plastic surgeons recognize and appreciate the benefits that our patients derive from these devices, society as a whole continues to remain skeptical. The reasons for this are complex and multifactorial but appear to be fueled by the media, oppositional organizations, and several trial lawyers. Prior to 1990, when the silicone gel implant controversy began, there were only eight indexed publications that dealt with the issue of silicone gel breast implants. Since 1990, there have been more than 500 indexed publications dealing with silicone gel implants. At the time of the moratorium in 1992, we as plastic surgeons did not have a leg to stand on because there was a paucity of scientific evidence to support our observations that silicone breast implants were safe and effective devices.

Smooth Prosthesis: Our Experience and Current State of Art in the Use of Smooth Sub-muscular Silicone Gel Breast Implants.

The objective of this clinical review is to provide an overview of the use of silicone gel-filled breast implants placed in the sub-muscular position, with a focus on complication rates reported for both smooth and textured implants. Furthermore, our experience in this field is also reviewed. MEDLINE, EMBASE, Web of Science, Scopus, the Cochrane Central and Google Scholar databases were reviewed to identify the literature related to smooth breast implants. Each article was reviewed by two independent reviewers to ensure all relevant publications were identified. The literature search identified 98 applicable articles. Of these, just a few articles were found to have a therapeutic level of evidence. The reference lists in each relevant paper were screened manually to include relevant papers not found through the initial search. Eight articles report the risk of capsular contracture when the breast implants were placed in the sub-muscular position. Six of these articles report a similar rate of capsular contracture in smooth and textured implants. Local complications such as wrinkling, late seroma and double capsules were found to be associated with the use of textured breast implants (4 articles). All articles concerning BIA-ALCL reported a total absence occurring in smooth breast implants. All cases have been associated with textured mammary prostheses. With our expertise in the field and the results of this up-to-date literature review, it can be concluded that there are no significant advantages of using one type of implant surface over the other when placed in the sub-pectoral position. 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.

Five-Year Retrospective Analysis of Eurosilicone's Silicone Gel-Filled Breast Implants.

BackgroundSilicone breast implants have been widely used for breast augmentation and reconstruction. During this time, silicone breast implants have undergone several modifications to improve their safety, quality, and clinical performance. Complications such as reoperation, capsular contracture, and rupture are risks often associated with breast implants.ObjectivesThe authors conducted a retrospective study to analyze and report complication rates associated with Eurosilicone’s (Eurosilicone S.A.S, Apt, Cedex, France) silicone gel–filled breast implants over a period of 5 years.MethodsIn this retrospective clinical study, 2151 women who underwent either breast augmentation or breast reconstruction with Eurosilicone breast implants were diagnosed. Data on early and late complications including implant removal (explantation/exchange), capsular contracture, and rupture were collected using questionnaires, completed by 39 surgeons across Italy.ResultsOf the 2151, only 60 patients (2.78%) required implant removal. Twenty-five patients experienced capsular contracture (Baker Grade III/IV), giving an actual rate of 1.2%. The actual rate of implant rupture confirmed by breast magnetic resonance images was 0.18% (4 implants). Six patients (0.27%) were diagnosed with breast cancer following breast augmentation, and local complications including hematoma (1 patient) and seroma (2 patients) were experienced.ConclusionsThis retrospective clinical study involving Eurosilicone’s round and anatomical textured silicone gel–filled mammary implants demonstrates an excellent safety profile through 5 years. Level of Evidence: 2

Is short term intraoperative application of disinfectants harmful to breast implants in breast reconstruction? An experimental study and literature survey

