BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ESSURE

    MDR report key: 6950845 · Received October 16, 2017

    Report

    Report Number
    2951250-2017-04723
    Event Type
    Injury
    Date Received
    October 16, 2017
    Date of Event
    June 1, 2010
    Report Date
    August 2, 2018
    Manufacturer
    BAYER PHARMA AG
    Product Code
    HHS
    PMA / PMN Number
    P020014
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF ABDOMINAL PAIN LOWER ("SEVERE LOWER ABDOMINAL PAIN"), GENITAL HAEMORRHAGE ("ABNORMAL HEAVY BLEEDING / ABNORMAL BLEEDING (GENERAL)") AND ENDOMETRIOSIS ABLATION ("FULGURATION OF ENDOMETRIOSIS") IN A 25-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 664655, 664666) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S PAST MEDICAL HISTORY INCLUDED GRAVIDA II (G2 P2 T2 PO AO EO MO L2), STREPTOCOCCAL BACTERAEMIA ((LAST PREGNANCY)), UTI ((PRIMARY ENCOUNTER DIAGNOSIS).) AND STREPTOCOCCAL BACTERAEMIA. PATIENT DENIES ANY DRUG USES SINCE (B)(6). ALERT AND ORIENTED X4, RESPIRATIONS EVEN AND UNLABORED. PREVIOUSLY ADMINISTERED PRODUCTS INCLUDED FOR PREGNANCY PREVENTATION: MEDROXYPROGESTERON FROM (B)(6) 2009 TO (B)(6) 2011; FOR BIRTH CONTROL: DEPO-PROVERA ON (B)(6) 2009; FOR AN UNREPORTED INDICATION: INFLUENZA VACCIN ON (B)(6) 2009, NUVARING FROM 2007 TO 2009, PRENATAL VITAMIN, MIRENA, VICODIN AND VALIUM. CONCURRENT CONDITIONS INCLUDED NONSMOKER SINCE (B)(6) 2009, PREGNANCY (DELIVERED.) SINCE (B)(6) 2009, MUSCLE CRAMPS SINCE (B)(6) 2010, HAEMORRHAGE NOS SINCE (B)(6) 2010, EYE INFECTION SINCE (B)(6) 2010, CONGESTION NASAL (GREEN NASAL DISCHARGE) SINCE (B)(6) 2010, NASAL OBSTRUCTION SINCE (B)(6) 2010, SINUS PAIN SINCE (B)(6) 2010, EYE PRURITUS SINCE (B)(6) 2010, FEVER SINCE (B)(6) 2010, CHRONIC SINUSITIS SINCE (B)(6) 2010, CONJUNCTIVITIS SINCE (B)(6) 2010, SORE THROAT SINCE (B)(6) 2010, IRREGULAR PERIODS (IRREGULAR MENSES FROM I YEAR SINCE ESSURE WANTS TO START OCP TO MAKE MENSES REGULAR. OCCASIONAL HEAVY.) SINCE (B)(6) 2011, PARITY 2 (G2 P2 T2 PO AO EO MO L2), WISDOM TEETH REMOVAL (EXTRACTION ERUPTED TOOTH/EXR COMMENT: WISDOM TEETH REMOVED 2003) SINCE 2003, INFLUENZA (PROPHYLACTIC VACCINE FOR INFLUENZA), DYSURIA (GENITOURINARY: POSITIVE FOR DYSURIA, URGENCY AND FREQUENCY.) SINCE (B)(6) 2011, ANXIETY SINCE (B)(6) 2012, PANIC ATTACK SINCE (B)(6) 2012, HYPOKALEMIA SINCE (B)(6) 2012, SHORT OF BREATH SINCE (B)(6) 2012, NUMBNESS SINCE (B)(6) 2012, PAIN IN FACE (NUMBNESS AND TINGLING ALL OVER,) SINCE (B)(6) 2012, MUSCLE SPASMS SINCE (B)(6) 2012, CHEST PAIN SINCE (B)(6) 2012, LIGHTHEADEDNESS SINCE (B)(6) 2012, PALPITATION SINCE (B)(6) 2012, DIZZINESS SINCE (B)(6) 2012, NERVOUS (NERVOUS/ANXIOUS.) SINCE (B)(6) 2012, SHAKING SINCE (B)(6) 2012, ERYTHEMA SINCE (B)(6) 2012, SKIN WARM SINCE (B)(6) 2012, DRY SKIN SINCE (B)(6) 2012, FACIAL BONES FRACTURE (WITH MINIMAL DISPLACEMENT.) SINCE (B)(6) 2012, PANIC DISORDER ((PRIMARY ENCOUNTER DIAGNOSIS)) SINCE (B)(6) 2012, ABRASION NOS SINCE (B)(6) 2012, ACCIDENT (CAUSE OF INJURY, ACCIDENTAL FALL) SINCE (B)(6) 2012, RADIUS FRACTURE (NONDISPLACED) SINCE (B)(6) 2012, CONTUSION OF ELBOW SINCE (B)(6) 2012, ARTHRALGIA SINCE (B)(6) 2012, HEAVY PERIODS SINCE (B)(6) 2012, PANIC DISORDER SINCE (B)(6) 2012, MENOMETRORRHAGIA ((PRIMARY ENCOUNTER DIAGNOSIS) MENOMETRORRHAGIA DUE TO HORMONAL CAUSES), BACK PAIN (HISTORY: BACK PAIN - POSSIBLE UTI + CHILLS X 1 WEEK.) SINCE (B)(6) 2013, CHILLS (HISTORY: BACK PAIN - POSSIBLE UTI + CHILLS X 1 WEEK.) SINCE (B)(6) 2013, ABDOMINAL PAIN SINCE (B)(6) 2013, FLANK PAIN (URGENCY, FREQUENCY FLANK PAIN.) SINCE (B)(6) 2013, TIREDNESS SINCE (B)(6) 2013, DRY EYE ((PRIMARY ENCOUNTER DIAGNOSIS)) SINCE (B)(6) 2013, HYPERMETROPIA SINCE (B)(6) 2013, BLEEDING BREAKTHROUGH, TENDERNESS SINCE (B)(6) 2013, AMENORRHEA SINCE (B)(6) 2014, POLYCYSTIC OVARY SINCE (B)(6) 2014, ENDOMETRIAL BIOPSY (IN 2014) SINCE (B)(6) 2014, ENDOMETRIAL