Abstract:
OBJECTIVE:To compare temporal trends of urogynecologic mesh medical device reports with sentinel U.S. Food and Drug Administration (FDA) notices and to examine all linked reports of patient death. METHODS:The Reed Tech Navigator is an online tool used to extract and analyze data in the Manufacturer and User Facility Device Experience database. We used FDA product codes to search for reports of synthetic mesh for stress urinary incontinence (SUI) and pelvic organ prolapse (POP). Reports with "death" listed as a patient event were queried further. RESULTS:There were 43,970 medical device reports involving urogynecologic mesh reported to the FDA between August 2000 and January 2019, with most occurring after the 2011 FDA communication (n=43,018, 97.8%). Of these medical device reports, 64.6% (n=28,422) were for SUI products, 27.0% (n=11,876) were for transvaginal POP products, and 8.4% (n=3,672) were for transabdominal POP products. Peak reporting occurred in 2013, which corresponded with the first major plaintiff verdicts and class action vaginal mesh settlement. There were 645 (1.5%) medical device reports of death, with 49.3% (n=318) having no cause of death identified. Only four (0.6%) could be directly attributed to the initial surgery. CONCLUSION:Since 2011, urogynecologic mesh has been the focus of thousands of medical device reports annually, although the data submitted are often incomplete. Few reported deaths are directly attributable to mesh products, and the majority lack sufficient information to draw causal conclusions. A high-quality registry is necessary to improve our understanding of the patient effect from urogynecologic mesh products.
journal_name
Obstet Gynecoljournal_title
Obstetrics and gynecologyauthors
Sassani JC,Artsen AM,Moalli PA,Bradley MSdoi
10.1097/AOG.0000000000003805subject
Has Abstractpub_date
2020-05-01 00:00:00pages
1084-1090issue
5eissn
0029-7844issn
1873-233Xpii
00006250-202005000-00013journal_volume
135pub_type
杂志文章abstract:OBJECTIVE:To assess the effectiveness of intrauterine local anesthesia in reducing pain associated with outpatient gynecologic procedures. DATA SOURCES:We searched online databases PubMed or MEDLINE, Embase, Google Scholar, and Clinicaltrials.gov and hand-searched reference lists from reviews evaluating pain-control m...
journal_title:Obstetrics and gynecology
pub_type: 杂志文章,评审
doi:10.1097/AOG.0b013e3182639ab5
更新日期:2012-09-01 00:00:00
abstract::A 26-year-old woman was admitted with a diagnosis of septic incomplete abortion. Subsequently she was discovered to have bilateral tubal ectopic pregnancies. The right tube was not badly damaged. Its contents were removed by linear salpingotomy and the tube was repaired. Fifteen months later the patient delivered a li...
journal_title:Obstetrics and gynecology
pub_type: 杂志文章
doi:
更新日期:1982-11-01 00:00:00
abstract:BACKGROUND:Cyclic vomiting syndrome is a condition that consists of recurrent episodes of vomiting occurring between periods of normal health, with no apparent organic cause of vomiting. We report the sentinel case of pregnancy complicated by preexisting cyclic vomiting syndrome. CASE:A primigravida presented at 8 wee...
journal_title:Obstetrics and gynecology
pub_type: 杂志文章
doi:10.1097/AOG.0b013e3181a458e0
更新日期:2009-08-01 00:00:00
abstract:OBJECTIVE:To examine associations between pregnancy weight gain outside and within ranges recommended by the Institute of Medicine and birth weight by both prepregnant body mass index (BMI) and race-ethnicity. METHODS:Mean birth weight and incidence of term low birth weight (LBW, less than 2500 g) and high birth weigh...
journal_title:Obstetrics and gynecology
pub_type: 杂志文章
doi:10.1016/s0029-7844(98)00106-9
更新日期:1998-06-01 00:00:00
abstract:BACKGROUND:Intrauterine parvovirus B19 infection is a well-known cause for hydrops fetalis and fetal demise. We present a case of isolated fetal obstructive hydrocephalus caused by an intrauterine parvovirus B19 infection. CASE:A 23-year-old woman, gravida 3 para 2, was referred for fetal obstructive hydrocephalus. Al...
