Abstract:
:Laparoscopic radiofrequency ablation of uterine leiomyomas with a new Federal Drug Administration (FDA)-approved device, a device that delivers radiofrequency energy, is a novel procedure that aims to meet patient and physician demand for effective, minimally invasive leiomyoma treatment. However, as a new procedure, the durability of symptom relief, the safety in widespread use, and ultimately the comparative effectiveness of radiofrequency ablation of leiomyomas need further study. In June 2013, the University of California Fibroid Network, a collaboration of the five University of California Departments of Obstetrics and Gynecology, launched the Uterine Leiomyoma Treatment with Radiofrequency Ablation Study, an investigator-initiated early postmarket approval clinical trial of radiofrequency ablation of leiomyomas. In this commentary, we provide a review of the FDA approval process for medical devices using the device that delivers radiofrequency energy as a case study and describe significant limitations of this process that may adversely affect clinical care. We show how the deficiencies in the FDA process have challenged our ability to conduct independent early postmarket research evaluating the safety and long-term effectiveness of this novel technology. Our experience validates the Institute of Medicine's recommendation that advancements in surgical technology introducing new treatments without long-term effectiveness data, comparative study, or both should emerge onto the market under research conditions. Until the FDA requires more rigorous study of novel devices, we suggest ways of working together as a community of gynecologic surgeons to evaluate promising new technologies in early postmarket studies, putting research before widespread adoption of surgical innovation.
journal_name
Obstet Gynecoljournal_title
Obstetrics and gynecologyauthors
Waetjen LE,Parvataneni R,Varon S,Saberi NS,Jacoby VL,University of California Fibroid Network (UCFN).doi
10.1097/AOG.0000000000000914subject
Has Abstractpub_date
2015-08-01 00:00:00pages
391-395issue
2eissn
0029-7844issn
1873-233Xpii
00006250-201508000-00025journal_volume
126pub_type
杂志文章abstract::Ureaplasma urealyticum is a common inhabitant of the lower genital tract of women. It is unclear whether or not the microorganism plays a role in provoking spontaneous abortion. Reported is a U urealyticum infection of placenta and amniotic fluid in an immunologically competent host resulting in abruptio placentae and...
journal_title:Obstetrics and gynecology
pub_type: 杂志文章
doi:
更新日期:1986-08-01 00:00:00
abstract::Four hundred sixty-five primary cesarean sections (10.4% of total deliveries) performed during 1977 and 1978 were reviewed and compared with 465 vaginal deliveries to ascertain factors that may be related to postpartum infection. The overall morbidity (19.7%) related to postpartum infection in the primary cesarean sec...
journal_title:Obstetrics and gynecology
pub_type: 杂志文章
doi:
更新日期:1981-02-01 00:00:00
abstract::Female sexual dysfunction (FSD) is characterized as chronic sexual symptoms that manifest with personal distress in the domains of desire, arousal, orgasm, and pain. Extensive epidemiologic evidence estimates that almost 50% of perimenopausal and postmenopausal women experience FSD. Screening for FSD is not readily co...
journal_title:Obstetrics and gynecology
pub_type: 杂志文章
doi:10.1097/AOG.0000000000002268
更新日期:2017-10-01 00:00:00
abstract:OBJECTIVE:To determine if pregnancy intendedness is associated with physical violence, and to identify factors that modify this association. METHODS:Three to 6 months after delivery, we mailed a questionnaire to a population-based sample of 12,612 mothers of infants born during 1990 and 1991 in four states. We used mu...
journal_title:Obstetrics and gynecology
pub_type: 杂志文章
doi:10.1016/0029-7844(95)00057-x
更新日期:1995-06-01 00:00:00
abstract::Piperacillin, a new semisynthetic penicillin, has broad spectrum activity against most clinically important aerobic and anaerobic bacteria. In the present study, piperacillin was compared with a combination of clindamycin and gentamicin for the treatment of 83 women with pelvic infection (42 with endometritis, 29 with...
