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

Model Number ESS305

Device Problems Break (1069); Detachment Of Device Component (1104); Migration or Expulsion of Device (1395)

Patient Problems Pain (1994); Heavier Menses (2666); Foreign Body In Patient (2687)

Event Date 03/28/2018

Event Type  Injury  

Event Description

I was being treated for chronic pelvic pain and heavy menstrual bleeding.(something i've been dealing with for 6 plus years.) my doctor performed a d and c, for diagnostic and possible therapeutic benefit.During the procedure it was discovered that one of my essure coils had migrated and was perforating my cervix.The doctor attempted to remove the coil.The coil broke off.My pain is far worse than it was previously.The other coil is missing.I'm being told a hysterectomy is my only option.I'm still trying to access how much of an impact these devices have been having on me and my health over the course of the past 7 years.

• Brand Name: ESSURE
• Type of Device: TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE
• Manufacturer (Section D): CONCEPTUS/ BAYER
• MDR Report Key: 7472385
• MDR Text Key: 107019910
• Report Number: MW5076868
• 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: 04/25/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/27/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: ESS305
• Device Lot Number: 731604
• Was Device Available for Evaluation?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Disability
• Patient Age: 38 YR
• Patient Weight: 94