Silicon chemistry and silicone breast implants

Breast implants are applied to correct the size, form, and feel of a woman’s breasts in post-mastectomy breast reconstruction, for correcting congenital defects and deformities of the chest wall, for aesthetic breast augmentation, and for creating breasts in the male-to-female transsexual patient. The most widely applied silicone implants have an elastomer silicone shell filled with viscous silicone gel. It has become increasingly clear that it is important for plastic surgeons to know and to provide patients with the latest information on silicone breast implants. This article was therefore written to provide more insight into the composition of silicone breast implants and their characteristics. After describing the chemical properties of silicones and silicone implants, gel bleeding and the consequences of aging of silicone implants will be discussed. The information provided can also give a hint as to why silicone implants have been consistently implicated in health issues ever since the late 1960s. Level of Evidence: Not ratable.     

硅胶囊假体隆乳术并发症

应用硅胶假体的隆乳术在我国普遍开展，各种并发症也屡有报道，手术医生应掌握该方面的相关知识及并发症的防治方法，以使受术者的痛苦减少到最低程度。过去的十年里在我科共施行１１５例硅胶假体隆乳术，发生并发症９例，主要包括血肿、积液、假体破裂、位置不正。血肿和积液早期都会引起局部疼痛且有并发感染的可能，应尽早引流血肿和积液。假体破裂的诊断很重要，最常用的方法是Ｂ超，但以ＭＲＩ最为准确。位置不正可通过准确的分离腔隙和有效的包扎固定得以预防。与硅胶假体隆乳术相关的自身免疫性疾病越来越引起关注，１５例硅凝胶乳房假体的受术者的免疫功能检查，ＩｇＧ，ＩｇＭ及Ｃ３增高提示硅胶做为一种异物长期存在体内引起非特异性免疫活动增强，但这方面尚需做进一步的临床与实验研究证实。     

Breast cancer after breast augmentation with silicone implants

Background: Although epidemiological studies have failed to demonstrate an increased incidence of breast cancer in women who had undergone prior prosthetic augmentation mammoplasty (PAM), it has been reported that when breast cancer arises in this group it presents mostly in a palpable form and at a more advanced stage. This is thought to be secondary to suboptimal mammographic evaluation caused by the masking effect of the implant. This study was undertaken to determine, in our experience, whether breast cancer arising in women who had undergone PAM could be detected in a prepalpable form by mammography and whether it presented at a more advanced stage as compared with nonaugmented women with breast cancer. Methods: The charts of 22 patients, treated by at least one of the authors, in whom 23 breast cancers developed after PAM (group A) were retrospectively reviewed. The comparison groups consisted of 611 nonaugmented patients who underwent 636 procedure for the treatment of primary breast cancer at our institution (group B) and the surveillance, epidemiology, and end results (SEER) data (group C). Parameters studied were mode of detection, tumor size, axillary lymph node involvement, and histopathology. Results: No significant differences between the groups were found in mean tumor size (group A vs. group B), the incidence of preinvasive cancer (group A vs. group B), or axillary lymph node involvement (group A vs. group B and group A vs. group C). Breast-preserving surgery was performed significantly less in augmented patients (group A vs. group B). Conclusion: We conclude that prepalpable and preinvasive breast cancer can be detected in the PAM patient by mammography and that the stage of presentation in this group is not significantly different than in nonaugmented patients. Total mastectomy is preferred over breast-preserving procedures for the treatment of breast cancer in the PAM patient. Presented at the 46th Annual Cancer Symposium of The Society of Surgical Oncology, Los Angeles, March 18–21, 1993.     

