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

Model Number ESS305

Device Problems Biocompatibility (2886); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Abdominal Pain (1685); Headache (1880); Nausea (1970); Pain (1994); Tinnitus (2103); Abnormal Vaginal Discharge (2123); Cramp(s) (2193); Dizziness (2194); Anxiety (2328); Sweating (2444); Weight Changes (2607)

Event Date 07/01/2014

Event Type  Injury  

Event Description

This spontaneous case was reported by a lawyer and describes the occurrence of pelvic pain ("severe pelvic pain") in a female patient who had essure inserted for birth control.The occurrence of additional non-serious events is detailed below.In (b)(6) 2013, the patient had essure inserted.In 2015, the patient experienced abdominal pain lower ("severe, lower abdominal pain"), abdominal pain ("severe abdominal cramping"), dyspareunia ("pain during intercourse"), dizziness ("dizziness"), night sweats ("night sweats"), nausea ("nausea"), anxiety ("worsening of anxiety") and tinnitus ("ringing in her ears").On an unknown date, the patient experienced pelvic pain (seriousness criteria medically significant and intervention required), migraine, weight fluctuation ("weight fluctuations"), vaginal discharge ("vaginal discharge") and fatigue ("fatigue").The patient was treated with surgery (underwent a bilateral salpingostomy).Essure was removed in (b)(6) 2016.At the time of the report, the pelvic pain, migraine, weight fluctuation, vaginal discharge, fatigue, abdominal pain lower, abdominal pain, dyspareunia, dizziness, night sweats, nausea, anxiety and tinnitus outcome was unknown.The reporter considered abdominal pain, abdominal pain lower, anxiety, dizziness, dyspareunia, fatigue, migraine, nausea, night sweats, pelvic pain, tinnitus, vaginal discharge and weight fluctuation to be related to essure.Company causality comment: 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 ("severe pelvic pain, pain (pelvis) mild to severe") in a 36-year-old female patient who had essure (batch no.B34605) inserted for female sterilisation.The occurrence of additional non-serious events is detailed below.The patient's past medical history included multigravida, parity 2 (b)(6) 2007, (b)(6) 2010 and cesarean section (b)(6) 2007, (b)(6) 2010.Previously administered products included for birth control: mirena from 2008 to 2009.Past adverse reactions to the above products included adverse drug reaction, migraine and palpitations with mirena.Concomitant products included contraceptives nos from 2008 to 2009.On (b)(6) 2013, the patient had essure inserted.On (b)(6) 2014, 9 months 14 days after insertion of essure, the patient experienced pelvic pain (seriousness criteria medically significant and intervention required).On (b)(6) 2014, the patient experienced migraine ("migraine headaches") and headache ("headaches, still have mild headaches/ pain head mild to severe").On (b)(6) 2014, the patient experienced vaginal discharge ("vaginal discharge") and fatigue ("fatigue").On (b)(6) 2014, the patient experienced weight increased ("weight gain").On (b)(6) 2015, the patient experienced allergy to metals ("nickel allergy"), dyspareunia ("pain during intercourse, dyspareunia (painful sexual intercourse)"), nausea ("nausea") and anxiety ("worsening of anxiety, psychological or psychiatric problems - condition: anxiety").In 2015, the patient experienced abdominal pain lower ("severe, lower abdominal pain, abdominal cramping (when not menstruating)"), abdominal pain ("severe abdominal cramping"), dizziness ("dizziness"), night sweats ("night sweats") and tinnitus ("ringing in her ears").On an unknown date, the patient experienced weight fluctuation ("weight fluctuations"), inflammation ("inflammation") and abdominal distension ("bloated").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, allergy to metals, weight fluctuation, fatigue, abdominal pain lower, abdominal pain, dyspareunia, dizziness, night sweats, nausea, anxiety, tinnitus, inflammation and abdominal distension had resolved, the migraine and headache was resolving and the vaginal discharge and weight increased had not resolved.The reporter considered abdominal distension, abdominal pain, abdominal pain lower, allergy to metals, anxiety, dizziness, dyspareunia, fatigue, headache, inflammation, migraine, nausea, night sweats, pelvic pain, tinnitus, vaginal discharge, weight fluctuation and weight increased to be related to essure.The reporter commented: physician stated that the essure implants needed to be removed due to a nickel allergy.The physician advised that the problems she was experiencing were not from essure but possibly due to her age.Current weight: 197 lbs.Diagnostic results (normal ranges are provided in parenthesis if available): hysterosalpingogram - on (b)(6) 2014: total bilateral occlusion.Most recent follow-up information incorporated above includes: on (b)(6) 2018: plaintiff fact sheet received : dyspareunia (painful sexual intercourse), nausea, nickel allergy, psychological or psychiatric problems - condition: anxiety, pain (pelvis and head)- mild to severe, migraines / headaches, fatigue, vaginal discharge, weight gain, abdominal cramping (when not menstruating), inflammation, dizziness, night sweats, bloated and ringing in ears added as event.The product lot number, start and stop date, patient demographic details and reporter information updated.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

