|
gptkbp:instanceOf
|
gptkb:medical_device
|
|
gptkbp:alternativeTo
|
gptkb:tubal_ligation
|
|
gptkbp:approvalYear
|
2002
|
|
gptkbp:approvedBy
|
gptkb:FDA
|
|
gptkbp:class
|
Class III medical device
|
|
gptkbp:clinicalTrialPhase
|
pre-market studies only
|
|
gptkbp:containsSettlement
|
Bayer agreed to pay $1.6 billion in 2020
|
|
gptkbp:controversy
|
safety and efficacy concerns
|
|
gptkbp:FDAWarning
|
2016 black box warning
patient decision checklist required
|
|
gptkbp:insertedBy
|
gptkb:fallopian_tubes
|
|
gptkbp:intendedUse
|
gptkb:permanent_birth_control
|
|
gptkbp:lawsuits
|
thousands filed in US
|
|
gptkbp:manufacturer
|
gptkb:Bayer
gptkb:Conceptus_Inc.
|
|
gptkbp:marketedIn
|
gptkb:Australia
gptkb:Brazil
gptkb:Canada
gptkb:Europe
gptkb:United_States
other countries
|
|
gptkbp:material
|
nickel-titanium alloy
polyethylene terephthalate (PET) fibers
|
|
gptkbp:mechanismOfAction
|
causes tissue growth to block tubes
|
|
gptkbp:method
|
hysteroscopic sterilization
|
|
gptkbp:notReversible
|
true
|
|
gptkbp:postMarketSurveillance
|
FDA required additional studies
|
|
gptkbp:recallStatus
|
not recalled in US
recalled in some countries
|
|
gptkbp:removalComplications
|
possible need for hysterectomy
possible tissue damage
|
|
gptkbp:removes
|
can require surgery
|
|
gptkbp:retired
|
safety concerns and declining sales
|
|
gptkbp:sideEffect
|
pain
bleeding
pregnancy
allergic reactions
autoimmune reactions
device migration
perforation of uterus or fallopian tubes
|
|
gptkbp:website
|
https://www.essure.com/
|
|
gptkbp:withdrawn
|
2018
|
|
gptkbp:bfsParent
|
gptkb:Conceptus_Inc.
|
|
gptkbp:bfsLayer
|
7
|
|
https://www.w3.org/2000/01/rdf-schema#label
|
Essure
|