ABLATION SINCE (B)(6) 2014, STRESS SINCE (B)(6) 2014, DISCOMFORT (SHE FEELS PARALYZED) SINCE (B)(6) 2014, HEART ATTACK SINCE (B)(6) 2014, STRESS SINCE (B)(6) 2014, SKIN DISORDER (ROS AND PHYSICAL EXAMINATION: LEFT BREAST WITH ANNULAR LESION ADJACENT TO NIPPLE AT 4 O¿CLOCK POSITION, RESEMBLING TINEA CORPORIS) SINCE (B)(6) 2014, SKIN LESION SINCE (B)(6) 2014, BREAST MASS ((PRIMARY ENCOUNTER DIAGNOSIS) PATIENT PRESENTS WITH SMALL BUT DEFINITE DARKENED AREA LEFT BREAST 4 O CLOCK POSITION X 3 MONTHS, WAS SMALLER BUT HAS ENLARGED, COULD BE TINEA CORPORIS BUT PT FEELS ITS INDENTED AT THE SITE, PLEASE EVALUATE. WILL TX FOR TINEA IN THE MEANTIME.) SINCE (B)(6) 2014, POST COITAL BLEEDING SINCE (B)(6) 2016, FATIGUE SINCE (B)(6) 2016, WEAKNESS SINCE (B)(6) 2016, HAIR LOSS SINCE (B)(6) 2016, NABOTHIAN CYST SINCE (B)(6) 2016, MYOMETRITIS (WITH NO SIGNIFICANT PATHOLOGIC LESION.) SINCE (B)(6) 2016, PARATUBAL CYST (FALLOPIAN TUBES SHOWING SMALL PARATUBAL CYSTS.) SINCE (B)(6) 2016, IRREGULAR MENSTRUATION SINCE (B)(6) 2016, ENDOMETRIOSIS ABLATION SINCE (B)(6) 2016, MASS (C/O MILD INTERMITTENT RIGHT THUMB PAIN X 1 MONTH. TINGLING AT THE RIGHT THUMB X 1 MONTH.) SINCE (B)(6) 2016, GANGLION CYST ((PRIMARY ENCOUNTER DIAGNOSIS)) SINCE (B)(6) 2016, NEUROMA SINCE (B)(6) 2016, LIGAMENT SPRAIN SINCE (B)(6) 2016 AND INJURY NOS ((RIGHT FOOT)) SINCE (B)(6) 2016. FAMILY HISTORY INCLUDED HEART DISEASE, UNSPECIFIED (FATHER) AND LEUKEMIA ((PATERNAL GRANDMOTHER).). CONCOMITANT PRODUCTS INCLUDED EUGYNON (LEVORA) FROM (B)(6) 2011 TO (B)(6) 2013 FOR IRREGULAR MENSTRUATION, CONTRACEPTIVES NOS FOR VAGINAL BLEEDING AS WELL AS CILEST (SPRINTEC) FROM (B)(6) 2012 TO (B)(6) 2016, CIPROFLOXACIN, IBUPROFEN, LORAZEPAM (ATIVAN), METHOCARBAMOL, OXAZEPAM FROM (B)(6) 2012 TO (B)(6) 2013 AND PHENAZOPYRIDINE. ON (B)(6) 2010, THE PATIENT HAD ESSURE INSERTED. ON THE SAME DAY, THE PATIENT EXPERIENCED GENITAL HAEMORRHAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT) AND MENSTRUATION IRREGULAR ("IRREGULAR PERIOD"). IN (B)(6) 2010, THE PATIENT EXPERIENCED COITAL BLEEDING ("POSTCOITAL SPOTTING"). IN (B)(6) 2010, THE PATIENT EXPERIENCED MENORRHAGIA ("PROLONGED MENSTRUAL BLEEDING / ABNORMAL BLEEDING (MENORRHAGIA)") AND VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL)"). IN (B)(6) 2010, THE PATIENT EXPERIENCED ABDOMINAL PAIN LOWER (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED) AND BACK PAIN ("SEVERE BACK PAIN"). IN (B)(6) 2010, THE PATIENT EXPERIENCED VAGINAL DISCHARGE ("IRREGULAR VAGINAL DISCHARGE"). IN (B)(6) 2011, THE PATIENT EXPERIENCED DYSMENORRHOEA ("SEVERE MENSTRUAL PAIN / DYSMENORRHEA (CRAMPING)"). IN (B)(6) 2011, THE PATIENT EXPERIENCED URINARY TRACT INFECTION ("URINARY TRACT INFECTION"), BLADDER DISORDER ("BLADDER PROBLEM OR CHANGES"), URINARY TRACT DISORDER ("URINARY PROBLEMS OR CHANGES") AND DYSURIA ("DYSURIA"). IN (B)(6) 2012, THE PATIENT EXPERIENCED ANXIETY ("ANXIETY"). IN (B)(6) 2012, THE PATIENT EXPERIENCED DYSPAREUNIA ("PAIN DURING INTERCOURSE / DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE)"). IN (B)(6) 2013, THE PATIENT EXPERIENCED FATIGUE ("FATIGUE"). IN (B)(6) 2013, THE PATIENT EXPERIENCED ALOPECIA ("HAIR LOSS"). IN (B)(6) 2014, THE PATIENT EXPERIENCED FEELING ABNORMAL ("BRAIN FOG") AND MEMORY IMPAIRMENT ("TROUBLE WITH SHORT TERM MEMORY"). IN (B)(6) 2014, THE PATIENT EXPERIENCED SKIN LESION ("SKIN LESION") AND CHEST PAIN ("SORES ON CHEST"). IN (B)(6) 2016, THE PATIENT EXPERIENCED MUSCLE SPASMS ("MUSCLE SPASM"). ON AN UNKNOWN DATE, THE PATIENT UNDERWENT ENDOMETRIOSIS ABLATION (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), VAGINAL INFECTION ("VAGINAL INFECTION"), PROCEDURAL PAIN ("PAINFUL POST-OPERATIVE RECOVERY"), HYPOKALAEMIA ("HYPOKALAEMIA"), PELVIC PAIN ("PAIN"), FLANK PAIN ("LEFT SIDE FLANK PAIN") AND RASH ("RASHES"). THE PATIENT WAS TREATED WITH METHOCARBAMOL (ROBAXIN), LORAZEPAM AND SURGERY (TOTAL HYSTERECTOMY