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

Model Number ESS305

Device Problems Material Integrity Problem (2978); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Pain (1994)

Event Type  Injury  

Event Description

This spontaneous case was originally reported by a lawyer on behalf of a consumer and describes the occurrence of pelvic pain ("pelvic pain") in a 46 year-old female patient who had essure inserted.Additional non-serious events are detailed below.Product or product use issues identified: device material issue ("mineralogical analysis confirmed release of heavy metals included tin into patient's body").There was no information on the patient's medical history or concurrent conditions.On (b)(6) 2011, the patient had essure inserted.An unknown time later she experienced pelvic pain (seriousness criterion intervention required), heavy menstrual bleeding ("patient experienced hemorrhagic menstruations"), headache ("helmet headaches"), ear, nose and throat disorder ("ent disorders"), musculoskeletal pain ("diffuse joint pain and muscle pain"), hyperhidrosis ("excessive sweating"), memory impairment ("memory disorder") and disturbance in attention ("concentration disorders").The patient was treated with surgery (hysterectomy).Essure was removed on (b)(6) 2017.At the time of the report, the pelvic pain was resolving.The outcomes for heavy menstrual bleeding, headache, ear, nose and throat disorder, musculoskeletal pain, hyperhidrosis, memory impairment and disturbance in attention were unknown.The reporter considered disturbance in attention, ear, nose and throat disorder, headache, heavy menstrual bleeding, hyperhidrosis, memory impairment, musculoskeletal pain and pelvic pain to be related to essure administration.The reporter commented: improvement of patient's state was noticed after removal of essure.Based on the available information, a review of our complaint records and other relevant data will be conducted; any new and reportable information that becomes available from our investigation will be provided in a supplementary report.

Manufacturer Narrative

This spontaneous case was originally reported by a lawyer on behalf of a consumer and describes the occurrence of pelvic pain ("pelvic pain") in a 46 year-old female patient who had essure inserted.Additional non-serious events are detailed below.Product or product use issues identified: device material corroded ("mineralogical analysis confirmed release of heavy metals included tin into patient's body").There was no information on the patient's medical history or concurrent conditions.On (b)(6) 2011, the patient had essure inserted.Essure was removed on (b)(6) 2017.An unknown time later she experienced pelvic pain (seriousness criterion intervention required), heavy menstrual bleeding ("patient experienced hemorrhagic menstruations"), headache ("helmet headaches"), ear, nose and throat disorder ("ent disorders"), musculoskeletal pain ("diffuse joint pain and muscle pain"), hyperhidrosis ("excessive sweating"), memory impairment ("memory disorder") and disturbance in attention ("concentration disorders").The patient was treated with surgery (hysterectomy).At the time of the report, the pelvic pain was resolving.The outcomes for heavy menstrual bleeding, headache, ear, nose and throat disorder, musculoskeletal pain, hyperhidrosis, memory impairment and disturbance in attention were unknown.The reporter considered disturbance in attention, ear, nose and throat disorder, headache, heavy menstrual bleeding, hyperhidrosis, memory impairment, musculoskeletal pain and pelvic pain to be related to essure administration.The reporter commented: improvement of patient's state was noticed after removal of essure.Quality-safety evaluation of ptc: for essure: no defect could be confirmed by the manufacturer.All product batches have met the specifications regarding labeling, material, and process controls at time of release.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 and batch record review could not be conducted, as no sample or batch number were available.The most recent follow-up information incorporated above includes data received on: 27-apr-2023: quality safety evaluation of ptc.27-apr-2023: health authority number was provided.Based on the available information, a review of our complaint records and other relevant data was conducted; any new and reportable information that becomes available from our investigation will be provided in a supplementary report.

Manufacturer Narrative

This spontaneous case was originally reported by a lawyer on behalf of a consumer and describes the occurrence of pelvic pain ("pelvic pain") in a 46 year-old female patient who had essure inserted.Additional non-serious events are detailed below.Product or product use issues identified: device material corroded ("mineralogical analysis confirmed release of heavy metals included tin into patient's body").There was no information on the patient's medical history or concurrent conditions.On (b)(6) 2011, the patient had essure inserted.Essure was removed on (b)(6) 2017.An unknown time later she experienced pelvic pain (seriousness criterion intervention required), heavy menstrual bleeding ("patient experienced hemorrhagic menstruations"), headache ("helmet headaches"), ear, nose and throat disorder ("ent disorders"), musculoskeletal pain ("diffuse joint pain and muscle pain"), hyperhidrosis ("excessive sweating"), memory impairment ("memory disorder") and disturbance in attention ("concentration disorders").The patient was treated with surgery (hysterectomy).At the time of the report, the pelvic pain was resolving.The outcomes for heavy menstrual bleeding, headache, ear, nose and throat disorder, musculoskeletal pain, hyperhidrosis, memory impairment and disturbance in attention were unknown.The reporter considered disturbance in attention, ear, nose and throat disorder, headache, heavy menstrual bleeding, hyperhidrosis, memory impairment, musculoskeletal pain and pelvic pain to be related to essure administration.The reporter commented: improvement of patient's state was noticed after removal of essure.Quality-safety evaluation of ptc: for essure: no defect could be confirmed by the manufacturer.All product batches have met the specifications regarding labeling, material, and process controls at time of release.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 and batch record review could not be conducted, as no sample or batch number were available.The most recent follow-up information incorporated above includes data received on: 28-apr-2023: upon receipt of follow up it was noted that this case is duplicate of (b)(4) so needs to be delete from argus database.All information , source document , references has been transferred to retained case (b)(4).Based on the available information, a review of our complaint records and other relevant data was conducted; any new and reportable information that becomes available from our investigation 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
• Manufacturer (Section G): BAYER PHARMA AG; müllerstr. 178; berlin, 13353 ; GM 13353
• Manufacturer Contact: k shaw lamberson ; 100 bayer blvd, p.o. box 915; whippany, nj
• MDR Report Key: 16793590
• MDR Text Key: 313803203
• Report Number: 2951250-2023-01815
• Device Sequence Number: 1
• Product Code: HHS
• UDI-Device Identifier: 10888853003051
• UDI-Public: (01)10888853003051
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: P020014
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Consumer
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 05/04/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/24/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: ESS305
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/28/2023
• 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): Required Intervention
• Patient Age: 46 YR
• Patient Sex: Female