Essure Problems 

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

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/