AND BILATERAL SALPINGECTOMY TO REMOVE THE ESSURE DEVICES). ESSURE WAS REMOVED ON (B)(6) 2016. AT THE TIME OF THE REPORT, THE ABDOMINAL PAIN LOWER, GENITAL HAEMORRHAGE, DYSMENORRHOEA, MENORRHAGIA, BACK PAIN, DYSPAREUNIA, ALOPECIA, VAGINAL DISCHARGE, VAGINAL INFECTION AND PROCEDURAL PAIN WAS RESOLVING, THE ENDOMETRIOSIS ABLATION, VAGINAL HAEMORRHAGE, URINARY TRACT INFECTION, BLADDER DISORDER, URINARY TRACT DISORDER, FEELING ABNORMAL, MEMORY IMPAIRMENT, HYPOKALAEMIA, PELVIC PAIN, FATIGUE, MUSCLE SPASMS, MENSTRUATION IRREGULAR, SKIN LESION, CHEST PAIN, COITAL BLEEDING, DYSURIA AND FLANK PAIN OUTCOME WAS UNKNOWN AND THE ANXIETY AND RASH HAD RESOLVED. THE REPORTER CONSIDERED ABDOMINAL PAIN LOWER, ALOPECIA, ANXIETY, BACK PAIN, BLADDER DISORDER, CHEST PAIN, COITAL BLEEDING, DYSMENORRHOEA, DYSPAREUNIA, DYSURIA, ENDOMETRIOSIS ABLATION, FATIGUE, FEELING ABNORMAL, FLANK PAIN, GENITAL HAEMORRHAGE, HYPOKALAEMIA, MEMORY IMPAIRMENT, MENORRHAGIA, MENSTRUATION IRREGULAR, MUSCLE SPASMS, PELVIC PAIN, PROCEDURAL PAIN, RASH, SKIN LESION, URINARY TRACT DISORDER, URINARY TRACT INFECTION, VAGINAL DISCHARGE, VAGINAL HAEMORRHAGE AND VAGINAL INFECTION TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: FOLLOWING THE REMOVAL SURGERY, PLAINTIFF SUFFERED A PAINFUL POST-OPERATIVE RECOVERY. SINCE HAVING THE SURGERY, PLAINTIFF'S SYMPTOMS WERE MOSTLY RESOLVED. UPON DETERMINING THAT THE PATIENTS ANATOMY WAS SUITABLE FOR MICRO-INSERT PLACEMENT, THE ESSURE DEVICES WERE PLACED IN STANDARD FASHION INTO THE BILATERAL TUBAL OSTIA WITH VISIBLE COILS SHOWING WITHIN THE ENDOMETRIAL CAVITY AS FOLLOWS: RIGHT: 6 COILS, LEFT 10COILS. PATIENT'S HAD ESSURE (B)(6) 2009. HYSTEROSALPINGOGRAM WITH INJECTION COMMENT: ESSURE (B)(6) 2009. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): HYSTEROSALPINGOGRAM - ON (B)(6) 2010: CONFIRMING FULL OCCLUSION OF FALLOPIAN TUBES (B)(6) 2009, DISCHARGE SUMMARIES: PREGNANCY PROBLEM LIST: GBS POSITIVE-NEEDS ABX IN LABOR (RESISTANT TO CLINDAMYCIN). UTI X 2 (E COLI 3109, GBS 5109)--RX MACROBID QHS REST OF PREG. EIF-SEE NOTE FROM C. SPRING, GENETICS. CURRENT MEDICATIONS WERE REVIEWED BYLETI. ON (B)(6) 2010, PREGNANCY URINE PREGNANCY TEST NEGATIVE. (B)(6) 2012 PATIENT STATES SINCE SHE TOOK MDMA ON JULY 4TH FOR THE FIRST TIME SHE HAS BEEN HAVING SIMILAR EPISODES MULTIPLE TIMES SINCE THEN. STATES TOOK "A LOT OF ESCTASY" ON FOURTH OF JULY AND HAS BEEN HAVING PANIC ATTACKS X 1 WEEK. ON (B)(6) 2013 POSSIBLE NEED FOR PELVIC SONOGRAPHY AND/OR EMB TO DO OTHER ETIOLOGIES OF IRREGULAR BLEEDING. ON (B)(6) 2013, SHE WAS PLACED ON COC S TO CONTROL BLEEDING WITHOUT ANY RELIEF. ON (B)(6) 2014, A TRANSVAGINAL ULTRASOUND WAS DONE THE UTERUS MEASURED 8 X 5 ~ 3CM THE ENDOMETRIAL STRIPE MEASURED 0.25 CM THE POSITION OF THE UTERUS IS MIDLINE THE RIGHT OVARY MEASURES 3X2~2, NO MASSES OR LESIONS THE LEFT OVARY MEASURES 3X2~2N, O MASSES OR LESIONS THERE IS NO FLUID IN THE CUL DE SAC. ON (B)(6) 2016, ADDITIONAL INFORMATION: BILATERAL ESSURE APPEAR TO BE LOCATED IN NORMAL POSITION IMPRESSION: FREE FLUID IN THE CUL-DE-SAC. BILATERAL ESSURE VISUALIZED. ON (B)(6) 2016, PROCEDURES: TOTAL LAPAROSCOPIC HYSTERECTOMY, BILATERAL SALPINGECTOMY, CYSTOSCOPY, FULGURATION OF ENDOMETRIOSIS, CYSTOSCOPY. FINDINGS: GROSSLY NORMAL APPEARING UTERUS, TUBES, AND OVARIES AREAS OF ENDOMETRIOSIS NOTED IN POSTERIOR CUL-DE-SAC ESSURE COILS NOTED IN BILATERAL TUBES. ON (B)(6) 2016, INLT (PRIMARY ENCOUNTER DIAGNOSIS). CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONES WERE CONFIRMED IN PATIENT¿S MEDICAL RECORDS CONFORMING: ABDOMINAL PAIN LOWER, GENITAL HAEMORRHAGE, MENORRHAGIA, BACK PAIN AND ALOPECIA. LOT NUMBERS AND EXP/MFR DATES 664655 AUG2012 / AUG2009. 664666 SEP2012 / SEP2009. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 25-JUL-2018: QUALITY-SAFETY EVALUATION OF PRODUCT TECHNICAL COMPLAINT UPDATE. 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.

