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

Model Number ESS305

Device Problems Migration or Expulsion of Device (1395); Biocompatibility (2886); Device Dislodged or Dislocated (2923); Material Twisted/Bent (2981); Migration (4003)

Patient Problems Abdominal Pain (1685); Anemia (1706); Cyst(s) (1800); Emotional Changes (1831); Fatigue (1849); Hair Loss (1877); Headache (1880); Hemorrhage/Bleeding (1888); Hypersensitivity/Allergic reaction (1907); Incontinence (1928); Inflammation (1932); Memory Loss/Impairment (1958); Pain (1994); Rash (2033); Thyroid Problems (2102); Urinary Tract Infection (2120); Blurred Vision (2137); Visual Impairment (2138); Anxiety (2328); Sleep Dysfunction (2517); Weight Changes (2607); Foreign Body In Patient (2687)

Event Date 05/31/2017

Event Type  Injury  

Event Description

Ntaneous case was reported by a lawyer and describes the occurrence of device dislocation ("coil migrated"), device expulsion ("migrated into her uterus") and autoimmune thyroiditis ("hashimoto's thyroiditis") in a (b)(6) female patient who had essure (batch no.664442 invalid) inserted for female sterilisation.The occurrence of additional non-serious events is detailed below.Other product or product use issues identified: device difficult to use "trouble inserting one of the essure implants" on (b)(6) 2009 and device physical property issue "one of the essure micro-inserts was bent".The patient's past medical history included chronic tonsillitis from 2005 to 2006 and hypothyroidism.Concurrent conditions included adnexal mass, genital bleeding, cholelithiasis, right lower quadrant pain, abdominal cramps, ovarian cyst and underweight.Concomitant products included iron from 2005 to 2017 for anemia, alprazolam (xanax) from 2015 to 2017 for insomnia as well as cyclobenzaprine hydrochloride (flexeril) since (b)(6) 2015, hormones nos since (b)(6) 2016 and zanex since 2015.In 2009, the patient experienced headache ("headaches").On (b)(6) 2009, the patient had essure inserted.On (b)(6) 2009, the patient experienced rash ("rashes"), weight increased ("weight gain"), exfoliative rash ("scaly rash") and weight decreased ("weight loss").On (b)(6) 2009, the patient experienced dyspareunia ("painful intercourse dyspareunia (painful sexual intercourse)").On (b)(6) 2010, the patient experienced vulvovaginal mycotic infection ("vaginal yeast infections").In (b)(6) 2010, the patient experienced blood oestrogen increased ("estrogen dominance") and libido decreased ("decreased libido").On (b)(6) 2010, the patient experienced fatigue ("chronic fatigue").In december 2010, the patient experienced tension ("tension"), anxiety ("anxiety") and depressed mood ("depressed mood").In january 2011, the patient experienced visual impairment ("vision changes") and vision blurred ("blurred vision").In 2011, the patient experienced allergy to metals ("nickel allergy").On (b)(6) 2016, the patient experienced autoimmune thyroiditis (seriousness criterion medically significant).On (b)(6) 2016, the patient experienced menorrhagia ("abnormally heavy menstrual bleeding/prolonged menstruation/abnormal menstruation/ abnormal bleeding (menorrhagia)"), alopecia ("hair loss") and vaginal haemorrhage ("abnormal bleeding (vaginal)").In (b)(6) 2017, the patient experienced incontinence ("incontinence"), dysuria ("dysuria") and memory impairment ("impaired memory").In (b)(6) 2017, the patient experienced ovarian cyst ("ovarian cysts, right