不同类型乳房假体隆乳术后并发症的临床分析

目的 统计不同类型的乳房假体置人人体后，远期并发症发生的几率，并分析其原因。方法 总结1993年至2002年间假体隆乳573例，随访到手术方法相同、假体放置位置相同、同一医生组手术的隆乳妇女427例共852只乳房，使用4种不同类型乳房假体：毛面硅凝胶、光面硅凝胶、毛面生理盐水充注式、光面生理盐水充注式乳房假体。出现的远期并发症有纤维包膜挛缩、假体破裂渗漏、疼痛移位等，对各种假体并发症发生率进行统计分析，比较各类假体的优劣。结果 427例852只中803只效果满意，无明显并发症，占94．24％。发生并发症者42例49只乳房，占5．76％。并发症中乳房硬化属Baker‘s分级Ⅲ～Ⅳ级的有26只，缩小变形24只，移位疼痛10只，经手术取出发现假体破裂渗漏的有30只。其中纤维包膜挛缩引起乳房硬化多发生于硅凝胶假体，假体渗漏引起乳房缩小变形多发生于生理盐水充注式假体；假体在体内放置时间越长，发生并发症的几率越高。结论 经统计学处理发现，光面生理盐水假体并发症明显少于光面硅凝胶假体，毛面硅凝胶假体和毛面生理盐水假体并发症发生率没有明显差异。49只有不同并发症的乳房假体中有30只假体破裂渗漏，占61．22％，假体破裂渗漏后又容易引发其它并发症，说明假体质量的提高是减少并发症的关键，长期留置体内假体的老化是目前的难题。     

Effect of cortisone on capsular contracture in double-lumen breast implants: Ten years' experience

Two groups of patients are compared with respect to capsular contracture after insertion of silicone breast prostheses. Six hundred seventy four women received single-lumen gel prostheses and 700 received double-lumen prostheses with cortisone. The addition of 12.5 mg of prednisolone to double-lumen prostheses diminished capsular contracture (Baker II to IV) dramatically; in patients with simple augmentation from 19% to 4.9%, in patients with subcutaneous mastectomy from 54% to 14.9%, and in patients with breast reconstruction from 64% to 24.4%. The use of double-lumen implants has three distinct advantages: (l) There is no bleeding and therefore no contact of the body with the silicone gel. (2) There is no danger of ruptured implants, even if the outer shell shows leakage. (3) if prednisolone is administered, capsular contracture is prevented to a significant degree.     

Inflammatory Reaction and Capsular Contracture Around Smooth Silicone Implants

Histologic studies were performed on capsular tissue resected from 21 patients who were implanted with smooth silicone prostheses filled with gel. The results disclosed a non-uniform response to the implants. The granulomatous reaction to the silicone showed important variations along the same surface of the implants, between the plane and the concave surfaces, between equivalent points at the right and left sides, and among the patients. Also, a significant difference was observed between reactions and capsules in early and late stages. The author believes these variations of the capsular inflammatory reaction promote different sites of contraction between cell-to-cell, or cell-to-collagen-to-cell. These adding forces result in vectors of different intensities and directions around the implants which explains the various clinical grades of capsular contracture.     

Polyurethane-covered mammary implants: a 12-year experience.

Polyurethane-covered mammary implants are the implants of choice in aesthetic and reconstructive mammary surgery. These implants give very good results in regard to breast contour and consistency, and have a very low complication rate. We present our 12-year experience using polyurethane-covered prostheses. We place the implant mostly in the subglandular or subcutaneous site, and their capsular contracture rate is extremely low (3.3%). Based on our experience, we also review the other complications and side effects occurring with polyurethane prostheses and discuss them in detail.     