    Additional Manufacturer Narrative · 0

    THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF ABDOMINAL PAIN LOWER ("SEVERE LOWER ABDOMINAL PAIN") AND GENITAL HAEMORRHAGE ("ABNORMAL HEAVY BLEEDING") IN AN ADULT FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 664655) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S PAST MEDICAL HISTORY INCLUDED GRAVIDA II (G2 P2 T2 PO AO EO MO L2), STREPTOCOCCAL BACTERAEMIA ((LAST PREGNANCY)) AND UTI ((PRIMARY ENCOUNTER DIAGNOSIS).). PATIENT DENIES ANY DRUG USES SINCE (B)(6). ALERT AND ORIENTED X4, RESPIRATIONS EVEN AND UNLABORED. PREVIOUSLY ADMINISTERED PRODUCTS INCLUDED FOR BIRTH CONTROL: DEPO-PROVERA ON (B)(6) 2009; FOR AN UNREPORTED INDICATION: INFLUENZA VACCIN ON (B)(6) 2009, VALIUM, MIRENA AND VICODIN. CONCURRENT CONDITIONS INCLUDED NONSMOKER SINCE (B)(6) 2009, PREGNANCY (DELIVERED.) SINCE (B)(6) 2009, CRAMP SINCE (B)(6) 2010, BLEEDING SINCE (B)(6) 2010, EYE INFECTION SINCE (B)(6) 2010, CONGESTION NASAL (GREEN NASAL DISCHARGE) SINCE (B)(6) 2010, NASAL OBSTRUCTION SINCE (B)(6) 2010, SINUS PAIN SINCE (B)(6) 2010, EYE PRURITUS SINCE (B)(6) 2010, FEVER SINCE (B)(6) 2010, CHRONIC SINUSITIS SINCE (B)(6) 2010, CONJUNCTIVITIS SINCE (B)(6) 2010, SORE THROAT SINCE (B)(6) 2010, IRREGULAR PERIODS (IRREGULAR MENSES FROM I YEAR SINCE ESSURE WANTS TO START OCP TO MAKE MENSES REGULAR. OCCASIONAL HEAVY.) SINCE (B)(6) 2011, PARITY 2 (G2 P2 T2 PO AO EO MO L2), WISDOM TEETH REMOVAL (EXTRACTION ERUPTED TOOTH/EXR COMMENT: WISDOM TEETH REMOVED 2003) SINCE 2003, INFLUENZA (PROPHYLACTIC VACCINE FOR INFLUENZA), DYSURIA (GENITOURINARY: POSITIVE FOR DYSURIA, URGENCY AND FREQUENCY.) SINCE (B)(6) 2011, ANXIETY SINCE (B)(6) 2012, PANIC ATTACK SINCE (B)(6) 2012, HYPOKALEMIA SINCE (B)(6) 2012, SHORT OF BREATH SINCE (B)(6) 2012, NUMBNESS SINCE (B)(6) 2012, PAIN IN FACE (NUMBNESS AND TINGLING ALL OVER,) SINCE (B)(6) 2012, MUSCLE SPASMS SINCE (B)(6) 2012, CHEST PAIN SINCE (B)(6) 2012, LIGHTHEADEDNESS SINCE (B)(6) 2012, PALPITATION SINCE (B)(6) 2012, DIZZINESS SINCE (B)(6) 2012, NERVOUS (NERVOUS/ANXIOUS.) SINCE (B)(6) 2012, SHAKING SINCE (B)(6) 2012, ERYTHEMA SINCE (B)(6) 2012, SKIN WARM SINCE (B)(6) 2012, DRY SKIN SINCE (B)(6) 2012, FACIAL BONES FRACTURE (WITH MINIMAL DISPLACEMENT.) SINCE (B)(6) 2012, PANIC DISORDER ((PRIMARY ENCOUNTER DIAGNOSIS)) SINCE (B)(6) 2012, ABRASION NOS SINCE (B)(6) 2012, ACCIDENT (CAUSE OF INJURY, ACCIDENTAL FALL) SINCE (B)(6) 2012, RADIUS FRACTURE (NONDISPLACED) SINCE (B)(6) 2012, CONTUSION OF ELBOW SINCE (B)(6) 2012, ARTHRALGIA SINCE (B)(6) 2012, HEAVY PERIODS SINCE (B)(6) 2012, PANIC DISORDER SINCE (B)(6) 2012, MENOMETRORRHAGIA ((PRIMARY ENCOUNTER DIAGNOSIS) MENOMETRORRHAGIA DUE TO HORMONAL CAUSES), BACK PAIN (HISTORY: BACK PAIN - POSSIBLE UTI + CHILLS X 1 WEEK.) SINCE (B)(6) 2013, CHILLS (HISTORY: BACK PAIN - POSSIBLE UTI + CHILLS X 1 WEEK.) SINCE (B)(6) 2013, ABDOMINAL PAIN SINCE (B)(6) 2013, FLANK PAIN (URGENCY, FREQUENCY FLANK PAIN.) SINCE (B)(6) 2013, TIREDNESS SINCE (B)(6) 2013, DRY EYE ((PRIMARY ENCOUNTER DIAGNOSIS)) SINCE (B)(6) 2013, HYPERMETROPIA SINCE (B)(6) 2013, BLEEDING BREAKTHROUGH, TENDERNESS SINCE (B)(6) 2013, AMENORRHEA SINCE (B)(6) 2014, POLYCYSTIC OVARY SINCE (B)(6) 2014, ENDOMETRIAL BIOPSY (IN 2014) SINCE (B)(6) 2014, ENDOMETRIAL ABLATION SINCE (B)(6) 2014, STRESS SINCE (B)(6) 2014, FEELING ABNORMAL (SHE FEELS PARALYZED) SINCE (B)(6) 2014, HEART ATTACK SINCE (B)(6) 2014, STRESS SINCE (B)(6) 2014, BREAST DISORDER NOS (ROS AND PHYSICAL EXAMINATION: LEFT BREAST WITH ANNULAR LESION ADJACENT TO NIPPLE AT 4 O¿CLOCK POSITION, RESEMBLING TINEA CORPORIS) SINCE (B)(6) 2014, SKIN LESION SINCE (B)(6) 2014, BREAST MASS ((PRIMARY ENCOUNTER DIAGNOSIS). PATIENT PRESENTS WITH SMALL BUT DEFINITE DARKENED AREA LEFT BREAST 4 O CLOCK POSITION X 3 MONTHS, WAS SMALLER BUT HAS ENLARGED, COULD BE TINEA CORPORIS BUT PT FEELS ITS INDENTED AT THE SITE, PLEASE EVALUATE. WILL TX FOR TINEA IN THE MEANTIME.) SINCE (B)(6) 2014, POST COITAL BLEEDING SINCE (B)(6) 2016, FATIGUE SINCE (B)(6) 2016, WEAKNESS SINCE (B)(6) 2016, HAIR LOSS SINCE (B)(6) 2016, NABOTHIAN CYST SINCE (B)(6) 2016, MYOMETRITIS (WITH NO SIGNIFICANT PATHOLOGIC LESION.) SINCE (B)(6) 2016, PARATUBAL CYST (FALLOPIAN TUBES SHOWING SMALL PARATUBAL CYSTS.) SINCE (B)(6) 2016, IRREGULAR MENSTRUATION SINCE (B)(6) 2016, ENDOMETRIOSIS ABLATION SINCE (B)(6) 2016, MASS (C/O MILD INTERMITTENT RIGHT THUMB PAIN X 1 MONTH. TINGLING