MAUDE Adverse Event Report: BAYER ESSURE

Device Problem Material Deformation (2976)

Patient Problems Abdominal Pain (1685); Emotional Changes (1831); Fatigue (1849); Swelling (2091); Ambulation Difficulties (2544); Weight Changes (2607)

Event Date 09/18/2012

Event Type  Injury  

Event Description

The moment those essure coils went into my body, i had extreme abdominal pain.I stayed in the dr.'s office for 4 hours with them pumping me full of pain pills to help, but to no avail.The pain didn't end until i had a partial hysterectomy to remove the coils, at which point the pain was gone.Pain the second essure was put in my body and full relief the second essure was taken out of my body.No doubt in the world, that it was essure that caused my two months of hell! i had an ultrasound of the area one week after the coils were inserted and the dr.Could see that one of the coils was already moved from its insertion point, my body's way of trying to force it out.I went through 2 months of extreme and constant abdominal pain.Always strong, sometimes shooting pain.Abdominal swelling enough to make me look several months pregnant.Weight gain.Barely able to walk at moments due to severe pain.Inability to have intercourse as it increased the pain, which i didn't think it was even possible to have worse pain.Back pain.Mood swings.Lack of energy.Days of missed work.Unbearable 2 months of my life.Then, had to go undergo a major and expensive surgery, a partial hysterectomy, to remove the essure coils.The dr.Took photos, during and post surgery, and you can see how they deformed inside my body.Unbelievable.I have a non blood related stepsister who has her own horror story and had to have a full hysterectomy to remove her essure coils.Never, ever put this product into your body! #medwatcher #mw156373.

• Brand Name: ESSURE
• Manufacturer (Section D): BAYER
• MDR Report Key: 3885954
• MDR Text Key: 4545313
• Report Number: MW5036714
• Device Sequence Number: 1
• Product Code: HHS
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Source Type: Invalid Data
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 06/11/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/20/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Is the Reporter a Health Professional?: No
• Patient Sequence Number: 1
• Treatment: MEDICATIONS FOR ABSENCE SEIZURES.
• Patient Outcome(s): Hospitalization; Other
• Patient Age: 39.000 YR