The Rise and Fall of Mesh in Pelvic Surgery and the Shortcomings of Medical Device Regulation.

Abstract:

:Two U.S. Food and Drug Administration public health warnings regarding the use of mesh in stress incontinence and prolapse repairs have had far-reaching clinical and legal consequences. In this commentary, we explore the drastically distinct results from these mesh-based procedures, which revealed systemic flaws with the medical device approval process across specialties and affected thousands of patients.

journal_name

Obstet Gynecol

authors

Trabuco EC,Montori VM

doi

10.1097/AOG.0000000000002776

subject

Has Abstract

pub_date

2018-09-01 00:00:00

pages

736-740

issue

3

eissn

0029-7844

issn

1873-233X

pii

00006250-201809000-00027

journal_volume

132

pub_type

社论
  • A new abortion technique: intravaginal and intramuscular prostaglandin.

    abstract::The 15-methyl analog of prostaglandin F2 alpha (15-ME-PGF2 alpha), administered in a 3-mg dose via a single vaginal suppository and supplemented at 24 hours by intramuscular injection(s) of 250 micrograms, successfully induced abortion in 80 of 81 patients in the midtrimester of pregnancy. The mean abortion time was 1...

    journal_title:Obstetrics and gynecology

    pub_type: 杂志文章

    doi:

    authors: Lauersen NH,Den T,Scher J,Iliescu C,Wilson KH

    更新日期:1981-07-01 00:00:00

  • Soft cup vacuum extraction: a comparison of outlet delivery.

    abstract::One hundred eighteen nulliparous patients delivered under conduction anesthesia who met the standard criteria for low forceps delivery were randomly assigned to one of three groups to be delivered by low Tucker-McLane forceps, Silastic vacuum extraction system, or Mityvac vacuum extractor. Significant maternal soft ti...

    journal_title:Obstetrics and gynecology

    pub_type: 临床试验,杂志文章,随机对照试验

    doi:

    authors: Dell DL,Sightler SE,Plauché WC

    更新日期:1985-11-01 00:00:00

  • Vaginal apex resection: a treatment option for vaginal apex pain.

    abstract:OBJECTIVE:Vaginal apex pain is a subset of chronic pelvic pain commonly treated with surgical excision of the vaginal apex. Our objective was to estimate long-term postoperative pain levels, recovery time, and return to sexual function in women who have undergone vaginal apex repair for chronic vaginal apex pain. METH...

    journal_title:Obstetrics and gynecology

    pub_type: 杂志文章

    doi:10.1097/01.AOG.0000143827.17061.7b

    authors: Lamvu G,Robinson B,Zolnoun D,Steege JF

    更新日期:2004-12-01 00:00:00

  • Neonatal performance of the selected term vaginal breech delivery.

    abstract::Several authorities have recommended cesarean section for all intrapartum breech presentations. The present study documents that judiciously selected fetuses at term in breech presentation may be safely delivered vaginally by a selective management protocol that requires cesarean section when mandated criteria are not...

    journal_title:Obstetrics and gynecology

    pub_type: 杂志文章

    doi:

    authors: Gimovsky ML,Petrie RH,Todd WD

    更新日期:1980-12-01 00:00:00

  • Mixed urinary incontinence symptoms: urodynamic findings, incontinence severity, and treatment response.

    abstract:OBJECTIVE:To investigate the relationship between the symptom of mixed urinary incontinence and incontinence severity, urodynamic findings, and treatment response. METHODS:This is a secondary analysis of data from 553 women randomized into a double-blind, placebo-controlled study evaluating duloxetine (serotonin-norep...

    journal_title:Obstetrics and gynecology

    pub_type: 临床试验,杂志文章,随机对照试验

    doi:10.1016/s0029-7844(03)00376-4

    authors: Bump RC,Norton PA,Zinner NR,Yalcin I,Duloxetine Urinary Incontinence Study Group.

