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); Appropriate Term/Code Not Available (3191)

Patient Problems Abdominal Pain (1685); Autoimmune Disorder (1732); Diarrhea (1811); Dry Eye(s) (1814); Emotional Changes (1831); Fatigue (1849); Flatus (1865); High Blood Pressure/ Hypertension (1908); Itching Sensation (1943); Nausea (1970); Pain (1994); Paralysis (1997); Thrombosis (2100); Thyroid Problems (2102); Urinary Tract Infection (2120); Cramp(s) (2193); Anxiety (2328); Depression (2361); Sleep Dysfunction (2517); Weight Changes (2607); Heavier Menses (2666)

Event Date 01/01/2016

Event Type  Injury  

Event Description

This spontaneous case was reported by a lawyer and describes the occurrence of pelvic pain, urinary tract infection, bladder hydrodistension, autoimmune thyroiditis, dry eye, paralysis, helicobacter gastritis, suicidal ideation and ovarian vein thrombosis in a (b)(6) female patient who had essure inserted.The patient's past medical history included three children, two pregnancies.Prior to placement of the essure inserts, the patient was in good general health and was not being followed for any problems.The patient's concurrent conditions included overweight.On (b)(6) 2008, the patient underwent sterilization by the essure method with no difficulties with four trailing spires on the right and seven trailing spirals on the left visible in the uterus.On (b)(6) 2009, pelvic ultrasound was normal.In 2010, major fatigue, weight gain, bloating, muscle pain in legs and abdomen, episodes of diarrhoea, abdominal pain, acne, itchy scalp and frequent nausea.Her gynecologist, mentioned asthenia, cramps, oedema of extremities, recurrent vaginal mycosis and urinary tract infections, increasingly severe menorrhagia, acne, high blood pressure and progressive weight gain.On (b)(6) 2010, blood tests found a vitamin d3 level of 11 ng/ml, i.E.A vitamin-d3 deficiency.On (b)(6) 2010, immuno-enzyme assays were performed due to suspicion of hashimoto's disease and found the following: thyroid peroxidase antibodies at 108 iu/l; thyroglobulin antibodies at 143 iu/l.These values are well above the normal range.On (b)(6) 2010 pelvic ultrasound, performed to check positioning of the inserts, was normal.On (b)(6) 2010, her endocrinologist noticed that the patient was found to have elevated tsh at 4.53 iu/l.On (b)(6) 2010, endocrinologist concluded to a toxic phase of hashimoto's thyroiditis, and prescribed levothyrox 25 to her.In (b)(6) 2010, she experienced muscle pain initially localized to the legs with recent spread to upper limbs.After 6 months, on (b)(6) 2011, the patient went to emergency for muscle pains that were persistent for some months.She was admitted for suspicion of lupus.Since 2009 or 2010, the patient had suddenly changed following an attack, assimilated to tetany.Extreme constant anxiety, both physical and psychological repercussions, mood disturbances, sleep disturbances, chronic fatigue, loss of energy and motivation, panic attacks, withdrawal into herself, eating disorder and phobic behavior.It was reported as a clinical picture of depression.Furthermore it was commented about anxiety of imminent death, sometimes going so far as to express suicidal ideas to put an end to her moral suffering and the feeling of exhaustion.On (b)(6) 2011, she attended a consultation with nephrologist, who noted that muscle pain was diffuse, sometimes accompanied by a feeling of trembling.There was no nephrological involvement.It was also noticed a few lesions of acne.On the same day, she reported episodes of diarrhea.On (b)(6) 2011, the patient was no longer physically able to exercise her professional activity.She was on disability leave until (b)(6) 2011.On (b)(6) 2011, the patient consulted neurologist, who mentioned that she had no personal or familial history of muscle disease, and noticed the reduction of serum potassium.The patient also referred about chronic diarrhea, which started several months earlier.On (b)(6) 2011, adrenal imaging showed no abnormality.On (b)(6) 2011, colonoscopy due to abdominal pain and muscle cramps was normal.On (b)(6) 2011, disability leave again due to diffuse pain, characterized as muscle pain from (b)(6) 2011, and from (b)(6) 2011.Starting on an unspecified date, she experienced chronic diarrhoea with reduced serum potassium and episodes of major muscle fatigue, indeed paralysis, with muscle pain, a feeling of muscle stiffness and constant contraction of muscles, somewhat like sore muscles.It was informed that the electrophysiological examination suggested muscle impairment.On (b)(6) 2012, duodenal and gastric biopsies were collected at multiple levels and it was concluded to: mild duodenitis, chronic active antral gastritis with helicobacter pylori and interstitial lymphocytic gastritis with no helicobacter pylori.She received a prescription of omeprazole to relieve abdominal pain and prevent chronic diarrhoea.On (b)(6) 2012, following further episode of functional impairment with muscle weakness and violent pain, accompanied by various problems of a cardiological nature, and due to rotatory positional vertigo, which started two weeks earlier, she went to emergency.She complained of pain in base of chest, around 3:00 pm and lasting a few seconds, like a stitch as well as marked palpitations.Heart sounds were irregular with numerous ectopic beats.Blood tests found several abnormalities concerning leucocyte, neutrophil and creatinine levels.(b)(6).On (b)(6) 2012, she consulted a physician due to worsening of dyspnoea on effort, palpitations and dizziness, and avlocardyl was prescribed.On (b)(6) 2012, ent (ears, nose, and throat) examination proved to be normal.According to physician, her symptoms suggested instability of otoconia following spontaneously resolutive benign paroxysmal positional vertigo, i.E.Bppv of "mechanical" origin.So, prescribed tanganil and biperidys.On (b)(6) 2012, pituitary and brain mri was normal.On (b)(6) 2012, she consulted other physician, due to episodes of myalgia/ muscle pain, predominating in lower limbs and paraesthesia, relieved by intake of magnesium, who mentioned that the patient experienced episodes of thyroid disorder, starting in 2009 and noticed that she had minor syndrome of dry eyes and therefore auto-immunity, also thyroid.Doctor also found serum potassium level strange at 6 mmol and was wondering about hemolysis.She continued taking magnesium to relieve her from muscle pains.On (b)(6) 2012, urine analysis found a free cortisol level, well above the normal range.On (b)(6) 2012, doppler ultrasound of abdominal aorta and of lower limbs arterial axis was indicated following lower limb oedema and pain.Doppler ultrasound was normal.On (b)(6) 2013, the following diagnosis was made: spasmophilia with normal serum calcium and vitamin deficiency, with fibromyalgia.Treatment with calcium and vitamin supplementation for at least 2 years was recommended by the physician.On (b)(6) 2013, she consulted for recurrent cystitis starting one and a half months earlier.On (b)(6) 2013, the patient consulted a physician for a wart on her left hand.She experienced inflammation of the scalp with dandruff and itching, and mycosis of nails.The patient received various treatments including blenderm (hypo-allergenic dressing) and akerat (cream against dryness and peeling).The physician also noticed that she had lower limb sclerosis.On (b)(6) 2013, ct-scan of urinary tract was normal.The reported commented that from (b)(6) 2011 to (b)(6) 2013, she underwent psychological follow-up due to somatic disturbances and rather incapacitating chronic join pain that caused a 'state of anxiety'.On (b)(6) 2014, holter ecg found very abundant, isolated, monomorphic ventricular ectopic beats with a pattern of bigeminy and trigeminy.On (b)(6) 2014, she was on flecaine 150 and sectral 200 due to frequent ventricular ectopic beats.It was reported that the patient was more and more tired and more and more short of breath on effort.On (b)(6) 2014, ct-urography showed no visible abnormality.On (b)(6) 2015, the patient experienced headaches with reported episodes of sleep apnoea syndrome as well as rhinopathy leading to sinus ct-scan, which found thickening of the lining in the fundus of both maxillary sinuses, minimal deviated septum to the right and hypertrophy of right inferior turbinate.On (b)(6) 2015, she consulted at emergency due to cruralgia.Treatment with tramadol 50, bi-profenid and paracetamol was prescribed.Pain persisted despite treatment.On (b)(6) 2015, she again consulted in emergency for pain extending from the left buttock to the left thigh, starting 3 days earlier, with no trauma, pain on walking and mobilisation, with pangs of pain.Local motor examination found sharp pain on palpation of the gluteus medius tendons, pain on mobilisation of hip.On (b)(6) 2015 ultrasound of left thigh was normal.On (b)(6) 2015, electromyography found neurogenic tracings on effort in muscles of quadriceps, toe extensors and anterior leg muscles on left.It was concluded to nerve root involvement at l4.On (b)(6) 2015, her epworth score was 12, reflecting major diurnal somnolence.On (b)(6) 2015 she underwent assessment of neurotransmitters.Her 5-hiaa level seemed to be below normal.On (b)(6) 2016, she underwent abdominal pelvic ct-scan for assessment of pelvic pain, which concluded to absence of kidney stones and multiple-level osteoarthritic disc disease predominantly involving l5-s1 on the left.On (b)(6) 2016, she consulted an urologist due to germ-free bladder pain starting 4 years earlier with progressively increasing frequency.She experienced at the time, 2 or 3 episodes a month.It was reported that the cystitis persisted despite antibiotics.On (b)(6) 2016, ultrasound found thyroid volume at the lower limit of normal and compatible in appearance with hashimoto's thyroiditis.On (b)(6) 2016, stress tests found no features to suggest myocardial ischaemia.The examination was stopped due to muscle fatigue.The patient received treatment with sectral for hypertension.On (b)(6) 2016, she underwent cystoscopy with hydrodistention, which concluded to the absence of frank signs of interstitial cystitis.In 2016, the patient had heavy menstrual periods and pelvic pain.On (b)(6) 2017 her gynaecologist noted that, since placement of the essure inserts, the patient had experienced major menorrhagia, recurrent urinary tract infection and progressive onset of autoimmune diseases.She also had recurrent vaginal mycosis.On (b)(6) 2017, kidney ultrasound was normal.On (b)(6) 2017, adrenal gland ct-scan showed a nodular formation on the medial limb of the left adrenal with negative spontaneous density, confirming that it was benign in nature.On (b)(6) 2017 (b)(6).On (b)(6) 2017, physician mentioned that the patient experienced multiple medical problems with progressive onset starting in 2009, among which: autoimmune thyroid disorder, on treatment, severe vitamin-d deficiency, severe attack of muscle pain with functional impairment of unknown origin, chronic asthenia despite well-conducted thyroid treatment on laboratory monitoring, cardiomyopathy of unknown origin with hypertension and ectopic beats, recurrent urinary tract infections, complicated by hydrodistention, recurrent severe digestive and vaginal mycosis, paroxysmal vertigo of unknown origin, pruritus with eczema-like attacks, major secondary dysmenorrhoea with no anatomical lesions detected, oedema of extremities, elevated cortisol levels related to recently discovered left adrenal adenoma, recently discovered intolerance to sugar with dyslipidaemia.On (b)(6) 2017, allergy tests showed delayed hypersensitivity to nickel.It was informed that after placement of the essure inserts, the patient developed frequent oedema of the hands, feet and face, she could no longer tolerate her gold wedding ring due to the risk of severe swelling of the hand and her abdomen was also constantly swollen.She gained weight of 12 kg in 18 months and of 18 kg in 3 years.Since (b)(6) 2017, successive periods of disability leave on (b)(6) 2017, the intervention was performed, and hysterectomy with bilateral salpingectomy was performed.The patient experienced pain in left iliac fossa following the procedure with anaesthesia of root of thigh.Post-operative abdominal brace was prescribed.In the post-operative period, ovarian vein stenosis and onset of a cyst on the left flank were reported.In the month following hysterectomy with bilateral salpingectomy, the patient was still under prescription of injectable anticoagulant.In (b)(6) 2017, one month after the procedure, it was noticed a gradual regression of chronic fatigue, joint and muscle pain, gradual regression of oedema of extremities, the reduction and then complete discontinuation of cardiological treatments for hypertension and palpitations and endocrine treatment for hyperthyroidism, and return to normal of blood test results.On (b)(6) 2017, physician noted complete discontinuation of antihypertensives, return to normal of bp, resolution of oedema and repression of muscle pain.On (b)(6) 2017, ct-scan found ovarian cyst on left, as well as thrombosis of the left ovarian vein, extending over approximately 10 cm.The pain in thigh persisted, and thrombosis required prescription of anticoagulant and pain-killers.On (b)(6) 2017, pelvic and left hip mri were prescribed due to left groin pain, pain on walking and on abduction.On (b)(6) 2017, blood pressure was perfectly normal.The reporter stated that the rest of the symptoms, however, more and more clearly regressed.And also informed that, considering herself to be a victim of the device, the plaintiff has decided to file an application with the courts to request the designation of an expert capable of adjudicating on the causal relationship between placement of the inserts and the numerous health problems she has encountered.The list of device similar incidents contains essure reports received by bayer and older cases received by conceptus with similar events coded in meddra.In this particular case a search in the database was performed on 13-sep-2017 for the following meddra preferred terms: pelvic pain.The analysis in the global safety database revealed 3996 cases.Ovarian vein thrombosis.The analysis in the global safety database revealed 1 case.Bayer is closely monitoring the benefit-risk profile of essure.A recent cumulative review of all available data on essure has not yielded any new safety signal with regard to these meddra pts.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, urinary tract infection, bladder hydrodistension, autoimmune thyroiditis, dry eye, paralysis, helicobacter gastritis, suicidal ideation and ovarian vein thrombosis in a (b)(6) year-old female patient who had essure inserted.The patient's past medical history included three children, two pregnancies.Prior to placement of the essure inserts, the patient was in good general health and was not being followed for any problems.The patient's concurrent conditions included overweight and an anteverted uterus.On (b)(6) 2008 a normal work-up (hematology, biological chemistry) was reported, and also on (b)(6) 2008 (hematology, hemostasis, immuno-hemostasis).On an unspecified date cytobacteriologic examination was done, and absence of candidas albicans on vaginal sample was noted, and negative result in culture.On (b)(6) 2008, the patient underwent sterilization by the essure method with no difficulties with four trailing spires on the right and seven trailing spirals on the left visible in the uterus.An unspecified oral contraception was used after essure placement for 3 months.On (b)(6) 2009, pelvic ultrasound was normal.Plain abdomen x-ray of control 3 months post placement was also performed.The implants were in place in fallopian tubes.In 2010, major fatigue, weight gain, bloating, muscle pain in legs and abdomen, episodes of diarrhoea, abdominal pain, acne, itchy scalp and frequent nausea.Her gynecologist, mentioned asthenia, cramps, oedema of extremities, recurrent vaginal mycosis and urinary tract infections, increasingly severe menorrhagia, acne, high blood pressure and progressive weight gain.On (b)(6) 2010, blood tests found a vitamin d3 level of 11 ng/ml, i.E.A vitamin-d3 deficiency/ insufficiency.On (b)(6) 2010, immuno-enzyme assays were performed due to suspicion of hashimoto's disease and found the following: thyroid peroxidase antibodies at 108 iu/l; thyroglobulin antibodies at 143 iu/l.These values are well above the normal range.On (b)(6) 2010 pelvic ultrasound, performed to check positioning of the inserts, was normal.On (b)(6) 2010, her endocrinologist noticed that the patient was found to have elevated tsh at 4.53 iu/l.On (b)(6) 2010, endocrinologist concluded to a toxic phase of hashimoto's thyroiditis, and prescribed levothyrox 25 to her.The patient complained of weight gain from plurifactorial origin.She was self-employed kinesitherapist, and did not take time for lunch, which is the main cause of her overweight.In (b)(6) 2010, she experienced muscle pain initially localized to the legs with recent spread to upper limbs.After 6 months, on (b)(6) 2011, the patient went to emergency for muscle pains that were persistent for some months.She was admitted for suspicion of lupus.Since 2009 or 2010, the patient had suddenly changed following an attack, assimilated to tetany.Extreme constant anxiety, both physical and psychological repercussions, mood disturbances, sleep disturbances, chronic fatigue, loss of energy and motivation, panic attacks, withdrawal into herself, eating disorder and phobic behavior.It was reported as a clinical picture of depression.Furthermore it was commented about anxiety of imminent death, sometimes going so far as to express suicidal ideas to put an end to her moral suffering and the feeling of exhaustion.In (b)(6) 2011 she experienced the first episode of function weakness.She also complained about muscular pain and difficulty to move, and went to emergency unit on an unspecified date.She received a prescription of hexaquine and myolastan, and was addressed to nephrologist.On (b)(6) 2011, she attended a