Statements (45)
| Predicate | Object |
|---|---|
| gptkbp:instanceOf |
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 |
| https://www.w3.org/2000/01/rdf-schema#label |
Essure
|
| gptkbp:insertedBy |
gptkb:fallopian_tubes
|
| gptkbp:intendedUse |
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| gptkbp:withdrawn |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
|