    更新日期:2003-07-01 00:00:00

  • Evaluation of the protein C global assay during normal pregnancy and after assisted reproduction.

    abstract:OBJECTIVE:To prospectively compare the Protein C Global assay results in a cohort of infertile women who conceived after assisted reproductive technology (ART) with results from women who conceived spontaneously. METHODS:Sixty-four infertile women who conceived after ART and 47 fertile women who conceived spontaneousl...

    journal_title:Obstetrics and gynecology

    pub_type: 杂志文章

    doi:10.1097/AOG.0b013e3181db67f3

    authors: Younis JS,Shukha M,Ben-Ami M,Izhaki I,Blumenfeld Z,Brenner B,Sarig G

    更新日期:2010-05-01 00:00:00

  • Cannabinoid hyperemesis syndrome: a cause of refractory nausea and vomiting in pregnancy.

    abstract:BACKGROUND:Cannabinoid hyperemesis syndrome is a condition present among chronic cannabis users resulting in abdominal pain, intractable nausea and vomiting, and compulsive bathing behaviors. Given the recent legalization of marijuana in certain areas of the United States, the incidence of this condition may increase a...

    journal_title:Obstetrics and gynecology

    pub_type: 杂志文章

    doi:10.1097/AOG.0000000000000595

    authors: Alaniz VI,Liss J,Metz TD,Stickrath E

    更新日期:2015-06-01 00:00:00

  • Choice of second-trimester genetic sonogram for detection of trisomy 21.

    abstract:OBJECTIVE:To determine the utilization rate of second-trimester genetic sonogram and its role in influencing the decision for amniocentesis in women at increased risk for fetal trisomy 21. METHODS:From November 1, 1993, to December 31, 1996, a second-trimester genetic sonogram or only genetic amniocentesis (as a first...

    journal_title:Obstetrics and gynecology

    pub_type: 杂志文章

    doi:10.1016/S0029-7844(97)00227-5

    authors: Vintzileos AM,Guzman ER,Smulian JC,McLean DA,Ananth CV

    更新日期:1997-08-01 00:00:00

  • Uterine contractility and placental histology in abortion by laminaria and metreurynter.

    abstract::Abortions by cervical dilatation with laminaria tents followed by placement of a metreurynter into the lower uterine cavity to provide a mechanical stretch (the method most often used in midterm abortions in Japan) was performed in 7 normal Japanese and American women, 19-24 weeks pregnant, to determine similarities ...

    journal_title:Obstetrics and gynecology

    pub_type: 杂志文章

    doi:

    authors: Manabe Y,Nakajima A,Griggs JF

    更新日期:1973-05-01 00:00:00

  • Ophthalmic artery velocimetry in normotensive and preeclamptic women with or without photophobia.

    abstract:OBJECTIVE:To compare ophthalmic arterial velocimetry in normotensive and preeclamptic gravidas with and without photophobia. METHODS:Ophthalmic arteries were studied by color-flow Doppler ultrasonography in 118 normotensive pregnant women, 20 gravidas with preeclampsia and no visual symptoms, and 11 with preeclampsia,...

    journal_title:Obstetrics and gynecology

    pub_type: 杂志文章

    doi:10.1016/s0029-7844(99)00294-x

    authors: Ohno Y,Kawai M,Wakahara Y,Kitagawa T,Kakihara M,Arii Y

    更新日期:1999-09-01 00:00:00

  • Endometriosis of the bowel.

