MAUDE Adverse Event Report: BAYER PHARMA AG ESSURE; INSERT, TUBAL OCCLUSION

Model Number ESS205

Device Problems Break (1069); Migration or Expulsion of Device (1395); Device Or Device Fragments Location Unknown (2590)

Patient Problems Menstrual Irregularities (1959); Pain (1994); Dizziness (2194); Heavier Menses (2666)

Event Type  Injury  

Event Description

Incident.Serious injury.Required intervention and malfunction this is a spontaneous case report received from a female consumer of unspecified age via regulatory authority (mw5043072) in united states on 20-jul-2015.She had essure (ess205) (fallopian tube occlusion insert) inserted on (b)(6) 2007 for permanent birth control.The consumer stated that before essure she never had problems with monthly periods.After getting essure, she was never the same.She had a period every 2 weeks and they were so heavy that she would get lightheaded at times.She also had at least once a year extreme pain in her lower abdomen that she went to the emergency room.There was never a reason.On (b)(6) 2015 essure was removed and a complete hysterectomy was done (fallopian tubes and uterus were removed).Only a tiny portion of the device was found and was still in her.In sometime between 2007-2015 essure broke and were expelled from her body without her knowing.Ptc investigation result was received on 24-jul-2015.This adverse event report is related to a product technical complaint (ptc).The bayer reference number for the ptc report is: ptc local number (b)(4) and ptc global number (b)(4).Final assessment: since no product was returned to us for investigation, we were unable to perform an investigation of the actual device involved in this complaint.Typically, we would inspect the micro-insert, outer catheter, the inner catheter, and all parts within the handle assembly to confirm that all parts are accounted for.Since we have no valid lot number for this case, we were unable to conduct a review of the manufacturing batch record.We were unable to confirm any quality defect or device malfunction at this time.The possibility of the micro-insert breaking is an anticipated event and there was no event reported which indicates a new technical failure mode for the device.Medical assessment: this ptc was initiated due to a request for confirmation of quality and a reported product quality issue.The reported adverse events considered related are not indicative of a quality deficit per se.No batch number was reported.Without this information no batch signal cluster review in the gpv database for a more detailed statistical medical evaluation is possible.Neither batch number nor complaint sample were available for further technical investigation.The technical assessment concluded unconfirmed quality defect.In summary, there is no reason to suspect a causal relationship to a potential quality deficit based on this report.Company causality comment: this non-medically confirmed, spontaneous case report, refers to a female consumer who had essure (fallopian tube occlusion insert) inserted and experienced extreme pain in her lower abdomen.She was submitted to a hysterectomy.During this surgery only a tiny portion of essure was found; she stated between 2007-2015 essure broke and was expelled from her body without her knowing.Device breakage is listed according to technical analysis.Also, the other events are listed in the reference safety information for essure.Abdominal and pelvic pain may occur with essure therapy.In this particular case, consumer stated her symptoms started after essure insertion.Additionally, according to her essure broke and was expelled.This could have been a contributory role in consumer's pain.Although the exact mechanism of the events is unknown, considering their nature a causal relationship with the suspect device cannot be excluded.Additionally, non-serious events were reported.This case was regarded as incident, since an intervention (hysterectomy) was required for devices removal.The product technical analysis concluded there is no reason to suspect a causal relationship to a potential quality deficit based on this report.Follow-up information is being sought.

Manufacturer Narrative

Follow up on 29-oct-2015: the required number of follow-up attempts have been completed, with no response to date.Case closed.Company causality comment : this non-medically confirmed, spontaneous case report, refers to a female consumer who had essure (fallopian tube occlusion insert) inserted and experienced extreme pain in her lower abdomen.She was submitted to a hysterectomy.During this surgery only a tiny portion of essure was found; she stated between 2007-2015 essure broke and was expelled from her body without her knowing.Device breakage is listed according to technical analysis.Also, the other events are listed in the reference safety information for essure.Abdominal and pelvic pain may occur with essure therapy.In this particular case, consumer stated her symptoms started after essure insertion.Additionally, according to her essure broke and was expelled.This could have been a contributory role in consumer's pain.Although the exact mechanism of the events is unknown, considering their nature a causal relationship with the suspect device cannot be excluded.Additionally, non-serious events were reported.This case was regarded as incident, since an intervention (hysterectomy) was required for devices removal.The product technical analysis concluded there is no reason to suspect a causal relationship to a potential quality deficit based on this report.