Histological analysis of capsule formation around silicone implants and comparison with titanium-coated silicone implants in rats

Silicone implants have been used for breast augmentation for more than 45 years. Complications, in particular capsular contracture, occur with an incidence of <10% and up to 60%. We investigated the influence of the surface of breast implants on the formation of capsular contracture by comparing silicone with titanium-coated silicone. Seventeen smooth saline-filled silicone (group A) and 14 saline-filled titanium-coated silicone (group B) implants were implanted in female Wistar rats. After 12 and 36 weeks, the implants and capsules were extracted; histological and immunohistochemical staining was performed. The evaluation of the capsules was performed by two examiners in a double-blinded manner. Histologically, no significant difference in total capsule thickness was found. There was a significant difference in synovial-like metaplasia layer (SLM) thickness between groups A and B (p = 0.041). Regarding implantation time (12 vs. 36 weeks), a significant difference was found in SLM thickness (p = 0.021). Immunohistochemical staining indicated a significantly lower infiltration with inflammatory cells in group B. A significant correlation (p = 0.019) between a thick SLM layer and inflammatory cell infiltration was detected. Titanium-coated silicone implants reduce SLM thickness and capsular inflammatory cell infiltration. These findings postulate that titanium-coated silicone implants might point out a new chance in the prevention of capsular contracture.     

Antipolymer antibodies in Danish women with silicone breast implants

OBJECTIVE: To use a new immunologic assay to evaluate antipolymer antibody (APA) levels among women with silicone breast implants (SBIs). METHODS: Women (n = 186) were identified through Danish population-based registers and categorized into six groups defined by prior breast surgery (silicone breast implantation/breast reduction/no breast surgery) and by the presence or absence of a prior hospital diagnosis of soft-tissue rheumatism (muscular rheumatism, ICD-8 codes 717.90 and 717.99). The women underwent blood tests, including an APA test, a clinical examination, and an interview focusing on rheumatic complaints. Blood samples were tested blindly. The severity of rheumatic symptoms/signs was scored from 1 (none) to 5 (severe) based on the clinical examination and interview. RESULTS: Women with SBIs did not have higher levels of APA than women without SBIs. The majority of women with SBIs had mild rheumatic complaints, and the severity of their symptoms was not related to APA levels. Among women who had previously been hospitalized because of soft-tissue rheumatism, there were more fibromyalgia cases, and their symptoms were more severe compared with those women without prior soft-tissue rheumatism; however, APA levels were not higher among these women. There was a significant difference in APA measurements resulting from between-kit variation (p less 0.01). CONCLUSIONS: Our data did not demonstrate higher APA levels among women with SBIs compared with controls. The large variation observed between the individual plates in the APA test should be evaluated in future studies.     

Anti-silicone antibodies and silicone containing breast implants.

The detection of anti-silicone antibodies in patients with silicone breast implants (SBI) has been undertaken principally in the USA. We undertook a study of 20 women with SBI from different manufacturers from 6 weeks to 20 years after surgery, including those with ruptured implants. They were compared with three control groups: 20 women without implants, 20 women with auto-immune disease and 20 anonymous blood donors. Potential anti-silicone antibodies (IgG) were tested against a variety of silicone polymer antigens using an enzyme linked immunosorbent assay (ELISA) technique which had previously detected positive results in an uncontrolled series. Silicone-free collecting tubes were used. No differences were found between the patients with SBI and controls. However, samples that had been stored for the longest time, or frozen and thawed several times, had the highest levels. These false positives appear to be due to an unknown but human specific IgG binding phenomenon. We conclude that there is no demonstrable anti-silicone antibody formation in these patients with SBI and we would caution that the effect of storage may have been an important factor in previously published assay methods. This study supports the safety of silicone containing breast implants.     

Removal of silicone breast implants and review of literature

Silicone breast implants have a finite life span and may need changing over the lifetime of the patient. The experience with removing first- and second-generation implants is frustrating, because thick capsules often form, in association with rupture and spread of the silicone gel into the surrounding tissue. Different techniques have been employed to try and avoid an unnecessarily large incision, yet still control the dissection so that entire capsule and contained silicone can be removed en bloc. The authors describe a technique that facilitates atraumatic removal using an effective and time-saving vacuum principle.     

