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

Model Number ESS305

Device Problems Device Operates Differently Than Expected (2913); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Abdominal Pain (1685); Rheumatoid Arthritis (1724); Autoimmune Disorder (1732); Fatigue (1849); Hemorrhage/Bleeding (1888); Incontinence (1928); Menstrual Irregularities (1959); Muscle Weakness (1967); Nausea (1970); Pain (1994); Thyroid Problems (2102); Visual Impairment (2138); Weakness (2145); Cramp(s) (2193); Anxiety (2328); Arthralgia (2355); Depression (2361)

Event Type  Injury  

Event Description

This spontaneous case was reported by a lawyer and describes the occurrence of pelvic pain ("severe pain/lower body pain"), procedural haemorrhage ("bleeding during the removal procedure"), rheumatoid arthritis ("rheumatoid arthritis"), autoimmune thyroiditis ("hoshimoto thyroid disease"), bipolar disorder ("bipolar disorder"), anxiety ("anxiety"), depression ("depression") and tooth disorder ("dental problems") in a (b)(6) female patient who had essure (batch no.A08323) inserted for female sterilization.The occurrence of additional non-serious events is detailed below.The patient's past medical history included depression, anxiety and bipolar disorder.Concurrent conditions included overweight, hypothyroidism, suicidal ideation, pain of lower extremities, lower extremities weakness of and muscular weakness.Concomitant products included aripiprazole (abilify) and levothyroxine.On (b)(6) 2012, the patient had essure inserted.In (b)(6) 2012, the patient experienced dysmenorrhoea ("menstrual cramping").In (b)(6) 2012, the patient experienced female sexual dysfunction ("apareunia").In (b)(6) 2012, the patient experienced nausea ("nausea"), urinary incontinence ("bladder or urinary problems: urinary incontinence"), arthralgia ("pain in hip"), back pain ("lower back pain") and abdominal pain ("abdominal pain").In (b)(6) 2012, the patient experienced rheumatoid arthritis (seriousness criterion medically significant), autoimmune thyroiditis (seriousness criterion medically significant) and fibromyalgia ("fibromyalgia").In 2013, the patient experienced tooth disorder (seriousness criterion medically significant), alopecia ("hair loss") and vaginal discharge ("vaginal discharge").On an unknown date, the patient experienced pelvic pain (seriousness criteria medically significant and intervention required), procedural haemorrhage (seriousness criterion medically significant), bipolar disorder (seriousness criteria hospitalization and medically significant), anxiety (seriousness criterion hospitalization), depression (seriousness criterion hospitalization), pain ("body aches"), menstruation irregular ("irregular periods"), thyroid disorder ("thyroid problems"), visual impairment ("eye sight got a lot worse"), fatigue ("fatigue"), weight increased ("weight gain"), diarrhoea ("chronic diarrhea") and adnexa uteri pain ("ovaries pain").The patient was treated with sertraline (zoloft), sodium chloride (respitol), surgery (bilateral salpingectomy) and surgery (removal of eight teeths).Essure was removed on (b)(6) 2016.At the time of the report, the pelvic pain, dysmenorrhoea, pain, menstruation irregular and thyroid disorder had not resolved, the procedural haemorrhage, rheumatoid arthritis, autoimmune thyroiditis, tooth disorder, female sexual dysfunction, nausea, visual impairment, fatigue, weight increased, diarrhoea, alopecia, fibromyalgia, urinary incontinence, arthralgia, back pain, abdominal pain, vaginal discharge and adnexa uteri pain outcome was unknown and the bipolar disorder, anxiety and depression was resolving.The reporter considered abdominal pain, adnexa uteri pain, alopecia, anxiety, arthralgia, autoimmune thyroiditis, back pain, bipolar disorder, depression, diarrhoea, dysmenorrhoea, fatigue, female sexual dysfunction, fibromyalgia, menstruation irregular, nausea, pain, pelvic pain, procedural haemorrhage, rheumatoid arthritis, thyroid disorder, tooth disorder, urinary incontinence, vaginal discharge, visual impairment and weight increased to be related to essure.The reporter commented: that everything looked good on (b)(6) 2016.Plaintiff¿s health condition substantially worsened and her vision substantially worsened.Diagnostic results (normal ranges are provided in parenthesis if available): body mass index was 38.8 kg/sqm.Hysterosalpingogram - in (b)(6) 2016: total bilateral occlusion.Most recent follow-up information incorporated above includes: on 30-may-2018: pfs received:case is now incident as plaintiff underwent bilateral salpingectomy on (b)(6) 2016.Hospitalization marked for events bipolar disorder,anxiety and depression and their outcome taken as recovering/resolving.Essure legal manufacture has changed from bayer healthcare, llc, milpitas to bayer pharma ag, berlin, and this report is being submitted as a follow up to a previous report submitted under the former legal manufacturer.Report type ¿initial¿ indicates here initial submission by the new legal manufacturer only.