硅凝胶乳房假体辐射接枝水凝胶的实验研究

目的研究减轻硅凝胶乳房假体置入体内后纤维囊壁形成的方法.方法利用60Co共辐射的方法把亲水性单体N-乙烯基吡咯烷酮(N-VP)接枝到硅凝胶乳房假体表面.选用日本兔10只,将乳房假体置入兔的背部两侧,一侧为改性后假体作为实验组,另一侧为未经改性的假体作为对照组,隔一定时间后通过大体观察及组织切片研究假体周围纤维囊壁的形成情况.结果改性后假体周围的炎症反应较轻,而且形成的纤维囊壁在各个时间段均薄于对照组,差异有显著意义(P＜0.01).结论在硅凝胶乳房假体表面接枝NVP后可以有效地改善假体表面的组织相容性,减少周围纤维囊壁的形成.     

乳腺囊性增生病乳腺全切除同期假体置入乳房整形术

目的：探讨弥漫性乳腺囊性增生病全乳腺切除同时置入硅胶乳房假体保持乳房外形的可能性。方法：经乳晕缘半环状切口,完整切除乳腺,胸大肌肌下分离形成合适大小腔隙,置入硅胶乳房假体,分层缝合胸大肌、皮下脂肪、真皮及乳晕皮肤。结果：8例患者手术创口一期愈合。本人及配偶对手术后外形均满意。皮下脂肪较丰满者,外观和触诊效果与一般隆乳者区别不明显。结论：中年女性双乳多发性结节及囊性肿块,特别是有乳癌家属史的高危人群,在乳腺全切除后置入硅胶乳房假体,在解除乳房的疼痛、阻断乳癌形成的可能进程的同时,保持乳房外形,减轻患者对乳腺切除后乳房外形破坏的心理负担。     

乳房假体周围纤维包囊的组织学研究

目的 观察分析不同内容物的乳房假体周围纤维包囊在组织病理学上的特点。方法 对20例隆乳术后因不同原因行假体取出者的假体周围纤维包囊进行组织学研究，行HE、Masson和Mallory染色后，在光学显微镜下观察不同假体包裹的组织构成和结构特征。结果 不同假体包囊均有胶原纤维的沉积、炎症细胞浸润和少量毛细血管增生，部分包囊内层可见有扁平上皮样细胞层。但不同假体包囊又各有其特点。结论 ①本组任何乳房假体都可引发纤维组织包囊形成。②部分假体纤维包囊的内层表面可能出现“滑膜化生”现象。③植物油假体纤维包囊胶原沉积过度，囊壁增厚，易出现硬化，不宜选用。④PVP假体包囊内大量的炎性细胞提示可能与嗜酸性粒细胞介导的迟发型超敏反应有关，应慎用。     

乳腺切除术后同期假体埋置临床效果观察

目的：观察乳腺切除后即时埋置硅胶假体手术的临床效果。方法：沿乳房皮下切除腺体组织，放置相应盐水假体，随访观察。结果：6例手术再造乳房两侧对称，外形美观。结论：该手术操作简便，切口隐蔽，临床效果满意。     

聚丙烯酰胺水凝胶在乳房纤维包膜挛缩病例中的应用

乳房纤维包膜挛缩是隆乳术后最棘手的问题，尽管预防和治疗的方法颇多，但收效仍不理想，复发率很高，目前尚无可靠治疗方法。本组从１９９７ 年１０ 月至今应用聚丙烯酰胺水凝胶替代５０ 例因硅胶囊乳房假体隆乳引起的纤维包膜挛缩。根据挛缩程度，包膜腔内有无被污染和包膜腔在乳房的位置等因素分Ⅰ期替换或Ⅱ期替换两种方式。本组５０ 例替换结果显示，原僵硬的乳房变为柔软，Ｂ超证实挛缩的囊壁在３ ～６ 个月后有变薄现象。本组资料结果证实，用聚丙烯酰胺水凝胶替代硅胶囊乳房包膜挛缩的假体隆乳，对原已形成的纤维包膜挛缩有良好的近期（半年）治疗效果。     

减少假体置入包膜挛缩的硅胶改性方法研究进展

硅胶由于其生理惰性和低毒性,常作为组织代用品广泛应用于乳房畸形矫正或美容性隆乳手术中,但是硅胶假体置入存在一系列的并发症,如包膜挛缩、挤压、血肿、感染、假体移位、假体破裂以及乳房假体相关间变性大细胞淋巴瘤（breast implant-associated anaplastic large cell lymphoma, BLA-ALCL）等。包膜挛缩作为乳房置入后常见的并发症,常常导致乳房变硬、变形、疼痛,最终导致置入失败,需要二次手术,影响临床效果。现通过阐述减少包膜挛缩的硅胶表面改性的方法,分析各种硅橡胶改性方法优缺点,探讨硅橡胶改性面临的问题和挑战,为提高硅橡胶的临床应用效果提供一些思路及理论依据。     

