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

Model Number ESS305

Device Problems Break (1069); Material Integrity Problem (2978); Insufficient Information (3190)

Patient Problems Pain (1994); Foreign Body In Patient (2687); Device Embedded In Tissue or Plaque (3165)

Event Type  Injury  

Event Description

This spontaneous case was reported by a lawyer and describes the occurrence of device breakage ('essure fragmented inside uterus') in a female patient who had essure inserted for contraception.The occurrence of additional non-serious events is detailed below.The patient's concurrent conditions included diabetes.In 2012, the patient had essure inserted.On an unknown date, the patient experienced device breakage (seriousness criteria medically significant and intervention required), abdominal pain lower ("strong cramps lower abdomen"), breast pain ("mastalgia"), abdominal distension ("distension nos"), oedema ("edema"), menometrorrhagia ("heavier and longer menstrual periods"), menorrhagia ("heavy menstrual bleeding with clots"), headache ("headache"), pain ("generalized pain"), oedema peripheral ("legs edema"), paraesthesia ("intense tingling"), tremor ("tremors"), back pain ("lumbar pain"), pelvic pain ("pelvic pain"), uterine pain ("uterus perforation sensation with stabbing sensation"), fatigue ("fatigue"), loss of libido ("lack of libido"), dyspareunia ("pain during sex"), coital bleeding ("bleed after sex"), uterine inflammation ("uterine inflammation"), arthralgia ("joint pain"), mood swings ("mood swings"), alopecia ("hair loss"), adenomyosis ("suspect adenomyosis"), intra-abdominal fluid collection ("abdominal fluid"), vaginal discharge ("bad smell from vaginal discharge"), urinary tract infection ("recurrent urinary tract infections") and mental disorder ("psychologic impact").The patient was treated with surgery (essure removal).The reporter considered abdominal distension, abdominal pain lower, adenomyosis, alopecia, arthralgia, back pain, breast pain, coital bleeding, device breakage, dyspareunia, fatigue, headache, intra-abdominal fluid collection, loss of libido, menometrorrhagia, menorrhagia, mental disorder, mood swings, oedema, oedema peripheral, pain, paraesthesia, pelvic pain, tremor, urinary tract infection, uterine inflammation, uterine pain and vaginal discharge to be related to 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 reported by a lawyer and describes the occurrence of device breakage ('essure fragmented inside uterus') in a female patient who had essure inserted for contraception.The occurrence of additional non-serious events is detailed below.The patient's concurrent conditions included diabetes.In 2012, the patient had essure inserted.On an unknown date, the patient experienced device breakage (seriousness criteria medically significant and intervention required), abdominal pain lower ("strong cramps lower abdomen"), breast pain ("mastalgia"), abdominal distension ("distension nos"), oedema ("edema"), prolonged heavy periods ("heavier and longer menstrual periods"), bleeding menstrual heavy ("heavy menstrual bleeding with clots"), headache ("headache"), pain ("generalized pain"), oedema peripheral ("legs edema"), paraesthesia ("intense tingling"), tremor ("tremors"), back pain ("lumbar pain"), pelvic pain ("pelvic pain"), uterine pain ("uterus perforation sensation with stabbing sensation"), fatigue ("fatigue"), loss of libido ("lack of libido"), dyspareunia ("pain during sex"), coital bleeding ("bleed after sex"), uterine inflammation ("uterine inflammation"), arthralgia ("joint pain"), mood swings ("mood swings"), alopecia ("hair loss"), adenomyosis ("suspect adenomyosis"), intra-abdominal fluid collection ("abdominal fluid"), vaginal discharge ("bad smell from vaginal discharge"), urinary tract infection ("recurrent urinary tract infections") and mental disorder ("psychologic impact").The patient was treated with surgery (essure removal).The reporter considered abdominal distension, abdominal pain lower, adenomyosis, alopecia, arthralgia, back pain, breast pain, coital bleeding, device breakage, dyspareunia, fatigue, headache, intra-abdominal fluid collection, loss of libido, mental disorder, mood swings, oedema, oedema peripheral, pain, paraesthesia, pelvic pain, prolonged heavy periods, tremor, urinary tract infection, uterine inflammation, uterine pain, vaginal discharge and bleeding menstrual heavy to be related to essure.Quality-safety evaluation of ptc: unable to confirm complaint.Most recent follow-up information incorporated above includes: on (b)(6) 2020: quality safety evaluation of ptc.