Preliminary (3 years) experience with smooth wall silicone gel implants for primary breast augmentation

The goal of this study is to obtain data concerning the incidence of capsular contracture and reoperation rates in patients having primary breast augmentation utilizing modern low-bleed smooth-wall silicone gel implants. Data were collected retrospectively and consisted of 44 patients who underwent primary breast augmentation using smooth silicone gel implants (Mentor Corporation) in the period between 2001 and 2003. Of the 131 patients identified, 44 patients fit the criteria of primary breast augmentation. Secondary cases and primary augmentation with mastopexy were excluded from this study. This group of patients is still followed, and the data are being updated periodically. A total of 44 patients underwent primary breast augmentation. Average age was 32 years (range, 19-57). Average follow-up was 34 months (range, 28-40). Average operative time was 52 minutes. The inframammary incision was used in 65% of patients and the areolar incision in 35%. The subglandular position was used in 35% of patients versus the submuscular position in 65%. Nine patients (20%) developed capsular contracture. Six patients (13.6%) had Baker 3 capsular contracture, which required revision. Four of the 9 patients with capsular contracture had implants placed in the submuscular space and 5 in the subglandular position. Relative to the implant position, 4 patients (9%) with implants placed in the submuscular position developed capsular contracture. Relative to the subglandular position, 5 patients (11.3%) with implants placed in the subglandular position developed capsular contracture. Eight patients (19%) required implant revision, 6 patients for capsular contracture, and 2 patients requested size change. Preliminary data from this study indicate that the use of the new generation of gel implants yields less capsular contracture, as well as decreased revision rates. Subglandular placement of gel implants did not significantly increase the risk of capsular contracture. Longer follow-up and multicenter studies are still needed to confirm these findings. This cumulative data could challenge the current status of gel implant moratorium imposed by the incidence of capsular contracture and revision rates.     

Silicone gel implants in breast augmentation and reconstruction

Silicone gel implants have been widely used for breast augmentation and reconstruction since the 1960s. Several alterations to both elastomer shell and filler gel have been made over the years to improve their ability to replicate the natural breast and to decrease the incidence of capsular contracture. The latter is a pathologic process involving the periprosthetic tissues formed in response to the presence of the implant. When severe, capsular contracture may cause firmness, distortion, and pain. In response to many claims of implant-related connective tissue disease, the US Food and Drug Administration placed a moratorium in 1992 on silicone gel breast implants for cosmetic purposes. Despite a preponderance of scientific data to their safety, silicone gel implants are presently available in the United States only as part of limited clinical trials. They continue to be used in Europe and other parts of the world.     

A Ten-Year Experience Using Polyurethane-Covered Breast Implants

The purpose of this study is to disclose the low incidence (0.98%) of capsular contracture using polyurethane-covered silicone gel breast implants. Four hundred seven surgical interventions were performed during the 10-year period, 404 for hypomastia and 3 for breast reconstruction.     

A new biologically,osmotically, and oncotically balanced gel that shows calcifications blocked by silicone

The radiodensity of silicone gel-filled breast implants is well documented. It has been suggested that silicone gel may block the transmission of x-rays sufficiently to prevent visualization of microcalcifications that are frequently an indicator of malignancy. A new biologically, oncotically balanced gel has been developed that has increased radiotranslucency to approximately the density of normal breast tissue, increased lubrication qualities, and is quickly and safely eliminated by the body should the shell rupture. We present a case wherein a patient's mammogram was read as negative two years prior to breast reaugmentation due to Baker IV capsular contracture. During surgery, complete calcification of the capsule was discovered, as well as two ruptured prostheses; neither condition had been detected by the mammogram. These capsules, with their calcifications and scar intact, were removed in toto and radiographically compared through standard silicone gel-filled breast implants and through implants containing the new biologically, osmotically, oncotically balanced gel. The calcifications were completely obscured by the silicone gel-filled prosthesis and completely visible when viewed through the bio-oncotic gel-filled prosthesis. Postoperative mammograms confirmed the radiolucency of the new gel-filled prostheses. This new gel appears to be a reasonable alternative to silicone gel for filling breast implants. Note: Dr. Ersek is a shareholder of Bioplasty, Inc. and therefore has a financial interest in this gel.     

