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

Model Number ESS305

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Abdominal Pain (1685); Emotional Changes (1831); Fatigue (1849); Hair Loss (1877); Hemorrhage/Bleeding (1888); Menstrual Irregularities (1959); Nerve Damage (1979); Pain (1994); Weight Changes (2607); Heavier Menses (2666)

Event Date 06/01/2010

Event Type  Injury  

Event Description

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 (batch no.20180238) inserted for female sterilization.The occurrence of additional non-serious events is detailed below.The patient's medical history included myofascial pain syndrome on (b)(6) 2014, hypertriglyceridemia on (b)(6) 2012, leukocytosis on 30-jun-2010, syncope on (b)(6) 2009, gerd on (b)(6) 2008, bipolar disorder in 2007 and abortion.Previously administered products included for prevent pregnancy: mirena from 2008 to 2010 and nuvaring from 2006 to 2008.Concurrent conditions included pap smear abnormal, weight gain, hair loss, mood swings and paratubal cyst.The patient also had a family history of bipolar disorder, gerd, syncope, hypertriglyceridemia and myofascial pain syndrome.In (b)(6) 2010, the patient experienced pelvic pain (seriousness criteria medically significant and intervention required) and nerve injury ("nerve damage").In 2010, the patient experienced vaginal haemorrhage ("abnormal bleeding (vaginal)") and menorrhagia ("abnormal bleeding (menorrhagia)").On (b)(6) 2010, the patient had essure inserted.In 2011, the patient experienced dysmenorrhoea ("dysmenorrhea (cramping)").On an unknown date, the patient experienced dyspareunia ("dyspareunia (painful sexual intercourse)"), fatigue ("fatigue"), abdominal pain ("abdominal pain"), back pain ("back pain") and pain in extremity ("leg pain").The patient was treated with surgery (hysterectomy with bilateral salpingectomy).Essure was removed on (b)(6) 2016.At the time of the report, the pelvic pain, dysmenorrhoea, nerve injury, abdominal pain, back pain and pain in extremity had resolved and the vaginal haemorrhage, menorrhagia, dyspareunia and fatigue had not resolved.The reporter considered abdominal pain, back pain, dysmenorrhoea, dyspareunia, fatigue, menorrhagia, nerve injury, pain in extremity, pelvic pain and vaginal haemorrhage to be related to essure.Diagnostic results (normal ranges are provided in parenthesis if available): hysterosalpingogram on (b)(6) 2010: total bilateral occlusion.Concerning the injuries reported in this case, the following ones were confirmed in patient¿s medical records: pelvic pain, leg pain.Most recent follow-up information incorporated above includes: on (b)(6) 2019: fu2 and fu3 were processed together.Plaintiff fact sheet received.Event injury was updated to events: pelvic pain, abnormal bleeding (vaginal), abnormal bleeding (menorrhagia), dysmenorrhea (cramping), dyspareunia (painful sexual intercourse), fatigue, nerve damage, abdominal pain, back pain and leg pain.Outcome for pelvic pain, dysmenorrhea (cramping), nerve damage, abdominal pain, back pain and leg pain were recovered.Events abnormal bleeding (vaginal), abnormal bleeding (menorrhagia), dyspareunia (painful sexual intercourse) and fatigue were not recovered.Lot number, medical history and concurrent condition were added.On (b)(6) 2019: same source document received.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 non-conformances data; should any new and reportable information become available as a result, 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 ('pelvic pain') in an adult female patient who had essure (batch no.20180238) inserted for female sterilization.The occurrence of additional non-serious events is detailed below.The patient's medical history included myofascial pain syndrome on (b)(6) 2014, hypertriglyceridemia on (b)(6) 2012, leukocytosis on (b)(6) 2010, syncope on (b)(6) 2009, gerd on (b)(6) 2008, bipolar disorder in 2007 and abortion.Previously administered products included for prevent pregnancy: mirena from 2008 to 2010 and nuvaring from 2006 to 2008.Concurrent conditions included pap smear abnormal, weight gain, hair loss, mood swings and paratubal cyst.The patient also had a family history of bipolar disorder, gerd, syncope, hypertriglyceridemia and myofascial pain syndrome.On (b)(6) 2010, the patient had essure inserted.In (b)(6) 2010, the patient experienced pelvic pain (seriousness criteria medically significant and intervention required) and nerve injury ("nerve damage").In 2010, the patient experienced vaginal haemorrhage ("abnormal bleeding (vaginal)") and menorrhagia ("abnormal bleeding (menorrhagia)").In 2011, the patient experienced dysmenorrhoea ("dysmenorrhea (cramping)").On an unknown date, the patient experienced dyspareunia ("dyspareunia (painful sexual intercourse)"), fatigue ("fatigue"), abdominal pain ("abdominal pain"), back pain ("back pain") and pain in extremity ("leg pain").The patient was