MAUDE Adverse Event Report: BAYER PHARMA AG ESSURE; TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE

Model Number ESS305

Device Problems Break (1069); Material Fragmentation (1261); Migration (4003)

Patient Problems Headache (1880); Nausea (1970); Pain (1994); Cramp(s) (2193); Weight Changes (2607); Heavier Menses (2666); Device Embedded In Tissue or Plaque (3165)

Event Date 06/11/2014

Event Type  Injury  

Event Description

This is a spontaneous case report received from a lawyer in the united states, on behalf of a female plaintiff/consumer of unspecified age in united states on (b)(6) 2016.It refers to the consumer, who had essure (fallopian tube occlusion insert) inserted in (b)(6) 2012 for permanent birth control, after the birth of her second child.In (b)(6) 2012, hysterosalpingogram confirmed that she was fully occluded.In (b)(6) 2013 she reported to her primary care physician that she was experiencing severe headaches, painful urination, cramps, painful intercourse, mood swings, fatigue, nausea, heavy menstrual cycles, weight gain and back pain.Doctor ordered a computed tomography scan and testing for thyroid issues and all came back negative.In (b)(6) 2014 her symptoms had not abated so doctor referred her for surgical evaluation.It was agreed that removal of essure was necessary and on (b)(6) 2014 she underwent a painful laparoscopic bilateral salpingectomy with removal of essure.During the procedure it was found that essure devices had fragmented and the surgery took much longer than expected because all the fragments had to be located and removed.She took time off from work to recover from this procedure, which was very painful and left her with permanent scars.She continues to experience excessive bleeding during her menstrual cycle, which is now infrequent and painful cramping.Additionally, it was reported essure coils became unpassivated, making it vulnerable to degradation, deterioration, leaching, breakage and fragmentation.Company causality comment: this non-medically confirmed, spontaneous case report was received from a lawyer/attorney and refers to a female plaintiff who had essure (fallopian tube occlusion insert) inserted and both essure devices had fragmented (essure coils degraded/became unpassivated).She was submitted to a bilateral salpingectomy and these fragments were removed.This event is unlisted in essure's reference safety information.In this particular case, the reported device breakage was diagnosed 2 years after essure insertion.Although the exact mechanism of this event is not known; given its nature a causal relationship with the suspect insert cannot be excluded.Non-serious events were also reported.This case was regarded as incident, since device removal was required.A product technical analysis is being sought.Further information will be obtained through the litigation process.

Manufacturer Narrative

Follow-up received on 27-may-2016: quality-safety evaluation: this adverse event report is related to a product technical complaint.The bayer reference number for the ptc report is (b)(4).For cases where a device failure during insertion is reported, we conduct an investigation of any returned device.For cases where an insert is removed at a later time after insertion, we typically do not conduct an inspection of the insert.In this case, no product was returned.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.There was no event reported which indicates a new technical failure mode for the device.A ptc investigation cannot be performed as no batch number or sample provided thus resulting in an unconfirmed quality defect.Company causality comment: this non-medically confirmed, spontaneous case report was received from a lawyer/attorney and refers to a female plaintiff who had essure (fallopian tube occlusion insert) inserted and both essure devices had fragmented (essure coils degraded/became unpassivated).She was submitted to a bilateral salpingectomy and these fragments were removed.This event is listed according to technical assessment.In this particular case, the reported device breakage was diagnosed 2 years after essure insertion.Although the exact mechanism of this event is not known; given its nature a causal relationship with the suspect insert cannot be excluded.Non-serious events were also reported.This case was regarded as incident, since device removal was required.A ptc assessment resulted in an unconfirmed quality defect.Further information will be obtained through the litigation process.

Manufacturer Narrative

Data correction for us reporting: the code knh was replaced with hhs.