journal_title:Obstetrics and gynecology
pub_type: 杂志文章
doi:10.1097/AOG.0b013e3181e7597e
更新日期:2010-08-01 00:00:00
abstract::The acute effects of cigarette smoking on fetal breathing movements and fetal movements were determined with a real-time ultrasound system in 10 healthy habitually smoking women in late gestation. The study was carried out for 1 hour before and 1 hour after the woman smoked a single cigarette. The maternal blood gluco...
journal_title:Obstetrics and gynecology
pub_type: 杂志文章
doi:
更新日期:1983-03-01 00:00:00
abstract:BACKGROUND:Diphallia poses several surgical, psychological, and esthetic issues. Currently, diphallia is only diagnosed after birth. CASE:We present a true diphallia in one fetus of dichorionic twins noted at 23 weeks of gestation. In this fetus, two phallus-like protrusions and a bifid scrotum, as well as a duplicate...
journal_title:Obstetrics and gynecology
pub_type: 杂志文章
doi:10.1097/AOG.0000000000000327
更新日期:2014-08-01 00:00:00
abstract::The serum concentration of placental protein 12 was measured by radioimmunoassay in 111 apparently healthy pregnant women at 33 to 40 weeks, and the results were compared with those of 39 women with preeclampsia either with or without proteinuria at similar stages of pregnancy. Because the placental protein 12 levels ...
journal_title:Obstetrics and gynecology
pub_type: 杂志文章
doi:
更新日期:1986-07-01 00:00:00
abstract:BACKGROUND:Neuroleptic malignant syndrome (NMS) is characterized by a tetrad of mental status changes, extrapyramidal symptoms, hyperpyrexia, and autonomic instability and can develop after the use of antipsychotics. CASE:A young, multiparous woman presented at 26 weeks of gestation with acute psychosis and was treate...
journal_title:Obstetrics and gynecology
pub_type: 杂志文章
doi:10.1097/AOG.0b013e31822864af
更新日期:2012-02-01 00:00:00
abstract::The prenatal diagnosis of anencephaly and spina bifida (neural tube defect, NTD) through amniotic fluid analysis for alpha-fetoprotein (AFP) is gradually gaining clinical recognition. AFP concentrations were determined in 237 amniotic fluids from normal pregnancies ranging between 7 and 42 weeks of gestation. A steady...
journal_title:Obstetrics and gynecology
pub_type: 杂志文章
doi:
更新日期:1976-02-01 00:00:00
abstract:OBJECTIVE:To assess the impact of childbirth on female sexual function by using an identical twin study design. METHODS:A survey including the Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire (PISQ-12) was administered to 542 twin sisters, and PISQ-12 scores of 29 twin pairs discordant for parity were c...
journal_title:Obstetrics and gynecology
pub_type: 杂志文章
doi:10.1097/01.AOG.0000207677.03235.76
更新日期:2006-04-01 00:00:00
abstract:OBJECTIVE:To determine gender-specific differences in anthropometric characteristics of full-term male and female infants. METHODS:Twelve hundred five term newborn infants were examined. All measures of length and skinfold thickness were performed in a standardized manner. RESULTS:After adjusting for confounding vari...
journal_title:Obstetrics and gynecology
pub_type: 杂志文章
doi:
更新日期:1993-02-01 00:00:00
abstract:BACKGROUND:Because of donor oocyte programs, women who previously were considered too old to successfully achieve conception and delivery can now bear children. To our knowledge, there have been no previous reports of pregnancy outcome in women over age 50 who conceived using donor oocytes. This study presents the preg...