Effect of silicone breast implants on myocardial imaging

The authors investigated the effect of silicone breast implants (SBIs) on thallium-201 myocardial perfusion scintigraphy. Twenty-nine patients with SBIs and 14 control subjects were included in the study. All of the participants underwent a resting thallium-201 myocardial perfusion study. Comparison of the thallium images between patients with SBI and control subjects was done both visually and semiquantitatively. On visual analysis, neither image distortion nor image artifact attributable to the SBIs was noted. Semiquantitative analysis revealed that in patients with SBIs, the uptake values of the anteroseptal, anterolateral, lateroanterior, and lateroinferior myocardial walls was slightly, but significantly, lower than those of control subjects: anteroseptal, 87.7+/-6.0% vs. 92.8+/-5.1%; anterolateral, 88.0+/-5% vs. 92.6+/-4.5%; lateroanterior, 87.4+/-5% vs. 91.4+/-4.7%; and lateroinferior, 86.0+/-6.0% vs. 91.7+/-7.0%. The uptake value of the remaining walls in patients with SBIs were not significantly different than the control subjects. In conclusion, SBIs did cause a significant decrease in uptake values of the myocardial walls, which should be considered during interpretation of the images.     

Allergic reaction to platinum in silicone breast implants

Platinum is used as a catalyst in the manufacture of silicone breast implants. Because platinum is recognized as a potent sensitizer in certain circumstances, some have expressed concern that women with silicone breast implants are exposed to platinum, which is causing allergic reactions. We searched the literature for information on the level of platinum in breast implants and reports of sensitization that clearly related to platinum in women with breast implants. We found no published report with convincing evidence that platinum causes allergic reactions in women with breast implants or that women with breast implants are any more likely to have allergic reactions than women without breast implants.     

Frequency and distribution of talc contamination in patients with silicone gel-filled breast implants

Talc was found to contaminate peri-implant scars in patients with silicone gel-filled breast prostheses resulting from the physical interaction between implant and surgical glove. This study reports the frequency and distribution of the problem and its relationship to changes in glove manufacture. Peri-implant scar tissue, obtained from a population with breast implants, was evaluated for talc. Patients were considered positive if more than two talc particles were seen intracellularly in more than two microscopic fields. The largest Texas glove manufacturer stopped using talc in 1983. Patients were grouped to demonstrate the difference in talc exposure in Texas after this manufacturing change. Of those receiving implants before 1984, 136 of 140 were positive for talc. Of those receiving implants after 1983, 24 of 54 were positive (p < 0.000; RR = 42.5; CI: 13.7-131.6). Widespread prevalence of contamination was evidenced by findings of talc in patients from various facilities, different surgeons, and multiple sites within Texas.     

Breast cancer in a patient with silicone breast implants after 13 years

The patient described in this article is a 45-year-old woman who developed an infiltrating ductal carcinoma in her left breast next to a Silastic mammary implant that had been used for augmentation some 13 years previously. She underwent a modified radical mastectomy and removal of the silicone prosthesis with an axillary lymph node dissection. Twenty-six axillary lymph nodes were negative for metastatic disease. The 165-gram silicone gel prosthesis was surrounded by a thin fibrous capsule with an attached 1-cm carcinoma that did not invade the fibrous capsule. It appeared that the capsule presented a barrier to the invading ductal carcinoma. The fibrous capsule surrounding the Silastic implant may have altered the spread of the breast cancer without being related to its genesis.     

Analysis of local complications following explantation of silicone breast implants

A study was undertaken to analyse local complications in patients with breast implants and the total number of implant-related interventions when silicone breast implants were explanted. We studied 53 patients who had received breast implants for cosmetic augmentation or breast reconstruction following surgery for breast cancer at the time of explantation. The clinical records of all these patients were analysed, and clinical information on reason for implantation, implant properties, number and kind of implant-related interventions and reason for explantation was elicited. A complication was defined as a surgical procedure performed for any of the following reasons: capsular contracture, loss of implant integrity, haematoma or seroma, infection of the implant site, extrusion or wound dehiscence, and dissatisfaction with the result. The mean numbers of implant-related operations were 3.1 in patients who had undergone breast reconstruction and 2.3 in patients who had cosmetic augmentation (P < 0.03). We found a total of 35 complications in 28 patients, 21 patients (75%) each had one complication, five patients (18%) had two and two patients (7%) had three complications. A significantly higher incidence of early complications in patients who had undergone breast reconstruction (P < 0.03) marks the difference from complications in the cosmetic group, most of which arose after a longer time (P < 0.02). A complication analysis is presented. At the time of explantation, 78% of the patients decided to have a new implant, while 12% requested permanent removal of the implant without replacement. In the present study we saw no patients with connective tissue or other autoimmune disorders. When breast reconstruction or augmentation with silicone devices is considered, patients must be informed of the possible complications and of the potential choices in later implant-related revision surgery.     

