BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ESSURE

    MDR report key: 9078834 · Received September 17, 2019

    Report

    Report Number
    2951250-2019-06809
    Event Type
    Injury
    Date Received
    September 17, 2019
    Report Date
    May 4, 2020
    Manufacturer
    BAYER PHARMA AG
    Product Code
    HHS
    UDI-DI
    10888853003051
    PMA / PMN Number
    P020014
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF UTERINE PERFORATION ('UTERINE PERFORATION') AND GENITAL HAEMORRHAGE ('GEN. ABNORM. BLEED') IN AN ADULT FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 922609, 901330) INSERTED FOR FEMALE STERILIZATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S CONCURRENT CONDITIONS INCLUDED GENITAL HERPES SINCE FEBRUARY 2010, OBESITY, INTRA-ABDOMINAL BLEEDING, GENITAL HERPES, DIZZINESS, ENDOMETRIAL BIOPSY, UTERINE BLEEDING, UTERINE DILATION AND CURETTAGE AND ADENOMYOSIS. CONCOMITANT PRODUCTS INCLUDED LEVONORGESTREL (MIRENA) FROM (B)(6) 2013 TO (B)(6) 2014 FOR INTRA-ABDOMINAL BLEEDING AS WELL AS AMITRIPTYLINE HYDROCHLORIDE (AMITRIPTYLINE HCL), BACLOFEN FROM (B)(6) 2014, IBUPROFEN FROM (B)(6) 2012, LORATADINE FROM (B)(6) 2012 TO (B)(6) 2016, LORAZEPAM FROM (B)(6) 2010 TO (B)(6) 2017, NORETHISTERONE ACETATE (NORETHINDRONE ACETATE) FROM (B)(6) 2014, PIROXICAM (PAXIL) FROM (B)(6) 2014, SUMATRIPTAN (IMITREX) FROM (B)(6) 2013 TO (B)(6) 2014, TRANEXAMIC ACID IN (B)(6) 2014 AND VALACICLOVIR HYDROCHLORIDE (VALACYCLOVIR) FROM (B)(6) 2014 TO (B)(6) 2015. IN (B)(6) 2012, THE PATIENT EXPERIENCED MOOD SWINGS ("MOOD SWING") AND HOT FLUSH ("HOT FLASHES"). ON (B)(6)2012, THE PATIENT HAD ESSURE INSERTED. IN 2012, THE PATIENT EXPERIENCED VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING VAGINAL") AND MENORRHAGIA ("ABNORMAL BLEEDING MENORRHAGIA"). IN (B)(6) 2012, THE PATIENT EXPERIENCED DYSMENORRHOEA ("DYSMENNORHEA CRAMPING"). IN 2013, THE PATIENT EXPERIENCED MIGRAINE ("MIGRAINE") AND WAS FOUND TO HAVE THE FIRST EPISODE OF WEIGHT INCREASED ("WEIGHT GAIN"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED UTERINE PERFORATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), GENITAL HAEMORRHAGE (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), DEPRESSION ("DEPRESSION/ PSYCH INJURY") AND ANXIETY ("ANXIETY WORSENED AFTER IMPLANT") AND WAS FOUND TO HAVE THE SECOND EPISODE OF WEIGHT INCREASED ("WEIGHT GAIN") AND HORMONE LEVEL ABNORMAL ("HORMONAL CHANGES"). THE PATIENT WAS TREATED WITH SURGERY (HYST. (FULL) AND ABLATION.). ESSURE WAS REMOVED ON (B)(6) 2015. AT THE TIME OF THE REPORT, THE UTERINE PERFORATION, THE LAST EPISODE OF WEIGHT INCREASED, MIGRAINE, HORMONE LEVEL ABNORMAL, MENORRHAGIA, DEPRESSION, ANXIETY, DYSMENORRHOEA, MOOD SWINGS AND HOT FLUSH OUTCOME WAS UNKNOWN, THE GENITAL HAEMORRHAGE HAD RESOLVED AND THE VAGINAL HAEMORRHAGE WAS RESOLVING. THE REPORTER CONSIDERED ANXIETY, DEPRESSION, DYSMENORRHOEA, GENITAL HAEMORRHAGE, HORMONE LEVEL ABNORMAL, HOT FLUSH, MENORRHAGIA, MIGRAINE, MOOD SWINGS, UTERINE PERFORATION, VAGINAL HAEMORRHAGE, THE FIRST EPISODE OF WEIGHT INCREASED AND THE SECOND EPISODE OF WEIGHT INCREASED TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: RECEIVED TREATMENT FOR PSYCH INJURY, WEIGHT GAIN, MIGRAINE. CURRENT WEIGHT 180 LBS. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 35.9 KG/SQM. HYSTEROSALPINGOGRAM - ON (B)(6) 2012: RESULT: TOTAL BILATERAL OCCLUSION. CONCERNING THE EVENTS INJURY WAS REPORTED IN THIS CASE WERE DESCRIBED IN MEDICAL RECORDS: WEIGHT GAIN, IRREGULAR VAGINAL BLEEDING, MENORRHAGIA, FEET PAIN, PERFORATION BLADDER, BACK PAIN. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT . MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 7-APR-2020: PLAINTIFF FACT SHEET RECEIVED. ADDED EVENTS HOT FLASHES, MOOD SWING. 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.