journal_title:Obstetrics and gynecology
pub_type: 杂志文章
doi:
更新日期:1993-05-01 00:00:00
abstract::One hundred patients undergoing pelvic exenteration (total 69, anterior 13, posterior 18) at the University of Michigan Medical Center from 1964-1984 are reported. All patients were followed for at least 5 years or until time of death. The overall cumulative survival was 66% at 3 years and 61% at 5 years. The age of t...
journal_title:Obstetrics and gynecology
pub_type: 杂志文章
doi:
更新日期:1989-12-01 00:00:00
abstract:OBJECTIVE:To evaluate the role of cerebral velocimetry as a predictor of perinatal outcome in high-risk pregnancies. METHODS:Middle cerebral artery pulsatility index was measured in 576 high-risk pregnancies undergoing umbilical velocimetry. The results of both tests were evaluated with respect to the birth of small f...
journal_title:Obstetrics and gynecology
pub_type: 杂志文章
doi:10.1016/s0029-7844(97)00482-1
更新日期:1997-12-01 00:00:00
abstract::A retrospective study of 51 thecomas and granulosa-theca cell tumors of the ovary seen at Confederate Memorial Medical Center in Shreveport, Louisiana, is presented. Endometrial tissue was available for study in 38 of the 51 patients. The relation of these tumors to endometrial morphology suggests an excessive estroge...
journal_title:Obstetrics and gynecology
pub_type: 杂志文章
doi:
更新日期:1977-07-01 00:00:00
abstract:BACKGROUND:Cervical varices are an extremely rare complication of pregnancy; they can result in significant maternal morbidity secondary to acute hemorrhage. There is limited evidence to guide the management of cervical varices during termination of pregnancy. CASE:A 37-year-old woman presented with recurrent vaginal ...
journal_title:Obstetrics and gynecology
pub_type: 杂志文章
doi:10.1097/01.AOG.0000435449.01356.99
更新日期:2014-02-01 00:00:00
abstract::Heavy menstrual bleeding is defined as excessive menstrual blood loss that interferes with a woman's physical, social, emotional, or material quality of life. If obstetrician-gynecologists suspect that a patient has a bleeding disorder, they should work in coordination with a hematologist for laboratory evaluation and...
journal_title:Obstetrics and gynecology
pub_type: 杂志文章
doi:10.1097/AOG.0000000000003412
更新日期:2019-09-01 00:00:00
abstract:OBJECTIVE:To analyze neonatal mortality and morbidity rates at 34, 35, and 36 weeks of gestation compared with births at term over the past 18 years at our hospital and to estimate the magnitude of increased risk associated with late preterm births compared with births later in gestation. METHODS:We performed a retros...
journal_title:Obstetrics and gynecology
pub_type: 杂志文章
doi:10.1097/01.AOG.0000297311.33046.73
更新日期:2008-01-01 00:00:00
abstract:OBJECTIVE:To identify the primary etiology of preterm birth in women with systemic lupus erythematosus, analyzing prospective data collected on 66 pregnancies in 58 women followed-up at a lupus pregnancy center. METHODS:Hospital records were reviewed and subjects were interviewed for pregnancies delivered after 23 com...
journal_title:Obstetrics and gynecology
pub_type: 杂志文章
doi:10.1016/0029-7844(95)00186-U
更新日期:1995-09-01 00:00:00
abstract:OBJECTIVE:To estimate the efficacy of paracervical block compared with saline for pain relief during office hysteroscopic sterilization. METHODS:This study was a randomized, placebo-controlled study of women desiring hysteroscopic sterilization. A paracervical block of 1% lidocaine or normal saline was administered be...
journal_title:Obstetrics and gynecology
pub_type: 杂志文章,随机对照试验
doi:10.1097/AOG.0b013e3181c51ace
更新日期:2010-01-01 00:00:00
abstract:BACKGROUND:Microangiopathic disorders during pregnancy remain a diagnostic challenge because these conditions often imitate more common obstetric diseases. CASE:A 31-year-old multigravid woman delivered at term with a postpartum course complicated by laboratory indices consistent with hemolysis, elevated liver enzymes...
