Essure ESS305Recalls & reported problems

Summary

The FDA's MAUDE database contains 44,004 adverse event reports that list this exact device (DI 10888853003051), received between Nov 6, 2013 and Sep 30, 2026 — classified as 71 deaths, 43,698 injuries, 235 malfunctions.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (7,848 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 44,004 reports, in the reporter's own words as published by the FDA.

• InjurySep 30, 2026Patient Device Interaction Problem

  Patient problems: Genital Bleeding; Pelvic Pain

  MAUDE report 50948230 ↗
• InjurySep 30, 2026Adverse Event Without Identified Device or Use Problem; Patient Device Interaction Problem

  Bayer Case Number: (b)(4)Pelvic pain Female "[Pelvic pain female]", asthenia "[Asthenia]" ,abdominal pain "[Abdominal pain]" , muscular pain "[Muscular pain]" ,impaired quality of life "[Impaired quality of life]", Scanty menstrual periods "[Hypomenorrhea]" ,Vaginal tenderness "[Vaginal pain]" ,Para tubal vestigial cysts "[Para tubal cyst]" ,adenomyosis "[Adenomyosis]" ,uterine leiomyoma "[Uterine leiomyoma]" ,Lumbar Pain "[Lumbar pain]" . Case Narrative: This spontaneous case was reported by a lawyer and describes the occurrence of PELVIC PAIN ("Pelvic pain Female") in a 44 year-old female patient who had ESSURE inserted for female sterilization. Additional non-serious events are detailed below.The patient had a MEDICAL HISTORY of Parity 4 (2001, 2003, 2006 and 2013). On (b)(6) 2016, the patient had ESSURE inserted. In 2020 she experienced PELVIC PAIN (seriousness criterion intervention required), ASTHENIA ("asthenia"), ABDOMINAL PAIN ("abdominal pain"), MYALGIA (" muscular pain "), IMPAIRED QUALITY OF LIFE ("impaired quality of life"), HYPOMENORRHOEA ("Scanty menstrual periods") and VULVOVAGINAL PAIN ("Vaginal tenderness"). ESSURE was removed on (b)(6) 2025. On unknown date she e

  Patient problems: Abdominal Pain; Back pain; Menstrual Irregularities; Pain; Pelvic Pain

  MAUDE report 50943437 ↗
• InjurySep 29, 2026Patient Device Interaction Problem; Migration

  Patient problems: Foreign Body In Patient; Genital Bleeding; Pelvic Pain

  MAUDE report 50938365 ↗
• InjurySep 25, 2026Adverse Event Without Identified Device or Use Problem; Patient Device Interaction Problem; Migration

  Bayer Case Number: (b)(4).Pelvic pain "[Pelvic pain female]". The implants have migrated out of the fallopian tubes "[Device migration]". Pain in the iliac fossae, predominantly on the left "[Iliac fossa pain]". Significant sleep disorders "[Sleep disorder]", wakefulness "[Wakefulness]", sensations of electric shocks in the legs, mainly at night "[Electric shock sensation]". Stiffness of the pelvis with restriction of certain daily movements (putting on my socks, for example); "[Muscle stiffness]", belly ache; "[Belly ache]", diffuse joint pain "[Joint pain]", dry skin "[Dry skin]", depressive episode in the context of chronic pain. "[Depressive episode]". Case Narrative: The below report was received by health authority ANSM (reference number: (b)(4)) on 21-SEP-2026. This spontaneous case was originally reported by a consumer and describes the occurrence of PELVIC PAIN ("Pelvic pain") in an adult female patient who had ESSURE inserted (lot no. 624104) for female sterilisation. Additional non-serious events are detailed below.There was no information on the patient's medical history or concurrent conditions. On (b)(6) 2007, the patient had ESSURE inserted. On (b)(6) 2026, 6955 days

  Patient problems: Abdominal Pain; Depression; Foreign Body In Patient; Pelvic Pain

