Identifying Visceral Kaposi Sarcoma (KS): A Responsibility to Avoid Anchoring on the Diagnosis of a Crohn's Flare.

The initial evaluation of reported inflammatory bowel disease (IBD) should include an assessment for immunosuppression which can broaden the differential diagnosis to include opportunistic infection as well as other processes. Here we present an exceedingly rare case of a patient with a self-reported history of Crohn's disease presenting with frequent diarrhea presumed to be a Crohn's flare, however, after further workup was found to have extensive visceral Kaposi sarcoma (KS).

Pregnancy Outcomes After Liver Transplantation: A Systematic Review and Meta-Analysis.

INTRODUCTION: Liver transplantation (LT) remains the gold standard for treatment of end-stage liver disease. Given the increasing number of liver transplantation in females of reproductive age, our aim was to conduct a systematic review and meta-analysis evaluating pregnancy outcomes after LT. METHODS: MEDLINE, Embase, and Scopus databases were searched for relevant studies. Study selection, quality assessment, and data extraction were conducted independently by 2 reviewers. Estimates of pregnancy-related outcomes in LT recipients were generated and pooled across studies using the random-effects model. RESULTS: A comprehensive search identified 1,430 potential studies. Thirty-eight studies with 1,131 pregnancies among 838 LT recipients were included in the analysis. Mean maternal age at pregnancy was 27.8 years, with a mean interval from LT to pregnancy of 59.7 months. The live birth rate was 80.4%, with a mean gestational age of 36.5 weeks. The rate of miscarriages (16.7%) was similar to the general population (10%-20%). The rates of preterm birth, preeclampsia, and cesarean delivery (32.1%, 12.5%, and 42.2%, respectively) among LT recipients were all higher than the rates for the general US population (9.9%, 4%, and 32%, respectively). Most analyses were associated with substantial heterogeneity. DISCUSSION: Pregnancy outcomes after LT are favorable, but the risk of maternal and fetal complications is increased. Large studies along with consistent reporting to national registries are necessary for appropriate patient counseling and to guide clinical management of LT recipients during pregnancy.

Analysis of FDA-Approved Orthopaedic Devices and Their Recalls.

BACKGROUND: The U.S. Food and Drug Administration (FDA) evaluates medical devices by two main pathways. The more stringent Premarket Approval (PMA) review requires clinical trials, and the Premarket Notification 510(k) process generally exempts devices from clinical trials if they prove to be substantially equivalent to existing devices. We hypothesized that orthopaedic devices are more likely to be cleared through the 510(k) process and thus are more susceptible to being recalled. METHODS: Using the FDA's public database, we searched for the following: PMA and 510(k) clearances for orthopaedics and non-orthopaedic specialties, including General & Plastic Surgery, Gastroenterology/Urology, Obstetrics/Gynecology, and Ear Nose & Throat, from 1992 to 2012. Additionally, we searched for all device recall events from 2002 to 2012. For the top-twenty recall companies, we calculated the odds ratio that compares the likelihood of recall for 510(k)-approved devices with that for PMA-approved devices. RESULTS: From 1992 to 2012, the proportion of non-orthopaedic devices cleared via the 510(k) process decreased from 91% to 53%. However, that of orthopaedic devices decreased only from 94% to 88%. Furthermore, we found that from 2002 to 2012, the percentage of recalled devices was 17.8% for 510(k)-cleared devices and 1.6% for PMA-approved devices. When stratified on the basis of recall class, the odds ratios were 3.5 for class-I devices, 13.2 for class-II devices, and 8.5 for class-III devices. CONCLUSIONS: Given that 510(k)-cleared devices were 11.5 times more likely to be recalled than PMA-approved devices, it is concerning that most orthopaedic devices are cleared through the 510(k) process with limited clinical trials data. CLINICAL RELEVANCE: When orthopaedic surgeons are considering using a new device clinically in their patients, it is important for them to consider how the new device was approved by the FDA. If the device was approved by the 510(k) pathway, then it may have been approved without additional clinical studies confirming efficacy or safety.