    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:

    authors: Weed JC,Ray JE

    更新日期:1987-05-01 00:00:00

  • Epidemiologic characteristics of women with idiopathic recurrent vulvovaginal candidiasis.

    abstract:OBJECTIVE:To evaluate risk factors related to anamnestic variables, sexual behavior, feminine hygiene habits, and microbiologic findings in women with idiopathic recurrent vulvovaginal candidiasis. METHODS:We conducted a multivariate observational study comparing sociodemographic, anamnestic, clinical, and microbiolog...

    journal_title:Obstetrics and gynecology

    pub_type: 杂志文章

    doi:

    authors: Spinillo A,Pizzoli G,Colonna L,Nicola S,De Seta F,Guaschino S

    更新日期:1993-05-01 00:00:00

  • Simple antenatal preparation to improve breastfeeding practice: a randomized controlled trial.

    abstract:OBJECTIVE:To address the impact of simple antenatal educational interventions on breastfeeding practice. METHODS:A randomized controlled trial was carried out in a tertiary referral center from May 2002 to December 2004. A random sample of eligible low-risk antenatal patients was recruited from clinics in the National...

    journal_title:Obstetrics and gynecology

    pub_type: 杂志文章,随机对照试验

    doi:10.1097/01.AOG.0000249613.15466.26

    authors: Mattar CN,Chong YS,Chan YS,Chew A,Tan P,Chan YH,Rauff MH

    更新日期:2007-01-01 00:00:00

  • Etiology of acute salpingitis: influence of episode number and duration of symptoms.

    abstract::The role of Neisseria gonorrhoeae in the etiology and pathogenesis of acute salpingitis and its relationship to nongonococcal salpingitis were investigated. To accomplish this goal, isolated microorganisms obtained from the fallopian tubes and cul-de-sac via laparoscopy were evaluated in relation to the number of epis...

    journal_title:Obstetrics and gynecology

    pub_type: 杂志文章

    doi:

    authors: Sweet RL,Draper DL,Hadley WK

    更新日期:1981-07-01 00:00:00

  • A fetal sacrococcygeal tumor obstructing labor after attempted home confinement.

    abstract::Obstructed labor due to a large sacrococcygeal tumor is reported. A technique of transabdominal intrauterine reduction in the size of the tumor to allow delivery of the infant in satisfactory condition is described. The method and the successful outcome have not previously been reported. It is recommended as a combine...

    journal_title:Obstetrics and gynecology

    pub_type: 杂志文章

    doi:

    authors: Edwards WR

    更新日期:1983-03-01 00:00:00

  • Primary ovarian pregnancy in a cystic teratoma.

    abstract::Hemoperitoneum was identified by culdocentesis in a 26-year-old woman suffering acute abdominal pain. A pregnancy test was positive. Operation indicated a ruptured ovarian pregnancy, and histologic examination revealed primary intrafollicular ovarian pregnancy in a cystic teratoma. Ovarian pregnancy in an ovarian tumo...

    journal_title:Obstetrics and gynecology

    pub_type: 杂志文章

    doi:10.1097/00006250-198409001-00014

    authors: Yu TJ,Iwasaki I,Teratani T,Tanaka T,Aoki M

    更新日期:1984-09-01 00:00:00

  • Ability of normal vaginal flora to produce detectable phosphatidylglycerol in amniotic fluid in vitro.

    abstract:OBJECTIVE:To determine if bacteria are capable of producing phosphatidylglycerol in amniotic fluid (AF) and the number of colony forming units (CFU) of bacteria necessary to produce this result. METHODS:Eleven species of bacteria and one species of yeast, common to the female genital tract and implicated in chorioamni...

    journal_title:Obstetrics and gynecology

    pub_type: 杂志文章

    doi:10.1016/0029-7844(95)00032-m

    authors: Lambers DS,Brady K,Leist PA,Setser C,Helmchen R

    更新日期:1995-05-01 00:00:00

  • Clinical significance of urethral instability.

    abstract::Variations of urethral pressure were registered with microtransducers in 427 gynecologic patients with lower urinary tract symptoms during urethrocystometry. Urethral instability (variation of urethral pressure greater than 15 cm of water) was found in 16.4% of patients. The comparison of the urinary symptoms and the ...

