MAUDE Adverse Event Report: BAYER HEALTHCARE LLC. ESSURE; TRANSCERVICAL CONTRACEPTICE TUBAL OCCLUSION DEVICE

Device Problem Product Quality Problem (1506)

Patient Problems Abscess (1690); Cyst(s) (1800); Headache (1880); Hypersensitivity/Allergic reaction (1907); Pain (1994); Rash (2033); Scar Tissue (2060); Ambulation Difficulties (2544); Confusion/ Disorientation (2553); Suicidal Ideation (4429); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Type  Injury  

Event Description

Pt states that she was implanted with an essure device in late 2010, and has been having related complications since 2014.Pt reports that she has been unsuccessfully attempting to remove the device since 2015.Pt reports after implantation in 2010, she had surgery for a breast augmentation and removal of overhanging tissue then 2 weeks later developed a 2 gallon abscess that needed to be drained surgically.Pt reports she contracted vre after surgery and had developed a 1 quart sized breast abscess and 2 abscesses in her arm that also needed surgical intervention.Pt states she has had a total of 5 surgeries.Pt reports that she has a nickel allergy and was not made aware of the metal in the essure at implantation.Pt reports that as a result of metal toxicity from the implant, she has mental confusion, brain fog, pain in her uterus that she notes radiates into her knees and gives her generalized body pains.Pt also stated that she lives in constant pain and expresses that she would rather die than live in pain but wants to live just pain free from metal toxicity.Additionally the pt states one of her ovaries has scar tissue and is wrapped around her hip bone.Pt also reports cyst and tumor formations, body rashes, metallic taste in her mouth, bilateral hip that causes ambulation difficulty and headaches.Pt notes that she has 2 coils placed in her right side and 1 in her left.Pt states 1 of her right sided coils is placed correctly and the other is embedded in her uterus covered in scar tissue.Pt reports that the left sided coil is wrapped around her left hip and positioned incorrectly.Of note, pt states she received a mental health assessment from a psychiatrist by the state of (b)(6) , the purpose and results of which she is unsure.Pt also alleges that she has been deemed mentally unstable and received misconceived diagnoses from medical professionals as a result of her essure complications and that this has prevented her from regaining custody of her children.

• Brand Name: ESSURE
• Type of Device: TRANSCERVICAL CONTRACEPTICE TUBAL OCCLUSION DEVICE
• Manufacturer (Section D): BAYER HEALTHCARE LLC.
• MDR Report Key: 12647535
• MDR Text Key: 276894178
• Report Number: MW5104659
• Device Sequence Number: 1
• Product Code: HHS
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 10/18/2021
• 3 Devices were Involved in the Event: 1 2 3

1 Patient was Involved in the Event

• Date FDA Received: 10/18/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• 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