Ntaneous case was reported by a lawyer and describes the occurrence of pelvic pain ("severe pelvic pain, pain (pelvis) mild to severe") in a 36-year-old female patient who had essure (batch no.B34605) inserted for female sterilisation.The occurrence of additional non-serious events is detailed below.The patient's past medical history included multigravida, parity 2 (( (b)(6)2007, (b)(6)2010)), cesarean section (b)(6)2007, (b)(6)2010)), recurrent abortion, nickel sensitivity, drug allergy, facial swelling and penicillin allergy.Previously administered products included for birth control: mirena from 2008 to 2009, mirena from 2008 to 2009 and mirena from 2008 to 2009; for an unreported indication: advil and motrin.Past adverse reactions to the above products included adverse drug reaction with mirena; migraine with mirena; and palpitations with mirena.Concomitant products included oral contraceptive nos from 2008 to 2009.On (b)(6)2013, the patient had essure inserted.On (b)(6)2014, 9 months 14 days after insertion of essure, the patient experienced pelvic pain (seriousness criteria medically significant and intervention required).On (b)(6)2014, the patient experienced migraine ("migraine headaches") and headache ("headaches, still have mild headaches/ pain head mild to severe").On (b)(6)-2014, the patient experienced vaginal discharge ("vaginal discharge") and fatigue ("fatigue").On (b)(6)2014, the patient experienced weight increased ("weight gain").On (b)(6)2015, the patient experienced allergy to metals ("nickel allergy"), dyspareunia ("pain during intercourse, dyspareunia (painful sexual intercourse)"), nausea ("nausea") and anxiety ("worsening of anxiety, psychological or psychiatric problems - condition: anxiety").In 2015, the patient experienced abdominal pain lower ("severe, lower abdominal pain, abdominal cramping (when not menstruating)"), abdominal pain ("severe abdominal cramping"), dizziness ("dizziness"), night sweats ("night sweats") and tinnitus ("ringing in her ears").On an unknown date, the patient experienced weight fluctuation ("weight fluctuations"), inflammation ("inflammation") and abdominal distension ("bloated").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, allergy to metals, weight fluctuation, fatigue, abdominal pain lower, abdominal pain, dyspareunia, dizziness, night sweats, nausea, anxiety, tinnitus, inflammation and abdominal distension had resolved, the migraine and headache was resolving and the vaginal discharge and weight increased had not resolved.The reporter considered abdominal distension, abdominal pain, abdominal pain lower, allergy to metals, anxiety, dizziness, dyspareunia, fatigue, headache, inflammation, migraine, nausea, night sweats, pelvic pain, tinnitus, vaginal discharge, weight fluctuation and weight increased to be related to essure.The reporter commented: physician stated that the essure implants needed to be removed due to a nickel allergy.The physician advised that the problems she was experiencing were not from essure but possibly due to her age.Current weight: 197 lbs.Each device was followed into the uterine cavity and the proximal end of each device was identified.Diagnostic results (normal ranges are provided in parenthesis if available): hysterosalpingogram - on (b)(6)2014: total bilateral occlusion ¿concerning the injuries reported in this case, the following one/ones were described in patient¿s medical record: pelvic pain quality-safety evaluation of ptc: unable to confirm complaint most recent follow-up information incorporated above includes: on (b)(6)2018: quality safety evaluation of ptc 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 ("severe pelvic pain, pain (pelvis) mild to severe") in a 36-year-old female patient who had essure (batch no.B34605) inserted for female sterilisation.The occurrence of additional non-serious events is detailed below.The patient's past medical history included multigravida, parity 2 ((b)(6) 2007, (b)(6) 2010)), cesarean section ((b)(6) 2007, (b)(6) 2010)), recurrent abortion, nickel sensitivity, drug allergy, facial swelling and penicillin allergy.Previously