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

Model Number ESS205

Device Problem Insufficient Information (3190)

Patient Problems Autoimmune Disorder (1732); Hair Loss (1877); Headache (1880); Hemorrhage/Bleeding (1888); Pain (1994); Cramp(s) (2193); Depression (2361); Palpitations (2467)

Event Type  Injury  

Event Description

This spontaneous case was reported by a lawyer and describes the occurrence of pelvic pain ("chronic pain / pain"), peripheral nerve injury ("nerve damage on legs and arms") and pituitary tumour benign ("pituitary adenoma") in a (b)(6) female patient who had essure (ess205) inserted for female sterilisation.The occurrence of additional non-serious events is detailed below.The patient's past medical history included parity 3.Concurrent conditions included uterine fibroid.Concomitant products included duloxetine hydrochloride (cymbalta), gabapentin and pregabalin (lyrica).On (b)(6) 2007, the patient had essure (ess205) inserted.In 2007, the patient experienced migraine ("migraines"), headache ("headaches") and dysmenorrhoea ("dysmenorrhea (cramping)").In 2008, the patient experienced pelvic pain (seriousness criteria medically significant and intervention required), dyspareunia ("pain during intercourse / dyspareunia (painful sexual intercourse)"), alopecia ("hair loss / hair loss"), vaginal haemorrhage ("abnormal bleeding (vaginal)") and menorrhagia ("abnormal bleeding (menorrhagia)").In 2009, the patient experienced depression ("depression").On an unknown date, the patient experienced peripheral nerve injury (seriousness criterion medically significant), pituitary tumour benign (seriousness criterion medically significant), abdominal pain ("severe abdominal pain"), fibromyalgia ("fibromyalgia"), palpitations ("heart palpitations") and abdominal distension ("bloating").The patient was treated with surgery (hysterectomy with bilateral salpingectomy).Essure (ess205) was removed on (b)(6) 2017.At the time of the report, the pelvic pain, peripheral nerve injury, pituitary tumour benign, dyspareunia, migraine, depression, fibromyalgia, headache, palpitations, dysmenorrhoea and abdominal distension outcome was unknown and the abdominal pain, alopecia, vaginal haemorrhage and menorrhagia had resolved.The reporter considered abdominal distension, abdominal pain, alopecia, depression, dysmenorrhoea, dyspareunia, fibromyalgia, headache, menorrhagia, migraine, palpitations, pelvic pain, peripheral nerve injury, pituitary tumour benign and vaginal haemorrhage to be related to essure (ess205).Diagnostic results: (b)(6) 2015 : transvaginal ultrasound (tvu) : that essure was seen, but it wasn't clear whether my tubes were occluded or not; i was also told that i had fibroids.Quality-safety evaluation of ptc: sample not available.Since we have no valid lot number for this case, we were unable to conduct a review of the manufacturing batch record.We are unable to confirm any quality defect or device malfunction at this time.Although we were unable to confirm this complaint, we cannot exclude the possibility of having a technical issue involved in the complaint.There was no event reported which indicates a new technical failure mode for the device.As a product quality defect could not be confirmed but is considered plausible a relationship with the reported medical events cannot be totally excluded.However, the reported medical events are not indicative of a quality deficit per se.Since no batch number was reported, a batch investigation with respect to similar ae cases is not applicable.No specific quality issue was defined, therefore no meddra llt can be provided.Most recent follow-up information incorporated above includes: on 28-feb-2018: pfs received.Events- "abnormal bleeding (vaginal), abnormal bleeding (menorrhagia), fibromyalgia, headaches, heart palpitations, nerve damage on legs and arms, dysmenorrhea (cramping), pituitary adenoma, bloating", reporter, concomittant drug, lab data added from pfs.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 pain / pain"), peripheral nerve injury ("nerve damage on legs and arms") and pituitary tumour benign ("pituitary adenoma") in a 28-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 past medical history included parity 3.Concurrent conditions included uterine fibroid, menses irregular, joint pain, swelling nos, uterine bleeding and urinary frequency.Concomitant products included duloxetine hydrochloride (cymbalta), gabapentin and pregabalin (lyrica).On (b)(6) 2007, the patient had essure (ess205) inserted.In (b)(6) 2007, the patient experienced abdominal distension ("bloating").In (b)(6) 2007, the patient experienced dysmenorrhoea ("dysmenorrhea (cramping)").In (b)(6) 2007, the patient experienced pituitary tumour benign (seriousness criterion medically significant), migraine ("migraines") and headache ("headaches").In (b)(6) 2008, the patient experienced pelvic pain (seriousness criteria medically significant and intervention required) and dyspareunia ("pain during intercourse / dyspareunia (painful sexual