Reconstruction of the breast after mastectomy for cancer.

Seventeen women who had had a mastectomy for cancer of the breast underwent reconstructions. Alloplastic implants were used in all. Preservation of the nipple and areola was possible in some of these patients. The normal (or uninvolved) breast sometimes required reduction in size or reshaping, to match as nearly as possible the reconstructed breast. The conditions suitable and unsuitable for mammary reconstruction, after mastectomy for cancer, are discussed.     

Anti-soya antibodies and trilucent breast implants

In light of the media attention surrounding the withdrawal of Trilucent breast implants in March of 1999, we undertook a study of 20 women with these implants to compare the level of serum antibodies to soya oil and protein with that of a control group. Two control groups were chosen: 20 women without breast implants and 20 women with silicone-containing breast implants. Serum antibodies to soya protein were detected with an enzyme-linked immunoabsorbent assay technique, because direct assay to soya oil is not possible owing to insolubility of the soya oil component. No antibody formation was detected in the patients with Trilucent breast implants or in either of the control groups, lending support to the view that these implants are unlikely to give rise to a systemic immune response.     

Silicone gel-filled breast implant integrity: a retrospective review of 478 consecutively explanted implants

Concern has been expressed over the long-term integrity of silicone gel breast implants. There are no large series representing experience with these implants outside of the United States. A retrospective case note review of explanted silicone breast implants was performed; 478 implants have been explanted during the past 11 years and relate to the use of these devices since 1971. Loss of implant integrity was not simply related to its age in vivo. Failure was more likely with implants of the late 1970s and early 1980s (second generation) and with subpectoral placement. Implant failure was independent of capsular contracture as the indication for removal (p = 0.09). There is no evidence that the currently used textured silicone gel breast implants are subject to the same loss of integrity as previous examples of these devices. The life span of these implants, the first of which are approaching 10 years in vivo, is at present unknown. Information concerning the integrity of silicone gel breast implants is essential in the current climate for counseling of both new and old implant recipients.     

Comparative experience with smooth and polyurethane breast implants using the Kaplan-Meier method of survival analysis.

Smooth-walled silicone implants have been widely used in breast surgery. Capsular contracture, causing undesirable firmness and spherical deformity, has been a common problem. Recent studies suggest that polyurethane-covered breast implants are associated with a lower incidence of capsular contracture. The statistical methodology employed in some of these studies, however, may be subject to criticism. Between July of 1984 and June of 1990 (72 months), 427 polyurethane breast implants were used in 279 patients and 439 smooth prostheses were used in 250 patients for a variety of aesthetic and reconstructive procedures. The occurrence of capsular contracture was carefully monitored and then analyzed using the Kaplan-Meier method of survival analysis. This method is particularly well suited to analysis of these types of clinical data because it allows for the fact that contractures occur at varying intervals after surgery and that follow-up of patients is incomplete. The probability of capsular contracture with smooth-walled prostheses was found to be significantly greater than with polyurethane-covered implants in each group of patients studied (p less than 0.05). Other complications occurred at a similar rate regardless of prosthesis type. This study supports the belief that polyurethane breast implants have a lower contracture rate; furthermore, it introduces the Kaplan-Meier method for analyzing the outcome of alternative plastic surgical therapies.     

Immunopathologic effects of silicone breast implants.

Silicone-gel breast implants have been associated with a myriad of autoimmune and connective tissue disorders by anecdotal reports and small observational series. To date, no prospective epidemiologic studies have been done to substantiate these observations, but an increasing body of literature is being developed and older studies are being recognized that point to immunotoxic or inflammatory effects of these breast implant components. The development of disease due to implants would depend on the interaction of genetic host factors so that only a few patients would potentially be at risk. Based on the example of other chemically mediated disorders, such as scleroderma in association with silica exposure, latency periods of more than 30 years before disease develops may be possible. Herein we review studies on silicone and immunity.     