Colchicine and capsular contracture around breast prostheses

Capsular contracture around the prosthetically reconstructed, breast is a very common problem which often leads to an unacceptable result. Colchicine, a drug known to inhibit contracture activity, was studied in an animal model of capsular contracture. Twenty-four 130 cc silicone gel breast prostheses were implanted subcutaneously into twelve rabbits. Colchicine was given daily in oral doses to half of the animals; the other half were used as controls. The prostheses were maintained insitu for two months. The degree of capsular contracture, as measured by applanation tonometry, was significantly less in the colchicine treated groups. The difference was often visually apparent. This study appears to be the first to demonstrate a significant inhibition of capsular contracture in an animal model by colchicine, an oral medication commonly used in the treatment of gout.Hospital where the work was done: Providence Hospital Southfield, Michigan, USA Correspondence to: C.B. Kelly     

Subjective and objective assessment of capsular contracture

Summary Contraction of the fibrous capsule around an implant after prosthetic breast surgery is a serious complication, which can adversely effect the outcome and spoil the overall result. Textured silicone implants are reported to have reduced rates of capsular contraction, but their exact mechanism, especially at the interface, remains unclear. Over a period of 21/2 years, 94 textured silicone implants were used in augmentation mammoplasty. A follow-up examination was possible in 74 cases. The clinical assessment of results was based on Baker's classification. In addition to the subjective assessment of breast firmness, objective measurements (mamma compliance) were obtained. The average follow-up period was 55.6 weeks. 79.7% of augmented breasts were classified as Baker I, 16.2% as Baker II, 4.1% as Baker III and 0% Baker IV In comparison to previous results reported in the literature, the incidence of capsular contracture obtained with textured implants was significantly lower. All Baker III cases were replacements of the original implant following advanced capsular contraction. The compliance measurements were found to correlate well with Baker's classification. Sixty-one of 72 cases of augmented breasts showed compliance values similar to normal breasts, which ranged between 0.64 and 3.7 cm at D20n. This measurement proves that 82.4% of the augmented breasts are as soft as normal breasts. A partial comparison between our clinical data and histological examination was possible. Firm adhesion of the capsule to the surface of the implant was characteristic of those breasts which showed no capsular contracture, while in breasts showing advanced capsular contraction, implant and capsule were separated by a liquid film. The use of surface textured silicone implants has led to a significantly decreased rate of capsular contraction without having to employ steroids. Close contact between implant and capsule seems to be the most important factor for reduced capsular contraction.     

Silicone breast prostheses: A cohort study of complaints,complications, and explantations between 2003 and 2015

Background

Complications after silicone implantation, with silicone extravasation being the most severe, remain a safety issue in breast implantation surgery. The purpose of our study was to determine the incidence of medium- and long-term postoperative complaints and complications and indications for explantation in patients with a silicone breast implant.

Breast Implant Stability in the Subfascial Plane and the New Shaped Silicone Gel Breast Implants

The author presents his experience with breast augmentation using a next-generation, form-stable, anatomically shaped silicone gel breast implant. Rotation is a potential complication for anatomically shaped breast implants. Anatomically shaped saline implants have been reported to have a rotation rate as high as 14%, while lower rotation rates of 1–2.6% for anatomic cohesive gel silicone implants have been reported. Currently, these implants are limited in the United States to US FDA-approved clinical trials. The author reviews the appropriate surgical techniques to prevent rotation when using these devices. A recent innovation, placement of the superior pole of the implant underneath the superficial fascia of the pectoralis major muscle, is described. Primary and secondary breast augmentations in 241 procedures using the Allergan Style 410 implant resulted in a 0.0% rotation rate. Overall, the anatomic form-stable silicone gel breast implants, when placed subfascially, improve common complications such as capsular contracture and implant rupture with improved aesthetic outcomes and patient satisfaction.     

Titanium-coated polypropylene mesh (TiLoop Bra®)—an effective prevention for capsular contracture?