consultation with nephrologist, who noted that muscle pain was diffuse, sometimes accompanied by a feeling of trembling.There was no nephrological involvement, and adrenal gland mri normal (while now adenoma).It was also noticed a few lesions of acne.On the same day, she reported episodes of diarrhea.On (b)(6) 2011, the patient was no longer physically able to exercise her professional activity.She was on sick leave prescription due to myalgia and diffuse pain from (b)(6) 2011.On (b)(6) 2011, the patient consulted neurologist, who mentioned that she had no personal or familial history of muscle disease, and noticed the reduction of serum potassium.The patient also referred about chronic diarrhea, which started several months earlier.On (b)(6) 2011, adrenal imaging showed no abnormality.On (b)(6) 2011, colonoscopy due to abdominal pain and muscle cramps was normal.On (b)(6) 2011, disability leave again due to diffuse pain, characterized as muscle pain from (b)(6) 2011, and from (b)(6) 2011.Starting on an unspecified date, she experienced chronic diarrhoea with reduced serum potassium and episodes of major muscle fatigue, indeed paralysis, with muscle pain, a feeling of muscle stiffness and constant contraction of muscles, somewhat like sore muscles.It was informed that the electrophysiological examination suggested muscle impairment.On (b)(6) 2012 work-up was normal.On (b)(6) 2012, duodenal and gastric biopsies were collected at multiple levels and it was concluded to: mild duodenitis, chronic active antral gastritis with helicobacter pylori and interstitial lymphocytic gastritis with no helicobacter pylori.She received a prescription of omeprazole to relieve abdominal pain and prevent chronic diarrhoea.On (b)(6) 2012, following further episode of functional impairment with muscle weakness and violent pain, dyspnoea on effort, dizziness, accompanied by various problems of a cardiological nature, and due to rotatory positional vertigo, which started two weeks earlier, she went to emergency.It was also reported that the patient experienced her second episode of functional weakness.She complained of pain in base of chest, around 3:00 pm and lasting a few seconds, like a stitch as well as marked palpitations.Heart sounds were irregular with numerous ectopic beats.Blood tests found several abnormalities concerning leucocyte, neutrophil and creatinine levels.Cardiac examination, holter and cardiac ultrasounds were performed, and her ecg (electrocardiogram) was normal.She received the prescription of avlocardyl.The patient's weight was of (b)(6) kg.On (b)(6) 2012, she consulted a physician due to worsening of dyspnoea on effort, palpitations and dizziness, and avlocardyl was prescribed.On (b)(6) 2012, ent (ears, nose, and throat) examination proved to be normal.According to physician, her symptoms suggested instability of otoconia following spontaneously resolutive benign paroxysmal positional vertigo, i.E.Bppv of "mechanical" origin.So, prescribed tanganil and biperidys.On (b)(6) 2012, pituitary and brain mri was normal.New sick leave from (b)(6) 2012.On (b)(6) 2012, she consulted other physician, due to episodes of myalgia/ muscle pain, predominating in lower limbs and paraesthesia, relieved by intake of magnesium, who mentioned that the patient experienced episodes of thyroid disorder, starting in 2009 and noticed that she had minor syndrome of dry eyes and therefore auto-immunity, also thyroid.Doctor also found serum potassium level strange at 6 mmol and was wondering about hemolysis.She continued taking magnesium to relieve her from muscle pains.On (b)(6) 2012, urine analysis found a free cortisol level, well above the normal range.On (b)(6) 2012, doppler ultrasound of abdominal aorta and of lower limbs arterial axis was indicated following lower limb oedema and pain.Doppler ultrasound was normal.Orl consultation for dizziness on (b)(6) 2012, and tanganil and illegible treatment were prescribed.Ct-scan for abdominal pain was performed, protein electrophoresis and hypophysis mri were abnormal, very high level of free cortisol was noted, helicobacter pylori was treated, and iron saturation coefficient was illegible.It was also informed that the muscular symptoms improved with 3 ampoules of illegible word + antalgic +cuprum, a prescription of dedidrogyl + mag2 + calcium was performed and tingling and myalgia improvement but no improvement of muscular weakness and fatigue and other symptoms.Work-up: pth elevated, low phosphorus and vitamin d improved with dedrogyl.On (b)(6) 2013, the following diagnosis was made: spasmophilia with normal serum calcium and vitamin deficiency, with fibromyalgia.Treatment with calcium and vitamin supplementation for at least 2 years was recommended by the physician.Recurrent cystitis treated with antibiotic but frequency increased.Due to that, on (b)(6) 2013, she consulted an urologist for kidney control.Onset of vaginal mycosis.Pylori was treated and was under control.On (b)(6) 2013, the patient consulted a physician for a wart on her left hand.She experienced inflammation of the scalp with dandruff and itching, and mycosis of nails.The patient received various treatments including blenderm (hypo-allergenic dressing) and akerat (cream against dryness and peeling).The physician also noticed that she had lower limb sclerosis.On (b)(6) 2013, ct-scan of urinary tract was normal.The reported commented that from (b)(6) 2011 to (b)(6) 2013, she underwent psychological follow-up due to somatic disturbances and rather incapacitating chronic join pain that caused a 'state of anxiety'.On an unspecified date a consultation with angiologist for oedema and lower limb pain, which increase with heat, was done.Venous and arterial echodoppler normal, and onset of varix requiring sclerosis was reported.Wart treated with nitrogel several times.On (b)(6) 2014, holter ecg found very abundant, isolated, monomorphic ventricular extrasystole/ectopic beats with a pattern of bigeminy and trigeminy.Work-up: urine calcium too important and low vitamin d again despite dedrogyl.On (b)(6) 2014, she was on flecaine 150 and sectral 200 due to frequent ventricular ectopic beats.It was reported that the patient was more and more tired and more and more short of breath on effort.Dedrogyl dosage regimen increased in (b)(6) 2014.Vitamin d and calcium control in (b)(6) 2014 were normal.In (b)(6) 2014 urine culture diagnosed urinary tract infection +++, infection with clear urine.It was informed that she had 2 or 3 episodes of urinary tract infection per months.Antibiotic protocol was initiated twice per week for 3 months.It was also reported a very frequent vaginal mycosis with local treatment for 3 months.On (b)(6) 2014, ct-urography showed no visible abnormality.On (b)(6) 2015, the patient experienced headaches and snoring, with reported episodes of sleep apnoea syndrome as well as rhinopathy leading to sinus ct-scan, which found thickening of the lining in the fundus of both maxillary sinuses, minimal deviated septum to the right and hypertrophy of right inferior turbinate.It was reported about the third episode of functional weakness, with a very strong pain in left thigh during the night, total functional weakness of left leg with hyperalgesia.On (b)(6) 2015, she consulted at emergency due to cruralgia.Treatment with tramadol 50, bi-profenid and paracetamol was prescribed, and also toplagic + illegible word + doliprane+acupan+laroxyl, and for mycosis episode: fungizone.Pain persisted despite treatment.On (b)(6) 2015, she again consulted in emergency for pain extending from the left buttock to the left thigh, starting 3 days earlier, with no trauma, pain on walking and mobilisation, with pangs of pain.Local motor examination found sharp pain on palpation of the gluteus medius tendons, pain on mobilisation of hip.Left thigh ultrasounds for persistent pain was done, and electromyogram showed neurogenic-like record on effort in area of quadriceps extensor muscle of toes and left anterior leg.New sick leave from (b)(6) 2015.On (b)(6) 2015 ultrasound of left thigh was normal.On (b)(6) 2015, electromyography found neurogenic tracings on effort in muscles of quadriceps, toe extensors and anterior leg muscles on left.It was concluded to nerve root involvement at l4.On (b)(6) 2015, her epworth score was 12, reflecting major diurnal somnolence.On (b)(6) 2015 she underwent assessment of neurotransmitters.Her 5-hiaa level seemed to be below normal.On (b)(6) 2016, she underwent abdominal pelvic ct-scan for assessment of pelvic pain, which concluded to absence of kidney stones and multiple-level osteoarthritic disc disease predominantly involving l5-s1 on the left.On (b)(6) 2016 she received the prescription of lyrica due to urinary tract infection.On (b)(6) 2016, she consulted an urologist due to germ-free bladder pain starting 4 years earlier with progressively increasing frequency.She experienced at the time, 2 or 3 episodes a month.It was reported that the cystitis persisted despite antibiotics.Work-up of control on (b)(6) 2016 was done, as treatment ongoing.Low phosphorus level, tsh inbalance, high glycaemia, and early diabetes was noticed.On (b)(6) 2016, ultrasound found thyroid volume at the lower limit of normal and compatible in appearance with hashimoto's thyroiditis.On (b)(6) 2016, stress tests found no features to suggest myocardial ischaemia.The examination was stopped due to muscle fatigue.The patient received treatment with sectral for hypertension.On (b)(6) 2016, she underwent cystoscopy with hydrodistention, which concluded to the absence of frank signs of interstitial cystitis.In 2016, the patient had heavy menstrual periods and pelvic pain.On an unspecified date control thyroid, and hydrodistension under general anaesthesia were done.On (b)(6) 2017 her gynaecologist noted that, since placement of the essure inserts, the patient had experienced major menorrhagia, recurrent urinary tract infection and progressive onset of autoimmune diseases.She also had recurrent vaginal mycosis.On (b)(6) 2017, kidney ultrasound was normal.On (b)(6) 2017, adrenal gland ct-scan showed a nodular formation on the medial limb of the left adrenal with negative spontaneous density, confirming that it was benign in nature.On (b)(6) 2017, her gynecologist informed that treatments for vaginal mycosis and menorrhagia were added.Her weight was (b)(6) kg.On (b)(6) 2017, physician mentioned that the patient experienced multiple medical problems with progressive onset starting in 2009, among which: autoimmune thyroid disorder, on treatment, severe vitamin-d deficiency, severe attack of muscle pain with functional impairment of unknown origin, chronic asthenia despite well-conducted thyroid treatment on laboratory monitoring, cardiomyopathy of unknown origin with hypertension and ectopic beats, recurrent urinary tract infections, complicated by hydrodistention, recurrent severe digestive and vaginal mycosis, paroxysmal vertigo of unknown origin, pruritus with eczema-like attacks, major secondary dysmenorrhoea with no anatomical lesions detected, oedema of extremities, elevated cortisol levels related to recently discovered left adrenal adenoma, recently discovered intolerance to sugar with dyslipidaemia.On (b)(6) 2017, allergy tests showed delayed hypersensitivity to nickel.It was informed that after placement of the essure inserts, the patient developed frequent oedema of the hands, feet and face, she could no longer tolerate her gold wedding ring due to the risk of severe swelling of the hand and her abdomen was also constantly swollen.She gained weight of 12 kg in 18 months and of 18 kg in 3 years.Since (b)(6) 2017, successive periods of disability leave.On (b)(6) 2017, the intervention was performed, and hysterectomy with bilateral salpingectomy was performed.The patient experienced pain in left iliac fossa following the procedure with anaesthesia of root of thigh.Post-operative abdominal brace was prescribed.In the post-operative period, ovarian vein stenosis and onset of a cyst on the left flank were reported.In the month following hysterectomy with bilateral salpingectomy, the patient was still under prescription of injectable anticoagulant.In (b)(6) 2017, one month after the procedure, it was noticed a gradual regression of chronic fatigue, joint and muscle pain, gradual regression of oedema of extremities, the reduction and then complete discontinuation of cardiological treatments for hypertension and palpitations and endocrine treatment for hyperthyroidism, and return to normal of blood test results.On (b)(6) 2017, physician noted complete discontinuation of antihypertensives, return to normal of bp, resolution of oedema and repression of muscle pain.On (b)(6) 2017, ct-scan found ovarian cyst on left, as well as thrombosis of the left ovarian vein, extending over approximately 10 cm.The pain in thigh persisted, and thrombosis required prescription of anticoagulant and pain-killers.On (b)(6) 2017, pelvic and left hip mri were prescribed due to left groin pain, pain on walking and on abduction.On (b)(6) 2017, blood pressure was perfectly normal.New endocrine work-up in 2017, heavy metal screening test, renal ultrasounds, and work-up for hypertension were performed.Elevated renal arteries blood flow was observed, nodule was found in adrenal gland (while examination was normal in 2011).The reporter stated that the rest of the symptoms, however, more and more clearly regressed.And also informed that, considering herself to be a victim of the device, the plaintiff has decided to file an application with the courts to request the designation of an expert capable of adjudicating on the causal relationship between placement of the inserts and the numerous health problems she has encountered.The list of device similar incidents contains essure reports received by bayer and older cases received by conceptus with similar events coded in meddra.In this particular case a search in the database was performed on 25-sep-2017 for the following meddra preferred terms: pelvic pain - the analysis in the global safety database revealed 4.399 cases.Ovarian vein thrombosis - the analysis in the global safety database revealed 1 case.Bayer is closely monitoring the benefit-risk profile of essure.A recent cumulative review of all available data on essure has not yielded any new safety signal with regard to these meddra pts.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, urinary tract infection, bladder hydrodistension, autoimmune thyroiditis, dry eye, paralysis, helicobacter gastritis, suicidal ideation and ovarian vein thrombosis in a (b)(6) -year-old female patient who had essure inserted.The patient's past medical history included three children, two pregnancies.Prior to placement of the essure inserts, the patient was in good general health and was not being followed for any problems.The patient's concurrent conditions included overweight and an anteverted uterus.On 09-may-2008 a normal work-up (hematology, biological chemistry) was reported, and also on (b)(6) 2008 (hematology, hemostasis, immuno-hemostasis).On an unspecified date cytobacteriologic examination was done, and absence of candidas albicans on vaginal sample was noted, and negative result in culture.On (b)(6) 2008, the patient underwent sterilization by the essure method with no difficulties with four trailing spires on the right and seven trailing spirals on the left visible in the uterus.An unspecified oral contraception was used after essure placement for 3 months.On (b)(6) 2009, pelvic ultrasound was normal.Plain abdomen x-ray of control 3 months post placement was also performed.The implants were in place in fallopian tubes.In 2010, major fatigue, weight gain, bloating, muscle pain in legs and abdomen, episodes of diarrhoea, abdominal pain, acne, itchy scalp and frequent nausea.Her gynecologist, mentioned asthenia, cramps, oedema of extremities, recurrent vaginal mycosis and urinary tract infections, increasingly severe menorrhagia, acne, high blood pressure and progressive weight gain.On (b)(6) 2010, blood tests found a vitamin d3 level of 11 ng/ml, i.E.A vitamin-d3 deficiency/insufficiency.On (b)(6) 2010, immuno-enzyme assays were performed due to suspicion of hashimoto's disease and found the following: thyroid peroxidase antibodies at 108 iu/l; thyroglobulin antibodies at 143 iu/l.These values are well above the normal range.On (b)(6) 2010 pelvic ultrasound, performed to check positioning of the inserts, was normal.On (b)(6) 2010, her endocrinologist noticed that the patient was found to have elevated tsh at 4.53 iu/l.On (b)(6) 2010, endocrinologist concluded to a toxic phase of hashimoto's thyroiditis, and prescribed levothyrox 25 to her.The patient complained of weight gain from plurifactorial origin.She was self-employed kinesitherapist, and did not take time for lunch, which is the main cause of her overweight.In (b)(6) 2010, she experienced muscle pain initially localized to the legs with recent spread to upper limbs.After 6 months, on (b)(6) 2011, the patient went to emergency for muscle pains that were persistent for some months.She was admitted for suspicion of lupus.Since 2009 or 2010, the patient had suddenly changed following an attack, assimilated to tetany.Extreme constant anxiety, both physical and psychological repercussions, mood disturbances, sleep disturbances, chronic fatigue, loss of energy and motivation, panic attacks, withdrawal into herself, eating disorder and phobic behavior.It was reported as a clinical picture of depression.Furthermore it was commented about anxiety of imminent death, sometimes going so far as to express suicidal ideas to put an end to her moral suffering and the feeling of exhaustion.In (b)(6) -2011 she experienced the first episode of function weakness.She also complained about muscular pain and difficulty to move, and went to emergency unit on an unspecified date.She received a prescription of hexaquine and myolastan, and was addressed to nephrologist.On (b)(6) 2011, she attended a consultation with nephrologist, who noted that muscle pain was diffuse, sometimes accompanied by a feeling of