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://hosted-p0.vresp.com/484861/2099956426/ARCHIVE
Implant Syndrome
http://www.ehcd.com/implant-syndrome/
http://www.aehf.com/articles/Implant-inform.html
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
FDA Talk about metal allergies
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
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.....
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
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
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