  MAUDE report 50895323 ↗
• InjurySep 24, 2026Difficult to Insert; Expulsion; Patient Device Interaction Problem

  Bayer Case Number: (b)(4).Severe pelvic floor pain "[Pelvic pain female]". Essure device had shifted from my ovary to my uterus "[Partial expulsion of device]". Unilateral left ESSURE placement. "[Device insertion failed]". Case Narrative: The below report was received by health authority (b)(6) (reference number: (b)(4)) on 21-SEP-2026. This spontaneous case was originally reported by a consumer and describes the occurrence of PELVIC PAIN ("severe pelvic floor pain.") in a 61 year-old female patient who had ESSURE inserted for female sterilisation. Additional non-serious events are detailed below.Product or product use issues identified: DEVICE INSERTION FAILED ("unilateral left ESSURE placement.")There was no information on the patient's medical history or concurrent conditions. On an unknown date, the patient had ESSURE inserted. On (b)(6) 2024 she experienced DEVICE EXPULSION ("Essure device had shifted from my ovary to my uterus"). In 2024 she experienced PELVIC PAIN (seriousness criterion medically important). At the time of the report, the PELVIC PAIN had not resolved. The outcome of DEVICE EXPULSION was unknown. The reporter considered DEVICE EXPULSION and PELVIC PAIN to be

  Patient problems: Foreign Body In Patient; Pelvic Pain

  MAUDE report 50882072 ↗
• InjurySep 23, 2026Patient Device Interaction Problem

  Patient problems: Itching Sensation

  MAUDE report 50874452 ↗
• InjurySep 23, 2026Adverse Event Without Identified Device or Use Problem; Patient Device Interaction Problem

  Bayer Case Number: (b)(4).Complicated hormonal cycles with periods of amenorrhoea "[Menstrual disorder]",numerous headaches "[Headache]",migraines "[Migraine]", Complicated hormonal cycles with periods of amenorrhoea "[Amenorrhoea]",Breast pain that can last up to 5 weeks at a time. "[Breast pain]", Case Narrative: The below report was received by health authority (b)(6) (reference number: (b)(4)) on 18-SEP-2026. This spontaneous case was originally reported by a consumer and describes the occurrence of MENSTRUAL DISORDER ("Complicated hormonal cycles with periods of amenorrhoea") in a 42 year-old female patient who had ESSURE inserted (lot no. E25514) for female sterilisation. Additional non-serious events are detailed below.There was no information on the patient's medical history or concurrent conditions. On (b)(6) 2016, the patient had ESSURE inserted. In (b)(6) 2019 she experienced HEADACHE ("Numerous headaches"). In 2021 she experienced MIGRAINE ("migraines"). On unknown date she experienced MENSTRUAL DISORDER (seriousness criterion medically important), AMENORRHOEA ("Complicated hormonal cycles with periods of amenorrhoea") and BREAST PAIN ("Breast pain that can last up to

  Patient problems: Headache; Menstrual Irregularities

  MAUDE report 50866217 ↗
• InjurySep 23, 2026Adverse Event Without Identified Device or Use Problem

  Bayer Case Number: (b)(4).Intense chronic fatigue "[Chronic fatigue]", disrupted sleep "[Sleep disturbance]", depression,two burnouts "[Burnout syndrome]",memory problems "[Memory disturbance]", Brain fog,low self-esteem "[Self esteem decreased]", aspiration of saliva (I can't sleep on my back without choking) "[Saliva secretion excessive]",intense and fluctuating joint pain "[Joint pain]", intense and fluctuating bone pain "[Bone pain]", inflammation,pubic symphysis pain "[Pubic pain]", periarthritis of the hip joints "[Periarthritis]", I become stiff and I have to change position "[Stiffness]". Case Narrative: The below report was received by health authority (b)(6) (reference number: (b)(4)) on 18-SEP-2026. This spontaneous case was originally reported by a consumer and describes the occurrence of FATIGUE ("intense chronic fatigue") in a 53 year-old female patient who had ESSURE inserted (lot no. 626917) for female sterilisation. Additional non-serious events are detailed below.There was no information on the patient's medical history or concurrent conditions. On (b)(6) 2008, the patient had ESSURE inserted. In 2012 she experienced FATIGUE (seriousness criterion medically import