trembling.There was no nephrological involvement, and adrenal gland mri normal (while now adenoma).It was also noticed a few lesions of acne.On the same day, she reported episodes of diarrhea.On (b)(6) 2011, the patient was no longer physically able to exercise her professional activity.She was on sick leave prescription due to myalgia and diffuse pain from (b)(6) 2011 to (b)(6) 2011.On (b)(6) 2011, the patient consulted neurologist, who mentioned that she had no personal or familial history of muscle disease, and noticed the reduction of serum potassium.The patient also referred about chronic diarrhea, which started several months earlier.On (b)(6) 2011, adrenal imaging showed no abnormality.On (b)(6) 2011, colonoscopy due to abdominal pain and muscle cramps was normal.On (b)(6) 2011, disability leave again due to diffuse pain, characterized as muscle pain from (b)(6) to (b)(6) 2011, and from (b)(6) to (b)(6) 2011.Starting on an unspecified date, she experienced chronic diarrhoea with reduced serum potassium and episodes of major muscle fatigue, indeed paralysis, with muscle pain, a feeling of muscle stiffness and constant contraction of muscles, somewhat like sore muscles.It was informed that the electrophysiological examination suggested muscle impairment.On (b)(6) 2012 work-up was normal.On (b)(6) 2012, duodenal and gastric biopsies were collected at multiple levels and it was concluded to: mild duodenitis, chronic active antral gastritis with helicobacter pylori and interstitial lymphocytic gastritis with no helicobacter pylori.She received a prescription of omeprazole to relieve abdominal pain and prevent chronic diarrhoea.On (b)(6) 2012, following further episode of functional impairment with muscle weakness and violent pain, dyspnoea on effort, dizziness, accompanied by various problems of a cardiological nature, and due to rotatory positional vertigo, which started two weeks earlier, she went to emergency.It was also reported that the patient experienced her second episode of functional weakness.She complained of pain in base of chest, around 3:00 pm and lasting a few seconds, like a stitch as well as marked palpitations.Heart sounds were irregular with numerous ectopic beats.Blood tests found several abnormalities concerning leucocyte, neutrophil and creatinine levels.Cardiac examination, holter and cardiac ultrasounds were performed, and her ecg (electrocardiogram) was normal.She received the prescription of avlocardyl.The patient's weight was of (b)(6) kg.On (b)(6) 2012, she consulted a physician due to worsening of dyspnoea on effort, palpitations and dizziness, and avlocardyl was prescribed.On (b)(6) 2012, ent (ears, nose, and throat) examination proved to be normal.According to physician, her symptoms suggested instability of otoconia following spontaneously resolutive benign paroxysmal positional vertigo, i.E.Bppv of "mechanical" origin.So, prescribed tanganil and biperidys.On (b)(6) 2012, pituitary and brain mri was normal.New sick leave from (b)(6) 2012 to (b)(6) 2012.On (b)(6) 2012, she consulted other physician, due to episodes of myalgia/ muscle pain, predominating in lower limbs and paraesthesia, relieved by intake of magnesium, who mentioned that the patient experienced episodes of thyroid disorder, starting in 2009 and noticed that she had minor syndrome of dry eyes and therefore auto-immunity, also thyroid.Doctor also found serum potassium level strange at 6 mmol and was wondering about hemolysis.She continued taking magnesium to relieve her from muscle pains.On (b)(6) 2012, urine analysis found a free cortisol level, well above the normal range.On (b)(6) 2012, doppler ultrasound of abdominal aorta and of lower limbs arterial axis was indicated following lower limb oedema and pain.Doppler ultrasound was normal.Orl consultation for dizziness on (b)(6) 2012, and tanganil and illegible treatment were prescribed.Ct-scan for abdominal pain was performed, protein electrophoresis and hypophysis mri were abnormal, very high level of free cortisol was noted, helicobacter pylori was treated, and iron saturation coefficient was illegible.It was also informed that the muscular symptoms improved with 3 ampoules of illegible word + antalgic +cuprum, a prescription of dedidrogyl + mag2 + calcium was performed and tingling and myalgia improvement but no improvement of muscular weakness and fatigue and other symptoms.Work-up: pth elevated, low phosphorus and vitamin d improved with dedrogyl.On (b)(6) 2013, the following diagnosis was made: spasmophilia with normal serum calcium and vitamin deficiency, with fibromyalgia.Treatment with calcium and vitamin supplementation for at least 2 years was recommended by the physician.Recurrent cystitis treated with antibiotic but frequency increased.Due to that, on (b)(6) 2013, she consulted an urologist for kidney control.Onset of vaginal mycosis.Pylori was treated and was under control.On (b)(6) 2013, the patient consulted a physician for a wart on her left hand.She experienced inflammation of the scalp with dandruff and itching, and mycosis of nails.The patient received various treatments including blenderm (hypo-allergenic dressing) and akerat (cream against dryness and peeling).The physician also noticed that she had lower limb sclerosis.On (b)(6) 2013, ct-scan of urinary tract was normal.The reported commented that from 19-sep-2011 to 23-oct-2013, she underwent psychological follow-up due to somatic disturbances and rather incapacitating chronic join pain that caused a 'state of anxiety'.On an unspecified date a consultation with angiologist for oedema and lower limb pain, which increase with heat, was done.Venous and arterial echodoppler normal, and onset of varix requiring sclerosis was reported.Wart treated with nitrogel several times.On (b)(6) 2014, holter ecg found very abundant, isolated, monomorphic ventricular extrasystole/ectopic beats with a pattern of bigeminy and trigeminy.Work-up: urine calcium too important and low vitamin d again despite dedrogyl.On (b)(6) 2014, she was on flecaine 150 and sectral 200 due to frequent ventricular ectopic beats.It was reported that the patient was more and more tired and more and more short of breath on effort.Dedrogyl dosage regimen increased in (b)(6) -2014.Vitamin d and calcium control in (b)(6) -2014 were normal.In (b)(6) -2014 urine culture diagnosed urinary tract infection +++, infection with clear urine.It was informed that she had 2 or 3 episodes of urinary tract infection per months.Antibiotic protocol was initiated twice per week for 3 months.It was also reported a very frequent vaginal mycosis with local treatment for 3 months.On (b)(6) 2014, ct-urography showed no visible abnormality.On (b)(6) 2015, the patient experienced headaches and snoring, with reported episodes of sleep apnoea syndrome as well as rhinopathy leading to sinus ct-scan, which found thickening of the lining in the fundus of both maxillary sinuses, minimal deviated septum to the right and hypertrophy of right inferior turbinate.It was reported about the third episode of functional weakness, with a very strong pain in left thigh during the night, total functional weakness of left leg with hyperalgesia.On (b)(6) 2015, she consulted at emergency due to cruralgia.Treatment with tramadol 50, bi-profenid and paracetamol was prescribed, and also toplagic + illegible word + doliprane+acupan+laroxyl, and for mycosis episode: fungizone.Pain persisted despite treatment.On (b)(6) 2015, she again consulted in emergency for pain extending from the left buttock to the left thigh, starting 3 days earlier, with no trauma, pain on walking and mobilisation, with pangs of pain.Local motor examination found sharp pain on palpation of the gluteus medius tendons, pain on mobilisation of hip.Left thigh ultrasounds for persistent pain was done, and electromyogram showed neurogenic-like record on effort in area of quadriceps extensor muscle of toes and left anterior leg.New sick leave from (b)(6) 2015 to (b)(6) 2015.On (b)(6) 2015 ultrasound of left thigh was normal.On (b)(6) 2015, electromyography found neurogenic tracings on effort in muscles of quadriceps, toe extensors and anterior leg muscles on left.It was concluded to nerve root involvement at l4.On (b)(6) 2015, her epworth score was 12, reflecting major diurnal somnolence.On (b)(6) 2015 she underwent assessment of neurotransmitters.Her 5-hiaa level seemed to be below normal.On (b)(6) 2016, she underwent abdominal pelvic ct-scan for assessment of pelvic pain, which concluded to absence of kidney stones and multiple-level osteoarthritic disc disease predominantly involving l5-s1 on the left.On (b)(6) 2016 she received the prescription of lyrica due to urinary tract infection.On (b)(6) 2016, she consulted an urologist due to germ-free bladder pain starting 4 years earlier with progressively increasing frequency.She experienced at the time, 2 or 3 episodes a month.It was reported that the cystitis persisted despite antibiotics.Work-up of control on (b)(6) 2016 was done, as treatment ongoing.Low phosphorus level, tsh inbalance, high glycaemia, and early diabetes was noticed.On (b)(6) 2016, ultrasound found thyroid volume at the lower limit of normal and compatible in appearance with hashimoto's thyroiditis.On (b)(6) 2016, stress tests found no features to suggest myocardial ischaemia.The examination was stopped due to muscle fatigue.The patient received treatment with sectral for hypertension.On (b)(6) 2016, she underwent cystoscopy with hydrodistention, which concluded to the absence of frank signs of interstitial cystitis.In 2016, the patient had heavy menstrual periods and pelvic pain.On an unspecified date control thyroid, and hydrodistension under general anaesthesia were done.On (b)(6) 2017 her gynaecologist noted that, since placement of the essure inserts, the patient had experienced major menorrhagia, recurrent urinary tract infection and progressive onset of autoimmune diseases.She also had recurrent vaginal mycosis.On (b)(6) 2017, kidney ultrasound was normal.On (b)(6) 2017, adrenal gland ct-scan showed a nodular formation on the medial limb of the left adrenal with negative spontaneous density, confirming that it was benign in nature.On (b)(6) 2017, her gynecologist informed that treatments for vaginal mycosis and menorrhagia were added.Her weight was (b)(6) kg.On (b)(6) 2017, physician mentioned that the patient experienced multiple medical problems with progressive onset starting in 2009, among which: autoimmune thyroid disorder, on treatment, severe vitamin-d deficiency, severe attack of muscle pain with functional impairment of unknown origin, chronic asthenia despite well-conducted thyroid treatment on laboratory monitoring, cardiomyopathy of unknown origin with hypertension and ectopic beats, recurrent urinary tract infections, complicated by hydrodistention, recurrent severe digestive and vaginal mycosis, paroxysmal vertigo of unknown origin, pruritus with eczema-like attacks, major secondary dysmenorrhoea with no anatomical lesions detected, oedema of extremities, elevated cortisol levels related to recently discovered left adrenal adenoma, recently discovered intolerance to sugar with dyslipidaemia.On (b)(6) 2017, allergy tests showed delayed hypersensitivity to nickel.It was informed that after placement of the essure inserts, the patient developed frequent oedema of the hands, feet and face, she could no longer tolerate her gold wedding ring due to the risk of severe swelling of the hand and her abdomen was also constantly swollen.She gained weight of 12 kg in 18 months and of 18 kg in 3 years.Since (b)(6) 2017, successive periods of disability leave on (b)(6) 2017, the intervention was performed, and hysterectomy with bilateral salpingectomy was performed.The patient experienced pain in left iliac fossa following the procedure with anaesthesia of root of thigh.Post-operative abdominal brace was prescribed.In the post-operative period, ovarian vein stenosis and onset of a cyst on the left flank were reported.In the month following hysterectomy with bilateral salpingectomy, the patient was still under prescription of injectable anticoagulant.In (b)(6) 2017, one month after the procedure, it was noticed a gradual regression of chronic fatigue, joint and muscle pain, gradual regression of oedema of extremities, the reduction and then complete discontinuation of cardiological treatments for hypertension and palpitations and endocrine treatment for hyperthyroidism, and return to normal of blood test results.On (b)(6) 2017, physician noted complete discontinuation of antihypertensives, return to normal of bp, resolution of oedema and repression of muscle pain.On (b)(6) 2017, ct-scan found ovarian cyst on left, as well as thrombosis of the left ovarian vein, extending over approximately 10 cm.The pain in thigh persisted, and thrombosis required prescription of anticoagulant and pain-killers.On (b)(6) 2017, pelvic and left hip mri were prescribed due to left groin pain, pain on walking and on abduction.On (b)(6) 2017, blood pressure was perfectly normal.New endocrine work-up in 2017, heavy metal screening test, renal ultrasounds, and work-up for hypertension were performed.Elevated renal arteries blood flow was observed, nodule was found in adrenal gland (while examination was normal in 2011).The reporter stated that the rest of the symptoms, however, more and more clearly regressed.And also informed that, considering herself to be a victim of the device, the plaintiff has decided to file an application with the courts to request the designation of an expert capable of adjudicating on the causal relationship between placement of the inserts and the numerous health problems she has encountered.Follow-up information received on 23-oct-2017 - quality-safety evaluation of ptc: unable to confirm complaint.The list of device similar incidents contains essure reports received by bayer and older cases received by conceptus with similar events coded in meddra.In this particular case a search in the database was performed on 25-oct-2017 for the following meddra preferred terms: pelvic pain - the analysis in the global safety database revealed 5.582 cases.Ovarian vein thrombosis - the analysis in the global safety database revealed 1 case.Bayer is closely monitoring the benefit-risk profile of essure.A recent cumulative review of all available data on essure has not yielded any new safety signal with regard to these meddra pts.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 ("pelvic pain"), ovarian vein thrombosis ("ovarian vein stenosis / thrombosis of the left ovarian vein"), urinary tract infection ("recurrent urinary tract infections, complicated by hydrodistention"), bladder hydrodistension ("recurrent urinary tract infections, complicated by hydrodistention"), cardiomyopathy ("cardiomyopathy of unknown origin with hypertension and ectopic beats"), autoimmune thyroiditis ("toxic phase of hashimoto¿s thyroiditis"), the first episode of dry eye ("minor syndrome of dry eyes"), paralysis ("episodes of major muscle fatigue indeed paralysis"), helicobacter gastritis ("chronic active antral gastritis with helicobacter pylori") and suicidal ideation ("anxiety of imminent death, sometimes going so far as to express suicidal ideas") in a 39-year-old female patient who had essure (batch no.626600) inserted.The occurrence of additional non-serious events is detailed below.The patient's past medical history included multigravida, parity 3, gravida i in 2000 and twin pregnancy, delivered in 2003.The patient was in good general health and was not being followed for any problems.Previously administered products included for an unreported indication: cerazette (desogestrel).Concurrent conditions included overweight.Concomitant products included oral contraceptive nos.On an unknown date, the patient started avlocardyl at an unspecified dose and frequency.On (b)(6) 2008, the patient had essure inserted.In 2010, the patient experienced the first episode of fatigue ("chronic fatigue, asthenia"), the first episode of asthenia ("chronic fatigue, asthenia"), weight increased ("weight gain of 12 kg in 18 months / weight gain from plurifactorial origin / 71 kg in 2012, 73 kg in 2014 and 81 kg in 2017 / progressive weight gain"), abdominal distension ("bloating, her abdomen was constantly swollen"), the first episode of myalgia ("muscle pain in abdomen"), the first episode of diarrhoea ("episodes of diarrhoea / chronic diarrhoea"), abdominal pain ("abdominal pain"), the first episode of acne ("acne"), pruritus ("itchy scalp") and nausea ("frequent nausea").In (b)(6) 2011, the patient experienced mobility decreased ("difficulty to move") and the first episode of muscular weakness ("first episode of functional weakness").In (b)(6) 2012, the patient experienced vertigo positional ("rotatory positional vertigo").On (b)(6) 2012, 3 years 3 months after insertion of essure, the patient experienced palpitations ("marked palpitations"), the second episode of muscular weakness ("second episode of functional weakness / muscular weakness"), the second episode of myalgia ("violent pain"), dyspnoea exertional ("dyspnoea on effort") and dizziness ("dizziness").On (b)(6) 2012, the patient experienced chest pain ("pain in base of chest lasting a few seconds, like a stitch").In 2013, the patient experienced cystitis ("recurrent cystitis").In (b)(6) 2014, the patient experienced ventricular extrasystoles ("very abundant ventricular extrasystole episode").On (b)(6) 2015, the patient experienced musculoskeletal pain ("pain extending from the left buttock to the left thigh / sharp pain on palpation of the gluteus medius tendons"), the first episode of arthralgia ("pain on walking and mobilisation of the hip, with pangs of pain"), the third episode of muscular weakness ("third episode of functional weakness") and pain in extremity ("very strong pain in left thigh during the night").In 2016, the patient experienced pelvic pain (seriousness criteria medically significant and intervention required).On (b)(6) 2016, the patient started lyrica at an unspecified dose and frequency.On (b)(6) 2017, the