    journal_title:Obstetrics and gynecology

    pub_type: 杂志文章

    doi:

    authors: Weil A,Miège B,Rottenberg R,Krauer F

    更新日期:1986-07-01 00:00:00

  • ACOG Committee Opinion No. 760 Summary: Dysmenorrhea and Endometriosis in the Adolescent.

    abstract::Dysmenorrhea, or menstrual pain, is the most common menstrual symptom among adolescent girls and young women. Most adolescents experiencing dysmenorrhea have primary dysmenorrhea, defined as painful menstruation in the absence of pelvic pathology. When the patient's history suggests primary dysmenorrhea, empiric treat...

    journal_title:Obstetrics and gynecology

    pub_type: 杂志文章

    doi:10.1097/AOG.0000000000002981

    authors:

    更新日期:2018-12-01 00:00:00

  • Analysis of cryolesions in the uterine cervix: application techniques, extension, and failures.

    abstract::Although cryosurgery is regularly used for treatment of cervical intraepithelial neoplasia (CIN), there are few data concerning freeze technique and attendant extension of the cryolesion. This study evaluated how to create cryolesions extensive enough to eradicate the CIN lesion completely. The way the extension of th...

    journal_title:Obstetrics and gynecology

    pub_type: 杂志文章

    doi:

    authors: Boonstra H,Koudstaal J,Oosterhuis JW,Wymenga HA,Aalders JG,Janssens J

    更新日期:1990-02-01 00:00:00

  • Natural history of cervical squamous intraepithelial lesions: a meta-analysis.

    abstract:OBJECTIVE:To define the strengths and weaknesses of existing research on the natural history of cervical squamous intraepithelial lesions (SIL) and to estimate rates of progression and regression without treatment. DATA SOURCES:Studies of women whose cervical smears showed squamous atypia or worse and who were observe...

    journal_title:Obstetrics and gynecology

    pub_type: 杂志文章,meta分析

    doi:10.1016/s0029-7844(98)00245-2

    authors: Melnikow J,Nuovo J,Willan AR,Chan BK,Howell LP

    更新日期:1998-10-01 00:00:00

  • Prenatal care in cocaine-exposed pregnancies.

    abstract:OBJECTIVE:To examine the effect of prenatal care with and without drug rehabilitation on perinatal outcome in cocaine-using women. METHODS:Cocaine-exposed pregnancies of 905 human immunodeficiency virus (HIV)-negative women were frequency matched (ratio 6:1) and compared with 150 nonusers. Cocaine subgroups consisted ...

    journal_title:Obstetrics and gynecology

    pub_type: 临床试验,杂志文章

    doi:10.1016/s0029-7844(98)00202-6

    authors: Burkett G,Gomez-Marin O,Yasin SY,Martinez M

    更新日期:1998-08-01 00:00:00

  • ACOG Committee Opinion No. 483: Primary and preventive care: periodic assessments.

    abstract::Periodic assessments offer an excellent opportunity for obstetricians and gynecologists to provide preventive screening, evaluation, and counseling. The American College of Obstetricians and Gynecologists' Committee on Gynecologic Practice recommends routine assessments in primary and preventive care for women based o...

    journal_title:Obstetrics and gynecology

    pub_type: 杂志文章,评审

    doi:10.1097/AOG.0b013e318219226e

    authors:

    更新日期:2011-04-01 00:00:00

  • Initiation of human parturition. III. Fetal membrane content of prostaglandin E2 and F2alpha precursor.

    abstract::Unesterified arachidonic acid is the obligatory precursor of the prostaglandins (PG), PGF2alpha and PGE2. In order to ascertain whether or not the human fetal membranes could represent a storage site for prostaglandin(s) precursor, the fatty acid content of human fetal membranes was measured. Approximately 20% of the ...

    journal_title:Obstetrics and gynecology

    pub_type: 杂志文章

    doi:

    authors: Schwarz BE,Schultz FM,Macdonald PC,Johnston JM

    更新日期:1975-11-01 00:00:00

  • Perinatal mortality and antepartum risk scoring.

