Significant Capsular Contracture Research Articles

Trilucent breast implants: five years' experience from an Italian perspective.

In June 2000 the Medical Devices Agency (MDA) issued a Hazard Notice recommending the explantation of Trilucent breast implants (TBP) as a precautionary measure. Following that recommendation, we reviewed our series of 52 patients (71 implants) operated on from 1994 to 1998 to recall and advise those still harboring TBP. We have analyzed all the recorded adverse events in our setting before June 2000 to estimate the adverse reaction frequency and their time relation (review series). We have also recorded the rate of preoperative symptoms and postoperative findings in 23 patients (29 implants) who underwent explantation after the MDA recommendation (explantation series). In addition, some histologic observations have been made. The rates of significant capsular contracture (Baker 3-4) and explantations were estimated using the Kaplan-Meier method of survival analysis, and the rates of wrinkling and palpability were compared at 1 and 5 years of follow-up. Overall, the rate of grade 3-4 capsular contracture was approximately 45% at 6 years of follow-up with no statistically significant difference among the reconstruction and augmentation groups. The analysis of survival curves showed an overall rate of approximately 55% of explantations at 6 years. Preoperatively, capsular contracture and volume modifications were the most frequent findings in the explantation series. Postoperatively, most implants opposed inadequate resistance to the operative stress and ruptured, showing a creamy content. Free oil has never been found in tissue surrounding the periprosthetic capsule. In conclusion, it appears that the TBP-claimed advantages over other available implants seem to be inconsistent and the MDA advice appropriate. The problems related to these implants have had a great impact on public opinion in Europe and have contributed to the implementation of the conformity assessment procedures to be followed for medical devices: on the 4th February 2003 breast implants were in fact reclassified as class 3 products, in order to provide the best guarantee for health protection. The publication of a communication by the European Parliament in November 2001 gives us hope for the future.

Detection of subclinical infection in significant breast implant capsules.

The pathogenesis of fibrous capsular contracture after augmentation mammaplasty is still debated. One hypothesis implicates low-grade bacterial infections as a cause. The presence of a staphylococcal biofilm in a patient with recurrent capsular contracture was previously reported. A comparative, prospective, blinded, clinical study of implants and capsules removed from patients with or without significant capsular contracture was conducted to investigate the association of biofilm contamination, breast implants, and capsular contracture. Capsule and implant samples obtained during explantation were tested by routine microbiological culture, sensitive broth culture (after maceration and sonication), and scanning electron microscopy. Clinical parameters were correlated with microbiological findings. A total of 48 implant and/or capsule samples were obtained from 27 breasts during a 22-month period. Of the 27 breasts, 19 exhibited significant contracture (Baker grade III/IV). The mean duration of implantation was 9.2 years (range, 0.4 to 26.0 years). Routine swab cultures obtained at the time of explantation were negative for bacterial growth for all samples. The sensitive broth culture technique yielded 24 positive samples (50 percent, n = 48). An analysis of capsules demonstrated that 17 of 19 samples obtained from patients with significant contracture were positive, compared with only one of eight samples obtained from patients with minimal or no contracture (p = 0.0006). Fourteen of the 17 positive cultures from significantly contracted breasts yielded coagulase-negative staphylococci, mainly, species of the Staphylococcus epidermidis group. The presence of coagulase-negative staphylococci was also significantly associated with capsular contracture (p = 0.01). There was no significant difference in the frequency of culture positivity for saline versus silicone implants (p = 0.885). Scanning electron microscopy confirmed the presence of extensive biofilm on implants and within capsules.Biofilm, in particular, S. epidermidis biofilm, was detected for a significant proportion of patients with capsular contracture. This implicates biofilm disease in the pathogenesis of contracture, and strategies for its prevention should be explored.

Women’s Psychosocial Outcomes of Breast Augmentation with Silicone Gel-Filled Implants: A 2-Year Prospective Study by Thomas F. Cash, Ph.D. Lois A. Duel, M.S. Laura L. Perkins, Ph.D.

