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The epidemiology and implant-specific risk for breast implant-associated (BIA) anaplastic large cell lymphoma (ALCL) has been previously reported for Australia and New Zealand. The authors now present updated data and risk assessment since their last report.New cases in Australia and New Zealand were identified and analyzed. Updated sales data from three leading breast implant manufacturers (i.e., Mentor, Allergan, and Silimed) were secured to estimate implant-specific risk.A total of 26 new cases of BIA-ALCL were diagnosed between January of 2017 and April of 2018, increasing the total number of confirmed cases in Australia and New Zealand to 81. This represents a 47 percent increase in the number of reported cases over this period. The mean age and time to development remain unchanged. The implant-specific risk has increased for Silimed polyurethane (23.4 times higher) compared with Biocell, which has remained relatively static (16.5 times higher) compared with Siltex implants.The number of confirmed cases of BIA-ALCL in Australia and New Zealand continues to rise. The implant-specific risk has now changed to reflect a strong link to implant surface area/roughness as a major association with this cancer.

Standard of care treatment of breast implant-associated anaplastic large cell lymphoma (BIA-ALCL) involves surgical resection with implant removal and complete capsulectomy. We report a case series of BIA-ALCL reconstruction with proposals for timing and technique selection.We retrospectively reviewed and prospectively enrolled all BIA-ALCL patients at 2 tertiary care centers and 1 private plastic surgery practice from 1998 to 2017. Demographics, treatment, reconstruction, pathology staging, patient satisfaction, and oncologic outcomes were reviewed.We treated 66 consecutive BIA-ALCL patients and 18 (27%) received reconstruction. Seven patients (39%) received immediate reconstruction, and 11 (61%) received delayed reconstruction. Disease stage at presentation was IA (T1N0M0 disease confined to effusion or a layer on luminal side of capsule with no lymph node involvement and no distant spread) in 56%, IB in 17%, IC (T3N0M0 cell aggregates or sheets infiltrating the capsule, no lymph node involvement and no distant spread) in 6%, IIA (T4N0M0 lymphoma infiltrating beyond the capsule, no lymph node involvement and no distant spread) in 11%, and III in 11%. Types of reconstruction included smooth implants (72%), immediate mastopexy (11%), autologous flaps (11%), and fat grafting (6%). Outcomes included no surgical complications, but 1 patient progressed to widespread bone metastasis (6%); ultimately, all patients achieved complete remission. Ninety-four percent were satisfied/highly satisfied with reconstructions, whereas 6% were highly unsatisfied with immediate smooth implants.Breast reconstruction following BIA-ALCL management can be performed with acceptable complications if complete surgical ablation is possible. Immediate reconstruction is reserved for disease confined to capsule on preoperative positive emission tomography/computed tomography scan. Genetic predisposition and bilateral cases suggest that BIA-ALCL patients should not receive textured implants. Autologous options are preferable for implant adverse BIA-ALCL patients. Patients with extensive disease at presentation should be considered for 6- to 12-month delayed reconstruction with interval positive emission tomography/computed tomography evaluation.

Background The introduction of texture to the outer shell of breast implants was aimed at increasing tissue incorporation and reducing capsular contracture. It has also been shown that textured surfaces promote a higher growth of bacteria and are linked to the development of breast implant-associated anaplastic large cell lymphoma. Methods The authors aimed to measure the surface area and surface roughness of 11 available implants. In addition, the authors aimed to subject these implant shells to an in vitro bacterial attachment assay with four bacterial pathogens (Staphylococcus epidermidis, S. aureus, Pseudomonas aeruginosa, and Ralstonia pickettii) and study the relationship among surface area, surface roughness, and bacterial growth. Results Surface area measurement showed grouping of implants into high, intermediate, low, and minimal. Surface roughness showed a correlation with surface area. The in vitro assay showed a significant linear relationship between surface area and bacterial attachment/growth. The high surface area/roughness implant texture grew significantly more bacteria at 24 hours, whereas the minimal surface area/roughness implant textures grew significantly fewer bacteria of all types at 24 hours. For implants with intermediate and low surface areas, some species differences were observed, indicating possible affinity of specific bacterial species to surface morphology. Conclusions Implant shells should be reclassified using surface area/roughness into four categories (high, intermediate, low, and minimal). This classification is superior to the use of descriptive terms such as macrotexture, microtexture, and nanotexture, which are not well correlated with objective measurement and/or functional outcomes.

