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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ESSURE TUBAL LIGATION
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ESSURE TUBAL LIGATION Back to Search Results
Device Problem Device Or Device Fragments Location Unknown (2590)
Patient Problems Emotional Changes (1831); Hair Loss (1877); Headache (1880); Menstrual Irregularities (1959); Miscarriage (1962); Pain (1994); Blurred Vision (2137); Numbness (2415); Weight Changes (2607); Pregnancy (3193)
Event Date 07/10/2014
Event Type  Injury  
Event Description
I was a healthy mother of four, who decided to 'tie my tubes'.In (b)(6) 2014, i decided to get the essure implant procedure done.In (b)(6) it was time to do three month check up, i wasn't able to do the xray for i had pulled by back and had two discs bulged and was on bed rest.On (b)(6) i went in to my o.B.For a concern of which my menstruation did not come for (b)(6), there i found out i was pregnant.I then was upset and concerned that following tuesday i started bleeding uncontrollably and was admitted to the e.R.Where i found out i was having a miscarriage.They did ultrasound and confirmed that my right tubal was sealed in, yet my left side was not.They couldn't find the coil in my place, or my cervix, tubes or anywhere.I have been, since the procedure, experiencing severe cramping with no menstruation, lower back pain, hair loss, pelvic pain, ovary pain.Migraines, increase of weight, blurred vision, dry mouth with metallic taste, mood swings that are unexplainable.I have also been having acne flare up, both my legs go numb without movement or cause.I have been very distraught since the miscarriage.I'm concerned about the missing coil.I was also at risk of ectopic pregnancy hence i had a tubal ligation.
 
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Brand Name
ESSURE TUBAL LIGATION
Type of Device
ESSURE TUBAL LIGATION
MDR Report Key4251142
MDR Text Key22162684
Report NumberMW5039003
Device Sequence Number1
Product Code HHS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Patient
Type of Report Initial
Report Date 11/05/2014
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 Health Professional
Initial Date Manufacturer Received Not provided
Initial Date FDA Received11/05/2014
Patient Sequence Number1
Patient Outcome(s) Hospitalization; Life Threatening;
Patient Age24 YR
Patient Weight75
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