The management of anterior chest wall deformity in patients presenting for breast augmentation

Anterior chest wall asymmetry is sometimes encountered in patients presenting for consideration of breast augmentation. The chest wall asymmetry or deficiency may be significant enough to consider reconstruction at the same time as breast augmentation in a small number of cases. Customized and prefabricated chest wall implants have been used in a variety of conditions including Poland syndrome, pectus excavatum, and sunken anterior chest. Careful moulage preparation and on-table implant modification are needed to "seat" these implants on the skeletal chest wall under the pectoralis major muscle. The chest wall implant provides a base for the subsequent breast prostheses and fills up a bony deficit that cannot be camouflaged by the breast prostheses alone.     

Long-term health status of Danish women with silicone breast implants

Long-term safety data are important in the evaluation of possible adverse health outcomes related to silicone breast implants. The authors evaluated long-term symptoms and conditions and medication use among 190 Danish women with cosmetic silicone breast implants compared with 186 women who had undergone breast reduction surgery and with 149 women from the general population. Breast implant and reduction surgeries were performed from 1973 to 1988 at one public hospital and one private plastic surgery clinic. Among women with breast implants, the average implantation time was 19 years, 60 percent (n = 114) had only one implantation, and 10 percent (n = 19) had undergone explantation before the time of study (1997 to 1998). The authors found no material differences in self-reported diseases or symptoms among study groups, except for breast pain, which was reported nearly three times as often by women with implants than by women with breast reduction (odds ratio, 2.8; 95 percent confidence interval, 1.4 to 5.3). Approximately 80 percent of women in each study group reported at least one symptom. No consistent differences were observed in the seroprevalences of antinuclear antibodies or other autoantibodies. Self-reported use of psychotropic drugs was higher among women with breast implants than among either control group. The authors conclude that long-term cosmetic breast implantation may cause capsular contracture and breast pain but does not appear to be associated with other symptoms, diseases, or autoimmune reactivity. The authors' finding of excess use of drugs for treatment of depression and anxiety among women with breast implants may warrant further investigation.     

Radiation therapy after immediate breast reconstruction with implants

The use of implants in immediate breast reconstruction is presently a common option. However, the practice should be evaluated in consideration of possible adjuvant therapies needed to control disease and to rule out negative interactions. This article discusses the effects of radiotherapy on breast implants with regard to the final cosmetic result. Six out of 124 cases of immediate breast reconstruction with implants were followed and evaluated in terms of capsular contracture and final aesthetic result after adjuvant radiotherapy and compared with the results of 118 patients who did not require irradiation. All of the patients who received irradiation demonstrated poor to fair results, with grade III to IV capsular contracture. Two patients received radiation therapy for local recurrences, which worsened their capsular contracture, emphasizing the deleterious effect of irradiation on breast implants. Statistical analysis of the results demonstrated a significant difference between the two groups in terms of capsular contracture and breast symmetry. In the selection of patient candidates for immediate breast reconstruction with implants, adjuvant radiation therapy must be considered as a contraindication, at least from an aesthetic point of view.     

Breast implants and cancer: causation, delayed detection, and survival

Concern for many women with breast implants has been focused on three topics: cancer (both breast and other cancers), delayed detection of breast cancer, and increased breast cancer recurrence or decreased length of survival. In this study, a qualitative review of the literature on these subjects was conducted, coupled with a meta-analysis of the risk for breast cancer or other cancers (excluding that of the breast). Researchers have consistently found no persuasive evidence of a causal association between breast implants and any type of cancer. The meta-analysis results obtained by combining the epidemiology studies support the overall conclusion that breast implants do not pose any additional risk for breast cancer (relative risk, 0.72; 95% confidence interval, 0.61 to 0.85) or for other cancers (relative risk, 1.03; 95% confidence interval, 0.87 to 1.24). This analysis suggests that breast implants may confer a protective effect against breast cancer. Women with implants should be reassured by the consistency of scientific studies which have uniformly determined that, compared with women without implants, they are not at increased risk for cancer, are not diagnosed with later-stage breast malignancies, are not at increased risk for breast cancer recurrence, and do not have a decreased length of survival.     

