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U.S. Department of Health and Human Services


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CONCEPTUS ESSURE Back to Search Results
Model Number ES305
Device Problem Labelling, Instructions for Use or Training Problem (1318)
Patient Problem Pain (1994)
Event Date 04/04/2013
Event Type  Injury  
Event Description
I was implanted with conceptus essure coils on (b)(6) 2012. Began having problems in (b)(6) 2013, extreme back pain not responding to drugs. X rays, ct scan and ultra sounds could not find anything causing the pain. (b)(6) brought on a right side pain which got progressively worse. Tried to get appointment with ob/gyn that implanted device and he claimed that essure would not cause those pains which made it impossible to get appointment covered by insurance. Another doctor in insurance plan directed by phone that implanting doctor should be one to take out coils. Another doctor in insurance plan said it would not be caused by essure or endometriosis, he would not consider surgery until all options were evaluated. Primary doctor made insurance required referral and met with implanting doctor who said essure would not cause this pain. Pt demanded the coils be removed thru hysterectomy to see if it would relieve the pain. He referred pt to another doctor in same office. New doctor agreed to do hysterectomy but did not feel the pain would be eliminated. Surgery finally happened on (b)(6) 2013. Tube, uterus and cervix were removed by open surgery. A small vessel leak required vaginal repair. In recovery room the pain in right side and back were gone. At post op appointment, the doctor said that coils were in tubes and removed. When pt said she was glad there are no parts of the coils floating in there. The doctor said that would not cause any problems. This device needs to have warnings that say, it can cause pain, infections, foggy brain, hair loss, heavy bleeding (causing anemia, numbness in arms and hands and a hysterectomy may be required to remove coils. And the nickel warning should never have been taken off as doctors tell those with nickel allergy that they can have essure. Pt's body rejects foreign objects as two mirena iud's fell out, one resulting in pregnancy. The pain was caused by the body trying to get rid of foreign object.
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Brand NameESSURE
Type of DeviceESSURE
Manufacturer (Section D)
MDR Report Key3339279
MDR Text Key3868465
Report NumberMW5031734
Device Sequence Number1
Product Code HHS
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Patient
Type of Report Initial
Report Date 09/03/2013
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/04/2013
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Other
Device Model NumberES305

Patient Treatment Data
Date Received: 09/04/2013 Patient Sequence Number: 1