MAUDE Adverse Event Report: CONCEPTUS ESSURE

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.

• Brand Name: ESSURE
• Type of Device: ESSURE
• Manufacturer (Section D): CONCEPTUS
• MDR Report Key: 3339279
• MDR Text Key: 3868465
• Report Number: MW5031734
• Device Sequence Number: 1
• Product Code: HHS
• Reporter Country Code: US
• Number of Events Reported: 1
• 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 Received: 09/04/2013
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Model Number: ES305

Patient Treatment Data

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