administered products included for birth control: mirena from 2010 to (b)(6) 2012, mirena from 2010 to (b)(6) 2012 and mirena from 2008 to 2009; for an unreported indication: advil and motrin.Past adverse reactions to the above products included adverse drug reaction with mirena; migraine with mirena; and palpitations with mirena.Concomitant products included oral contraceptive nos from 2008 to 2009.On (b)(6) 2013, the patient had essure inserted.On (b)(6) 2014, 9 months 14 days after insertion of essure, the patient experienced pelvic pain (seriousness criteria medically significant and intervention required).On (b)(6) -2014, the patient experienced migraine ("migraine headaches") and headache ("headaches, still have mild headaches/ pain head mild to severe").On (b)(6) 2014, the patient experienced vaginal discharge ("vaginal discharge") and fatigue ("fatigue").On (b)(6) 2014, the patient experienced weight increased ("weight gain").On (b)(6) 2015, the patient experienced allergy to metals ("nickel allergy"), dyspareunia ("pain during intercourse, dyspareunia (painful sexual intercourse)"), nausea ("nausea") and anxiety ("worsening of anxiety, psychological or psychiatric problems - condition: anxiety").In 2015, the patient experienced abdominal pain lower ("severe, lower abdominal pain, abdominal cramping (when not menstruating)"), abdominal pain ("severe abdominal cramping"), dizziness ("dizziness"), night sweats ("night sweats") and tinnitus ("ringing in her ears").On an unknown date, the patient experienced weight fluctuation ("weight fluctuations"), inflammation ("inflammation") and abdominal distension ("bloated").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, allergy to metals, weight fluctuation, fatigue, abdominal pain lower, abdominal pain, dyspareunia, dizziness, night sweats, nausea, anxiety, tinnitus, inflammation and abdominal distension had resolved, the migraine and headache was resolving and the vaginal discharge and weight increased had not resolved.The reporter considered abdominal distension, abdominal pain, abdominal pain lower, allergy to metals, anxiety, dizziness, dyspareunia, fatigue, headache, inflammation, migraine, nausea, night sweats, pelvic pain, tinnitus, vaginal discharge, weight fluctuation and weight increased to be related to essure.The reporter commented: physician stated that the essure implants needed to be removed due to a nickel allergy.The physician advised that the problems she was experiencing were not from essure but possibly due to her age.Current weight: 197 lbs.Each device was followed into the uterine cavity and the proximal end of each device was identified.Diagnostic results (normal ranges are provided in parenthesis if available): hysterosalpingogram - on (b)(6) 2014: total bilateral occlusion.¿concerning the injuries reported in this case, the following one/ones were described in patient¿s medical record: pelvic pain.Quality-safety evaluation of ptc: unable to confirm complaint.Most recent follow-up information incorporated above includes: on 25-oct-2018: update of quality-safety evaluation of product technical complaints.( fda codes update).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.

• 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: 6701524
• MDR Text Key: 79639860
• Report Number: 2951250-2017-02503
• Device Sequence Number: 1
• Product Code: HHS
• 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
• Report Date: 10/25/2018

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: 05/31/2016
• Device Model Number: ESS305
• Device Lot Number: B34605
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/03/2017
• Initial Date FDA Received: 07/11/2017
• Supplement Dates Manufacturer Received: 02/27/2018; 08/13/2018; 10/25/2018
• Supplement Dates FDA Received: 03/20/2018; 08/15/2018; 10/25/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: CONTRACEPTIVES NOS; CONTRACEPTIVES NOS; CONTRACEPTIVES NOS; ORAL CONTRACEPTIVE NOS; ORAL CONTRACEPTIVE NOS; ORAL CONTRACEPTIVE NOS; ORAL CONTRACEPTIVE NOS; ORAL CONTRACEPTIVE NOS; ORAL CONTRACEPTIVE NOS
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 36 YR