Polyurethane implants: a 6-year review of 416 patients

The author reviews 6 years of experience and 416 patients in whom polyurethane implants were used for augmentation and reconstruction of the breast. As with many other plastic surgeons, early use was confined to "salvage cases." Owing to the impressive results, use was extended to routine augmentation. Polyurethane implants are now used exclusively for aesthetic breast surgery. Results are evaluated for replacement of gel capsules and simple and radical mastectomy reconstruction. Gel capsules (Baker stages III to IV), in which prostheses were removed and replaced with polyurethane-covered implants, improved in 29 of 32 patients (87 percent). For reconstruction, placement of polyurethane implants in unscarred situations gives far superior results than following repeated procedures. The incidence of infection is no higher than with gel implants. Removal without capsulectomy was not a problem in most instances. However, on two recent occasions capsulectomy was extremely difficult.     

Comparison of the Postoperative Incidence Rate of Capsular Contracture among Different Breast Implants: A Cumulative Meta-Analysis

BackgroundA large number of clinical studies have reported that the different materials used in breast implants were a possible cause of the different incidence rates of capsular contracture observed in patients after implantation. However, this theory lacks comprehensive support from evidence-based medicine, and considerable controversy remains.ObjectivesIn this study, a cumulative systematic review examined breast augmentation that used implants with textured or smooth surfaces to analyze the effects of these two types of implants on the occurrence of postoperative capsular contracture.MethodsWe conducted a comprehensive search of literature databases, including PubMed and EMBASE, for clinical reports on the incidence of capsular contracture after the implantation of breast prostheses. We performed a cumulative meta-analysis on the incidence of capsular contracture in order from small to large sample sizes and conducted subgroup analyses according to the prosthetic material used, the implant pocket placement, the incision type and the duration of follow-up. Relative risks (RR) and 95% confidence intervals (CI) were used as the final pooled statistics.ResultsThis meta-analysis included 16 randomized controlled trials (RCTs) and two retrospective studies. The cumulative comparison of textured and smooth breast implants showed statistical significance at 2.13 (95% CI, 1.18-3.86) when the fourth study was entered into the analysis. With the inclusion of more reports, the final results indicated that smooth breast implants were more likely to be associated with capsular contracture, with statistical significance at 3.10 (95% CI, 2.23-4.33). In the subgroup analyses, the subgroups based on implant materials included the silicone implant group and the saline implant group, with significant pooled statistical levels of 4.05 (95% CI, 1.97-8.31) and 3.12 (95% CI, 2.19-4.42), respectively. According to implant pocket placement, a subglandular group and a submuscular group were included in the analyses, and only the subglandular group had a statistically significant pooled result of 3.59 (95% CI, 2.43-5.30). Four subgroups were included in the analyses according to incision type: the inframammary incision group, the periareolar incision group, the transaxillary incision group and the mastectomy incision group. Among these groups, only the pooled results of the inframammary and mastectomy incision groups were statistically significant, at 2.82 (95% CI, 1.30-6.11) and 2.30 (95% CI, 1.17-4.50), respectively. Three follow-up duration subgroups were included in the analyses: the one-year group, the two- to three-year group and the ≥five-year group. These subgroups had statistically significant results of 4.67 (95% CI, 2.35-9.28), 3.42 (95% CI, 2.26-5.16) and 2.71 (95% CI, 1.64-4.49), respectively.ConclusionIn mammaplasty, the use of textured implants reduces the incidence of postoperative capsular contracture. Differences in implant pocket placement and incision type are also likely to affect the incidence of capsular contracture; however, this conclusion awaits further study.     

Subfascial breast implant: a new procedure

Breast augmentation techniques using the submuscular and subglandular planes to introduce the implant are well known and widely used procedures. The authors have been using the subfascial dissection plane, a new concept for breast augmentation. From October of 1998 to September of 2001, 263 patients underwent breast augmentation. In all cases, the implants were inserted into the subfascial plane. McGhan 410 anatomic biodimensional, cohesive gel implants (size, 155 to 310 g) were used. There are additional benefits using this technique; these include avoiding implant deformation or distortion (as seen in the retromuscular position), leaving additional soft tissue between the implant and the skin, and minimizing implant edge prominence (inherent to retroglandular placement). These technical details lead to fewer patient complaints. Morbidity is similar to that of other techniques.     

