MAUDE Adverse Event Report: BAYER ESSURE

Device Problems Migration or Expulsion of Device (1395); Misfire (2532)

Patient Problems Adhesion(s) (1695); Bruise/Contusion (1754); Flatus (1865); Hair Loss (1877); Hemorrhage/Bleeding (1888); Menstrual Irregularities (1959); Pain (1994); Complaint, Ill-Defined (2331); Inadequate Pain Relief (2388); Foreign Body In Patient (2687)

Event Date 12/15/2010

Event Type  Injury  

Event Description

(b)(4).I had the essure implanted in (b)(6) 2010.During the procedure, one of the coils "misfired ", so my physician put an extra one in , "just in case".Not long after, i started experiencing severe pelvic pain, bloating, very painful periods, hair loss, plus numerous other ailments.After multiple trips to my gyn, numerous ultrasounds and test, my dr performed a diagnostic laparoscopy.My post op diagnosis was adhesions.I then lived with the pain for the next two and a half years, with all of the above mentioned symptoms plus multiple new ailments, including but not limited to back pain, restless leg skin issues, increased bruising, etc.In (b)(6) 2014, i had a total abdominal hysterectomy.The procedure went uncomplicated, despite my multiple adhesions.Several hours post op, i developed an unexplainable, internal bleed and had to be rushed back in for emergency surgery.The surgeon never did find a "bleeder" but instead oozing throughout my abdominal cavity.It was a whirlwind, but regardless of the complications, i was so happy to finally be done with my horrible, no good, girl organs!! post op went well but i have had a persistent pelvic pain and unbearable back pain ever since.In (b)(6) 2016, i went to see an orthopedic dr for the ongoing back pain.He sent me for lumbar x-rays, where it was discovered that i have not one, not two, but three essure coils embedded in my abdominal wall.I am scheduled for an exploratory surgery to have the coils finally removed!! it has been hell since (b)(6) 2010.

• Brand Name: ESSURE
• Manufacturer (Section D): BAYER
• MDR Report Key: 5440248
• MDR Text Key: 38289071
• Report Number: MW5060191
• Device Sequence Number: 1
• Product Code: HHS
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 02/04/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/16/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Is the Reporter a Health Professional?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening; Other; Required Intervention; Disability
• Patient Age: 38.000 YR