Our strategy in complication management of augmentation mammaplasty with polyacrylamide hydrogel injection in 235 patients *

Transcription

1 Journal of Plastic, Reconstructive & Aesthetic Surgery (2011) 64, 731e737 Our strategy in complication management of augmentation mammaplasty with polyacrylamide hydrogel injection in 235 patients * Sheng-Kang Luo a,c, Gunang-Ping Chen a, Zhong-Shen Sun a, Ning-Xin Cheng b, *,c a Department of Aesthetic and Plastic Surgery, Guangdong.2 Provincial People s Hospital, Guangzhou, PR China b Department of Aesthetic and Plastic Surgery, First Affiliated Hospital, School of Clinical Medicine, Guangdong Pharmaceutical University, nglinxialu 19, Guangzhou , Guangdong, PR China Received 14 May 2010; accepted 6 October 2010 KEYWORDS Strategy; Polyacrylamide hydrogel; Augmentation mammaplasty; Complication; Breast contour restoration Summary Polyacrylamide hydrogel (PAAG) was once widely used in breast augmentation in China. Although it had been banned for augmentation mammaplasty in 2006, a large number of patients whose breasts were augmented with the gel injection have continued to seek medical advice because of its complications. The clinical management of these complications has never been standardised. The data of a total of 235 patients with complications following PAAG-injected breast augmentation have been summarised and the types and causations analysed. Magnetic resonance imaging (MRI) was undertaken in 228 patients with palpable masses, breast pain or tenderness, asymmetry or deformity and functional or psychological problems to eliminate neoplasm, infection and to delineate the diseases. The surgical gel evacuation via periareolar incisions was performed for all patients and immediate silicone breast prostheses were implanted in 108 patients and were delayed in 28 cases by 6 months. Most patients (214/235) of the group were satisfied with the treatment, and symptoms disappeared after removal of the gel. The gel distribution and involved tissue were well defined and neoplasm was ruled out by MRI. Postoperative MRI in 68 patients revealed that no obvious PAAG remaining. In either immediate or delayed reconstructive patients with silicone breast implants, good breast contour presented. A diagnosis and management strategy for these complications is proposed. In conclusion, the breast masses, pain and deformity are major complications after PAAG-injected breast augmentation. Psychological problems should be paid attention to. MRI is * Part of this article was presented at the 10th National Congress of Chinese Plastic Surgery Society in Nanjing, China, on 18 September * Corresponding author. Tel.: þ ; fax: þ addresses: Luo_shengkang@hotmail.com (S.-K. Luo), cheng.ningxin@yahoo.com.cn (N.-X. Cheng). c Dr. Luo and Cheng contributed equally to this work /$ - see front matter ª 2010 British Association of Plastic, Reconstructive and Aesthetic Surgeons. Published by Elsevier Ltd. All rights reserved. doi: /j.bjps

2 732 S.-K. Luo et al. a sensitive and accurate method for diagnosis and treatment evaluation. Surgical removal of injected gel is the preferred method for complication management. The implantation of silicone prostheses for breast contour restoration after PAAG evacuation is effective for patients under strict selection. Our strategy for treating PAAG-related complications proved useful. ª 2010 British Association of Plastic, Reconstructive and Aesthetic Surgeons. Published by Elsevier Ltd. All rights reserved.!?a3b2 tlsb=-0.01w?>polyacrylamide hydrogel (PAAG) was used for the first time in 1994 as an injectable material in plastic surgery in Ukraine and introduced into China in It rapidly gained popularity as a soft tissue filler for facial depressions, lip enhancement and breast augmentation. 1e6 Over time, more and more complications after PAAG injection were reported. 