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

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Abdominal Pain (1685); Emotional Changes (1831); Hair Loss (1877); Headache (1880); Hemorrhage/Bleeding (1888); Hypersensitivity/Allergic reaction (1907); Menstrual Irregularities (1959); Pain (1994); Discomfort (2330); Joint Swelling (2356); Depression (2361); Weight Changes (2607)

Event Date 08/25/2003

Event Type  Injury  

Event Description

Reporter alleges after essure was implanted, she felt discomfort and severe pain.She reports rectal bleeding for days, her doctor advised it was her period coming through her rectum.Reporter reports her health has declined since the implant.She was admitted on (b)(6) 2009 with breathing issues and spent days in the icu.Doctors told her it was an allergic reaction, but they were not sure what she was allergic to, her current physician believes it is essure.Reporter advises weight gain since implant, swelling in her joint¿s, feet, hands and legs, hair loss on the left side of her head, headaches mostly at nights, lower right abdominal pain, distended abdomen she states, "i look pregnant", painful sex which makes her not desire sex, sneezing and coughing causes so much pain that it brings her to her knees.Reporter advises she suffered severe depression in 2016 and was suicidal, she was evaluated in a psych ward.She wants the device out and has surgery scheduled for (b)(6) 2019.She has a pre -op appointment (b)(6) 2019.Her physician ordered a colonoscopy as well, and she had that done (b)(6) 2019.She reports it was painful and she received i.V pain meds.Reporter advised all these side effects have been going on since essure was implanted in her.She wants the fda to be aware of these adverse events.

• Brand Name: ESSURE
• Type of Device: TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE
• Manufacturer (Section D): BAYER HEALTHCARE, LLC
• MDR Report Key: 8781889
• MDR Text Key: 150745145
• Report Number: MW5088027
• 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: 07/11/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/11/2019
• Is this an Adverse Event Report?: Yes
• Device Operator: No Information
• Is the Reporter a Health Professional?: No
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other
• Patient Age: 43 YR
• Patient Weight: 122