The association between breast implants and breast implant-associated anaplastic large cell lymphoma (ALCL) has been confirmed. Implant-related risk has been difficult to estimate to date due to incomplete datasets.All cases in Australia and New Zealand were identified and analyzed. Textured implants reported in this group were subjected to surface area analysis. Sales data from three leading breast implant manufacturers (i.e., Mentor, Allergan, and Silimed) dating back to 1999 were secured to estimate implant-specific risk.Fifty-five cases of breast implant-associated ALCL were diagnosed in Australia and New Zealand between 2007 and 2016. The mean age of patients was 47.1 years and the mean time of implant exposure was 7.46 years. There were four deaths in the series related to mass and/or metastatic presentation. All patients were exposed to textured implants. Surface area analysis confirmed that higher surface area was associated with 64 of the 75 implants used (85.3 percent). Biocell salt loss textured (Allergan, Inamed, and McGhan) implants accounted for 58.7 percent of the implants used in this series. Comparative analysis showed the risk of developing breast implant-associated ALCL to be 14.11 times higher with Biocell textured implants and 10.84 higher with polyurethane (Silimed) textured implants compared with Siltex textured implants.This study has calculated implant-specific risk of breast implant-associated ALCL. Higher-surface-area textured implants have been shown to significantly increase the risk of breast implant-associated ALCL in Australia and New Zealand. The authors present a unifying hypothesis to explain these observations.

Tracking world cases of breast implant-associated anaplastic large cell lymphoma (ALCL) is currently limited to patient registries at a few academic centers, dependent upon patient referral and case reports in the literature. The purpose of this study was to review and compare federal database adverse event reports of breast implant-associated ALCL encompassing the major breast implant markets worldwide.Federal implantable device regulatory bodies were contacted and database queries were performed for 40 countries. Demographics, device characteristics, pathology, treatment modalities, and outcomes were assessed when available.For the countries queried, 363 unique cases were reported for breast implant-associated ALCL. Search terms "anaplastic" and "ALCL" were queried of the U.S. Manufacturer and User Facility Device Experience (MAUDE) database and yielded 258 unique cases as of September 2015, of which only 130 had pathologic markers performed. Implant surface was textured significantly more than smooth (50 percent versus 4.2 percent; p = 0.0001). Treatment, when reported (n = 136), included explantation [n = 125 (91.9 percent)], chemotherapy [n = 42 (30.8 percent)], radiation therapy [n = 25 (18.4 percent)], and/or stem cell transplant [n = 9 (6.6 percent)], and five deaths were reported.Federal reporting of breast implant-associated ALCL has limitations in providing clinical history, treatment, and oncologic follow-up. Worldwide and country-specific total and textured implant sales data are needed to determine critical incidence and prevalence analysis. International multi-institutional collaborations and centralized tissue consortiums working in concert with federal authorities are necessary to acquire accurate complete data on breast implant-associated ALCL.

BACKGROUND The development of chronic nodules and granulomatous inflammation after filler injections has been attributed to bacterial biofilm infection. The authors aimed to investigate the relationship between filler and bacterial biofilm using a combined in vitro and in vivo study. METHODS In vitro assays to investigate the ability of filler materials to support the growth of Staphylococcus epidermidis biofilm and the effect of multiple needle passes through a biofilm-contaminated surface were designed. Analysis of clinical biopsy specimens from patients presenting with chronic granulomas following filler administration using a number of laboratory tests for biofilm was performed. RESULTS All fillers (i.e., hyaluronic acid, polyacrylamide gel, and poly-L-lactic acid) supported the growth of S. epidermidis biofilm in vitro. Multiple needle passes through a biofilm-contaminated surface resulted in significantly increased contamination of filler material by a factor of 10,000 (p < 0.001). Six clinical samples from five patients all demonstrated bacterial biofilm. The mean number of bacteria was found to be 2.2 × 10 bacteria/mg tissue (range, 5.6 × 10 to 3.7 × 10 bacteria/mg tissue). Microbiome analysis detected a predominance of Pseudomonas, Staphylococcus, and Propionibacterium as present in these samples. CONCLUSIONS Filler material can support the growth of bacterial biofilm in vitro. Multiple needle passes can significantly increase the risk of filler contamination. Biofilm appears to be associated with high numbers in clinical samples of patients presenting with chronic granulomatous inflammation. Strategies to reduce the risk of bacterial contamination need to be further studied and translated into clinical practice. CLINICAL QUESTION/LEVEL OF EVIDENCE Therapeutic, V.