AT THE RIGHT THUMB X 1 MONTH.) SINCE (B)(6) 2016, GANGLION CYST ((PRIMARY ENCOUNTER DIAGNOSIS)) SINCE (B)(6) 2016, NEUROMA SINCE (B)(6) 2016, LIGAMENT SPRAIN SINCE (B)(6) 2016 AND INJURY NOS ((RIGHT FOOT)) SINCE (B)(6) 2016. FAMILY HISTORY INCLUDED HEART DISEASE, UNSPECIFIED (FATHER) AND LEUKEMIA ((PATERNAL GRANDMOTHER).). CONCOMITANT PRODUCTS INCLUDED CONTRACEPTIVES NOS FOR VAGINAL BLEEDING AS WELL AS CIPROFLOXACIN, IBUPROFEN, LORAZEPAM (ATIVAN), METHOCARBAMOL AND PHENAZOPYRIDINE. ON (B)(6) 2010, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED ABDOMINAL PAIN LOWER (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), GENITAL HAEMORRHAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), DYSMENORRHOEA ("SEVERE MENSTRUAL PAIN"), MENORRHAGIA ("PROLONGED MENSTRUAL BLEEDING"), BACK PAIN ("SEVERE BACK PAIN"), DYSPAREUNIA ("PAIN DURING INTERCOURSE"), ALOPECIA ("HAIR LOSS"), VAGINAL DISCHARGE ("IRREGULAR VAGINAL DISCHARGE"), VAGINAL INFECTION ("VAGINAL INFECTION") AND PROCEDURAL PAIN ("PAINFUL POST-OPERATIVE RECOVERY"). THE PATIENT WAS TREATED WITH SURGERY (TOTAL HYSTERECTOMY AND BILATERAL SALPINGECTOMY TO REMOVE THE ESSURE DEVICES). ESSURE WAS REMOVED ON (B)(6) 2016. AT THE TIME OF THE REPORT, THE ABDOMINAL PAIN LOWER, GENITAL HAEMORRHAGE, DYSMENORRHOEA, MENORRHAGIA, BACK PAIN, DYSPAREUNIA, ALOPECIA, VAGINAL DISCHARGE, VAGINAL INFECTION AND PROCEDURAL PAIN WAS RESOLVING. THE REPORTER CONSIDERED ABDOMINAL PAIN LOWER, ALOPECIA, BACK PAIN, DYSMENORRHOEA, DYSPAREUNIA, GENITAL HAEMORRHAGE, MENORRHAGIA, PROCEDURAL PAIN, VAGINAL DISCHARGE AND VAGINAL INFECTION TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: FOLLOWING THE REMOVAL SURGERY, PLAINTIFF SUFFERED A PAINFUL POST-OPERATIVE RECOVERY. SINCE HAVING THE SURGERY, PLAINTIFF'S SYMPTOMS WERE MOSTLY RESOLVED. UPON DETERMINING THAT THE PATIENTS ANATOMY WAS SUITABLE FOR MICRO-INSERT PLACEMENT, THE ESSURE DEVICES WERE PLACED IN STANDARD FASHION INTO THE BILATERAL TUBAL OSTIA WITH VISIBLE COILS SHOWING WITHIN THE ENDOMETRIAL CAVITY AS FOLLOWS: RIGHT: 6 COILS, LEFT 10COILS. PATIENT'S HAD ESSURE (B)(6) 2009. HYSTEROSALPINGOGRAM WITH INJECTION COMMENT: ESSURE DEC 2009 DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): HYSTEROSALPINGOGRAM - IN APRIL 2010: CONFIRMING FULL OCCLUSION OF FALLOPIAN TUBES (B)(6) 2009, DISCHARGE SUMMARIES: PREGNANCY PROBLEM LIST: 1. GBS POSITIVE-NEEDS ABX IN LABOR (RESISTANT TO CLINDAMYCIN) 2. UTI X 2 (E COLI 3109, GBS 5109)--RX MACROBID QHS REST OF PREG 3. EIF-SEE NOTE FROM C. SPRING, GENETICS. CURRENT MEDICATIONS WERE REVIEWED BYLETI. ON (B)(6) 2010,PREGNANCY URINE PREGNANCY TEST NEGATIVE. (B)(6) 2012 PATIENT STATES SINCE SHE TOOK MDMA ON (B)(6) FOR THE FIRST TIME SHE HAS BEEN HAVING SIMILAR EPISODES MULTIPLE TIMES SINCE THEN. STATES TOOK "A LOT OF ESCTASY" ON (B)(6) AND HAS BEEN HAVING PANIC ATTACKS X 1 WEEK. ON (B)(6) 2013 POSSIBLE NEED FOR PELVIC SONOGRAPHY AND/OR EMB TO DO OTHER ETIOLOGIES OF IRREGULAR BLEEDING. ON (B)(6) 2013, SHE WAS PLACED ON COC S TO CONTROL BLEEDING WITHOUT ANY RELIEF. ON (B)(6) 2014, A TRANSVAGINAL ULTRASOUND WAS DONE THE UTERUS MEASURED 8 X 5 ~ 3CM THE ENDOMETRIAL STRIPE MEASURED 0.25 CM THE POSITION OF THE UTERUS IS MIDLINE THE RIGHT OVARY MEASURES 3X2~2, NO MASSES OR LESIONS THE LEFT OVARY MEASURES 3X2~2N, O MASSES OR LESIONS THERE IS NO FLUID IN THE CUL DE SAC. ON 23-FEB-2016, ADDITIONAL INFORMATION: BILATERAL ESSURE APPEAR TO BE LOCATED IN NORMAL POSITION IMPRESSION: * FREE FLUID IN THE CUL-DE-SAC. * BILATERAL ESSURE VISUALIZED. ON (B)(6) 2016, PROCEDURES: TOTAL LAPAROSCOPIC HYSTERECTOMY, BILATERAL SALPINGECTOMY, CYSTOSCOPY, FULGURATION OF ENDOMETRIOSIS, CYSTOSCOPY. FINDINGS: GROSSLY NORMAL APPEARING UTERUS, TUBES, AND OVARIES AREAS OF ENDOMETRIOSIS NOTED IN POSTERIOR CUL-DE-SAC ESSURE COILS NOTED IN BILATERAL TUBES. ON (B)(6) 2016, INLT (PRIMARY ENCOUNTER DIAGNOSIS). CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONES WERE CONFIRMED IN PATIENT¿S MEDICAL RECORDS: ABDOMINAL PAIN LOWER, GENITAL HAEMORRHAGE, MENORRHAGIA, BACK PAIN AND ALOPECIA. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 27-FEB-2018: MR RECEIVED. REPORTERS WERE ADDED. PATIENT¿S DETAILS, HISTORICAL DRUG, HISTORICAL DRUG, CONCOMITANT DISEASE, CONCOMITANT DRUGS, FAMILY HISTORY AND UNSTRUCTURED RELEVANT TESTS WERE ADDED. MEDICALLY CONFIRMED CASE. ESSURE LOT NUMBER ADDED. 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.