国产硅胶乳房假体隆乳术486例

探讨采用国产硅胶囊乳房假体隆乳的手术方法和术后并发症的预防及处理。方法：对486例女性采用腋下、乳晕、乳房下皱襞等不同切口进行置入国产硅胶囊乳房假体，术后1～6年随访，总结出现并发症的情况。结果：常见的并发症是血肿、假体破裂、纤维挛缩变硬、外形欠佳。结论：硅胶假体隆乳术中预防并发症的主要措施是术中彻底止血，置放时注意保护假体，操作勿粗暴，手术分离范围应充分，术后坚持按摩等。     

聚丙烯酰胺水凝胶在乳房纤维包膜挛缩病例中的应用（Ⅱ）

目的：介绍一种治疗硅胶囊假体隆乳术后纤维包膜挛缩的有效治疗方法和新材料。方法：从1997年10月至2000年9月,此方法治疗167只因硅胶囊假体隆乳引起纤维包膜挛缩的乳房,根据包膜囊内有无出血分为I期置换或II期置换,对包膜严重挛缩或乳房下皱襞高低不一致的病例提出具体的矫正方法,对取出假体后能否I期置换水凝胶和严重挛缩的包膜腔是否能在扩大分离后I期置入水凝胶作了分析。结果：本组167只乳房除3例4只乳房在术中分离扩大我膜腔和1只乳房换术后因外伤造成出血更换水凝胶外,均取得了满意的术后效果,乳房形态自然,质地柔软,结论：聚丙烯酰胺水凝胶置换硅胶囊假体,治疗因硅胶囊假体隆乳术后造成纤维包膜挛缩取得良好的治疗效果。从随访的结果看,这是解决这一顽症的有效方法。     

隆乳术后纤维包膜囊完整摘出一例

病例女,32岁。因双侧乳房发育不良于1989年1月在全麻下经乳房下皱襞切口行胸大肌下硅胶囊假体置入隆乳术。手术过程及术后恢复顺利。术后2周出院并即行乳房按摩。1992年5月发现右侧乳房缩小变硬,呈圆球状。1994年5月经门诊检查以右乳硅胶囊周围纤维包膜囊形成(Backer 氏Ⅲ级)入院治疗。住院前检查血小板9.5万,余正常。在全麻下行纤维包膜囊切除术。术中见硅胶囊四周形成一层厚约0.3 cm 的坚韧纤维包膜,呈褐白色,外与周围组织粘连紧密,剥离困难,内与假体间滑动自如。在剥离显露出纤维包膜囊前     

隆乳术后并发假体疝出和包膜挛缩一例

２０００年４月广州市第一人民医院整形外科收治１例隆乳术后先后出现假体疝出和双侧乳房纤维包膜挛缩的患者，现将处理情况报道如下。１临床资料某女，３７岁，已婚，双侧乳房哺乳后萎缩１０年，于２０００年４月入院，查体双侧乳房萎缩，平坦，未及包块，入院后在硬膜外麻醉下行“腋窝横纹切口隆乳术”，所用材料为２００ml国产硅胶乳房假体。术后双侧乳房柔软，乳头、乳晕位置对称，外形满意。２个月后，患者因右侧乳房假体疝出，再次入院。当时查体：双侧乳房外形不对称，右侧乳房外形不圆，右侧（外下象限）较左侧乳房低２cm，右侧乳房…     

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.     

The effect of liposome‐delivered prednisolone on collagen density,myofibroblasts, and fibrous capsule thickness around silicone breast implants in rats

Capsular contracture is a potential adverse effect of breast implants. An inflammatory reaction is most likely the origin of fibrosis around the implant. It is possible that some substances may act to prevent this inflammatory reaction. Thus, our goal was to evaluate the effectiveness of local depot prednisolone phosphate‐liposomes (PPL) on fibrous capsule formation around textured silicone breast implants. Shell prostheses (2 mL) were implanted in the right (plus PPL group) and left (plus saline solution, saline group) subcutaneous dorsum of 18 rats. In another 18 rats, the implants were positioned in the left of the back without any drug instillation (control group). In the PPL group, the capsule thickness (μm) and density (%) of collagen were significantly (p<0.0001) lower compared with the control group on days 35 and 90 postsurgery. Furthermore, in the PPL group, a significant reduction in myofibroblast count was observed on day 90 postsurgery (p<0.0001). In conclusion, a single dose of depot liposome‐delivered prednisolone was effective at impairing capsule formation around the silicone implant. The results suggest a strong local and weak systemic effect of PPL on the fibrous tissue around silicone implants. To our knowledge, no study has yet assessed the effect of PPL on silicone breast implants.     

Early tissue reaction to textured breast implant surfaces.

