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

Model Number ESS205

Device Problems Difficult to Remove (1528); Biocompatibility (2886); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Abdominal Pain (1685); Fatigue (1849); Itching Sensation (1943); Pain (1994); Cramp(s) (2193); Weight Changes (2607); Heavier Menses (2666)

Event Type  Injury  

Event Description

This spontaneous case was reported by a lawyer and describes the occurrence of pelvic pain ("chronic pelvic pain") in a female patient who had essure (ess205) inserted for female sterilization.The occurrence of additional non-serious events is detailed below.On (b)(6) 2006, the patient had essure (ess205) inserted.On an unknown date, the patient experienced pelvic pain (seriousness criteria medically significant and intervention required), menorrhagia ("excessive and abnormal bleeding during menstruation/clotting"), back pain ("back pain"), abdominal pain lower ("severe cramping/abdominal pain"), fatigue ("fatigue"), migraine ("migraines"), weight fluctuation ("weight fluctuations") and pruritus ("itching").The patient was treated with surgery (surgically removed).Essure (ess205) was removed on (b)(6) 2017.At the time of the report, the pelvic pain, menorrhagia, back pain, abdominal pain lower, fatigue, migraine, weight fluctuation and pruritus outcome was unknown.The reporter considered abdominal pain lower, back pain, fatigue, menorrhagia, migraine, pelvic pain, pruritus and weight fluctuation to be related to essure (ess205).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

