BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ESSURE

    MDR report key: 9102811 · Received September 23, 2019

    Report

    Report Number
    2951250-2019-07779
    Event Type
    Injury
    Date Received
    September 23, 2019
    Date of Event
    January 1, 2011
    Report Date
    November 11, 2019
    Manufacturer
    BAYER PHARMA AG
    Product Code
    HHS
    UDI-DI
    10888853003051
    PMA / PMN Number
    P020014
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ('PELVIC PAIN') AND GENITAL HAEMORRHAGE ('BLEEDING: GENERAL ABNORMAL BLEED') IN A 32-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. CO-SUSPECT PRODUCTS INCLUDED IBUPROFEN. THE PATIENT'S MEDICAL HISTORY INCLUDED STOMACH PAIN, UTI, EYE PAIN, NASAL CONGESTION, TIREDNESS, ALLERGIC RHINITIS, NEUROLOGIC DISORDER NOS, SINUS DISORDER AND VITILIGO. CONCURRENT CONDITIONS INCLUDED SKIN LIGHTENING, MENSES IRREGULAR, HIRSUTISM, FATIGUE, POLYCYSTIC OVARIAN SYNDROME, ITCHY, RASH, DERMATOPHYTOSIS OF THE BODY, SKIN EXFOLIATION, FLANK PAIN, VOMITING, MASS, HEADACHE, BACK PAIN, FATIGUE, VAGINAL ITCHING, GARDNERELLA VAGINALIS VAGINITIS AND LIGHT SENSITIVITY TO EYE. CONCOMITANT PRODUCTS INCLUDED CEFALEXIN (KEFLEX), GRISEOFULVIN (GRIFULVIN V), HYDROCODONE BITARTRATE;PARACETAMOL (NORCO), IBUPROFEN, KETOCONAZOLE (NIZORAL) AND METFORMIN HYDROCHLORIDE (GLUCOPHAGE). ON AN UNKNOWN DATE, THE PATIENT STARTED IBUPROFEN 800 MG AT AN UNSPECIFIED FREQUENCY. ON (B)(6) 2010, THE PATIENT HAD ESSURE INSERTED. IN (B)(6) 2011, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), DYSPAREUNIA ("DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE)"), ABDOMINAL PAIN ("ABDOMINAL PAIN"), ABDOMINAL DISTENSION ("OTHER INJURIES/SYMPTOMS: GASTROINTESTINAL (GI) CONDITIONS/BLOATING"), VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL)") AND MENORRHAGIA ("ABNORMAL BLEEDING (MENORRHAGIA)"). IN (B)(6) 2014, THE PATIENT EXPERIENCED SKIN DEPIGMENTATION ("ALLERGY: RASH/SKIN CONDITION/LOST PIGMENTATION IN SKIN/LOST MELANIN IN SKIN") AND ALOPECIA ("OTHER INJURIES/SYMPTOMS: HAIR LOSS"). IN (B)(6) 2016, THE PATIENT EXPERIENCED MIGRAINE ("OTHER INJURIES/SYMPTOMS: MIGRAINE/MIGRAINES / HEADACHES"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED GENITAL HAEMORRHAGE (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED) AND SKIN DISORDER ("SKIN CONDITION"). THE PATIENT WAS TREATED WITH SURGERY (HYSTERECTOMY (PARTIAL) , ON (B)(6) 2019, BILATERAL SALPINGECTOMY). ESSURE WAS REMOVED ON (B)(6) 2019. AT THE TIME OF THE REPORT, THE PELVIC PAIN, GENITAL HAEMORRHAGE, DYSPAREUNIA, ABDOMINAL PAIN, SKIN DEPIGMENTATION, ALOPECIA, ABDOMINAL DISTENSION, MIGRAINE, VAGINAL HAEMORRHAGE AND MENORRHAGIA HAD RESOLVED AND THE SKIN DISORDER OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL DISTENSION, ABDOMINAL PAIN, ALOPECIA, DYSPAREUNIA, GENITAL HAEMORRHAGE, MENORRHAGIA, MIGRAINE, PELVIC PAIN, SKIN DEPIGMENTATION, SKIN DISORDER AND VAGINAL HAEMORRHAGE TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: PLAINTIFF RECEIVED TREATMENT FOR MIGRAINE, HAIR LOSS, GASTROINTESTINAL (GI) CONDITIONS. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): HYSTEROSALPINGOGRAM - ON (B)(6) 2010: TOTAL BILATERAL OCCLUSION. NO EXTRAVASATION OF CONTRAST NOTED BILATERALLY COMPATIBLE WITH COMPLETE OCCLUSION OF EACH FALLOPIAN TUBE.. IMAGING PROCEDURE - ON (B)(6) 2010: ESSURE CONFIRMATION TEST(S) (UNSPECIFIED) BILATERAL OCCLUSION. CONCERNING THE INJURIES WERE REPORTED IN THIS CASE, THE FOLLOWING ONES WERE DESCRIBED IN PATIENT'S MEDICAL RECORDS: HAIR LOSS, ABDOMINAL PAIN, BLOATING, PELVIC PAIN, SKIN DEPIGMENTATION. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 18-OCT-2019: PFS & MR RECEIVED- NEW EVENTS ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA) WERE ADDED. EVENT GASTROINTESTINAL DISORDER WAS UPDATED TO BLOATING AND ALLERGIC RASH WAS UPDATED TO LOST PIGMENTATION IN SKIN/ LOST MELANIN IN SKIN. THE OUTCOME OF EVENT HAIR LOSS AND MIGRAINES / HEADACHES WERE UPDATED FROM UNKNOWN TO RECOVERED. EVENT ONSET DATE WAS ADDED. CONCOMITANT DRUGS, MEDICAL HISTORY AND LAB DATA WERE ADDED. PATIENT'S HEIGHT WAS ADDED. REPORTER'S INFORMATION WAS ADDED. NO LOT NUMBER OR DEVICE SAMPLE WAS RECEIVED IN THIS CASE. AT THIS TIME, WE HAVE NO INFORMATION SUGGESTING THAT THE DEVICE FAILED TO MEET ITS SPECIFICATIONS. WE WILL CONDUCT A REVIEW OF OUR COMPLAINT RECORDS AND OTHER NON-CONFORMANCES DATA; SHOULD ANY NEW AND REPORTABLE INFORMATION BECOME AVAILABLE FROM OUR INVESTIGATION, THIS WILL BE PROVIDED IN A SUPPLEMENTARY REPORT.