Manufacturer Narrative

This spontaneous case was reported by a lawyer and describes the occurrence of device breakage ("both essure devices had fragmented/essure coils degraded/became unpassivated and fragmented in her body") in a 35-year-old female patient who had essure (batch no.893017) inserted for female sterilisation.The occurrence of additional non-serious events is detailed below.The patient's past medical history included gestational diabetes, breast reduction, arthritis, ovarian cystectomy and multigravida.Concurrent conditions included parity 2 since april 2012, nonsmoker, diarrhea, dehydration, fever chills, dizziness, blurry vision, depression, helicobacter pylori infection and foreign body in pharynx.Family history included breast cancer (paternal aunt), diabetes (grandmother) and uterine cancer (mother).On (b)(6) 2012, the patient had essure inserted.On (b)(6) 2013, 8 months 16 days after insertion of essure, the patient experienced pelvic pain ("pain"), dyspareunia ("painful intercourse /dyspareunia (painful sexual intercourse)"), fatigue ("fatigue"), menorrhagia ("heavy menstrual cycles/excessive bleeding during menstrual cycle/abnormal bleeding (vaginal, menorrhagia) (event splitted for coding"), vaginal haemorrhage ("abnormal bleeding (vaginal, menorrhagia) (event splitted for coding)"), depression ("psychological or psychiatric problems condition:depression"), dysmenorrhoea ("dysmenorrhea (cramping)") and alopecia ("hair loss").On (b)(6) 2014, the patient experienced device breakage (seriousness criteria medically significant and intervention required) and procedural pain ("ainful laparoscopic bilateral salpingectomy with removal of essure/painful procedure").On an unknown date, the patient experienced abdominal pain lower ("cramps/painful cramping"), headache ("severe headaches"), dysuria ("painful urination"), mood swings ("mood swings"), nausea ("nausea"), weight increased ("weight gain"), back pain ("back pain") and scar ("procedure left her with permanent scars").The patient was treated with surgery (salpingectomy and essure removal bilaterally hysterectomy (full)on 11-06-2014).Essure was removed on (b)(6) 2014.At the time of the report, the device breakage outcome was unknown and the pelvic pain, abdominal pain lower, headache, dysuria, dyspareunia, mood swings, fatigue, nausea, menorrhagia, weight increased, back pain, procedural pain, scar, vaginal haemorrhage, depression, dysmenorrhoea and alopecia was resolving.The reporter considered abdominal pain lower, alopecia, back pain, depression, device breakage, dysmenorrhoea, dyspareunia, dysuria, fatigue, headache, menorrhagia, mood swings, nausea, pelvic pain, procedural pain, scar, vaginal haemorrhage and weight increased to be related to essure.Diagnostic results (normal ranges are provided in parenthesis if available): computerised tomogram - in july 2013: negative hysterosalpingogram - on (b)(6) 2012: total bilateral occlusion; in august 2012: fully occluded testing for thyroid issues: negative.From (b)(6) 2007 to (b)(6) 2012 patient took unknown drug for unknown indication.Most recent follow-up information incorporated above includes: on (b)(6) 2018: pfs received.Reporters details were added.Patient¿s detail, lab data and unstructured relevant tests were added.Abnormal bleeding (vaginal, menorrhagia), psychological or psychiatric problems condition:depression, dysmenorrhea (cramping), pain and hair loss were added as events.Incident at the time of reporting, there is no evidence that a device-related defect or malfunction caused a death or serious injury.If additional information becomes available it will be provided on a supplemental report.

Manufacturer Narrative

Ntaneous case was reported by a lawyer and describes the occurrence of device breakage ("both essure devices had fragmented/essure coils degraded/became unpassivated and fragmented in her body") in a 35-year-old female patient who had essure (batch no.893017) inserted for female sterilisation.The occurrence of additional non-serious events is detailed below.The patient's past medical history included gestational diabetes, breast reduction, arthritis, ovarian cystectomy and multigravida.Concurrent conditions included parity 2 since (b)(6) 2012, nonsmoker, diarrhea, dehydration, fever chills, dizziness, blurry vision, depression, helicobacter pylori infection and foreign body in pharynx.Family history included breast cancer (paternal aunt), diabetes (grandmother) and uterine cancer (mother).On (b)(6) 2012, the patient had essure inserted.On (b)(6) 2013, 8 months 16 days after insertion of essure, the patient experienced pelvic pain ("pain"), dyspareunia ("painful intercourse /dyspareunia (painful sexual intercourse)"), fatigue ("fatigue"), menorrhagia ("heavy menstrual cycles/excessive bleeding during menstrual cycle/abnormal bleeding (vaginal, menorrhagia) (event splitted for coding"), vaginal haemorrhage ("abnormal bleeding (vaginal, menorrhagia) (event splitted for coding)"), depression ("psychological or psychiatric problems condition:depression"), dysmenorrhoea ("dysmenorrhea (cramping)") and alopecia ("hair loss").On (b)(6) 2014, the patient experienced device breakage (seriousness criteria medically significant and intervention required) and procedural pain ("ainful laparoscopic bilateral salpingectomy with removal of essure/painful procedure").On an unknown date, the patient experienced abdominal pain lower ("cramps/painful cramping"), headache ("severe headaches"), dysuria ("painful urination"), mood swings ("mood swings"), nausea ("nausea"), weight increased ("weight gain"), back pain ("back pain") and scar ("procedure left her with permanent scars").The patient was treated with surgery (salpingectomy and essure removal bilaterally hysterectomy (full)on (b)(6) 2014).Essure was removed on (b)(6) 2014.At the time of the report, the device breakage outcome was unknown and the pelvic pain, abdominal pain lower, headache, dysuria, dyspareunia, mood swings, fatigue, nausea, menorrhagia, weight increased, back pain, procedural pain, scar, vaginal haemorrhage, depression, dysmenorrhoea and alopecia was resolving.The reporter considered abdominal pain lower, alopecia, back pain, depression, device breakage, dysmenorrhoea, dyspareunia, dysuria, fatigue, headache, menorrhagia, mood swings, nausea, pelvic pain, procedural pain, scar, vaginal haemorrhage and weight increased to be related to essure.Diagnostic results (normal ranges are provided in parenthesis if available): computerised tomogram - in (b)(6) 2013: negative.Hysterosalpingogram - on (b)(6) 2012: total bilateral occlusion; in august 2012: fully occluded testing for thyroid issues: negative.From (b)(6) 2007 to (b)(6) 2012 patient took unknown drug for unknown indication.Quality-safety evaluation of ptc: unable to confirm complaint.Most recent follow-up information incorporated above includes: on 27-jul-2018: quality-safety evaluation of ptc update.Incident at the time of reporting, there is no evidence that a device-related defect or malfunction caused a death or serious injury.If additional information becomes available it will be provided on a supplemental report.