This study examined the experiences of 360 women receiving bilateral breast augmentation with Dow Corning's Silastic MSI (textured) or Silastic II (smooth) gelfilled 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. (Plast. Reconstr. Surg. 109: 2112, 2002.)

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.

Breast reconstruction using tissue expanders and implants in Hodgkin's patients with prior mantle irradiation.

Women treated for Hodgkin's disease with mantle irradiation have an increased risk for developing breast cancer. Typically, breast malignancy in Hodgkin's patients presents bilaterally in a younger age group. Skin flap ischemia, poor skin expansion, implant extrusion, capsular contracture, and poor cosmesis are common sequelae of tissue expander/implant breast reconstruction after breast irradiation for failed breast conservation therapy. This has led most surgeons to favor autologous tissue reconstruction in this setting. This study was performed to determine the efficacy of tissue expander/implant breast reconstruction in breast cancer patients who have been treated with prior mantle irradiation for Hodgkin's disease. A retrospective analysis of all breast cancer patients with a history of Hodgkin's disease and mantle irradiation treated with mastectomy and tissue expander/implant reconstruction between 1992 and 1999 was performed. There were seven patients, with a mean age of 35 years (range, 28 to 42 years). The average interval between mantle irradiation and breast cancer diagnosis was 16 years (range, 12 to 23 years). All patients underwent two-stage reconstruction. Textured surface tissue expanders were placed in a complete submuscular position at the time of mastectomy. Expansion was initiated 2 weeks after insertion and continued on a weekly basis until completion. Expanders were replaced with textured surface saline-filled implants as a second stage. Patients were evaluated for skin flap ischemia, infection, quality of skin expansion, implant extrusion, capsular contracture, rippling, symmetry, and final aesthetic outcome. Breast cancer was bilateral in five patients and unilateral in two. Two patients did not undergo simultaneous bilateral breast reconstruction because of metachronous cancer development. One of the patients had an initial transverse rectus abdominis muscle flap breast reconstruction, followed by a tissue expander/implant reconstruction of the opposite breast. The average follow-up was 3 years. Complications were limited to one case of cellulitis after implant placement that resolved with intravenous antibiotics. There were no cases of skin flap ischemia, poor skin expansion, or implant extrusion. Overall patient satisfaction was high and revisions were not requested or required. Symmetry was best achieved with bilateral implants. This study demonstrates the efficacy of tissue expander/implant breast reconstruction in patients treated with prior mantle irradiation. In this series, tissue expansion was reliable with low morbidity. Second-stage placement of permanent implants yielded good aesthetic results without significant capsular contracture. Mantle irradiation did not appear to compromise the prosthetic breast reconstruction. Tissue expander/implant breast reconstruction should remain a viable option in this category of irradiated patients.

Current Status of Breast Implant Survival Properties and the Management of the Woman with Silicone Gel Breast Implants

