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

Model Number ESS305

Device Problems Difficult to Remove (1528); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Pain (1994)

Event Date 01/01/2009

Event Type  Injury  

Event Description

This spontaneous case was reported by a lawyer and describes the occurrence of pelvic pain ("pain") in a female patient who had essure inserted.In (b)(6) 2008, the patient had essure inserted.On an unknown date, the patient experienced pelvic pain (seriousness criteria medically significant and intervention required).The patient was treated with surgery (to remove the essure).Essure was removed in 2011.At the time of the report, the pelvic pain outcome was unknown.The reporter considered pelvic pain to be related to essure.Incident.No lot number or sample available for investigation.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 pelvic pain ("pain") in a 27-year-old female patient who had essure (batch no.627097-valid,627087-invalid) inserted for female sterilisation.The occurrence of additional non-serious events is detailed below.Other product or product use issues identified: device monitoring procedure not performed "essure confirmation test(s) conducted no".The patient's previously administered products included for an unreported indication: depo provera.Concomitant products included drospirenone w/ethinylestradiol (yasmin).On (b)(6) 2008, the patient had essure inserted.On (b)(6) 2008,24 days after insertion of essure, the patient experienced migraine ("migraine") and headache ("headache").In (b)(6) 2008,the patient experienced vaginal discharge ("vaginal discharge have a thicker and heavy milk discharge since having this essure implanted with different smell").In (b)(6) 2008, the patient experienced alopecia ("hair loss").In 2009, the patient experienced pelvic pain (seriousness criteria medically significant and intervention required) and abdominal pain upper ("upper abdominal pain").On an unknown date, the patient experienced weight increased ("weight gain/she gained weight since having this procedure.She had always worked out but cant drop the weight and more sollen around her pelvis area after having kids"), abdominal pain ("abdominal pain"), scar ("reversal did not work and that i have a lot of scar tissue") and complication of device removal ("essure coiled around my tubes in an odd way, couldn¿t take out all of the essure").The patient was treated with surgery (surgical removal of coil).Essure was removed on 11-may-2012.At the time of the report, the pelvic pain, alopecia, migraine, headache, vaginal discharge, weight increased, abdominal pain upper and abdominal pain had not resolved and the scar and complication of device removal outcome was unknown.The reporter considered abdominal pain, abdominal pain upper, alopecia, complication of device removal, headache, migraine, pelvic pain, scar, vaginal discharge and weight increased to be related to essure.Diagnostic results (normal ranges are provided in parenthesis if available): body mass index was 25.7 kg/sqm.Quality-safety evaluation of ptc: unable to confirm complaint.Most recent follow-up information incorporated above includes: on (b)(6) 2008: update of information (batch is invalid).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