ObjectivesBacterial contamination of breast implants and biofilm formation has been discussed as a major reason for implant loss and capsular contraction. Intra- and perioperative treatment of breast implants with disinfectants to prevent bacterial contamination has been frequently reported. Given the increasing awareness of concerns about product liability the question of whether short-time irrigation of implants with antimicrobial substances during the operative procedure would potentially alter the integrity of the implant shell has attracted legal and medical interest. In this study we therefore investigated whether irrigating breast implants with antimicrobials commonly used in clinical practice with a clinically relevant application time would affect the physical integrity of the implant shell. Materials and methodsSamples, which were previously punched from the shell of explanted standard silicone gel filled breast implants in a defined way, were exposed to different disinfectant solutions for two minutes. Multiple defined specimens from 5 different explants from 4 different producers (including PIP) were tested. The testing included tensile strength and disruption tests. ResultsIn our prospective test series we could not find a significant influence of a single distinct disinfectant on silicone shell implant surfaces. ConclusionDespite the potential legal implications that might be considered when a surgeon manipulates an implant with disinfectants intraoperatively, we find it worthwhile to state that from a material and surgical standpoint there is no evidence that short-time treatment of alloplastic materials would be detrimental to the physical properties of the implant shell.

Interstitial lung diseases associated with metal content in silicone breast implants: a case series.

Background: Silicone gel-filled breast implants have been widely used for breast augmentation and reconstruction since the 1960’s when the FDA approved them in women over 22 years of age. Concerns have been raised about the safety of those implants, with the focus upon whether silicone leak can spread to regional lymph nodes and remote organs and possibly cause inflammatory and immune responses. Objective: To present laboratory workup findings in 3 cases of interstitial lung diseases (ILD) linked with silicone implant leakage. Methods: ILD was diagnosed by tissue biopsy and Computerized Tomography (CT). We analyzed the metal content in both biological samples and raw material of the implants by means of scanning electron microscopy (SEM) and X-ray fluorescence (XRF). The metals lymphocyte proliferation analysis (MELISA®) was used to assess sensitization of the immune system to 19 metals. Results: The biological samples contained metals (silicon, nickel, zinc, tungsten, iron, aluminum, and zirconium) which are also present in the silicone implant. The MELISA test showed sensitization to nickel, zinc and tin. Limitations: Some of the immunogenic metals present in the implant were under the limits of detection of SEM and XRF and the sensitivity of MELISA test is unknown. Conclusions: The laboratory assessments of the 3 herein described women indicated that their interstitial lung disease was associated with the metal content of their silicone gel-filled breast implantations. (Sarcoidosis Vasc Diffuse Lung Dis 2018; 35: 381-389)

Is Silicone Breast Implant Toxicity an Extreme Form of a More Generalized Toxicity Adversely Affecting the Population as a Whole?

In humans the element silicon is essential for normal growth and development. It is extensively biointegrated into a wide variety of matrix macromolecules that display endless variations of complex overlapping interactions. When living organisms are confronted with artificial man-made organosilicon and organosiloxane compounds there is a finite limit of adaptive mechanisms by which normal cells and tissues can dispose of these molecules. Exposure to silicone gel-filled breast implants is particularly harmful due to biochemical chaos caused by in vivo degradation of an exceedingly excessive polymer presence. The worldwide proliferatioin of 60,000 other man-made silicon-containing compounds permeates all aspects of everyday living and has created generalized environmental exposure via inhalation, dermal absorption, and ingestion. These exposures are producing heightened public health concerns because prior assertions that organosiloxanes are chemically and biologically inert are no longer tenable. It is proposed that vague syndromes, such as fibromylagia and chronic fatigue syndrome, are disorders caused by insidious slow-paced toxicity mechanisms similar to the more rapid and profound biochemical disruptions occurring in sick breast implant recipients.

Mechanisms of Breast Implant Toxicity: Will the Real Ringmaster Please Stand Up

The past five years have witnessed a recurrent public health debacle encompassing illness caused by silicone gel-filled breast implants. In an attempt to explain this epidemiologic reality, researchers from many institutions have resurrected the faulty device-related autoimmune theories of the early 1990’s. These researchers are genuinely convinced that breast implants initiate a novel disease, but their methodology utilized to prove this premise is unsound. The inability to consider mechanisms of widespread biochemical disruptions caused by in vivo exposure to organosilicon molecules is coexisting with multiple deficiencies in detecting the voluminous clinical manifestations of ailing implant recipients. Chief among the latter are the use of truncated data bases to record symptoms and signs, coupled with the lack of appreciation that silicone-induced disease evolves chronologically in a manner simulating a dose-response curve. This failure to correlate the diverse clinical features present in toxic breast implant recipients with logical mechanisms of disease causation provides a clear understanding of why the silicone breast implant chaos of the early 1990’s was inevitably destined to repeat itself.