The survival properties of silicone gel breast implants are dependent on their vintage (year of manufacture), duration in situ and manufacturer. A total of 527 gel implants have been explanted and analyzed in the author's laboratories. Of the 28 first-generation implants (1963 to 1972), 27 (96.4%) remained intact after 14 to 28 years in situ (mean 20.8 years). Of the 216 second-generation implants (1973 to mid-1980s) that were explanted from 1992 to 1998, 158 (73%) had disrupted. Kaplan-Meier survival curves demonstrated significantly different survival properties among second-generation manufacturers. Surgitek implants were by far the least durable. After 14 years, all second-generation Surgitek implants had disrupted. By contrast, after 20 years, about half of the Dow Corning and Heyer-Schulte implants remained intact. Among third-generation implants (mid-1980s to 1992), 43 of 46 (93.4%) remained intact after a mean of 6.3 years (range three to 12 years). The three disruptions were Surgitek implants. Implants from other manufacturers remained intact. However, the disruption frequencies of third-generation implants have yet to be measured over the relevant periods of time. Survival patterns appeared to be related to the thickness of the elastomeric shell of the three generations of implants. Mechanical strength analyses of the elastomeric shells of explants have exhibited little or no large scale material degradation, even after as long as 28 years in situ. The mechanism of implant disruption likely involves the ‘fold flaw’ theory, whereby an internal abrasion can develop over time at the site of a fold in the implant wall. Diagnosis of disruption is difficult. Mammography is helpful only if there has been extravasation of silicone gel into breast tissue. Extravasation was observed in only 4.2% of second-generation implants removed from 1992 to 1998. It was not seen with first- or third-generation implants. Ultrasound analyses are not generally helpful to predict disruption because they are very operator dependent and because capsular contracture causes folds in the implant wall, which result in false positives. Magnetic resonance imaging is the most accurate imaging modality to detect implant disruption. However, this technology is not indicated for monitoring implant status because it is too costly and time consuming, and because it has significant limitations, particularly with first-generation and textured implants. Careful explantation and direct visual examination are the standards for diagnosing gel implant disruption. Many implant disruptions are likely ‘silent’, with no specific symptoms or clinical findings. After disruption, none of the following are elevated above the levels seen in control women without implant exposure: serum autoantibodies, blood and serum silicon, and the incidence of breast cancer, autoimmune disease or any other medical disease. There is no evidence to support the existence of any ‘novel’ or ‘atypical’ syndrome associated with gel implants. Women over 30 years of age with breast implants require regular monitoring for breast cancer detection. This should include monthly breast self examination and annual clinical breast examination. In addition, women over 50 years old require annual eight-view mammographic assessment using the implant displacement technique. Even then, breast implants have been shown to interfere with complete imaging, particularly if the implants are subglandular, large or associated with significant capsular contracture. A logical approach to explantation should involve consideration of a patient's personal concerns and anxiety, her implant vintage, the plane of insertion of her implants, her current clinical status and whether she chooses to replace her gel implants. Women requesting explantation require extensive information before deciding on surgery. At explantation, capsulectomy seems to be indicated if there is capsular calcification or major capsular thickening. (Pour le résumé, voir page suivante)

Breast conservation therapy after augmentation mammaplasty: is it appropriate?

Breast conservation therapy, consisting of lumpectomy, axillary node dissection, whole-breast irradiation, and a boost to the tumor bed, is an increasingly popular option for the treatment of breast cancer. Among patients with stage I and stage II disease, breast conservation therapy yields survival rates equivalent to those for mastectomy. The cosmetic results of radiotherapy are usually good, and this approach preserves an intact, sensate breast. Most studies on breast conservation therapy, however, have been performed in nonaugmented patients. Relatively little has been published regarding breast conservation therapy in the presence of silicone implants. Between 1981 and 1994, we treated 33 augmented patients with breast conservation therapy. Among 26 individuals for whom complete follow-up data were available, 17 (65 percent) developed significant capsular contracture on the irradiated side. Thus far 8 patients with radiation-induced contracture have undergone corrective surgery. In our experience, augmented breast cancer patients treated with breast conservation therapy have less satisfactory cosmetic results than nonaugmented women. In addition, mammographic follow-up, critical for identifying local recurrence, may be impaired by the presence of an implant and capsular contracture. On the basis of these considerations, breast conservation therapy may be less than optimal in augmented cancer patients unless explantation is performed before treatment.

