MAUDE Adverse Event Report: BAYER HEALTHCARE, LLC. ESSURE; TRANCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE

Model Number ESS205

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Autoimmune Disorder (1732); Toxicity (2333); Pregnancy (3193)

Event Date 07/01/2005

Event Type  Injury  

Event Description

I had the essure device implanted in 2005.Shortly after i was diagnosed with hashimoto's and my health has been declining ever since.I was a healthy (b)(6) y/o woman with no medical problems and took no medication.I also had a pregnancy with the essure implant 8 yrs after placement and had to make the unimaginable decision to abort the pregnancy which had physical and psychological impacts for me.With the unk risk of being pregnant with essure it was the advisable option.For the past 12 yrs, i have struggled to do basic daily things.My life, my marriage and my children's lives were impacted greatly from this and after seeing drs for multiple health issues with no answers.In 2017 i was informed from a friend, not my dr or bayer, of the side effects of essure which i had many on the list.I had essure removed (hysterectomy) in 2018 and am still dealing with the effects of heavy metal toxicity and autoimmune disease.I take 4 medications a day and many supplements to try and live a normal life.

• Brand Name: ESSURE
• Type of Device: TRANCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE
• Manufacturer (Section D): BAYER HEALTHCARE, LLC.
• MDR Report Key: 7681227
• MDR Text Key: 113919991
• Report Number: MW5078333
• 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: 07/09/2018

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: No Information
• Device Model Number: ESS205
• Device Lot Number: 12269696
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/11/2018
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other; Disability
• Patient Age: 29 YR
• Patient Weight: 84