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 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 device breakage ("essure fragmented inside uterus") in a 43 year-old female patient who had essure inserted for contraception.Additional non-serious events are detailed below.As concurrent condition the report mentioned diabetes.In 2012, the patient had essure inserted.Essure was removed in (b)(6) 2018.An unknown time later she experienced device breakage (seriousness criterion intervention required), abdominal pain lower ("strong cramps lower abdomen"), breast pain ("mastalgia"), abdominal distension ("distension nos"), oedema ("edema"), prolonged heavy periods ("heavier and longer menstrual periods"), bleeding menstrual heavy ("heavy menstrual bleeding with clots"), headache ("headache"), pain ("generalized pain"), oedema peripheral ("legs edema"), paraesthesia ("intense tingling"), tremor ("tremors"), back pain ("lumbar pain"), pelvic pain ("pelvic pain"), uterine pain ("uterus perforation sensation with stabbing sensation"), fatigue ("fatigue"), loss of libido ("lack of libido"), dyspareunia ("pain during sex"), coital bleeding ("bleed after sex"), uterine inflammation ("uterine inflammation"), arthralgia ("joint pain"), mood swings ("mood swings"), alopecia ("hair loss"), adenomyosis ("suspect adenomyosis"), intra-abdominal fluid collection ("abdominal fluid"), vaginal discharge ("bad smell from vaginal discharge"), urinary tract infection ("recurrent urinary tract infections"), mental disorder ("psychologic impact"), joint pain ("joint pain"), gastrointestinal disorder ("intestinal problems"), migraine ("migraines") and genital haemorrhage ("genital bleeding").The patient was treated with surgery (total hysterectomy).At the time of the report, the outcomes for device breakage, arthralgia, gastrointestinal disorder, migraine and genital haemorrhage were unknown.The reporter considered abdominal distension, abdominal pain lower, adenomyosis, alopecia, arthralgia, joint pain, back pain, breast pain, coital bleeding, device breakage, dyspareunia, fatigue, gastrointestinal disorder, genital haemorrhage, headache, prolonged heavy periods, bleeding menstrual heavy, intra-abdominal fluid collection, loss of libido, mental disorder, migraine, mood swings, oedema, oedema peripheral, pain, paraesthesia, pelvic pain, tremor, urinary tract infection, uterine inflammation, uterine pain and vaginal discharge to be related to essure administration.Quality-safety evaluation of ptc: for essure: unable to confirm complaint.The most recent follow-up information incorporated above includes data received on: 29-sep-2023: event intestinal problem, genital bleeding, joint pain & migraines added.Essure removal surgery details updated.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 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 device breakage ("essure fragmented inside uterus") in a 43 year-old female patient who had essure inserted for contraception.Additional non-serious events are detailed below.As concurrent condition the report mentioned diabetes.In 2012, the patient had essure inserted.Essure was removed in (b)(6) 2018.An unknown time later she experienced device breakage (seriousness criterion intervention required), pelvic pain ("pelvic pain"), dyspareunia ("pain during sex"), uterine pain ("uterus perforation sensation with stabbing sensation"), uterine inflammation ("uterine inflammation"), abdominal pain lower ("strong cramps lower abdomen"), back pain ("lumbar pain"), pain ("generalized pain"), abdominal distension ("distension nos"), heavy menstrual bleeding ("heavier and longer menstrual periods/ heavy periods with clots"), genital haemorrhage ("genital bleeding"), headache ("headache"), adenomyosis ("suspect adenomyosis"), coital bleeding ("bleed after sex"), breast pain ("mastalgia"), oedema peripheral ("legs edema"), oedema ("edema"), paraesthesia ("intense tingling"), tremor ("tremors"), fatigue ("fatigue"), loss of libido ("lack of libido"), arthralgia ("joint pain"), mood swings ("mood swings"), alopecia ("hair loss"), intra-abdominal fluid collection ("abdominal fluid"), vaginal discharge ("bad smell from vaginal discharge"), urinary tract infection ("recurrent urinary tract infections"), mental disorder ("psychologic impact"), joint pain ("joint pain"), gastrointestinal disorder ("intestinal problems") and migraine ("migraines").The patient was treated with surgery (total hysterectomy).At the time of the report, the outcomes for device breakage, genital haemorrhage, arthralgia, gastrointestinal disorder and migraine were unknown.The reporter considered abdominal distension, abdominal pain lower, adenomyosis, alopecia, arthralgia, joint pain, back pain, breast pain, coital bleeding, device breakage, dyspareunia, fatigue, gastrointestinal disorder, genital haemorrhage, headache, heavy menstrual bleeding, intra-abdominal fluid collection, loss of libido, mental disorder, migraine, mood swings, oedema, oedema peripheral, pain, paraesthesia, pelvic pain, tremor, urinary tract infection, uterine inflammation, uterine pain and vaginal discharge to be related to essure administration.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: 16-oct-2023: quality safety evaluation of ptc.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 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: 9982730
• MDR Text Key: 196416609
• Report Number: 2951250-2020-04697
• Device Sequence Number: 1
• Product Code: HHS
• UDI-Device Identifier: 10888853003051
• UDI-Public: (01)10888853003051
• Combination Product (y/n): N
• Reporter Country Code: BR
• 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,Followup
• Report Date: 10/20/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/21/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ESS305
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/16/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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; Other
• Patient Age: 43 YR
• Patient Sex: Female