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

Model Number ESS205

Device Problems Break (1069); Material Integrity Problem (2978); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Pain (1994); Device Embedded In Tissue or Plaque (3165); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/01/2007

Event Type  Injury  

Event Description

This spontaneous case was reported by a lawyer and describes the occurrence of pelvic pain ('pelvic pain') in a female patient who had essure (ess205) inserted for female sterilisation.The occurrence of additional non-serious events is detailed below.The patient's concurrent conditions included hypothyroidism and stress.On (b)(6) 2007, the patient had essure (ess205) inserted.In (b)(6) 2007, the patient experienced pelvic pain (seriousness criteria medically significant and intervention required).In 2010, the patient experienced vaginal haemorrhage ("vaginal bleeding").On an unknown date, the patient experienced menorrhagia ("menorrhagia").The patient was treated with surgery (full hysterectomy and salphingectomy to remove essure).Essure (ess205) was removed on (b)(6) 2012.On (b)(6) 2012, the pelvic pain had resolved.At the time of the report, the vaginal haemorrhage outcome was unknown and the menorrhagia had resolved.The reporter considered menorrhagia, pelvic pain and vaginal haemorrhage to be related to essure (ess205).Quality-safety evaluation of ptc: unable to confirm complaint.Most recent follow-up information incorporated above includes: on 10-apr-2020: pfs received: additional reporter information addedevents added: vaginal bleeding, pelvic pain, menorrhagia.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 pelvic pain ('pelvic pain/ chronic pelvic pain') and device breakage ('x-ray/ mri showed essure (partial coil) on her left side') in a 36-year-old female patient who had essure (ess205) inserted for female sterilisation.The occurrence of additional non-serious events is detailed below.The patient's concurrent conditions included hypothyroidism and post-traumatic stress disorder (complex).On (b)(6) 2007, the patient had essure (ess205) inserted.In (b)(6) 2007, the patient experienced pelvic pain (seriousness criteria medically significant and intervention required).In (b)(6) 2010, the patient experienced menorrhagia ("menorrhagia"), uterine haemorrhage ("uterine bleeding") and vaginal haemorrhage ("vaginal bleeding").On (b)(6) 2014, the patient experienced device breakage (seriousness criterion medically significant), 7 years 6 months after insertion of essure (ess205).On an unknown date, the patient experienced complication of device removal ("partial coil still on her left side").The patient was treated with surgery (full hysterectomy and salpingectomy to remove essure).Essure (ess205) was removed on (b)(6) 2012.On (b)(6) 2012, the pelvic pain had resolved.At the time of the report, the device breakage, uterine haemorrhage, vaginal haemorrhage and complication of device removal outcome was unknown and the menorrhagia had resolved.The reporter considered complication of device removal, device breakage, menorrhagia, pelvic pain, uterine haemorrhage and vaginal haemorrhage to be related to essure (ess205).The reporter commented: (b)(6) 2014: patient recently involved in a car accident, x-ray/ mri showed an essure (partial coil) on her left side.Diagnostic results (normal ranges are provided in parenthesis if available): hysterosalpingogram - on (b)(6) 2007: total bilateral occlusion.Hysteroscopy - on (b)(6) 2017: essure procedure performed without difficulty, 2 coils visualized emerging into uterine cavity.Laparoscopy - on (b)(6) 2012: small mobile uterus, no adnexal mass.Operative findings showed a normal-sized uterus.Also several small bilateral physiological ovarian cysts, drained during surgery.Magnetic resonance imaging - on (b)(6) 2014: recent accident, x-ray/ mri showed essure (partial coil) on left side.Pathology test - on (b)(6) 2012: pathologist noted coiled [illegible] in the cornu region of uterus bilaterally.Quality-safety evaluation of ptc: unable to confirm complaint.Most recent follow-up information incorporated above includes: on 5-aug-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 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 pelvic pain ('pelvic pain') in an adult female patient who had essure (ess205) inserted for female sterilisation.The occurrence of additional non-serious events is detailed below.The patient's concurrent conditions included hypothyroidism and post-traumatic stress disorder.On (b)(6) 2007, the patient had essure (ess205) inserted.In (b)(6) 2007, the patient experienced pelvic pain (seriousness criteria medically significant and intervention required).In (b)(6) 2010, the patient experienced vaginal haemorrhage ("vaginal bleeding"), menorrhagia ("menorrhagia") and uterine haemorrhage ("uterine bleeding").The patient was treated with surgery (full hysterectomy and salpingectomy to remove essure).Essure (ess205) was removed on (b)(6) 2012.On (b)(6) 2012, the pelvic pain had resolved.At the time of the report, the vaginal haemorrhage and uterine haemorrhage outcome was unknown and the menorrhagia had resolved.The reporter considered menorrhagia, pelvic pain, uterine haemorrhage and vaginal haemorrhage to be related to essure (ess205).Diagnostic results (normal ranges are provided in parenthesis if available): hysterosalpingogram - on (b)(6) 2007: total bilateral occlusion.Quality-safety evaluation of ptc: unable to confirm complaint.Most recent follow-up information incorporated above includes: on 25-jun-2020: pfs received : event "uterine bleeding", reporter added.