  Patient problems: Fatigue

  MAUDE report 50866170 ↗
• InjurySep 22, 2026Adverse Event Without Identified Device or Use Problem; Patient Device Interaction Problem

  Bayer Case Number: (b)(4). Chronic, debilitating pain "[Pelvic pain female]". Recurrent joint pain "[Joint pain]" . Generalized flare-up of osteoarthritis "[Generalized osteoarthritis]" . Dry mucous membranes "[Mucosal dryness]" . Asthenia "[Asthenia]" Case Narrative: The below report was received by health authority ANSM (reference number: (b)(4)) on 18-SEP-2026. This spontaneous case was originally reported by a consumer and describes the occurrence of PELVIC PAIN ("Chronic, debilitating pain") in a 43 year-old female patient who had ESSURE inserted for female sterilization. Additional non-serious events are detailed below. There was no information on the patient's medical history or concurrent conditions. On (b)(6) 2015, the patient had ESSURE inserted. In 2016 she experienced PELVIC PAIN (seriousness criterion medically important), ARTHRALGIA ("Recurrent joint pain"), OSTEOARTHRITIS ("Generalized flare-up of osteoarthritis"), MUCOSAL DRYNESS ("Dry mucous membranes") and ASTHENIA ("Asthenia"). The patient was treated with Surgery (Planned total hysterectomy and bilateral salpingectomy.). ESSURE treatment was not changed. At the time of the report, the PELVIC PAIN and ASTHENIA ha

  Patient problems: Pelvic Pain

  MAUDE report 50851363 ↗
• InjurySep 18, 2026Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  Bayer Case Number: (b)(4)foreign-body material has been removed "[Medical device removal]" Case Narrative: This spontaneous case was reported by a consumer and describes the occurrence of MEDICAL DEVICE REMOVAL ("foreign-body material has been removed") in a female patient who had ESSURE inserted for female sterilization. There was no information on the patient's medical history or concurrent conditions. On (b)(6) 2010, the patient had ESSURE inserted. On unknown date she underwent MEDICAL DEVICE REMOVAL (seriousness criterion intervention required). The patient was treated with Surgery (To Remove Essure). At the time of the report, the outcome of the event was unknown. The reporter considered MEDICAL DEVICE REMOVAL to be related to ESSURE administration. The reporter commented: After this procedure, various physical symptoms have developed. I have since had follow-up treatments, and the foreign-body material has been removed. As a result of the symptoms, I am hindered in my normal daily functioning, and I suffer damages. Case Comments: Based on the available information, a review of our complaint records and other relevant data will be conducted; any new and reportable informatio

  Patient problems: Insufficient Information

  MAUDE report 50813823 ↗
• InjurySep 15, 2026Insufficient Device Problem Information

  Bayer Case Number: (b)(4)foreign-body material will be removed "[Medical device removal]" . Case Narrative: This spontaneous case was reported by a consumer and describes the occurrence of MEDICAL DEVICE REMOVAL ("foreign-body material will be removed") in a female patient who had ESSURE inserted for female sterilization. There was no information on the patient's medical history or concurrent conditions. In 2008, the patient had ESSURE inserted. On unknown date she underwent MEDICAL DEVICE REMOVAL (seriousness criterion intervention required). The patient was treated with Surgery (To remove Essure is scheduled On (b)(6) 2026,). At the time of the report, the outcome of the event was unknown. The reporter considered MEDICAL DEVICE REMOVAL to be related to ESSURE administration. The reporter commented: At the end of 2008, I underwent a medical procedure known as the ¿Essure sterilization method¿ After this procedure, various physical symptoms have developed. On (b)(6) 2026, a follow-up procedure will be performed, and the foreign-body material will be removed. Case Comments: Based on the available information, a review of our complaint records and other relevant data will be conducte