intercourse)").In (b)(6) 2008, the patient experienced alopecia ("hair loss / hair loss").In (b)(6) 2008, the patient experienced vaginal haemorrhage ("abnormal bleeding (vaginal)") and menorrhagia ("abnormal bleeding (menorrhagia)").In (b)(6) 2009, the patient experienced depression ("depression").In (b)(6) 2010, the patient experienced peripheral nerve injury (seriousness criterion medically significant) and fibromyalgia ("fibromyalgia").In (b)(6) 2015, the patient experienced palpitations ("heart palpitations").On an unknown date, the patient experienced abdominal pain ("severe abdominal pain"), pain in extremity ("thumb pain/ finger pain/ toe pain"), peripheral swelling ("swollen toe"), fatigue ("tired all the time"), supraventricular tachycardia ("supraventricular tachycardia"), cardiac murmur ("heart murmur"), weight loss poor ("cant lose weight"), asthenia ("no energy at all") and pelvic discomfort ("little pressure while i walk").The patient was treated with surgery (hysterectomy with bilateral salpingectomy).Essure (ess205) was removed on (b)(6) 2017.At the time of the report, the pelvic pain, peripheral nerve injury, pituitary tumour benign, dyspareunia, migraine, depression, fibromyalgia, headache, palpitations, dysmenorrhoea, abdominal distension, pain in extremity, peripheral swelling, fatigue, supraventricular tachycardia, cardiac murmur, weight loss poor, asthenia and pelvic discomfort outcome was unknown and the abdominal pain, alopecia, vaginal haemorrhage and menorrhagia had resolved.The reporter considered abdominal distension, abdominal pain, alopecia, asthenia, cardiac murmur, depression, dysmenorrhoea, dyspareunia, fatigue, fibromyalgia, headache, menorrhagia, migraine, pain in extremity, palpitations, pelvic discomfort, pelvic pain, peripheral nerve injury, peripheral swelling, pituitary tumour benign, supraventricular tachycardia, vaginal haemorrhage and weight loss poor to be related to essure (ess205).Diagnostic results: (b)(6) 2015 : transvaginal ultrasound (tvu) : that essure was seen, but it wasn't clear whether my tubes were occluded or not; i was also told that i had fibroids.On (b)(6) 2015, transvaginal ultrasound, indication: dyspareunia.Impression: small uterine fibroid.On (b)(6) 2015, transvaginal ultrasound addendum, bilateral essure procedure noted.On (b)(6) 2017, pathology, diagnosis: uterus and bilateral fallopian tubes, hysterectomy and salpingectomy.Uterus with small leiomyoma.Proliferative pattern endometrium.Mild chronic cervicitis.Bilateral fallopian tubes with essure devices in place.Right paratubal cyst.Clinical history: patient wants to keep essure device.Gross description: fallopian tubes demonstrate bilateral essure coils located in proximal tubes (isthmus and interstitial segments) concerning the injuries reported in this case, the following ones were confirmed in patient¿s medical records: dyspareunia, abdominal pain, abdominal distension, migraine, pelvic pain.Concerning the injuries reported in this case, the following ones were described in patient¿ social media:thumb pain/ finger pain/ toe pain, swollen toe, tired all the time, supraventricular tachycardia, heart murmur, cant lose weight, no energy, pelvic pressure quality-safety evaluation of ptc: sample not available.Since we have no valid lot number for this case, we were unable to conduct a review of the manufacturing batch record.We are unable to confirm any quality defect or device malfunction at this time.Although we were unable to confirm this complaint, we cannot exclude the possibility of having a technical issue involved in the complaint.There was no event reported which indicates a new technical failure mode for the device.As a product quality defect could not be confirmed but is considered plausible a relationship with the reported medical events cannot be totally excluded.However, the reported medical events are not indicative of a quality deficit per se.Since no batch number was reported, a batch investigation with respect to similar ae cases is not applicable.No specific quality issue was defined, therefore no meddra llt can be provided.Most recent follow-up information incorporated above includes: on (b)(6) 2018: social media received.Events: thumb pain/ finger pain/ toe pain, swollen toe, tired all the time, supraventricular tachycardia, heart murmur, cant lose weight, no energy, pelvic pressure were added.On (b)(6) 2018: events onset date updated.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.

• 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: 7446045
• MDR Text Key: 106010556
• Report Number: 2951250-2018-01896
• 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
• Report Date: 06/26/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/20/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: ESS205
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/07/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: CYMBALTA; CYMBALTA; GABAPENTIN; GABAPENTIN; LYRICA; LYRICA; CYMBALTA; GABAPENTIN; LYRICA
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 28 YR