treated with surgery (hysterectomy with bilateral salpingectomy).Essure was removed on (b)(6) 2016.At the time of the report, the pelvic pain, dysmenorrhoea, nerve injury, abdominal pain, back pain and pain in extremity had resolved and the vaginal haemorrhage, menorrhagia, dyspareunia and fatigue had not resolved.The reporter considered abdominal pain, back pain, dysmenorrhoea, dyspareunia, fatigue, menorrhagia, nerve injury, pain in extremity, pelvic pain and vaginal haemorrhage to be related to essure.Diagnostic results (normal ranges are provided in parenthesis if available): hysterosalpingogram - on (b)(6) 2010: total bilateral occlusion.Concerning the injuries reported in this case, the following ones were confirmed in patient¿s medical records: pelvic pain, leg pain.Quality-safety evaluation of ptc: unable to confirm complaint.Most recent follow-up information incorporated above includes: on 6-dec-2019: quality safety evaluation of product technical complaint.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 non-conformances data; should any new and reportable information become available as a result, 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 ('pelvic pain') in an adult female patient who had essure (batch no.20180238) inserted for female sterilization.The occurrence of additional non-serious events is detailed below.The patient's medical history included myofascial pain syndrome on (b)(6) 2014, hypertriglyceridemia on (b)(6) 2012, leukocytosis on (b)(6) 2010, syncope on (b)(6) 2009, gerd on (b)(6) 2008, bipolar disorder in 2007, abortion and body mass index increased.Previously administered products included for prevent pregnancy: mirena from 2008 to 2010 and nuvaring from 2006 to 2008.Concurrent conditions included pap smear abnormal, weight gain, hair loss, mood swings and paratubal cyst.The patient also had a family history of bipolar disorder, gerd, syncope, hypertriglyceridemia and myofascial pain syndrome.Concomitant products included clindamycin, codeine, cyclobenzaprine, ethinylestradiol;norelgestromin (ortho evra), guaifenesin;phenylephrine hydrochloride;phenylpropanolamine (amitex), hydrocodone, ibuprofen, naproxen, paracetamol (acetaminophen) and promethazine.In (b)(6) 2010, the patient experienced pelvic pain (seriousness criteria medically significant and intervention required) and nerve injury ("nerve damage").In 2010, the patient experienced vaginal haemorrhage ("abnormal bleeding (vaginal)") and menorrhagia ("abnormal bleeding (menorrhagia)").On (b)(6) 2010, the patient had essure inserted.In 2011, the patient experienced dysmenorrhoea ("dysmenorrhea (cramping)").On an unknown date, the patient experienced dyspareunia ("dyspareunia (painful sexual intercourse)"), fatigue ("fatigue"), abdominal pain ("abdominal pain"), back pain ("back pain") and pain in extremity ("leg pain").The patient was treated with surgery (hysterectomy with bilateral salpingectomy).Essure was removed on (b)(6)2016.At the time of the report, the pelvic pain, vaginal haemorrhage, menorrhagia, dysmenorrhoea, nerve injury, abdominal pain and pain in extremity had resolved and the dyspareunia, fatigue and back pain was resolving.The reporter considered abdominal pain, back pain, dysmenorrhoea, dyspareunia, fatigue, menorrhagia, nerve injury, pain in extremity, pelvic pain and vaginal haemorrhage to be related to essure.Diagnostic results (normal ranges are provided in parenthesis if available): body mass index was 30.7 kg/sqm.Hysterosalpingogram - on 27-sep-2010: total bilateral occlusion.Concerning the injuries reported in this case, the following ones were confirmed in patient¿s medical records: pelvic pain, leg pain quality-safety evaluation of ptc: unable to confirm complaint most recent follow-up information incorporated above includes: on (b)(6) 2019: plaintiff fact sheet received.Patient demographic information updated.Product information details updated.Other relevant history updated.Outcome of events fatigue, dyspareunia, back pain changed from ¿unknown¿ to ¿recovering/resolving¿ and events abnormal bleeding vaginal, menorrhagia, dysmenorrhea, nerve damage from ¿not recovered/not resolved¿ to ¿recovered/resolved¿.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.

• 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: 9414947
• MDR Text Key: 172000184
• Report Number: 2951250-2019-11957
• 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
• Report Date: 01/02/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/05/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 06/01/2012
• Device Model Number: ESS305
• Device Lot Number: 20180238
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/09/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ACETAMINOPHEN.; AMITEX.; CLINDAMYCIN.; CODEINE.; CYCLOBENZAPRINE.; HYDROCODONE.; IBUPROFEN.; NAPROXEN.; ORTHO EVRA.; PROMETHAZINE.
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 28 YR
• Patient Weight: 81