This spontaneous case was reported by a lawyer and describes the occurrence of pelvic pain ("pain") in a 27-year-old female patient who had essure (batch no: 627097) inserted for female sterilisation.The occurrence of additional non-serious events is detailed below.Other product or product use issues identified: device monitoring procedure not performed "essure confirmation test(s) conducted- no".On (b)(6) 2008, the patient had essure inserted.On (b)(6) 2008, the patient experienced migraine ("migraine") and headache ("headache").On (b)(6) 2008, the patient experienced vaginal discharge ("vaginal discharge").On (b)(6) 2008, the patient experienced alopecia ("hair loss").In 2009, the patient experienced pelvic pain (seriousness criteria medically significant and intervention required) and abdominal pain upper ("upper abdominal pain").On an unknown date, the patient experienced weight increased ("weight gain").The patient was treated with surgery (surgical removal of coil).Essure was removed on (b)(6) 2012.At the time of the report, the pelvic pain, alopecia, migraine, headache, vaginal discharge, weight increased and abdominal pain upper outcome was unknown.The reporter considered abdominal pain upper, alopecia, headache, migraine, pelvic pain, vaginal discharge and weight increased to be related to essure.Diagnostic results (normal ranges are provided in parenthesis if available): body mass index was 25.7 kg/sqm.Most recent follow-up information incorporated above includes: on 13-jun-2018: pfs received, reporter added, demographic added, product information updated, lot number received.Events added are as follows- alopecia, migraine, headache, vaginal discharge, weight increased, abdominal pain lower.Events onset date added.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 pelvic pain ("pain") in a 27-year-old female patient who had essure (batch no.627097) inserted for female sterilisation.The occurrence of additional non-serious events is detailed below.Other product or product use issues identified: device monitoring procedure not performed "essure confirmation test(s) conducted- no".On (b)(6) 2008, the patient had essure inserted.On (b)(6) 2008, 24 days after insertion of essure, the patient experienced migraine ("migraine") and headache ("headache").In (b)(6) 2008, the patient experienced vaginal discharge ("vaginal discharge have a thicker and heavy milk discharge since having this essure implanted with different smell").In (b)(6) 2008, the patient experienced alopecia ("hair loss").In 2009, the patient experienced pelvic pain (seriousness criteria medically significant and intervention required) and abdominal pain upper ("upper abdominal pain").On an unknown date, the patient experienced weight increased ("weight gain/she gained weight since having this procedure.She had always worked out but cant drop the weight and more sollen around her pelvis area after having kids"), abdominal pain ("abdominal pain"), scar ("reversal did not work and that i have a lot of scar tissue") and complication of device removal ("essure coiled around my tubes in an odd way, couldn¿t take out all of the essure").The patient was treated with surgery (surgical removal of coil).Essure was removed on (b)(6) 2012.At the time of the report, the pelvic pain, alopecia, migraine, headache, vaginal discharge, weight increased, abdominal pain upper and abdominal pain had not resolved and the scar and complication of device removal outcome was unknown.The reporter considered abdominal pain, abdominal pain upper, alopecia, complication of device removal, headache, migraine, pelvic pain, scar, vaginal discharge and weight increased to be related to essure.Diagnostic results (normal ranges are provided in parenthesis if available): body mass index was 25.7 kg/sqm.Quality-safety evaluation of ptc: unable to confirm complaint.Most recent follow-up information incorporated above includes: on 14-aug-2018: quality safety evaluation of ptc (product technical complaint ).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 pelvic pain ("pain") in a 27-year-old female patient who had essure (batch no.627097,627087) inserted for female sterilisation.The occurrence of additional non-serious events is detailed below.Other product or product use issues identified: device monitoring procedure not performed "essure confirmation test(s) conducted- no".The patient's previously administered products included for an unreported indication: depo provera.Concomitant products included drospirenone w/ethinylestradiol (yasmin).On (b)(6) 2008, the patient had essure inserted.On (b)(6) 2008, 24 days after insertion of essure, the patient experienced migraine ("migraine") and headache ("headache").In (b)(6) 2008, the patient experienced vaginal discharge ("vaginal discharge have a thicker and heavy milk discharge since having this essure implanted with different smell").In (b)(6) 2008, the patient experienced alopecia ("hair loss").In 2009, the patient experienced pelvic pain (seriousness criteria medically significant and intervention required) and abdominal pain upper ("upper abdominal pain").On an unknown date, the patient experienced weight increased ("weight gain/she gained weight since having this procedure.She had always worked out but cant drop the weight and more sollen around her pelvis area after having kids"), abdominal pain ("abdominal pain"), scar ("reversal did not work and that i have a lot of scar tissue") and complication of device removal ("essure coiled around my tubes in an odd way, couldn¿t take out all of the essure").The patient was treated with surgery (surgical removal of coil).Essure was removed on (b)(6) 2012.At the time of the report, the pelvic pain, alopecia, migraine, headache, vaginal discharge, weight increased, abdominal pain upper and abdominal pain had not resolved and the scar and complication of device removal outcome was unknown.The reporter considered abdominal pain, abdominal pain upper, alopecia, complication of device removal, headache, migraine, pelvic pain, scar, vaginal discharge and weight increased to be related to essure.Diagnostic results (normal ranges are provided in parenthesis if available): body mass index was 25.7 kg/sqm.Quality-safety evaluation of ptc: unable to confirm complaint.Most recent follow-up information incorporated above includes: on 25-oct-2018: plaintiff fact sheet received lot number added.Product, patient & reporter information updated.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