  Patient problems: Insufficient Information

  MAUDE report 50766712 ↗
• InjurySep 8, 2026Adverse Event Without Identified Device or Use Problem

  Bayer Case Number: (b)(4).belly ache "[Belly ache]".Very significant fatigue "[Fatigue]". Hair loss "[Hair loss]". Memory loss "[Memory loss]". ophthalmic migraine "[Ophthalmic migraine]". Headaches "[Headache]". cluster headache "[Cluster headache]". Cervical pain "[Neck pain]". Back pain "[Back pain]". Pain in arms "[Pain in upper extremities]". Hand formication that made her wake up in the night "[Formication]". Heavy and painful menstruations "[Bleeding menstrual heavy]". Heavy and painful menstruations "[Menses painful]". Cough "[Cough]". Mucositis "[Mucositis]". Mediastinal adenopathies "[Mediastinal lymphadenopathy]". Lung nodule "[Lung nodule]". digestive disorders "[Digestion impaired]". Pelvic pain "[Pelvic pain female]". pain in right hypochondrium "[Hypochondrium pain right]".Pain in flank "[Pain flank]".bloating "[Bloating]".constipation "[Constipation]". diarrhea "[Diarrhea]".peri orbital pain / Peri-orbital pain spreading to the left frontal area "[Periorbital pain]". Chest pain / patient complained about left anterior chest pain, above breast, spreading to the back "[Chest pain]". bronchitis "[Bronchitis]". cystitis episodes "[Cystitis]". depressive syndrome "[Depre

  Patient problems: Abdominal Distention; Abdominal Pain; Menorrhagia; Pain; Pelvic Pain

  MAUDE report 50666757 ↗
• InjurySep 7, 2026Insufficient Device Problem Information

  Patient problems: Insufficient Information

  MAUDE report 50646837 ↗
• InjurySep 4, 2026Patient-Device Incompatibility; Patient Device Interaction Problem

  Bayer Case Number: (b)(4).Pelvic pain "[Pelvic pain female]" .Diffuse pain appeared gradually or suddenly "[Diffuse pain]" .Mainly joint pain "[Joint pain]" .muscular pains "[Muscular pains]" .abdominal pain "[Abdominal pain]" .haemorrhagic periods "[Heavy menstrual bleeding]" .recurrent urinary tract infections "[Recurrent urinary tract infection]" .Plus intense tiredness "[Tiredness]" . as ear, nose and throat (ENT) disorders "[Ear, nose and throat disorder]" .allergic reactions with itching "[Itching]" .Allergic reaction "[Allergic reaction]" .irritable bowel syndrome "[Irritable bowel syndrome]" .adenomyosis of the uterus "[Adenomyosis uteri]" . neuropathic pain "[Neuropathic pain]" .chronic inflammation. "[Inflammation]" .L5-S1 herniated disc "[Lumbosacral disc herniation]" .osteoarthrosis "[Osteoarthrosis]" .epicondylitis "[Epicondylitis]" .tinnitus "[Tinnitus]" .degenerative discopathy "[Discopathy]" .lumbosciatalgia "[Lumbosciatalgia]" .genital itching "[Genital itching]" . musculoskeletal disorders "[Musculoskeletal disorder]" .Depression "[Depression]" .anxiety "[Anxiety]" . Case Narrative: The below report was received by health authority ANSM (reference number: (b)(4))

  Patient problems: Abdominal Pain; Hypersensitivity/Allergic reaction; Itching Sensation; Menorrhagia; Pain; Pelvic Pain

  MAUDE report 50609941 ↗
• InjurySep 4, 2026Use of Device Problem; Patient Device Interaction Problem; Migration