Manufacturer Narrative

Data correction: the product code knh was replaced with hhs.

Manufacturer Narrative

Medical conditions: the consumer stated that before essure she never had problems with monthly periods.After getting essure, she was never the same.After implantation (and never before) she experienced increasingly severe pain and discomfort, including (previously reported:) heavy menstrual bleeding, abdominal pain, (newly reported:) chronic pelvic pain, pain during intercourse, excessive weight gain, chronic back pain, she never experienced those before essure.The reporter commented: she never experienced the events before essure implantation.Only a tiny portion of the device was found and was still in her.In sometime between 2007-2015 essure broke and were expelled from her body without her knowing.Diagnostic results (normal ranges are provided in parenthesis if available): on an unknown date: hysterosalpingogram result was inserts properly placed.On (b)(6) 2017: histology after fallopian tube removal: only tiny portion of device found.Most recent follow-up information incorporated above includes: on (b)(6) 2017: now reported via lawyer: she was (b)(6) at time of essure placement in or around (b)(6) 2007 (prev.Reported (b)(6) 2007), hsg done (inserts properly placed), she experienced increasingly severe pain and discomfort, including (previously reported:) heavy menstrual bleeding, abdominal pain, (newly reported:) chronic pelvic pain, pain during intercourse, excessive weight gain, chronic back pain, she never experienced those before essure, and considered related to essure.In or around (b)(6) 2015 (prev.Reported on (b)(6) 2015) fallopian tubes and essure removed.Company causality comment: this non-medically confirmed, spontaneous case report, refers to a female consumer who had essure (fallopian tube occlusion insert) inserted and experienced extreme pain in her lower abdomen (complemented by at least once a year, went to emergency room, there never was a reason).She was submitted to a hysterectomy with fallopian tubes and essure removal.During this surgery only a tiny portion of essure was found; she stated between 2007-2015 essure broke and was expelled from her body without her knowing.All events are anticipated in the reference safety information for essure.Abdominal pain may occur with essure therapy.In this particular case, consumer stated her symptoms started after essure insertion.Additionally, according to her, essure broke and was expelled.This could have been a contributory role in consumer's pain.Although the exact mechanism of the events is unknown, considering their nature a causal relationship with the suspect device cannot be excluded.Additionally, non-serious events were reported.This case was regarded as incident, as a surgical intervention was required.The product technical analysis concluded there is no reason to suspect a causal relationship to a potential quality deficit based on this report.Further information will be obtained through the litigation process.

• Brand Name: ESSURE
• Type of Device: INSERT, TUBAL OCCLUSION
• Manufacturer (Section D): BAYER PHARMA AG; müllerstr. 178; berlin, CA 13353 ; GM 13353
• Manufacturer (Section G): BAYER PHARMA AG; müllerstr. 178; berlin, CA 13353 ; GM 13353
• Manufacturer Contact: k shaw lamberson ; 100 bayer blvd, p.o. box 915; p.o. box 915; whippany, NJ 07981-0915
• MDR Report Key: 5008028
• MDR Text Key: 23217918
• Report Number: 2951250-2015-00605
• 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: Followup,Followup,Followup
• Report Date: 04/10/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ESS205
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/17/2015
• Supplement Dates Manufacturer Received: Not provided; Not provided; Not provided
• Supplement Dates FDA Received: 11/19/2015; 01/20/2017; 04/10/2017
• 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