    Description of Event or Problem · 1

    THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ('PELVIC PAIN') AND GENITAL HAEMORRHAGE ('BLEEDING: GENERAL ABNORMAL BLEED') IN AN ADULT FEMALE PATIENT WHO HAD ESSURE INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. ON (B)(6) 2010, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), GENITAL HAEMORRHAGE (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), DYSPAREUNIA ("DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE)"), ABDOMINAL PAIN ("ABDOMINAL PAIN"), SKIN DISORDER ("SKIN CONDITION"), RASH ("ALLERGY: RASH/SKIN CONDITION"), ALOPECIA ("OTHER INJURIES/SYMPTOMS: HAIR LOSS"), GASTROINTESTINAL DISORDER ("OTHER INJURIES/SYMPTOMS: GASTROINTESTINAL (GI) CONDITIONS") AND MIGRAINE ("OTHER INJURIES/SYMPTOMS: MIGRAINE"). THE PATIENT WAS TREATED WITH SURGERY (HYSTERECTOMY (PARTIAL) , ON (B)(6) 2019). ESSURE WAS REMOVED ON (B)(6) 2019. AT THE TIME OF THE REPORT, THE PELVIC PAIN, GENITAL HAEMORRHAGE, DYSPAREUNIA AND ABDOMINAL PAIN HAD RESOLVED AND THE SKIN DISORDER, RASH, ALOPECIA, GASTROINTESTINAL DISORDER AND MIGRAINE OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL PAIN, ALOPECIA, DYSPAREUNIA, GASTROINTESTINAL DISORDER, GENITAL HAEMORRHAGE, MIGRAINE, PELVIC PAIN, RASH AND SKIN DISORDER TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: PLAINTIFF RECEIVED TREATMENT FOR MIGRAINE, HAIR LOSS, GASTROINTESTINAL (GI) CONDITIONS. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): IMAGING PROCEDURE ON (B)(6) 2010: ESSURE CONFIRMATION TEST(S) (UNSPECIFIED) BILATERAL OCCLUSION. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 6-SEP-2019: PFS RECEIVED. PREVIOUSLY REPORTED EVENT "INJURY NOS" REPLACED WITH "PELVIC PAIN", EVENTS- "DYSPAREUNIA, ABDOMINAL PAIN, GENERAL ABNORMAL BLEED, RASH/SKIN CONDITION, MIGRAINE, HAIR LOSS, GASTROINTESTINAL (GI) CONDITIONS", LAB DATA, PATIENT¿S DEMOGRAPHICS WERE ADDED. NO LOT NUMBER OR DEVICE SAMPLE WAS RECEIVED IN THIS CASE. AT THIS TIME, WE HAVE NO INFORMATION SUGGESTING THAT THE DEVICE FAILED TO MEET ITS SPECIFICATIONS. WE WILL CONDUCT A REVIEW OF OUR COMPLAINT RECORDS AND OTHER NON-CONFORMANCES DATA; SHOULD ANY NEW AND REPORTABLE INFORMATION BECOME AVAILABLE FROM OUR INVESTIGATION, THIS WILL BE PROVIDED IN A SUPPLEMENTARY REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    900925 ESSURE TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE HHS BAYER PHARMA AG ESS305 10888853003051

    Patients

    Seq Age Sex Outcome Treatment
    1 32 YR Other| R GLUCOPHAGE| GRIFULVIN V| IBUPROFEN| KEFLEX [CEFALEXIN]| NIZORAL| NORCO