Capsular contracture around breast implants with smooth surfaces continues to be an unpredictable complication. Some surgeons believe that silicone implants covered with porous polyurethane foam have a lowered potential to contract. These textured implants are not as biocompatible as silicone. Recently, silicone implants with textured surfaces have been introduced with the hope that the incidence of unacceptable implant contracture will be reduced. Using a rat implant model, the tissue reaction to textured implant surfaces was assessed. The implant surfaces evaluated were Silastic II, Siltex, MISTI, Biocell, Silastic MSI, and Même. Disks of each implant material were implanted under the dorsal skin of rats for a period of 28 days. Each implant with its surrounding tissue was excised, processed for histological analysis, and assessed for the tissue's response to the implant with particular emphasis on the formation of a continuous collagen capsule. The results indicated that the magnitude of surface texturing influenced the development of a complete capsule. Implant surfaces with a texture of less than 150 microns in height or depth (Silastic II, Siltex, and MISTI) resulted in the formation of complete capsules. An implant (Biocell) with irregular texturing (200-350 microns) produced an organized capsule over most of its surface with localized interruptions of the capsule at the sites of its deepest cavities. Implant surfaces with texturing that exceeded 350 microns in height or depth (Silastic MSI and Même) resulted in inhibition of the formation of a continuous capsule during this 28-day study.     

Effect of Slow-Release 5-Fluorouracil on Capsule Formation Around Silicone Breast Implants: An Experimental Study with Mice

Background Capsule formation around breast implants, development of tendon adhesions after tendon repair, intestinal brits after laparatomies, hypertrophic scars in skin incisions all are the results of excessive collagen synthesis to the extracellular matrix by fibroblasts. Any intervention that leads to cessation of collagen synthesis in these clinical situations may help to prevent these untoward results of wound healing. Although 5-fluorouracil (5-FU) is used mainly as a cytotoxic drug in chemotherapy protocols, it decreases cellular metabolism and blocks protein synthesis only at lower concentrations. Findings have shown that 5-FU downregulates fibroblast proliferation and differentiation in vitro. It has been used to treat fibroproliferative disorders of the eye and skin and is thought to inhibit thymidylate synthetase, blocking DNA replication. Methods This study used five treatment groups: (1) gelatin only, (2) silicone only, (3) silicone + gelatin, (4) silicone + gelatin containing 1 mg of 5-FU, and (5) silicone + gelatin containing 5 mg of 5-FU. The release kinetics of 5-FU from gelatin have been investigated by means of ultraviolet spectrophotometric analysis. Specimens were obtained on postoperative day 30. Gross evaluation and histopathologic examination were conducted for capsule formation and the development of inflammation. Results The silicone group had the most prominent capsule formation among all the groups. The gelatin group was second, and the silicone + gelatin group was third. As compared with the other groups, the 5-FU–containing groups had the least capsule formation. The 5-mg 5-FU–containing group had the most inflammation. The silicone + gelatin group was second in inflammation. Although the silicone, gelatin, and 1-mg 5-FU–containing groups had the same means, the results of the silicone group showed the most divergent data within the group. Conclusions Because 5-FU loaded to a gelatin carrier for its slow release seems to prevent capsule formation around silicone blocks, it may be used to prevent capsule formation around silicone breast implants.     

选择性COX-2抑制剂减少硅凝胶假体置入后包膜形成的实验研究

目的：探讨选择性环氧化酶（Cyclooxygenase-2,COX-2）抑制剂对硅凝胶假体置入后包膜形成的影响。方法：20只雌性新西兰白兔,随机分为2组,于胸肌下置入15ml光面硅凝胶假体,实验组每天饮用含有选择性COX-2抑制剂Celecoxib的蒸馏水,对照组饮用相同容量的蒸馏水。于术后第14、28、60天切取包膜组织,分别做免疫组化检测包膜中COX-2、TGF—β1及α-SMA含量;术后第60天切取包膜组织行HE染色,并以Image—pro—plus软件测量包膜厚度。结果：术后60天,实验组包膜厚度明显薄于对照组,两者比较有显著性差异（P〈0．01）;术后14天及28天,实验组COX-2和TGF—β1表达明显弱于对照组：术后60天,实验组α-SMA表达弱于对照组。结论：选择性COX-2抑制剂对硅凝胶假体置入后包膜形成有抑制作用。     

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

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

The fate of the fibrous capsule after saline implant removal

After removal of a silicone breast implant, if a capsulectomy is not performed, the residual capsule may persist, become calcified, and appear on routine mammograms. The fate of the capsule around saline implants is less clear. The purpose of this study was to determine the fate of the capsule around saline-filled implants in an animal model. Rats were implanted with 6-ml tissue expanders, which were left in place for 4 months. The implants were then removed and the capsules around the injection port (smooth surface) and tissue expander (textured surface) were examined sequentially. The capsules contracted and dissipated gradually over a year in association with a pericapsular vascular proliferation. It may not be necessary to perform a capsulectomy at the time of saline implant removal.     

The Effect of Local Application of Mitomycin-C on the Development of Capsule Around Silicone Implants in the Breast: An Experimental Study in Mice

In this experimental study on mice we try to prove that capsule formation around breast implants is considerably diminished after topical application of Mitomycin-C (MMC). MMC solution is applied under the breast tissue or pectoralis major muscle, in the pocket of the silicone implant and just before placing it. This is a morphological study of the connective tissue formed around the implant, under light and electron microscope. Our results suggest that it is worthwhile working on a clinical study trying to prevent the most common complication of breast implants, contracture of a capsule.     

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.     

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.