patient experienced ovarian vein thrombosis (seriousness criterion medically significant) and ovarian cyst ("cyst on the left flank / ovarian cyst on left extending over approximately 10 cm").On an unknown date, the patient experienced abdominal pain lower ("cramps"), oedema peripheral ("oedema of extremities, oedema of the hands, feet and face"), face oedema ("oedema of extremities, oedema of the hands, feet and face"), vulvovaginal mycotic infection ("recurrent vaginal mycosis"), urinary tract infection (seriousness criterion medically significant), bladder hydrodistension (seriousness criterion medically significant), menorrhagia ("increasingly severe menorrhagia, heavy menstrual periods"), cardiomyopathy (seriousness criterion medically significant), hypertension ("cardiomyopathy of unknown origin with hypertension and ectopic beats"), extrasystoles ("cardiomyopathy of unknown origin with hypertension and ectopic beats"), muscle spasms ("spasmophilia with normal serum calcium and vitamin-d3 deficiency"), vitamin d deficiency ("spasmophilia with normal serum calcium and vitamin-d3 deficiency"), autoimmune thyroiditis (seriousness criterion medically significant), the first episode of dry eye (seriousness criterion medically significant), fibromyalgia ("fibromyalgia") with myalgia and limb discomfort, the second episode of diarrhoea ("chronic diarrhoea"), blood potassium decreased ("reduced serum potassium"), paralysis (seriousness criterion medically significant), muscle fatigue ("episodes of major muscle fatigue indeed paralysis"), musculoskeletal stiffness ("feeling of muscle stiffness"), muscle contractions involuntary ("constant contraction of muscles, somewhat like sore muscles"), the third episode of myalgia ("constant contraction of muscles, somewhat like sore muscles"), the second episode of acne ("lesions of acne"), skin papilloma ("wart on her left hand"), dermatitis ("inflammation of the scalp with dandruff and itching") with dandruff and pruritus, onychomycosis ("mycosis of nails"), duodenitis ("mild duodenitis"), helicobacter gastritis (seriousness criterion medically significant), chronic gastritis ("interstitial lymphocytic gastritis with no helicobacter pylori"), limb discomfort ("lower limb sclerosis"), headache ("headaches"), sleep apnoea syndrome ("episodes of sleep apnoea syndrome"), nasal disorder ("rhinopathy"), bladder pain ("germ-free bladder pain"), adrenal adenoma ("benign ular formation on the medial limb of the left adrenal / nodular formation on the medial limb of the left adrenal with negative spontaneous density, confirming that it was benign in nature/left adrenal adenoma"), the second episode of arthralgia ("chronic joint pain"), anxiety ("state of constant anxiety / anxiety of imminent death"), suicidal ideation (seriousness criterion medically significant), tetany ("attack, assimilated to tetany"), mood altered ("mood disturbances"), sleep disorder ("sleep disturbances"), the second episode of asthenia ("loss of energy and motivation"), apathy ("loss of energy and motivation"), the second episode of fatigue ("feeling of exhaustion"), eating disorder ("eating disorder"), phobia ("phobic behaviour"), peripheral swelling ("no longer tolerate her gold wedding ring due to the risk of severe swelling of the hand"), allergy to metals ("allergy tests showed delayed hypersensitivity to nickel"), arthropathy ("chronic joint fatigue"), metrorrhagia ("metrorrhagia"), vaginal infection ("vaginitis"), gastrointestinal fungal infection ("digestive mycosis"), eczema ("pruritus with eczema-like attacks"), dysmenorrhoea ("major secondary dysmenorrhoea"), carbohydrate intolerance ("recently discovered intolerance to sugar"), dyslipidaemia ("dyslipidaemia"), procedural pain ("pain in left iliac fossa following the procedure with anaesthesia of root of thigh"), the second episode of dry eye ("dry eye syndrome"), varicose vein ("varix"), snoring ("snoring"), blood cholesterol abnormal ("cholesterol"), rheumatic disorder ("rheumatologic disorders"), ear disorder ("ent disorders"), pharyngeal disorder ("ent disorders") and general physical health deterioration ("health status progressively deteriorated").The patient was treated with levothyroxine sodium (levothyrox), magnesium, omeprazole, flecainide acetate (flecaine), acebutolol hydrochloride (sectral), acetylleucine (tanganil), domperidone (biperidys), antibiotics, antithrombotic agents, analgesics, sertaconazole nitrate (monazol), ciclopirox olamine (mycoster), dydrogesterone (duphaston), hexaquine, tetrazepam (myolastan), ergocalciferol (calciferol), magnesium pidolate (mag 2), calcium, tramadol hydrochloride (topalgic), paracetamol (doliprane), nefopam hydrochloride (acupan), amitriptyline hydrochloride (laroxyl), amphotericin b (fungizone), rilmenidine (hyperium), surgery (on (b)(6) 2017 hysterectomy with bilateral salpingectomy) and alternative therapy (sclerosis).Essure was removed on (b)(6) 2017.At the time of the report, the pelvic pain, ovarian vein thrombosis, weight increased, abdominal distension, abdominal pain, pruritus, nausea, abdominal pain lower, vulvovaginal mycotic infection, urinary tract infection, bladder hydrodistension, menorrhagia, autoimmune thyroiditis, fibromyalgia, the last episode of diarrhoea, blood potassium decreased, paralysis, muscle fatigue, musculoskeletal stiffness, muscle contractions involuntary, the last episode of myalgia, chest pain, palpitations, musculoskeletal pain, the last episode of acne, skin papilloma, dermatitis, onychomycosis, duodenitis, helicobacter gastritis, chronic gastritis, limb discomfort, vertigo positional, headache, sleep apnoea syndrome, nasal disorder, cystitis, bladder pain, adrenal adenoma, the last episode of arthralgia, anxiety, suicidal ideation, tetany, mood altered, sleep disorder, the last episode of asthenia, apathy, the last episode of fatigue, eating disorder, phobia, peripheral swelling, allergy to metals, arthropathy, metrorrhagia, vaginal infection, gastrointestinal fungal infection, eczema, dysmenorrhoea, carbohydrate intolerance, dyslipidaemia, procedural pain, ovarian cyst, mobility decreased, dyspnoea exertional, dizziness, the last episode of dry eye, varicose vein, ventricular extrasystoles, snoring, the last episode of muscular weakness, pain in extremity, blood cholesterol abnormal, rheumatic disorder, ear disorder, pharyngeal disorder and general physical health deterioration outcome was unknown, the oedema peripheral and face oedema had resolved and the cardiomyopathy, hypertension, extrasystoles, muscle spasms and vitamin d deficiency was resolving.The reporter considered abdominal distension, abdominal pain, abdominal pain lower, adrenal adenoma, allergy to metals, anxiety, apathy, arthropathy, autoimmune thyroiditis, bladder hydrodistension, bladder pain, blood cholesterol abnormal, blood potassium decreased, carbohydrate intolerance, cardiomyopathy, chest pain, chronic gastritis, cystitis, dermatitis, dizziness, duodenitis, dyslipidaemia, dysmenorrhoea, dyspnoea exertional, ear disorder, eating disorder, eczema, extrasystoles, face oedema, fibromyalgia, gastrointestinal fungal infection, general physical health deterioration, headache, helicobacter gastritis, hypertension, limb discomfort, menorrhagia, metrorrhagia, mobility decreased, mood altered, muscle contractions involuntary, muscle fatigue, muscle spasms, musculoskeletal pain, musculoskeletal stiffness, nasal disorder, nausea, oedema peripheral, onychomycosis, ovarian cyst, ovarian vein thrombosis, pain in extremity, palpitations, paralysis, pelvic pain, peripheral swelling, pharyngeal disorder, phobia, procedural pain, pruritus, rheumatic disorder, skin papilloma, sleep apnoea syndrome, sleep disorder, snoring, suicidal ideation, tetany, urinary tract infection, vaginal infection, varicose vein, ventricular extrasystoles, vertigo positional, vitamin d deficiency, vulvovaginal mycotic infection, weight increased, the first episode of acne, the first episode of arthralgia, the first episode of asthenia, the first episode of diarrhoea, the first episode of dry eye, the first episode of fatigue, the first episode of muscular weakness, the first episode of myalgia, the second episode of acne, the second episode of arthralgia, the second episode of asthenia, the second episode of diarrhoea, the second episode of dry eye, the second episode of fatigue, the second episode of muscular weakness, the second episode of myalgia, the third episode of muscular weakness and the third episode of myalgia to be related to essure.Diagnostic results (normal ranges are provided in parenthesis if available): body mass index was 29.8 kg/sqm.Allergy test - on (b)(6) 2017: delayed hypersensitivity to nickel anti-thyroid antibody - on (b)(6) 2010: 108 iu/l (elevated) then 143 iu/l (elevated) blood potassium - on (b)(6) 2011: reduced mmol; on (b)(6) 2012: 6 / loss of potassium mmol (abnormal nos) blood pressure measurement - on (b)(6) 2017: perfectly normal blood thyroid stimulating hormone - on (b)(6) 2010: 4.53 iu/l (elevated) colonoscopy - on (b)(6) 2011: normal.Computerised tomogram - on (b)(6) 2017: ovarian cyst on left, as well as thrombosis culture urine - in (b)(6) 2014: urinary tract infection+.Infection w/ clear urine ultrasound kidney - on (b)(6) 2017: normal.Ultrasound pelvis - on (b)(6) 2009: implants in place in fallopian tubes (normal); on (b)(6) 2010: normal positioning of the inserts.Ultrasound thyroid - on (b)(6) 2016: thyroid volume at the lower limit of normal vitamin d - on (b)(6) 2010: 11 ng/ml (depressed).The list of device similar incidents contains essure reports received by bayer and older cases received by conceptus coded with the same meddra preferred term (pt).In this particular case a search in the global safety database was performed on (b)(6) 2018 for the following meddra pts (excluding this case): pelvic pain: 10848 cases were identified.Ovarian vein thrombosis: 1 cases were identified.Bayer is closely monitoring the benefit-risk profile of essure.A recent cumulative review of all available data on essure has not yielded any new safety signal with regard to these meddra pts.Quality-safety evaluation of ptc: unable to confirm complaint most recent follow-up information incorporated above includes: on 12-apr-2018: the case (b)(4) was identified as duplicate of this case, and all information was transferred.Events added: rheumatologic disorders, ent disorders and health status progressively deteriorated.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 ("pelvic pain"), ovarian vein thrombosis ("ovarian vein stenosis / thrombosis of the left ovarian vein"), urinary tract infection ("recurrent urinary tract infections, complicated by hydrodistention"), bladder hydrodistension ("recurrent urinary tract infections, complicated by hydrodistention"), cardiomyopathy ("cardiomyopathy of unknown origin with hypertension and ectopic beats"), autoimmune thyroiditis ("toxic phase of hashimoto¿s thyroiditis"), the first episode of dry eye ("minor syndrome of dry eyes"), paralysis ("episodes of major muscle fatigue indeed paralysis"), helicobacter gastritis ("chronic active antral gastritis with helicobacter pylori") and suicidal ideation ("anxiety of imminent death, sometimes going so far as to express suicidal ideas") in a 39-year-old female patient who had essure (batch no.626600) inserted.The occurrence of additional non-serious events is detailed below.The patient's past medical history included multigravida, parity 3, gravida i in (b)(6) and twin pregnancy, delivered in (b)(6).The patient was in good general health and was not being followed for any problems.Previously administered products included for an unreported indication: cerazette (desogestrel).Concurrent conditions included overweight.Concomitant products included fosfomycin trometamol (uridoz) from (b)(6) 2018 to (b)(6) 2018, lidocaine (xylocaine) from (b)(6) 2018 to (b)(6) 2018 and sodium chloride from (b)(6) 2018 to (b)(6) 2018 for laboratory test as well as oral contraceptive nos.On an unknown date, the patient started avlocardyl at an unspecified dose and frequency.On (b)(6) 2008, the patient had essure inserted.In (b)(6), the patient experienced the first episode of fatigue ("chronic fatigue, asthenia"), the first episode of asthenia ("chronic fatigue, asthenia"), weight increased ("weight gain of 12 kg in 18 months / weight gain from plurifactorial origin / 71 kg in (b)(6), 73 kg in (b)(6) and 81 kg in (b)(6) / progressive weight gain"), abdominal distension ("bloating, her abdomen was constantly swollen"), the first episode of myalgia ("muscle pain in abdomen"), the first episode of diarrhoea ("episodes of diarrhoea / chronic diarrhoea"), abdominal pain ("abdominal pain"), the first episode of acne ("acne"), pruritus ("itchy scalp") and nausea ("frequent nausea").In (b)(6) 2011, the patient experienced mobility decreased ("difficulty to move") and the first episode of muscular weakness ("first episode of functional weakness").In (b)(6) 2012, the patient experienced vertigo positional ("rotatory positional vertigo").On (b)(6) 2012, 3 years 3 months after insertion of essure, the patient experienced palpitations ("marked palpitations"), the second episode of muscular weakness ("second episode of functional weakness / muscular weakness"), the second episode of myalgia ("violent pain"), dyspnoea exertional ("dyspnoea on effort") and dizziness ("dizziness").On (b)(6) 2012, the patient experienced chest pain ("pain in base of chest lasting a few seconds, like a stitch").In (b)(6), the patient experienced cystitis ("recurrent cystitis").In (b)(6) 2014, the patient experienced ventricular extrasystoles ("very abundant ventricular extrasystole episode").On (b)(6) 2015, the patient experienced musculoskeletal pain ("pain extending from the left buttock to the left thigh / sharp pain on palpation of the gluteus medius tendons"), the first episode of arthralgia ("pain on walking and mobilisation of the hip, with pangs of pain"), the third episode of muscular weakness ("third episode of functional weakness") and pain in extremity ("very strong pain in left thigh during the night").In (b)(6), the patient experienced pelvic pain (seriousness criteria medically significant and intervention required).On (b)(6) 2016, the patient started lyrica at an unspecified dose and frequency.On (b)(6) 2017, the patient experienced ovarian vein thrombosis (seriousness criterion medically significant) and ovarian cyst ("cyst on the left flank / ovarian cyst on left extending over approximately 10 cm").On an unknown date, error in f_event_with_onset_srsns_nt:-6502-ora-06502: pl/sql: numeric or value error: character string buffer too small.Detail: line 1 ora-06512: at "bbs_owner.Pkg_custom_auto_narrative", line 10282 the patient was treated with levothyroxine sodium (levothyrox), magnesium, omeprazole, flecainide acetate (flecaine), acebutolol hydrochloride (sectral), acetylleucine (tanganil), domperidone (biperidys), antibiotics, antithrombotic agents, analgesics, sertaconazole nitrate (monazol), ciclopirox olamine (mycoster), dydrogesterone (duphaston), hexaquine, tetrazepam (myolastan), ergocalciferol (calciferol), magnesium pidolate (mag 2), calcium, tramadol hydrochloride (topalgic), paracetamol (doliprane), nefopam hydrochloride (acupan), amitriptyline hydrochloride (laroxyl), amphotericin b (fungizone), rilmenidine (hyperium), surgery (on (b)(6) 2017 hysterectomy with bilateral salpingectomy) and alternative therapy (sclerosis).Essure was removed on (b)(6) 2017.At the time of the report, the pelvic pain, ovarian vein thrombosis, weight increased, abdominal distension, abdominal pain, pruritus, nausea, abdominal pain lower, vulvovaginal mycotic infection, urinary tract infection, bladder hydrodistension, menorrhagia, autoimmune thyroiditis, fibromyalgia, the last episode of diarrhoea, blood potassium decreased, paralysis, muscle fatigue, musculoskeletal stiffness, muscle contractions involuntary, the last episode of myalgia, chest pain, palpitations, musculoskeletal pain, the last episode of acne, skin papilloma, dermatitis, onychomycosis, duodenitis, helicobacter gastritis, chronic gastritis, limb discomfort, vertigo positional, headache, sleep apnoea syndrome, nasal disorder, cystitis, bladder pain, adrenal adenoma, the last episode of arthralgia, anxiety, suicidal ideation, tetany, mood altered, sleep disorder, the last episode of asthenia, apathy, the last episode of fatigue, eating disorder, phobia, peripheral swelling, allergy to metals, arthropathy, metrorrhagia, vaginal infection, gastrointestinal fungal infection, eczema, dysmenorrhoea, carbohydrate intolerance, dyslipidaemia, procedural pain, ovarian cyst, mobility decreased, dyspnoea exertional, dizziness, the last episode of dry eye, varicose vein, ventricular extrasystoles, snoring, the last episode of muscular weakness, pain in extremity, blood cholesterol abnormal, rheumatic disorder, ear disorder, pharyngeal disorder, general physical health deterioration, urinary incontinence, granuloma and dyspareunia outcome was unknown, the oedema peripheral and face oedema had resolved and the cardiomyopathy, hypertension, extrasystoles, muscle spasms and vitamin d deficiency was resolving.The reporter considered abdominal distension, abdominal pain, abdominal pain lower, adrenal adenoma, allergy to metals, anxiety, apathy, arthropathy, autoimmune thyroiditis, bladder hydrodistension, bladder pain, blood cholesterol abnormal, blood potassium decreased, carbohydrate intolerance, cardiomyopathy, chest pain, chronic gastritis, cystitis, dermatitis, dizziness, duodenitis, dyslipidaemia, dysmenorrhoea, dyspareunia, dyspnoea exertional, ear disorder, eating disorder, eczema, extrasystoles, face oedema, fibromyalgia, gastrointestinal fungal infection, general physical health deterioration, granuloma, headache, helicobacter gastritis, hypertension, limb discomfort, menorrhagia, metrorrhagia, mobility decreased, mood altered, muscle contractions involuntary, muscle fatigue, muscle spasms, musculoskeletal pain, musculoskeletal stiffness, nasal disorder, nausea, oedema