Essure Problems 

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The meeting minutes between Conceptus and the FDA regarding PMA 

http://www.fda.gov/ohrms/dockets/ac/02/transcripts/3881t1.doc

 

summary of minutes

http://www.fda.gov/ohrms/dockets/ac/02/minutes/3881m1_summary%20minutes.htm

 

Stop to Conceptus, a timeline

http://www.dipity.com/Krystaldonahue/S-TOP-Essure-From-Concept-to-Post-Market/#timeline

 

 

Information on nickel

 

Manufacturer Narrative

The essure ifu contains the following warning statement: the essure micro-insert includes nickel-titanium alloy, which is generally considered safe. However, in vitro testing has demonstrated that nickel is released from this device. Pts who are allergic to nickel may have an allergic reaction to this device, especially those with a history of metal allergies. In addition, some pts may develop an allergy to nickel if this device is implanted. Typical allergy symptoms reported for this device include rash, pruritus, and hives.

 

 

Nickel warning removed from Essure label

http://globenewswire.com/news-release/2011/08/04/453229/228677/en/Conceptus-R-Announces-FDA-Approval-to-Remove-Nickel-Contraindication-From-the-Essure-Procedure-Instructions.html

 

http://hosted-p0.vresp.com/484861/2099956426/ARCHIVE

 

http://www.google.com/url?sa=t&rct=j&q=&esrc=s&frm=1&source=web&cd=9&ved=0CG0QFjAI&url=http%3A%2F%2Fwww.dshs.state.tx.us%2FWorkArea%2Flinkit.aspx%3FLinkIdentifier%3Did%26ItemID%3D8589967982&ei=ZXXaUvbDB_PnsASMvYDgCQ&usg=AFQjCNFBFJtsWMUuvS_K4eAjV3_EdAzHSw&bvm=bv.59568121,d.cWc

 

 

Implant Syndrome

 

http://www.ehcd.com/implant-syndrome/

 

http://www.aehf.com/articles/Implant-inform.html

 

http://www.google.com/url?sa=t&rct=j&q=&esrc=s&frm=1&source=web&cd=1&ved=0CCoQFjAA&url=http%3A%2F%2Fwww.ehcd.com%2Fpdf%2FImplant_Syndrome_070711.pdf&ei=O3baUoXFCcjRsATpsoGwAg&usg=AFQjCNG5eZkgPuCiPYktSLaGLivLw2kLQw&bvm=bv.59568121,d.cWc

 

http://link.springer.com/article/10.1007%2Fs13317-012-0044-1#page-1

 

Metal corrosion in the human body

http://www.electrochem.org/dl/interface/sum/sum08/su08_p31-34.pdf

 

Nickel compounds toxicity

http://digitalfire.com/4sight/hazards/ceramic_hazard_nickel_compounds_toxicity_327.html

 

Can I be allergic to a metal implant?

http://orthopedics.about.com/od/orthopedicsinformation/f/metalallergy.htm

 

 

Nickel and surgical implants

http://www.nickelinstitute.org/en/HealthScienceEnvironmentalScienceAndSafeUse/ProductUseAdvisoryNotes/~/media/Files/HealthEnvironmentSafeUse/AdvisoryNotes/EN/AdvisoryNotesSurgicalA4rev.ashx

 

FDA Talk about metal allergies

http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/TipsandArticlesonDeviceSafety/ucm070171.htm

 

Nickel allergies symptoms and treatment

http://www.steadyhealth.com/articles/Nickel_Allergy_Symptoms_and_Treatment_a885.html

 

 

 

Information on PET (polyethylene terephthalate)

 

Mesh implants in hernia repair

http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm142636.htm

 

Mirena PET reactions

http://pennstatehershey.adam.com/content.aspx?productId=45&pid=45&gid=5106

 

PET

http://www.plasticsmadesimple.com/DataSheets/PET_MSDS.pdf

 

PET in Mesh is the same as Essure

http://tvtno.org/the-facts/surgical-mesh-and-autoimmune-disease-connection/

 

 

Expulsion

 

Expulsion of coils even after 3 month HSG

http://www.facebook.com/groups/Essureproblems/544908338874217/

 

 

Important links

 

 

Surgical aspects of removal of Essure microinsert

http://www.facebook.com/groups/Essureproblems/540777282620656/

http://www.ncbi.nlm.nih.gov/pubmed/23290426

http://www.mdlinx.com/obstetrics-gynecology/news-article.cfm/4373495/surgical-technique

http://pubget.com/paper/23290426/Surgical_aspects_of_removal_of_Essure_microinsert

http://memfert.com/index.php?cat=essure.htm

http://pregnantagain.com/tubal-reversal/essure-removal/

http://www.tubal-reversal.net/removing-essure.htm

 

Your complete guide to the essure procedure

http://www.womenshealthfremont.com/webdocuments/Essure-Patient-Information-Booklet.pdf 2009

http://thinz.org/b/3247961/Patient-Information-Booklet-U-S-Food-And-Drug-Administration-/ 2002

 

perscribing information

http://www.urogyn.org/essure/CC-0366-Perscribing-Information-Summary.pdf

 

advisory committees FDA

http://www.fda.gov/AdvisoryCommittees/CommitteesMeetingMaterials/MedicalDevices/MedicalDevicesAdvisoryCommittee/ObstetricsandGynecologyDevices/ucm124806.htm

 

Clinical testing

http://urogyn.org/essure/clinical_testing.html

 

Three year follow up

http://www.thefreelibrary.com/Three-year+follow-up+data+reported+for+Essure.-a0124489966

 

Conceptus Essure DRAFT Instructions for Use L2133 Rev. A (06/12/02)

http://www.fda.gov/ohrms/dockets/ac/02/briefing/3881b1_03.pdf

 

Summary of Safety and Effectiveness Data

 http://www.accessdata.fda.gov/cdrh_docs/pdf2/P020014b.pdf

 

How to search for Essure related articles on pubmed

http://www.ncbi.nlm.nih.gov/pubmed?term=Essure

 

Essure adverse events reported to the FDA so far.....