This spontaneous case was reported by a lawyer and describes the occurrence of pelvic pain ('chronic pelvic pain') in an adult female patient who had essure (ess205) (batch no.508297) inserted for female sterilization.The occurrence of additional non-serious events is detailed below.The patient's medical history included cervix inflammation, adenomyosis, endometriosis, vaginal laceration and cervical dysplasia.Concurrent conditions included body mass index normal and unspecified disorder of knee joint.Concomitant products included oral contraceptive nos.On (b)(6) 2006, the patient had essure (ess205) inserted.On an unknown date, the patient experienced pelvic pain (seriousness criteria medically significant and intervention required), heavy menstrual bleeding ("excessive and abnormal bleeding during menstruation/clotting"), back pain ("back pain"), abdominal pain lower ("severe cramping/ abdominal pain"), abdominal pain ("abdominal pain"), fatigue ("fatigue"), migraine ("migraines"), weight fluctuation ("weight fluctuations"), pruritus ("itching"), anxiety ("hormonal changes: anxiety"), vaginal haemorrhage ("abnormal bleeding (vaginal)"), allergy to metals ("allergic or hypersensitivity/ nickel allergy"), headache ("headaches"), dysmenorrhoea ("dysmenorrhea (cramping)"), dyspareunia ("dyspareunia"), vaginal discharge ("vaginal discharge"), proctalgia ("rectal pain"), alopecia ("hair loss"), arthralgia ("joint pain"), inflammation ("inflammation"), eye disorder ("vision/ eye problems"), rash ("rashes or skin conditions") and complication of device removal ("surgery: repair due to complications from removal") and was found to have weight increased ("weight gain").The patient was treated with surgery (surgically removed, hysterectomy (full)/tlh).Essure (ess205) was removed on (b)(6) 2017.At the time of the report, the pelvic pain, back pain, abdominal pain, fatigue, migraine, weight fluctuation, pruritus, anxiety, vaginal haemorrhage, allergy to metals, headache, dysmenorrhoea, dyspareunia, vaginal discharge, proctalgia, alopecia, weight increased, arthralgia, inflammation, eye disorder, rash and complication of device removal outcome was unknown and the heavy menstrual bleeding and abdominal pain lower had not resolved.The reporter considered abdominal pain, abdominal pain lower, allergy to metals, alopecia, anxiety, arthralgia, back pain, complication of device removal, dysmenorrhoea, dyspareunia, eye disorder, fatigue, headache, heavy menstrual bleeding, inflammation, migraine, pelvic pain, proctalgia, pruritus, rash, vaginal discharge, vaginal haemorrhage, weight fluctuation and weight increased to be related to essure (ess205).The reporter commented: essure device was inserted without difficulty and again 2-3 coils were noted in the uterine cavity patient tolerated the procedure well 2-3 coils in uterine cavity on both sides.Diagnostic results (normal ranges are provided in parenthesis if available): body mass index was 23.3 kg/sqm.Hysterosalpingogram - on (b)(6) 2006: results: total bilateral occlusion.Concerning the injuries reported in this case, the following ones were confirmed in patient¿s media records: pelvic pain.Quality-safety evaluation of ptc: unable to confirm complaint.Most recent follow-up information incorporated above includes: on 04-may-2021: mr received.Reporter information, other relevant history added and rcc was updated.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 ("chronic pelvic pain") in an adult female patient who had essure (ess205) (batch no.508297) inserted for female sterilization.The occurrence of additional non-serious events is detailed below.The patient's concurrent conditions included body mass index normal and unspecified disorder of knee joint.Concomitant products included oral contraceptive nos.On (b)(6) 2006, the patient had essure (ess205) inserted.On an unknown date, the patient experienced pelvic pain (seriousness criteria medically significant and intervention required), menorrhagia ("excessive and abnormal bleeding during menstruation/clotting"), back pain ("back pain"), abdominal pain lower ("severe cramping/abdominal pain"), fatigue ("fatigue"), migraine ("migraines"), weight fluctuation ("weight fluctuations"), pruritus ("itching"), anxiety ("hormonal changes: anxiety"), vaginal haemorrhage ("abnormal bleeding (vaginal)"), allergy to metals ("allergic or hypersensitivity/nickel allergy"), headache ("headaches"), dysmenorrhoea ("dysmenorrhea (cramping)"), dyspareunia ("dyspareunia"), vaginal discharge ("vaginal discharge"), proctalgia ("rectal pain"), alopecia ("hair loss"), weight increased ("weight gain"), arthralgia ("joint pain"), inflammation ("inflammation"), abdominal pain ("abdominal pain"), eye disorder ("vision/eye problems"), rash ("rashes or skin conditions") and complication of device removal ("surgery: repair due to complications