"Out points" criteria for breast implant removal without replacement and criteria to minimize reoperations following breast augmentation

Breast augmentation is a totally elective, medically unnecessary procedure, and surgeons and patients must prioritize minimizing tradeoffs, costs, and risks at the primary operation and at reoperations. At the U.S. Food and Drug Administration's advisory panel hearings in October of 2003 to consider approval of conventional silicone gel implants, data documented an overall reoperation rate of 20 percent at just 3 years after primary breast augmentation. Subsequently, the premarket approval was not granted. Similarly high reoperation rates have been reported in previous saline and silicone gel premarket approval studies over the past two decades, demonstrating that high reoperation rates are not device dependent and suggesting a need to reexamine surgical management criteria. Bilateral implant removal without replacement limits additional reoperations in a wide range of clinical situations. Surgeons and patients often prefer other options to avoid removal without replacement, but other options carry a higher tradeoffs, costs, and risks to the patient. If minimizing tradeoffs, costs, and risks of reoperations is a priority, surgeons must define and patients must understand and accept "out points," that is, specific criteria for bilateral implant removal without replacement. Defining out points is challenging. Enforcing them when difficult clinical situations occur is even more challenging. This article presents out points that have been incorporated into staged, repetitive informed consent documents and used in the author's practice for more than 10 years. In peer-reviewed and published reports of more than 1600 patients, these out points criteria, in conjunction with the TEPID system (tissue characteristics of the envelope, parenchyma, and implant and the dimensions and fill distribution dynamics of the implant) of implant and pocket selection based on individual patient quantifiable tissue criteria and surgical techniques that minimize tissue trauma and bleeding, resulted in an overall reoperation rate of 3 percent in 1662 reported cases with up to 7 years of follow-up, compared with the 20 percent reoperation rate at 3 years in the most recent Food and Drug Administration study.     

The correction of capsular contracture by conversion to "dual-plane" positioning: technique and outcomes

Little has been published regarding the treatment of patients with long-established capsular contracture after previous submuscular or subglandular breast augmentation. This study reviews 7 years of experience in treating established capsular contracture after augmentation mammaplasty by relocating implants to the "dual-plane" or partly subpectoral position. A retrospective chart review was performed on all patients who were treated for capsular contracture using this technique between 1993 and 1999. Data collected included the date of the original augmentation, the original implant location, date of revision and type of implant used, length of follow-up, outcome, and any ensuing complications. Different surgical techniques were used, depending on whether the prior implant was located in a subglandular or submuscular plane. All patients had revisions such that their implants were relocated to a dual plane, with the superior two thirds or so of the implant located beneath the pectoralis major muscle and the inferior one third located subglandularly. Of 85 patients reviewed, 54 had their original implants in a submuscular position and 31 had their initial augmentation in a subglandular position. Of the 54 patients whose implants were initially submuscular, 23 patients (43 percent) had silicone gel implants, 15 patients (28 percent) had double-lumen implants, and the remaining 16 patients (30 percent) had saline implants. Of the 31 patients whose implants were initially subglandular, 20 patients (65 percent) had silicone gel implants, three patients (10 percent) had double-lumen implants, and the remaining eight patients (26 percent) had saline implants. Fifty-one patients (60 percent) had replacement with saline implants (37 smooth saline, 14 textured saline), whereas 34 (40 percent) had silicone gel implants (seven smooth gel, 27 textured gel). The average time from previous augmentation to revision was 9 years 9 months. The average follow-up time after conversion to the dual-plane position was 11.5 months. Only three of 85 patients required reoperation for complications, all of which involved some degree of implant malposition. Of patients converted to the dual plane, 98 percent were free of capsular contracture and were Baker class I at follow-up, whereas 2 percent were judged as Baker class II. There were no Baker level III or IV contractures at follow-up. The dual-plane method of breast augmentation has proved to be an effective technique for correcting established capsular contracture after previous augmentation mammaplasty. This technique appears to be effective when performed with either silicone or saline-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.     

