ESSURE
Report
- Report Number
- 2951250-2018-02500
- Event Type
- Injury
- Date Received
- June 5, 2018
- Date of Event
- January 1, 2016
- Report Date
- May 19, 2020
- Manufacturer
- BAYER PHARMA AG
- Product Code
- HHS
- PMA / PMN Number
- P020014
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AZ, US
- Reporter Occupation
- OTHER
Narratives
THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ("PELVIC PAIN"), LUPUS-LIKE SYNDROME ("AUTOIMMUNE DISORDER (PSEUDO-LUPUS)") AND SCLERITIS ("VISION/EYE PROBLEMS (SCLERITIS)") IN A 38-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 880431) INSERTED FOR FEMALE STERILIZATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S PAST MEDICAL HISTORY INCLUDED CONTRACEPTIVE RHYTHM METHOD FROM 2008 TO 2011. PREVIOUSLY ADMINISTERED PRODUCTS INCLUDED FOR AN UNREPORTED INDICATION: LOESTRIN 24 F IN 2011 AND DEPO-PROVERA. CONCURRENT CONDITIONS INCLUDED OVERWEIGHT, ENDOMETRIOSIS AND ASTHMA. CONCOMITANT PRODUCTS INCLUDED AXOTAL (FIORICET), CETIRIZINE HYDROCHLORIDE (CETIRIZIN AL), DICLOFENAC, MELOXICAM, MOMETASONE FUROATE (ASMANEX) AND SALBUTAMOL (VENTOLIN). ON (B)(6) 2011, THE PATIENT HAD ESSURE INSERTED. IN 2012, THE PATIENT EXPERIENCED NAUSEA ("NAUSEA,"). IN (B)(6) 2012, THE PATIENT EXPERIENCED ANXIETY ("ANXIETY,PSYCHOLOGICAL OR PSYCHIATRIC PROBLEMS CONDITION: INCREASED ANXIETY") AND POST-TRAUMATIC STRESS DISORDER ("PTSD"). IN 2016, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED). IN (B)(6) 2016, THE PATIENT EXPERIENCED SCLERITIS (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT). IN 2017, THE PATIENT EXPERIENCED VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL)"), MENORRHAGIA ("MENORRHAGIA"), MIGRAINE ("MIGRAINES") AND HEADACHE ("HEADACHES"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED LUPUS-LIKE SYNDROME (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), MENSTRUAL DISORDER ("MENSTRUATION ISSUES"), DYSPAREUNIA ("DYSPAREUNIA"), FATIGUE ("FATIGUE"), AMNESIA ("MEMORY LOSS/SHORT TERM MEMORY LOSS"), MUSCLE SPASMS ("MUSCLE SPASMS ON LEFT SIDE OF HEAD/"), DEPRESSION ("DEPRESSION"), WEIGHT INCREASED ("WEIGHT GAIN"), PREMENSTRUAL DYSPHORIC DISORDER ("CONCERNS ABOUT POSSIBLE PMDD,"), FEELING ABNORMAL ("BRAIN FOG"), SPEECH DISORDER ("SPEECH CONFUSION"), VISION BLURRED ("BLURRED VISION"), INTRAOCULAR PRESSURE INCREASED ("INCREASED EYE PRESSURE"), BACK PAIN ("LOWER LUMBER BACK"), NECK PAIN ("BACK OF NECK"), DYSMENORRHOEA ("CRAMPING DURING MENSTRUATION "), OVULATION PAIN ("OVULATION PAIN"), EYE PAIN ("EYE PAIN"), VULVOVAGINAL PAIN ("VAGINA/ ABDOMINAL PAIN DURING INTERCOURSE") AND ABDOMINAL PAIN ("NAL PAIN DURING INTERCOURSE"). THE PATIENT WAS TREATED WITH SURGERY (HYSTERECTOMY WITH BILATERAL SALPINGECTOMY). ESSURE WAS REMOVED ON (B)(6) 2017. AT THE TIME OF THE REPORT, THE PELVIC PAIN WAS RESOLVING, THE LUPUS-LIKE SYNDROME, MENSTRUAL DISORDER, VAGINAL HAEMORRHAGE, MENORRHAGIA, FATIGUE, AMNESIA, SCLERITIS, WEIGHT INCREASED, NAUSEA, SPEECH DISORDER, VISION BLURRED, INTRAOCULAR PRESSURE INCREASED, NECK PAIN, DYSMENORRHOEA, EYE PAIN, VULVOVAGINAL PAIN AND ABDOMINAL PAIN OUTCOME WAS UNKNOWN, THE DYSPAREUNIA, MUSCLE SPASMS, MIGRAINE, HEADACHE, POST-TRAUMATIC STRESS DISORDER, PREMENSTRUAL DYSPHORIC DISORDER, FEELING ABNORMAL, BACK PAIN AND OVULATION PAIN HAD RESOLVED AND THE DEPRESSION AND ANXIETY HAD NOT RESOLVED. THE REPORTER CONSIDERED ABDOMINAL PAIN, AMNESIA, ANXIETY, BACK PAIN, DEPRESSION, DYSMENORRHOEA, DYSPAREUNIA, EYE PAIN, FATIGUE, FEELING ABNORMAL, HEADACHE, INTRAOCULAR PRESSURE INCREASED, LUPUS-LIKE SYNDROME, MENORRHAGIA, MENSTRUAL DISORDER, MIGRAINE, MUSCLE SPASMS, NAUSEA, NECK PAIN, OVULATION PAIN, PELVIC PAIN, POST-TRAUMATIC STRESS DISORDER, PREMENSTRUAL DYSPHORIC DISORDER, SCLERITIS, SPEECH DISORDER, VAGINAL HAEMORRHAGE, VISION BLURRED, VULVOVAGINAL PAIN AND WEIGHT INCREASED TO BE RELATED TO ESSURE. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 28.3 KG/SQM. HYSTEROSALPINGOGRAM - ON AN UNKNOWN DATE: NORMAL. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 13-JUN-2018: PLAINTIFF FACT SHEET, NEW REPORTER , PATIENT DEMOGRAPHIC INFORMATION, LAB DATA, NEW EVENTS PSYCHOLOGICAL OR PSYCHIATRIC PROBLEMS CONDITION: INCREASED ANXIETY AND PTSD, CONCERNS ABOUT POSSIBLE PMDD, BRAIN FOG, SPEECH CONFUSION, VISION/EYE PROBLEMS TYPE: SCLERITIS FROM PSEUDO LUPUS, INCREASED EYE PRESSURE AND BLURRED VISION, LOWER LUMBER BACK, BACK OF NECK, CRAMPING DURING MENSTRUATION, OVULATION PAIN, EYE PAIN AND VAGINA/ ABDOMEN PAIN DURING INTERCOURSE 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 IN A SUPPLEMENTAL REPORT.
THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF EMBEDDED DEVICE ("MIGRATION OF ESSURE DEVICE: MYOMETRIUM"), PELVIC PAIN ("PELVIC PAIN"), SCLERITIS ("VISION/EYE PROBLEMS (SCLERITIS)") AND LUPUS-LIKE SYNDROME ("AUTOIMMUNE DISORDER (PSEUDO-LUPUS)") IN A 38-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 880431) INSERTED FOR FEMALE STERILIZATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. OTHER PRODUCT OR PRODUCT USE ISSUES IDENTIFIED: DEVICE MONITORING PROCEDURE NOT PERFORMED "SHE DID NOT UNDERGO AN ESSURE CONFIRMATION TEST.". THE PATIENT'S MEDICAL HISTORY INCLUDED CONTRACEPTIVE RHYTHM METHOD FROM 2008 TO 2011, OVULATION PAIN, FAINTING, UTERINE BLEEDING AND PERINEAL PAIN. PREVIOUSLY ADMINISTERED PRODUCTS INCLUDED FOR AN UNREPORTED INDICATION: LOESTRIN 24 F IN 2011 AND DEPO-PROVERA. CONCURRENT CONDITIONS INCLUDED OVERWEIGHT, ENDOMETRIOSIS, ASTHMA, ALLERGIC RHINITIS, POLLEN ALLERGY, CERVICALGIA, LOW BACK PAIN, COUGH, DYSFUNCTIONAL UTERINE BLEEDING AND MIGRAINE. CONCOMITANT PRODUCTS INCLUDED BUTALBITAL;CAFFEINE;PARACETAMOL (FIORICET), CAFFEINE;PARACETAMOL (EXCEDRIN ASPIRIN FREE) SINCE 2013, CETIRIZINE HYDROCHLORIDE (CETIRIZIN AL), DICLOFENAC, MELOXICAM SINCE 2013, MOMETASONE FUROATE (ASMANEX), PARACETAMOL (ACETAMINOPHEN) SINCE 2011 AND SALBUTAMOL. ON (B)(6) 2011, THE PATIENT HAD ESSURE INSERTED. IN (B)(6) 2011, THE PATIENT EXPERIENCED VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL)"), MENORRHAGIA ("MENORRHAGIA"), DEPRESSION ("DEPRESSION"), ANXIETY ("ANXIETY,PSYCHOLOGICAL OR PSYCHIATRIC PROBLEMS CONDITION: INCREASED ANXIETY"), MIGRAINE ("MIGRAINES"), HEADACHE ("HEADACHES"), DYSMENORRHOEA ("CRAMPING DURING MENSTRATION / DYSMENORRHEA (CRAMPING)") AND MOOD SWINGS ("HORMONAL CHANGES DESCRIBE: MOOD SWINGS"). IN (B)(6) 2012, THE PATIENT EXPERIENCED THE FIRST EPISODE OF DYSPAREUNIA ("DYSPAREUNIA / DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE)") AND WAS FOUND TO HAVE WEIGHT INCREASED ("WEIGHT GAIN"). IN 2012, THE PATIENT EXPERIENCED NAUSEA ("NAUSEA"). IN (B)(6) 2012, THE PATIENT EXPERIENCED AMNESIA ("MEMORY LOSS/SHORT TERM MEMORY LOSS / NEUROLOGICAL CONDITIONS OR PROBLEMS - TYPE: MEMORY LOSS"), MUSCLE SPASMS ("MUSCLE SPASMS ON LEFT SIDE OF HEAD / NEUROLOGICAL CONDITIONS OR PROBLEMS - TYPE :MUSCLE SPASMS ON LEFT SIDE OF HEAD"), POST-TRAUMATIC STRESS DISORDER ("PTSD / PSYCHOLOGICAL OR PSYCHIATRIC PROBLEMS CONDITION: PTSD") AND SPEECH DISORDER ("SPEECH CONFUSION / NEUROLOGICAL CONDITIONS OR PROBLEMS - TYPE: SPEECH CONFUSION"). IN (B)(6) 2013, THE PATIENT EXPERIENCED FATIGUE ("FATIGUE"). IN (B)(6) 2014, THE PATIENT EXPERIENCED LUPUS-LIKE SYNDROME (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT) AND WAS FOUND TO HAVE INTRAOCULAR PRESSURE INCREASED ("INCREASED EYE PRESSURE"). IN 2016, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED). IN (B)(6) 2016, THE PATIENT EXPERIENCED SCLERITIS (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT) AND VISION BLURRED ("BLURRED VISION"). ON (B)(6) 2017, THE PATIENT EXPERIENCED EMBEDDED DEVICE (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), 6 YEARS AFTER INSERTION OF ESSURE. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED DEVICE EXPULSION ("MIGRATION OF ESSURE DEVICE: MYOMETRIUM"), MENSTRUAL DISORDER ("MENSTRUATION ISSUES"), PREMENSTRUAL DYSPHORIC DISORDER ("CONCERNS ABOUT POSSIBLE PMDD / PSYCHOLOGICAL OR PSYCHIATRIC PROBLEMS CONDITION: PMDD"), FEELING ABNORMAL ("BRAIN FOG"), BACK DISORDER ("LOWER LUMBER BACK"), NECK PAIN ("BACKM OF NECK"), OVULATION PAIN ("OVULATION PAIN"), EYE PAIN ("EYE PAIN"), THE SECOND EPISODE OF DYSPAREUNIA ("VAGINA/ ABDOMINAL PAIN DURING INTERCOURSE"), THE THIRD EPISODE OF DYSPAREUNIA ("ABDOMINAL PAIN DURING INTERCOURSE"), BACK PAIN ("LOW BACK PAIN"), MENSTRUATION IRREGULAR ("IRREGULAR MENSTRUATION") AND ENDOMETRIOSIS ("ENDOMETRIOSIS"). THE PATIENT WAS TREATED WITH SURGERY (HYSTERECTOMY WITH BILATERAL SALPINGECTOMY). ESSURE WAS REMOVED ON (B)(6) 2017. AT THE TIME OF THE REPORT, THE EMBEDDED DEVICE, SCLERITIS, LUPUS-LIKE SYNDROME, DEVICE EXPULSION, MENSTRUAL DISORDER, VAGINAL HAEMORRHAGE, MENORRHAGIA, FATIGUE, AMNESIA, WEIGHT INCREASED, NAUSEA, SPEECH DISORDER, VISION BLURRED, INTRAOCULAR PRESSURE INCREASED, DYSMENORRHOEA, THE LAST EPISODE OF DYSPAREUNIA, MOOD SWINGS AND ENDOMETRIOSIS OUTCOME WAS UNKNOWN, THE PELVIC PAIN, NECK PAIN, EYE PAIN AND BACK PAIN WAS RESOLVING, THE MUSCLE SPASMS, MIGRAINE, HEADACHE, POST-TRAUMATIC STRESS DISORDER, PREMENSTRUAL DYSPHORIC DISORDER, FEELING ABNORMAL, BACK DISORDER, OVULATION PAIN AND MENSTRUATION IRREGULAR HAD RESOLVED AND THE DEPRESSION AND ANXIETY HAD NOT RESOLVED. THE REPORTER CONSIDERED AMNESIA, ANXIETY, BACK DISORDER, BACK PAIN, DEPRESSION, DEVICE EXPULSION, DYSMENORRHOEA, EMBEDDED DEVICE, ENDOMETRIOSIS, EYE PAIN, FATIGUE, FEELING ABNORMAL, HEADACHE, INTRAOCULAR PRESSURE INCREASED, LUPUS-LIKE SYNDROME, MENORRHAGIA, MENSTRUAL DISORDER, MENSTRUATION IRREGULAR, MIGRAINE, MOOD SWINGS, MUSCLE SPASMS, NAUSEA, NECK PAIN, OVULATION PAIN, PELVIC PAIN, POST-TRAUMATIC STRESS DISORDER, PREMENSTRUAL DYSPHORIC DISORDER, SCLERITIS, SPEECH DISORDER, VAGINAL HAEMORRHAGE, VISION BLURRED, WEIGHT INCREASED, THE FIRST EPISODE OF DYSPAREUNIA, THE SECOND EPISODE OF DYSPAREUNIA AND THE THIRD EPISODE OF DYSPAREUNIA TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: CURRENT WEIGHT 188 LBS. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 28.3 KG/SQM. HYSTEROSALPINGOGRAM - ON AN UNKNOWN DATE: RESULTS: NORMAL. CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONES WERE CONFIRMED IN PATIENT¿S MEDICAL RECORDS: MIGRAINES, NECK PAIN, PELVIC PAIN, DYSMENORRHOEA AND HEADACHE. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 7-MAY-2019: FU11+FU12 PROCESS TOGETHER- NEW EVENT ENDOMETRIOSIS WERE ADDED. INCIDENT WE RECEIVED A LOT NUMBER. 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.
THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF EMBEDDED DEVICE ('MIGRATION OF ESSURE DEVICE: MYOMETRIUM'), PELVIC PAIN ('PELVIC PAIN'), SCLERITIS ('VISION/EYE PROBLEMS (SCLERITIS)') AND LUPUS-LIKE SYNDROME ('AUTOIMMUNE DISORDER (PSEUDO-LUPUS)') IN A 38-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 880431) INSERTED FOR FEMALE STERILIZATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. OTHER PRODUCT OR PRODUCT USE ISSUES IDENTIFIED: DEVICE MONITORING PROCEDURE NOT PERFORMED "SHE DID NOT UNDERGO AN ESSURE CONFIRMATION TEST.". THE PATIENT'S MEDICAL HISTORY INCLUDED CONTRACEPTIVE RHYTHM METHOD FROM 2008 TO 2011, OVULATION PAIN, FAINTING, UTERINE BLEEDING AND PERINEAL PAIN. PREVIOUSLY ADMINISTERED PRODUCTS INCLUDED FOR AN UNREPORTED INDICATION: LOESTRIN 24 F IN 2011 AND DEPO-PROVERA. CONCURRENT CONDITIONS INCLUDED OVERWEIGHT, ENDOMETRIOSIS, ASTHMA, ALLERGIC RHINITIS, POLLEN ALLERGY, CERVICALGIA, LOW BACK PAIN, COUGH, DYSFUNCTIONAL UTERINE BLEEDING AND MIGRAINE. CONCOMITANT PRODUCTS INCLUDED BUTALBITAL;CAFFEINE;PARACETAMOL (FIORICET), CAFFEINE;PARACETAMOL (EXCEDRIN ASPIRIN FREE) SINCE 2013, CETIRIZINE HYDROCHLORIDE (CETIRIZIN AL), DICLOFENAC, MELOXICAM SINCE 2013, MOMETASONE FUROATE (ASMANEX), PARACETAMOL (ACETAMINOPHEN) SINCE 2011 AND SALBUTAMOL. ON (B)(6) 2011, THE PATIENT HAD ESSURE INSERTED. IN (B)(6) 2011, THE PATIENT EXPERIENCED VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL)"), MENORRHAGIA ("MENORRHAGIA"), DEPRESSION ("DEPRESSION"), ANXIETY ("ANXIETY,PSYCHOLOGICAL OR PSYCHIATRIC PROBLEMS CONDITION: INCREASED ANXIETY"), MIGRAINE ("MIGRAINES"), HEADACHE ("HEADACHES"), DYSMENORRHOEA ("CRAMPING DURING MENSTRUATION / DYSMENORRHEA (CRAMPING)") AND MOOD SWINGS ("HORMONAL CHANGES DESCRIBE: MOOD SWINGS"). IN (B)(6) 2012, THE PATIENT EXPERIENCED DYSPAREUNIA ("DYSPAREUNIA / DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE)") AND WAS FOUND TO HAVE WEIGHT INCREASED ("WEIGHT GAIN"). IN 2012, THE PATIENT EXPERIENCED NAUSEA ("NAUSEA"). IN (B)(6) 2012, THE PATIENT EXPERIENCED AMNESIA ("MEMORY LOSS/SHORT TERM MEMORY LOSS / NEUROLOGICAL CONDITIONS OR PROBLEMS - TYPE: MEMORY LOSS"), MUSCLE SPASMS ("MUSCLE SPASMS ON LEFT SIDE OF HEAD / NEUROLOGICAL CONDITIONS OR PROBLEMS - TYPE :MUSCLE SPASMS ON LEFT SIDE OF HEAD"), POST-TRAUMATIC STRESS DISORDER ("PTSD / PSYCHOLOGICAL OR PSYCHIATRIC PROBLEMS CONDITION: PTSD") AND SPEECH DISORDER ("SPEECH CONFUSION / NEUROLOGICAL CONDITIONS OR PROBLEMS - TYPE: SPEECH CONFUSION"). IN (B)(6) 2013, THE PATIENT EXPERIENCED FATIGUE ("FATIGUE"). IN (B)(6) 2014, THE PATIENT EXPERIENCED LUPUS-LIKE SYNDROME (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT) AND WAS FOUND TO HAVE INTRAOCULAR PRESSURE INCREASED ("INCREASED EYE PRESSURE"). IN 2016, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED). IN (B)(6) 2016, THE PATIENT EXPERIENCED SCLERITIS (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT) AND VISION BLURRED ("BLURRED VISION"). ON (B)(6) 2017, THE PATIENT EXPERIENCED EMBEDDED DEVICE (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), 6 YEARS AFTER INSERTION OF ESSURE. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED DEVICE EXPULSION ("MIGRATION OF ESSURE DEVICE: MYOMETRIUM"), MENSTRUAL DISORDER ("MENSTRUATION ISSUES"), PREMENSTRUAL DYSPHORIC DISORDER ("CONCERNS ABOUT POSSIBLE PMDD / PSYCHOLOGICAL OR PSYCHIATRIC PROBLEMS CONDITION: PMDD"), FEELING ABNORMAL ("BRAIN FOG"), BACK DISORDER ("LOWER LUMBER BACK"), NECK PAIN ("BACK OF NECK"), OVULATION PAIN ("OVULATION PAIN"), EYE PAIN ("EYE PAIN"), VULVOVAGINAL PAIN ("VAGINA/ ABDOMINAL PAIN DURING INTERCOURSE"), ABDOMINAL PAIN ("ABDOMINAL PAIN DURING INTERCOURSE"), BACK PAIN ("LOW BACK PAIN"), IRREGULAR MENSTRUATION ("IRREGULAR MENSTRUATION"), ENDOMETRIOSIS ("ENDOMETRIOSIS"), FLATULENCE ("GAS PAINS"), SYNCOPE ("FAINTING SPELLS"), TOOTHACHE ("TOOTH PAIN"), INFLAMMATION ("INFLAMMATION"), ALOPECIA ("LOSS OF HAIR"), IRREGULAR PERIODS ("IRREGULAR PERIODS"), ABDOMINAL DISTENSION ("E-BELLY"), PROCEDURAL PAIN ("PAIN FROM SURGERY"), MYALGIA ("MUSCULAR PAIN"), ARTHRALGIA ("JOINT PAIN") AND CHEST PAIN ("CHEST PAIN"). THE PATIENT WAS TREATED WITH SURGERY (DAVINCI LAPAROSCOPIC HYSTERECTOMY WITH BILATERAL SALPINGECTOMY ). ESSURE WAS REMOVED ON (B)(6) 2017. AT THE TIME OF THE REPORT, THE EMBEDDED DEVICE, SCLERITIS, LUPUS-LIKE SYNDROME, DEVICE EXPULSION, MENSTRUAL DISORDER, VAGINAL HAEMORRHAGE, MENORRHAGIA, FATIGUE, AMNESIA, WEIGHT INCREASED, NAUSEA, SPEECH DISORDER, VISION BLURRED, INTRAOCULAR PRESSURE INCREASED, DYSMENORRHOEA, VULVOVAGINAL PAIN, ABDOMINAL PAIN, MOOD SWINGS, ENDOMETRIOSIS, SYNCOPE, INFLAMMATION, ALOPECIA, IRREGULAR PERIODS, PROCEDURAL PAIN, MYALGIA, ARTHRALGIA AND CHEST PAIN OUTCOME WAS UNKNOWN, THE PELVIC PAIN, NECK PAIN, EYE PAIN AND BACK PAIN WAS RESOLVING, THE DYSPAREUNIA, MUSCLE SPASMS, MIGRAINE, HEADACHE, POST-TRAUMATIC STRESS DISORDER, PREMENSTRUAL DYSPHORIC DISORDER, FEELING ABNORMAL, BACK DISORDER, OVULATION PAIN, IRREGULAR MENSTRUATION, TOOTHACHE AND ABDOMINAL DISTENSION HAD RESOLVED AND THE DEPRESSION AND ANXIETY HAD NOT RESOLVED. THE REPORTER CONSIDERED ABDOMINAL DISTENSION, ABDOMINAL PAIN, ALOPECIA, AMNESIA, ANXIETY, ARTHRALGIA, BACK DISORDER, BACK PAIN, CHEST PAIN, DEPRESSION, DEVICE EXPULSION, DYSMENORRHOEA, DYSPAREUNIA, EMBEDDED DEVICE, ENDOMETRIOSIS, EYE PAIN, FATIGUE, FEELING ABNORMAL, FLATULENCE, HEADACHE, INFLAMMATION, INTRAOCULAR PRESSURE INCREASED, IRREGULAR MENSTRUATION, LUPUS-LIKE SYNDROME, MENORRHAGIA, MENSTRUAL DISORDER, MIGRAINE, MOOD SWINGS, MUSCLE SPASMS, MYALGIA, NAUSEA, NECK PAIN, OVULATION PAIN, PELVIC PAIN, POST-TRAUMATIC STRESS DISORDER, PREMENSTRUAL DYSPHORIC DISORDER, PROCEDURAL PAIN, SCLERITIS, SPEECH DISORDER, SYNCOPE, TOOTHACHE, VAGINAL HAEMORRHAGE, VISION BLURRED, VULVOVAGINAL PAIN, WEIGHT INCREASED AND IRREGULAR PERIODS TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: CURRENT WEIGHT 188 LBS. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 28.3 KG/SQM. HYSTEROSALPINGOGRAM - ON AN UNKNOWN DATE: RESULTS: NORMAL. CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONES WERE CONFIRMED IN PATIENT¿S MEDICAL RECORDS: MIGRAINES, NECK PAIN, PELVIC PAIN, DYSMENORRHOEA AND HEADACHE. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 26-NOV-2019: SOCIAL MEDIA RECEIVED. REPORTER INFORMATION UPDATED. NEW EVENTS: GAS PAINS, FAINTING SPELLS, TOOTH PAIN, INFLAMMATION, LOSS OF HAIR, IRREGULAR PERIODS,E-BELLY,PAIN FROM SURGERY,MUSCULAR PAIN,JOINT PAIN, CHEST PAIN WERE ADDED. INCIDENT: WE RECEIVED A LOT NUMBER. 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.
THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF EMBEDDED DEVICE ("MIGRATION OF ESSURE DEVICE: MYOMETRIUM"), PELVIC PAIN ("PELVIC PAIN"), SCLERITIS ("VISION/EYE PROBLEMS (SCLERITIS)") AND LUPUS-LIKE SYNDROME ("AUTOIMMUNE DISORDER (PSEUDO-LUPUS)") IN A 38-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO: 952107) INSERTED FOR FEMALE STERILIZATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. OTHER PRODUCT OR PRODUCT USE ISSUES IDENTIFIED: MEDICAL DEVICE MONITORING ERROR "SHE DID NOT UNDERGO AN ESSURE CONFIRMATION TEST." THE PATIENT'S MEDICAL HISTORY INCLUDED CONTRACEPTIVE RHYTHM METHOD FROM 2008 TO 2011. PREVIOUSLY ADMINISTERED PRODUCTS INCLUDED FOR AN UNREPORTED INDICATION: LOESTRIN 24 F IN 2011 AND DEPO-PROVERA. CONCURRENT CONDITIONS INCLUDED OVERWEIGHT, ENDOMETRIOSIS, ASTHMA, ALLERGIC RHINITIS, POLLEN ALLERGY, CERVICALGIA, LOW BACK PAIN, COUGH, DYSFUNCTIONAL UTERINE BLEEDING AND MIGRAINE. CONCOMITANT PRODUCTS INCLUDED BUTALBITAL;CAFFEINE;PARACETAMOL (FIORICET), CAFFEINE;PARACETAMOL (EXCEDRIN ASPIRIN FREE) SINCE 2013, CETIRIZINE HYDROCHLORIDE (CETIRIZIN AL), DICLOFENAC, MELOXICAM SINCE 2013, MOMETASONE FUROATE (ASMANEX), PARACETAMOL (ACETAMINOPHEN) SINCE 2011 AND SALBUTAMOL. ON (B)(6) 2011, THE PATIENT HAD ESSURE INSERTED. IN NOVEMBER 2011, THE PATIENT EXPERIENCED VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL)"), MENORRHAGIA ("MENORRHAGIA"), FATIGUE ("FATIGUE"), DEPRESSION ("DEPRESSION"), ANXIETY ("ANXIETY,PSYCHOLOGICAL OR PSYCHIATRIC PROBLEMS CONDITION: INCREASED ANXIETY"), MIGRAINE ("MIGRAINES"), HEADACHE ("HEADACHES"), DYSMENORRHOEA ("CRAMPING DURING MENSTRATION / DYSMENORRHEA (CRAMPING)") AND MOOD SWINGS ("HORMONAL CHANGES DESCRIBE: MOOD SWINGS"). IN JANUARY 2012, THE PATIENT EXPERIENCED THE FIRST EPISODE OF DYSPAREUNIA ("DYSPAREUNIA / DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE)") AND WAS FOUND TO HAVE WEIGHT INCREASED ("WEIGHT GAIN"). IN 2012, THE PATIENT EXPERIENCED NAUSEA ("NAUSEA"). IN AUGUST 2012, THE PATIENT EXPERIENCED AMNESIA ("MEMORY LOSS/SHORT TERM MEMORY LOSS / NEUROLOGICAL CONDITIONS OR PROBLEMS - TYPE: MEMORY LOSS"), MUSCLE SPASMS ("MUSCLE SPASMS ON LEFT SIDE OF HEAD / NEUROLOGICAL CONDITIONS OR PROBLEMS - TYPE :MUSCLE SPASMS ON LEFT SIDE OF HEAD"), POST-TRAUMATIC STRESS DISORDER ("PTSD / PSYCHOLOGICAL OR PSYCHIATRIC PROBLEMS CONDITION: PTSD") AND SPEECH DISORDER ("SPEECH CONFUSION / NEUROLOGICAL CONDITIONS OR PROBLEMS - TYPE: SPEECH CONFUSION"). IN JULY 2014, THE PATIENT EXPERIENCED LUPUS-LIKE SYNDROME (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT) AND WAS FOUND TO HAVE INTRAOCULAR PRESSURE INCREASED ("INCREASED EYE PRESSURE"). IN 2016, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED). IN DECEMBER 2016, THE PATIENT EXPERIENCED SCLERITIS (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT) AND VISION BLURRED ("BLURRED VISION"). ON (B)(6) 2017, THE PATIENT EXPERIENCED EMBEDDED DEVICE (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), 6 YEARS AFTER INSERTION OF ESSURE. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED DEVICE EXPULSION ("MIGRATION OF ESSURE DEVICE: MYOMETRIUM"), MENSTRUAL DISORDER ("MENSTRUATION ISSUES"), PREMENSTRUAL DYSPHORIC DISORDER ("CONCERNS ABOUT POSSIBLE PMDD / PSYCHOLOGICAL OR PSYCHIATRIC PROBLEMS CONDITION: PMDD"), FEELING ABNORMAL ("BRAIN FOG"), BACK DISORDER ("LOWER LUMBER BACK"), NECK PAIN ("BACKM OF NECK"), OVULATION PAIN ("OVULATION PAIN"), EYE PAIN ("EYE PAIN"), THE SECOND EPISODE OF DYSPAREUNIA ("VAGINA/ ABDOMINAL PAIN DURING INTERCOURSE"), THE THIRD EPISODE OF DYSPAREUNIA ("ABDOMINAL PAIN DURING INTERCOURSE"), BACK PAIN ("LOW BACK PAIN") AND MENSTRUATION IRREGULAR ("IRREGULAR MENSTRUATION"). THE PATIENT WAS TREATED WITH SURGERY (HYSTERECTOMY WITH BILATERAL SALPINGECTOMY). ESSURE WAS REMOVED ON (B)(6) 2017. AT THE TIME OF THE REPORT, THE EMBEDDED DEVICE, SCLERITIS, LUPUS-LIKE SYNDROME, DEVICE EXPULSION, MENSTRUAL DISORDER, VAGINAL HAEMORRHAGE, MENORRHAGIA, FATIGUE, AMNESIA, WEIGHT INCREASED, NAUSEA, SPEECH DISORDER, VISION BLURRED, INTRAOCULAR PRESSURE INCREASED, DYSMENORRHOEA, THE LAST EPISODE OF DYSPAREUNIA AND MOOD SWINGS OUTCOME WAS UNKNOWN, THE PELVIC PAIN, NECK PAIN, EYE PAIN AND BACK PAIN WAS RESOLVING, THE MUSCLE SPASMS, MIGRAINE, HEADACHE, POST-TRAUMATIC STRESS DISORDER, PREMENSTRUAL DYSPHORIC DISORDER, FEELING ABNORMAL, BACK DISORDER, OVULATION PAIN AND MENSTRUATION IRREGULAR HAD RESOLVED AND THE DEPRESSION AND ANXIETY HAD NOT RESOLVED. THE REPORTER CONSIDERED AMNESIA, ANXIETY, BACK DISORDER, BACK PAIN, DEPRESSION, DEVICE EXPULSION, DYSMENORRHOEA, EMBEDDED DEVICE, EYE PAIN, FATIGUE, FEELING ABNORMAL, HEADACHE, INTRAOCULAR PRESSURE INCREASED, LUPUS-LIKE SYNDROME, MENORRHAGIA, MENSTRUAL DISORDER, MENSTRUATION IRREGULAR, MIGRAINE, MOOD SWINGS, MUSCLE SPASMS, NAUSEA, NECK PAIN, OVULATION PAIN, PELVIC PAIN, POST-TRAUMATIC STRESS DISORDER, PREMENSTRUAL DYSPHORIC DISORDER, SCLERITIS, SPEECH DISORDER, VAGINAL HAEMORRHAGE, VISION BLURRED, WEIGHT INCREASED, THE FIRST EPISODE OF DYSPAREUNIA, THE SECOND EPISODE OF DYSPAREUNIA AND THE THIRD EPISODE OF DYSPAREUNIA TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: CURRENT WEIGHT 188 LBS. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 28.3 KG/SQM. HYSTEROSALPINGOGRAM: ON AN UNKNOWN DATE: RESULTS: NORMAL. CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONES WERE CONFIRMED IN PATIENT¿S MEDICAL RECORDS: MIGRAINES, NECK PAIN, PELVIC PAIN, DYSMENORRHOEA AND HEADACHE. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 30-NOV-2018: NEW PFS RECEIVED. NEW EVENTS: MIGRATION OF ESSURE DEVICE: MYOMETRIUM , MOOD SWINGS, LOWER BACK PAIN, MENSTRUATION IRREGULAR AND SHE DID NOT UNDERGO AN ESSURE CONFIRMATION TEST WERE ADDED. CONCOMITANT DRUG AND OUTCOME OF EVENTS PAIN, NECK PAIN AND EYE PAIN WAS UPDATED FROM UNKNOWN TO RECOVERING/RESOLVING. INCIDENT: WE RECEIVED A LOT NUMBER/RETURNED SAMPLE 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.
NTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ("PELVIC PAIN"), SCLERITIS ("VISION/EYE PROBLEMS (SCLERITIS)") AND LUPUS-LIKE SYNDROME ("AUTOIMMUNE DISORDER (PSEUDO-LUPUS)") IN A 38-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 952107) INSERTED FOR FEMALE STERILIZATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S PAST MEDICAL HISTORY INCLUDED CONTRACEPTIVE RHYTHM METHOD FROM 2008 TO 2011. PREVIOUSLY ADMINISTERED PRODUCTS INCLUDED FOR AN UNREPORTED INDICATION: LOESTRIN 24 F IN 2011 AND DEPO-PROVERA. CONCURRENT CONDITIONS INCLUDED OVERWEIGHT, ENDOMETRIOSIS AND ASTHMA. CONCOMITANT PRODUCTS INCLUDED AXOTAL (FIORICET), CETIRIZINE HYDROCHLORIDE (CETIRIZINE AL), DICLOFENAC, MELOXICAM, MOMETASONE FUROATE (ASMANEX) AND SALBUTAMOL (VENTOLIN). ON (B)(6)2011, THE PATIENT HAD ESSURE INSERTED. IN 2012, THE PATIENT EXPERIENCED NAUSEA ("NAUSEA"). IN (B)(6)2012, THE PATIENT EXPERIENCED ANXIETY ("ANXIETY,PSYCHOLOGICAL OR PSYCHIATRIC PROBLEMS CONDITION: INCREASED ANXIETY") AND POST-TRAUMATIC STRESS DISORDER ("PTSD"). IN 2016, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED). IN (B)(6)2016, THE PATIENT EXPERIENCED SCLERITIS (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT). IN 2017, THE PATIENT EXPERIENCED VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL)"), MENORRHAGIA ("MENORRHAGIA"), MIGRAINE ("MIGRAINES") AND HEADACHE ("HEADACHES"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED LUPUS-LIKE SYNDROME (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), MENSTRUAL DISORDER ("MENSTRUATION ISSUES"), THE FIRST EPISODE OF DYSPAREUNIA ("DYSPAREUNIA"), FATIGUE ("FATIGUE"), AMNESIA ("MEMORY LOSS/SHORT TERM MEMORY LOSS"), MUSCLE SPASMS ("MUSCLE SPASMS ON LEFT SIDE OF HEAD"), DEPRESSION ("DEPRESSION"), WEIGHT INCREASED ("WEIGHT GAIN"), PREMENSTRUAL DYSPHORIC DISORDER ("CONCERNS ABOUT POSSIBLE PMDD,"), FEELING ABNORMAL ("BRAIN FOG"), SPEECH DISORDER ("SPEECH CONFUSION"), VISION BLURRED ("BLURRED VISION"), INTRAOCULAR PRESSURE INCREASED ("INCREASED EYE PRESSURE"), BACK DISORDER ("LOWER LUMBER BACK"), NECK PAIN ("BACKM OF NECK"), DYSMENORRHOEA ("CRAMPING DURING MENSTRUATION"), OVULATION PAIN ("OVULATION PAIN"), EYE PAIN ("EYE PAIN"), THE SECOND EPISODE OF DYSPAREUNIA ("VAGINA/ ABDOMINAL PAIN DURING INTERCOURSE") AND THE THIRD EPISODE OF DYSPAREUNIA ("ABDOMINAL PAIN DURING INTERCOURSE"). THE PATIENT WAS TREATED WITH SURGERY (HYSTERECTOMY WITH BILATERAL SALPINGECTOMY). ESSURE WAS REMOVED ON (B)(6)2017. AT THE TIME OF THE REPORT, THE PELVIC PAIN WAS RESOLVING, THE SCLERITIS, LUPUS-LIKE SYNDROME, MENSTRUAL DISORDER, VAGINAL HAEMORRHAGE, MENORRHAGIA, FATIGUE, AMNESIA, WEIGHT INCREASED, NAUSEA, SPEECH DISORDER, VISION BLURRED, INTRAOCULAR PRESSURE INCREASED, NECK PAIN, DYSMENORRHOEA, EYE PAIN AND THE LAST EPISODE OF DYSPAREUNIA OUTCOME WAS UNKNOWN, THE MUSCLE SPASMS, MIGRAINE, HEADACHE, POST-TRAUMATIC STRESS DISORDER, PREMENSTRUAL DYSPHORIC DISORDER, FEELING ABNORMAL, BACK DISORDER AND OVULATION PAIN HAD RESOLVED AND THE DEPRESSION AND ANXIETY HAD NOT RESOLVED. THE REPORTER CONSIDERED AMNESIA, ANXIETY, BACK DISORDER, DEPRESSION, DYSMENORRHOEA, EYE PAIN, FATIGUE, FEELING ABNORMAL, HEADACHE, INTRAOCULAR PRESSURE INCREASED, LUPUS-LIKE SYNDROME, MENORRHAGIA, MENSTRUAL DISORDER, MIGRAINE, MUSCLE SPASMS, NAUSEA, NECK PAIN, OVULATION PAIN, PELVIC PAIN, POST-TRAUMATIC STRESS DISORDER, PREMENSTRUAL DYSPHORIC DISORDER, SCLERITIS, SPEECH DISORDER, VAGINAL HAEMORRHAGE, VISION BLURRED, WEIGHT INCREASED, THE FIRST EPISODE OF DYSPAREUNIA, THE SECOND EPISODE OF DYSPAREUNIA AND THE THIRD EPISODE OF DYSPAREUNIA TO BE RELATED TO ESSURE. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 28.3 KG/SQM. HYSTEROSALPINGOGRAM - ON AN UNKNOWN DATE: NORMAL. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 8-AUG-2018: QUALITY-SAFETY EVALUATION OF PTC. 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 IN A SUPPLEMENTAL REPORT.
THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF EMBEDDED DEVICE ('MIGRATION OF ESSURE DEVICE: MYOMETRIUM'), PELVIC PAIN ('PELVIC PAIN'), SCLERITIS ('VISION/EYE PROBLEMS (SCLERITIS)') AND LUPUS-LIKE SYNDROME ('AUTOIMMUNE DISORDER (PSEUDO-LUPUS)/ AUTOIMMUNE DISORDER TYPE OF DISORDER: PSEUDO LUPUS') IN A 38-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 880431) INSERTED FOR FEMALE STERILIZATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. OTHER PRODUCT OR PRODUCT USE ISSUES IDENTIFIED: DEVICE MONITORING PROCEDURE NOT PERFORMED "SHE DID NOT UNDERGO AN ESSURE CONFIRMATION TEST.". THE PATIENT'S MEDICAL HISTORY INCLUDED CONTRACEPTIVE RHYTHM METHOD FROM 2008 TO 2011, OVULATION PAIN, FAINTING, UTERINE BLEEDING AND PERINEAL PAIN. PREVIOUSLY ADMINISTERED PRODUCTS INCLUDED FOR AN UNREPORTED INDICATION: LOESTRIN 24 F IN 2011 AND DEPO-PROVERA. CONCURRENT CONDITIONS INCLUDED OVERWEIGHT, ENDOMETRIOSIS, ASTHMA, ALLERGIC RHINITIS, POLLEN ALLERGY, CERVICALGIA, LOW BACK PAIN, COUGH, DYSFUNCTIONAL UTERINE BLEEDING AND MIGRAINE. CONCOMITANT PRODUCTS INCLUDED BUTALBITAL;CAFFEINE;PARACETAMOL (FIORICET), CAFFEINE;PARACETAMOL (EXCEDRIN ASPIRIN FREE) SINCE 2013, CETIRIZINE HYDROCHLORIDE (CETIRIZIN AL), DICLOFENAC, MELOXICAM SINCE 2013, MOMETASONE FUROATE (ASMANEX), PARACETAMOL (ACETAMINOPHEN) SINCE 2011 AND SALBUTAMOL. ON (B)(6) 2011, THE PATIENT HAD ESSURE INSERTED. IN (B)(6) 2011, THE PATIENT EXPERIENCED VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL)"), MENORRHAGIA ("MENORRHAGIA"), DEPRESSION ("DEPRESSION"), ANXIETY ("ANXIETY,PSYCHOLOGICAL OR PSYCHIATRIC PROBLEMS CONDITION: INCREASED ANXIETY"), MIGRAINE ("MIGRAINES"), HEADACHE ("HEADACHES/ MUSCLE SPASM AT SIDE OF HEAD"), DYSMENORRHOEA ("CRAMPING DURING MENSTRATION / DYSMENORRHEA (CRAMPING)") AND MOOD SWINGS ("HORMONAL CHANGES DESCRIBE: MOOD SWINGS"). IN (B)(6) 2012, THE PATIENT EXPERIENCED THE FIRST EPISODE OF DYSPAREUNIA ("DYSPAREUNIA / DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE)") AND BACK PAIN ("LOW BACK PAIN") AND WAS FOUND TO HAVE WEIGHT INCREASED ("WEIGHT GAIN"). IN 2012, THE PATIENT EXPERIENCED NAUSEA ("NAUSEA"). IN (B)(6) 2012, THE PATIENT EXPERIENCED AMNESIA ("MEMORY LOSS/SHORT TERM MEMORY LOSS / NEUROLOGICAL CONDITIONS OR PROBLEMS - TYPE: MEMORY LOSS"), MUSCLE SPASMS ("MUSCLE SPASMS ON LEFT SIDE OF HEAD / NEUROLOGICAL CONDITIONS OR PROBLEMS - TYPE :MUSCLE SPASMS ON LEFT SIDE OF HEAD/ BRAIN SPASAM"), POST-TRAUMATIC STRESS DISORDER ("PTSD / PSYCHOLOGICAL OR PSYCHIATRIC PROBLEMS CONDITION: PTSD"), PREMENSTRUAL DYSPHORIC DISORDER ("CONCERNS ABOUT POSSIBLE PMDD / PSYCHOLOGICAL OR PSYCHIATRIC PROBLEMS CONDITION: PMDD") AND SPEECH DISORDER ("SPEECH CONFUSION / NEUROLOGICAL CONDITIONS OR PROBLEMS - TYPE: SPEECH CONFUSION"). IN APRIL 2013, THE PATIENT EXPERIENCED FATIGUE ("FATIGUE"). IN (B)(6) 2014, THE PATIENT EXPERIENCED LUPUS-LIKE SYNDROME (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT) AND WAS FOUND TO HAVE INTRAOCULAR PRESSURE INCREASED ("INCREASED EYE PRESSURE"). IN 2016, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED). IN (B)(6) 2016, THE PATIENT EXPERIENCED SCLERITIS (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT) AND VISION BLURRED ("BLURRED VISION"). ON (B)(6) 2017, THE PATIENT EXPERIENCED EMBEDDED DEVICE (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), 6 YEARS AFTER INSERTION OF ESSURE. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED DEVICE EXPULSION ("MIGRATION OF ESSURE DEVICE: MYOMETRIUM"), MENSTRUAL DISORDER ("MENSTRUATION ISSUES"), FEELING ABNORMAL ("BRAIN FOG"), BACK DISORDER ("LOWER LUMBER BACK"), NECK PAIN ("BACKM OF NECK"), OVULATION PAIN ("OVULATION PAIN"), EYE PAIN ("EYE PAIN"), THE SECOND EPISODE OF DYSPAREUNIA ("VAGINA/ ABDOMINAL PAIN DURING INTERCOURSE"), THE THIRD EPISODE OF DYSPAREUNIA ("ABDOMINAL PAIN DURING INTERCOURSE"), IRREGULAR MENSTRUATION ("IRREGULAR MENSTRUATION"), ENDOMETRIOSIS ("ENDOMETRIOSIS"), FLATULENCE ("GAS PAINS"), SYNCOPE ("FAINTING SPELLS"), TOOTHACHE ("TOOTH PAIN"), INFLAMMATION ("INFLAMMATION"), ALOPECIA ("LOSS OF HAIR"), IRREGULAR PERIODS ("IRREGULAR PERIODS"), ABDOMINAL DISTENSION ("E-BELLY"), PROCEDURAL PAIN ("PAIN FROM SURGERY"), MYALGIA ("MUSCULAR PAIN"), ARTHRALGIA ("JOINT PAIN"), CHEST PAIN ("CHEST PAIN") AND SCLERAL HYPERAEMIA ("VISION/EYE PROBLEMS TYPE: SCLORITIS FROM PSEUDO LUPUS"). THE PATIENT WAS TREATED WITH SURGERY (DAVINCI LAPAROSCOPIC HYSTERECTOMY WITH BILATERAL SALPINGECTOMY AND HYSTERECTOMY WITH BILATERAL SALPINGECTOMY). ESSURE WAS REMOVED ON (B)(6) 2017. AT THE TIME OF THE REPORT, THE EMBEDDED DEVICE, SCLERITIS, LUPUS-LIKE SYNDROME, DEVICE EXPULSION, MENSTRUAL DISORDER, VAGINAL HAEMORRHAGE, MENORRHAGIA, FATIGUE, AMNESIA, WEIGHT INCREASED, NAUSEA, SPEECH DISORDER, VISION BLURRED, INTRAOCULAR PRESSURE INCREASED, DYSMENORRHOEA, THE LAST EPISODE OF DYSPAREUNIA, MOOD SWINGS, ENDOMETRIOSIS, SYNCOPE, INFLAMMATION, ALOPECIA, IRREGULAR PERIODS, PROCEDURAL PAIN, MYALGIA, ARTHRALGIA, CHEST PAIN AND SCLERAL HYPERAEMIA OUTCOME WAS UNKNOWN, THE PELVIC PAIN, NECK PAIN AND EYE PAIN WAS RESOLVING AND THE MUSCLE SPASMS, DEPRESSION, ANXIETY, MIGRAINE, HEADACHE, POST-TRAUMATIC STRESS DISORDER, PREMENSTRUAL DYSPHORIC DISORDER, FEELING ABNORMAL, BACK DISORDER, OVULATION PAIN, BACK PAIN, IRREGULAR MENSTRUATION, TOOTHACHE AND ABDOMINAL DISTENSION HAD RESOLVED. THE REPORTER CONSIDERED ABDOMINAL DISTENSION, ALOPECIA, AMNESIA, ANXIETY, ARTHRALGIA, BACK DISORDER, BACK PAIN, CHEST PAIN, DEPRESSION, DEVICE EXPULSION, DYSMENORRHOEA, EMBEDDED DEVICE, ENDOMETRIOSIS, EYE PAIN, FATIGUE, FEELING ABNORMAL, FLATULENCE, HEADACHE, INFLAMMATION, INTRAOCULAR PRESSURE INCREASED, IRREGULAR MENSTRUATION, LUPUS-LIKE SYNDROME, MENORRHAGIA, MENSTRUAL DISORDER, MIGRAINE, MOOD SWINGS, MUSCLE SPASMS, MYALGIA, NAUSEA, NECK PAIN, OVULATION PAIN, PELVIC PAIN, POST-TRAUMATIC STRESS DISORDER, PREMENSTRUAL DYSPHORIC DISORDER, PROCEDURAL PAIN, SCLERAL HYPERAEMIA, SCLERITIS, SPEECH DISORDER, SYNCOPE, TOOTHACHE, VAGINAL HAEMORRHAGE, VISION BLURRED, WEIGHT INCREASED, THE FIRST EPISODE OF DYSPAREUNIA, IRREGULAR PERIODS, THE SECOND EPISODE OF DYSPAREUNIA AND THE THIRD EPISODE OF DYSPAREUNIA TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: CURRENT WEIGHT 188 LBS. INSERTION DATE DISCREPANCY NOTED IN DELETION CASE 2017-228091: (B)(6) 2014. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 28.3 KG/SQM. HYSTEROSALPINGOGRAM - IN (B)(6) 2012: RESULTS: NORMAL. CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONES WERE CONFIRMED IN PATIENT¿S MEDICAL RECORDS: MIGRAINES, NECK PAIN, PELVIC PAIN, DYSMENORRHOEA AND HEADACHE. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 4-MAR-2020: PLAINTIFF FACT SHEET RECEIVED. PATIENT DEMOGRAPHICS WERE ADDED. ADDED EVENT VISION/EYE PROBLEMS TYPE: SCLORITIS FROM PSEUDO LUPUS,. OUTCOME OF EVENT BACK PAIN, ANXIETY, DEPRESSION WAS RECOVERED. 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 RELEVANT DATA; SHOULD ANY NEW AND REPORTABLE INFORMATION BECOME AVAILABLE FROM OUR INVESTIGATION, THIS WILL BE PROVIDED IN A SUPPLEMENTARY REPORT.
THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF EMBEDDED DEVICE ('MIGRATION OF ESSURE DEVICE: MYOMETRIUM'), PELVIC PAIN ('PELVIC PAIN'), SCLERITIS ('VISION/EYE PROBLEMS (SCLERITIS)') AND LUPUS-LIKE SYNDROME ('AUTOIMMUNE DISORDER (PSEUDO-LUPUS)/ AUTOIMMUNE DISORDER TYPE OF DISORDER: PSEUDO LUPUS') IN A 38-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 880431) INSERTED FOR FEMALE STERILIZATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. OTHER PRODUCT OR PRODUCT USE ISSUES IDENTIFIED: DEVICE MONITORING PROCEDURE NOT PERFORMED "SHE DID NOT UNDERGO AN ESSURE CONFIRMATION TEST.". THE PATIENT'S MEDICAL HISTORY INCLUDED CONTRACEPTIVE RHYTHM METHOD FROM 2008 TO 2011, OVULATION PAIN, FAINTING, UTERINE BLEEDING AND PERINEAL PAIN. PREVIOUSLY ADMINISTERED PRODUCTS INCLUDED FOR AN UNREPORTED INDICATION: LOESTRIN 24 F IN 2011 AND DEPO-PROVERA. CONCURRENT CONDITIONS INCLUDED OVERWEIGHT, ENDOMETRIOSIS, ASTHMA, ALLERGIC RHINITIS, POLLEN ALLERGY, CERVICALGIA, LOW BACK PAIN, COUGH, DYSFUNCTIONAL UTERINE BLEEDING AND MIGRAINE. CONCOMITANT PRODUCTS INCLUDED BUTALBITAL;CAFFEINE;PARACETAMOL (FIORICET), CAFFEINE;PARACETAMOL (EXCEDRIN ASPIRIN FREE) SINCE 2013, CETIRIZINE HYDROCHLORIDE (CETIRIZIN AL), DICLOFENAC, MELOXICAM SINCE 2013, MOMETASONE FUROATE (ASMANEX), PARACETAMOL (ACETAMINOPHEN) SINCE 2011 AND SALBUTAMOL. ON (B)(6) 2011, THE PATIENT HAD ESSURE INSERTED. IN (B)(6) 2011, THE PATIENT EXPERIENCED VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL)"), MENORRHAGIA ("MENORRHAGIA"), DEPRESSION ("DEPRESSION"), ANXIETY ("ANXIETY,PSYCHOLOGICAL OR PSYCHIATRIC PROBLEMS CONDITION: INCREASED ANXIETY"), MIGRAINE ("MIGRAINES"), HEADACHE ("HEADACHES/ MUSCLE SPASM AT SIDE OF HEAD"), DYSMENORRHOEA ("CRAMPING DURING MENSTRATION / DYSMENORRHEA (CRAMPING)") AND MOOD SWINGS ("HORMONAL CHANGES DESCRIBE: MOOD SWINGS"). IN (B)(6) 2012, THE PATIENT EXPERIENCED THE FIRST EPISODE OF DYSPAREUNIA ("DYSPAREUNIA / DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE)") AND BACK PAIN ("LOW BACK PAIN") AND WAS FOUND TO HAVE WEIGHT INCREASED ("WEIGHT GAIN"). IN 2012, THE PATIENT EXPERIENCED NAUSEA ("NAUSEA"). IN (B)(6) 2012, THE PATIENT EXPERIENCED AMNESIA ("MEMORY LOSS/SHORT TERM MEMORY LOSS / NEUROLOGICAL CONDITIONS OR PROBLEMS - TYPE: MEMORY LOSS"), MUSCLE SPASMS ("MUSCLE SPASMS ON LEFT SIDE OF HEAD / NEUROLOGICAL CONDITIONS OR PROBLEMS - TYPE :MUSCLE SPASMS ON LEFT SIDE OF HEAD/ BRAIN SPASAM"), POST-TRAUMATIC STRESS DISORDER ("PTSD / PSYCHOLOGICAL OR PSYCHIATRIC PROBLEMS CONDITION: PTSD"), PREMENSTRUAL DYSPHORIC DISORDER ("CONCERNS ABOUT POSSIBLE PMDD / PSYCHOLOGICAL OR PSYCHIATRIC PROBLEMS CONDITION: PMDD") AND SPEECH DISORDER ("SPEECH CONFUSION / NEUROLOGICAL CONDITIONS OR PROBLEMS - TYPE: SPEECH CONFUSION"). IN (B)(6) 2013, THE PATIENT EXPERIENCED FATIGUE ("FATIGUE"). IN (B)(6) 2014, THE PATIENT EXPERIENCED LUPUS-LIKE SYNDROME (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT) AND WAS FOUND TO HAVE INTRAOCULAR PRESSURE INCREASED ("INCREASED EYE PRESSURE"). IN 2016, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED). IN (B)(6) 2016, THE PATIENT EXPERIENCED SCLERITIS (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT) AND VISION BLURRED ("BLURRED VISION"). ON (B)(6) 2017, THE PATIENT EXPERIENCED EMBEDDED DEVICE (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), 6 YEARS AFTER INSERTION OF ESSURE. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED DEVICE EXPULSION ("MIGRATION OF ESSURE DEVICE: MYOMETRIUM"), MENSTRUAL DISORDER ("MENSTRUATION ISSUES"), FEELING ABNORMAL ("BRAIN FOG"), BACK DISORDER ("LOWER LUMBER BACK"), NECK PAIN ("BACKM OF NECK"), OVULATION PAIN ("OVULATION PAIN"), EYE PAIN ("EYE PAIN"), THE SECOND EPISODE OF DYSPAREUNIA ("VAGINA/ ABDOMINAL PAIN DURING INTERCOURSE"), THE THIRD EPISODE OF DYSPAREUNIA ("ABDOMINAL PAIN DURING INTERCOURSE"), IRREGULAR MENSTRUATION ("IRREGULAR MENSTRUATION"), ENDOMETRIOSIS ("ENDOMETRIOSIS"), FLATULENCE ("GAS PAINS"), SYNCOPE ("FAINTING SPELLS"), TOOTHACHE ("TOOTH PAIN"), INFLAMMATION ("INFLAMMATION"), ALOPECIA ("LOSS OF HAIR"), IRREGULAR PERIODS ("IRREGULAR PERIODS"), ABDOMINAL DISTENSION ("E-BELLY"), PROCEDURAL PAIN ("PAIN FROM SURGERY"), MYALGIA ("MUSCULAR PAIN"), ARTHRALGIA ("JOINT PAIN"), CHEST PAIN ("CHEST PAIN"), SCLERAL HYPERAEMIA ("VISION/EYE PROBLEMS TYPE: SCLORITIS FROM PSEUDO LUPUS") AND GENITAL HAEMORRHAGE ("GENERAL ABNORMAL BLEEDING"). THE PATIENT WAS TREATED WITH SURGERY (DAVINCI LAPAROSCOPIC HYSTERECTOMY WITH BILATERAL SALPINGECTOMY AND HYSTERECTOMY WITH BILATERAL SALPINGECTOMY). ESSURE WAS REMOVED ON (B)(6) 2017. AT THE TIME OF THE REPORT, THE EMBEDDED DEVICE, SCLERITIS, LUPUS-LIKE SYNDROME, DEVICE EXPULSION, MENSTRUAL DISORDER, VAGINAL HAEMORRHAGE, MENORRHAGIA, FATIGUE, AMNESIA, WEIGHT INCREASED, NAUSEA, SPEECH DISORDER, VISION BLURRED, INTRAOCULAR PRESSURE INCREASED, DYSMENORRHOEA, THE LAST EPISODE OF DYSPAREUNIA, MOOD SWINGS, ENDOMETRIOSIS, SYNCOPE, INFLAMMATION, ALOPECIA, IRREGULAR PERIODS, PROCEDURAL PAIN, MYALGIA, ARTHRALGIA, CHEST PAIN AND SCLERAL HYPERAEMIA OUTCOME WAS UNKNOWN, THE PELVIC PAIN, MUSCLE SPASMS, DEPRESSION, ANXIETY, MIGRAINE, HEADACHE, POST-TRAUMATIC STRESS DISORDER, PREMENSTRUAL DYSPHORIC DISORDER, FEELING ABNORMAL, BACK DISORDER, OVULATION PAIN, BACK PAIN, IRREGULAR MENSTRUATION, TOOTHACHE, ABDOMINAL