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.
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.
INTRODUCTION: Salivary gland tumors are rare, often benign, mostly originating from the parotid gland. Tumors can also arise from submandibular and sublingual glands, and while these tumors tend to be more rare, they are more often malignant. Salivary gland tumors usually metastasize to the lung, bone, and liver. CASE DESCRIPTION/METHODS: A 77-year-old Albanian male with history of a right-sided mandibular abscess s/p drainage in 2015 presented with confusion and abdominal pain. Labs were unremarkable. He underwent CT head, which was concerning for an occipital lesion, for which he proceeded with an MRI brain that revealed multiple intracranial lesions concerning for metastatic disease. He then had a CT Abdomen/Pelvis that revealed several hepatic lesions, innumerable pulmonary nodules, and an area of focal thickening and enhancement of the proximal ascending colon. Bone scan revealed likely metastasis to the L5 vertebral body. His CEA was 4.7 and CA 19-9 was 43.6. AFP was 1.7. He then had a colonoscopy, which was significant for 2 polyps in the descending colon, 2 umbilicated polyps in the transverse colon, a 4 mm sessile polyp in the transverse colon, and a submucosal and ulcerated non-obstructing mass in the proximal ascending colon distal to the ileocecal valve. Pathology showed small, round, blue cells with trabecular growth pattern and necrosis, consistent with invasive, poorly differentiated carcinoma with basaloid features. In addition, the immunohistochemistry was positive for CK7 and Sox10, focally positive for S100, and weakly positive for CD 117, all suggestive of an adenoid cystic carcinoma. Treatment first consisted of palliative radiation to his CNS lesions, a dexamethasone taper, and an Oncology consult for consideration of palliative chemotherapy. He was offered palliative paclitaxel and carboplatin, however he ultimately decided to return to Albania and forego treatment. DISCUSSION: This patient likely had undiagnosed, malignant, primary salivary gland cancer for many years; despite having his mandibular ‘abscess’ drained several years prior. In addition, the lesion metastasized to several uncommon locations, notably the brain and colon, which are the 2 sites that ultimately produced symptoms that prompted him to receive further medical care. Salivary gland tumors must be considered in patients presenting with head and neck swelling, and proper diagnostic workup must be obtained. In addition, uncommon sites of metastasis, such as colon, must be considered during staging of disease.
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