Mark W. Clemens

Acellular dermal matrix for the treatment and prevention of implant-associated breast deformities.

Background: Acellular dermal matrix has been increasingly accepted in prosthetic breast reconstruction. Observed benefits include improved control and support of implant position, better implant coverage, and the suggestion of a decreased capsular contracture rate. Based on this positive experience, it is not surprising that acellular dermal matrix would be applied to other challenging implant-related problems. This study investigates the use of acellular dermal matrix for correction or prevention of implant-associated breast deformities. Methods: Patients who underwent primary aesthetic breast surgery or secondary aesthetic or reconstructive breast surgery using acellular dermal matrix and implants between November of 2003 and October of 2009 were reviewed retrospectively. Patient demographics, indications for acellular dermal matrix, and acellular dermal matrix type and inset pattern were identified. Preoperative and postoperative photographs, success or failure of the procedure, complications, and need for related or unrelated revision surgery were recorded. Results: Fifty-two patients had acellular dermal matrix placed alongside 77 breast prostheses, with a mean follow-up of 8.6 months (range, 0.4 to 30.4 months). Indications included prevention of implant bottoming-out (n = 6), treatment of malposition (n = 32), rippling (n = 20), capsular contracture (n = 16), and skin flap deficiency (n = 16). Seventy-four breasts (96.1 percent) were managed successfully with acellular dermal matrix. Three failures consisted of one breast with bottoming-out following treatment of capsular contracture, one breast with major infection requiring device explantation, and one breast with recurrent rippling. There was a 9.1 percent total complication rate, consisting of three mild infections, one major infection necessitating explantation, one hematoma, and one seroma. Conclusion: Based on this experience in 77 breasts, acellular dermal matrix has shown promise in treating and preventing capsular contracture, rippling, implant malposition, and soft-tissue thinning.

Bacterial Biofilm Infection Detected in Breast Implant-Associated Anaplastic Large-Cell Lymphoma.

Background: A recent association between breast implants and the development of anaplastic large-cell lymphoma (ALCL) has been observed. The purpose of this study was to identify whether bacterial biofilm is present in breast implant–associated ALCL and, if so, to compare the bacterial microbiome to nontumor capsule samples from breast implants with contracture. Methods: Twenty-six breast implant–associated ALCL samples were analyzed for the presence of biofilm by real-time quantitative polymerase chain reaction, next-generation sequencing, fluorescent in situ hybridization, and scanning electron microscopy, and compared to 62 nontumor capsule specimens. Results: Both the breast implant–associated ALCL and nontumor capsule samples yielded high mean numbers of bacteria (breast implant–associated ALCL, 4.7 × 106 cells/mg of tissue; capsule, 4.9 × 106 cells/mg of tissue). Analysis of the microbiome in breast implant–associated ALCL specimens showed significant differences with species identified in nontumor capsule specimens. There was a significantly greater proportion of Ralstonia spp. present in ALCL specimens compared with nontumor capsule specimens (p < 0.05). In contrast, significantly more Staphylococcus spp. were found associated with nontumor capsule specimens compared with breast implant–associated ALCL specimens (p < 0.001). Bacterial biofilm was visualized both on scanning electron microscopy and fluorescent in situ hybridization. Conclusions: This novel finding of bacterial biofilm and a distinct microbiome in breast implant–associated ALCL samples points to a possible infectious contributing cause. Breast implants are widely used in both reconstructive and aesthetic surgery, and strategies to reduce their contamination should be more widely studied and practiced. CLINICAL QUESTION/LEVEL OF EVIDENCE: Risk, V.

Complete Surgical Excision Is Essential for the Management of Patients With Breast Implant–Associated Anaplastic Large-Cell Lymphoma

PURPOSE Breast implant-associated anaplastic large-cell lymphoma (BI-ALCL) is a rare type of T-cell lymphoma that arises around breast implants. The optimal management of this disease has not been established. The goal of this study is to evaluate the efficacy of different therapies used in patients with BI-ALCL to determine an optimal treatment approach. PATIENTS AND METHODS In this study, we applied strict criteria to pathologic findings, assessed therapies used, and conducted a clinical follow-up of 87 patients with BI-ALCL, including 50 previously reported in the literature and 37 unreported. A Prentice, Williams, and Peterson model was used to assess the rate of events for each therapeutic intervention. RESULTS The median and mean follow-up times were 45 and 30 months, respectively (range, 3 to 217 months). The median overall survival (OS) time after diagnosis of BI-ALCL was 13 years, and the OS rate was 93% and 89% at 3 and 5 years, respectively. Patients with lymphoma confined by the fibrous capsule surrounding the implant had better event-free survival (EFS) and OS than did patients with lymphoma that had spread beyond the capsule (P = .03). Patients who underwent a complete surgical excision that consisted of total capsulectomy with breast implant removal had better OS (P = .022) and EFS (P = .014) than did patients who received partial capsulectomy, systemic chemotherapy, or radiation therapy. CONCLUSION Surgical management with complete surgical excision is essential to achieve optimal EFS in patients with BI-ALCL.