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 pain/lower body pain"), procedural haemorrhage ("bleeding during the removal procedure"), rheumatoid arthritis ("rheumatoid arthritis"), autoimmune thyroiditis ("hoshimoto thyroid disease"), bipolar disorder ("bipolar disorder"), anxiety ("anxiety"), depression ("depression") and tooth disorder ("dental problems") in a 26-year-old female patient who had essure (batch no.A08323-inv) inserted for female sterilization.The occurrence of additional non-serious events is detailed below.The patient's past medical history included depression, anxiety and bipolar disorder.Concurrent conditions included overweight, hypothyroidism, suicidal ideation, pain of lower extremities, lower extremities weakness of and muscular weakness.Concomitant products included aripiprazole (abilify) and levothyroxine.In (b)(6) 2012, the patient experienced dysmenorrhoea ("menstrual cramping").On (b)(6) 2012, the patient had essure inserted.In (b)(6) 2012, the patient experienced female sexual dysfunction ("apareunia").In (b)(6) 2012, the patient experienced nausea ("nausea"), urinary incontinence ("bladder or urinary problems: urinary incontinence"), arthralgia ("pain in hip"), back pain ("lower back pain") and abdominal pain ("abdominal pain").In (b)(6) 2012, the patient experienced rheumatoid arthritis (seriousness criterion medically significant), autoimmune thyroiditis (seriousness criterion medically significant) and fibromyalgia ("fibromyalgia").In 2013, the patient experienced tooth disorder (seriousness criterion medically significant), alopecia ("hair loss") and vaginal discharge ("vaginal discharge").On an unknown date, the patient experienced pelvic pain (seriousness criteria medically significant and intervention required), procedural haemorrhage (seriousness criterion medically significant), bipolar disorder (seriousness criteria hospitalization and medically significant), anxiety (seriousness criterion hospitalization), depression (seriousness criterion hospitalization), pain ("body aches"), menstruation irregular ("irregular periods"), thyroid disorder ("thyroid problems"), visual impairment ("eye sight got a lot worse"), fatigue ("fatigue"), weight increased ("weight gain"), diarrhoea ("chronic diarrhea") and adnexa uteri pain ("ovaries pain").The patient was treated with sertraline (zoloft), sodium chloride (respitol), surgery (bilateral salpingectomy) and surgery (removal of eight teeths).Essure was removed on (b)(6) 2016.At the time of the report, the pelvic pain, dysmenorrhoea, pain, menstruation irregular and thyroid disorder had not resolved, the procedural haemorrhage, rheumatoid arthritis, autoimmune thyroiditis, tooth disorder, female sexual dysfunction, nausea, visual impairment, fatigue, weight increased, diarrhoea, alopecia, fibromyalgia, urinary incontinence, arthralgia, back pain, abdominal pain, vaginal discharge and adnexa uteri pain outcome was unknown and the bipolar disorder, anxiety and depression was resolving.The reporter considered abdominal pain, adnexa uteri pain, alopecia, anxiety, arthralgia, autoimmune thyroiditis, back pain, bipolar disorder, depression, diarrhoea, dysmenorrhoea, fatigue, female sexual dysfunction, fibromyalgia, menstruation irregular, nausea, pain, pelvic pain, procedural haemorrhage, rheumatoid arthritis, thyroid disorder, tooth disorder, urinary incontinence, vaginal discharge, visual impairment and weight increased to be related to essure.The reporter commented: that everything looked good on (b)(6) 2016.Plaintiff¿s health condition substantially worsened and her vision substantially worsened.Diagnostic results (normal ranges are provided in parenthesis if available): body mass index was 38.8 kg/sqm.Hysterosalpingogram - in (b)(6) 2016: total bilateral occlusion.Most recent follow-up information incorporated above includes: on 29-aug-2018: update of information (batch is invalid).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.

• 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: 7637425
• MDR Text Key: 112304213
• Report Number: 2951250-2018-02807
• 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: 08/30/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/26/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: ESS305
• Device Lot Number: A08323-INV
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/29/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ABILIFY.; ABILIFY.; LEVOTHYROXINE.; LEVOTHYROXINE.; ABILIFY; LEVOTHYROXINE
• Patient Outcome(s): Hospitalization; Other; Required Intervention
• Patient Age: 26 YR
• Patient Weight: 96