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

Device Problem Material Deformation (2976)

Patient Problems Hair Loss (1877); Menstrual Irregularities (1959); Pain (1994); Depression (2361); Sensitivity of Teeth (2427); Sleep Dysfunction (2517); Abdominal Distention (2601)

Event Date 04/14/2015

Event Type  Injury  

Event Description

Started having constant pains in reproductive area.Started having issues in other areas such as my back, teeth and jaw.Hair started falling out.Depression, sleepless nights, no energy.Looked 7 months pregnant due to belly bloat.Periods became abnormal.I released large calcium deposits that i felt move through my cervix and into my underwear.There were three of them and hard as rocks.My chiropractor took x-rays and it appeared that one of the coils was shaped in a circle, not sure what happened there.Since the removal of the coils, i no longer have pain anywhere.I finally got to sleep the whole night through and woke up refreshed and full of energy.Of course i can't use that energy because i am still healing from the surgery.The doctor said my uterus and ovaries were superb so there is no other cause for the pain i experienced.The jaw pain, teeth pain and movement of teeth and all the other issues have miraculously disappeared with the coils.I am going to have four scars now due to the surgery.I feel cheated because the doctor who delivered my last child said they don't tie tubes at that hospital and told me to get the coils.I trusted her.I knew it was metal, but not nickel.I knew there would be a few possible side effects, but nothing like it turned out to be and i was told my chances of having the side effects were slim to none.I had all the side effects she told me about and other side effects.I didn't get pregnant and my teeth didn't get loose enough to fall out, so i can't say i had all the side effects, but i had almost all of them.The worst experience in my life.That says a lot considering i have broken my femur bone, had teeth pulled and got dry socket and gave natural birth to three children, 2 without meds.I'm hoping that i will no longer get ear infections now that these coils are out.I'm pretty sure the ear infections were related to the swelling in my jaw caused from the coils.Finally the doctor removed the essure coils.He may still have them or at least have pictures of them.He did not let me see them when i came to after surgery.

• Brand Name: ESSURE COILS
• Type of Device: TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE
• Manufacturer (Section D): BAYER
• MDR Report Key: 7457786
• MDR Text Key: 106695017
• Report Number: MW5076711
• 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: 04/21/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/24/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Was Device Available for Evaluation?: No
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 31 YR
• Patient Weight: 64