Primary Fascial Closure with Mesh Reinforcement Is Superior to Bridged Mesh Repair for Abdominal Wall Reconstruction

BACKGROUND Many surgeons believe that primary fascial closure with mesh reinforcement should be the goal of abdominal wall reconstruction (AWR), yet others have reported acceptable outcomes when mesh is used to bridge the fascial edges. It has not been clearly shown how the outcomes for these techniques differ. We hypothesized that bridged repairs result in higher hernia recurrence rates than mesh-reinforced repairs that achieve fascial coaptation. STUDY DESIGN We retrospectively reviewed prospectively collected data from consecutive patients with 1 year or more of follow-up, who underwent midline AWR between 2000 and 2011 at a single center. We compared surgical outcomes between patients with bridged and mesh-reinforced fascial repairs. The primary outcomes measure was hernia recurrence. Multivariate logistic regression analysis was used to identify factors predictive of or protective for complications. RESULTS We included 222 patients (195 mesh-reinforced and 27 bridged repairs) with a mean follow-up of 31.1 ± 14.2 months. The bridged repairs were associated with a significantly higher risk of hernia recurrence (56% vs 8%; hazard ratio [HR] 9.5; p < 0.001) and a higher overall complication rate (74% vs 32%; odds ratio [OR] 3.9; p < 0.001). The interval to recurrence was more than 9 times shorter in the bridged group (HR 9.5; p < 0.001). Multivariate Cox proportional hazard regression analysis identified bridged repair and defect width > 15 cm to be independent predictors of hernia recurrence (HR 7.3; p < 0.001 and HR 2.5; p = 0.028, respectively). CONCLUSIONS Mesh-reinforced AWRs with primary fascial coaptation resulted in fewer hernia recurrences and fewer overall complications than bridged repairs. Surgeons should make every effort to achieve primary fascial coaptation to reduce complications.

Acellular dermal matrix in irradiated tissue expander/implant-based breast reconstruction: evidence-based review.

Background: The benefits of acellular dermal matrix for breast reconstruction have been well described. However, its clinical impact for breast reconstruction in the setting of radiation therapy has not been well reported. Methods: The MEDLINE and EMBASE databases were reviewed for articles published between January of 2005 and February of 2012 on breast reconstruction using acellular dermal matrix in the setting of radiation therapy. The authors also reviewed their institutional experience of consecutive patients who met these criteria between January of 2008 and October of 2011. Results: Thirteen articles were identified for review: three animal studies on acellular dermal matrix and 10 with level III evidence of its use in humans. The 10 clinical studies included 246 irradiated patients. The M. D. Anderson experience included 30 irradiated acellular dermal matrix patients for a total of 276 irradiated patients evaluated in this review. Use of acellular dermal matrix in implant-based breast reconstruction in the setting of radiation therapy did not predispose to higher infection or overall complication rates or prevent bioprosthetic mesh incorporation. However, the rate of mesh incorporation may be slowed. Its use allowed for increased intraoperative saline fill volumes, which improved aesthetic outcomes and allowed patients to awake from surgery with a formed breast. Conclusions: Use of acellular dermal matrix for implant-based breast reconstruction does not appear to increase or decrease the risk of complications, but it might provide psychological and aesthetic benefits. Multicenter or single-center randomized controlled trials that provide high-quality, level I evidence are warranted.

Augmentation/mastopexy: a 3-year review of a single surgeon's practice.

Background: Augmentation/mastopexy is of considerable interest to plastic surgeons who perform breast surgery because of its complexity as well as its high rate of legal claims. Methods: This single-surgeon, 3-year study evaluated complications, outcomes, and reoperation rates among 166 patients who underwent 171 procedures for primary and secondary augmentation and primary and secondary augmentation/mastopexy. Aspects of the treatment plan were reviewed, including classification of ptosis, procedure selection, surgical planning, and operative technique. There were 57 primary breast augmentations, 60 secondary breast augmentations, 17 primary mastopexies, eight secondary mastopexies, 23 primary augmentation/mastopexies, and 30 secondary augmentation/mastopexies. Results: The 23 primary and 30 secondary augmentation/mastopexy patients had 17 percent and 23 percent complication rates, respectively. The revision rate for augmentation mastopexy was 8.7 percent for the primary group and 16.6 percent for the secondary group. For reference, primary augmentation and secondary augmentation had complication rates of 1.7 percent and 21.6 percent, respectively. Primary augmentation had a 1.7 percent revision rate compared with 18.7 percent for secondary augmentation. The authors reviewed the most common problems leading to a revision, which were capsular contracture and asymmetry correction. Other complications included size change and rupture. Conclusions: Primary augmentation/mastopexy is a commonly performed procedure and has a significantly higher complication rate than primary augmentation. Secondary augmentation/mastopexy is also common and has higher revision and complication rates.

