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：:A healthy young woman with recurrent spontaneous abortion and septate uterus underwent hysteroscopic metroplasty with intracavitary instillation of 1350 mL of 10% dextran 40 in normal saline. After the operation, the patient developed acute hypervolemic pulmonary edema and severe coagulopathy due to temporary impairme...
journal_title：Obstetrics and gynecology
pub_type： 杂志文章
doi：
更新日期：1992-05-01 00:00:00
abstract：OBJECTIVE:To develop a scoring system to predict the likelihood of vaginal birth in patients undergoing a trial of labor after previous cesarean delivery using factors known at the time of hospital admission. METHODS:Trial of labor was attempted in 5022 patients who were assigned randomly to score derivation and score...
journal_title：Obstetrics and gynecology
pub_type： 临床试验,杂志文章,多中心研究,随机对照试验
doi：10.1016/s0029-7844(97)00531-0
更新日期：1997-12-01 00:00:00
abstract：BACKGROUND:Currently, maternal-fetal surgery for repair of myelomeningocele requires an upper-segment hysterotomy, which likely increases maternal postsurgical risks. If fetoscopic repair of myelomeningocele achieves similar or better fetal outcomes while decreasing maternal risks, it would be a better option. CASE:A ...
journal_title：Obstetrics and gynecology
pub_type： 杂志文章
doi：10.1097/AOG.0000000000000835
更新日期：2015-10-01 00:00:00
abstract：:An unusually rapid growing vulvar verrucous carcinoma found associated with human papillomavirus type 6 is described. Both human papillomavirus structural antigens and deoxyribonucleic acid (DNA) sequences were detected in the tumor biopsy. The human papillomavirus genome was isolated and compared with the genome of h...
journal_title：Obstetrics and gynecology
pub_type： 杂志文章
doi：10.1097/00006250-198603001-00021
更新日期：1986-03-01 00:00:00
abstract：:The CO2 laser has become a valuable tool for the treatment of lower genital tract neoplasia. The records of 52 women who underwent CO2 laser cervical conization were analyzed retrospectively to evaluate the effect of tissue thermal damage on histopathologic interpretation. Lesion evaluability, defined by the ability t...
journal_title：Obstetrics and gynecology
pub_type： 杂志文章
doi：
更新日期：1992-05-01 00:00:00
abstract：:The effect of an 8-hour, 3-dose perioperative regimen of cefazolin or placebo was evaluated in 97 patients. Postoperative morbidity occurred in 13 patients (27.1%) in the cefazolin group and in 17 patients (34.7%) who received placebo. The clinical sites of infection were similar in both groups except that wound infec...
journal_title：Obstetrics and gynecology
pub_type： 临床试验,杂志文章
doi：
更新日期：1978-09-01 00:00:00
abstract：BACKGROUND:Women with a history of pregnancy loss in the second trimester are often diagnosed with cervical insufficiency and are treated with cervical cerclage. We present an unusual complication of this procedure that mimicked preterm rupture of membranes. CASE:A 38-year-old woman with a history of cervical conizati...
journal_title：Obstetrics and gynecology
pub_type： 杂志文章
doi：10.1097/01.AOG.0000247291.00155.88
更新日期：2007-02-01 00:00:00
abstract：OBJECTIVE:To compare sexual function in women with and without uterovaginal prolapse and urinary incontinence. METHODS:Eighty women with prolapse and with or without incontinence and 30 continent women without prolapse completed questionnaires assessing sexual function and underwent a physical examination. RESULTS:Wo...
journal_title：Obstetrics and gynecology
pub_type： 杂志文章
doi：10.1016/0029-7844(94)00434-F
更新日期：1995-04-01 00:00:00
abstract：OBJECTIVE:The objective was to describe timely refills of hormonal contraceptive products among a large, geographically diverse population of U.S. women as an estimate of method continuation over time. METHODS:Longitudinal prescription refills from the Verispan database were collected from 99% of retail pharmacies in ...
journal_title：Obstetrics and gynecology
pub_type： 杂志文章
doi：10.1097/AOG.0b013e3181875ec5
更新日期：2008-10-01 00:00:00
abstract：OBJECTIVE:To explore the pregnancy and childbirth experiences and preferences of women with a history of sexual trauma in order to identify trauma-informed care practices that health care providers may use to improve obstetric care. METHODS:We conducted a qualitative study consisting of semistructured interviews with ...