Variability in the properties of silicone gel breast implants.

Several generations of silicone gel breast implants have been produced by implant manufacturers. The primary material usually viewed as the base material in the manufacture of implants is polydimethylsiloxane. Polymeric reactions are notorious for their variability and nonuniformity. The elastomer used in different types of implants can have vastly different properties. Furthermore, the material properties associated with a particular type of implant can vary considerably from one lot to the next. Considering the various designs, styles, and manufacturing techniques associated with silicone gel implants, knowledge of the original properties of the implants before implantation is important in determining the effects of aging in vivo. This study was conducted to investigate differences in key mechanical and chemical properties of silicone gel breast implant materials. The two types of implants chosen for analysis were Silastic I and Silastic II control implants. Material property data were determined for both types of controls and significant differences were found in their values. Lot-to-lot variability was also investigated and found to be significant.     

Mammographic measurements before and after augmentation mammaplasty

Thirty-five augmented women underwent mammography using both the standard implant-compression technique and, when possible, the implant-displacement technique; all had preaugmentation film-screen mammography available for evaluation. The area of mammographically visualized breast tissue before and after augmentation mammaplasty was measured using a transparent grid. Patients with subglandular implants had a mean decrease of 49 percent of measurable tissue area with compression mammography and a 39 percent decrease with displacement mammography. Patients with submuscular implants had a 28 percent decrease in measurable tissue area with compression mammography and a 9 percent decrease with displacement mammography. Anterior breast tissue was seen better with displacement mammography; posterior breast tissue, with compression mammography. Most patients had some degree of parenchymal scarring and lower image quality after augmentation. State-of-the-art mammography was not possible in most patients augmented with silicone-gel-filled implants.     

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.     

Immediate breast reconstruction with saline-filled implants: no interference with the oncologic outcome?

The possible adverse effects on cancer control due to immediate breast reconstruction have been addressed recently for both silicone-filled implants and flap reconstruction. To evaluate those possible effects after immediate breast reconstruction with saline-filled implants, 49 patients reconstructed with saline-filled breast implants at the Jules Bordet Cancer Institute were studied. Selection was only based on the possibility to find a matched patient. These patients were matched with a control group of 49 matched women with breast cancer treated in the same center by mastectomy without any type of breast reconstruction. The two groups were comparable according to age at diagnosis (within 3 years), year of diagnosis (same year), stage of the tumor, histology, and nodal status. The only difference between the two groups was that radiation therapy was applied to some of the patients who were not reconstructed (due to tumor location). The results show, in terms of local recurrences, distant metastasis, and deaths, no significant difference between the two groups, even for the irradiated patients, within a mean follow-up period of 72 months (range, 24 to 108) months.     

Prevalence of silicone breast implant rupture among Danish women

The durability of silicone gel-filled breast implants is of concern, but there are few epidemiological studies on this issue. To date, most of the relevant findings are derived from studies of explantation, which suffer from bias by including women with symptoms or concerns about their implants. As part of a long-term magnetic resonance imaging study of the incidence of rupture, this study involved 271 women with 533 cosmetic breast implants who were randomly selected from among women who underwent cosmetic breast implantation from 1973 through 1997 at one public and three private plastic-surgery clinics in Denmark. The prevalence of rupture was determined from the first magnetic resonance screening. The images were evaluated by four independent readers, using a standardized, validated form. The outcomes under study were rupture, possible rupture, and intact implant. Ruptures were categorized as intracapsular or extracapsular. Overall, 26 percent of implants in 36 percent of the women examined were found to be ruptured, and an additional 6 percent were possibly ruptured. Of the ruptured implants, 22 percent were extracapsular. In multiple regression analyses, age of implant was significantly associated with rupture among second- and third-generation implants, with a 12-fold increased prevalence odds ratio for rupture of implants that were between 16 and 20 years of age, compared with implants between 3 and 5 years of age. Surgitek implants (Medical Engineering Corporation, Racine, Wis.) had a significantly increased prevalence odds ratio of 2.6 for rupture, compared with the reference implants. No significant association was found with the position (subglandular or submuscular) or the type of implant (single- or double-lumen). Extracapsular ruptures were significantly associated with a history of closed capsulotomy (p = 0.001). In the future, the authors plan to examine the women in their cohort with a second magnetic resonance imaging scan to establish the incidence of rupture, a parameter unknown to date in the literature, and to further characterize those factors associated with the actual risk of rupture.     