7e11 In April 2006, the Chinese State Food and Drug Administration announced that PAAG would be prohibited from production and clinical application in plastic surgery. In the future, we can expect that more patients will present for treatment of various adverse reactions after PAAG injection. In this article, the authors propose a standardised diagnosis and treatment strategy for PAAG-related complications in breast augmentation patients, based on their clinical experience. Patients and methods Between October 2005 and June 2008, 235 female patients suffering from complications after PAAG-injected breast augmentation presented at our hospitals. Among these 235 cases, 89 patients had no history of breast feeding, and the remaining 146 had post-lactation breast atrophy. Their ages ranged from 20 to 38 years (average age, 27.5 years). The time elapsed from breast augmentation with PAAG injection to presentation with complications in our hospitals ranged from 6 months to 10 years (mean 39.2 months). The trade name of the injective gel was either Interfallä (produced in Ukraine, 98 cases) or Amazingelä (produced in China, 137 cases). Clinical data for the amount and location of injected PAAG was available for 176 cases. In these cases, 50e260 ml (mean ml) gel had been injected per breast, mostly into the subglandular plane. In other 59 patients, the injected volume and location were not provided because the records were lost or not mentioned. The most common complications after augmentation mammaplasty with PAAG were breast indurations and masses (78.9% of patients, 161 with multiple and 24 with single lesion, 34 cases with breast hardness) and pain (67.2%). The other complications included breast deformities or asymmetry in 47 patients (20%), psychological problem in 29 patients (12.3%), mastalgia with movement in 20 cases (8.5%), distant gel migration in 21 patients (8.9%) and nipple retraction and infection in each of six patients. A total of 171 patients (72.8%) had more than one complication, simultaneously. According our diagnosis and management strategy (Figure 1), all patients in this series were divided into two groups: one with palpable masses and the other without. Patients were scanned with a Philips 1.5 T magnetic resonance imaging (MRI) machine before their operation, to rule out breast neoplasm and to determine the position of the injected PAAG. Surgical technique According to the MRI findings, the location and depth of the gel indurations or lumps and the desired inframammary fold were marked on the breast skin before operation. All patients were informed preoperatively that complete removal of the injected gel was impossible, and that re-examination by MRI would be needed 6 months postoperatively. Under epidural anaesthesia or general anaesthesia, an open evacuation operation via periareolar incisions was preferably performed. The dissection is performed between the subcutaneous tissue and the mammary tissue and then extends to the inferior margin of the pectoralis fascia. The subglandular space is exposed and the injected PAAG can be drained out after repeat irrigation with antibiotic saline. If the PAAG is located in breast parenchyma and/or the major pectoralis muscle, the dissection should be performed to expose the PAAG collections and visible residual hydrogel shoul2 be cleaned out. When the injected gel lumps became hard, which cannot be aspirated after saline dilution and were surrounded by a fibrous capsule, extracapsular or intracapsular excision is recommended. The resection of the degradation and non-bacterial inflammation of glandular and muscular tissue and partial mastectomies under optical retractor should be carried out to maximise the efficacy of surgical removal. All excised tissues are sent for histological analysis. After haemostasis, placement of vacuum surgical drains and closure of the incisions, a mild compressive dressing should be worn for at least 3 days. When breast contour restoration is strongly desired by patients, immediate breast augmentation with silicone prostheses might be considered. Dual-plane augmentation mammaplasty via the same periareolar or intra-areolar incision is performed. Case presentations Case 1 A 27-year-old female underwent PAAG injection for breast augmentation 2 years ago. Multiple indurations with pain and tenderness developed in both breasts 3 weeks later and lower-back discomfort aggravated by tiredness was also reported. Breast asymmetry and unnatural appearance (Figure 2(a)) were found. The hard masses of various sizes were palpable. MRI demonstrated the presence of PAAG in chest subcutaneous tissue, mammary gland and pectoralis major muscle.