journal_title:Obstetrics and gynecology
pub_type: 杂志文章
doi:10.1097/AOG.0000000000001675
更新日期:2016-12-01 00:00:00
abstract:OBJECTIVE:To quantitatively and qualitatively describe the patient experience for clinically stable patients presenting with miscarriage to the emergency department (ED) or ambulatory clinics. METHODS:We present a subanalysis of a mixed-methods study from 2016 on factors that influence miscarriage treatment decision-m...
journal_title:Obstetrics and gynecology
pub_type: 杂志文章
doi:10.1097/AOG.0000000000003571
更新日期:2019-12-01 00:00:00
abstract::Fourteen women with amenorrhea-galactorrhea were treated with bromo-ergocryptine. Serum prolactin hPRL, hLH, hFSH, estradiol 17-beta (E2), and progesterone values were determined before and during treatment. No consistent pretreatment hormonal pattern was found. During treatment hPRL levels fell in 13 of 14 patients, ...
journal_title:Obstetrics and gynecology
pub_type: 杂志文章
doi:
更新日期:1976-07-01 00:00:00
abstract:OBJECTIVE:To review our experience with antenatal detection and subsequent neonatal outcome of fetuses with a persistent right umbilical vein. METHODS:In a prospective observational study, 33 cases of persistent right umbilical vein were detected during 15,237 obstetric ultrasound examinations performed after 15 weeks...
journal_title:Obstetrics and gynecology
pub_type: 杂志文章
doi:
更新日期:1994-12-01 00:00:00
abstract:OBJECTIVE:The effect of exogenous hormones on the incidence of breast cancer has been extensively studied. Most studies regarding hormonal contraception have focused on combined oral contraceptives, and there is paucity of literature regarding nonoral and progestin-only contraceptives. The present study analyzed the re...
journal_title:Obstetrics and gynecology
pub_type: 杂志文章
doi:10.1097/01.AOG.0000178754.88912.b9
更新日期:2005-10-01 00:00:00
abstract:BACKGROUND:Postpartum uterine scar dehiscence is a rare but potentially lethal complication of cesarean deliveries. CASE:Concurrent abdominal and uterine dehiscences after cesarean delivery for arrest of descent with chorioamnionitis occurred in a 16-year-old patient after her first delivery. The uterine and fascia in...
journal_title:Obstetrics and gynecology
pub_type: 杂志文章
doi:10.1097/AOG.0b013e31821619e9
更新日期:2011-08-01 00:00:00
abstract:OBJECTIVE:Obesity is an established risk factor for development of endometrial cancer. We hypothesized that obesity might also be associated with an earlier age at endometrial cancer diagnosis, because mechanisms that drive the obesity-endometrial cancer association might also accelerate tumorigenesis. METHODS:A retro...
journal_title:Obstetrics and gynecology
pub_type: 杂志文章
doi:10.1097/AOG.0000000000000381
更新日期:2014-08-01 00:00:00
abstract:OBJECTIVE:Preeclampsia is associated with abnormal lipid metabolism, including fatty acid metabolism. Carnitine plays an indispensable role in the oxidation of fatty acids. The aim of the study was to evaluate the possible role of abnormal fatty acid oxidation in preeclampsia by comparing plasma carnitine levels betwee...
journal_title:Obstetrics and gynecology
pub_type: 杂志文章
doi:10.1097/01.AOG.0000125699.60416.03
更新日期:2004-05-01 00:00:00
abstract:OBJECTIVE:To estimate the clinical effectiveness, as determined by positive pregnancy test, of letrozole compared with clomiphene citrate for ovarian stimulation in patients with unexplained infertility. DATA SOURCES:We conducted a systematic review and meta-analysis of data from electronic databases including Ovid-ME...
journal_title:Obstetrics and gynecology
pub_type: 杂志文章,meta分析
doi:10.1097/AOG.0000000000003105
更新日期:2019-03-01 00:00:00