  Bayer Case Number: (b)(4).perforations "[Perforation of organ]" .bleeding "[Genital bleeding]" .Severe pain "[Pelvic pain female]" .difficulties with insertion or removal "[Device insertion difficult]" .difficulties with insertion or removal "[Device difficult to remove]" . Case Narrative: This spontaneous case was reported by a consumer and describes the occurrence of PERFORATION ("perforations"), GENITAL HAEMORRHAGE ("bleeding") and PELVIC PAIN ("Severe pain") in a female patient who had ESSURE inserted for female sterilisation. Product or product use issues identified: DEVICE INSERTION DIFFICULT ("difficulties with insertion or removal") and DEVICE DIFFICULT TO REMOVE ("difficulties with insertion or removal"). There was no information on the patient's medical history or concurrent conditions. On an unknown date, the patient had ESSURE inserted. On unknown dates she experienced PERFORATION (seriousness criteria hospitalisation and medically important), GENITAL HAEMORRHAGE (seriousness criterion hospitalisation) and PELVIC PAIN (seriousness criterion hospitalisation). At the time of the report, all of the events were resolving. The reporter considered GENITAL HAEMORRHAGE, PELVIC

  Patient problems: Genital Bleeding; Internal Organ Perforation; Pelvic Pain

  MAUDE report 50609704 ↗
• InjurySep 4, 2026Use of Device Problem; Patient Device Interaction Problem; Migration

  Bayer Case Number: (b)(4).Perforation.Severe pain "[Pelvic pain female]". Bleeding "[Genital bleeding]". Difficulties with insertion or removal "[Device difficult to remove]". Difficulties with insertion or removal "[Device insertion difficult]". Case Narrative: This spontaneous case was reported by a consumer and describes the occurrence of PERFORATION, PELVIC PAIN ("severe pain") and GENITAL HAEMORRHAGE ("bleeding") in a female patient who had ESSURE inserted for female sterilisation. Product or product use issues identified: DEVICE DIFFICULT TO REMOVE ("difficulties with insertion or removal") and DEVICE INSERTION DIFFICULT ("difficulties with insertion or removal"). There was no information on the patient's medical history or concurrent conditions. On an unknown date, the patient had ESSURE inserted. On unknown dates she experienced PERFORATION (seriousness criteria hospitalisation and medically important), PELVIC PAIN (seriousness criterion hospitalisation) and GENITAL HAEMORRHAGE (seriousness criterion hospitalisation). At the time of the report, all of the events were resolving. The reporter considered GENITAL HAEMORRHAGE, PELVIC PAIN and PERFORATION to be related to ESSURE

  Patient problems: Genital Bleeding; Pelvic Pain; Perforation

  MAUDE report 50609179 ↗
• InjurySep 4, 2026Insufficient Device Problem Information

  Bayer Case Number: (b)(4). foreign-body material has been removed "[Medical device removal]". Case Narrative: This spontaneous case was reported by a consumer and describes the occurrence of MEDICAL DEVICE REMOVAL ("foreign-body material has been removed") in a female patient who had ESSURE inserted for female sterilization. There was no information on the patient's medical history or concurrent conditions. In (b)(6) 2011, the patient had ESSURE inserted. In (b)(6) 2018 she underwent MEDICAL DEVICE REMOVAL (seriousness criterion intervention required). ESSURE was removed on an unknown day of the same month. The patient was treated with Surgery (TO Remove Essure). At the time of the report, the outcome of the event was unknown. The reporter considered MEDICAL DEVICE REMOVAL to be related to ESSURE administration. The reporter commented: After this procedure, various physical symptoms have developed. I have since had follow-up treatments, and the foreign-body material has been removed in (b)(6)2018 As a result of the symptoms, I am hindered in my normal daily functioning, and I suffer damaged. Case Comments: Based on the available information, a review of our complaint records and ot

  Patient problems: Insufficient Information

  MAUDE report 50606880 ↗
• InjurySep 3, 2026Adverse Event Without Identified Device or Use Problem; Patient Device Interaction Problem

