Total hip replacement, partial hip replacement, and revision hip replacement are associated with different rates of postoperative complications and readmissions. Advanced age, comorbidities, and nonelective admissions are associated with inferior outcomes.

Background: In January of 2011, the US Food and Drug Administration released a safety communication regarding the potential association between breast implants and anaplastic large cell lymphoma (ALCL). In August of 2012, the American Society of Plastic Surgeons, The Plastic Surgery Foundation, and the Food and Drug Administration signed a cooperative research and development agreement to develop a patient registry entitled the “Patient Registry and Outcomes for Breast Implants and Anaplastic Large Cell Lymphoma Etiology and Epidemiology” (PROFILE). Methods: The first report of the registry findings is presented here. Results: From August of 2012 to March of 2018, a total of 186 distinct cases of breast implant–associated ALCL (BIA-ALCL) in the United States were reported to PROFILE. At the time of this present analysis, complete detailed case report forms have been received for 89 (48%) cases. Median time from implantation of any device to BIA-ALCL diagnosis was 11.0 years (range = 2–44 years; n = 89). At the time of presentation, 96% of cases had local symptoms and 9% had concurrent systemic symptoms. The most common local symptom was a periprosthetic fluid collection seen in 86% of patients. All patients had a history of a textured device; there were no patients who had a smooth-only device history. At the time of initial case report submission, 3 deaths were reported. Conclusions: The PROFILE Registry has shown to be an essential tool in unifying the collection of data pertaining to BIA-ALCL. These data have broadened our understanding of the disease and emphasize the critical importance of detailed tracking of BIA-ALCL cases.

ONITORING THE SAFETY OF approved medical productsisofvitalpublichealth importance, given that in clinical practice such medical products are often used in numbers far greater and in patient populations more diverse than when studied in premarket evaluations and clinical trials. [1][2][3][4][5][6] Within the broad range of medical products, implantable medical devices represent high-risk products that are uniquely challenging to monitor because there is little consensus regarding the most appropriate methods to account for the complex interactions amongdevices,medications,patients,and implanting physicians. In addition, the lack of unique medical device identifiers challenges the effective use of administrative claims data and electronic health records as a primary data source to evaluate manufacturer-specific device safety. 7 To support clinical research and quality-improvement efforts, detailed clinical registries have been established in recent years at the state, regional, and national levels for many high-risk implantable medical devices, [8][9][10][11] which may provide unique opportunities to pro-spectively monitor the safety of such devices. 12 The Massachusetts statewide coronary intervention registry 13 was established in 2003 to monitor the quality of care of hospitals and physicians in the state. This registry is a mandatory clinical outcomes registry based on the American College of Cardiology National Cardiovascular Data Repository (NCDR) CathPCI data set and includes For editorial comment see p 2065.

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Background Assuring the safety of medical devices is challenged by reliance on voluntary reporting of adverse events. We evaluated a strategy of prospective, active surveillance of a national clinical registry to monitor the safety of a vascular closure device suspected as potentially associated with increased adverse events. Methods We used an integrated clinical-data-surveillance system to conduct a prospective, propensity-matched analysis of the safety of the Mynx vascular closure device, as compared with alternative approved vascular closure devices, using the National Cardiovascular Data Repository CathPCI Registry. Outcomes were vascular complications including the composite of access-site bleeding, access-site hematoma, retroperitoneal bleeding, any vascular complication requiring intervention or blood transfusion. Results Between 1/1/2011 and 9/30/2013, 73,124 patients receiving Mynx devices used following femoral percutaneous coronary intervention (PCI) procedures were analyzed. When compared with alternative vascular closure devices, the Mynx device was associated with an increased risk of vascular complications (absolute risk [AR]: 1.21% vs. 0.76%; relative risk [RR]: 1.59; 95% CI: 1.42-1.78), access-site bleeding (AR: 0.38% vs. 0.28%; RR: 1.34; 95% CI: 1.10-1.62) and transfusion (AR: 1.82% vs. 1.48%; RR: 1.23; 95% CI: 1.13-1.34). The initial alerts occurred within the first 12 months of monitoring. Relative risks were greater for three prespecified high-risk subsets (diabetics, elderly patients and women). These safety signals were confirmed in an independent sample of 48,992 cases between 4/1/14 and 9/30/15. Conclusions A strategy of prospective, active surveillance of a clinical registry was capable of rapidly identifying potential safety signals following use of an implantable medical device.

Asthma prevalence in the Cataño Air Basin of Puerto Rico is 27% for children aged 13-14 years and 45% for children aged 5-6 years. There is concern that these rates are related to air pollution. The authors conducted a nested case-control study to evaluate whether proximity to air pollution point sources was associated with increased risk of asthma attacks. For 1997-2001, 1,382 asthma-related medical visits (International Classification of Diseases, Ninth Revision, codes 493 and 493.9) in children under 17 were identified through health insurance claims. Controls were children with no asthma attacks who were randomly selected from enrollees in two health insurance companies by incidence density sampling (1:5) and matched to cases on gender, age, insurance company, and event date. The distance from a point source to the subject's residence area represented a surrogate exposure measurement. Odds ratios for a 1-km decrease in distance were obtained by conditional logistic regression. Risk of asthma attack was associated with residing near a grain mill (odds ratio (OR) = 1.35), petroleum refinery (OR = 1.44), asphalt plant (OR = 1.23), or power plant (OR = 1.28) (all p's < 0.05). Residence near major air emissions sources (>100 tons/year) increased asthma attack risk by 108% (p < 0.05). These results showed that proximity to some air pollution sources is associated with increased risks of asthma attacks.

Our results suggest that problems and injuries associated with breast pump use can happen to mothers of all socioeconomic characteristics. Breastfeeding mothers may reduce their risks of problems and injury by not using battery-operated pumps and may reduce breast pump problems by not using manual pumps and by learning breast pump skills from a person rather than following written or video instructions.

This study showed a high prevalence of asthma and related symptoms in Northern Puerto Rico. FHA was strongly associated with asthma and its symptoms. Further research is recommended to look at genetics, sensitivity levels, indoor and outdoor pollution, and gene-environment interactions.