journal_title:Obstetrics and gynecology
pub_type: 杂志文章
doi:
更新日期:1984-12-01 00:00:00
abstract:OBJECTIVE:Despite a change of fetal physiologic and biochemical functions with gestational age, stationary umbilical cord acid-base reference values are used as measures of obstetric care quality. The aim of this study was to assess the risk of low Apgar score relative to low pH when using stationary versus gestational...
journal_title:Obstetrics and gynecology
pub_type: 杂志文章
doi:10.1016/s0029-7844(03)00512-x
更新日期:2003-08-01 00:00:00
abstract:OBJECTIVE:To calculate pooled risk estimates for combinations of cytology result, human papillomavirus (HPV) 16/18 genotype and colposcopy impression to provide a basis for risk-stratified colposcopy and biopsy practice. DATA SOURCE:A PubMed search was conducted on June 1, 2016, and a ClinicalTrials.gov search was con...
journal_title:Obstetrics and gynecology
pub_type: 杂志文章,meta分析
doi:10.1097/AOG.0000000000002812
更新日期:2018-09-01 00:00:00
abstract:OBJECTIVE:To examine the concordance between self-collected and clinician-collected samples for human papillomavirus (HPV) DNA. METHODS:Sexually active adolescent and young adult women aged 14-21 years (N = 101) were enrolled in a prospective cohort study of HPV testing. Participants self-collected vaginal samples for...
journal_title:Obstetrics and gynecology
pub_type: 杂志文章
doi:10.1097/01.AOG.0000124569.61462.8d
更新日期:2004-05-01 00:00:00
abstract:OBJECTIVE:To evaluate simultaneous human immunodeficiency virus (HIV)-related nucleic acids and human papillomavirus (HPV)-DNA in cervicovaginal secretions of HIV-seropositive women. METHODS:We collected 47 paired blood and cervicovaginal lavage samples from 124 known HIV-1-seropositive women. Proviral HIV-1 DNA, cell...
journal_title:Obstetrics and gynecology
pub_type: 杂志文章
doi:10.1016/s0029-7844(01)01130-9
更新日期:2001-06-01 00:00:00
abstract::This article, for the "To the Point" series prepared by the Association of Professors of Gynecology and Obstetrics Undergraduate Medical Education Committee, supplies educators with a review of best practices regarding incorporation of the electronic medical record (EMR) into undergraduate medical education. The uniqu...
journal_title:Obstetrics and gynecology
pub_type: 杂志文章,评审
doi:10.1097/AOG.0000000000001004
更新日期:2015-09-01 00:00:00
abstract::Caffeine citrate in doses of 6.96 mg/kg (equivalent to 3.50 mg/kg of caffeine) of combined maternal and fetal weight and 69.6 mg/kg (35.0 mg/kg of caffeine) was administered in 1-dl solutions intravenously over ten minutes to chronically prepared pregnant sheep. The ewes and their fetuses were monitored for cardiovasc...
journal_title:Obstetrics and gynecology
pub_type: 杂志文章
doi:
更新日期:1983-04-01 00:00:00
abstract:OBJECTIVE:The purposes of this prospective investigation were to determine the frequency of glove perforation during obstetric and gynecologic procedures and to assess the value of double gloving in preventing damage to the inner glove. METHODS:During a 2-month period, surgeons in the Department of Obstetrics and Gyne...
journal_title:Obstetrics and gynecology
pub_type: 杂志文章
doi:
更新日期:1991-12-01 00:00:00
abstract:OBJECTIVE:To investigate the interaction of exogenous adenosine 5'-triphosphate (ATP), a P2 receptor agonist, with prostaglandin F(2alpha) (PGF(2alpha)) on pregnant women in labor as well as on isolated human pregnant uterus preparations. METHODS:For an in vitro study, myometrial samples were obtained from 27 women un...