    abstract::A simplified, numerical form for antepartum risk scoring was introduced as a component of the prenatal record for use in all pregancies in a large geographic area under a variety of collection practices. In a population of approximately 1,000,000 with 16,733 deliveries, 19% of the pregnant population scored greater th...

    journal_title:Obstetrics and gynecology

    pub_type: 杂志文章

    doi:

    authors: Morrison I,Olsen J

    更新日期:1979-03-01 00:00:00

  • Preeclampsia: is induction of labor more successful?

    abstract:OBJECTIVE:To test the hypothesis that preeclamptic women are more readily inducible than are nonpreeclamptic women, regardless of cervical condition. METHODS:One hundred eighty-three preeclamptic women and 461 nonpreeclamptic women requiring labor induction were studied prospectively. Patients were categorized by Bish...

    journal_title:Obstetrics and gynecology

    pub_type: 临床试验,杂志文章

    doi:10.1016/S0029-7844(97)00043-4

    authors: Xenakis EM,Piper JM,Field N,Conway D,Langer O

    更新日期:1997-04-01 00:00:00

  • Fertility-conserving surgery for young women with stage IA1 cervical cancer: safety and access.

    abstract:OBJECTIVE:To estimate the safety of fertility-conserving surgery for stage IA1 cervical cancer and to analyze predictors of access to conization. METHODS:We analyzed women with stage IA1 cervical cancer aged 40 years or younger who were diagnosed between 1988 and 2005 and recorded in the Surveillance, Epidemiology, an...

    journal_title:Obstetrics and gynecology

    pub_type: 杂志文章

    doi:10.1097/AOG.0b013e3181d06b68

    authors: Wright JD,Nathavithrana R,Lewin SN,Sun X,Deutsch I,Burke WM,Herzog TJ

    更新日期:2010-03-01 00:00:00

  • Mifepristone and misoprostol administered simultaneously versus 24 hours apart for abortion: a randomized controlled trial.

    abstract:OBJECTIVE:Mifepristone and oral misoprostol are typically used for medical abortion in women up to 49 days of gestation, with a 36- to 48-hour interval between the medications. Alternative routes of misoprostol administration allow for use beyond 49 days of gestation. We designed this randomized, noninferiority trial t...

    journal_title:Obstetrics and gynecology

    pub_type: 杂志文章,多中心研究,随机对照试验

    doi:10.1097/01.AOG.0000258298.35143.d2

    authors: Creinin MD,Schreiber CA,Bednarek P,Lintu H,Wagner MS,Meyn LA,Medical Abortion at the Same Time (MAST) Study Trial Group.

    更新日期:2007-04-01 00:00:00

  • Urinary conduits in gynecologic oncology.

    abstract::Over an 11-year period (1971 to 1981), 212 urinary conduit surgeries were performed by the Department of Gynecology at the University of Texas, M. D. Anderson Hospital and Tumor Institute at Houston. The urinary diversions were performed as part of the pelvic exenteration operation in 154 patients, for radiation injur...

    journal_title:Obstetrics and gynecology

    pub_type: 杂志文章

    doi:10.1097/00006250-198605000-00015

    authors: Hancock KC,Copeland LJ,Gershenson DM,Saul PB,Wharton JT,Rutledge FN

    更新日期:1986-05-01 00:00:00

  • Cushing's syndrome complicating pregnancy. A case report.

    abstract::A case of a rare association between pregnancy and the development of Cushing's syndrome is discussed. A 29-year-old woman developed Cushing's syndrome, characterized by hypokalemia, a high level of urinary 17-hydroxycorticoids not suppressed by dexamethasone therapy, a high level of plasma 11-hydroxycorticoids which...

    journal_title:Obstetrics and gynecology

    pub_type: 杂志文章

    doi:

    authors: Wieland RG,Shaffer MB Jr,Glove RP

    更新日期:1971-12-01 00:00:00