    Additional Manufacturer Narrative · 0

    THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF ABDOMINAL PAIN LOWER ("SEVERE LOWER ABDOMINAL PAIN"), GENITAL HAEMORRHAGE ("ABNORMAL HEAVY BLEEDING / ABNORMAL BLEEDING (GENERAL)") AND ENDOMETRIOSIS ABLATION ("FULGURATION OF ENDOMETRIOSIS") IN A 25-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 664655, 664666) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S PAST MEDICAL HISTORY INCLUDED GRAVIDA II (G2 P2 T2 PO AO EO MO L2), STREPTOCOCCAL BACTERAEMIA ((LAST PREGNANCY)) AND UTI ((PRIMARY ENCOUNTER DIAGNOSIS).). PATIENT DENIES ANY DRUG USES SINCE (B)(6). ALERT AND ORIENTED X4, RESPIRATIONS EVEN AND UNLABORED. PREVIOUSLY ADMINISTERED PRODUCTS INCLUDED FOR PREGNANCY PREVENTATION: MEDROXYPROGESTERONE FROM 10-NOV-2009 TO 24-JAN-2011; FOR BIRTH CONTROL: DEPO-PROVERA ON (B)(6) 2009; FOR AN UNREPORTED INDICATION: INFLUENZA VACCIN ON (B)(6) 2009, NUVARING FROM 2007 TO 2009, PRENATAL VITAMIN, MIRENA, VICODIN AND VALIUM. CONCURRENT CONDITIONS INCLUDED NONSMOKER SINCE (B)(6) 2009, PREGNANCY (DELIVERED.) SINCE (B)(6) 2009, MUSCLE CRAMPS SINCE (B)(6) 2010, HAEMORRHAGE NOS SINCE (B)(6) 2010, EYE INFECTION SINCE (B)(6) 2010, CONGESTION NASAL (GREEN NASAL DISCHARGE) SINCE (B)(6) 2010, NASAL OBSTRUCTION SINCE (B)(6) 2010, SINUS PAIN SINCE (B)(6) 2010, EYE PRURITUS SINCE (B)(6) 2010, FEVER SINCE (B)(6) 2010, CHRONIC SINUSITIS SINCE (B)(6) 2010, CONJUNCTIVITIS SINCE (B)(6) 2010, SORE THROAT SINCE (B)(6) 2010, IRREGULAR PERIODS (IRREGULAR MENSES FROM I YEAR SINCE ESSURE WANTS TO START OCP TO MAKE MENSES REGULAR. OCCASIONAL HEAVY.) SINCE (B)(6) 2011, PARITY 2 (G2 P2 T2 PO AO EO MO L2), WISDOM TEETH REMOVAL (EXTRACTION ERUPTED TOOTH/EXR COMMENT: WISDOM TEETH REMOVED 2003) SINCE 2003, INFLUENZA (PROPHYLACTIC VACCINE FOR INFLUENZA), DYSURIA (GENITOURINARY: POSITIVE FOR DYSURIA, URGENCY AND FREQUENCY.) SINCE (B)(6) 2011, ANXIETY SINCE (B)(6) 2012, PANIC ATTACK SINCE (B)(6) 2012, HYPOKALEMIA SINCE (B)(6) 2012, SHORT OF BREATH SINCE (B)(6) 2012, NUMBNESS SINCE (B)(6) 2012, PAIN IN FACE (NUMBNESS AND TINGLING ALL OVER,) SINCE (B)(6) 2012, MUSCLE SPASMS SINCE (B)(6) 2012, CHEST PAIN SINCE (B)(6) 2012, LIGHTHEADEDNESS SINCE (B)(6) 2012, PALPITATION SINCE (B)(6) 2012, DIZZINESS SINCE (B)(6) 2012, NERVOUS (NERVOUS/ANXIOUS.) SINCE (B)(6) 2012, SHAKING SINCE (B)(6) 2012, ERYTHEMA SINCE (B)(6) 2012, SKIN WARM SINCE (B)(6) 2012, DRY SKIN SINCE (B)(6) 2012, FACIAL BONES FRACTURE (WITH MINIMAL DISPLACEMENT.) SINCE (B)(6) 2012, PANIC DISORDER ((PRIMARY ENCOUNTER DIAGNOSIS)) SINCE (B)(6) 2012, ABRASION NOS SINCE (B)(6) 2012, ACCIDENT (CAUSE OF INJURY, ACCIDENTAL FALL) SINCE (B)(6) 2012, RADIUS FRACTURE (NONDISPLACED) SINCE (B)(6) 2012, CONTUSION OF ELBOW SINCE (B)(6) 2012, ARTHRALGIA SINCE (B)(6) 2012, HEAVY PERIODS SINCE (B)(6) 2012, PANIC DISORDER SINCE (B)(6) 2012, MENOMETRORRHAGIA ((PRIMARY ENCOUNTER DIAGNOSIS). MENOMETRORRHAGIA DUE TO HORMONAL CAUSES), BACK PAIN (HISTORY: BACK PAIN - POSSIBLE UTI + CHILLS X 1 WEEK.) SINCE (B)(6) 2013, CHILLS (HISTORY: BACK PAIN - POSSIBLE UTI + CHILLS X 1 WEEK.) SINCE (B)(6) 2013, ABDOMINAL PAIN SINCE (B)(6) 2013, FLANK PAIN (URGENCY, FREQUENCY FLANK PAIN.) SINCE (B)(6) 2013, TIREDNESS SINCE (B)(6) 2013, DRY EYE ((PRIMARY ENCOUNTER DIAGNOSIS)) SINCE (B)(6) 2013, HYPERMETROPIA SINCE (B)(6) 2013, BLEEDING BREAKTHROUGH, TENDERNESS SINCE (B)(6) 2013, AMENORRHEA SINCE (B)(6) 2014, POLYCYSTIC OVARY SINCE (B)(6) 2014, ENDOMETRIAL BIOPSY (IN 2014) SINCE (B)(6) 2014, ENDOMETRIAL ABLATION SINCE (B)(6) 2014, STRESS SINCE (B)(6) 2014, DISCOMFORT (SHE FEELS PARALYZED) SINCE (B)(6) 2014, HEART ATTACK SINCE (B)(6) 2014, STRESS SINCE (B)(6) 2014, SKIN DISORDER (ROS AND PHYSICAL EXAMINATION: LEFT BREAST WITH ANNULAR LESION ADJACENT TO NIPPLE AT 4 O'CLOCK POSITION, RESEMBLING TINEA CORPORIS) SINCE (B)(6) 2014, SKIN LESION SINCE (B)(6) 2014, BREAST MASS ((PRIMARY ENCOUNTER DIAGNOSIS). PATIENT PRESENTS WITH SMALL BUT DEFINITE DARKENED AREA LEFT BREAST 4 O CLOCK POSITION X 3 MONTHS, WAS SMALLER BUT HAS ENLARGED, COULD BE TINEA CORPORIS BUT PT FEELS ITS INDENTED AT THE SITE, PLEASE EVALUATE. WILL TX FOR TINEA IN THE MEANTIME.) SINCE (B)(6) 2014, POST COITAL BLEEDING SINCE (B)(6) 2016, FATIGUE SINCE (B)(6) 2016, WEAKNESS SINCE (B)(6) 2016, HAIR LOSS SINCE (B)(6) 2016, NABOTHIAN CYST SINCE (B)(6) 2016, MYOMETRITIS (WITH NO SIGNIFICANT PATHOLOGIC LESION.) SINCE (B)(6) 2016, PARATUBAL CYST (FALLOPIAN TUBES SHOWING SMALL PARATUBAL CYSTS.) SINCE (B)(6) 2016, IRREGULAR MENSTRUATION SINCE (B)(6) 2016, ENDOMETRIOSIS ABLATION SINCE (B)(6) 2016, MASS (C/O MILD INTERMITTENT RIGHT THUMB PAIN X 1 