journal_title:Obstetrics and gynecology
pub_type: 临床试验,杂志文章,随机对照试验
doi:10.1097/01.AOG.0000161314.50808.dd
更新日期:2005-06-01 00:00:00
abstract:OBJECTIVE:To report our institutional experience with the accuracy and usefulness of cervical conization with frozen section before planned hysterectomy. METHODS:One hundred fifty-nine patients who planned to have hysterectomies for or with a concomitant diagnosis of cervical intraepithelial neoplasia (CIN) underwent ...
journal_title:Obstetrics and gynecology
pub_type: 杂志文章
doi:
更新日期:1993-09-01 00:00:00
abstract:OBJECTIVE:To compare the attitudes and expectations that obstetric patients and medical students bring to the student-patient relationship in intrapartum care. METHODS:Written questionnaires were distributed to obstetric patients who had students assist in their labor and delivery care and to medical students who had ...
journal_title:Obstetrics and gynecology
pub_type: 杂志文章
doi:10.1016/0029-7844(96)00191-3
更新日期:1996-08-01 00:00:00
abstract:OBJECTIVE:To describe the incidence and type of fetal injury identified in women undergoing cesarean delivery. METHODS:Between January 1, 1999, and December 31, 2000, a prospective cohort study of all cesarean deliveries was conducted at 13 university centers. Information regarding maternal and infant outcomes was abs...
journal_title:Obstetrics and gynecology
pub_type: 杂志文章,多中心研究
doi:10.1097/01.AOG.0000237116.72011.f3
更新日期:2006-10-01 00:00:00
abstract::Marketing of genetic testing, although similar to direct-to-consumer advertising of prescription drugs, raises additional concerns and considerations. These include issues of limited knowledge among patients and health care providers of available genetic tests, difficulty in interpretation of genetic testing results, ...
journal_title:Obstetrics and gynecology
pub_type: 杂志文章,实务指引
doi:10.1097/AOG.0b013e31817d250e
更新日期:2008-06-01 00:00:00
abstract::Cefmenoxime, a new third-generation cephalosporin, was used as a single drug in the therapy for female genital tract infections. Therapeutic response was considered satisfactory in 21 of 22 cases of pelvic inflammatory disease, six of nine tuboovarian abscesses, two of three severe wound infections, and all five cases...
journal_title:Obstetrics and gynecology
pub_type: 杂志文章
doi:
更新日期:1985-09-01 00:00:00
abstract::Ultrasonography plays an integral part in the prenatal diagnosis of neural tube defects. However, experienced sonographers with careful evaluation are successful in accurately diagnosing spina bifida only 80-90% of the time. This study was conducted to evaluate the accuracy and reliability of certain cranial ultrasoun...
journal_title:Obstetrics and gynecology
pub_type: 杂志文章
doi:
更新日期:1990-07-01 00:00:00
abstract:OBJECTIVE:To correlate symptoms of uterine adenomyosis with histopathologic features. METHODS:One hundred eleven specimens of uteri and cervices that weighed under 280 g were reevaluated. When adenomyosis was identified, assessment included depth of adenomyotic foci, graded as deep (above 80%), intermediate (40-80%), ...
journal_title:Obstetrics and gynecology
pub_type: 杂志文章
doi:10.1016/s0029-7844(99)00659-6
更新日期:2000-05-01 00:00:00
abstract:OBJECTIVE:To examine predictors of health care providers perceiving intrauterine devices (IUDs) as unsafe for nulliparous women and of infrequent provision of IUDs to nulliparous women. METHODS:We analyzed questionnaire data obtained during December 2009 to March 2010 from 635 office-based providers (physicians) and 1...
journal_title:Obstetrics and gynecology
pub_type: 杂志文章
doi:10.1097/AOG.0b013e31824aca39
更新日期:2012-04-01 00:00:00
abstract:BACKGROUND:Endometrial stromal nodule is a rare subtype of endometrial stromal tumor. Although such nodules are benign, hysterectomy has been considered the treatment of choice, because evaluation of the margin is required for diagnosis. The similarity between low-grade stromal sarcoma and stromal nodule suggests that ...