Saline-filled breast implant safety and efficacy: a multicenter retrospective review

Our center undertook an industry-funded, outcomes-based, multicenter, retrospective review to evaluate the safety and efficacy of saline-filled breast implants. Our review was part of a pre-market approval review process mandated by the U.S. Food and Drug Administration. The design of our review was modeled on a Plastic Surgery Educational Foundation outcomes study previously conducted by our center. For this study, several significant changes were made to our previous protocol, including improved patient tracking, stronger biostatistical support, and a mandatory 10-year minimum patient follow-up period. Physician-reported and patient-reported data on 450 patients with 882 saline-filled breast implants placed between January 1, 1980, and June 30, 1986, were obtained. Mean patient follow-up period was 13.0 years. Most implants (93.9 percent) were placed for breast augmentation. Seventy-four percent were placed in a submammary position; 25.6 percent, subpectorally; and 0.2 percent, subcutaneously. The overall complication rate was 20.2 percent. Reoperation for capsular contracture or implant deflation was necessary in 104 of 450 patients (23.1 percent). Deflation occurred in 73 implants (8.3 percent) and was underreported according to the physicians' record review alone. This deflation rate is higher than the 5.5 percent previously reported by our center. However, 26 of these 73 deflations (35.6 percent) occurred in a single cohort of patients at one center using Surgitek saline implants. If this cohort is excluded, the deflation rate drops to 5.8 percent, a figure more consistent with data published in the literature and found in our previous study. Of the 73 deflations, spontaneous deflation was reported for 50 (74.6 percent), and the remainder were iatrogenic. Actuarial survival of the non-Surgitek implants was 98.4 percent to 99.8 percent at 5 years and 96.9 percent to 98.9 percent at 10 years (95 percent confidence interval). Risk factors for implant deflation included the use of Surgitek saline-filled implants (odds ratio = 17.5, p < 0.01), use of Heyer-Schulte and Mentor model 1800 implants (odds ratio = 3.0, p < 0.01), and implant size greater than 450 cc (odds ratio = 1.01, p < 0.02). Risk factors for capsular contracture included submammary implant position (odds ratio = 2.05, p = 0.03) and implant size greater than 450 cc (odds ratio = 1.01, p < 0.01). Overall, satisfaction was high: 93 percent of patients were "satisfied" or "very satisfied" with their implants. As in our earlier study, risk factors for patient dissatisfaction were reconstruction after mastectomy (odds ratio = 7.6, p = 0.011), significant breast firmness (odds ratio = 6.2, p < 0.001), and patient desire for smaller implants (odds ratio = 3.0, p = 0.020). In conclusion, our review provides additional outcomes-based evidence that saline-filled breast implants remain a safe, effective alternative to silicone gel-filled models.     

Self-reported symptoms among women after cosmetic breast implant and breast reduction surgery

A retrospective cohort study was performed in Sweden to evaluate the possibility that an individual symptom or constellation of illness symptoms related to silicone occurs in women after breast implant surgery. A random sample (n = 2500) of all women in the Swedish national implant registry who underwent breast augmentation surgery with alloplastic breast implants during the years 1965 through 1993 was compared with a sample (n = 3500) of women who underwent breast reduction surgery during the same period, frequency matched to the implant patients for age and calendar year at the time of surgery. In total, 65 percent of the breast implant patients (n = 1546) and 72 percent of the breast reduction patients (n = 2496) completed a self-administered questionnaire covering 28 rheumatologic and other symptoms and lifestyle and demographic factors. Practically all of the 28 symptoms inquired about were reported more often by women in the breast implant cohort, with 16 (57 percent) significantly more common in breast implant recipients. In contrast, few significant differences or consistent patterns were observed in the length of time since the implant and in the type (silicone or saline) or volume of the implant. Although women with breast implants report a multitude of symptoms more often than women who have breast reduction surgery, the lack of specificity and absence of dose-response relationships suggest that the excess of reported symptoms is not causally related to cosmetic implants.     

