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

Model Number ESS305

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)

Patient Problem Pain (1994)

Event Date 01/01/2015

Event Type  Injury  

Event Description

The below report was received by health authority ansm (reference number: (b)(4)) on 16-feb-2024.This spontaneous case was originally reported by a consumer and describes the occurrence of back pain ("muscular-skeletal pain, which progresses every month (especially, at the hip and lumbar level)") in a 34 year-old female patient who had essure inserted (lot no.61989) for female sterilisation.Additional non-serious events are detailed below.There was no information on the patient's medical history or concurrent conditions.On (b)(6) 2015, the patient had essure inserted.In 2015 she experienced back pain (seriousness criterion intervention required), arthralgia ("muscular-skeletal pain, which progresses every month (especially, at the hip and lumbar level)"), dysmenorrhoea ("pelvic pain during menstrual periods"), heavy menstrual bleeding ("haemorrhagic menstrual periods for 72 hours per 6-day cycles"), polymenorrhoea ("haemorrhagic menstrual periods for 72 hours per 6-day cycles"), diarrhoea ("diarrhoea, 2 days per cycle"), constipation ("constipation"), ovulation pain ("ovulation pain, 4 days per cycle"), asthenia ("asthaenia (even when taking magnesium) "), insomnia ("insomnia"), menstrual headache ("headaches during menstrual cycles"), acne ("acne on face, back, chest"), dry skin ("dry skin on thighs"), keratosis pilaris ("keratosis pilaris on thighs and calves"), abdominal distension ("bloating during ovulation"), memory impairment ("memory impairment"), alopecia ("hair loss"), hair texture abnormal ("poor quality of hair (brittle and dry)") and trichorrhexis ("poor quality of hair (brittle and dry)") and was found to have weight increased ("weight gain 3 kg").On unknown date she experienced onychoclasis ("poor quality of nails (brittle and dry)").The patient was treated with surgery (hysterectomy with conservation of ovaries).Essure was removed on (b)(6) 2024.No causality assessment was received for essure with regard to back pain, arthralgia, dysmenorrhoea, heavy menstrual bleeding, polymenorrhoea, diarrhoea, constipation, ovulation pain, weight increased, asthenia, insomnia, menstrual headache, acne, dry skin, keratosis pilaris, abdominal distension, memory impairment, alopecia, hair texture abnormal, onychoclasis or trichorrhexis.The reporter commented: patient¿s current status: hysterectomy with conservation of ovaries.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

The below report was received by health authority ansm (reference number: (b)(4)) on (b)(6)2024.The most recent information was received on 28-feb-2024.This spontaneous case was originally reported by a consumer and describes the occurrence of back pain ("muscular-skeletal pain, which progresses every month (especially, at the hip and lumbar level)") in a 34 year-old female patient who had essure inserted (lot no.61989-invalid) for female sterilisation.Additional non-serious events are detailed below.There was no information on the patient's medical history or concurrent conditions.On (b)(6)2015, the patient had essure inserted.In 2015 she experienced back pain (seriousness criterion intervention required), arthralgia ("muscular-skeletal pain, which progresses every month (especially, at the hip and lumbar level)"), dysmenorrhoea ("pelvic pain during menstrual periods"), heavy menstrual bleeding ("haemorrhagic menstrual periods for 72 hours per 6-day cycles"), prolonged periods ("haemorrhagic menstrual periods for 72 hours per 6-day cycles"), diarrhoea ("diarrhoea, 2 days per cycle"), constipation ("constipation"), ovulation pain ("ovulation pain, 4 days per cycle"), asthenia ("asthaenia (even when taking magnesium)"), insomnia ("insomnia"), menstrual headache ("headaches during menstrual cycles"), acne ("acne on face, back, chest"), dry skin ("dry skin on thighs"), keratosis pilaris ("keratosis pilaris on thighs and calves"), abdominal distension ("bloating during ovulation"), memory impairment ("memory impairment"), alopecia ("hair loss"), hair texture abnormal ("poor quality of hair (brittle and dry)") and trichorrhexis ("poor quality of hair (brittle and dry)") and was found to have weight increased ("weight gain 3 kg").Essure was removed on (b)(6)2024.On unknown date she experienced onychoclasis ("poor quality of nails (brittle and dry)").The patient was treated with surgery (hysterectomy with conservation of ovaries).No causality assessment was received for essure with regard to back pain, arthralgia, dysmenorrhoea, heavy menstrual bleeding, prolonged periods, diarrhoea, constipation, ovulation pain, weight increased, asthenia, insomnia, menstrual headache, acne, dry skin, keratosis pilaris, abdominal distension, memory impairment, alopecia, hair texture abnormal, onychoclasis or trichorrhexis.The reporter commented: patient¿s current status: hysterectomy with conservation of ovaries.Lot number: 61989 is invalid.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-feb-2024: quality safety evaluation of ptc.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
• Manufacturer (Section G): BAYER PHARMA AG; müllerstr. 178; berlin, 13353 ; GM 13353
• Manufacturer Contact: janice miller ; 100 bayer blvd.; p.o. box 915; whippany, NJ 07981
• MDR Report Key: 18758100
• MDR Text Key: 335999029
• Report Number: 2951250-2024-00152
• Device Sequence Number: 1
• Product Code: HHS
• 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
• Report Date: 02/29/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/22/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: ESS305
• Device Lot Number: 61989-INVALID
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/28/2024
• 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: 34 YR
• Patient Sex: Female