The link between breast implants and systemic disease has been reported since the 1960s. Although many studies have looked at either supporting or refuting its existence, the issue still persists and has now been labeled "breast implant illness." The rise of patient advocacy and communication through social media has led to an increasing number of presentations to plastic surgeons. This article summarizes the history of breast implants and systemic disease, critically analyzes the literature (and any associated deficiencies), and suggests a way forward through systematic scientific study.

With breast implant-associated anaplastic large cell lymphoma (BIA-ALCL) now accepted as a unique (iatrogenic) subtype of ALCL directly associated with textured breast implants, we are now at a point where a sound epidemiologic profile and risk estimate are required. The aim of this article is to provide a comprehensive and up-to-date global review of the available epidemiologic data and literature relating to the incidence, risk, and prevalence of BIA-ALCL.All current literature relating to the epidemiology of BIA-ALCL was reviewed. Barriers relating to sound epidemiologic study were identified, and trends relating to geographical distribution, prevalence of breast implants, and implant characteristics were analyzed.Significant barriers exist to the accurate estimate of both the number of women with implants (denominator) and the number of cases of BIA-ALCL (numerator), including poor registries, underreporting, lack of awareness, cosmetic tourism, and fear of litigation. The incidence and risk of BIA-ALCL have increased dramatically from initial reports of 1 per million to current estimates of 1/2,832, and is largely dependant on the "population" (implant type and characteristics) examined and increased awareness of the disease.Although many barriers stand in the way of calculating accurate estimates of the incidence and risk of developing BIA-ALCL, steady progress, international registries, and collegiality between research teams are for the first time allowing early estimates. Most striking is the exponential rise in incidence over the last decade, which can largely be explained by the increasingly specific implant subtypes examined-driven by our understanding of the pathologic mechanism of the disease. High-textured high-surface area implants (grade 4 surface) carry the highest risk of BIA-ALCL (1/2,832).

Breast implant-associated anaplastic large cell lymphoma is a malignancy of T lymphocytes that is associated with the use of textured breast implants in both esthetic and reconstructive surgeries. Patients typically present with a delayed seroma 8-10 years following implantation or-less commonly-with a capsular mass or systemic disease. Current theories on disease pathogenesis focus on the interplay among textured implants, Gram-negative bacteria, host genetics, and time. The possible roles of silicone leachables and particles have been less well substantiated. This review aims to synthesize the existing scientific evidence regarding breast implant-associated anaplastic large cell lymphoma etiopathogenesis.

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

Biofilm infection of breast implants significantly potentiates capsular contracture. This study investigated whether chronic biofilm infection could promote T-cell hyperplasia.In the pig study, 12 textured and 12 smooth implants were inserted into three adult pigs. Implants were left in situ for a mean period of 8.75 months. In the human study, 57 capsules from patients with Baker grade IV contracture were collected prospectively over a 4-year period. Biofilm and surrounding lymphocytes were analyzed using culture, nucleic acid, and visualization techniques.In the pig study, all samples were positive for bacterial biofilm. There was a significant correlation between the bacterial numbers and grade of capsular contracture (p = 0.04). Quantitative real-time polymerase chain reaction showed that all lymphocytes were significantly more numerous on textured compared with smooth implants (p0.001). T cells accounted for the majority of the lymphocytic infiltrate. Imaging confirmed the presence of activated lymphocytes. In the human study, all capsules were positive for biofilm. Analysis of lymphocyte numbers showed a T-cell predominance (p0.001). There was a significant linear correlation between the number of T and B cells and the number of detected bacteria (p0.001). Subset analysis showed a significantly higher number of bacteria for polyurethane implants (p0.005).Chronic biofilm infection around breast prostheses produces an increased T-cell response both in the pig and in humans. A possible link between bacterial biofilm and T-cell hyperplasia is significant in light of breast implant-associated anaplastic large-cell lymphoma.Risk, V.