This spontaneous case was reported by a lawyer and describes the occurrence of pelvic pain ('pain') in a 27-year-old female patient who had essure (batch no.627097-valid,627087-inv) inserted for female sterilisation.The occurrence of additional non-serious events is detailed below.Other product or product use issues identified: device monitoring procedure not performed "essure confirmation test(s) conducted- no".The patient's previously administered products included for an unreported indication: depo provera.Concurrent conditions included grand multiparity, seizures and ethmoidal sinusitis.Concomitant products included drospirenone;ethinylestradiol (yasmin).On (b)(6) 2008, the patient had essure inserted.On (b)(6) 2008, the patient experienced migraine ("migraine") and headache ("headache"), 24 days after insertion of essure.In (b)(6) 2008, the patient experienced vaginal discharge ("vaginal discharge have a thicker and heavy milk discharge since having this essure implanted with different smell").In (b)(6) 2008, the patient experienced alopecia ("hair loss").In 2009, the patient experienced pelvic pain (seriousness criteria medically significant and intervention required) and abdominal pain upper ("upper abdominal pain").On an unknown date, the patient was found to have weight increased ("weight gain/she gained weight since having this procedure.She had always worked out but cant drop the weight and more sollen around her pelvis area after having kids") and experienced abdominal pain ("abdominal pain"), scar ("reversal did not work and that i have a lot of scar tissue") and complication of device removal ("essure coiled around my tubes in an odd way, couldn¿t take out all of the essure").The patient was treated with surgery (surgical removal of coil).Essure was removed on (b)(6) 2012.At the time of the report, the pelvic pain, alopecia, migraine, headache, vaginal discharge, weight increased, abdominal pain upper and abdominal pain had not resolved and the scar and complication of device removal outcome was unknown.The reporter considered abdominal pain, abdominal pain upper, alopecia, complication of device removal, headache, migraine, pelvic pain, scar, vaginal discharge and weight increased to be related to essure.Diagnostic results (normal ranges are provided in parenthesis if available): body mass index was 25.7 kg/sqm.Quality-safety evaluation of ptc: unable to confirm complaint.Most recent follow-up information incorporated above includes: on 21-apr-2021: real fu was received and there was no significant change in the medical context of case.No new information added.We received a lot number in this case.A technical investigation will be conducted, including a batch review, and a review of complaint records and other relevant data; should any new and reportable information become available from our investigation, this will be provided in a supplementary report.

Manufacturer Narrative

This spontaneous case was reported by a lawyer and describes the occurrence of pelvic pain ('pain') in a 27-year-old female patient who had essure (batch no.627087-inv, 627097) inserted for female sterilisation.The occurrence of additional non-serious events is detailed below.Other product or product use issues identified: device monitoring procedure not performed "essure confirmation test(s) conducted- no".The patient's previously administered products included for an unreported indication: depo provera.Concurrent conditions included grand multiparity, seizures and ethmoidal sinusitis.Concomitant products included drospirenone;ethinylestradiol (yasmin).On (b)(6) 2008, the patient had essure inserted.On (b)(6) 2008, the patient experienced migraine ("migraine") and headache ("headache"), 24 days after insertion of essure.In (b)(6)2008, the patient experienced vaginal discharge ("vaginal discharge have a thicker and heavy milk discharge since having this essure implanted with different smell").In (b)(6) 2008, the patient experienced alopecia ("hair loss").In 2009, the patient experienced pelvic pain (seriousness criteria medically significant and intervention required) and abdominal pain upper ("upper abdominal pain").On an unknown date, the patient was found to have weight increased ("weight gain/she gained weight since having this procedure.She had always worked out but cant drop the weight and more sollen around her pelvis area after having kids") and experienced abdominal pain ("abdominal pain"), scar ("reversal did not work and that i have a lot of scar tissue") and complication of device removal ("essure coiled around my tubes in an odd way, couldn¿t take out all of the essure").The patient was treated with surgery (surgical removal of coil).Essure was removed on 11-(b)(6) 2012.At the time of the report, the pelvic pain, alopecia, migraine, headache, vaginal discharge, weight increased, abdominal pain upper and abdominal pain had not resolved and the scar and complication of device removal outcome was unknown.The reporter considered abdominal pain, abdominal pain upper, alopecia, complication of device removal, headache, migraine, pelvic pain, scar, vaginal discharge and weight increased to be related to essure.Diagnostic results (normal ranges are provided in parenthesis if available): body mass index was 25.7 kg/sqm.Lot number: 627097 manufacturing date: 2008-04, expiration date: 2010-04.Lot#627087 is invalid.Quality-safety evaluation of ptc: no defect could be confirmed by the manufacturer.All component batches used for manufacturing of this product batch fulfilled the set specifications.Batch documentation did not reveal any deviations during the manufacturing process that could have caused the described complaint reason.Trend analyses of complaints are reviewed regularly, no signal was observed with regard to the reported complaint reason.The risk management file was reviewed and an update was not deemed required.A technical investigation of the complaint sample could not be conducted, as no sample was available.Most recent follow-up information incorporated above includes: on 3-may-2021: quality safety evaluation of ptc we received a lot number in this case.A technical investigation was conducted, including a batch review, and a review of complaint records and other relevant data; should any new and reportable information become available from our investigation, this will be provided in a supplementary report.

• Brand Name: ESSURE
• Type of Device: TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE
• Manufacturer (Section D): BAYER PHARMA AG; müllerstr. 178; berlin, 13353 ; GM 13353
• MDR Report Key: 7084439
• MDR Text Key: 93774062
• Report Number: 2951250-2017-09961
• 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,other
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 05/07/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/05/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/01/2010
• Device Model Number: ESS305
• Device Lot Number: 627087-INV, 627097
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/03/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: YASMIN; YASMIN; YASMIN; YASMIN
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 27 YR
• Patient Weight: 68