Clinical and laboratory investigation of women with intact and women with ruptured silicone gel breast implants

In a retrospective study, 34 women with silicone gel breast implants were examined, 22 patients had intact (Group A) and 12 had ruptured (Group B) implants. The objective of the study was to investigate if there are any differences between Groups A and B regarding the clinical profile and the results of immunological and rheumatoid parameters. In addition, when connective tissue disease was diagnosed, was it associated with a leak of silicone gel. The average age of the women in the study was 46.9 years. The average duration of implant placement was 5.4 years in Group A and 11.3 years in Group B. The patients underwent a general clinical check-up with emphasis on symptoms of connective tissue disease. A clinical examination of the breast was performed to detect possible complications after augmentation. The laboratory studies were immunological and rheumatoid. Clinical results: In Group A, 1 woman (4.5%) demonstrated joint pain, 1 (4.5%) muscle pain, and 8 (36.4%) breast-specific symptoms. In Group B, one patient (8.3%) experienced joint pain and 6 (50%) breast-specific symptoms. There was no statistically significant difference in the frequency of abnormal clinical findings between the two groups. Laboratory results: Abnormal laboratory values were obtained in 15 women (68.2%) from Group A and in 5 women (41.7%) from Group B. There was no significant difference between the two groups. At follow-up, 22 patients with intact and 12 women with ruptured silicone gel breast implants demonstrated no significantly different abnormal clinical findings or laboratory results. None of the patients with pathological findings showed any evidence of connective tissue disease. Received: 28 October 1997 / Accepted: 5 May 1998     

Predictors of satisfaction in patient with silicone breast implants and its association with drug intake habits

Background: Satisfaction is an important outcome variable in surgical success. The purpose of this study is to evaluate predictors of satisfaction in women submitted to silicone textured breast implant surgery.

Methods: A retrospective evaluation of women receiving textured silicone breast implants was performed. Patients were divided in four groups: cosmetic cohort (n?=?104), reconstructive cohort (n?=?120), general population control cohort (n?=?120) and aesthetic control cohort (n?=?54). Data were collected based on information retrieved from patient records, a planned consultation and a self-administered structured questionnaire.

Results: Patient satisfaction was influenced by preoperative information (p?=?.007), cohort (p?p?p?Conclusion: The purpose of the surgery, preoperative information and the occurrence of postoperative complications have an impact on the degree of satisfaction of women submitted to silicone breast implant surgery. Women using psychotropic drugs are more likely to report poor satisfaction.     

硅胶假体隆乳咨询心理调查2000例及相关分析

目的 调查隆乳女性术前咨询时的心理状态,以探讨更好的隆乳咨询模式.方法 自2005年9月至2013年8月,对来我院咨询,但未行手术的2000例隆乳求美者进行了现场问卷调查,了解其心理状态.结果 分别对虽行隆乳咨询但未行手术的原因、咨询较多整形医师的原因、求美者期望的整形医师,3个心理状态调查后得出相关结果.结论 临床咨询过程中,首先应建立与求美者之间的信任感;并认真倾听其对手术的具体要求;运用规范化的流程进行咨询.这些措施有利于整形医师更好地开展咨询工作,并为更多的隆乳求美者提供高质量的服务.     

硅胶假体隆乳术并发症的防治进展

丰满的乳房是现代女性形体美的重要标志之一,乳房形态是否完美往往给某些女性心理产生很大的影响。硅胶假体隆乳术由Cronin和Cerow于1963年首创[1],是指将硅胶假体置入到胸部,使乳房体积扩大、形态丰满匀称,改善女性体型、恢复女性特有的曲线美的一种手术,至今已成为临床上成