Manufacturer Narrative

Spontaneous case was reported by a lawyer and describes the occurrence of device breakage ("both essure devices had fragmented/essure coils degraded/became unpassivated and fragmented in her body") and genital haemorrhage ("abnormal bleeding") in a 35-year-old female patient who had essure (batch no.893017) inserted for female sterilisation.The occurrence of additional non-serious events is detailed below.The patient's past medical history included gestational diabetes, breast reduction, arthritis, ovarian cystectomy and multigravida.Concurrent conditions included parity 2 since (b)(6) 2012, nonsmoker, diarrhea, dehydration, fever chills, dizziness, blurry vision, depression, helicobacter pylori infection and foreign body in pharynx.Family history included breast cancer (paternal aunt), diabetes (grandmother) and uterine cancer (mother).On (b)(6) 2012, the patient had essure inserted.On (b)(6) 2013, 8 months 16 days after insertion of essure, the patient experienced pelvic pain ("pain"), dyspareunia ("painful intercourse /dyspareunia (painful sexual intercourse)"), fatigue ("fatigue"), menorrhagia ("heavy menstrual cycles/excessive bleeding during menstrual cycle/abnormal bleeding (vaginal, menorrhagia) (event splitted for coding"), vaginal haemorrhage ("abnormal bleeding (vaginal, menorrhagia) (event splitted for coding)"), depression ("psychological or psychiatric problems condition:depression"), dysmenorrhoea ("dysmenorrhea (cramping)") and alopecia ("hair loss").On (b)(6) 2014, the patient experienced device breakage (seriousness criteria medically significant and intervention required) and procedural pain ("painful laparoscopic bilateral salpingectomy with removal of essure/painful procedure").On an unknown date, the patient experienced genital haemorrhage (seriousness criterion medically significant), abdominal pain lower ("cramps/painful cramping"), headache ("severe headaches"), dysuria ("painful urination"), mood swings ("mood swings"), nausea ("nausea"), weight increased ("weight gain"), back pain ("back pain"), scar ("procedure left her with permanent scars"), migraine ("migraines"), abdominal distension ("bloating") and infection ("infections").The patient was treated with surgery (salpingectomy and essure removal bilaterally hysterectomy (full)on (b)(6) 2014).Essure was removed on (b)(6) 2014.At the time of the report, the device breakage outcome was unknown, the genital haemorrhage, back pain, migraine, abdominal distension and infection had resolved and the pelvic pain, abdominal pain lower, headache, dysuria, dyspareunia, mood swings, fatigue, nausea, menorrhagia, weight increased, procedural pain, scar, vaginal haemorrhage, depression, dysmenorrhoea and alopecia was resolving.The reporter considered abdominal distension, abdominal pain lower, alopecia, back pain, depression, device breakage, dysmenorrhoea, dyspareunia, dysuria, fatigue, genital haemorrhage, headache, infection, menorrhagia, migraine, mood swings, nausea, pelvic pain, procedural pain, scar, vaginal haemorrhage and weight increased to be related to essure.Diagnostic results (normal ranges are provided in parenthesis if available): computerised tomogram - in (b)(6) 2013: negative.Hysterosalpingogram - on (b)(6) 2012: total bilateral occlusion; in (b)(6) 2012: fully occluded.Testing for thyroid issues: negative.From (b)(6) 2007 to (b)(6) 2012 patient took unknown drug for unknown indication.Quality-safety evaluation of ptc: unable to confirm complaint.Most recent follow-up information incorporated above includes: on 18-oct-2018: pfs received event " migraines, bloating, back aches, infections, abnormal bleeding" were added and outcome of these event were updated as recovered.Incident: at the time of reporting, there is no evidence that a device-related defect or malfunction caused a death or serious injury.If additional information becomes available it will be provided on a supplemental report.

• Brand Name: ESSURE
• Type of Device: TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE
• Manufacturer (Section D): BAYER PHARMA AG; müllerstr. 178; berlin, CA 13353 ; GM 13353
• MDR Report Key: 5580544
• MDR Text Key: 42783350
• Report Number: 2951250-2016-00329
• Device Sequence Number: 1
• Product Code: HHS
• Combination Product (y/n): N
• PMA/PMN Number: P020014
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,health professional
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 10/26/2018

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 Expiration Date: 08/01/2014
• Device Model Number: ESS305
• Device Lot Number: 893017
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/22/2016
• Initial Date FDA Received: 04/15/2016
• Supplement Dates Manufacturer Received: Not provided; Not provided; 02/27/2018; 07/27/2018; 10/18/2018
• Supplement Dates FDA Received: 06/23/2016; 01/23/2017; 04/12/2018; 08/03/2018; 10/26/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 35 YR