ovarian cyst") and cervical cyst ("benign nabothian cyst").On (b)(6) 2017, the patient experienced device dislocation (seriousness criteria medically significant and intervention required) with abdominal pain lower, pelvic pain and back pain.On an unknown date, the patient experienced device expulsion (seriousness criterion medically significant) with abdominal pain, dysmenorrhoea ("abnormally severe menstrual pain"), arthralgia ("severe hip pain even when not menstruating/severe joint pain"), dental caries ("tooth decay"), tooth loss ("tooth loss"), pruritus ("itching"), migraine ("migraines"), inflammation ("major inflammation"), fibromyalgia ("fibromyalgia") and myalgia ("muscle pain").The patient was treated with fluconazole, ibuprofen, ricinus communis oil (castor oil), tranexamic acid, cortisone, vitamins and surgery (total laparoscopic hysterectomy, bilateral salpingectomy, and two bilateral ovarian cystotomies).Essure was removed on (b)(6) 2017.In 2009, the migraine had resolved.In 2017, the fatigue had resolved.At the time of the report, the device dislocation, vaginal haemorrhage, vulvovaginal mycotic infection, exfoliative rash, weight decreased, inflammation, blood oestrogen increased, incontinence, dysuria, memory impairment, allergy to metals, tension, anxiety, depressed mood, visual impairment, vision blurred, cervical cyst, libido decreased, fibromyalgia and myalgia outcome was unknown, the device expulsion, autoimmune thyroiditis, dysmenorrhoea, arthralgia, menorrhagia, dental caries, tooth loss, ovarian cyst, dyspareunia, rash, pruritus, alopecia and weight increased had not resolved and the headache had resolved.The reporter considered allergy to metals, alopecia, anxiety, arthralgia, autoimmune thyroiditis, blood oestrogen increased, cervical cyst, dental caries, depressed mood, device dislocation, device expulsion, dysmenorrhoea, dyspareunia, dysuria, exfoliative rash, fatigue, fibromyalgia, headache, incontinence, inflammation, libido decreased, memory impairment, menorrhagia, migraine, myalgia, ovarian cyst, pruritus, rash, tension, tooth loss, vaginal haemorrhage, vision blurred, visual impairment, vulvovaginal mycotic infection, weight decreased and weight increased to be related to essure.The reporter commented: current weight (b)(6).Diagnostic results (normal ranges are provided in parenthesis if available): body mass index was 18.2 kg/sqm.Hysterosalpingogram - on (b)(6) 2009: full occlusion of fallopian tubes x-ray - on (b)(6) 2017: one essure bent and potentially migrated to uterus 09nov2015, ultrasound transabdominal and transvaginal pelvic imaging the endometrium is not thickened.No uterine mass or fibroid.On (b)(6) 2017 ultrasound transvaginal pelvic imaging the uterus demonstrates a small amount of fluid in the cervical canal with two areas of either debris or small polyps.There is a 3 cm complex cyst in the right ovary, overall of similar size to the previous examination, although the septations are thicker and more irregular and therefore more concerning.Consideration should be given to laparoscopic removal to ensure benignity.Quality-safety evaluation of ptc: unable to confirm complaint.Most recent follow-up information incorporated above includes: on 17-jul-2018: quality department mentioned that the reported lot number was invalid.Fda codes were added.No follow-up ptc investigation will be provided incident: no valid 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