peripheral, onychomycosis, ovarian cyst, ovarian vein thrombosis, pain in extremity, palpitations, paralysis, pelvic pain, peripheral swelling, pharyngeal disorder, phobia, procedural pain, pruritus, rheumatic disorder, skin papilloma, sleep apnoea syndrome, sleep disorder, snoring, suicidal ideation, tetany, urinary incontinence, urinary tract infection, vaginal infection, varicose vein, ventricular extrasystoles, vertigo positional, vitamin d deficiency, vulvovaginal mycotic infection, weight increased, the first episode of acne, the first episode of arthralgia, the first episode of asthenia, the first episode of diarrhoea, the first episode of dry eye, the first episode of fatigue, the first episode of muscular weakness, the first episode of myalgia, the second episode of acne, the second episode of arthralgia, the second episode of asthenia, the second episode of diarrhoea, the second episode of dry eye, the second episode of fatigue, the second episode of muscular weakness, the second episode of myalgia, the third episode of muscular weakness and the third episode of myalgia to be related to essure.The reporter commented: hypertension nearly returned to normal (135/85) without ongoing treatment.In the following of hysterectomy for removal, the patient complained of urinary leakage occurrence (attributed to urethral reflectivity disorder).Diagnostic results (normal ranges are provided in parenthesis if available): body mass index was 29.8 kg/sqm.Allergy test - on (b)(6) 2017: delayed hypersensitivity to nickel.Anti-thyroid antibody - on (b)(6) 2010: 108 iu/l (elevated) then 143 iu/l (elevated).Blood potassium - on (b)(6) 2011: reduced mmol; on (b)(6) 2012: 6 / loss of potassium mmol (abnormal nos).Blood pressure measurement - on (b)(6) 2017: perfectly normal.Blood thyroid stimulating hormone - on (b)(6) 2010: 4.53 iu/l (elevated).Colonoscopy - on (b)(6) 2011: normal.Computerised tomogram - on (b)(6) 2017: ovarian cyst on left, as well as thrombosis.Culture urine - in may 2014: urinary tract infection+.Infection w/ clear urine.Ultrasound kidney - on (b)(6) 2017: normal.Ultrasound pelvis - on (b)(6) 2009: implants in place in fallopian tubes (normal); on (b)(6) 2010: normal positioning of the inserts.Ultrasound thyroid - on (b)(6) 2016: thyroid volume at the lower limit of normal.Vitamin d - on (b)(6) 2010: 11 ng/ml (depressed).Quality-safety evaluation of ptc: unable to confirm complaint.Most recent follow-up information incorporated above includes: on (b)(6) 2018: new events: inflammatory granuloma on vaginal scar following hysterectomy, cause of her dyspareunia and urinary leakage (required perineal rehabilitation).Lab tests and reporter's comment updated.Treatment drugs 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

This spontaneous case was reported by a lawyer and describes the occurrence of pelvic pain ("pelvic pain"), ovarian vein thrombosis ("ovarian vein stenosis / thrombosis of the left ovarian vein"), urinary tract infection ("recurrent urinary tract infections, complicated by hydrodistention"), bladder hydrodistension ("recurrent urinary tract infections, complicated by hydrodistention"), cardiomyopathy ("cardiomyopathy of unknown origin with hypertension and ectopic beats"), autoimmune thyroiditis ("toxic phase of hashimoto¿s thyroiditis"), the first episode of dry eye ("minor syndrome of dry eyes"), paralysis ("episodes of major muscle fatigue indeed paralysis"), helicobacter gastritis ("chronic active antral gastritis with helicobacter pylori") and suicidal ideation ("anxiety of imminent death, sometimes going so far as to express suicidal ideas") in a 39-year-old female patient who had essure (batch no.626600) inserted.The occurrence of additional non-serious events is detailed below.Co-suspect products included avlocardyl [propranolol] for hypertension and heart rate irregular and lyrica for urinary tract infection.The patient's medical history included multigravida, parity 3, gravida i in 2000 and twin pregnancy, delivered in 2003.The patient was in good general health and was not being followed for any problems.Previously administered products included for an unreported indication: cerazette (desogestrel).Concurrent conditions included overweight.Concomitant products included fosfomycin trometamol (uridoz) from (b)(6)2018 to (b)(6)2018, lidocaine (xylocaine) from (b)(6)2018 to (b)(6)2018 and sodium chloride from (b)(6)2018 to (b)(6)2018 for urological examination as well as oral contraceptive nos.On (b)(6)2008, the patient had essure inserted.In 2010, the patient experienced fatigue ("chronic fatigue / feeling of exhaustion"), asthenia ("asthenia / loss of energy"), abdominal distension ("bloating, her abdomen was constantly swollen"), the first episode of myalgia ("muscle pain in abdomen"), the first episode of diarrhoea ("episodes of diarrhoea / chronic diarrhoea"), abdominal pain ("abdominal pain"), acne ("acne / lesions of acne"), the first episode of pruritus ("itchy scalp") and nausea ("frequent nausea") and was found to have weight increased ("weight gain of 12 kg in 18 months / weight gain from plurifactorial origin / 71 kg in 2012, 73 kg in 2014 and 81 kg in 2017 / progressive weight gain").In (b)(6)2011, the patient experienced mobility decreased ("difficulty to move") and the first episode of muscular weakness ("first episode of functional weakness").In (b)(6)2012, the patient experienced vertigo positional ("rotatory positional vertigo").On (b)(6)2012, the patient experienced chest pain ("pain in base of chest lasting a few seconds, like a stitch") and experienced palpitations ("marked palpitations"), the second episode of muscular weakness ("second episode of functional weakness / muscular weakness"), the second episode of myalgia ("violent pain"), dyspnoea exertional ("dyspnoea on effort") and dizziness ("dizziness"), 3 years 3 months after insertion of essure.On (b)(6)2012, the patient started avlocardyl [propranolol] at an unspecified dose and frequency.In 2013, the patient experienced cystitis ("recurrent cystitis").In (b)(6)2014, the patient experienced ventricular extrasystoles ("very abundant ventricular extrasystole episode").On (b)(6)2015, the patient experienced musculoskeletal pain ("pain extending from the left buttock to the left thigh / sharp pain on palpation of the gluteus medius tendons"), the first episode of arthralgia ("pain on walking and mobilisation of the hip, with pangs of pain"), the third episode of muscular weakness ("third episode of functional weakness") and pain in extremity ("very strong pain in left thigh during the night").In 2016, the patient experienced pelvic pain (seriousness criteria medically significant and intervention required).On (b)(6)2016, the patient started lyrica at an unspecified dose and frequency.On (b)(6)2017, the patient experienced ovarian vein thrombosis (seriousness criterion medically significant) and ovarian cyst ("cyst on left flank / ovarian cyst on left").The patient was treated with acebutolol hydrochloride (sectral), acetylleucine (tanganil), amitriptyline hydrochloride (laroxyl), amphotericin b (fungizone), analgesics, antibiotics, antithrombotic agents, calcifediol (didrogyl), calcium, ciclopirox (mycoster), domperidone (biperidys), dydrogesterone (duphaston), flecainide acetate (flecaine), levothyroxine sodium (levothyrox), magnesium, melaleuca viridiflora oil;quinine benzoate;thiamine hydrochloride (hexaquine), nefopam hydrochloride (acupan), omeprazole, paracetamol (doliprane), rilmenidine phosphate (hyperium), sertaconazole nitrate (monazol), tetrazepam (myolastan), tramadol hydrochloride (topalgic), surgery (on (b)(6)2017 hysterectomy with bilateral salpingectomy) and sclerosis.Essure was removed on (b)(6)2017.At the time of the report, the pelvic pain, ovarian vein thrombosis, weight increased, abdominal distension, abdominal pain, acne, nausea, abdominal pain lower, vulvovaginal mycotic infection, urinary tract infection, bladder hydrodistension, menorrhagia, autoimmune thyroiditis, fibromyalgia, the last episode of diarrhoea, blood potassium decreased, paralysis, muscle fatigue, musculoskeletal stiffness, muscle contractions involuntary, the last episode of myalgia, chest pain, palpitations, musculoskeletal pain, skin papilloma, dermatitis, onychomycosis, duodenitis, helicobacter gastritis, chronic gastritis, the last episode of limb discomfort, vertigo positional, headache, sleep apnoea syndrome, nasal disorder, cystitis, bladder pain, adrenal adenoma, the last episode of arthralgia, anxiety, suicidal ideation, tetany, mood altered, sleep disorder, apathy, eating disorder, phobia, peripheral swelling, allergy to metals, arthropathy, metrorrhagia, vaginal infection, gastrointestinal fungal infection, eczema, dysmenorrhoea, carbohydrate intolerance, dyslipidaemia, procedural pain, ovarian cyst, mobility decreased, dyspnoea exertional, dizziness, the last episode of dry eye, varicose vein, ventricular extrasystoles, snoring, the last episode of muscular weakness, pain in extremity, blood cholesterol abnormal, rheumatic disorder, ear disorder, pharyngeal disorder, general physical health deterioration, post procedural urine leak, suture related complication, dyspareunia, cervical cyst, adenomyosis and adnexa uteri cyst outcome was unknown, the fatigue, asthenia, cardiomyopathy, hypertension, extrasystoles, muscle spasms and vitamin d deficiency was resolving and the oedema peripheral and face oedema had resolved.The reporter considered abdominal distension, abdominal pain, abdominal pain lower, acne, adenomyosis, adnexa uteri cyst, adrenal adenoma, allergy to metals, anxiety, apathy, arthropathy, asthenia, autoimmune thyroiditis, bladder hydrodistension, bladder pain, blood cholesterol abnormal, blood potassium decreased, carbohydrate intolerance, cardiomyopathy, cervical cyst, chest pain, chronic gastritis, cystitis, dermatitis, dizziness, duodenitis, dyslipidaemia, dysmenorrhoea, dyspareunia, dyspnoea exertional, ear disorder, eating disorder, eczema, extrasystoles, face oedema, fatigue, fibromyalgia, gastrointestinal fungal infection, general physical health deterioration, headache, helicobacter gastritis, hypertension, menorrhagia, metrorrhagia, mobility decreased, mood altered, muscle contractions involuntary, muscle fatigue, muscle spasms, musculoskeletal pain, musculoskeletal stiffness, nasal disorder, nausea, oedema peripheral, onychomycosis, ovarian cyst, ovarian vein thrombosis, pain in extremity, palpitations, paralysis, pelvic pain, peripheral swelling, pharyngeal disorder, phobia, post procedural urine leak, procedural pain, rheumatic disorder, skin papilloma, sleep apnoea syndrome, sleep disorder, snoring, suicidal ideation, suture related complication, tetany, urinary tract infection, vaginal infection, varicose vein, ventricular extrasystoles, vertigo positional, vitamin d deficiency, vulvovaginal mycotic infection, weight increased, the first episode of arthralgia, the first episode of diarrhoea, the first episode of dry eye, the first episode of limb discomfort, the first episode of muscular weakness, the first episode of myalgia, the first episode of pruritus, the second episode of arthralgia, the second episode of diarrhoea, the second episode of dry eye, the second episode of limb discomfort, the second episode of muscular weakness, the second episode of myalgia, the second episode of pruritus, the third episode of muscular weakness, the third episode of myalgia and the fourth episode of myalgia to be related to essure.The reporter commented: hypertension nearly returned to normal (135/85) without ongoing treatment.In the following of hysterectomy for removal, the patient complained of urinary leakage occurrence (attributed to urethral reflectivity disorder).Total hysterectomy, bilateral salpingectomy conclusion: glandular cystic dystrophy within the canal (leading to nabothian cysts); trophic endometrium, absence of hyperplasia and adenomata; extensive adenomyosis; bilateral paratubal cysts; absence of histological sign of malignancy.Diagnostic results (normal ranges are provided in parenthesis if available): body mass index was 29.8 kg/sqm.Allergy test - on (b)(6)2017: delayed hypersensitivity to nickel.Anti-thyroid antibody - on (b)(6)2010: 108 iu/l (elevated); on (b)(6)2010: 143 iu/l (elevated).Blood cholesterol (< 2 g/l) - on (b)(6)2018: 2.06 g/l.Blood potassium - on (b)(6)2011: reduced; on (b)(6)2012: 6 mmol / loss of potassium mmol.Blood pressure measurement - on (b)(6)2017: perfectly normal; on (b)(6)2017: 138/80 mmhg.Blood thyroid stimulating hormone - on (b)(6)2010: 4.53 iu/l (elevated).Cardiac stress test - on (b)(6)2016: no signs of myocardial ischemia.Colonoscopy - on (b)(6)-2011: normal.Computerised tomogram - on (b)(6)2015: thickening of the lining in the fundus of both maxillary sinuses, minimal deviated septum to the right and hypertrophy of right inferior turbinate; on (b)(6)2016: absence of kidney stones and multiple-level osteoarthritic disc disease predominantly involving l5-s1 on the left; on (b)(6)2017: ovarian cyst on left, as well as thrombosis, extending over approximately 10 cm.Culture urine - in (b)(6)2014: urinary tract infection+++ / infection w/ clear urine.Electrocardiogram ambulatory - on (b)(6)2014: very abundant, isolated, monomorphic ventricular extrasystoles with a pattern of bigeminy and trigeminy.Electromyogram - on (b)(6)2015: neurogenic tracings on effort in muscles of quadriceps, toe extensors and anterior leg muscles on left.It was concluded to nerve root involvement at l4.Neurogenic-like record on effort in area of quadriceps extensor muscle of toes and left anterior leg.Laboratory test - on (b)(6)2016: low phosphorus level, tsh imbalance, high glycaemia, early diabetes.Ultrasound kidney - on (b)(6)2017: normal.Ultrasound pelvis - on (b)(6)2009: implants in place in fallopian tubes, normal; on (b)(6)2010: normal positioning of the inserts.Ultrasound thyroid - on (b)(6)2016: thyroid volume at the lower limit of normal, compatible with hashimoto thyroiditis.Vitamin d - on (b)(6)2010: 11 ng/ml (depressed); in (b)(6)2014: normal.Quality-safety evaluation of ptc: unable to confirm complaint.Amendment: the report was amended on (b)(6)2019 for the following reason: coding correction: event diffuse muscle pain in legs which spread to upper limbs sometimes with a feeling of trembling was splited before, but discomfort feeling arms and legs was now considered as a diagnosis.No new follow-up information was received from the reporter.We received a lot number in this case.A technical investigation was 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"), ovarian vein thrombosis ("ovarian vein stenosis / thrombosis of the left ovarian vein"), urinary tract infection ("recurrent urinary tract infections, complicated by hydrodistention"), bladder hydrodistension ("recurrent urinary tract infections, complicated by hydrodistention"), cardiomyopathy ("cardiomyopathy of unknown origin with hypertension and ectopic beats"), autoimmune thyroiditis ("toxic phase of hashimoto¿s thyroiditis"), the first episode of dry eye ("minor syndrome of dry eyes"), paralysis ("episodes of major muscle fatigue indeed paralysis"), helicobacter gastritis ("chronic active antral gastritis with helicobacter pylori") and suicidal ideation ("anxiety of imminent death, sometimes going so far as to express suicidal ideas") in a 39-year-old female patient who had essure (batch no.626600) inserted.The occurrence of additional non-serious events is detailed below.Co-suspect products included avlocardyl for hypertension and heart rate irregular and lyrica for urinary tract infection.The patient's medical history included multigravida, parity 3, gravida i in 2000 and twin pregnancy, delivered in 2003.The patient was in good general health and was not being followed for any problems.Previously administered products included for an unreported indication: cerazette (desogestrel).Concurrent conditions included overweight.Concomitant products included fosfomycin trometamol (uridoz) from (b)(6) 2018, lidocaine (xylocaine) from (b)(6) 2018 and sodium chloride from (b)(6) 2018 for urological examination as well as oral contraceptive nos.Error in f_prod_evt_latency_info:-22835-ora-22835: buffer too small for clob to char or blob to raw conversion (actual: 4275, maximum: 4000).Detail: line 11652 the patient was treated with acebutolol hydrochloride (sectral), acetylleucine (tanganil), amitriptyline hydrochloride (laroxyl), amphotericin b (fungizone), analgesics, antibiotics, antithrombotic agents, calcium, ciclopirox olamine (mycoster), domperidone (biperidys), dydrogesterone (duphaston), ergocalciferol (calciferol), flecainide acetate (flecaine), levothyroxine sodium (levothyrox), magnesium, magnesium pidolate (mag 2), melaleuca viridiflora oil;quinine benzoate;thiamine hydrochloride (hexaquine), nefopam hydrochloride (acupan), omeprazole, paracetamol (doliprane), rilmenidine phosphate (hyperium), sertaconazole nitrate (monazol), tetrazepam (myolastan), tramadol hydrochloride (topalgic), surgery (on (b)(6) 2017 hysterectomy with bilateral salpingectomy) and sclerosis.Essure was removed on (b)(6) 2017.At the time of the report, the pelvic pain, ovarian vein thrombosis, weight increased, abdominal distension, abdominal pain, pruritus, nausea, abdominal pain lower, vulvovaginal mycotic infection, urinary tract infection, bladder hydrodistension, menorrhagia, autoimmune thyroiditis, fibromyalgia, the last episode of diarrhoea, blood potassium decreased, paralysis, muscle fatigue, musculoskeletal stiffness, muscle contractions involuntary, the last episode of myalgia, chest pain, palpitations, musculoskeletal pain, the last episode of acne, skin papilloma, dermatitis, onychomycosis, duodenitis, helicobacter gastritis, chronic gastritis, limb discomfort, vertigo positional, headache, sleep apnoea syndrome, nasal disorder, cystitis, bladder pain, adrenal adenoma, the last episode of arthralgia, anxiety, suicidal ideation, tetany, mood altered, sleep disorder, the last episode of asthenia, apathy, the last episode of fatigue, eating