Coming of Age: Breast Implant-Associated Anaplastic Large Cell Lymphoma After 18 Years of Investigation.

Breast implant associated anaplastic large cell lymphoma (BIALCL) is a distinct clinical entity that can present in patients receiving either reconstructive or cosmetic breast implants. Presenting symptoms include onset of a delayed (>1 year after implantation) fluid collection, mass of the capsule, or lymphadenopathy. Treatment has progressed in recent years and most commonly includes implant removal and total resection of the tumor, including capsule, mass, and involved lymph nodes. Further research is warranted to determine potential malignant drivers, disease progression, and optimal treatment strategies in advanced disease.

U.s. Epidemiology of Breast Implant–associated Anaplastic Large Cell Lymphoma

Background: Breast implant–associated anaplastic large cell lymphoma (ALCL) is a distinctive type of T-cell lymphoma that arises around breast implants. Although rare, all cases with adequate history have involved a textured breast implant. The objective of this study was to determine the U.S. incidence and lifetime prevalence of breast implant–associated ALCL in women with textured breast implants. Methods: This is a retrospective review of documented cases of breast implant–associated ALCL in the United States from 1996 to 2015. The incidence and prevalence were determined based on a literature and institutional database review of breast implant–associated ALCL cases and textured breast implant sales figures from implant manufacturers’ annualized data. Results: One hundred pathologically confirmed breast implant–associated ALCL cases were identified in the United States. Mean age at diagnosis was 53.2 ± 12.3 years. Mean interval from implant placement to diagnosis was 10.7 ± 4.6 years. Forty-nine patients had breast implants placed for cosmetic reasons, 44 for mastectomy reconstruction, and seven for unknown reasons. Assuming that breast implant–associated ALCL occurs only in textured breast implants, the incidence rate is 2.03 per 1 million person-years (203 per 100 million person-years), which is 67.6 times higher than that of primary ALCL of the breast in the general population (three per 100 million per year; p < 0.001). Lifetime prevalence was 33 per 1 million persons with textured breast implants. Conclusions: This study demonstrates a statistically significant association between textured breast implants and breast implant–associated ALCL. Although women with a textured breast implant have a low risk of developing breast implant–associated ALCL, the current U.S. incidence is significantly higher than that of primary ALCL of the breast in the general population.

The "neosubpectoral" pocket for the correction of symmastia.

Background: Symmastia is a rare but challenging problem to correct. A number of techniques have been proposed, but each has drawbacks in terms of reliability, accuracy, and difficulty. A recently described technique to treat subpectoral symmastia is reported whereby a new pocket is created between the deep surface of the pectoralis major muscle and the anterior surface of the periprosthetic capsule, the boundaries of which are limited by the adherence between the capsule and overlying tissue. The “neosubpectoral” pocket is therefore not a “repair” of the excessively medialized symmastia pocket, but is a new pocket, limited at its perimeter by the patients own tissues rather than by sutures or a patch. Methods: A precise neosubpectoral plane is developed between the pectoralis major and the anterior implant capsule wall, with dissection limited to creating only the space necessary for proper placement of the implant. The technical details of this procedure are described. A chart review was conducted of all patients who underwent symmastia correction using this technique since December of 2003 at Georgetown University Hospital in the practices of Steven Teitelbaum, M.D., and G. Patrick Maxwell, M.D. Results: A total of 23 patients underwent symmastia correction using the neosubpectoral technique. Several of these patients presented for recurrence after failed capsulorrhaphy. There has been no recurrence of symmastia to date in this study. The average follow-up was 22 months. One postoperative hematoma and one seroma occurred. One patient had uncorrected, underdiagnosed inferior malposition from an earlier procedure requiring revision. Conclusions: The neosubpectoral technique is a method for the correction of symmastia that may offer a more efficient, accurate, and effective solution in a single stage. It is an appealing concept that allows for a site change while maintaining the subpectoral position. This procedure is technically straightforward and may offer a reliable means of correcting many other forms of implant malposition and difficult reconstructions.

NCCN Consensus Guidelines for the Diagnosis and Management of Breast Implant-Associated Anaplastic Large Cell Lymphoma

Published case series demonstrate a lack of treatment standardization for breast implant-associated anaplastic large cell lymphoma (BIA-ALCL) with a wide variety of therapeutic strategies being employed at all stages of disease. The National Comprehensive Cancer Network (NCCN) annually publishes Clinical Practice Guidelines for Non-Hodgkin Lymphomas. For the first time, BIA-ALCL management will be included which signifies an important and needed guideline addition. The new BIA-ALCL guideline was achieved by a consensus of lymphoma oncologists, plastic surgeons, radiation oncologists, and surgical oncologists. NCCN guidelines focus on the diagnosis and management throughout the stages of many lymphoma subtypes based upon the most current data available. This article summarizes the essential recommendations and optimal therapeutic strategies of the NCCN guidelines critical to the plastic surgery community. We encourage international adoption of these BIA-ALCL treatment standards by our specialty societies across the oncology and surgery disciplines.