Eighty-Four Consecutive Breast Reconstructions Using a Textured Silicone Tissue Expander

Breast reconstruction utilizing smooth-surface silicone tissue expanders is associated with certain problems. Significant capsular contracture may develop around the expander with subsequent expander displacement necessitating repositioning or capsulectomy at the time of expander removal. Infection, pain on expansion, chest-wall compression, and complications related to the remote fill valve also have been reported. A textured-surface silicone expander with an integrated fill valve was developed to address these issues. Eighty-four consecutive breast reconstructions were performed by a single surgeon using textured expanders in 55 patients. Intraexpander pressures were measured during expansion for a group of these patients, and both initial and postinflation pressure readings were quite low (average initial pressure 2.88 mmHg; average postinflation pressure 12.87 mmHg). Eighty-one of the reconstructions have been completed without any expander losses and with minimal complications. Tissue expander volume averaged 580 cc, and the expansion duration averaged 5.6 months. Various types and configurations of permanent implants were used to complete the reconstructions. Eighty-four percent of our patients' completed reconstructions (including nippleareola reconstruction and opposite breast alteration, when necessary) were accomplished with just two procedures. Seventeen long-term adjustable textured-surface expander/implants with anatomic breast shape are still in place, all after only one operation. The inframmary fold has generally been established passively by the expansion process alone. Textured-surface silicone expanders have stayed where positioned, have expanded easily with minimal patient pain, and have created a noncontractile soft-tissue cover for the final implant. The textured expander with an integrated fill valve has simplified breast reconstruction by helping to limit the problems encountered with smooth silicone expanders. The resulting reconstructions have remained soft with a very acceptable aesthetic appearance. The patient office and hospital charts and photographs of this consecutive series were notarized and submitted to the Editor of this Journal, whose biostatistician randomly selected the cases illustrated.

Use of Stacked Polyurethane-Covered Mammary Implants in Aesthetic and Reconstructive Breast Surgery

The use of stacked polyurethane-covered mammary implants has proven useful in improving results in the correction of deficiencies of mammary form and projection that can occur in certain cases of congenital and acquired breast deformity. The method has been used in 57 patients (102 breasts). The rate of significant complications, including seroma, rash, infection, hematoma, and capsular contracture, has been low (1 to 6 percent). Polyurethane-covered implants will maintain their position when used in a stacked system because of their unique biophysical characteristics, which include tissue bonding and a high friction coefficient between the implant surfaces.

Conservation Therapy for Breast Cancer Following Augmentation Mammaplasty

Breast conservation therapy (wide local excision, axillary lymph node dissection, and whole-breast irradiation) is an increasingly popular alternative to mastectomy for breast cancer patients. A sizable (and growing) number of breast cancers occur in women with prior augmentation mammaplasty. Augmented breast cancer patients are currently being treated with conservation therapy, but no study has investigated complications and cosmetic results of radiation therapy specifically in this group of women. Between 1981 and 1988, we used conservation therapy in 17 augmented breast cancer patients. Fifteen patients were available for follow-up. In 10 (67 percent), significant capsular contracture occurred in the irradiated breast an average of 12 weeks following completion of treatment. Four patients have undergone revisionary surgery to correct symptoms arising from contracture. This poor outcome contradicts the results reported in previously published studies. We conclude that irradiation of the breast for cancer in augmented women results in a high incidence of scar-tissue contracture and poor cosmetic results.

Use of a Permanent Tissue Expander for Breast Reconstruction

The use of tissue expansion in breast reconstruction is a recognized alternative surgical approach. The second generation of tissue-expanding prostheses is the permanent reverse double-lumen expander. In a series of 100 breast reconstructions using a permanent tissue expander, the clinical benefits of producing a moderate degree of mound ptosis along with observed reduction in pain during expansion are discussed. Additional advantages to the use of the device are the cost savings realized, elimination of a second procedure and a second anesthetic exposure, and a high degree of patient acceptance and satisfaction. This study includes breast reconstruction following mastectomies for malignant and premalignant disease, as demonstrated in 75 delayed and 25 immediate reconstructions, with the longest follow-up being 3 years. Complications of infection (3 percent), significant capsular contracture (4 percent), and implant failure (3 percent) are the most frequent and major complications observed yet. In no instance was breast reconstruction rendered unachievable in the face of these complications. The demonstrated results achieved with permanent tissue-expanding prosthesis, complemented by the obvious benefits and a low rate of significant complications, endorse this method as a viable alternative approach in reconstructive breast surgery.