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.

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Background: 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. Methods: 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. Results: 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. Conclusions: 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.

Study design: Randomized clinical trial. Objective: To investigate the effect of including manual therapy (MT) in a pulmonary rehabilitation program for patients with chronic obstructive pulmonary disease (COPD). Background: The primary source of exercise limitation in people with COPD is dyspnea. The dyspnea is partly caused by changes in chest wall mechanics, with an increase in chest wall rigidity (CWR) contributing to a decrease in lung function. As MT is known to increase joint mobility, administering MT to people with COPD carries with it the potential to influence CWR and lung function. Methods: Thirty-three participants with COPD, aged between 55 and 70 years (mean565.5¡4 years), were randomly assigned to three groups: pulmonary rehabilitation (PR) only, soft tissue therapy (ST) and PR, and ST, spinal manipulative therapy (SM), and PR. Outcome measures including forced expiratory volume in the 1st second (FEV 1 ), forced vital capacity (FVC), 6-minute walking test (6MWT), St. George's respiratory questionnaire (SGRQ), and the hospital anxiety and depression (HAD) scale were recorded at 0, 8, 16, and 24 weeks. Results: There was a significant difference in FVC between the three groups at 24 weeks (P50.04). For the STzSMzPR group versus PR only the increase was 0.40 l (CI: 0.02, 0.79; P50.03). No major or moderate adverse events (AE) were reported following the administration of 131 ST and 272 SM interventions. Discussion: The increase in FVC is a unique finding. Although the underlying mechanisms responsible for this outcome are not yet understood, the most likely explanation is the synergistic effect resulting from the combination of interventions. These results support the call for a larger clinical trial in the use of MT for COPD.

Models for infant growth have usually been based on parametric forms, commonly an exponential or similar model, which have been shown to fit poorly especially during the first year of life. An alternative approach is to use a non-parametric model, based on a shape invariant model (SIM), where a single function is transformed by shifting and scaling to fit each subject. In the model a regression spline is used as the function, with log transformation of the data and a simplification of the SIM, obtained from the relationship with the exponential model. All subjects are fitted as a nonlinear mixed effects model, allowing the variation in the parameters between subjects to be determined. Methods for the inclusion of covariates in growth models based on SIM are developed, with parameters for time independent covariates included in the model by varying either the shape, the size parameter or the growth parameter and time-dependent co-variates included by transforming the time axis, to either increase or decrease the growth rate dependent on the co-variate, similar to methods used for accelerated failure-time models. The model is used to fit weight data for 602 infants, measured from 0 to 2 years as part of the Childhood Asthma Prevention Study (CAPS) trial, and to determine the effect of breastfeeding on infant weight.

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Background Breast implant-associated anaplastic large cell lymphoma (BIA-ALCL) is an emerging cancer that has been linked to the use of textured devices. The recent increase in number and frequency of cases has led to worldwide regulatory action. Objectives The authors aimed to longitudinally study BIA-ALCL in Australia since the index case was first reported in 2007. Methods Confirmed historical cases were collected and then prospectively analyzed from October 2015 to May 2019. Clinical and implant exposure data were determined and compared with company sales data for 4 devices to generate implant-specific risk. Results A total 104 cases of BIA-ALCL were diagnosed in Australia with exposure to 149 unique breast implants. The mean age of patients was 48.2 years (range, 22.4-78.5 years). They had an average time from implantation to diagnosis of 6.8 years. A total 51.7% of implants utilized in this cohort were Allergan Biocell devices. The indication for implant usage was for primary cosmetic augmentation in 70%, post-breast cancer reconstruction in 23%, and following weight loss/pregnancy in 7%. The majority of women presented with early (stage 1) disease (87.5%). The risk for developing BIA-ALCL ranged from 1 in 1947 sales (95% confidence interval = 1199-3406) for Silimed Polyurethane devices to 1 in 36,730 (95% confidence interval = 12,568-178,107) for Siltex imprinted textured devices. Conclusions Implants with higher surface area/texture seem to be more associated with BIA-ALCL in Australia. Recent regulatory action to suspend, cancel, or recall some of these higher risk devices is supported by these findings. Level of Evidence: 2