Background

Silicone implants have been used in breast augmentation for more than 45 years. Complications, in particular, capsular contracture, still occur with a high incidence. Titanium-coated polypropylene mesh (TCPM; TiLoop Bra®, pfm medical, Cologne, Germany) provides new opportunities for implant-based breast reconstruction. We investigated the influence of the surface of silicone implants on the formation of capsular contracture by comparing textured silicone with TCPM-covered smooth silicone implants.

Methods

Twenty textured silicone gel-filled (group A) and twenty TCPM-covered smooth silicone gel implants (group B) (Silimed®, Rio de Janeiro, Brazil) were implanted in female Wistar rats. After 60 days, the implants and capsules were extracted, and histological and immunohistochemical staining was performed. The double-blind evaluation of the capsules was performed by two examiners.

Results

We were able to detect a thinner, but stiffer, capsule and a less development of an inner synovia metaplasia layer as well as a lower vascularity in capsules around TCPM-covered silicone implants. We found a higher percentage of myofibroblasts within the capsule structure and more inflammatory cell infiltration.

Conclusions

The quality of capsule structure around both tested implants differs significantly. Although capsules around TCPM-covered implants presented were thinner, they integrated with the mesh in a rigid cage structure capsule with higher infiltration of inflammatory cells caused by a significant foreign body reaction. TCPM-covered silicone implants showed no apparent advantage in the reduction of capsular contracture. On the other hand, the indication for using this material as a supportive soft tissue structure can be confirmed. Level of Evidence: not ratable, experimental study.     

Capsular contracture – What are the risk factors? A 14 year series of 1400 consecutive augmentations

The modern era of breast augmentation and reconstruction began in 1963, with the introduction of silicone implants by Cronin and Gerow. To date, the demand for cosmetic augmentation continues to increase exponentially. However, whilst the surgical techniques and quality of mammary prosthesis have improved dramatically in recent years, patients are still confronted with significant potential complications. We performed a retrospective study of 1400 consecutive primary breast augmentations performed between March 1995 and March 2009 by a single surgeon. We specifically examined the incidence of capsular contracture and the possible causative factors. Follow up ranged from 1 to 16 years. The mean age at the time of surgery was 32.8 years and fill volume was between 195?ml and 800?ml. Our capsular contracture rate was in the order of 26.9%. BMI >30, fill volumes >350?ml, smoking and alcohol consumption did not significantly increase capsular contracture rate. Implant type, pregnancy, infection and delayed haematoma significantly increased the risk of capsular contracture. Our series has given us a unique insight into the frequency of capsular contracture and identified several risk factors. To our knowledge, this is the first report of pregnancy having a significant effect on capsular contracture. We now counsel patients thoroughly into the detrimental effects of pregnancy on the implant.     

保留纤维包膜的乳房假体置换术

目的 探讨胸大胸后间隙乳房假体置入术后纤维包膜挛缩所致远期并发症的手术治疗原则及方法。方法 乳晕切口行假体转换术,在充分保留原纤维包膜的原则下,针对手感较硬,乳房变形等并发症行相应的手术处理。结果 ２４例术后均取得满意效果。结论 转换假体结合对症处理可有效纠治隆乳术后纤维包膜挛缩所致并发症,充分保留原纤维膜可获得较好远期效果。     

Does the Surface Structure of Implants Have an Impact on the Formation of a Capsular Contracture?