Rate and incidence of capsular contracture: a comparison of smooth and textured silicone double-lumen breast prostheses

Capsular contracture results in dissatisfaction and deformity among the 2 million women who have had silicone implants. The literature describes contracture rates as high as 74 percent. I present a comparison of rates and incidences of contracture in patients augmented with smooth and textured double-lumen silicone implants. A total of 165 "smooth" and 63 "textured" implant patients were included in this study, which spans 12 years, 1978-1990. All patients underwent bilateral aesthetic augmentation performed by the same surgeon. Of the 165 smooth implant patients, 74 (44.8 percent) experienced contractures requiring treatment. Of the 63 textured implant patients, 3 (4.8 percent) previous contracture patients experienced sudden fibrosis within 3 months. All others remained soft. It appears that deeply textured silicone surfaces delay or decrease the rate and incidence of clinical capsular contracture, at least for 2 years.     

Long-term use of polyurethane breast prostheses: a 14-year experience

I have used polyurethane prostheses for the past 14 years, implanting 220 implants into 130 patients who desired breast reconstruction after subcutaneous mastectomy or cancer ablation or simply breast augmentation. I theorize that a polyurethane-covered implant resists contracture, retaining its compressibility because the fibroblasts proliferate into the polyurethane in many different directions. When the fibrils contract, the forces of contracture counterbalance one another, resisting contracture. However, when smooth prostheses are implanted, fibrils are directed in a circular fashion around the implant and naturally contract, leading to firmer breasts. There were 115 prostheses inserted following subcutaneous mastectomy, and 22 percent developed contracted capsules. Seven implants became exposed because of skin necroses; one was removed because of a Staphylococcus infection; and two patients developed a combination of polyurethane and silicone granulomas. These developed only with the earlier implant, where there was shedding of the polyurethane sponge layer and silicone bled from the low-viscosity silicone used in the earlier implants. No granulomas were noted with the currently used Surgitek Replicon implant. Eighty-five breasts were reconstructed after cancer ablation with polyurethane implants, and the contracture rate was 2.3 percent. Other complications were minimal. A smaller group of patients had augmentation mammaplasty, and 20 prostheses were placed in 10 patients. A 15 percent contracture rate was noted in this group. In this study, 82 percent of patients were followed for up to 14 years. Capsular contractures occurred in 30 implants between 1 and 11 years, for an average recurrence at 6.3 years. The overall contracture rate was 13 percent. Other complications were minimal. All implants were placed subcutaneously or subglandularly, and all were drained.     

The effect of breast implants on the radiographic detection of microcalcification and soft-tissue masses

Current implants for breast augmentation containing silicone gel, saline, or both can totally obscure mammographic detection of microcalcifications and soft-tissue masses. To investigate the possibility of developing a more radiolucent implant, radiographs were obtained of silicone shells that contained silicone gel, saline, silicone gel and saline, polyurethane-covered silicone gel, gelatin, sunflower oil, and peanut oil. All radiographs were obtained using a Siemens Mammomat by placing the implant over an American College of Radiology mammography phantom. Results were measured by the ability to visualize or resolve the artifacts in the mammography phantom. The silicone shell alone minimally altered artifact resolution. Silicone shells filled with silicone gel, silicone gel and saline, saline alone, polyurethane-covered silicone gel, and gelatin were equal in radiodensity and completely obscured all phantom artifacts. Silicone shells filled with peanut oil and sunflower oil had equal radiodensity and allowed visualization of large microcalcifications and some soft-tissue masses. Current implants used for augmentation mammaplasty can totally obscure mammographic detection of microcalcifications and soft-tissue masses. A more radiolucent breast implant is possible, and further research is needed to define the best filler material and test its biocompatibility.     

An analysis of telephone interview data collected in 1992 from 820 women who reported problems with their breast implants to the food and drug administration

How health care providers deal with concerns and feelings of women who have problems with their breast implants affects the women's satisfaction with their breast implants, yet in 1992 little was known about the concerns and feelings of these women. A qualitative analysis of in-depth telephone interviews conducted in 1992 with 820 women from all regions of the United States who reported problems with their breast implants to the Food and Drug Administration and responded to an invitation to be interviewed provided data. Respondents were primarily 40 to 69 years of age at the time of interview, Caucasian, married, and educated beyond high school. The sample was almost equally divided in reason for breast implants, with 65 percent being dissatisfied with their breast implants. Nearly all of the women had heard of problems with silicone gel-filled implants. Their main sources of information were television, newspapers, and magazines rather than their physicians or the breast implant manufacturers. Some women tried to avoid hearing the reports, and many tried to put the reported problems out of their minds. However, a majority (88.7 percent) wanted more information. The women expressed feelings of anger, regret, and worry, and repeatedly said they needed more information. Women who contacted the Food and Drug Administration about breast implant problems needed accurate and honest information from health care professionals. They wanted their physicians to explore their symptoms, fears, and concerns.     