from removal").The patient was treated with surgery (surgically removed,hysterectomy (full)).Essure (ess205) was removed on (b)(6) 2017.At the time of the report, the pelvic pain, back pain, fatigue, migraine, weight fluctuation, pruritus, anxiety, vaginal haemorrhage, allergy to metals, headache, dysmenorrhoea, dyspareunia, vaginal discharge, proctalgia, alopecia, arthralgia, inflammation, abdominal pain, eye disorder, rash and complication of device removal outcome was unknown and the menorrhagia and abdominal pain lower had not resolved.The reporter considered abdominal pain, abdominal pain lower, allergy to metals, alopecia, anxiety, arthralgia, back pain, complication of device removal, dysmenorrhoea, dyspareunia, eye disorder, fatigue, headache, inflammation, menorrhagia, migraine, pelvic pain, proctalgia, pruritus, rash, vaginal discharge, vaginal haemorrhage, weight fluctuation and weight increased to be related to essure (ess205).The reporter commented: essure device was inserted without difficulty and again 2-3 coils were noted in the uterine cavity patient tolerated the procedure well.Diagnostic results (normal ranges are provided in parenthesis if available): body mass index was 23.3 kg/sqm.Hysterosalpingogram - on (b)(6) 2006: total bilateral occlusion.Most recent follow-up information incorporated above includes: on (b)(6) 2018: fu from pfs: new events: anxiety, vaginal haemorrhage, allergy to metals, headache, dysmenorrhoea, dyspareunia, vaginal discharge, proctalgia, alopecia, weight increased, arthralgia, inflammation, abdominal pain, eye disorder, complication of device removal were added.Reporter, patient demographic information updated.Product start date, batch number updated.Previously reported event "abdominal pain" outcome updated.On (b)(6) 2018: reporter added0 on (b)(6) 2018: no new clinical information.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 ("chronic pelvic pain") in an adult female patient who had essure (ess205) (batch no.508297) inserted for female sterilization.The occurrence of additional non-serious events is detailed below.The patient's concurrent conditions included body mass index normal and unspecified disorder of knee joint.Concomitant products included oral contraceptive nos.On (b)(6) 2006, the patient had essure (ess205) inserted.On an unknown date, the patient experienced pelvic pain (seriousness criteria medically significant and intervention required), menorrhagia ("excessive and abnormal bleeding during menstruation/clotting"), back pain ("back pain"), abdominal pain lower ("severe cramping/abdominal pain"), abdominal pain ("abdominal pain"), fatigue ("fatigue"), migraine ("migraines"), weight fluctuation ("weight fluctuations"), pruritus ("itching"), anxiety ("hormonal changes: anxiety"), vaginal haemorrhage ("abnormal bleeding (vaginal)"), allergy to metals ("allergic or hypersensitivity/nickel allergy"), headache ("headaches"), dysmenorrhoea ("dysmenorrhea (cramping)"), dyspareunia ("dyspareunia"), vaginal discharge ("vaginal discharge"), proctalgia ("rectal pain"), alopecia ("hair loss"), weight increased ("weight gain"), arthralgia ("joint pain"), inflammation ("inflammation"), eye disorder ("vision/eye problems"), rash ("rashes or skin conditions") and complication of device removal ("surgery: repair due to complications from removal").The patient was treated with surgery (surgically removed,hysterectomy (full)).Essure (ess205) was removed on (b)(6) 2017.At the time of the report, the pelvic pain, back pain, abdominal pain, fatigue, migraine, weight fluctuation, pruritus, anxiety, vaginal haemorrhage, allergy to metals, headache, dysmenorrhoea, dyspareunia, vaginal discharge, proctalgia, alopecia, weight increased, arthralgia, inflammation, eye disorder, rash and complication of device removal outcome was unknown and the menorrhagia and abdominal pain lower had not resolved.The reporter considered abdominal pain, abdominal pain lower, allergy to metals, alopecia, anxiety, arthralgia, back pain, complication of device removal, dysmenorrhoea, dyspareunia, eye disorder, fatigue, headache, inflammation, menorrhagia, migraine, pelvic pain, proctalgia, pruritus, rash, vaginal discharge, vaginal haemorrhage, weight fluctuation and weight increased to be related to essure (ess205).The reporter commented: essure device was inserted without difficulty and again 2-3 coils were noted in the uterine cavity patient tolerated the procedure well diagnostic results (normal ranges are provided in parenthesis if available): body mass index was 23.3 kg/sqm.Hysterosalpingogram - on (b)(6) 2006: total bilateral occlusion.Quality-safety evaluation of ptc: unable to confirm complaint.Most recent follow-up information incorporated above includes: on 24-jul-2018: received quality safety evaluation of 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

