Essure Problems 

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The meeting minutes between Conceptus and the FDA regarding PMA


summary of minutes




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,d.cWc



Implant Syndrome,d.cWc


Metal corrosion in the human body


Nickel compounds toxicity


Can I be allergic to a metal implant?



Nickel and surgical implants


FDA Talk about metal allergies


Nickel allergies symptoms and treatment




Information on PET (polyethylene terephthalate)


Mesh implants in hernia repair


Mirena PET reactions




PET in Mesh is the same as Essure





Expulsion of coils even after 3 month HSG



Important links



Surgical aspects of removal of Essure microinsert


Your complete guide to the essure procedure 2009 2002


perscribing information


advisory committees FDA


Clinical testing


Three year follow up


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


Summary of Safety and Effectiveness Data


How to search for Essure related articles on pubmed


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


Essure: Be careful what you wish for


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


Complications of implants


Study of HSG imaging


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


FDA Public Health Notification: Unretrieved Device Fragments


What is chronic inflammation?


The Medical Device Safety Act of 2009


Doctor admits Essure as problem


MRI Safety and Essure



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


conceptus accelerates essure pma submission


medical device definition. class explanations


overview: fda regulation of medical devices 


 us patents


protocols for in office hysteroscopic sterilization


essure instructions for use


one clinical trial exclusion criteria


clinical trials


pma approval and conditions


post approval study 1


post approval study 2


fact sheet complete immunity preemtion


difference between drug and device preemption


preemption in medical device litigation


many documents on essure


Class III devices


The FDA, preemption, and public safety


When conduct becomes a crime


Doctors paid for referrals


False claims suit against Bayer


Mirena and Essure causing problems