Self-reported diseases and symptoms by rupture status among unselected Danish women with cosmetic silicone breast implants

Epidemiologic evidence does not support an association between silicone breast implants and connective tissue or other rheumatic diseases. However, a recent study has suggested that women with ruptured implants may be at increased risk of developing fibromyalgia. An analysis of adverse health outcomes according to breast implant rupture status was conducted in 238 unselected Danish women with cosmetic silicone breast implants. Ninety-two of the women had definite implant rupture, and 146 had intact implants as determined by magnetic resonance imaging. Before undergoing imaging, the women provided blood samples and completed a self-administered questionnaire. Women with ruptured implants overall, and the subgroup with extracapsular ruptures (n = 23), were compared with women with intact implants regarding a number of self-reported diseases and symptoms and the presence of specific autoantibodies, such as antinuclear antibodies, rheumatoid factor, and cardiolipin immunoglobulin G and M antibodies. Overall, there were no differences in the occurrence of self-reported diseases or symptoms or in the presence of autoantibodies between women with intact implants and women with ruptured implants, including extracapsular rupture. The only exception was capsular contracture, which was reported six times more frequently by women with extracapsular ruptures than by women with intact implants (OR, 6.3; 95 percent CI, 1.7 to 23.5). In conclusion, this study of unselected women with silicone breast implants could establish no association between silicone implant rupture and specific diseases or symptoms related to connective tissue disease or other rheumatic conditions, except for an excess of capsular contracture among women with extracapsular rupture.     

Women's psychosocial outcomes of breast augmentation with silicone gel-filled implants: a 2-year prospective study

This study examined the experiences of 360 women receiving bilateral breast augmentation with Dow Corning's Silastic MSI (textured) or Silastic II (smooth) gel-filled mammary implants. Before surgery, the women completed a quantitative assessment of their surgical expectations and concerns. At 6, 12, and 24 months postoperatively, they rated their satisfaction with surgery and its specific psychosocial outcomes, their concerns, and benefits-to-risks appraisals of the augmentation. The women reported very high levels of satisfaction with the procedure and its psychosocial outcomes, which did not change over time. Throughout the 2-year period, over 90 percent of the women were satisfied with surgery and their resultant body-image changes. Their concerns about risks, reported by 19 percent before surgery, declined after surgery and remained subsequently stable. Most participants (75 to 85 percent) reported that the benefits of surgery exceeded its risks. Postoperative events such as significant capsular contracture that compromised aesthetic results diminished aspects of satisfaction, whereas less obvious events did not. Systematic analysis of attrition (i.e., missing assessments) did not indicate any biases because of complications or psychosocial outcomes. Evaluation of a possible impact of the publicity surrounding the Food and Drug Administration's voluntary moratorium on the use of silicone gel-filled breast implants, which occurred during the study, revealed a limited effect, if any, on women's psychosocial outcomes. Findings are discussed in relation to the study's methodological strengths and limitations and with respect to the broader context of patient care.     

Capsular contracture after breast reconstruction with silicone-gel and saline-filled implants: a 6-year follow-up

A major problem after breast reconstruction with augmentation mammaplasty is contracture of the fibrous capsule around the prosthesis. In a series of 72 breasts in 65 women, silicone-gel and saline-filled implants were randomly selected prior to breast reconstruction. The results were judged with respect to consistency, tenderness, wrinkles, and sounds by two independent plastic surgeons according to the breast augmentation classification (BAC) and by the patients themselves. Capsular contracture was found by the surgeons in 50 percent of the gel implant group and in 16 percent of the saline implant group, which is in conformity with the results of the follow-up 5 years earlier. The incidence of deflation was 16 percent in the saline group and occurred in different sizes of both overinflated and underinflated prostheses. The degree of slow leakage from saline implants will be discussed. Despite the high rate of contractures in the gel group, 85 percent of all patients were satisfied with the result of the reconstruction.     

