MAUDE Adverse Event Report: BAYER HEALTHCARE LLC ESSURE; INSERT, TUBAL OCCLUSION

Model Number ESS305

Device Problems Loose or Intermittent Connection (1371); Device Operates Differently Than Expected (2913); Therapeutic or Diagnostic Output Failure (3023)

Patient Problems Abdominal Pain (1685); Fatigue (1849); Hearing Loss (1882); Failure of Implant (1924); Pain (1994); Discomfort (2330); Weight Changes (2607); Heavier Menses (2666); Pregnancy (3193)

Event Date 10/01/2008

Event Type  Injury  

Event Description

This is a spontaneous case report received from a lawyer in the united states, on behalf of a plaintiff in united states on 04-aug-2016.It refers to an adult female plaintiff who had essure (fallopian tube occlusion insert) inserted in (b)(6) 2007.Shortly after undergoing the essure procedure, a hysterosalpingogram test was performed and plaintiff was advised that one of her coils did not completely block her fallopian tube.Her post-procedure period has been marked by increasingly severe pain and discomfort, heavy menstrual bleeding, abdominal pain, excessive weight gain, excessive hair loss and chronic fatigue.Plaintiff never experienced any of these conditions prior to undergoing the essure procedure.She subsequently sought treatment for her symptoms from her physicians but was unable to resolve her symptoms.In or around (b)(6) 2008, plaintiff discovered she was pregnant and later gave birth to a child in or around (b)(6) 2009.In or around (b)(6) 2014, plaintiff underwent surgery to remove her essure coils.Company causality comment: this non-medically confirmed spontaneous case report is under litigation.It refers to an adult female plaintiff who had essure (fallopian tube occlusion insert) inserted and had chronic pelvic pain.Almost a year later, she found out she was pregnant and later gave birth to a child.Five years after delivery she underwent a surgery to remove essure coils.Pelvic pain and pregnancy with essure are listed in the reference safety information for essure.Considering that essure therapy may cause pelvic pain and that in this case there is no alternative explanation, a causal relationship with essure cannot be excluded.Unintended pregnancies may occur during any contraceptive use, including the use of essure micro-inserts.In this particular case, a hysterosalpingogram was performed but results were not provided.Since the pregnancy occurred more than 3 months after essure insertion and the results of hsg were not provided, a causal relationship with essure therapy cannot be excluded (device ineffective).This case is regarded as incident since device removal was required.A product technical complaint analysis is being sought.Further information will be obtained through litigation process.

Manufacturer Narrative

Follow-up received on 06-sep-2016.Quality-safety evaluation of ptc.The bayer reference number for the ptc report is (b)(4).No sample available for this investigation.Since we have no valid lot number for this case, we were unable to conduct a review of the manufacturing batch record.We are unable to confirm any quality defect or device malfunction at this time, although we were unable to confirm this complaint, we cannot exclude the possibility of having a technical issue involved in the complaint.There was no event reported which indicates a new technical failure mode for the device.Based on the provided information the defect type corresponds to the following meddra llt: device ineffective.As a product quality defect could not be confirmed but is considered plausible a relationship with the reported medical events cannot be totally excluded.However, the reported medical events are not indicative of a quality deficit per se.Since no batch number was reported, a patch investigation with respect to similar ae cases is not applicable company causality comment: this non-medically confirmed spontaneous case report is under litigation.It refers to an adult female plaintiff who had essure (fallopian tube occlusion insert) inserted and had chronic pelvic pain.Almost a year later, she found out she was pregnant and later gave birth to a child.Five years after delivery she underwent a surgery to remove essure coils.Pelvic pain and pregnancy with essure are listed in the reference safety information for essure.Considering that essure therapy may cause pelvic pain and that in this case there is no alternative explanation, a causal relationship with essure cannot be excluded.Unintended pregnancies may occur during any contraceptive use, including the use of essure micro-inserts.In this particular case, a hysterosalpingogram was performed but results were not provided.Since the pregnancy occurred more than 3 months after essure insertion and the results of hsg were not provided, a causal relationship with essure therapy cannot be excluded (device ineffective).This case is regarded as incident since device removal was required.According to technical analysis, a product quality defect could not be confirmed but is considered plausible.Further information will be obtained through litigation process.

• Brand Name: ESSURE
• Type of Device: INSERT, TUBAL OCCLUSION
• Manufacturer (Section D): BAYER HEALTHCARE LLC; milpitas CA
• Manufacturer (Section G): BAYER HEALTHCARE LLC; 1011 mccarthy blvd.; milpitas CA 95035
• Manufacturer Contact: k. shaw lamberson ; 100 bayer blvd., p.o. box 915; whippany, NJ 07981-0915
• MDR Report Key: 5911190
• MDR Text Key: 53395134
• Report Number: 2951250-2016-01840
• Device Sequence Number: 1
• Product Code: HHS
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P020014
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 10/04/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/29/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ESS305
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/06/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 29 YR