3 Complication management after breast augmentation 733 Palpable Mass N o Palpable Mass Pain or Tenderness Infection Tumor Suspected Tumor Check-up and Treatment Abnormal Breast Function N o Anti-infection and Drainage MRI or US PAAG Collection/ Evacuation < 90% > 90% Delayed Implantation Asymmetry and Deformity N o Contour Restoration Required Immediate Implantation Psychological Problem Psych Observation and Follow-up Figure 1 Strategy of clinical diagnosis and management to the complications of PAAG injection for augmentation mammaplasty. Through a periareolar incision, gel lumps in the subcutaneous tissue, mammary gland and pectoralis muscle were verified. The fibrous capsules were excised and more than 100 ml hydrogel were extracted. Subcutaneous partial mastectomy was carried out to remove the hydrogel as completely as possible. Many pearly gel globules could be extruded (Figure 2(b)) from the involved tissue. Pathology examination demonstrated PAAG within muscular, mammary and adipose tissue, accompanied by fibroblast proliferation, granulation formation and foreign body reaction. During 6 months of follow-up, the breasts became soft without any undesirable signs or deformities. Although there were traces of residual PAAG within the breasts on MRI examination, it was deemed unnecessary to attempt further removal. Case 2 A 29-year-old female patient was worried about the adverse reaction to the injected PAAG in her breasts, which caused her obvious depression and insomnia over the past year. Physical examination revealed the breasts were soft, painless and had no significant palpable masses, except that the right breast was slightly lower than the left (Figure 3(a)). MRI demonstrated hemispherical-shaped aquiferous lesions filled in retromammary spaces. The low-signal intensity in T1- weighted imaging and high-signal intensity in T2-weighted imaging were uniform and homogeneous and the margins of the lesion were smooth (Figure 3(b)). During operation, most of the granular, yellow, jelly-like PAAG encapsulated in the retromammary space was Figure 2 Anterior views of pre-operation (a) in case 1. There are appearances of excised lesion tissues, from which pearly globules could be extruded (b).

4 734 S.-K. Luo et al. Case 2: Anterior views of pre-operation (a), T2-weighted (b) MRI images preoperatively and three months post-oper- Figure 3 ation (c). confirmed and was extruded. The capsulectomy was performed and the surface of pectoralis major was smooth. The dual-plane spaces were further dissected and the McGhanä silicone gel (style 230 g, textured surface) mammary prostheses were implanted. Postoperative recovery was uneventful. The breast shape was satisfactory (Figure 3(c)) and MRI re-examination revealed no obvious residual PAAG in the 3 month postoperative follow-up. Case 3 A 32-year-old female patient with breast atrophy and ptoses after lactation underwent PAAG injections for breast augmentation 5 years ago. However, this procedure actually had worsened her breast ptoses and the breast volumes were approximately 300 ml larger than before (Figure 4(a)). The procedures of PAAG removal and vertical reductive mammaplasty were performed simultaneously. After separating the capsule, many scattered black spots distributed on its surface (Figure 4(b)) were revealed. When the light yellow, grainy PAAG was debrided, the posterior part of the breasts was obviously destroyed and only retained a little moth-eaten vascularity. Subsequently, the middle and lower parts of the breast tissue were excised. The remaining breast was separated from the pectoralis fascia and mastopexy was performed. The pathological findings included chronic inflammatory infiltration and foreign-body reaction. The appearance of the breasts was satisfactory in the follow-up 2 years after operation (Figure 4(c)). The preoperative symptoms had been completely relieved. Results MRI evaluation In the 228 cases checked by MRI, the injected gel was found relatively to concentrate in the retromammary space to form hemispherical prostheses in 138 cases. T1-weighted imaging showed low signal, T2-weighted imaging showed high signal, and the internal signal was uniform. The edge of each prosthesis was smooth, with a low-signal capsule visible around the prosthesis (Figure 3(b)). However, in the remaining 90 cases, the hydrogel was scattered throughout the breast tissue, including in subcutaneous tissue in 21 cases, mammary tissue in 65 cases, pectoralis major and/or serratus anterior muscles in 44 cases. In these cases, the shapes of the PAAG prostheses were irregular, and their edges and internal signals were uneven. The multiple lines of low signal separating the high signal of PAAG on Figure 4 Anterior views of case 3e preoperative (a) and two years postoperative (c). Copious scattered black punctuate matter was found to distribute on the surface of mammary tissues (b) during operation.

