Charles E. Butler

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.

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.

BACKGROUND: Perineal wound complications after chemoradiotherapy and abdominoperineal resection (APR) for anorectal cancer occur in up to 60% of patients, including perineal abscess and wound dehiscence. Vertical rectus abdominis myocutaneous (VRAM) flaps have been used in an attempt to reduce these complications by obliterating the noncollapsible dead space with vascularized tissue and closing the perineal skin defect with nonirradiated flap skin. Many surgeons are reluctant to use VRAM flaps unless primary closure is not possible. STUDY DESIGN: All patients who underwent chemoradiotherapy and APR during a 12-year period at the University of Texas MD Anderson Cancer Center were retrospectively reviewed. Patient, tumor, and treatment characteristics and surgical complications and outcomes were compared between patients who underwent VRAM flap reconstruction of wounds that could have been closed primarily (flap group, n = 35) and those who had primary closure of the perineal wound (control group, n = 76). RESULTS: Overall, there were no significant differences in the incidence of perineal wound complications between the groups; the flap group had a significantly lower incidence of perineal abscess (9% versus 37%, p = 0.002), major perineal wound dehiscence (9% versus 30%, p = 0.014), and drainage procedures required for perineal/pelvic fluid collections (3% versus 25%, p = 0.003) than the control group had. Despite flap harvest and the need for donor site closure in the flap group, there was no significant difference in abdominal wall complications between groups during the study's mean patient followup of 3.8 years. CONCLUSIONS: VRAM flap reconstruction of irradiated APR defects reduces major perineal wound complications without increasing early abdominal wall complications. Strong consideration should be given to immediate VRAM flap reconstruction after chemoradiation and APR.

OBJECTIVE: To analyze the long-term safety and efficacy outcomes of patients with breast implants. SUMMARY BACKGROUND DATA: Research is ongoing regarding the safety of silicone breast implants. Despite the number of patients with breast implants followed by United States Food and Drug Administration large postapproval studies (LPAS), this database has not been thoroughly analyzed or reported. METHODS: This is a multicentered, cohort study. LPAS prospectively monitor long-term implant-related outcomes and systemic harms for silicone/saline implants from 2 manufacturers (Allergan and Mentor) placed for primary/revision augmentation/reconstruction. Systemic harms, self-harm, and reproductive outcomes are compared with normative data. Implant-related complications are analyzed by implant composition and operative indication in the short and long terms. RESULTS: LPAS data includes 99,993 patients, 56% of implants were silicone for primary augmentation. Long-term magnetic resonance imaging surveillance is under 5%. Compared with normative data, silicone implants are associated with higher rates of Sjogren syndrome (Standardized incidence ratio [SIR]8.14), scleroderma (SIR 7.00), rheumatoid arthritis (SIR5.96), stillbirth (SIR4.50), and melanoma (SIR3.71). One case of BI-ALCL is reported. There is no association with suicide. In the short term, rupture is higher for saline (2.5% vs. 0.5%, P < 0.001), and capsular contracture higher for silicone (5.0% vs. 2.8%, P < 0.001). At 7 years, reoperation rate is 11.7% for primary augmentation, and 25% for primary/revision reconstruction. Capsular contracture (III/IV) occurs in 7.2% of primary augmentations, 12.7% primary reconstructions, and is the most common reason for reoperation among augmentations. CONCLUSIONS: This is the largest study of breast implant outcomes. Silicone implants are associated with an increased risk of certain rare harms; associations need to be further analyzed with patient-level data to provide conclusive evidence. Long-term safety and implant-related outcomes should inform patient and surgeon decision-making when selecting implants.