DISTENSION AND GENITAL HAEMORRHAGE HAD RESOLVED AND THE NECK PAIN AND EYE PAIN WAS RESOLVING. THE REPORTER CONSIDERED ABDOMINAL DISTENSION, ALOPECIA, AMNESIA, ANXIETY, ARTHRALGIA, BACK DISORDER, BACK PAIN, CHEST PAIN, DEPRESSION, DEVICE EXPULSION, DYSMENORRHOEA, EMBEDDED DEVICE, ENDOMETRIOSIS, EYE PAIN, FATIGUE, FEELING ABNORMAL, FLATULENCE, GENITAL HAEMORRHAGE, HEADACHE, INFLAMMATION, INTRAOCULAR PRESSURE INCREASED, IRREGULAR MENSTRUATION, LUPUS-LIKE SYNDROME, MENORRHAGIA, MENSTRUAL DISORDER, MIGRAINE, MOOD SWINGS, MUSCLE SPASMS, MYALGIA, NAUSEA, NECK PAIN, OVULATION PAIN, PELVIC PAIN, POST-TRAUMATIC STRESS DISORDER, PREMENSTRUAL DYSPHORIC DISORDER, PROCEDURAL PAIN, SCLERAL HYPERAEMIA, SCLERITIS, SPEECH DISORDER, SYNCOPE, TOOTHACHE, VAGINAL HAEMORRHAGE, VISION BLURRED, WEIGHT INCREASED, THE FIRST EPISODE OF DYSPAREUNIA, IRREGULAR PERIODS, THE SECOND EPISODE OF DYSPAREUNIA AND THE THIRD EPISODE OF DYSPAREUNIA TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: CURRENT WEIGHT 188 LBS. INSERTION DATE DISCREPANCY NOTED IN DELETION CASE (B)(4): (B)(6) DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 28.3 KG/SQM. HYSTEROSALPINGOGRAM - IN (B)(6) 2012: RESULTS: NORMAL. CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONES WERE CONFIRMED IN PATIENT¿S MEDICAL RECORDS: MIGRAINES, NECK PAIN, PELVIC PAIN, DYSMENORRHOEA AND HEADACHE. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 5-MAY-2020: PLAINTIFF FACT SHEET RECEIVED. ADDED EVENT GENERAL ABNORMAL BLEEDING. OUTCOME OF EVENTS PELVIC PAIN, GENITAL HAEMORRHAGE WAS RECOVERED. A TECHNICAL INVESTIGATION WAS CONDUCTED, INCLUDING A BATCH REVIEW, AND A REVIEW OF COMPLAINT RECORDS AND OTHER RELEVANT DATA; SHOULD ANY NEW AND REPORTABLE INFORMATION BECOME AVAILABLE FROM OUR INVESTIGATION, THIS WILL BE PROVIDED IN A SUPPLEMENTARY REPORT.
THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ("PELVIC PAIN") AND AUTOIMMUNE DISORDER ("AUTOIMMUNE DISORDER (PSEUDO-LUPUS)") IN A FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 880431) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S CONCURRENT CONDITIONS INCLUDED OVERWEIGHT. ON (B)(6) 2011, THE PATIENT HAD ESSURE INSERTED. IN 2016, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED). IN (B)(6) 2016, THE PATIENT EXPERIENCED SCLERITIS ("VISION/EYE PROBLEMS (SCLERITIS)"). IN 2017, THE PATIENT EXPERIENCED VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL)"), MENORRHAGIA ("MENORRHAGIA"), MIGRAINE ("MIGRAINES") AND HEADACHE ("HEADACHES"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED MENSTRUAL DISORDER ("MENSTRUATION ISSUES"), AUTOIMMUNE DISORDER (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), DYSPAREUNIA ("DYSPAREUNIA"), FATIGUE ("FATIGUE"), AMNESIA ("MEMORY LOSS"), MUSCLE SPASMS ("MUSCLE SPASMS ON LEFT SIDE OF HEAD"), DEPRESSION ("DEPRESSION"), ANXIETY ("ANXIETY") AND WEIGHT INCREASED ("WEIGHT GAIN"). THE PATIENT WAS TREATED WITH SURGERY (HYSTERECTOMY WITH BILATERAL SALPINGECTOMY). ESSURE WAS REMOVED ON (B)(6) 2017. AT THE TIME OF THE REPORT, THE PELVIC PAIN WAS RESOLVING AND THE MENSTRUAL DISORDER, VAGINAL HAEMORRHAGE, MENORRHAGIA, AUTOIMMUNE DISORDER, DYSPAREUNIA, FATIGUE, AMNESIA, MUSCLE SPASMS, DEPRESSION, ANXIETY, SCLERITIS, WEIGHT INCREASED, MIGRAINE AND HEADACHE OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED AMNESIA, ANXIETY, AUTOIMMUNE DISORDER, DEPRESSION, DYSPAREUNIA, FATIGUE, HEADACHE, MENORRHAGIA, MENSTRUAL DISORDER, MIGRAINE, MUSCLE SPASMS, PELVIC PAIN, SCLERITIS, VAGINAL HAEMORRHAGE AND WEIGHT INCREASED TO BE RELATED TO ESSURE. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 28.3 KG/SQM. HYSTEROSALPINGOGRAM - ON (B)(6) 2012: TOTAL BILATERAL OCCLUSION. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON (B)(6) 2018: PLAINTIFF FACT SHEET WAS RECEIVED AND THE FOLLOWING INFORMATION WAS PROVIDED: PATIENT¿S DATE OF BIRTH, WEIGHT AND HEIGHT ADDED; ESSURE LOT NUMBER 880431 WAS REMOVED ON (B)(6) 2017; ABNORMAL BLEEDING (VAGINAL), MENORRHAGIA, AUTOIMMUNE DISORDER (PSEUDO-LUPUS), DYSPAREUNIA, FATIGUE, MEMORY LOSS, MUSCLE SPASMS ON LEFT SIDE OF HEAD, DEPRESSION, ANXIETY, VISION/EYE PROBLEMS (SCLERITIS), MIGRAINES, HEADACHES, AND WEIGHT GAIN WERE ADDED AS EVENT; PELVIC PAIN DECREASED SHORTLY AFTER REMOVAL VIA HYSTERECTOMY WITH BILATERAL SALPINGECTOMY; LAB DATA 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 IN A SUPPLEMENTAL REPORT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 411070 | ESSURE | TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE | HHS | BAYER PHARMA AG | ESS305 | 880431 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 38 YR | Other| R | ACETAMINOPHEN| ACETAMINOPHEN| ACETAMINOPHEN| ACETAMINOPHEN| ACETAMINOPHEN| ASMANEX| ASMANEX| ASMANEX| ASMANEX| ASMANEX| ASMANEX| ASMANEX| CETIRIZIN AL| CETIRIZIN AL| CETIRIZIN AL| CETIRIZIN AL| CETIRIZIN AL| CETIRIZIN AL| CETIRIZIN AL| DICLOFENAC| DICLOFENAC| DICLOFENAC| DICLOFENAC| DICLOFENAC| DICLOFENAC| DICLOFENAC| EXCEDRIN ASPIRIN FREE| EXCEDRIN ASPIRIN FREE| EXCEDRIN ASPIRIN FREE| EXCEDRIN ASPIRIN FREE| EXCEDRIN ASPIRIN FREE| FIORICET| FIORICET| FIORICET| FIORICET| FIORICET| FIORICET| FIORICET| MELOXICAM| MELOXICAM| MELOXICAM| MELOXICAM| MELOXICAM| MELOXICAM| MELOXICAM| SALBUTAMOL| SALBUTAMOL| SALBUTAMOL| SALBUTAMOL| SALBUTAMOL| VENTOLIN| VENTOLIN |