    Additional Manufacturer Narrative · 0

    THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF UTERINE PERFORATION ('UTERINE PERFORATION') AND GENITAL HAEMORRHAGE ('GEN. ABNORM. BLEED') IN AN ADULT FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 922609, 901330) INSERTED FOR FEMALE STERILIZATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S CONCURRENT CONDITIONS INCLUDED OBESITY, INTRA-ABDOMINAL BLEEDING, GENITAL HERPES, DIZZINESS, ENDOMETRIAL BIOPSY, UTERINE BLEEDING, UTERINE DILATION AND CURETTAGE AND ADENOMYOSIS. CONCOMITANT PRODUCTS INCLUDED LEVONORGESTREL (MIRENA) FROM (B)(6) 2013 TO (B)(6) 2014 FOR INTRA-ABDOMINAL BLEEDING AS WELL AS AMITRIPTYLINE, BACLOFEN FROM (B)(6) 2014, LORATADINE FROM (B)(6) 2012 TO (B)(6) 2016, NORETHISTERONE ACETATE (NORETHINDRONE ACETATE) FROM (B)(6) 2014, PIROXICAM (PAXIL) FROM (B)(6) 2014, SUMATRIPTAN (IMITREX) FROM (B)(6) 2013 TO (B)(6) 2014, TRANEXAMIC ACID IN DECEMBER 2014 AND VALACICLOVIR HYDROCHLORIDE (VALACYCLOVIR HCL) FROM (B)(6) 2014 TO (B)(6) 2015. ON (B)(6) 2012, THE PATIENT HAD ESSURE INSERTED. IN (B)(6) 2012, THE PATIENT EXPERIENCED DYSMENORRHOEA ("DYSMENNORHEA(CRAMPING)"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED UTERINE PERFORATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), GENITAL HAEMORRHAGE (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), MIGRAINE ("MIGRAINE"), VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL)"), MENORRHAGIA ("ABNORMAL BLEEDING (MENORRHAGIA)"), DEPRESSION ("DEPRESSION/ PSYCH INJURY") AND ANXIETY ("ANXIETY") AND WAS FOUND TO HAVE THE FIRST EPISODE OF WEIGHT INCREASED ("WEIGHT GAIN"), HORMONE LEVEL ABNORMAL ("HORMONAL CHANGES") AND THE SECOND EPISODE OF WEIGHT INCREASED ("WEIGHT GAIN"). THE PATIENT WAS TREATED WITH SURGERY (HYST. (FULL) AND ABLATION.). ESSURE WAS REMOVED ON (B)(6) 2015. AT THE TIME OF THE REPORT, THE UTERINE PERFORATION, MIGRAINE, HORMONE LEVEL ABNORMAL, MENORRHAGIA, DEPRESSION, ANXIETY, DYSMENORRHOEA AND THE LAST EPISODE OF WEIGHT INCREASED OUTCOME WAS UNKNOWN, THE GENITAL HAEMORRHAGE HAD RESOLVED AND THE VAGINAL HAEMORRHAGE WAS RESOLVING. THE REPORTER CONSIDERED ANXIETY, DEPRESSION, DYSMENORRHOEA, GENITAL HAEMORRHAGE, HORMONE LEVEL ABNORMAL, MENORRHAGIA, MIGRAINE, UTERINE PERFORATION, VAGINAL HAEMORRHAGE, THE FIRST EPISODE OF WEIGHT INCREASED AND THE SECOND EPISODE OF WEIGHT INCREASED TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: RECEIVED TREATMENT FOR PSYCH INJURY, WEIGHT GAIN, MIGRAINE. CURRENT WEIGHT 180 LBS. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 35.9 KG/SQM. HYSTEROSALPINGOGRAM - ON (B)(6) 2012: BILATERAL OCCLUSION (PER PPF). CONCERNING THE EVENTS INJURY WAS REPORTED IN THIS CASE WERE DESCRIBED IN MEDICAL RECORDS: WEIGHT GAIN, IRREGULAR VAGINAL BLEEDING, MENORRHAGIA, FEET PAIN, PERFORATION BLADDER, BACK PAIN. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 20-SEP-2019: PFS +MR RECEIVED. LOT NUMBER WAS ADDED. NEW EVENTS ADDED(MR): UTERINE PERFORATION. NEW EVENTS ADDED(PFS): HORMONAL CHANGES, ABNORMAL BLEEDING (VAGINAL, (MENORRHAGIA), ANXIETY, MIGRAINES / HEADACHES, DYSMENORRHEA (CRAMPING), WEIGHT GAIN. PREVIOUSLY ADDED PSYCH INJURY WAS UPDATED TO DEPRESSION. CONCOMITANT DRUGS, CONCOMITANT CONDITIONS, LAB DATA, REPORTERS WERE 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.