  Bayer Case Number:(b)(4).stomach pains during menstruation "[Pain menstrual]". Severe headache "[Headache]". Case Narrative: The below report was received by health authority ANSM (reference number: R2624455) on (b)(6) 2026. This spontaneous case was originally reported by a consumer and describes the occurrence of DYSMENORRHOEA ("stomach pains during menstruation") in an adult female patient who had ESSURE inserted for female sterilisation. Additional non-serious events are detailed below.There was no information on the patient's medical history or concurrent conditions. On an unknown date, the patient had ESSURE inserted. On unknown dates she experienced DYSMENORRHOEA (seriousness criterion medically important) and HEADACHE ("Severe headache"). At the time of the report, the outcomes for these events were unknown. No causality assessment was received for ESSURE with regard to HEADACHE or DYSMENORRHOEA. The reporter commented: Patient¿s current status: not specified Actions taken to treat the patient in the healthcare facility: not specified. Case Comments: Based on the available information, a review of our complaint records and other relevant data will be conducted; any new and

  Patient problems: Abdominal Pain; Headache

  MAUDE report 50586217 ↗
• InjurySep 3, 2026Break; Patient-Device Incompatibility; Adverse Event Without Identified Device or Use Problem; Patient Device Interaction Problem

  Bayer Case Number: (b)(4)a small 5-mm fragment of which can be seen in the right paramedian region "[Device breakage]" ,pelvic pain "[Pelvic pain female]" ,NIckel allergy "[Nickel allergy]" ,I soon began having bleeding "[Genital bleeding]" ,Adenomyosis "[Adenomyosis]" ,fatigue / tiredness but a need for movement "[Tiredness]" ,depression "[Depression]" ,Burnout "[Burnout syndrome]" ,sleep difficulties "[Difficulty sleeping]" , obsessive-compulsive disorder (OCD) "[Obsessive-compulsive disorder]" , foggy feeling in head "[Foggy feeling in head]" ,anxiety state "[Anxiety state]" ,paraesthesia in the hands and feet "[Tingling feet/hands]" ,restlessness "[Restlessness]" ,burning sensation in the legs "[Burning leg]" ,carpal tunnel syndrome in both limbs with recurrence on the right "[Carpal tunnel syndrome]", blood circulation problems "[Disorder circulatory system]" ,dizziness "[Dizziness]" ,sensation of a blocked head "[Head fullness]" ,difficulty concentrating "[Concentration impairment]" ,loss of memory "[Loss of memory]" ,teeth grinding (wearing a mouthguard) "[Teeth grinding]" ,nosebleeds "[Nose bleeds]" ,abdominal swelling "[Swelling abdomen]" ,constipation "[Constipation]" ,Ne

  Patient problems: Abdominal Distention; Dizziness; Fatigue; Genital Bleeding; Hypersensitivity/Allergic reaction; Menstrual Irregularities; Pelvic Pain

  MAUDE report 50583204 ↗
• InjurySep 3, 2026Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  Bayer Case Number: (b)(4)Medical Device removal "[Medical device removal]" ,physical Exahaution "[Exhaustion]" ,mental exhaustion, "[Mental exhaustion]" ,Burn out "[Burnout syndrome]" ,Brain fog "[Brain fog]" ,muscle and joint pain "[Arthromyalgia]" ,bruxism "[Bruxism]" ,Hair loss "[Hair loss]" ,continuous headaches "[Persistent headache]" . Case Narrative: The below report was received by health authority Ansm (reference number: (b)(4) on 31-AUG-2026. This spontaneous case was originally reported by a consumer and describes the occurrence of MEDICAL DEVICE REMOVAL ("Medical Device removal") in a 58 year-old female patient who had ESSURE inserted (lot no. 6863565) for female sterilization. Additional non-serious events are detailed below.There was no information on the patient's medical history or concurrent conditions. On (b)(6) 2012, the patient had ESSURE inserted. On (b)(6) 2023, 4017 days after ESSURE insertion, she experienced FATIGUE ("physical Exhaustion"), MENTAL FATIGUE ("mental exhaustion,"), BURNOUT SYNDROME ("Burn out"), BRAIN FOG ("Brain fog"), ARTHRALGIA ("muscle and joint pain"), HEADACHE ("continuous headaches"), BRUXISM ("bruxism") and ALOPECIA ("Hair loss"). On (