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/results.cfm?start_search=1&searchyear=&productcode=&productproblem=&devicename=&knumber=K&pmanumber=P&manufacturer=conceptus&brandname=essure&eventtype=&reportdatefrom=01%2F01%2F2002&reportdateto=06%2F29%2F2012&pagenum=10&key_count=518

 

Essure: Be careful what you wish for

http://thirdcoastdigest.com/2008/05/essure-be-careful-what-you-wish-for/

 

Multimodality Imaging of the Essure Permanent Birth Control Device: Emphasis on Commonly Overlooked Abnormalities

http://www.ajronline.org/content/196/5/W648.full.pdf+html

 

Complications of implants

http://www.ask.com/wiki/Implant_(medicine)

 

Study of HSG imaging

https://kb.osu.edu/dspace/bitstream/handle/1811/51903/Jaime_Hartley_Thesis.pdf?sequence=1

 

Use of intraoperative fluoroscopy during laparotomy to identify fragments of retained Essure microinserts: case report.

 http://www.ncbi.nlm.nih.gov/pubmed/?term=flouroscopy+essure+fragments

 

FDA Public Health Notification: Unretrieved Device Fragments 

 http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/PublicHealthNotifications/ucm062015.htm

 

What is chronic inflammation?

http://www.womentowomen.com/inflammation/whatischronicinflammation.aspx

 

The Medical Device Safety Act of 2009

http://www.nejm.org/doi/pdf/10.1056/NEJMe0902377

http://www.govtrack.us/congress/bills/111/hr1346

http://thomas.loc.gov/cgi-bin/query/z?c111:H.R.1346:

http://www.lexology.com/library/detail.aspx?g=6689b667-6b8c-444a-ab75-8cc0ea5dada5

 

Doctor admits Essure as problem

http://www.justanswer.com/ob-gyn/636em-essure-procedure-performed-feb-2011.html

 

MRI Safety and Essure

http://mrisafety.com/safety_article.asp?subject=148

 

 

 FDA compliance Activities for Medical Devices. Medical Device Premarket Approval and Postmarket Inspections

 http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/ComplianceActivities/ucm295675.htm

 

conceptus accelerates essure pma submission

http://investor.conceptus.com/releasedetail.cfm?ReleaseID=252051

 

medical device definition. class explanations

http://en.wikipedia.org/wiki/Medical_device

 

overview: fda regulation of medical devices

http://www.qrasupport.com/FDA_MED_DEVICE.html 

 

 us patents

http://patft.uspto.gov/netacgi/nph-Parser?Sect1=PTO1&Sect2=HITOFF&d=PALL&p=1&u=%2Fnetahtml%2FPTO%2Fsrchnum.htm&r=1&f=G&l=50&s1=6705323.PN.&OS=PN%2F6705323&RS=PN%2F6705323

 

protocols for in office hysteroscopic sterilization

http://www.obgmanagement.com/Essure/pdf/October_2005.pdf

 

essure instructions for use

http://www.obgmanagement.com/Essure/pdf/October_2005.pdf

 

one clinical trial exclusion criteria

http://apps.who.int/trialsearch/Trial.aspx?TrialID=NCT01221974

 

clinical trials

http://clinicaltrials.gov/ct2/results?term=Essure&Search=Search

 

pma approval and conditions

http://www.accessdata.fda.gov/cdrh_docs/pdf2/P020014a.pdf

 

post approval study 1

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma_pas.cfm?c_id=112&t_id=367828

 

post approval study 2

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMA/pma_pas.cfm?t_id=405774&c_id=788#tt

 

fact sheet complete immunity preemtion

http://www.justice.org/cps/rde/xchg/justice/hs.xsl/2674.htm

 

difference between drug and device preemption

http://druganddevicelaw.blogspot.com/search?q=Medical+device+preemption

 

preemption in medical device litigation

http://www.thefederation.org/documents/24.Preemption%20Medical%20Device.pdf

 

many documents on essure

http://ebookbrowse.com/es/essure

 

Class III devices

http://www.loosecannon.name/files/Misclassified.html

http://www.mddionline.com/mddi-index-ad.html?gotourl=http://www.mddionline.com/article/does-your-medical-device-really-need-be-class-iii

 

The FDA, preemption, and public safety

http://scholarship.law.georgetown.edu/cgi/viewcontent.cgi?article=1694&context=facpub

 

When conduct becomes a crime

http://blogs.fda.gov/fdavoice/index.php/2013/06/when-conduct-becomes-a-crime/

 

Doctors paid for referrals

http://m.whiotv.com/news/news/local/investigation-finds-docs-paid-dollars-referrals/nWLnH/

 

False claims suit against Bayer

http://www.courthousenews.com/2013/09/05/60892.htm

 

Mirena and Essure causing problems

http://norfolk.legalexaminer.com/fda-prescription-drugs/are-mirena-and-essure-birth-control-methods-more-dangerous-than-women-think/