MAUDE Adverse Event Report: BAYER HEALTHCARE LLC ESSURE CONTRACEPTIVE; TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE

Device Problem Insufficient Information (3190)

Patient Problems Anemia (1706); Arthritis (1723); Fainting (1847); Headache (1880); Hemorrhage/Bleeding (1888); Pain (1994); Anxiety (2328); Joint Swelling (2356); Depression (2361); Reaction (2414); Palpitations (2467); Weight Changes (2607); Patient Problem/Medical Problem (2688)

Event Date 08/23/2012

Event Type  Injury  

Event Description

I had essure implanted on (b)(6) 2012.Ever since i suffered from a sharp stabbing pain on my right abdomen like being stabbed with knife.I was diagnosed with vitamin d deficiency.I developed depression and anxiety.Soon after my belly began to bloat over the six years i had it, i got to the point i looked 8 months pregnant.I gained weight, could not lose any even through healthy diet and exercise.I would faint while exercising, i was later diagnosed with acute anemia.My depression worsen and began to have debilitating periods three years after essure implanted.I would hemorrhage like a miscarriage every month, would get back pains so bad, i could not get out of bed.Began to have super strong heart palpitation ended up in hosp diagnosed with anxiety attack.My depression worsened developed suicidal thoughts, i could not live in so much pain.Headaches were so frequent and migraines were at least twice monthly.I lived on motrin and excedrin to ease the pains and swelling.My joints hurt so much thought i had arthritis.My hair became very thin.Could not stand to drink water would taste metal in my mouth.Sex became uncomfortable and loss of libido as well.Developed brain fog could not concentrate i had short term memory loss would forget everything.Getting essure was the worse mistake i ever made.The dr told me there was no side effects, it would be pain free and worry free.Nothing could be further from the truth, and the hell i have endured for 6 years which almost cost me my career, my marriage and my life.I had to have a hysterectomy to remove essure on (b)(6) 2018 lost my fallopian tubes, my uterus, and my cervix thanks to essure being nonreversible which the dr to mention also i thought it was like an iud you could take it out as easy as they put it in.I was deceived, i was lied to, i was used as a guinea pig and implanted a permanent medical device without informed consent.I had no idea i was allergic to nickel.I can be reach at (b)(6).

• Brand Name: ESSURE CONTRACEPTIVE
• Type of Device: TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE
• Manufacturer (Section D): BAYER HEALTHCARE LLC
• MDR Report Key: 7869268
• MDR Text Key: 120135821
• Report Number: MW5079752
• Device Sequence Number: 1
• Product Code: HHS
• Combination Product (y/n): N
• 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: 09/06/2018

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: Lay User/Patient
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/11/2018
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening; Other; Required Intervention; Disability
• Patient Age: 48 YR
• Patient Weight: 111