Bacteria/biofilm on breast implant surfaces has been implicated in capsular contracture and breast implant-associated anaplastic large-cell lymphoma (ALCL). Macrotextured breast implants have been shown to harbor more bacteria than smooth or microtextured implants. Recent reports also suggest that macrotextured implants are associated with a significantly higher incidence of breast implant-associated ALCL. Using techniques to reduce the number of bacteria around implants, specifically, the 14-point plan, has successfully minimized the occurrence of capsular contracture. The authors hypothesize that a similar effect may be seen in reducing the risk of breast implant-associated ALCL.Pooled data from eight plastic surgeons assessed the use of macrotextured breast implants (Biocell and polyurethane) and known cases of breast implant-associated ALCL. Surgeon adherence to the 14-point plan was also analyzed.A total of 42,035 Biocell implants were placed in 21,650 patients; mean follow-up was 11.7 years (range, 1 to 14 years). A total of 704 polyurethane implants were used, with a mean follow-up of 8.0 years (range, 1 to 20 years). The overall capsular contracture rate was 2.2 percent. There were no cases of implant-associated ALCL. All surgeons routinely performed all 13 perioperative components of the 14-point plan; two surgeons do not routinely prescribe prophylaxis for subsequent unrelated procedures.Mounting evidence implicates the role of a sustained T-cell response to implant bacteria/biofilm in the development of breast implant-associated ALCL. Using the principles of the 14-point plan to minimize bacterial load at the time of surgery, the development and subsequent sequelae of capsular contracture and breast implant-associated ALCL may be reduced, especially with higher-risk macrotextured implants.Therapeutic, IV.

There is increasing evidence that bacterial biofilm is responsible for the failure of medical devices, leading to device-associated infection. As plastic surgeons, we are among the leading users of prostheses in surgery, and it is important that we are kept informed of this growing problem. This article summarizes the pathogenesis of device-associated infection, outlines the evidence for such infection in a number of medical devices, and outlines operative strategies aimed at reducing the risk of bacterial contamination at the time of device deployment. It also outlines strategies under investigation to combat the development of device-associated infection.

Topical negative pressure has been demonstrated to improve graft take in a number of noncomparative studies. This study aimed to assess whether split-thickness skin graft take is improved qualitatively or quantitatively with topical negative pressure therapy compared with standard bolster dressings. A blinded, prospective, randomized trial was conducted of 22 adult inpatients of Liverpool Hospital between July of 2001 and July of 2002 who had wounds requiring skin grafting. After grafting, each wound half was randomized to receive either a standard bolster dressing or a topical negative pressure dressing. Skin graft assessment was performed at 2 weeks by a single observer blinded to the randomization. Two patients were lost to follow-up and were excluded from the study. There were 20 patients (12 men and eightwomen) in the study group. The median patient age was 64 years (range, 27 to 88 years), and the mean wound size was 128 cm2 (range, 35 to 450 cm2). The wound exposed subcutaneous fat in eight patients, muscle in six patients, paratenon in four patients, and deep fascia in two patients. At 2 weeks, wounds that received a topical negative pressure dressing had a greater degree of epithelialization in six cases (30 percent), the same degree of epithelialization in nine cases (45 percent), and less epithelialization in five cases (25 percent) compared with their respective control wounds. Graft quality following topical negative pressure therapy was subjectively determined to be better in 10 cases (50 percent), equivalent in seven cases (35 percent), and worse in three cases (15 percent). Although the quantitative graft take was not significant, the qualitative graft take was found to be significantly better with the use of topical negative pressure therapy (p < 0.05). Topical negative pressure significantly improved the qualitative appearance of split-thickness skin grafts as compared with standard bolster dressings.