This spontaneous case was reported by a lawyer and describes the occurrence of pelvic pain ('chronic pelvic pain') in an adult female patient who had essure (ess205) (batch no.508297) inserted for female sterilization.The occurrence of additional non-serious events is detailed below.The patient's medical history included cervix inflammation, adenomyosis, endometriosis, vaginal laceration and cervical dysplasia.Concurrent conditions included body mass index normal and unspecified disorder of knee joint.Concomitant products included oral contraceptive nos.On (b)(6) 2006, the patient had essure (ess205) inserted.On an unknown date, the patient experienced pelvic pain (seriousness criteria medically significant and intervention required), heavy menstrual bleeding ("excessive and abnormal bleeding during menstruation/clotting"), back pain ("back pain"), abdominal pain lower ("severe cramping/abdominal pain"), abdominal pain ("abdominal pain"), fatigue ("fatigue"), migraine ("migraines"), weight fluctuation ("weight fluctuations"), pruritus ("itching"), anxiety ("hormonal changes: anxiety"), vaginal haemorrhage ("abnormal bleeding (vaginal)"), allergy to metals ("allergic or hypersensitivity/nickel allergy"), headache ("headaches"), dysmenorrhoea ("dysmenorrhea (cramping)"), dyspareunia ("dyspareunia"), vaginal discharge ("vaginal discharge"), proctalgia ("rectal pain"), alopecia ("hair loss"), arthralgia ("joint pain"), inflammation ("inflammation"), eye disorder ("vision/eye problems"), rash ("rashes or skin conditions") and complication of device removal ("surgery: repair due to complications from removal") and was found to have weight increased ("weight gain").The patient was treated with surgery (surgically removed,hysterectomy (full)/tlh).Essure (ess205) was removed on (b)(6) 2017.At the time of the report, the pelvic pain, back pain, abdominal pain, fatigue, migraine, weight fluctuation, pruritus, anxiety, vaginal haemorrhage, allergy to metals, headache, dysmenorrhoea, dyspareunia, vaginal discharge, proctalgia, alopecia, weight increased, arthralgia, inflammation, eye disorder, rash and complication of device removal outcome was unknown and the heavy menstrual bleeding and abdominal pain lower had not resolved.The reporter considered abdominal pain, abdominal pain lower, allergy to metals, alopecia, anxiety, arthralgia, back pain, complication of device removal, dysmenorrhoea, dyspareunia, eye disorder, fatigue, headache, heavy menstrual bleeding, inflammation, migraine, pelvic pain, proctalgia, pruritus, rash, vaginal discharge, vaginal haemorrhage, weight fluctuation and weight increased to be related to essure (ess205).The reporter commented: essure device was inserted without difficulty and again 2-3 coils were noted in the uterine cavity patient tolerated the procedure well 2-3 coils in uterine cavity on both sides.Diagnostic results (normal ranges are provided in parenthesis if available): body mass index was 23.3 kg/sqm.Hysterosalpingogram - on (b)(6) 2006: results: total bilateral occlusion.Concerning the injuries reported in this case, the following ones were confirmed in patient¿s media records: pelvic pain.Quality-safety evaluation of ptc: unable to confirm complaint.Most recent follow-up information incorporated above includes: on 4-may-2021: mr received.Reporter information , other relevant history added and rcc was updated.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 ('chronic pelvic pain') in an adult female patient who had essure (ess205) (batch no.508297) inserted for female sterilization.The occurrence of additional non-serious events is detailed below.The patient's medical history included cervix inflammation, adenomyosis, endometriosis, vaginal laceration and cervical dysplasia.Concurrent conditions included body mass index normal and unspecified disorder of knee joint.Concomitant products included oral contraceptive nos.On (b)(6) 2006, the patient had essure (ess205) inserted.On an unknown date, the patient experienced pelvic pain (seriousness criteria medically significant and intervention required), heavy menstrual bleeding ("excessive and abnormal bleeding during menstruation/clotting"), back pain ("back pain"), abdominal pain lower ("severe cramping/abdominal pain"), abdominal pain ("abdominal pain"), fatigue ("fatigue"), migraine ("migraines"), weight fluctuation ("weight fluctuations"), pruritus ("itching"), anxiety ("hormonal changes: anxiety"), vaginal haemorrhage ("abnormal bleeding (vaginal)"), allergy to metals ("allergic or hypersensitivity/nickel allergy"), headache ("headaches"), dysmenorrhoea ("dysmenorrhea (cramping)"), dyspareunia ("dyspareunia"), vaginal discharge ("vaginal discharge"), proctalgia ("rectal pain"), alopecia ("hair loss"), arthralgia ("joint pain"), inflammation ("inflammation"), eye disorder ("vision/eye problems"), rash ("rashes or skin conditions") and complication of device removal ("surgery: repair due to complications from removal") and was found to have weight increased ("weight gain").The patient was treated with surgery (surgically removed,hysterectomy (full)/tlh).Essure (ess205) was removed on (b)(6) 2017.At the time of the report, the pelvic pain, back pain, abdominal pain, fatigue, migraine, weight fluctuation, pruritus, anxiety, vaginal haemorrhage, allergy to metals, headache, dysmenorrhoea, dyspareunia, vaginal discharge, proctalgia, alopecia, weight increased, arthralgia, inflammation, eye disorder, rash and complication of device removal outcome was unknown and the heavy menstrual bleeding and abdominal pain lower had not resolved.The reporter considered abdominal pain, abdominal pain lower, allergy to metals, alopecia, anxiety, arthralgia, back pain, complication of device removal, dysmenorrhoea, dyspareunia, eye disorder, fatigue, headache, heavy menstrual bleeding, inflammation, migraine, pelvic pain, proctalgia, pruritus, rash, vaginal discharge, vaginal haemorrhage, weight fluctuation and weight increased to be related to essure (ess205).The reporter commented: essure device was inserted without difficulty and again 2-3 coils were noted in the uterine cavity patient tolerated the procedure well 2-3 coils in uterine cavity on both sides.Diagnostic results (normal ranges are provided in parenthesis if available): body mass index was 23.3 kg/sqm.Hysterosalpingogram - on (b)(6) 2006: results: total bilateral occlusion.Concerning the injuries reported in this case, the following ones were confirmed in patient¿s media records: pelvic pain.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 26-nov-2021: quality safety evaluation of product technical complaint.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
• 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, NJ 07981
• MDR Report Key: 6731596
• MDR Text Key: 80681656
• Report Number: 2951250-2017-02619
• 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: Other,Consumer
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 11/26/2021

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?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/01/2007
• Device Model Number: ESS205
• Device Lot Number: 508297
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/13/2017
• Initial Date FDA Received: 07/21/2017
• Supplement Dates Manufacturer Received: 02/27/2018; 07/24/2018; 05/04/2021; 08/11/2021; 11/26/2021
• Supplement Dates FDA Received: 03/29/2018; 08/01/2018; 05/18/2021; 08/11/2021; 11/26/2021
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 08/01/2005
• 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
• Treatment: ORAL CONTRACEPTIVE NOS; ORAL CONTRACEPTIVE NOS; ORAL CONTRACEPTIVE NOS; ORAL CONTRACEPTIVE NOS; ORAL CONTRACEPTIVE NOS
• Patient Outcome(s): Required Intervention; Other
• Patient Sex: Female
• Patient Weight: 63 KG