Long-term results of MISTI gold breast implants: a retrospective study

MISTI Gold breast implants (Bioplasty, St. Paul, Minn.) filled with polyvinylpyrrolidone-hydrogel were developed as a promising alternative to silicone-filled implants. Some studies have reported on the positive effects of the implant, such as improved radiolucency and biocompatibility of the gel; however, there are also reports that such implants increased in volume and were subject to capsular contracture in the human body, resulting in demands for their removal. The purpose of this retrospective study was to analyze the long-term results of a series of patients with MISTI Gold breast implants. Between 1991 and 1993, the authors inserted 83 MISTI Gold implants in 61 patients with an average age of 46 years (range, 16 to 69). The authors were able to follow up 48 patients with 71 MISTI Gold implants. The average follow-up was 68 months (range, 10 to 108 months). The retrospective study found that 59 percent of all MISTI Gold implants were removed after an average period of 4.14 years. The main reason for implant removal was an increase in volume of 38 percent, followed by capsular contracture in 14 percent of all 71 MISTI Gold implants. The average increase in volume of all removed MISTI Gold implants was 43 percent. Capsular contracture was graded as Baker I and II in 63 percent and as Baker III and IV in 37 percent. In conclusion, the authors believe that MISTI Gold implants do not fulfill the criteria of safe breast implants, and they agree with the December of 2000 opinion of the Medical Devices Agency of the Department of Health in London that the hydrogel-filled breast implants should not be used until more information about the filler material and its metabolic fate is available.     

Antinuclear antibodies and breast implants.

Anecdotal reports have linked silicone breast implants to autoimmune diseases, with scleroderma being mentioned most often. In view of other environmental influences--such as silica mining and the toxic oil syndrome--thought to predispose to scleroderma, more systematic immunologic information on women with silicone implants is needed to assess any possible relation to autoimmunity. A cross-sectional survey was carried out with 150 women, of whom 131 had implants. Group 0 consisted of 19 volunteer women without breast implants who felt healthy, group I was 38 volunteer women with breast implants who felt healthy, group II was 82 women with implants who had various symptoms, and group III was 11 women with implants who had autoimmune disease. Scleroderma was overrepresented in group III (6 of 11). Antinuclear antibodies were determined on Hep-2 cells, using serum dilutions of 1:16, 1:64, and 1:256. A positive test was indicated by 1+ or more fluorescence at 1:256. Antinuclear antibody tests were positive in 0% of group 0, 18% of group I (P < .05 versus group 0), 26% of group II, and 64% of group III. There was no correlation between antinuclear antibody positivity and type of implant, indication for implantation, time since first implantation, total number of implants, and report of implant leak or rupture. Women with breast implants may be at risk for the development of antinuclear antibodies. Proof of such an association will require large-scale prospective studies and epidemiologic analyses.     

Trilucent breast implants: voluntary removal following the Medical Device Agency recommendation. Report on 115 consecutive patients

In June of 2000, the U.K. Medical Device Agency recommended the removal of Trilucent implants as a precautionary maneuver in response to reports of local inflammatory reactions. This decision allowed the authors to operate on 115 consecutive patients between June of 2000 and January of 2001. On the preoperative examination, the authors found a very high incidence of rippling (66 percent), whereas capsular contracture was seen in only three patients (2.6 percent). Rippling was significantly more common in patients with subglandular implants. Five implants were found ruptured during the operation. This figure, together with the relative ease of implant breakage at removal, shows a premature deterioration of the implant shell. The authors also comment on implant bleeding, which seems common in this type of breast implant. The authors think that this is a possible cause for the rippling phenomenon, resulting from a reduction of the implant content. On the basis of these findings, the authors conclude that Trilucent implants are associated with a poor cosmetic outcome and a high rate of complications.