Postmastectomy breast reconstruction in Connecticut: trends and predictors.

Using the population-based Connecticut Tumor Registry, postmastectomy breast reconstruction was examined in the 10,756 breast cancers in Connecticut women (including 10,133 in white women and 554 in black women) diagnosed from 1988 to 1995. Reconstruction increased from 6.4 percent of cancers in 1988 to 9.1 percent in 1991, but it declined to 4.7 percent of cancers in 1992 (when the Food and Drug Administration instituted a restriction on the use of silicone gel implants); by 1995, the rate had recovered to 8.5 percent. Reconstruction was negatively associated with age, poverty rate of the census tract of residence, and black (versus white) race; these associations require further study.     

Recurrence of subglandular breast implant capsular contracture: anterior versus total capsulectomy

The objective of this study was to determine whether the type of capsulectomy, anterior or total, affects the recurrence of capsular contracture around subglandular silicone-gel breast implants. A retrospective analysis was performed of patients who underwent either anterior or total capsulectomy for Baker grade 3 or 4 subglandular capsular contracture in our unit. All patients were invited to a review clinic where their capsular status was assessed. There were 100 anterior- disc capsulectomies in 60 patients between 1988 and 1997 and 99 total capsulectomies in 60 patients between 1990 and 1998. The follow-up in the former group was a median of 7 years and mean 6.9 years, compared with median 2.5 and mean 3.1 years in the latter group. Eighty-six percent of the implants removed from both groups at capsulectomy were smooth-walled gel-filled implants. Sixty-nine breasts in the anterior group received textured gel implants at capsulectomy; the remaining 31 received polyurethane-coated Meme implants. In the total capsulectomy group, all but two breasts (one patient) received textured gel implants. After review, the capsular status was known in 80 percent of the anterior and 92 percent of the total capsulectomy group. The review clinic found eight new contractures in five patients to have developed in the anterior compared with none in the total group. Recurrent contractures affected 50 percent of patients (46 percent of breasts) in the anterior and 11 percent of patients (10 percent of breasts) in the total capsulectomy group. Kaplan-Meier survival analysis was applied to the data. By including only patients who received textured gel implants at capsulectomy, the Logrank found a statistical difference between the two treatment groups (0.01 < p < 0.5). We believe that this study provides some evidence that total capsulectomy for subglandular silicone breast implant capsular contracture results in a lower capsular recurrence than anterior- disc capsulectomy. The pattern and risk of recurrence after total capsulectomy and exchange for a modern textured prosthesis appear to approach those following primary augmentation.     

Breast augmentation: choosing the optimal incision, implant, and pocket plane

A retrospective study of 220 patients was performed to review surgical design in breast augmentation. Three specific issues were studied: incision site, implant variables, and pocket plane selection. The influence of these three factors on aesthetic results in both primary and secondary cases was the focus of the analysis. No attempt was made to address long-term issues such as capsular contracture or saline implant deflation rates. In 77 primary augmentation patients and 80 unilateral augmentations for symmetry in breast reconstruction, there were the following untoward results: 11 revisions for unilateral malposition, change to a different implant shape, or change to a larger implant size; four deflations of saline implants requiring replacement; and four conversions of saline to silicone gel implants. In 63 secondary cases, there were two hematomas and two infections requiring implant removal and subsequent replacement. Operative technique in breast augmentation is described, as are recommendations for each of the options associated with the three variables studied.     