journal_title:Obstetrics and gynecology
pub_type: 杂志文章
doi:10.1016/s0029-7844(98)00332-9
更新日期:1999-05-01 00:00:00
abstract:BACKGROUND:Advanced abdominal pregnancy is rare, and one that occurs after uterine rupture with delivery of a viable fetus is exceptional. CASE:A multiparous patient was admitted at 29 weeks of gestation for conservative management of placenta previa. She complained of intermittent abdominal pain, but repeated assessm...
journal_title:Obstetrics and gynecology
pub_type: 杂志文章
doi:10.1097/01.AOG.0000279451.51446.c1
更新日期:2008-02-01 00:00:00
abstract::Sexually transmitted infections (STIs) disproportionately affect women and create a preventable threat to their fertility. One factor that contributes to young women's high rates of STIs is reinfection from an untreated sexual partner. One way to address this problem is through expedited partner therapy, the practice ...
journal_title:Obstetrics and gynecology
pub_type: 杂志文章
doi:10.1097/01.AOG.0000466366.67312.8c
更新日期:2015-06-01 00:00:00
abstract::Questionnaires were sent to 63 women with anal sphincter rupture that occurred during vaginal delivery two to seven years earlier. Half of them had significant trouble, such as incontinence for gas, dyspareunia, and pain. We performed anal pressure profilometry in 14 of these women and in ten controls for comparison, ...
journal_title:Obstetrics and gynecology
pub_type: 杂志文章
doi:
更新日期:1987-07-01 00:00:00
abstract::Enzymatic peroxidase oxidation was used to study albumin-bilirubin binding in the serum of pregnant women, their term infants, and nonpregnant women. When the bilirubin titration curves were corrected for differing albumin concentrations in the three groups, the bilirubin binding of pregnant women was inferior to that...
journal_title:Obstetrics and gynecology
pub_type: 杂志文章
doi:
更新日期:1985-05-01 00:00:00
abstract:OBJECTIVE:To use a decision-analytic model to assess a comprehensive set of outcomes of prenatal genetic testing strategies among women of varying ages. METHODS:We assessed outcomes of six testing strategies incorporating diagnostic testing with chromosomal microarray, multiple marker screening, cell-free DNA screenin...
journal_title:Obstetrics and gynecology
pub_type: 杂志文章
doi:10.1097/AOG.0000000000001029
更新日期:2015-10-01 00:00:00
abstract::A fetal extracranial mass seen on ultrasound was found by Doppler velocimetry to have low resistance to blood flow through its channels. The antenatal diagnosis of giant cavernous hemangioma was confirmed after birth. ...
journal_title:Obstetrics and gynecology
pub_type: 杂志文章
doi:
更新日期:1988-09-01 00:00:00
abstract::As hospitals and medical schools confronted coronavirus disease 2019 (COVID-19), medical students were essentially restricted from all clinical work in an effort to prioritize their safety and the safety of others. One downstream effect of this decision was that students were designated as nonessential, in contrast to...
journal_title:Obstetrics and gynecology
pub_type: 杂志文章
doi:10.1097/AOG.0000000000004113
更新日期:2020-10-01 00:00:00
abstract:OBJECTIVE:To evaluate whether hysteroscopic morcellation or bipolar electrosurgical resection is more favorable for removing endometrial polyps in an office setting in terms of feasibility, speed, pain, and acceptability. METHODS:A multicenter, single-blind, randomized, controlled trial of office hysteroscopic morcell...
journal_title:Obstetrics and gynecology
pub_type: 杂志文章,多中心研究,随机对照试验
doi:10.1097/AOG.0000000000000187
更新日期:2014-04-01 00:00:00