5 Complication management after breast augmentation 735 T2-weighted imaging and the long T1 signal and T2 signal of PAAG mass within the intermediate signal of breast tissue and pectoralis major muscle were identified. Breast neoplasm is ruled out by MRI evaluation in all patients. Postoperative follow-up The postoperative follow-up period varied from 2 months to 27 months (mean, 5.4 months) and complication symptoms had resolved completely in 214 patients (Figures 3(c) and 4(c)) with surgical gel evacuation. Only 11 patients still complained of breast pain, although gel was significantly reduced. In addition, three patients stated that there were small nodules at the original site of injection. These symptoms were relieved completely after subsequent surgical removal of the residual PAAG. Breast infection in six patients completely subsided after surgical drainage, but the bacterial cultures were negative. Histological examination of excised tissue from injected breasts demonstrated that injected PAAG presented in muscular, mammary and adipose tissue, even in blood vessels, and was accompanied by fibroblast proliferation, foreign body reaction, chronic inflammation and granulation formation in some patients. Furthermore, postoperative re-examination with MRI in 68 patients demonstrated no obvious residual PAAG. Breast contour reconstruction In 108 patients who underwent immediate implantation of silicone breast prostheses, 104 cases achieved an excellent postoperative result with no complications (Figure 3(c)). The capsular contracture between Becker s IIeIII developed in three patients. Only one patient had an inflammatory reaction 10 days after operation. After the prostheses removal, the symptoms completely subsided. Four months later, the patient had breast prostheses reimplanted, and was subsequently satisfied with the appearance of her breasts. An additional 28 patients had breast prostheses implanted 6 months after the evacuation procedure, all with good breast contour result. Discussion In recent years, a variety of local adverse reactions have developed in patients who had breast augmentation by PAAG injection. 7e9,12e14 There are few articles focussed on the strategy for complication management for PAAG breast augmentation. 13,14 We divided the patients into two groups, one with palpable masses and other without, because the managements are different in principle. In the palpable mass group, to rule out breast neoplasm and to restore the breast shape after gel evacuation are the major aims. Even if there is no definite evidence that PAAG increases the damage of vital organs and incidence of breast cancer in our clinical practice, it is suggested that early diagnosis of breast cancer could be delayed by the presence of injected gel. 15 In the non-palpable mass group, infection and other functional or mental problems should be faced. The psychological influence of a possible malignancy on patients with PAAG injection is not to be neglected. The clinical presentations of the complications are various. The following complications often appear simultaneously in one patient, even one breast. Palpable indurations and masses Incorrect injection positions resulting in uneven gel distribution and gel collections in mammary or subcutaneous tissues are suggested as the major causes of this more common complication. 16 Breast hardness is a special form of gel induration with capsulisation. It is usually presented in the patients with severe foreign body reaction or granulomatous formation. The encapsulated gel had turned into semisolid jelly or rubber. Careful examination of the breasts should be undertaken to eliminate tumour, haematoma and infection. Surgical evacuation is the only effective procedure for gel masses. Sentinel lymph node biopsy should be considered in any patient in whom there is a suspicion of malignancy. Pain and mastalgia This complication, which is aggravated during movements of upper extremities, is usually observed in patients with gel-related severe muscular and mammary tissue degeneration, granulation formation or chronic inflammation, such as pectoral myofascitis or myositis, and may not be completely relieved after degenerative tissue excision, due to the persistence of pectoral lesions. Disfigurement and asymmetry The presentations of PAAG-related breast disfigurement were various (Figure 2(a)). The non-uniform distribution of the gel and the breakdown of insubstantial and non-integrated soft capsules of the injected PAAG are reasons for the complication and gel flow and migration under squeeze, massage, gravity, trauma, movements of upper extremities or pectoral muscles may also tend to result in disfigurement of the breast. 16 The possible reason of nipple retraction is mammary duct- and fibre bundle contraction caused by the adjacent injected gel. Distant migration The migration of the gel distant from the original breast region may present in axilla, abdomen or even pubes. The main cause for distant migration is the same as for the disfigured and asymmetric breast. When migrated gel passes through the subcutaneous tunnel, distant gel lumps are formed. It is necessary to make accessory incisions in the location of the migrated gel, such as in the axillary, abdominal and pubes regions, to remove as much of the PAAG as possible. Infection It is believed that breast duct injury and perioperative contamination during gel injection play an important role in infection. 17 Such mastitis often occurs in the later period of pregnancy and lactation, which means that gel blockage of mammary ducts, gel-related congestion and degradation