disorder, phobia, peripheral swelling, allergy to metals, arthropathy, metrorrhagia, vaginal infection, gastrointestinal fungal infection, eczema, dysmenorrhoea, carbohydrate intolerance, dyslipidaemia, procedural pain, ovarian cyst, mobility decreased, dyspnoea exertional, dizziness, the last episode of dry eye, varicose vein, ventricular extrasystoles, snoring, the last episode of muscular weakness, pain in extremity, blood cholesterol abnormal, rheumatic disorder, ear disorder, pharyngeal disorder, general physical health deterioration, post procedural urine leak, granuloma and dyspareunia outcome was unknown, the oedema peripheral and face oedema had resolved and the cardiomyopathy, hypertension, extrasystoles, muscle spasms and vitamin d deficiency was resolving.The reporter considered abdominal distension, abdominal pain, abdominal pain lower, adenomyosis, adnexa uteri cyst, adrenal adenoma, allergy to metals, anxiety, apathy, arthropathy, autoimmune thyroiditis, bladder hydrodistension, bladder pain, blood cholesterol abnormal, blood potassium decreased, carbohydrate intolerance, cardiomyopathy, cervical cyst, chest pain, chronic gastritis, cystitis, dermatitis, dizziness, duodenitis, dyslipidaemia, dysmenorrhoea, dyspareunia, dyspnoea exertional, ear disorder, eating disorder, eczema, extrasystoles, face oedema, fibromyalgia, gastrointestinal fungal infection, general physical health deterioration, granuloma, headache, helicobacter gastritis, hypertension, limb discomfort, menorrhagia, metrorrhagia, mobility decreased, mood altered, muscle contractions involuntary, muscle fatigue, muscle spasms, musculoskeletal pain, musculoskeletal stiffness, nasal disorder, nausea, oedema peripheral, onychomycosis, ovarian cyst, ovarian vein thrombosis, pain in extremity, palpitations, paralysis, pelvic pain, peripheral swelling, pharyngeal disorder, phobia, post procedural urine leak, procedural pain, pruritus, rheumatic disorder, skin papilloma, sleep apnoea syndrome, sleep disorder, snoring, suicidal ideation, tetany, urinary tract infection, vaginal infection, varicose vein, ventricular extrasystoles, vertigo positional, vitamin d deficiency, vulvovaginal mycotic infection, weight increased, the first episode of acne, the first episode of arthralgia, the first episode of asthenia, the first episode of diarrhoea, the first episode of dry eye, the first episode of fatigue, the first episode of muscular weakness, the first episode of myalgia, the second episode of acne, the second episode of arthralgia, the second episode of asthenia, the second episode of diarrhoea, the second episode of dry eye, the second episode of fatigue, the second episode of muscular weakness, the second episode of myalgia, the third episode of muscular weakness and the third episode of myalgia to be related to essure.The reporter commented: hypertension nearly returned to normal (135/85) without ongoing treatment.In the following of hysterectomy for removal, the patient complained of urinary leakage occurrence (attributed to urethral reflectivity disorder).Total hysterectomy, bilateral salpingectomy conclusion: glandular cystic dystrophy within the canal (leading to nabothian cysts); trophic endometrium, absence of hyperplasia and adenomata; extensive adenomyosis; bilateral paratubal cysts; absence of histological sign of malignancy diagnostic results (normal ranges are provided in parenthesis if available): body mass index was 29.8 kg/sqm.Allergy test - on (b)(6) 2017: results: delayed hypersensitivity to nickel.Anti-thyroid antibody - on (b)(6) 2010: assessment: elevated results: 108 iu/l; on (b)(6) 2010: assessment: elevated results: 143 iu/l.Blood potassium - on (b)(6) 2011: results: reduced mmol; on (b)(6) 2012: assessment: abnormal nos results: 6 / loss of potassium mmol.Blood pressure measurement - on (b)(6) 2017: results: perfectly normal.Blood thyroid stimulating hormone (iu/l) - on (b)(6) 2010: 4.53 iu/l.Colonoscopy - on (b)(6) 2011: results: normal.Computerised tomogram - on (b)(6) 2015: found thickening of the lining in the fundus of both maxillary sinuses, minimal deviated septum to the right and hypertrophy of right inferior turbinate.; on (b)(6) 2016: which concluded to absence of kidney stones and multiple-level osteoarthritic disc disease predominantly involving l5-s1 on the left.; on (b)(6) 2017: low phosphorus level, tsh inbalance, high glycaemia, early diabetes.; on (b)(6) 2017: results: ovarian cyst on left, as well as thrombosis, extending over approximately 10 cm.Culture urine - in (b)(6) 2014: results: urinary tract infection+.Infection w/ clear urine.Electromyogram - on (b)(6) 2015: neurogenic tracings on effort in muscles of quadriceps, toe extensors and anterior leg muscles on left.It was concluded to nerve root involvement at l4.Neurogenic-like record on effort in area of quadriceps extensor muscle of toes and left anterior leg.Laboratory test - on (b)(6) 2016: low phosphorus level, tsh inbalance, high glycaemia, early diabetes.Ultrasound kidney - on (b)(6) 2017: results: normal.Ultrasound pelvis - on (b)(6) 2009: assessment: normal results: implants in place in fallopian tubes; on (b)(6) 2010: results: normal positioning of the inserts.Ultrasound thyroid - on (b)(6) 2016: results: thyroid volume at the lower limit of normal.Vitamin d - on (b)(6) 2010: assessment: depressed results: 11 ng/ml.Quality-safety evaluation of ptc: unable to confirm complaint most recent follow-up information incorporated above includes: on 7-jan-2019: for the event diffuse muscle pain in legs which spread to upper limbs outcome was updated to recovering.The following adverse events were added: ¿glandular cystic dystrophy within the canal - nabothian cyst¿; "bilateral paratubal cysts and extensive adenomyosis".Lab data added.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'), ovarian vein thrombosis ('ovarian vein stenosis / thrombosis of the left ovarian vein'), cardiomyopathy ('cardiomyopathy of unknown origin with hypertension and ectopic beats') and helicobacter gastritis ('chronic active antral gastritis with helicobacter pylori') in a 39-year-old female patient who had essure (batch no.626600) inserted.The occurrence of additional non-serious events is detailed below.The patient's medical history included twin pregnancy, delivered in 2003, gravida ii in 2000 and parity 3 (1 ((b)(6) 2000) and twins ((b)(6) 2003)).History of good general health.As for result of urodynamics measurement, advice to perform perineal self-rehabilitation (in order to improve the perino-detrusor inhibitory reflex by reinforcing the sphincter muscle retention), perineal rehabilitation using bio feedback and electrostimulation was recommended to stabilize and strengthen urethral tone.If the urinary disorders persist, a neuro-urological consult could be considered.Previously administered products included for an unreported indication: cerazette (desogestrel).Concurrent conditions included overweight.Concomitant products included fosfomycin trometamol (uridoz) from (b)(6) 2018 to (b)(6) 2018, lidocaine (xylocaine) from (b)(6) 2018 to (b)(6) 2018 and sodium chloride from (b)(6) 2018 to (b)(6) 2018 for urological examination as well as oral contraceptive nos.On (b)(6) 2008, the patient had essure inserted.In 2008, the patient experienced hypertension ("cardiomyopathy of unknown origin with hypertension and ectopic beats") and acne ("acne / lesions of acne") and was found to have weight increased ("weight gain of (b)(6) in 18 months / weight gain from plurifactorial origin / (b)(6) in 2012, (b)(6) in 2014 and (b)(6) in 2017 / progressive weight gain").In 2010, the patient experienced abdominal pain ("abdominal pain"), abdominal distension ("bloating, her abdomen was constantly swollen"), pruritus ("itchy scalp"), diarrhoea ("episodes of diarrhoea / chronic diarrhoea"), fatigue ("chronic fatigue / feeling of exhaustion"), asthenia ("asthenia / loss of energy"), localised muscle pain ("muscle pain in abdomen") and nausea ("frequent nausea").In (b)(6) 2011, the patient experienced muscular weakness ("repeated episodes of functional weakness ((b)(6) 2011, (b)(6) 2012, (b)(6) 2015)").In (b)(6) 2012, the patient experienced vertigo positional ("rotatory positional vertigo").On (b)(6) 2012, the patient experienced palpitations ("marked palpitations"), pain ("violent pain"), dyspnoea exertional ("dyspnoea on effort") and dizziness ("dizziness") and experienced chest pain ("pain in base of chest lasting a few seconds, like a stitch"), 3 years 3 months after insertion of essure.In 2013, the patient experienced cystitis ("recurrent cystitis").In (b)(6) 2014, the patient experienced ventricular extrasystoles ("very abundant ventricular extrasystole episode").On (b)(6) 2015, the patient experienced musculoskeletal pain ("pain extending from the left buttock to the left thigh / sharp pain on palpation of the gluteus medius tendons") and pain in extremity ("very strong pain in left thigh during the night").In 2016, the patient experienced pelvic pain (seriousness criteria medically significant and intervention required).On (b)(6) 2017, the patient experienced ovarian vein thrombosis (seriousness criterion medically significant) and ovarian cyst ("cyst on left flank / ovarian cyst on left").On an unknown date, the patient experienced arthralgia ("pain on walking and mobilisation of the hip, with pangs of pain/ chronic joint pain").On an unknown date, the patient experienced abdominal pain lower ("cramps"), dysmenorrhoea ("major secondary dysmenorrhoea"), dyspareunia ("dyspareunia"), allergy to metals ("allergy tests showed delayed hypersensitivity to nickel"), dermatitis ("inflammation of the scalp"), menorrhagia ("increasingly severe menorrhagia, heavy menstrual periods"), metrorrhagia ("metrorrhagia"), headache ("headaches"), cardiomyopathy (seriousness criterion medically significant), extrasystoles ("cardiomyopathy of unknown origin with hypertension and ectopic beats"), urinary tract infection ("recurrent urinary tract infections, complicated by hydrodistention"), bladder pain ("germ-free bladder pain / cystalgia"), autoimmune thyroiditis ("toxic phase of hashimoto¿s thyroiditis"), helicobacter gastritis (seriousness criterion medically significant), chronic gastritis ("interstitial lymphocytic gastritis with no helicobacter pylori"), duodenitis ("mild duodenitis"), fibromyalgia ("fibromyalgia"), muscle pain ("diffuse muscle pain in legs which spread to upper limbs/ sore muscles"), muscle spasms ("spasmophilia with normal serum calcium"), muscle fatigue ("episodes of major muscle fatigue indeed paralysis"), muscle contractions involuntary ("constant contraction of muscles"), musculoskeletal stiffness ("feeling of muscle stiffness"), limb discomfort ("sometimes with a feeling of trembling / sclerosis in limbs"), arthropathy ("chronic joint fatigue"), tetany ("attack, assimilated to tetany"), generalised oedema ("oedema of extremities, oedema of the hands, feet and face"), peripheral swelling ("no longer tolerate her gold wedding ring due to the risk of severe swelling of the hand"), vulvovaginal mycotic infection ("recurrent vaginal mycosis"), vitamin d deficiency ("vitamin-d3 deficiency"), onychomycosis ("mycosis of nails"), sleep apnoea syndrome ("episodes of sleep apnoea syndrome"), nasal disorder ("rhinopathy"), vaginal infection ("vaginitis"), gastrointestinal fungal infection ("digestive mycosis"), eczema ("pruritus with eczema-like attacks"), carbohydrate intolerance ("recently discovered intolerance to sugar"), dyslipidaemia ("dyslipidaemia"), procedural pain ("pain in left iliac fossa following the procedure with anaesthesia of root of thigh"), dry eye ("dry eye syndrome"), varicose vein ("varix"), snoring ("snoring"), rheumatic disorder ("rheumatologic disorders"), ear disorder ("ent disorders"), pharyngeal disorder ("ent disorders"), general physical health deterioration ("health status progressively deteriorated"), post procedural urine leak ("urinary leakage occurrence following of hysterectomy (attributed to urethral reflectivity disorder)"), suture related complication ("inflammatory granuloma on vaginal scar following hysterectomy"), cervical cyst ("glandular cystic dystrophy within the canal - nabothian cyst"), adenomyosis ("extensive adenomyosis"), adnexa uteri cyst ("bilateral paratubal cysts"), alopecia ("hair loss"), onychomadesis ("nail loss"), hyperandrogenism ("hyperandrogenism"), radicular pain ("radiculalgia"), spinal osteoarthritis ("lumbar arthrosis"), otolithiasis ("otolith"), depression ("depression - anxio-depressive syndrome") with sleep disorder, eating disorder, mood altered, anxiety, apathy and suicidal ideation, phobia ("phobic behaviour") and dandruff ("dandruff"), underwent bladder hydrodistension ("recurrent urinary tract infections, complicated by hydrodistention") and was found to have adrenal adenoma ("benign nodular formation on the medial limb of the left adrenal / left adrenal adenoma"), blood potassium decreased ("reduced serum potassium"), skin papilloma ("wart on her left hand") and blood cholesterol abnormal ("cholesterol").The patient was treated with acebutolol hydrochloride (sectral), acetylleucine (tanganil), alprazolam, amitriptyline hydrochloride (laroxyl), amphotericin b (fungizone), analgesics, antibiotics, antithrombotic agents, calcifediol (didrogyl), calcium, ciclopirox (mycoster), domperidone (biperidys), dydrogesterone (duphaston), flecainide acetate (flecaine), levothyroxine sodium (levothyrox), magnesium, melaleuca viridiflora oil;quinine benzoate;thiamine hydrochloride (hexaquine), nefopam hydrochloride (acupan), omeprazole, paracetamol (doliprane), pregabalin (lyrica), propranolol (avlocardyl), rilmenidine phosphate (hyperium), sertaconazole nitrate (monazol), tetrazepam (myolastan), tramadol hydrochloride (topalgic), surgery (hysterectomy with bilateral salpingectomy) and sclerosis.Essure was removed on (b)(6) 2017.At the time of the report, the pelvic pain, ovarian vein thrombosis, abdominal pain lower, abdominal pain, abdominal distension, dysmenorrhoea, dyspareunia, allergy to metals, pruritus, menorrhagia, metrorrhagia, headache, ventricular extrasystoles, palpitations, urinary tract infection, cystitis, bladder hydrodistension, bladder pain, autoimmune thyroiditis, adrenal adenoma, helicobacter gastritis, chronic gastritis, duodenitis, diarrhoea, weight increased, fibromyalgia, muscle fatigue, muscle contractions involuntary, musculoskeletal pain, musculoskeletal stiffness, arthralgia, arthropathy, tetany, acne, nausea, peripheral swelling, vulvovaginal mycotic infection, blood potassium decreased, chest pain, skin papilloma, onychomycosis, vertigo positional, sleep apnoea syndrome, nasal disorder, vaginal infection, gastrointestinal fungal infection, eczema, carbohydrate intolerance, dyslipidaemia, blood cholesterol abnormal, procedural pain, ovarian cyst, pain, dyspnoea exertional, dizziness, dry eye, varicose vein, snoring, pain in extremity, rheumatic disorder, ear disorder, pharyngeal disorder, general physical health deterioration, post procedural urine leak, suture related complication, cervical cyst, adenomyosis, adnexa uteri cyst, alopecia, onychomadesis, hyperandrogenism, radicular pain, spinal osteoarthritis, otolithiasis, depression, phobia and dandruff outcome was unknown, the cardiomyopathy, hypertension, extrasystoles, fatigue, asthenia, localised muscle pain, muscle pain, muscle spasms, limb discomfort and vitamin d deficiency was resolving and the generalised oedema and muscular weakness had resolved.The reporter considered abdominal distension, abdominal pain, abdominal pain lower, acne, adenomyosis, adnexa uteri cyst, adrenal adenoma, allergy to metals, alopecia, arthralgia, arthropathy, asthenia, autoimmune thyroiditis, bladder hydrodistension, bladder pain, blood cholesterol abnormal, blood potassium decreased, carbohydrate intolerance, cardiomyopathy, cervical cyst, chest pain, chronic gastritis, cystitis, dandruff, depression, dermatitis, diarrhoea, dizziness, dry eye, duodenitis, dyslipidaemia, dysmenorrhoea, dyspareunia, dyspnoea exertional, ear disorder, eczema, extrasystoles, fatigue, fibromyalgia, gastrointestinal fungal infection, general physical health deterioration, generalised oedema, headache, helicobacter gastritis, hyperandrogenism, hypertension, limb discomfort, localised muscle pain, menorrhagia, metrorrhagia, muscle contractions involuntary, muscle fatigue, muscle spasms, muscular weakness, musculoskeletal pain, musculoskeletal stiffness, nasal disorder, nausea, onychomadesis, onychomycosis, otolithiasis, ovarian cyst, ovarian vein thrombosis, pain, pain in extremity, palpitations, pelvic pain, peripheral swelling, pharyngeal disorder, phobia, post procedural urine leak, procedural pain, pruritus, radicular pain, rheumatic disorder, skin papilloma, sleep apnoea syndrome, snoring, spinal osteoarthritis, suture related complication, tetany, urinary tract infection, vaginal infection, varicose vein, ventricular extrasystoles, vertigo positional, vitamin d deficiency, vulvovaginal mycotic infection, weight increased and muscle pain to be related to essure.No further causality assessment were provided for the product.The reporter commented: qualifiers reported for "episodes of major muscle fatigue": "indeed paralysis", "difficulty to move".Hypertension nearly returned to normal (135/85) without ongoing treatment.In follow up of hysterectomy for removal, patient complained of urinary leakage (attributed to urethral reflectivity disorder).From 2008, patient experienced weight gain, acne, arterial hypertension possibly corresponding to hyperandrogenism (no search of cause in records).Menorrhagia, adenomyosis due to pre-menopause.Vaginal mycosis not significant.Patient experienced musculoskeletal polyalgesic syndrome secondary to fibromyalgia.Radiculalgia due to lumbar arthrosis, non-significant at that age.Patient had no sequelae due to vitamin d deficiency.Dizziness due to otolith, diagnosed by ent specialist.Urinary incontinence fostered by age, multiple pregnancies and overweight, disclosed by hysterectomy.Cystalgia not related