Jill Brown

National Institute of Allergy and Infectious Diseases, Bethesda, MD, USA

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Publications (3)19.7 Total impact

  • Article: Minimally invasive endometrial ablation device complications and use outside of the manufacturers' instructions.
    Jill Brown, Ken Blank
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    ABSTRACT: : To review the U.S. Food and Drug Administration (FDA) Manufacturer and User Facility Device Experience database for reports describing serious adverse events and adverse events reports describing use outside of the manufacturers' labeled instructions for the five FDA-approved minimally invasive endometrial ablation devices. : We queried the Manufacturer and User Facility Device Experience database for reports of device malfunction, patient injury, or death reported for each device from January 1, 2005 to December 31, 2011. We reviewed U.S. reports individually for annotations of patient injury or death and tabulated the reports by type of injury and device. We identified nine categories of serious injury (death, sepsis or bacteremia, intra-abdominal abscess, uterine rupture, thermal bowel injury, mechanical bowel injury, transmural uterine thermal injury, urologic injury, and lower genital tract or skin burns) and noted all reports citing device use outside of the manufacturers' labeled instructions. We also identified reports of hysterectomy or bowel resection attributable to an adverse event. : Serious adverse events, including bowel injury (n=128), sepsis or bacteremia (n=47), intra-abdominal abscess (n=18), urologic injury (n=2), and uterine rupture (n=1) were reported. Death was also reported (n=4). Eight percent (66 of 829) of serious adverse events reports cited use outside of the manufacturers' labeled instructions, as did 7.3% (6 of 82) of reports citing need for hysterectomy and 8.7% (9 of 103) of reports of bowel resection. : The findings from the Manufacturer and User Facility Device Experience database highlight the potential risk of serious complications related to endometrial ablation and underscore the importance of training in correct device use and familiarity with the manufacturer's labeled instructions. : III.
    Obstetrics and Gynecology 10/2012; 120(4):865-70. · 4.73 Impact Factor
  • Article: Study of 30 patients with unexplained developmental delay and dysmorphic features or congenital abnormalities using conventional cytogenetics and multiplex FISH telomere (M-TEL) integrity assay.
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    ABSTRACT: Cryptic subtelomeric chromosome rearrangements are a major cause of mild to severe mental retardation pointing out the necessity of sensitive screening techniques to detect such aberrations among affected patients. In this prospective study a group of 30 patients with unexplained developmental retardation and dysmorphic features or congenital abnormalities were analysed using the recently published multiplex FISH telomere (M-TEL) integrity assay in combination with conventional G-banding analysis. The patients were selected by one or more of the following criteria defined by de Vries et al.: (a) family history with two or more affected individuals, (b) prenatal onset growth retardation, (c) postnatal growth abnormalities, (d) facial dysmorphic features, (e) non-facial dysmorphism and congenital abnormalities. In addition, we included two patients who met these criteria and revealed questionable chromosome regions requiring further clarification. In four patients (13.3%) cryptic chromosome aberrations were successfully determined by the M-TEL integrity assay and in two patients with abnormal chromosome regions intrachromosomal aberrations were characterized by targetted FISH experiments. Our results accentuate the requirement of strict selection criteria prior to patient testing with the M-TEL integrity assay. Another essential precondition is high-quality banding analysis to identify structural abnormal chromosomes. The detection of familial balanced translocation carriers in 50% of the cases emphasizes the significance of such an integrated approach for genetic counselling and prenatal diagnosis.
    Human Genetics 08/2002; 111(1):31-9. · 5.07 Impact Factor
  • Article: A cryptic t(5;11)(q35;p15.5) in 2 children with acute myeloid leukemia with apparently normal karyotypes, identified by a multiplex fluorescence in situ hybridization telomere assay.
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    ABSTRACT: The identification of specific chromosome abnormalities in acute myeloid leukemia (AML) is important for the stratification of patients into the appropriate treatment protocols. However, a significant proportion of diagnostic bone marrow karyotypes in AML is reported as normal by conventional cytogenetic analysis and it is suspected that these karyotypes may conceal the presence of diagnostically significant chromosome rearrangements. To address this question, we have developed a novel 12-color fluorescence in situ hybridization (FISH) assay for telomeric rearrangements (termed M-TEL), which uses an optimized set of chromosome-specific subtelomeric probes. We report here the application of the M-TEL assay to 69 AML cases with apparently normal karyotypes or an isolated trisomy. Of the 69 cases examined, 3 abnormalities were identified, all in the normal karyotype group. The first was a t(11;19)(q23;p13), identified in an infant with AML-M4. In 2 other young patients with AML (< 19 years), an apparently identical t(5;11)(q35;p15.5) was identified. Breakpoint mapping by FISH and reverse transcriptase polymerase chain reaction (RT-PCR) analysis confirmed that this was the same t(5;11) as previously identified in 3 children with AML, associated with del(5q) and resulting in the NUP98-NSD1 gene fusion. The t(5;11) was not detected by 24-color karyotyping using multiplex FISH (M-FISH), emphasizing the value of screening with subtelomeric probes for subtle translocations. This is the first report of the t(5;11)(q35;p15.5) in association with an apparently normal karyotype, and highlights this as a new, potentially clinically significant chromosome rearrangement in childhood AML.
    Blood 04/2002; 99(7):2526-31. · 9.90 Impact Factor