Effect of povidone iodine on silicone gel breast implants in vitro: implications for clinical practice

Irrigation of breast implants and breast implant pockets with various solutions, including povidone iodine, has been a common practice among plastic surgeons for many years. Recent reports of potential weakening of silicone tubing have led the Food and Drug Administration to pronounce any contact of povidone iodine with breast implants a contraindication. An in vitro experimental study was undertaken to assess the effect of povidone iodine on the physical properties of silicone breast implant shells. Identical specimens were obtained from the shells of silicone breast implants according to published standards. The specimens were randomly assigned to eight groups of five and incubated in various solutions of decreasing concentration of povidone iodine (10% to 0.01%), and a control group (0.9% saline) was used. The containers were stored in a warming cabinet at 37 degrees C for 4 weeks. Testing of the specimens for tensile strength following 4 weeks of incubation showed no significant difference among any of the groups, including the control group. In addition, no correlation was shown between the concentration of the solution used and the tensile strength of the specimens.     

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.     

Aesthetic augmentation of the malar-midface structures

Based on extensive experience with bone grafts for augmentation of the midface-malar region, an implant design has been developed using Proplast. After careful preoperative assessment, a very specific surgical method, described herein, allows precise implant positioning without the need for suture fixation. In many instances, the 6-mm implant can be inserted unchanged. One-hundred and six patients have been operated on using 176 implants over the past 6 years. There were four unilateral infections (2.3 percent of implants and 3.8 percent of patients). None had permanent motor or sensory nerve problems. Fifteen implants (8.5 percent) in 12 patients (11.3 percent) were either removed or repositioned. In those having augmentation for entirely aesthetic reasons, 3 of 60 patients (5.0 percent) required implant removal or repositioning. The incidence of needing to remove or reposition implants has decreased as the technique has evolved.     

Biocompatibility of radiolucent breast implants

Current implants for breast augmentation containing silicone gel, saline, or both are radiopaque on mammographic examination and can totally obscure microcalcifications and soft-tissue masses. The effect of these implants on the detection of early breast cancers in patients who have undergone augmentation mammaplasty remains unproven and controversial. Implants filled with medium-chain triglycerides (peanut oil) are radiolucent on mammographic examination and allow visualization of both soft-tissue masses and microcalcifications. To investigate the biocompatibility of radiolucent implants, 10 cc of sterile, nonpyrogenic peanut oil was injected subcutaneously into rats using silicone gel as a control. Twenty-one rabbits had two 125-cc silicone shell implants inserted on either side of the chest wall. The right-sided shell was filled with 125 cc of sterile saline, and the left-sided shell was filled with 125 cc of sterile, nonpyrogenic peanut oil. Results were determined by both histologic and radiographic examination. Rats injected with peanut oil equivalent to 7 percent of their body weight rapidly absorbed the freely injected oil without detriment. Histologic examination of the lungs, liver, kidneys, and tissues adjacent to the injection sites demonstrated no abnormalities. There was no evidence of allergic, toxic, inflammatory, or neoplastic response. Eighteen of 21 rabbits survived more than 3 months. Radiographs showed the oil-filled implants to be radiolucent, whereas the saline-filled controls obscured the surrounding soft and bony tissues. Histologic examination demonstrated a fibrous capsule surrounding both types of implants. Histologic examination of the lungs, liver, and kidneys showed no significant abnormalities. These and previous studies have shown peanut oil to be biocompatible when freely injected either intramuscularly or subcutaneously. This study demonstrates that a radiolucent, peanut oil-filled implant is biocompatible in animals and that further long-term studies for its use in humans are merited.     

Ten-year review of a prospective randomized controlled trial of textured versus smooth subglandular silicone gel breast implants

Although textured silicone breast implants have been shown to reduce the incidence of capsular contracture, there is little evidence if this effect is maintained in the long term. It has been 10 years since the double-blind randomized trial in which 53 patients received either Mentor smooth (26) or textured silicone gel implants (27). Of the 14 patients who were not known to have developed a contracture in the smooth group, 11 were reviewed. Three had bilateral contractures. In the textured group, 18 of the 24 patients not known to have contractures were reviewed. None had developed contractures. At 10 years, the incidence of capsular contracture was 65 percent of patients with smooth implants (an increase of 6 percent on the 3-year results) and 11 percent for the textured implant patients (no change on the 3-year results). A database containing the details of 1100 patients reinforces these results by examining the differences in contracture rates of textured, smooth, and polyurethane-coated implants. The effect of submuscular placement on reducing contracture rates regardless of texturing is discussed, as is the apparent increase in capsular contracture in patients who smoke.