MAUDE Adverse Event Report: BAYER ESSURE

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Autoimmune Disorder (1732); Hypersensitivity/Allergic reaction (1907); Incontinence (1928); Menstrual Irregularities (1959); Pain (1994); Anxiety (2328); Complaint, Ill-Defined (2331); Inadequate Pain Relief (2388)

Event Date 06/06/2012

Event Type  Injury  

Event Description

I had essure placed in 2012 and have been extremely sick since.Severe pelvic pain on a daily basis; debilitating pain during period and ovulation.Autoimmune issues have began and i remain sick for 30 days plus when i contract a cold.My body is attacking the coils due to a nickel allergy.I was told they were titanium coils when i had them placed and it turns out they have nickel in them.I suffer from severe anxiety on a daily basis which requires a lot of medication to fix.I have significant bloating daily and look about 4 months pregnant.I have to remain in my bed for the entire week of my period and during the 3 to 5 days of my ovulation.I have increased incontinence that causes significant problems and have no infections in my urinary or vaginal area that would otherwise cause the problem.I am now facing either a removal of my fallopian tubes or a full hysterectomy depending on what the doctor sees once in there.I am only (b)(6) and should not have to have my full fallopian tubes or entire reproductive system removed; but, due to essure making me extremely sick, i not have to.I have two children who are affected by this because their mother has to manage daily pain and anxiety, and is bed ridden 2 weeks out of each month from cycle changes interacting with this device.My medical costs for er visits, medications, labs, xrays, and ob visits are huge, putting a significant financial strain on my family.Especially because my husband is the only one who can work due to me being in debilitating pain for half of every month.Since having essure placed my health and quality of life has been extremely poor.It is sad that my whole family and i have to suffer day in and day out because i wanted to prevent future pregnancies.Two children is enough for me, and it is devastating that myself, my husband, my 5 year old son, and my 3 year old daughter have to be punished on a daily basis because of the decision by my doctor that this would be the best device for me as opposed to a regular tubal ligation.My life will never be the same again and my family will forever be affected by this awful product.

• Brand Name: ESSURE
• Type of Device: ESSURE
• Manufacturer (Section D): BAYER
• MDR Report Key: 4438970
• MDR Text Key: 15972940
• Report Number: MW5040299
• 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: 01/14/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/14/2015
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention; Disability
• Patient Age: 27 YR
• Patient Weight: 100