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 pelvic pain ('pelvic pain/ chronic pelvic pain') and device breakage ('x-ray/ mri showed essure (partial coil) on her left side') in a 36-year-old female patient who had essure (ess205) inserted for female sterilisation.The occurrence of additional non-serious events is detailed below.The patient's concurrent conditions included hypothyroidism and post-traumatic stress disorder (complex).On (b)(6) 2007, the patient had essure (ess205) inserted.In (b)(6) 2007, the patient experienced pelvic pain (seriousness criteria medically significant and intervention required).In (b)(6) 2010, the patient experienced menorrhagia ("menorrhagia"), uterine haemorrhage ("uterine bleeding") and vaginal haemorrhage ("vaginal bleeding").On (b)(6) 2014, the patient experienced device breakage (seriousness criterion medically significant), 7 years 6 months after insertion of essure (ess205).On an unknown date, the patient experienced complication of device removal ("partial coil still on her left side").The patient was treated with surgery (full hysterectomy and salpingectomy to remove essure).Essure (ess205) was removed on (b)(6) 2012.On (b)(6) 2012, the pelvic pain had resolved.At the time of the report, the device breakage, uterine haemorrhage, vaginal haemorrhage and complication of device removal outcome was unknown and the menorrhagia had resolved.The reporter considered complication of device removal, device breakage, menorrhagia, pelvic pain, uterine haemorrhage and vaginal haemorrhage to be related to essure (ess205).The reporter commented: (b)(6) 2014: patient recently involved in a car accident, x-ray/ mri showed an essure (partial coil) on her left side.Diagnostic results (normal ranges are provided in parenthesis if available): hysterosalpingogram - on (b)(6) 2007: total bilateral occlusion.Hysteroscopy - on (b)(6) 2017: essure procedure performed without difficulty, 2 coils visualized emerging into uterine cavity.Laparoscopy - on (b)(6) 2012: small mobile uterus, no adnexal mass.Operative findings showed a normal-sized uterus.Also several small bilateral physiological ovarian cysts, drained during surgery.Magnetic resonance imaging - on (b)(6) 2014: recent accident, x-ray/ mri showed essure (partial coil) on left side.Pathology test - on (b)(6) 2012: pathologist noted coiled [illegible] in the cornu region of uterus bilaterally.Quality-safety evaluation of ptc: unable to confirm complaint.Most recent follow-up information incorporated above includes: on 27-jul-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 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 pelvic pain ('pelvic pain/ chronic pelvic pain') and device breakage ('x-ray/ mri showed essure (partial coil) on her left side') in a 36-year-old female patient who had essure (ess205) inserted for female sterilisation.The occurrence of additional non-serious events is detailed below.The patient's concurrent conditions included hypothyroidism and post-traumatic stress disorder (complex).On (b)(6) 2007, the patient had essure (ess205) inserted.In (b)(6) 2007, the patient experienced pelvic pain (seriousness criteria medically significant and intervention required).In (b)(6) 2010, the patient experienced heavy menstrual bleeding ("menorrhagia"), uterine haemorrhage ("uterine bleeding") and vaginal haemorrhage ("vaginal bleeding").On (b)(6) 2014, the patient experienced device breakage (seriousness criterion medically significant), 7 years 6 months after insertion of essure (ess205).On an unknown date, the patient experienced complication of device removal ("partial coil still on her left side").The patient was treated with surgery (full hysterectomy and salpingectomy to remove essure).Essure (ess205) was removed on (b)(6) 2012.On (b)(6) 2012, the pelvic pain had resolved.At the time of the report, the device breakage, uterine haemorrhage, vaginal haemorrhage and complication of device removal outcome was unknown and the heavy menstrual bleeding had resolved.The reporter considered complication of device removal, device breakage, heavy menstrual bleeding, pelvic pain, uterine haemorrhage and vaginal haemorrhage to be related to essure (ess205).The reporter commented: (b)(6) 2014: patient recently involved in a car accident, x-ray/ mri showed an essure (partial coil) on her left side.Diagnostic results (normal ranges are provided in parenthesis if available): hysterosalpingogram - on (b)(6) 2007: total bilateral occlusion.Hysteroscopy - on (b)(6) 2017: essure procedure performed without difficulty, 2 coils visualized emerging into uterine cavity.Laparoscopy - on (b)(6) 2012: small mobile uterus, no adnexal mass.Operative findings showed a normal-sized uterus.Also several small bilateral physiological ovarian cysts, drained during surgery.Magnetic resonance imaging - on (b)(6) 2014: recent accident, x-ray/ mri showed essure (partial coil) on left side.Pathology test - on (b)(6) 2012: pathologist noted coiled [illegible] in the cornu region of uterus bilaterally.Quality-safety evaluation of ptc: unable to confirm complaint.Most recent follow-up information incorporated above includes: on 28-apr-2021: fu 8 and 9 processed together.Pif received: no new information added.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.

• 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: 10020129
• MDR Text Key: 190314503
• Report Number: 2951250-2020-06616
• Device Sequence Number: 1
• Product Code: HHS
• UDI-Device Identifier: 10888853003051
• UDI-Public: (01)10888853003051
• 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: 05/12/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/04/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ESS205
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/28/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 36 YR