journal_title：Obstetrics and gynecology
pub_type： 杂志文章
doi：10.1097/AOG.0000000000002956
更新日期：2018-12-01 00:00:00
abstract：OBJECTIVE:To estimate the rate of histologic chorioamnionitis in the presence of diagnosed clinical chorioamnionitis and determine whether clinical markers of maternal and neonatal infection are associated with histologic chorioamnionitis. METHODS:We identified singleton pregnancies from 1996 in which discharge diagno...
journal_title：Obstetrics and gynecology
pub_type： 杂志文章
doi：10.1016/s0029-7844(99)00416-0
更新日期：1999-12-01 00:00:00
abstract：:Unsustainable health care costs combined with suboptimal patient outcomes have led health policy experts and payers to consider value-based payment or alternative payment models. Replacing fee-for-service reimbursement, these models link payment to value by rewarding efforts to enhance the quality of care at similar o...
journal_title：Obstetrics and gynecology
pub_type： 杂志文章
doi：10.1097/AOG.0000000000002753
更新日期：2018-08-01 00:00:00
abstract：BACKGROUND:Only one case of plasma cell cervicitis, a rare variant of chronic cervicitis, has been reported. We report a second case and present data supporting the detection of human papillomavirus (HPV) outside of epithelial tissues. CASE:A 67-year-old woman was found to have a large cervical tumor. Extensive diagno...
journal_title：Obstetrics and gynecology
pub_type： 杂志文章
doi：
更新日期：1993-10-01 00:00:00
abstract：OBJECTIVE:To assess long-term clinical and urodynamic outcomes of suburethral sling procedures using polytetrafluoroethylene grafts. METHODS:Between January 1986 and May 1991, 108 women underwent suburethral sling placement to treat genuine stress incontinence. At least 1 year after surgery, 62 women participated in a...
journal_title：Obstetrics and gynecology
pub_type： 临床试验,杂志文章
doi：10.1016/0029-7844(95)00098-C
更新日期：1995-07-01 00:00:00
abstract：:For certain medical conditions, available data and expert opinion support optimal timing of delivery in the late-preterm or early-term period for improved neonatal and infant outcomes. However, for nonmedically indicated early-term deliveries such an improvement has not been demonstrated. Morbidity and mortality rates...
journal_title：Obstetrics and gynecology
pub_type： 杂志文章
doi：10.1097/01.AOG.0000428649.57622.a7
更新日期：2013-04-01 00:00:00
abstract：OBJECTIVE:To compare the contraceptive effectivenesses of a polyurethane condom and a standard latex condom. Secondary outcomes of interest were safety, functionality, discontinuation, and acceptability. METHODS:We randomized 901 couples to use either the polyurethane condom or a standard latex condom as their only fo...
journal_title：Obstetrics and gynecology
pub_type： 临床试验,杂志文章,多中心研究,随机对照试验
doi：10.1016/s0029-7844(02)02732-1
更新日期：2003-03-01 00:00:00
abstract：OBJECTIVE:To evaluate whether preeclampsia is associated with risk of maternal retinal disease in the decades after pregnancy. METHODS:We carried out a longitudinal cohort study of 1,108,541 women who delivered neonates in any hospital in Quebec, Canada, between 1989 and 2013. We tracked women for later hospitalizatio...
journal_title：Obstetrics and gynecology
pub_type： 杂志文章
doi：10.1097/AOG.0000000000001758
更新日期：2017-01-01 00:00:00
abstract：:The Apgar score provides an accepted and convenient method for reporting the status of the newborn infant immediately after birth and the response to resuscitation if needed. The Apgar score alone cannot be considered to be evidence of or a consequence of asphyxia, does not predict individual neonatal mortality or neu...
journal_title：Obstetrics and gynecology
pub_type： 杂志文章
doi：10.1097/AOG.0000000000001108
更新日期：2015-10-01 00:00:00
abstract：:Sixty-two patients with primary amenorrhea were retrospectively categorized into 4 groups: 1) breast development absent and uterus present (29 patients), 2) breast development present and uterus absent (9 patients), 3) both breast development and uterus absent (2 patients), and 4) both breast development and uterus pr...
journal_title：Obstetrics and gynecology
pub_type： 杂志文章
doi：
更新日期：1981-06-01 00:00:00
abstract：:One hundred sixty-three cases of endometriosis of the bowel (5.4% of 3037 laparotomies for endometriosis at the Ochsner Foundation Hospital) were reviewed to assess the management of this complication. Colon and rectal surgeons performed bowel resections of the colon in 30 cases and resections of the ileum and/or cecu...