Destiny rides again: the reappearance of silicone gel-filled breast implant toxicity.

Background Twenty-five years ago attorneys representing ailing women in class action litigation against silicone breast implant manufacturers made the procedural error of defining silicone-induced toxicity in the courtroom before it was properly studied in the exam room. This aberrant methodology perverted the proper research process, rendered verification of any real disease elusive, and cemented the groundwork for a repeat public health crisis potentially affecting two million women in the USA who possess new silicone gel devices inserted over the past 10 years. Patients and methods Six women, previously well, aged 27 to 53 (mean 42), were recipients of the new generations of cohesive silicone gel-filled breast implants approved for general use by the Food and Drug Administration (FDA) since December of 2006. They averaged seven years of total implantation time, and none experienced implant rupture. Results All six became ill on average 3.5 years from the time of implantation. By seven years the women manifested multiple types of skin rashes, polyarthritis, fatigue, protracted AM stiffness, myalgias, headaches, photosensitivity, hair loss, paresthesias, tinnitus, lymphadenopathy, chest pain, cognitive dysfunction, dry eyes, skin pigment changes, itching, muscle twitching, dizziness, nausea, easy bruising, and odor and smell sensitivity. Three of the four who were explanted noted improvement and/or resolution of at least 50% of their total disease manifestations. Conclusions These six women are representative of over 70,000 other breast implant recipients who, over the past three years, have had their new silicone devices permanently removed because of alleged gel-induced toxicity. The recurrence of this public health crisis has been fueled by manufacturers' research fraud, FDA ineptness, faulty informed consent, patient abandonment, proprietary manufacturing secrecy, misleading advertising, physician indifference, aberrant research methodology, and lax Congressional oversight.

Halo and spillover effect illustrations for selected beneficial medical devices and drugs.

BackgroundNegative news media reports regarding potential health hazards of implanted medical devices and pharmaceuticals can lead to a ‘negative halo effect,’ a phenomenon whereby judgments about a product or product type can be unconsciously altered even though the scientific support is tenuous. To determine how a ‘negative halo effect’ may impact the rates of use and/or explantation of medical products, we analyzed the occurrence of such an effect on three implanted medical devices and one drug: 1) intrauterine contraceptive devices (IUDs); 2) silicone gel-filled breast implants (SGBI); 3) metal-on-metal hip implants (MoM); and 4) the drug Tysabri.MethodsData on IUD use from 1965 to 2008 were gathered from the Department of Health and Human Services Vital and Health Statistics and peer-reviewed publications. Data regarding SGBI implant and explantation rates from 1989 to 2012 were obtained from the Institute of Medicine and the American Society of Plastic Surgeons. MoM implant and explantation data were extracted from the England and Wales National Joint Registry and peer-reviewed publications. Tysabri patient data were reported by Elan Corporation or Biogen Idec Inc. Data trends for all products were compared with historical recall or withdrawal events and discussed in the context of public perceptions following such events.ResultsWe found that common factors altered public risk perceptions and patterns of continued use. First, a negative halo effect may be driven by continuing patient anxiety despite positive clinical outcomes. Second, negative reports about one product can spill over to affect the use of dissimilar products in the same category. Third, a negative halo effect on an entire category of medical devices can be sustained regardless of the scientific findings pertaining to safety. Fourth, recovery of a product’s safety reputation and prevalent use may take decades in the U.S., even while these products may exhibit widespread use and good safety records in other countries.ConclusionsWe conclude that the ‘negative halo effect’ associated with a stigma, rather than an objective risk-benefit assessment of medical products can increase negative health outcomes for patients due to reduced or inappropriate product usage.