  Patient problems: Headache; Insufficient Information

  MAUDE report 50580992 ↗
• InjurySep 3, 2026Insufficient Device Problem Information

  Bayer Case Number: (b)(4)Medical Device Removal "[Medical device removal]" ,Musculoskeletal pain "[Musculoskeletal pain]" ,debilitating fatigue "[Fatigue]" . Case Narrative: The below report was received by health authority ANSM (reference number: (b)(4) on 31-AUG-2026. This spontaneous case was originally reported by a consumer and describes the occurrence of MEDICAL DEVICE REMOVAL ("Medical Device Removal") in a 58 year-old female patient who had ESSURE inserted (lot no. 774386) for female sterilization. Additional non-serious events are detailed below.There was no information on the patient's medical history or concurrent conditions. On (b)(6) 2011, the patient had ESSURE inserted. In 2024 she experienced FATIGUE ("debilitating fatigue"). On unknown date she experienced MUSCULOSKELETAL PAIN ("Musculoskeletal pain").On (b)(6) 2026 she underwent MEDICAL DEVICE REMOVAL (seriousness criterion intervention required). ESSURE was removed the same day. At the time of the report, the outcomes for these events were unknown. No causality assessment was received for ESSURE with regard to MUSCULOSKELETAL PAIN, FATIGUE or MEDICAL DEVICE REMOVAL. The reporter commented: Musculoskeletal pain an

  Patient problems: Insufficient Information

  MAUDE report 50579135 ↗
• InjurySep 2, 2026Entrapment of Device; Improper or Incorrect Procedure or Method; Migration; Lack of Effect

  Patient problems: Device Embedded In Tissue or Plaque; Fallopian Tube Perforation; Pregnancy with a Contraceptive Device

  MAUDE report 50572062 ↗
• InjurySep 1, 2026Insufficient Device Problem Information; Patient Device Interaction Problem; Lack of Effect

  Patient problems: Foreign Body Reaction; Pregnancy with a Contraceptive Device; Spontaneous Abortion

  MAUDE report 50540033 ↗
• InjuryAug 31, 2026Adverse Event Without Identified Device or Use Problem; Patient Device Interaction Problem; Migration

  Patient problems: Abdominal Pain; Discomfort; Foreign Body In Patient; Genital Bleeding; Pelvic Pain

  MAUDE report 50518888 ↗
• InjuryAug 21, 2026Break; Patient-Device Incompatibility; Expulsion; Patient Device Interaction Problem

  Bayer Case Number: (b)(4)My body reacts to these metal and plastic fragments with a constan "[Device breakage]" ,The implants came off when trying to extract the Essure "[Device expulsion]" ,failing health "[General physical health deterioration]" ,significant weight gain "[Abnormal weight gain]" , impaired immune system (Lichen sclerosus) "[Lichen sclerosus]" , constantly elevated CRP "[CRP increased]" ,(systemic inflammation "[Systemic inflammatory response syndrome]" ,My body reacts to these metal and plastic fragments with a constan "[Discomfort bodily]" ,abdominal swelling "[Swelling abdomen]" ,extreme drug sensitivity "[Drug hypersensitivity]" ,food sensitivities "[Food allergy]" ,Discomfort persists as the uterus remains "[Uterine cervical pain]" . Case Narrative: The below report was received by health authority THE SWEDISH MEDICAL PRODUCTS AGENCY (reference number: (b)(4) on 18-AUG-2026. This spontaneous case was originally reported by a consumer and describes the occurrence of DEVICE BREAKAGE ("My body reacts to these metal and plastic fragments with a constan") in an adult female patient who had ESSURE inserted. Additional non-serious events are detailed below.There was

  Patient problems: Abdominal Distention; Discomfort; Foreign Body In Patient; Hypersensitivity/Allergic reaction; Pain

  MAUDE report 50373738 ↗