Background The formation of a fibrous capsule around a silicone breast implant is part of a physiologic foreign body reaction after breast augmentation. In contrast, the formation of a capsular contracture is a local complication of unknown cause. This study aimed to discover whether the surface structure of the implant (textured vs smooth) has any impact on the formation of a capsular contracture. Methods This prospective study included 48 female patients with unilateral capsular fibrosis grades 1 to 4 in Baker’s clinical scaling system. Of these patients, 14 received implants with a textured surface (Mentor), and 34 received implants with a smooth surface (Mentor). The implants all were placed in a submuscular position by the same experienced plastic surgeon. The clinical data were assessed using standardized patient questionnaires. For histologic diagnosis, operatively excised capsular tissue was examined. Preoperatively, venous blood samples for determining serum hyaluronan concentrations were taken from the patients. The control group consisted of 20 patients without capsular fibrosis. Results The separate analysis of clinical data for the patients with textured and those with smooth-surfaced breast implants showed a slightly reduced degree of symptoms for the patients with textured silicone breast implants, as compared with those who had smooth-surfaced implants. The histologic assessment of the fibrosis showed a symmetric distribution for Wilflingseder scores 1 to 3 (29% each), whereas 13% of the capsular tissues could be assigned to Wilflingseder score 4. In contrast, the histologic assessment of the patients with smooth-surfaced implants predominantly showed a Wilflingseder score of 3 (65%). The serologic investigations via enzyme-linked immunoassay (ELISA) showed serum hyaluronan concentrations of 10 to 57 ng/ml (25.0 ± 11.7 ng/ml). Therefore, no statistically significant differences in terms of serum hyaluronan levels could be determined between the two groups of patients. In comparison with the control group, the patients with implants showed elevated serum hyaluronan levels (p < 0.05). Conclusions The histologic examination and serum hyaluronan concentration analysis showed no statistically significant difference between smooth-surfaced and textured implants (Mentor) with respect to the development of capsular contracture. On the other hand, the severity of capsular contracture showed a positive linear correlation with the degree of local inflammatory reactions, which were independent of the implant surface.     

Incidence of capsular contracture in silicone versus saline cosmetic augmentation mammoplasty: A meta-analysis

INTRODUCTION:

Capsular contracture after augmentation mammoplasty occurs at a rate of 15% to 45%. The purpose of the present study was to determine the effect of implant core type (silicone versus saline) on the rate of capsular contracture in augmentation mammoplasty.

METHODS:

A systematic review was conducted through a search of three electronic databases. Two reviewers independently scanned titles yielded by the search and identified potentially relevant papers. Inter-reviewer variability and the scientific quality of the articles were assessed. Meta-analysis was performed.

RESULTS:

Eighty-eight titles of potential relevance were selected from the 393 articles yielded by the search. Inter-rater agreement for selection of potentially relevant articles was 84% (κ=0.54). Four comparative studies were included in the analysis. Scientific quality scores of the included studies ranged from 5 of 14 to 9 of 14. Three of the four studies reported a higher rate of capsular contracture in patients with silicone implants. A combined odds ratio calculated on two of the studies found a 2.25-fold increased risk of capsular contracture in patients who received silicone implants. Eight series of patients who received cohesive gel silicone implants reported rates of capsular contracture from 0% to 13.6%.

CONCLUSIONS:

Higher rates of capsular contracture were found in patients who received silicone implants when compared with those who received saline implants. However, the scientific quality of the comparative studies to date on this subject is poor. Recent series evaluating cohesive gel implants report relatively low rates of capsular contracture. A randomized controlled trial comparing rates of capsular contracture in cohesive gel and saline implants is recommended.     

FLUID RETENTION IN BIOPLASTY MISTI GOLD II BREAST PROSTHESES WITH DEVELOPMENT OF CAPSULAR CONTRACTURE

We compared the incidence of capsular contracture in an implant (Bioplasty Misti® Gold II) which has a textured surface and is filled with polyvinyl-pirrolidone (PVP)-hydrogel, with that in saline-filled implants with textured surfaces when the implants are placed subcutaneously during immediate reconstruction after subcutaneous mastectomy. In 41 patients, mean age 55 years (range 30-81), with breast cancer that was not suitable for breast conservation, 20 patients had 22 Misti Gold II prostheses inserted (two patients bilaterally) and 21 patients had saline-filled prostheses (one patient bilaterally). The development of capsular contracture was assessed using Baker's classification and applanation tonometry. Fourteen patients with Misti Gold II implants were classified one year postoperatively as Baker 2 and 3 compared with five with saline-filled implants (p