to essure.Lower urinary tract infection not significant, from menopause.Depression, anxiety, weight gain not unexplained.Allergy to gold not reported while essure was in place.Patient did not have symptoms of allergy to nickel, despite reported signs.Anxio-depressive syndrome, probably spasmophilia with psychogenic origin.Permanent exhaustion started in 2011, during disclosure of hashimoto¿s hypothyroidism.Psychologic diagnosis and management started in 2011, late compared to date of essure insertion.Improvement of health status after essure removal was not enough to state symptoms were due to essure.Symptoms were explained by functional or organic diagnosis.The medico-legal discussion stated that there was no causal relationship between essure, symptoms, functional syndrome, pathologies of patient.Symptoms experienced between 2010 and 2017 were not related to essure.Diagnostic results (normal ranges are provided in parenthesis if available): body mass index was (b)(6).Allergy test - on (b)(6) 2010: no results provided; on (b)(6) 2017: delayed hypersensitivity to nickel.Anti-thyroid antibody (iu/l) - on (b)(6) 2010: 108 iu/l; on (b)(6) 2010: 143 iu/l.Blood cholesterol (2 g/l) - on (b)(6) 2018: 2.06 g/l.Blood potassium - on (b)(6) 2011: reduced; on (b)(6) 2012: 6 mmol / loss of potassium mmol.Blood pressure measurement - on (b)(6) 2017: normal; on (b)(6) 2017: 138/80 mmhg.Blood thyroid stimulating hormone (iu/l) - on (b)(6) 2010: 4.53 iu/l.Cardiac stress test - on (b)(6) 2016: no signs of myocardial ischemia.Colonoscopy - on (b)(6) 2011: normal.Computerised tomogram - on (b)(6) 2015: thickening of lining in fundus of both maxillary sinuses, minimal deviated septum to right and hypertrophy of right inferior turbinate; on (b)(6) 2016: no kidney stones and multiple-level osteoarthritic disc disease involving l5-s1 on the left; on (b)(6) 2017: ovarian cyst and thrombosis on the left, approx.10 cm.Culture urine - in (b)(6) 2014: urinary tract infection+++ / infection w/ clear urine.Electrocardiogram ambulatory - on (b)(6) 2014: very abundant, isolated, monomorphic ventricular extrasystoles with a pattern of bigeminy and trigeminy.Electromyogram - on (b)(6) 2015: neurogenic tracings on effort in muscles of quadriceps, toe extensors and anterior leg muscles on left.It was concluded to nerve root involvement at l4.Neurogenic-like record on effort in area of quadriceps extensor muscle of toes and left anterior leg.Laboratory test - on (b)(6) 2016: low phosphorus, tsh imbalance, high glycaemia- early diabetes.Pathology test - on (b)(6) 2017: total hysterectomy, bilateral salpingectomy conclusion: glandular cystic dystrophy within the canal (leading to nabothian cysts); trophic endometrium, absence of hyperplasia and adenomata; extensive adenomyosis; bilateral paratubal cysts; absence of histological sign of malignancy.Ultrasound kidney - on (b)(6) 2017: normal.Ultrasound pelvis - on (b)(6) 2009: implants in situ, normal; on (b)(6) 2010: implants in situ.Ultrasound thyroid - on (b)(6) 2016: thyroid volume at the lower limit of normal, compatible with hashimoto thyroiditis.Vitamin d (ng/ml) - on (b)(6) 2010: 11 ng/ml; in (b)(6) 2014: normal.Quality-safety evaluation of ptc: unable to confirm complaint most recent follow-up information incorporated above includes: on (b)(6) 2020: quality safety evaluation of ptc we received a lot number in this case.A technical investigation was conducted, including a batch review, and a review of complaint records and other non-conformances data; should any new and reportable information become available , 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'), ovarian vein thrombosis ('ovarian vein stenosis / thrombosis of the left ovarian vein'), cardiomyopathy ('cardiomyopathy of unknown origin with hypertension and ectopic beats') and helicobacter gastritis ('chronic active antral gastritis with helicobacter pylori') in a 39-year-old female patient who had essure (batch no.626600) inserted.The occurrence of additional non-serious events is detailed below.The patient's medical history included twin pregnancy, delivered in 2003, gravida ii in 2000 and parity 3 (b)(6) 2000 and twins (b)(6) 2003.History of good general health.As for result of urodynamics measurement, advice to perform perineal self-rehabilitation (in order to improve the perino-detrusor inhibitory reflex by reinforcing the sphincter muscle retention), perineal rehabilitation using bio feedback and electrostimulation was recommended to stabilize and strengthen urethral tone.If the urinary disorders persist, a neuro-urological consult could be considered.Previously administered products included for an unreported indication: cerazette (desogestrel).Concurrent conditions included overweight.Concomitant products included fosfomycin trometamol (uridoz) from (b)(6) 2018, lidocaine (xylocaine) from (b)(6) 2018 and sodium chloride from (b)(6) 2018 for urological examination as well as oral contraceptive nos.In 2008, the patient experienced hypertension ("cardiomyopathy of unknown origin with hypertension and ectopic beats") and acne ("acne / lesions of acne") and was found to have weight increased ("weight gain of 12 kg in 18 months / weight gain from plurifactorial origin / 71 kg in 2012, 73 kg in 2014 and 81 kg in 2017 / progressive weight gain").On (b)(6) 2008, the patient had essure inserted.In 2010, the patient experienced abdominal pain ("abdominal pain"), abdominal distension ("bloating, her abdomen was constantly swollen"), pruritus ("itchy scalp"), diarrhoea ("episodes of diarrhoea / chronic diarrhoea"), fatigue ("chronic fatigue / feeling of exhaustion"), asthenia ("asthenia / loss of energy"), localised muscle pain ("muscle pain in abdomen") and nausea ("frequent nausea").In (b)(6) 2011, the patient experienced muscular weakness ("repeated episodes of functional weakness (b)(6) 2011, (b)(6) 2012, (b)(6) 2015.In (b)(6) 2012, the patient experienced vertigo positional ("rotatory positional vertigo").On (b)(6) 2012, the patient experienced palpitations ("marked palpitations"), pain ("violent pain"), dyspnoea exertional ("dyspnoea on effort") and dizziness ("dizziness") and experienced chest pain ("pain in base of chest lasting a few seconds, like a stitch"), 3 years 3 months after insertion of essure.In 2013, the patient experienced cystitis ("recurrent cystitis").In (b)(6) 2014, the patient experienced ventricular extrasystoles ("very abundant ventricular extrasystole episode").On (b)(6) 2015, the patient experienced musculoskeletal pain ("pain extending from the left buttock to the left thigh / sharp pain on palpation of the gluteus medius tendons") and pain in extremity ("very strong pain in left thigh during the night").In 2016, the patient experienced pelvic pain (seriousness criteria medically significant and intervention required).On (b)(6) 2017, the patient experienced ovarian vein thrombosis (seriousness criterion medically significant) and ovarian cyst ("cyst on left flank / ovarian cyst on left").On an unknown date, the patient experienced arthralgia ("pain on walking and mobilisation of the hip, with pangs of pain/ chronic joint pain").On an unknown date, the patient experienced abdominal pain lower ("cramps"), dysmenorrhoea ("major secondary dysmenorrhoea"), dyspareunia ("dyspareunia"), allergy to metals ("allergy tests showed delayed hypersensitivity to nickel"), dermatitis ("inflammation of the scalp"), menorrhagia ("increasingly severe menorrhagia, heavy menstrual periods"), metrorrhagia ("metrorrhagia"), headache ("headaches"), cardiomyopathy (seriousness criterion medically significant), extrasystoles ("cardiomyopathy of unknown origin with hypertension and ectopic beats"), urinary tract infection ("recurrent urinary tract infections, complicated by hydrodistention"), bladder pain ("germ-free bladder pain / cystalgia"), autoimmune thyroiditis ("toxic phase of hashimoto¿s thyroiditis"), helicobacter gastritis (seriousness criterion medically significant), chronic gastritis ("interstitial lymphocytic gastritis with no helicobacter pylori"), duodenitis ("mild duodenitis"), fibromyalgia ("fibromyalgia"), muscle pain ("diffuse muscle pain in legs which spread to upper limbs/ sore muscles"), muscle spasms ("spasmophilia with normal serum calcium"), muscle fatigue ("episodes of major muscle fatigue indeed paralysis"), muscle contractions involuntary ("constant contraction of muscles"), musculoskeletal stiffness ("feeling of muscle stiffness"), limb discomfort ("sometimes with a feeling of trembling / sclerosis in limbs"), arthropathy ("chronic joint fatigue"), tetany ("attack, assimilated to tetany"), generalised oedema ("oedema of extremities, oedema of the hands, feet and face"), peripheral swelling ("no longer tolerate her gold wedding ring due to the risk of severe swelling of the hand"), vulvovaginal mycotic infection ("recurrent vaginal mycosis"), vitamin d deficiency ("vitamin-d3 deficiency"), onychomycosis ("mycosis of nails"), sleep apnoea syndrome ("episodes of sleep apnoea syndrome"), nasal disorder ("rhinopathy"), depression ("depression - anxio-depressive syndrome") with anxiety, mood altered, sleep disorder, apathy, eating disorder and suicidal ideation, vaginal infection ("vaginitis"), gastrointestinal fungal infection ("digestive mycosis"), eczema ("pruritus with eczema-like attacks"), carbohydrate intolerance ("recently discovered intolerance to sugar"), dyslipidaemia ("dyslipidaemia"), procedural pain ("pain in left iliac fossa following the procedure with anaesthesia of root of thigh"), dry eye ("dry eye syndrome"), varicose vein ("varix"), snoring ("snoring"), rheumatic disorder ("rheumatologic disorders"), ear disorder ("ent disorders"), pharyngeal disorder ("ent disorders"), general physical health deterioration ("health status progressively deteriorated"), post procedural urine leak ("urinary leakage occurrence following of hysterectomy (attributed to urethral reflectivity disorder)"), suture related complication ("inflammatory granuloma on vaginal scar following hysterectomy"), cervical cyst ("glandular cystic dystrophy within the canal - nabothian cyst"), adenomyosis ("extensive adenomyosis"), adnexa uteri cyst ("bilateral paratubal cysts"), alopecia ("hair loss"), onychomadesis ("nail loss"), hyperandrogenism ("hyperandrogenism"), radicular pain ("radiculalgia"), spinal osteoarthritis ("lumbar arthrosis"), otolithiasis ("otolith") and dandruff ("dandruff"), underwent bladder hydrodistension ("recurrent urinary tract infections, complicated by hydrodistention") and was found to have adrenal adenoma ("benign nodular formation on the medial limb of the left adrenal / left adrenal adenoma"), blood potassium decreased ("reduced serum potassium"), skin papilloma ("wart on her left hand") and blood cholesterol abnormal ("cholesterol").The patient was treated with acebutolol hydrochloride (sectral), acetylleucine (tanganil), alprazolam, amitriptyline hydrochloride (laroxyl), amphotericin b (fungizone), analgesics, antibiotics, antithrombotic agents, calcifediol (didrogyl), calcium, ciclopirox (mycoster), domperidone (biperidys), dydrogesterone (duphaston), flecainide acetate (flecaine), levothyroxine sodium (levothyrox), magnesium, melaleuca viridiflora oil;quinine benzoate;thiamine hydrochloride (hexaquine), nefopam hydrochloride (acupan), omeprazole, paracetamol (doliprane), pregabalin (lyrica), propranolol (avlocardyl), rilmenidine phosphate (hyperium), sertaconazole nitrate (monazol), tetrazepam (myolastan), tramadol hydrochloride (topalgic), surgery (hysterectomy with bilateral salpingectomy) and sclerosis.Essure was removed on 3-apr-2017.At the time of the report, the pelvic pain, ovarian vein thrombosis, abdominal pain lower, abdominal pain, abdominal distension, dysmenorrhoea, dyspareunia, allergy to metals, pruritus, menorrhagia, metrorrhagia, headache, ventricular extrasystoles, palpitations, urinary tract infection, cystitis, bladder hydrodistension, bladder pain, autoimmune thyroiditis, adrenal adenoma, helicobacter gastritis, chronic gastritis, duodenitis, diarrhoea, weight increased, fibromyalgia, muscle fatigue, muscle contractions involuntary, musculoskeletal pain, musculoskeletal stiffness, arthralgia, arthropathy, tetany, acne, nausea, peripheral swelling, vulvovaginal mycotic infection, blood potassium decreased, chest pain, skin papilloma, onychomycosis, vertigo positional, sleep apnoea syndrome, nasal disorder, depression, vaginal infection, gastrointestinal fungal infection, eczema, carbohydrate intolerance, dyslipidaemia, procedural pain, ovarian cyst, pain, dyspnoea exertional, dizziness, dry eye, varicose vein, snoring, pain in extremity, blood cholesterol abnormal, rheumatic disorder, ear disorder, pharyngeal disorder, general physical health deterioration, post procedural urine leak, suture related complication, cervical cyst, adenomyosis, adnexa uteri cyst, alopecia, onychomadesis, hyperandrogenism, radicular pain, spinal osteoarthritis, otolithiasis and dandruff outcome was unknown, the cardiomyopathy, hypertension, extrasystoles, fatigue, asthenia, localised muscle pain, muscle pain, muscle spasms, limb discomfort and vitamin d deficiency was resolving and the generalised oedema and muscular weakness had resolved.The reporter considered abdominal distension, abdominal pain, abdominal pain lower, acne, adenomyosis, adnexa uteri cyst, adrenal adenoma, allergy to metals, alopecia, arthralgia, arthropathy, asthenia, autoimmune thyroiditis, bladder hydrodistension, bladder pain, blood cholesterol abnormal, blood potassium decreased, carbohydrate intolerance, cardiomyopathy, cervical cyst, chest pain, chronic gastritis, cystitis, dandruff, depression, dermatitis, diarrhoea, dizziness, dry eye, duodenitis, dyslipidaemia, dysmenorrhoea, dyspareunia, dyspnoea exertional, ear disorder, eczema, extrasystoles, fatigue, fibromyalgia, gastrointestinal fungal infection, general physical health deterioration, generalised oedema, headache, helicobacter gastritis, hyperandrogenism, hypertension, limb discomfort, localised muscle pain, menorrhagia, metrorrhagia, muscle contractions involuntary, muscle fatigue, muscle spasms, muscular weakness, musculoskeletal pain, musculoskeletal stiffness, nasal disorder, nausea, onychomadesis, onychomycosis, otolithiasis, ovarian cyst, ovarian vein thrombosis, pain, pain in extremity, palpitations, pelvic pain, peripheral swelling, pharyngeal disorder, post procedural urine leak, procedural pain, pruritus, radicular pain, rheumatic disorder, skin papilloma, sleep apnoea syndrome, snoring, spinal osteoarthritis, suture related complication, tetany, urinary tract infection, vaginal infection, varicose vein, ventricular extrasystoles, vertigo positional, vitamin d deficiency, vulvovaginal mycotic infection, weight increased and muscle pain to be related to essure.The reporter commented: qualifiers reported for "episodes of major muscle fatigue": "indeed paralysis", "difficulty to move".Hypertension nearly returned to normal (135/85) without ongoing treatment.In follow up of hysterectomy for removal, patient complained of urinary leakage (attributed to urethral reflectivity disorder).From 2008, patient experienced weight gain, acne, arterial hypertension possibly corresponding to hyperandrogenism (no search of cause in records).Menorrhagia, adenomyosis due to pre-menopause.Vaginal mycosis not significant.Patient experienced musculoskeletal polyalgesic syndrome secondary to fibromyalgia.Radiculalgia due to lumbar arthrosis, non-significant at that age.Patient had no sequelae due to vitamin d deficiency.Dizziness due to otolith, diagnosed by ent specialist.Urinary incontinence fostered by age, multiple pregnancies and overweight, disclosed by hysterectomy.Cystalgia not related to essure.Lower urinary tract infection not significant, from menopause.Depression, anxiety, weight gain not unexplained.Allergy to gold not reported while essure was in place.Patient did not have symptoms of allergy to nickel, despite reported signs.Anxio-depressive syndrome, probably spasmophilia with psychogenic origin.Permanent exhaustion started in 2011, during disclosure of hashimoto¿s hypothyroidism.Psychologic diagnosis and management started in 2011, late compared to date of essure insertion.Improvement of health status after essure removal was not enough to state symptoms were due to essure.Symptoms were explained by functional or organic diagnosis.The medico-legal discussion stated that there was no causal relationship between essure, symptoms, functional syndrome, pathologies of patient.Symptoms experienced between 2010 and 2017 were not related to essure.Diagnostic results (normal ranges are provided in parenthesis if available): body mass index was 29.8 kg/sqm.Allergy test - on (b)(6) 2010: no results provided; on (b)(6) 2017: delayed hypersensitivity to nickel.Anti-thyroid antibody (iu/l) - on (b)(6) 2010: 108 iu/l; on (b)(6) 2010: 143 iu/l.Blood cholesterol (2 g/l) - on (b)(6) 2018: 2.06 g/l.Blood potassium - on (b)(6) 2011: reduced; on (b)(6) 2012: 6 mmol / loss of potassium mmol.Blood pressure measurement - on (b)(6) 2017: normal; on (b)(6) 2017: 138/80 mmhg.Blood thyroid stimulating hormone (iu/l) - on (b)(6) 2010: 4.53 iu/l.Cardiac stress test - on (b)(6) 2016: no signs of myocardial ischemia.Colonoscopy - on (b)(6) 2011: normal.Computerised tomogram - on (b)(6) 2015: thickening of lining in fundus of both maxillary sinuses, minimal deviated septum to right and hypertrophy of right inferior turbinate; on (b)(6) 2016: no kidney stones and multiple-level osteoarthritic disc disease involving l5-s1 on the left; on (b)(6) 2017: ovarian cyst and thrombosis on the left, approx.10 cm.Culture urine - in (b)(6) 2014: urinary tract infection / infection w/ clear urine.Electrocardiogram ambulatory - on (b)(6) 2014: very abundant, isolated, monomorphic ventricular extrasystoles with a pattern of bigeminy and trigeminy.Electromyogram - on (b)(6) 2015: neurogenic tracings on effort in muscles of quadriceps, toe extensors and anterior leg muscles on left.It was concluded to nerve root involvement at l4.Neurogenic-like record on