Ntaneous case was reported by a lawyer and describes the occurrence of device dislocation ("coil migrated"), device expulsion ("migrated into her uterus") and autoimmune thyroiditis ("hashimoto's thyroiditis") in a 42-year-old female patient who had essure (batch no.664442) inserted for female sterilisation.The occurrence of additional non-serious events is detailed below.Other product or product use issues identified: device difficult to use "trouble inserting one of the essure implants" on (b)(6) 2009 and device physical property issue "one of the essure micro-inserts was bent".The patient's past medical history included chronic tonsillitis from 2005 to 2006 and hypothyroidism.Concurrent conditions included adnexal mass, genital bleeding, cholelithiasis, right lower quadrant pain, abdominal cramps, ovarian cyst and underweight.Concomitant products included iron from 2005 to 2017 for anemia, alprazolam (xanax) from 2015 to 2017 for insomnia as well as cyclobenzaprine hydrochloride (flexeril) since (b)(6) 2015, hormones nos since (b)(6) 2016 and zanex since 2015.On (b)(6) 2009, the patient had essure inserted.In 2009, the patient experienced headache ("headaches").On (b)(6) 2009, the patient experienced rash ("rashes"), weight increased ("weight gain"), exfoliative rash ("scaly rash") and weight decreased ("weight loss").On (b)(6) 2009, the patient experienced dyspareunia ("painful intercourse dyspareunia (painful sexual intercourse)").On (b)(6) 2010, the patient experienced vulvovaginal mycotic infection ("vaginal yeast infections").In (b)(6) 2010, the patient experienced blood oestrogen increased ("estrogen dominance") and libido decreased ("decreased libido").On (b)(6) 2010, the patient experienced fatigue ("chronic fatigue").In (b)(6) 2010, the patient experienced tension ("tension"), anxiety ("anxiety") and depressed mood ("depressed mood").In (b)(6) 2011, the patient experienced visual impairment ("vision changes") and vision blurred ("blurred vision").In 2011, the patient experienced allergy to metals ("nickel allergy").On (b)(6) 2016, the patient experienced autoimmune thyroiditis (seriousness criterion medically significant).On (b)(6) 2016, the patient experienced menorrhagia ("abnormally heavy menstrual bleeding/prolonged menstruation/abnormal menstruation/ abnormal bleeding (menorrhagia)"), alopecia ("hair loss") and vaginal haemorrhage ("abnormal bleeding (vaginal)").In (b)(6) 2017, the patient experienced incontinence ("incontinence"), dysuria ("dysuria") and memory impairment ("impaired memory").In (b)(6) 2017, the patient experienced ovarian cyst ("ovarian cysts, right ovarian cyst") and cervical cyst ("benign nabothian cyst").On (b)(6) 2017, the patient experienced device dislocation (seriousness criteria medically significant and intervention required) with abdominal pain lower, pelvic pain and back pain.On an unknown date, the patient experienced device expulsion (seriousness criterion medically significant) with abdominal pain, dysmenorrhoea ("abnormally severe menstrual pain"), arthralgia ("severe hip pain even when not menstruating/severe joint pain"), dental caries ("tooth decay"), tooth loss ("tooth loss"), pruritus ("itching"), migraine ("migraines"), inflammation ("major inflammation"), fibromyalgia ("fibromyalgia") and myalgia ("muscle pain").The patient was treated with fluconazole, ibuprofen, ricinus communis oil (castor oil), tranexamic acid, cortisone, vitamins and surgery (total laparoscopic hysterectomy, bilateral salpingectomy, and two bilateral ovarian cystotomies).Essure was removed on (b)(6) 2017.In 2009, the migraine had resolved.In 2017, the fatigue had resolved.At the time of the report, the device dislocation, vaginal haemorrhage, vulvovaginal mycotic infection, exfoliative rash, weight decreased, inflammation, blood oestrogen increased, incontinence, dysuria, memory impairment, allergy to metals, tension, anxiety, depressed mood, visual impairment, vision blurred, cervical cyst, libido decreased, fibromyalgia and myalgia outcome was unknown, the device expulsion, autoimmune thyroiditis, dysmenorrhoea, arthralgia, menorrhagia, dental caries, tooth loss, ovarian cyst, dyspareunia, rash, pruritus, alopecia and weight increased had not resolved and the headache had resolved.The reporter considered allergy to metals, alopecia, anxiety, arthralgia, autoimmune thyroiditis, blood oestrogen increased, cervical cyst, dental caries, depressed mood, device dislocation, device expulsion, dysmenorrhoea, dyspareunia, dysuria, exfoliative rash, fatigue, fibromyalgia, headache, incontinence, inflammation, libido decreased, memory impairment, menorrhagia, migraine, myalgia, ovarian cyst, pruritus, rash, tension, tooth loss, vaginal haemorrhage, vision blurred, visual impairment, vulvovaginal mycotic infection, weight decreased and weight increased to be related to essure.The reporter commented: current weight 120.00 lbs.Diagnostic results (normal ranges are provided in parenthesis if available): body mass index was 18.2 kg/sqm.Hysterosalpingogram - on (b)(6) 2009: full occlusion of fallopian tubes x-ray - on (b)(6) 2017: one essure bent and potentially migrated to uterus (b)(6) 2015, ultrasound transabdominal and transvaginal pelvic imaging the endometrium is not thickened.No uterine mass or fibroid.(b)(6) 2017 ultrasound transvaginal pelvic imaging the uterus demonstrates a small amount of fluid in the cervical canal with two areas of either debris or small polyps.There is a 3 cm complex cyst in the right ovary, overall of similar size to the previous examination, although the septations are thicker and more irregular and therefore more concerning.Consideration should be given to laparoscopic removal to ensure benignity.Quality-safety evaluation of ptc: unable to confirm complaint.Most recent follow-up information incorporated above includes: on 29-aug-2018: quality safety evaluation of product technical complaints.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: 7709692
• MDR Text Key: 114687696
• Report Number: 2951250-2018-03140
• 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
• Report Date: 08/30/2018

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: 08/01/2012
• Device Model Number: ESS305
• Device Lot Number: 664442
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/17/2018
• Initial Date FDA Received: 07/23/2018
• Supplement Dates Manufacturer Received: 08/29/2018
• Supplement Dates FDA Received: 08/30/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: FLEXERIL.; FLEXERIL.; HORMONES NOS.; HORMONES NOS.; IRON.; IRON.; UNCODEABLE "UNCLASSIFIABLE".; UNCODEABLE "UNCLASSIFIABLE".; XANAX.; XANAX.; FLEXERIL; HORMONES NOS; IRON; UNCODEABLE "UNCLASSIFIABLE"; XANAX
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 42 YR
• Patient Weight: 47