MONTH. TINGLING AT THE RIGHT THUMB X 1 MONTH.) SINCE (B)(6) 2016, GANGLION CYST ((PRIMARY ENCOUNTER DIAGNOSIS)) SINCE (B)(6) 2016, NEUROMA SINCE (B)(6) 2016, LIGAMENT SPRAIN SINCE (B)(6) 2016 AND INJURY NOS ((RIGHT FOOT)) SINCE (B)(6) 2016. FAMILY HISTORY INCLUDED HEART DISEASE, UNSPECIFIED (FATHER) AND LEUKEMIA ((PATERNAL GRANDMOTHER).). CONCOMITANT PRODUCTS INCLUDED EUGYNON (LEVORA) FROM 24-JAN-2011 TO 23-JAN-2013 FOR IRREGULAR MENSTRUATION, CONTRACEPTIVES NOS FOR VAGINAL BLEEDING AS WELL AS CILEST (SPRINTEC) FROM 7-NOV-2012 TO 2-MAR-2016, CIPROFLOXACIN, IBUPROFEN, LORAZEPAM (ATIVAN), METHOCARBAMOL, OXAZEPAM FROM 7-AUG-2012 TO 3-FEB-2013 AND PHENAZOPYRIDINE. ON (B)(6) 2010, THE PATIENT HAD ESSURE INSERTED. ON THE SAME DAY, THE PATIENT EXPERIENCED GENITAL HAEMORRHAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT) AND MENSTRUATION IRREGULAR ("IRREGULAR PERIOD"). IN (B)(6) 2010, THE PATIENT EXPERIENCED COITAL BLEEDING ("POSTCOITAL SPOTTING"). IN (B)(6) 2010, THE PATIENT EXPERIENCED MENORRHAGIA ("PROLONGED MENSTRUAL BLEEDING / ABNORMAL BLEEDING (MENORRHAGIA)") AND VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL)"). IN (B)(6) 2010, THE PATIENT EXPERIENCED ABDOMINAL PAIN LOWER (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED) AND BACK PAIN ("SEVERE BACK PAIN"). IN (B)(6) 2010, THE PATIENT EXPERIENCED VAGINAL DISCHARGE ("IRREGULAR VAGINAL DISCHARGE"). IN (B)(6) 2011, THE PATIENT EXPERIENCED DYSMENORRHOEA ("SEVERE MENSTRUAL PAIN / DYSMENORRHEA (CRAMPING)"). IN (B)(6) 2011, THE PATIENT EXPERIENCED URINARY TRACT INFECTION ("URINARY TRACT INFECTION"), BLADDER DISORDER ("BLADDER PROBLEM OR CHANGES"), URINARY TRACT DISORDER ("URINARY PROBLEMS OR CHANGES") AND DYSURIA ("DYSURIA"). IN (B)(6) 2012, THE PATIENT EXPERIENCED ANXIETY ("ANXIETY"). IN (B)(6) 2012, THE PATIENT EXPERIENCED DYSPAREUNIA ("PAIN DURING INTERCOURSE / DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE)"). IN (B)(6) 2013, THE PATIENT EXPERIENCED FATIGUE ("FATIGUE"). IN (B)(6) 2013, THE PATIENT EXPERIENCED ALOPECIA ("HAIR LOSS"). IN (B)(6) 2014, THE PATIENT EXPERIENCED FEELING ABNORMAL ("BRAIN FOG") AND MEMORY IMPAIRMENT ("TROUBLE WITH SHORT TERM MEMORY"). IN (B)(6) 2014, THE PATIENT EXPERIENCED SKIN LESION ("SKIN LESION") AND CHEST PAIN ("SORES ON CHEST"). IN (B)(6) 2016, THE PATIENT EXPERIENCED MUSCLE SPASMS ("MUSCLE SPASM"). ON AN UNKNOWN DATE, THE PATIENT UNDERWENT ENDOMETRIOSIS ABLATION (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), VAGINAL INFECTION ("VAGINAL INFECTION"), PROCEDURAL PAIN ("PAINFUL POST-OPERATIVE RECOVERY"), HYPOKALAEMIA ("HYPOKALAEMIA"), PELVIC PAIN ("PAIN"), FLANK PAIN ("LEFT SIDE FLANK PAIN") AND RASH ("RASHES"). THE PATIENT WAS TREATED WITH METHOCARBAMOL (ROBAXIN), LORAZEPAM AND SURGERY (TOTAL HYSTERECTOMY AND BILATERAL SALPINGECTOMY TO REMOVE THE ESSURE DEVICES). ESSURE WAS REMOVED ON (B)(6) 2016. AT THE TIME OF THE REPORT, THE ABDOMINAL PAIN LOWER, GENITAL HAEMORRHAGE, DYSMENORRHOEA, MENORRHAGIA, BACK PAIN, DYSPAREUNIA, ALOPECIA, VAGINAL DISCHARGE, VAGINAL INFECTION AND PROCEDURAL PAIN WAS RESOLVING, THE ENDOMETRIOSIS ABLATION, VAGINAL HAEMORRHAGE, URINARY TRACT INFECTION, BLADDER DISORDER, URINARY TRACT DISORDER, FEELING ABNORMAL, MEMORY IMPAIRMENT, HYPOKALAEMIA, PELVIC PAIN, FATIGUE, MUSCLE SPASMS, MENSTRUATION IRREGULAR, SKIN LESION, CHEST PAIN, COITAL BLEEDING, DYSURIA AND FLANK PAIN OUTCOME WAS UNKNOWN AND THE ANXIETY AND RASH HAD RESOLVED. THE REPORTER CONSIDERED ABDOMINAL PAIN LOWER, ALOPECIA, ANXIETY, BACK PAIN, BLADDER DISORDER, CHEST PAIN, COITAL BLEEDING, DYSMENORRHOEA, DYSPAREUNIA, DYSURIA, ENDOMETRIOSIS ABLATION, FATIGUE, FEELING ABNORMAL, FLANK PAIN, GENITAL HAEMORRHAGE, HYPOKALAEMIA, MEMORY IMPAIRMENT, MENORRHAGIA, MENSTRUATION IRREGULAR, MUSCLE SPASMS, PELVIC PAIN, PROCEDURAL PAIN, RASH, SKIN LESION, URINARY TRACT DISORDER, URINARY TRACT INFECTION, VAGINAL DISCHARGE, VAGINAL HAEMORRHAGE AND VAGINAL INFECTION TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: FOLLOWING THE REMOVAL SURGERY, PLAINTIFF SUFFERED A PAINFUL POST-OPERATIVE RECOVERY. SINCE HAVING THE SURGERY, PLAINTIFF'S SYMPTOMS WERE MOSTLY RESOLVED. UPON DETERMINING THAT THE PATIENTS ANATOMY WAS SUITABLE FOR MICRO-INSERT PLACEMENT, THE ESSURE DEVICES WERE PLACED IN STANDARD FASHION INTO THE BILATERAL TUBAL OSTIA WITH VISIBLE COILS SHOWING WITHIN THE ENDOMETRIAL CAVITY AS FOLLOWS: RIGHT: 6 COILS, LEFT 10 COILS. PATIENT'S HAD ESSURE (B)(6) 2009. HYSTEROSALPINGOGRAM WITH INJECTION COMMENT: ESSURE (B)(6) 2009. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): HYSTEROSALPINGOGRAM - ON (B)(6) 2010: CONFIRMING FULL OCCLUSION OF FALLOPIAN TUBES (B)(6) 2009, DISCHARGE SUMMARIES: PREGNANCY PROBLEM LIST: 1. GBS POSITIVE-NEEDS ABX IN LABOR (RESISTANT TO CLINDAMYCIN). 