effort in area of quadriceps extensor muscle of toes and left anterior leg.Laboratory test - on (b)(6) 2016: low phosphorus, tsh imbalance, high glycaemia- early diabetes.Pathology test - on (b)(6) 2017: total hysterectomy, bilateral salpingectomy conclusion: glandular cystic dystrophy within the canal (leading to nabothian cysts); trophic endometrium, absence of hyperplasia and adenomata; extensive adenomyosis; bilateral paratubal cysts; absence of histological sign of malignancy.Ultrasound kidney - on (b)(6) 2017: normal.Ultrasound pelvis - on (b)(6) 2009: implants in situ, normal; on (b)(6) 2010: implants in situ.Ultrasound thyroid - on (b)(6) 2016: thyroid volume at the lower limit of normal, compatible with hashimoto thyroiditis.Vitamin d (ng/ml) - on (b)(6) 2010: 11 ng/ml; in (b)(6) 2014: normal.Quality-safety evaluation of ptc: unable to confirm complaint.Most recent follow-up information incorporated above includes: on 2-mar-2020: lawyer provided medical records.Patient received alprazolam for anxiety since 2015.New events added: hair -and nail loss, hyperandrogenism, radiculalgia, lumbar arthrosis, otolith, cystalgia, depression/anxio-depressive syndrome.Outcome of the medico-legal discussion was added to comment section.We received a lot number in this case.A technical investigation was 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'), ovarian vein thrombosis ('ovarian vein stenosis / thrombosis of the left ovarian vein'), cardiomyopathy ('cardiomyopathy of unknown origin with hypertension and ectopic beats') and helicobacter gastritis ('chronic active antral gastritis with helicobacter pylori') in a 39-year-old female patient who had essure (batch no.626600) inserted.The occurrence of additional non-serious events is detailed below.The patient's medical history included twin pregnancy, delivered in 2003, gravida ii in 2000 and parity 3 (1 ((b)(6) 2000) and twins ((b)(6) 2003)).History of good general health.As for result of urodynamics measurement, advice to perform perineal self-rehabilitation (in order to improve the perino-detrusor inhibitory reflex by reinforcing the sphincter muscle retention), perineal rehabilitation using bio feedback and electrostimulation was recommended to stabilize and strengthen urethral tone.If the urinary disorders persist, a neuro-urological consult could be considered.Previously administered products included for an unreported indication: cerazette (desogestrel).Concurrent conditions included overweight.Concomitant products included fosfomycin trometamol (uridoz) from (b)(6) 2018 to (b)(6) 2018, lidocaine (xylocaine) from (b)(6) 2018 to (b)(6) 2018 and sodium chloride from (b)(6) 2018 to (b)(6) 2018 for urological examination as well as oral contraceptive nos.On (b)(6) 2008, the patient had essure inserted.In 2008, the patient experienced hypertension ("cardiomyopathy of unknown origin with hypertension and ectopic beats") and acne ("acne / lesions of acne") and was found to have weight increased ("weight gain of 12 kg in 18 months / weight gain from plurifactorial origin / 71 kg in 2012, 73 kg in 2014 and 81 kg in 2017 / progressive weight gain").In 2010, the patient experienced abdominal pain ("abdominal pain"), abdominal distension ("bloating, her abdomen was constantly swollen"), pruritus ("itchy scalp"), diarrhoea ("episodes of diarrhoea / chronic diarrhoea"), fatigue ("chronic fatigue / feeling of exhaustion"), asthenia ("asthenia / loss of energy"), localised muscle pain ("muscle pain in abdomen") and nausea ("frequent nausea").In (b)(6) 2011, the patient experienced muscular weakness ("repeated episodes of functional weakness ((b)(6) 2011, (b)(6) 2012, (b)(6) 2015)").In (b)(6) 2012, the patient experienced vertigo positional ("rotatory positional vertigo").On (b)(6) 2012, the patient experienced palpitations ("marked palpitations"), pain ("violent pain"), dyspnoea exertional ("dyspnoea on effort") and dizziness ("dizziness") and experienced chest pain ("pain in base of chest lasting a few seconds, like a stitch"), 3 years 3 months after insertion of essure.In 2013, the patient experienced cystitis ("recurrent cystitis").In (b)(6) 2014, the patient experienced ventricular extrasystoles ("very abundant ventricular extrasystole episode").On (b)(6)2015, the patient experienced musculoskeletal pain ("pain extending from the left buttock to the left thigh / sharp pain on palpation of the gluteus medius tendons") and pain in extremity ("very strong pain in left thigh during the night").In 2016, the patient experienced pelvic pain (seriousness criteria medically significant and intervention required).On (b)(6) 2017, the patient experienced ovarian vein thrombosis (seriousness criterion medically significant) and ovarian cyst ("cyst on left flank / ovarian cyst on left").On an unknown date, the patient experienced arthralgia ("pain on walking and mobilisation of the hip, with pangs of pain/ chronic joint pain").On an unknown date, the patient experienced abdominal pain lower ("cramps"), dysmenorrhoea ("major secondary dysmenorrhoea"), dyspareunia ("dyspareunia"), allergy to metals ("allergy tests showed delayed hypersensitivity to nickel"), dermatitis ("inflammation of the scalp"), menorrhagia ("increasingly severe menorrhagia, heavy menstrual periods"), metrorrhagia ("metrorrhagia"), headache ("headaches"), cardiomyopathy (seriousness criterion medically significant), extrasystoles ("cardiomyopathy of unknown origin with hypertension and ectopic beats"), urinary tract infection ("recurrent urinary tract infections, complicated by hydrodistention"), bladder pain ("germ-free bladder pain / cystalgia"), autoimmune thyroiditis ("toxic phase of hashimoto¿s thyroiditis"), helicobacter gastritis (seriousness criterion medically significant), chronic gastritis ("interstitial lymphocytic gastritis with no helicobacter pylori"), duodenitis ("mild duodenitis"), fibromyalgia ("fibromyalgia"), muscle pain ("diffuse muscle pain in legs which spread to upper limbs/ sore muscles"), muscle spasms ("spasmophilia with normal serum calcium"), muscle fatigue ("episodes of major muscle fatigue indeed paralysis"), muscle contractions involuntary ("constant contraction of muscles"), musculoskeletal stiffness ("feeling of muscle stiffness"), limb discomfort ("sometimes with a feeling of trembling / sclerosis in limbs"), arthropathy ("chronic joint fatigue"), tetany ("attack, assimilated to tetany"), generalised oedema ("oedema of extremities, oedema of the hands, feet and face"), peripheral swelling ("no longer tolerate her gold wedding ring due to the risk of severe swelling of the hand"), vulvovaginal mycotic infection ("recurrent vaginal mycosis"), vitamin d deficiency ("vitamin-d3 deficiency"), onychomycosis ("mycosis of nails"), sleep apnoea syndrome ("episodes of sleep apnoea syndrome"), nasal disorder ("rhinopathy"), vaginal infection ("vaginitis"), gastrointestinal fungal infection ("digestive mycosis"), eczema ("pruritus with eczema-like attacks"), carbohydrate intolerance ("recently discovered intolerance to sugar"), dyslipidaemia ("dyslipidaemia"), procedural pain ("pain in left iliac fossa following the procedure with anaesthesia of root of thigh"), dry eye ("dry eye syndrome"), varicose vein ("varix"), snoring ("snoring"), rheumatic disorder ("rheumatologic disorders"), ear disorder ("ent disorders"), pharyngeal disorder ("ent disorders"), general physical health deterioration ("health status progressively deteriorated"), post procedural urine leak ("urinary leakage occurrence following of hysterectomy (attributed to urethral reflectivity disorder)"), suture related complication ("inflammatory granuloma on vaginal scar following hysterectomy"), cervical cyst ("glandular cystic dystrophy within the canal - nabothian cyst"), adenomyosis ("extensive adenomyosis"), adnexa uteri cyst ("bilateral paratubal cysts"), alopecia ("hair loss"), onychomadesis ("nail loss"), hyperandrogenism ("hyperandrogenism"), radicular pain ("radiculalgia"), spinal osteoarthritis ("lumbar arthrosis"), otolithiasis ("otolith"), depression ("depression - anxio-depressive syndrome") with sleep disorder, eating disorder, mood altered, anxiety, apathy and suicidal ideation, phobia ("phobic behaviour") and dandruff ("dandruff"), underwent bladder hydrodistension ("recurrent urinary tract infections, complicated by hydrodistention") and was found to have adrenal adenoma ("benign nodular formation on the medial limb of the left adrenal / left adrenal adenoma"), blood potassium decreased ("reduced serum potassium"), skin papilloma ("wart on her left hand") and blood cholesterol abnormal ("cholesterol").The patient was treated with acebutolol hydrochloride (sectral), acetylleucine (tanganil), alprazolam, amitriptyline hydrochloride (laroxyl), amphotericin b (fungizone), analgesics, antibiotics, antithrombotic agents, calcifediol (didrogyl), calcium, ciclopirox (mycoster), domperidone (biperidys), dydrogesterone (duphaston), flecainide acetate (flecaine), levothyroxine sodium (levothyrox), magnesium, melaleuca viridiflora oil;quinine benzoate;thiamine hydrochloride (hexaquine), nefopam hydrochloride (acupan), omeprazole, paracetamol (doliprane), pregabalin (lyrica), propranolol (avlocardyl), rilmenidine phosphate (hyperium), sertaconazole nitrate (monazol), tetrazepam (myolastan), tramadol hydrochloride (topalgic), surgery (hysterectomy with bilateral salpingectomy) and sclerosis.Essure was removed on (b)(6) 2017.At the time of the report, the pelvic pain, ovarian vein thrombosis, abdominal pain lower, abdominal pain, abdominal distension, dysmenorrhoea, dyspareunia, allergy to metals, pruritus, menorrhagia, metrorrhagia, headache, ventricular extrasystoles, palpitations, urinary tract infection, cystitis, bladder hydrodistension, bladder pain, autoimmune thyroiditis, adrenal adenoma, helicobacter gastritis, chronic gastritis, duodenitis, diarrhoea, weight increased, fibromyalgia, muscle fatigue, muscle contractions involuntary, musculoskeletal pain, musculoskeletal stiffness, arthralgia, arthropathy, tetany, acne, nausea, peripheral swelling, vulvovaginal mycotic infection, blood potassium decreased, chest pain, skin papilloma, onychomycosis, vertigo positional, sleep apnoea syndrome, nasal disorder, vaginal infection, gastrointestinal fungal infection, eczema, carbohydrate intolerance, dyslipidaemia, blood cholesterol abnormal, procedural pain, ovarian cyst, pain, dyspnoea exertional, dizziness, dry eye, varicose vein, snoring, pain in extremity, rheumatic disorder, ear disorder, pharyngeal disorder, general physical health deterioration, post procedural urine leak, suture related complication, cervical cyst, adenomyosis, adnexa uteri cyst, alopecia, onychomadesis, hyperandrogenism, radicular pain, spinal osteoarthritis, otolithiasis, depression, phobia and dandruff outcome was unknown, the cardiomyopathy, hypertension, extrasystoles, fatigue, asthenia, localised muscle pain, muscle pain, muscle spasms, limb discomfort and vitamin d deficiency was resolving and the generalised oedema and muscular weakness had resolved.The reporter considered abdominal distension, abdominal pain, abdominal pain lower, acne, adenomyosis, adnexa uteri cyst, adrenal adenoma, allergy to metals, alopecia, arthralgia, arthropathy, asthenia, autoimmune thyroiditis, bladder hydrodistension, bladder pain, blood cholesterol abnormal, blood potassium decreased, carbohydrate intolerance, cardiomyopathy, cervical cyst, chest pain, chronic gastritis, cystitis, dandruff, depression, dermatitis, diarrhoea, dizziness, dry eye, duodenitis, dyslipidaemia, dysmenorrhoea, dyspareunia, dyspnoea exertional, ear disorder, eczema, extrasystoles, fatigue, fibromyalgia, gastrointestinal fungal infection, general physical health deterioration, generalised oedema, headache, helicobacter gastritis, hyperandrogenism, hypertension, limb discomfort, localised muscle pain, menorrhagia, metrorrhagia, muscle contractions involuntary, muscle fatigue, muscle spasms, muscular weakness, musculoskeletal pain, musculoskeletal stiffness, nasal disorder, nausea, onychomadesis, onychomycosis, otolithiasis, ovarian cyst, ovarian vein thrombosis, pain, pain in extremity, palpitations, pelvic pain, peripheral swelling, pharyngeal disorder, phobia, post procedural urine leak, procedural pain, pruritus, radicular pain, rheumatic disorder, skin papilloma, sleep apnoea syndrome, snoring, spinal osteoarthritis, suture related complication, tetany, urinary tract infection, vaginal infection, varicose vein, ventricular extrasystoles, vertigo positional, vitamin d deficiency, vulvovaginal mycotic infection, weight increased and muscle pain to be related to essure.The reporter commented: qualifiers reported for "episodes of major muscle fatigue": "indeed paralysis", "difficulty to move".Hypertension nearly returned to normal (135/85) without ongoing treatment.In follow up of hysterectomy for removal, patient complained of urinary leakage (attributed to urethral reflectivity disorder).From 2008, patient experienced weight gain, acne, arterial hypertension possibly corresponding to hyperandrogenism (no search of cause in records).Menorrhagia, adenomyosis due to pre-menopause.Vaginal mycosis not significant.Patient experienced musculoskeletal polyalgesic syndrome secondary to fibromyalgia.Radiculalgia due to lumbar arthrosis, non-significant at that age.Patient had no sequelae due to vitamin d deficiency.Dizziness due to otolith, diagnosed by ent specialist.Urinary incontinence fostered by age, multiple pregnancies and overweight, disclosed by hysterectomy.Cystalgia not related to essure.Lower urinary tract infection not significant, from menopause.Depression, anxiety, weight gain not unexplained.Allergy to gold not reported while essure was in place.Patient did not have symptoms of allergy to nickel, despite reported signs.Anxio-depressive syndrome, probably spasmophilia with psychogenic origin.Permanent exhaustion started in 2011, during disclosure of hashimoto¿s hypothyroidism.Psychologic diagnosis and management started in 2011, late compared to date of essure insertion.Improvement of health status after essure removal was not enough to state symptoms were due to essure.Symptoms were explained by functional or organic diagnosis.The medico-legal discussion stated that there was no causal relationship between essure, symptoms, functional syndrome, pathologies of patient.Symptoms experienced between 2010 and 2017 were not related to essure.Diagnostic results (normal ranges are provided in parenthesis if available): body mass index was 29.8 kg/sqm.Allergy test - on (b)(6) 2010: no results provided; on (b)(6) 2017: delayed hypersensitivity to nickel.Anti-thyroid antibody (iu/l) - on (b)(6) 2010: 108 iu/l; on (b)(6) 2010: 143 iu/l.Blood cholesterol (2 g/l) - on (b)(6) 2018: 2.06 g/l.Blood potassium - on (b)(6) 2011: reduced; on (b)(6) 2012: 6 mmol / loss of potassium mmol.Blood pressure measurement - on (b)(6) 2017: normal; on (b)(6) 2017: 138/80 mmhg.Blood thyroid stimulating hormone (iu/l) - on (b)(6) 2010: 4.53 iu/l.Cardiac stress test - on (b)(6) 2016: no signs of myocardial ischemia.Colonoscopy - on (b)(6) 2011: normal.Computerised tomogram - on (b)(6) 2015: thickening of lining in fundus of both maxillary sinuses, minimal deviated septum to right and hypertrophy of right inferior turbinate; on (b)(6) 2016: no kidney stones and multiple-level osteoarthritic disc disease involving l5-s1 on the left; on (b)(6) 2017: ovarian cyst and thrombosis on the left, approx.10 cm.Culture urine - in (b)(6) 2014: urinary tract infection+++ / infection w/ clear urine.Electrocardiogram ambulatory - on (b)(6) 2014: very abundant, isolated, monomorphic ventricular extrasystoles with a pattern of bigeminy and trigeminy.Electromyogram - on (b)(6) 2015: neurogenic tracings on effort in muscles of quadriceps, toe extensors, and anterior leg muscles on left.It was concluded to nerve root involvement at l4.Neurogenic-like record on effort in area of quadriceps extensor muscle of toes and left anterior leg.Laboratory test - on (b)(6) 2016: low phosphorus, tsh imbalance, high glycaemia- early diabetes.Pathology test - on (b)(6) 2017: total hysterectomy, bilateral salpingectomy conclusion: glandular cystic dystrophy within the canal (leading to nabothian cysts); trophic endometrium, absence of hyperplasia and adenomata; extensive adenomyosis; bilateral paratubal cysts; absence of histological sign of malignancy.Ultrasound kidney - on (b)(6) 2017: normal.Ultrasound pelvis - on (b)(6) 2009: implants in situ, normal; on (b)(6) 2010: implants in situ.Ultrasound thyroid - on (b)(6) 2016: thyroid volume at the lower limit of normal, compatible with hashimoto thyroiditis.Vitamin d (ng/ml) - on (b)(6) 2010: 11 ng/ml; in (b)(6) 2014: normal.Quality-safety evaluation of ptc: unable to confirm complaint.Most recent follow-up information incorporated above includes: on (b)(6) 2020: ¿extension of expected date of next report¿.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.

• 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: 6911431
• MDR Text Key: 88107557
• Report Number: 2951250-2017-04160
• 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,foreign,other
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 05/21/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/03/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/01/2010
• Device Model Number: ESS305
• Device Lot Number: 626600
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/21/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ORAL CONTRACEPTIVE NOS; ORAL CONTRACEPTIVE NOS; ORAL CONTRACEPTIVE NOS; ORAL CONTRACEPTIVE NOS; ORAL CONTRACEPTIVE NOS; ORAL CONTRACEPTIVE NOS; ORAL CONTRACEPTIVE NOS; ORAL CONTRACEPTIVE NOS (ORAL CONTRACEPTIVE NOS); SODIUM CHLORIDE; SODIUM CHLORIDE; SODIUM CHLORIDE; SODIUM CHLORIDE; SODIUM CHLORIDE; SODIUM CHLORIDE; URIDOZ; URIDOZ; URIDOZ; URIDOZ; URIDOZ; URIDOZ; XYLOCAINE; XYLOCAINE [LIDOCAINE]; XYLOCAINE [LIDOCAINE]; XYLOCAINE [LIDOCAINE]; XYLOCAINE [LIDOCAINE]; XYLOCAINE [LIDOCAINE]
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 39 YR
• Patient Weight: 81