6 736 S.-K. Luo et al. tissue or delayed rejection are reasons for the infection. Because micro-organisms will grow easily in gel solution 17 and diffuse with gel migration, treatment becomes more complex. Even if all the bacterial cultures in our report were negative, the fungus, Staphylococcus aureus and Alcaligenes faecalis, as conditioned pathogens, have been found in other reports. 18 Surgical drainage and intravenous antibiotics are the first choice for management. Psychological problems Some patients suffered a consequent psychological burden after PAAG injection. Being worried about the possible fatal complication and breast cancer, they appeared depressed or manifested anxiety symptoms, such as dyspnoea, chest tightness, insomnia and heart palpitations in our clinical practice. Even with no definite breast masses, these patients desired gel removal after failed psychological interventions; surgical evacuation is recommended. Dysgalactia Dysgalactia is caused by obturation of the mammary ducts by injected PAAG and is often subsequent to pregnancy and delivery. 19 Compared with mastitis, there appears more remarkable breast swelling, greater skin tension, less pain and erythema in dysgalactia after PAAG injection for breast augmentation. An obvious milk decrease during lactation occurs. Treatment including PAAG removal, anti-infection and lactation suppression should be undertaken to prevent mastitis, abscess and galactocoele formation. Many imaging techniques have been reported for the diagnosis of complications from PAAG breast augmentation. 20e22 The density of the hydrogel under mammography is similar to that of normal mammary tissue; hence, the gel boundaries are obscure. Although computer tomography (CT) has quite a highdensity resolution for bone disease, it is poor at detecting microcalcification lesions, and a high radiation dose is required for breast imaging. The reliability of ultrasound and MRI has been confirmed by our clinical findings in patients with PAAG complication. 21,22 We recommend MRI as the modality of choice for the evaluation of complications and detection of breast neoplasm after PAAG breast augmentation. The needle aspiration and suction under tumescent technique had been reported for the complication treatment in the literature. 8 However, the unsatisfactory results were presented as resulting not only in more hydrogel residue but also in secondary gel displacement and breast injury. 9 It has been proved that those procedures cannot clean the gel in or around the pectoral muscles and fascial tissue. We believe that the most reliable procedure to eliminate the PAAG and related pathological tissues is surgical evacuation through periareolar approach under direct visualisation with optical retractor, which also is beneficial for simultaneous breast reconstruction and correction of the tuberous or ptotic breast. 13 For patients who have strongly requested breast contour reconstruction, immediate reconstruction using the dualplane approach with silicone breast prostheses can be considered. 14 According to our experience of preventing palpable edges of the breast prostheses, beneficial to adjusting implant/soft-tissue relationships and rebuilding a satisfactory breast shape, dual-plane augmentation is the best technique to ensure adequate soft-tissue coverage for the implants. However, the indications for immediate breast shape repair were quite restrictive in this series, as follows: (1)there is no breast neoplasm and infection; (2) more than 90% of the injected gel is removed; (3) there is no residual hydrogel in pectoral muscles and/or the subpectoral space; (4) enough healthy mammary tissue and pectoral muscle are present to cover the breast prostheses; (5) the inframammary folds are intact or can be reconstructed simultaneously; and (6) there are no systemic or psychological problems. Alternatively, a strictly clinical observation or delayed reconstruction is recommended, especially in patients with several pathological changes or insufficient normal tissue. In conclusion, PAAG is not an ideal filler for breast augmentation because its above-mentioned adverse reactions and pathologic changes, unstable localisation and nature. 7e9,12e19,23,24 The management strategy for patients with complications of PAAG injection for breast augmentation depends on many clinical factors and the outlines are based on our clinical experience (Figure 1). It should be emphasised that not only to rule out a potential tumour and remove the injected gel but also to repair the breast contour and supply psychological support for those patients are very important obligations of plastic surgeons. Conflict of interest There are no conflicts of interest relevant to this article. The authors have indicated no significant interest with a commercial supporter. Funding There was no funding for this article. References 1. Zemskov VS, Zavgorodniĭ IA, Roshchina LA, et al. Endoprosthesis of mammary glands using hydrogel prosthesis PAAG Interfall. 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