2. UTI X 2 (E COLI 3109, GBS 5109)--RX MACROBID QHS REST OF PREG. 3. EIF-SEE NOTE FROM C. SPRING, GENETICS. CURRENT MEDICATIONS WERE REVIEWED BYLETI. ON (B)(6) 2010,PREGNANCY URINE PREGNANCY TEST NEGATIVE. ON (B)(6) 2012 PATIENT STATES SINCE SHE TOOK MDMA ON (B)(6) FOR THE FIRST TIME SHE HAS BEEN HAVING SIMILAR EPISODES MULTIPLE TIMES SINCE THEN. STATES TOOK "A LOT OF ESCTASY" ON (B)(6) AND HAS BEEN HAVING PANIC ATTACKS X 1 WEEK. ON (B)(6) 2013 POSSIBLE NEED FOR PELVIC SONOGRAPHY AND/OR EMB TO DO OTHER ETIOLOGIES OF IRREGULAR BLEEDING. ON (B)(6) 2013, SHE WAS PLACED ON COC S TO CONTROL BLEEDING WITHOUT ANY RELIEF. ON (B)(6) 2014, A TRANSVAGINAL ULTRASOUND WAS DONE. THE UTERUS MEASURED 8 X 5 ~ 3CM. THE ENDOMETRIAL STRIPE MEASURED 0.25 CM. THE POSITION OF THE UTERUS IS MIDLINE. THE RIGHT OVARY MEASURES 3X2~2, NO MASSES OR LESIONS. THE LEFT OVARY MEASURES 3X2~2N, O MASSES OR LESIONS. THERE IS NO FLUID IN THE CUL DE SAC. ON (B)(6) 2016, ADDITIONAL INFORMATION: BILATERAL ESSURE APPEAR TO BE LOCATED IN NORMAL POSITION. IMPRESSION: FREE FLUID IN THE CUL-DE-SAC. BILATERAL ESSURE VISUALIZED. ON (B)(6) 2016, PROCEDURES: TOTAL LAPAROSCOPIC HYSTERECTOMY, BILATERAL SALPINGECTOMY, CYSTOSCOPY, FULGURATION OF ENDOMETRIOSIS, CYSTOSCOPY. FINDINGS: GROSSLY NORMAL APPEARING UTERUS, TUBES, AND OVARIES AREAS OF ENDOMETRIOSIS NOTED IN POSTERIOR CUL-DE-SAC ESSURE COILS NOTED IN BILATERAL TUBES. ON (B)(6) 2016, INLT (PRIMARY ENCOUNTER DIAGNOSIS). CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONES WERE CONFIRMED IN PATIENT¿S MEDICAL RECORDS CONFORMING: ABDOMINAL PAIN LOWER, GENITAL HAEMORRHAGE, MENORRHAGIA, BACK PAIN AND ALOPECIA. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON (B)(6) 2018: PFS RECEIVED - NEW EVENT "ABNORMAL BLEEDING (VAGINAL), URINARY TRACT INFECTION, ANXIETY, BLADDER PROBLEM OR CHANGES, URINARY PROBLEMS OR CHANGES, BRAIN FOG, TROUBLE WITH SHORT TERM MEMORY, FULGURATION OF ENDOMETRIOSIS, HYPOKALAEMIA, PAIN, MUSCLE SPASM, IRREGULAR PERIOD, SKIN LESION, POSTICTAL SPOTTING, DYSURIA, LEFT SIDE FLANK PAIN, RASHES" WERE ADDED. LOT NUMBER WAS ADDED. HISTORICAL AND CONCOMITANT CONDITIONS AND TREATMENT MEDICATION WERE ADDED. NEW REPORTER WERE ADDED. 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.

    Description of Event or Problem · 1

    THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF ABDOMINAL PAIN LOWER ("SEVERE LOWER ABDOMINAL PAIN") AND GENITAL HAEMORRHAGE ("ABNORMAL HEAVY BLEEDING") IN A 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 ABDOMINAL PAIN LOWER (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), GENITAL HAEMORRHAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), DYSMENORRHOEA ("SEVERE MENSTRUAL PAIN"), MENORRHAGIA ("PROLONGED MENSTRUAL BLEEDING"), BACK PAIN ("SEVERE BACK PAIN"), DYSPAREUNIA ("PAIN DURING INTERCOURSE"), ALOPECIA ("HAIR LOSS"), VAGINAL DISCHARGE ("IRREGULAR VAGINAL DISCHARGE"), VAGINAL INFECTION ("VAGINAL INFECTION") AND PROCEDURAL PAIN ("PAINFUL POST-OPERATIVE RECOVERY"). THE PATIENT WAS TREATED WITH SURGERY (TOTAL HYSTERECTOMY AND BILATERAL SALPINGECTOMY TO REMOVE THE ESSURE DEVICES). ESSURE WAS REMOVED ON (B)(6) 2016. AT THE TIME OF THE REPORT, THE ABDOMINAL PAIN LOWER, GENITAL HAEMORRHAGE, DYSMENORRHOEA, MENORRHAGIA, BACK PAIN, DYSPAREUNIA, ALOPECIA, VAGINAL DISCHARGE, VAGINAL INFECTION AND PROCEDURAL PAIN WAS RESOLVING. THE REPORTER CONSIDERED ABDOMINAL PAIN LOWER, ALOPECIA, BACK PAIN, DYSMENORRHOEA, DYSPAREUNIA, GENITAL HAEMORRHAGE, MENORRHAGIA, PROCEDURAL PAIN, VAGINAL DISCHARGE AND VAGINAL INFECTION TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: FOLLOWING THE REMOVAL SURGERY, PLAINTIFF SUFFERED A PAINFUL POST-OPERATIVE RECOVERY. SINCE HAVING THE SURGERY, PLAINTIFF'S SYMPTOMS WERE MOSTLY RESOLVED. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): HYSTEROSALPINGOGRAM - IN (B)(6) 2010: CONFIRMING FULL OCCLUSION OF FALLOPIAN TUBES. 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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    730875 ESSURE TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE HHS BAYER PHARMA AG ESS305 664655, 664666

    Patients

    Seq Age Sex Outcome Treatment
    1 25 YR Other| R ATIVAN| ATIVAN| ATIVAN| CIPROFLOXACIN| CIPROFLOXACIN| CIPROFLOXACIN| CONTRACEPTIVES NOS| CONTRACEPTIVES NOS| CONTRACEPTIVES NOS| IBUPROFEN| IBUPROFEN| IBUPROFEN| LEVORA| LEVORA| METHOCARBAMOL| METHOCARBAMOL| METHOCARBAMOL| OXAZEPAM| OXAZEPAM| PHENAZOPYRIDINE| PHENAZOPYRIDINE| PHENAZOPYRIDINE| SPRINTEC| SPRINTEC