journal_title：Obstetrics and gynecology
pub_type： 杂志文章
doi：
更新日期：1987-05-01 00:00:00
abstract：:Mental health disorders in adolescence are a significant problem, relatively common, and amenable to treatment or intervention. Obstetrician-gynecologists who see adolescent patients are highly likely to see adolescents and young women who have one or more mental health disorders. Some of these disorders may interfere...
journal_title：Obstetrics and gynecology
pub_type： 杂志文章,实务指引
doi：10.1097/AOG.0000000000002153
更新日期：2017-07-01 00:00:00
abstract：:A double-blind study was carried out to compare the effect of submucous paracervical blockade using 12 mL 0.25% bupivacaine (55 women) to the effect of intramuscular injection of 75 mg meperidine (62 women) during the first stage of labor. All 117 were normal primiparous pregnancies. Seventy-eight percent of the women...
journal_title：Obstetrics and gynecology
pub_type： 临床试验,杂志文章
doi：
更新日期：1984-11-01 00:00:00
abstract：:Reversal of gender-discriminatory insurance coverage policies has led to a substantial increase in access to gender-affirming surgical care in the United States over the past 20 years. Although the evidence supports the safety, feasibility, and medical necessity of gender-affirming hysterectomy and oophorectomy, there...
journal_title：Obstetrics and gynecology
pub_type： 社论
doi：10.1097/AOG.0000000000003472
更新日期：2019-10-01 00:00:00
abstract：OBJECTIVE:To evaluate use (both appropriate and inappropriate) of rescue corticosteroids before and after the implementation of a guideline for their use. METHODS:We conducted a retrospective cohort study using a pharmacy log to identify women who received an initial course of antenatal corticosteroids in the year bef...
journal_title：Obstetrics and gynecology
pub_type： 杂志文章
doi：10.1097/AOG.0000000000001934
更新日期：2017-04-01 00:00:00
abstract：:The long-term follow-up is presented of three infants with vulvovaginal rhabdomyosarcoma treated at 10, 11, and 15 months of age by radical surgery, pelvic radiation therapy, and chemotherapy. Two patients developed colonic stricture requiring operative repair. One of these two patients also has urinary incontinence s...
journal_title：Obstetrics and gynecology
pub_type： 杂志文章
doi：
更新日期：1988-03-01 00:00:00
abstract：:Pelvic organ prolapse (POP) is a common, benign condition in women. For many women it can cause vaginal bulge and pressure, voiding dysfunction, defecatory dysfunction, and sexual dysfunction, which may adversely affect quality of life. Women in the United States have a 13% lifetime risk of undergoing surgery for POP ...
journal_title：Obstetrics and gynecology
pub_type： 杂志文章,实务指引
doi：10.1097/AOG.0000000000002008
更新日期：2017-04-01 00:00:00
abstract：:Intrauterine exposure to diethylstilbestrol (DES) has been associated with ths subsequent rare development of clear cell adenocarcinoma of the vagina and cervix in exposed female progeny. These tumors have been seen thus far in patients between the ages of 7 and 29 years. In addition, nonmalignant epithelial and struc...
journal_title：Obstetrics and gynecology
pub_type： 杂志文章,评审
doi：
更新日期：1981-11-01 00:00:00
abstract：:The purpose of the present retrospective study was to examine the relationship between hypertension and abruptio placentae. Two hundred sixty-five consecutive cases of abruption were reviewed, with an emphasis on the occurrence and severity of hypertensive disease. The results confirm a close relationship between abru...
journal_title：Obstetrics and gynecology
pub_type： 杂志文章
doi：
更新日期：1984-03-01 00:00:00
abstract：:A case of primary endodermal sinus tumor (EST) of the endometrium in a 28-year-old woman is described. EST has been reported to arise in several extragonadal sites, but to the authors' knowledge this is the first documented instance of origin in the endometrium. The histologic study is verified by the detection of alp...
journal_title：Obstetrics and gynecology
pub_type： 杂志文章
doi：
更新日期：1980-09-01 00:00:00
abstract：BACKGROUND:Alimentary tract duplications are rare congenital lesions that may arise at any location throughout the gastrointestinal tract. The most common site of enteric duplications is the ileum, with only 13% of cases occurring in the colon. CASE:Prenatal sonography at 39 weeks' gestation showed a cystic structure ...
journal_title：Obstetrics and gynecology
pub_type： 杂志文章
doi：
更新日期：2003-05-01 00:00:00