    Description of Event or Problem · 1

    THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF GENITAL HAEMORRHAGE ('GEN. ABNORM. BLEED') IN AN ADULT FEMALE PATIENT WHO HAD ESSURE INSERTED FOR FEMALE STERILIZATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. ON (B)(6) 2012, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED GENITAL HAEMORRHAGE (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), PSYCHOLOGICAL TRAUMA ("PSYCH INJURY") AND MIGRAINE ("MIGRAINE") AND WAS FOUND TO HAVE WEIGHT INCREASED ("WEIGHT GAIN"). THE PATIENT WAS TREATED WITH SURGERY (HYST. (FULL), AND ABLATION). ESSURE WAS REMOVED ON (B)(6) 2015. AT THE TIME OF THE REPORT, THE GENITAL HAEMORRHAGE HAD RESOLVED AND THE PSYCHOLOGICAL TRAUMA, WEIGHT INCREASED AND MIGRAINE OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED GENITAL HAEMORRHAGE, MIGRAINE, PSYCHOLOGICAL TRAUMA AND WEIGHT INCREASED TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: RECEIVED TREATMENT FOR PSYCH INJURY, WEIGHT GAIN, MIGRAINE. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): IMAGING PROCEDURE ON (B)(6) 2012: BILATERAL OCCLUSION (PER PPF). QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 4-SEP-2019: PFS RECEIVED. CASE BECOMES AN INCIDENT. INJURY EVENT WAS REMOVED. NEW EVENTS ADDED: GEN. ABNORMAL BLEED, PSYCH INJURY, WEIGHT GAIN, MIGRAINE. OUTCOME OF THE EVENT GEN. ABNORMAL BLEED UPDATED TO RECOVERED/RESOLVED. REPORTER'S INFORMATION WAS UPDATED. INCIDENT: 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
    869094 ESSURE TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE HHS BAYER PHARMA AG ESS305 922609, 901330 10888853003051

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R AMITRIPTYLINE| AMITRIPTYLINE HCL| BACLOFEN| BACLOFEN| IBUPROFEN| IMITREX [SUMATRIPTAN]| IMITREX [SUMATRIPTAN]| LORATADINE| LORATADINE| LORAZEPAM| MIRENA| MIRENA| NORETHINDRONE ACETATE| NORETHINDRONE ACETATE| PAXIL [PIROXICAM]| PAXIL [PIROXICAM]| TRANEXAMIC ACID| TRANEXAMIC ACID| VALACYCLOVIR HCL| VALACYCLOVIR [VALACICLOVIR HYDROCHLORIDE]