ESSURE
Report
- Report Number
- 2951250-2017-04847
- Event Type
- Injury
- Date Received
- October 17, 2017
- Date of Event
- March 30, 2012
- Report Date
- May 28, 2021
- Manufacturer
- BAYER PHARMA AG
- Product Code
- HHS
- PMA / PMN Number
- P020014
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OH, US
- Reporter Occupation
- OTHER
Narratives
E WAS INITIALLY RECEIVED VIA REGULATORY AUTHORITY (FOOD AND DRUG ADMINISTRATION, REFERENCE NUMBER: MW5037305) ON 24-SEP-2014. THE MOST RECENT INFORMATION WAS RECEIVED ON 11-JUL-2018. THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ("SEVERE PELVIC PAIN"), MENORRHAGIA ("HEAVY PERIODS / ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA)"), DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING)") AND RASH ("RASH") IN A 33-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 880425) INSERTED FOR FEMALE STERILIZATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S PAST MEDICAL HISTORY INCLUDED MULTIGRAVIDA, PARITY 4, C-SECTION, MISSED ABORTION AND UTERINE DILATION AND CURETTAGE. CONCURRENT CONDITIONS INCLUDED OBESITY, HYPERTENSION, HYPOTHYROIDISM, ANXIETY AND DEPRESSION. ON (B)(6) 2012, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), MENORRHAGIA (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), DYSMENORRHOEA (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), RASH (SERIOUSNESS CRITERION DISABILITY), ALOPECIA ("HAIR LOSS"), PAIN IN EXTREMITY ("LEG PAIN"), ABDOMINAL DISTENSION ("BLOATING / BIG BELLY LOOK"), ADVERSE EVENT ("THE LIST GOES ON AND ON"), BACK PAIN ("PAIN IN MY LOWER BACK"), SKIN DISORDER ("SKIN LOOKS AWFUL"), ACNE CYSTIC ("ACNE CYSTS APPEAR ALL OVER AREAS OF MY BODY"), FURUNCLE ("BOILS APPEAR ALL OVER AREAS OF MY BODY"), HYPERTENSION ("HIGH BLOOD PRESSURE"), HYPERSENSITIVITY ("ALLERGIC REACTION"), AMNESIA ("MEMORY LOSS"), MENSTRUAL DISORDER ("MENSTRUATION ISSUES"), INFECTION ("INFECTION"), ACNE ("PIMPLES ON CHEST AND BACK"), BLADDER DISORDER ("BLADDER PROBLEMS"), URINARY TRACT DISORDER ("URINARY PROBLEMS"), TOOTH DISORDER ("DENTAL PROBLEMS"), DYSPAREUNIA ("DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE)"), FATIGUE ("FATIGUE"), THE FIRST EPISODE OF GASTROINTESTINAL DISORDER ("GASTROINTESTINAL SYSTEM CONDITION"), THE SECOND EPISODE OF GASTROINTESTINAL DISORDER ("DIGESTIVE SYSTEM CONDITION"), MIGRAINE ("MIGRAINES"), HEADACHE ("HEADACHE"), WEIGHT INCREASED ("WEIGHT GAIN") AND DYSGEUSIA ("METAL TASTE IN THE MOUTH"). THE PATIENT WAS TREATED WITH SURGERY (HYSTERECTOMY WITH BILATERAL SALPINGECTOMY, RIGHT OOPHORECTOMY), SURGERY (HYSTERECTOMY WITH BILATERAL SALPINGECTOMY, RIGHT OOPHORECTOMY) AND SURGERY (HYSTERECTOMY WITH BILATERAL SALPINGECTOMY, RIGHT OOPHORECTOMY). ESSURE WAS REMOVED ON (B)(6) 2016. AT THE TIME OF THE REPORT, THE PELVIC PAIN HAD RESOLVED AND THE MENORRHAGIA, DYSMENORRHOEA, RASH, ALOPECIA, PAIN IN EXTREMITY, ABDOMINAL DISTENSION, ADVERSE EVENT, BACK PAIN, SKIN DISORDER, ACNE CYSTIC, FURUNCLE, HYPERTENSION, HYPERSENSITIVITY, AMNESIA, MENSTRUAL DISORDER, INFECTION, ACNE, BLADDER DISORDER, URINARY TRACT DISORDER, TOOTH DISORDER, DYSPAREUNIA, FATIGUE, THE LAST EPISODE OF GASTROINTESTINAL DISORDER, MIGRAINE, HEADACHE, WEIGHT INCREASED AND DYSGEUSIA OUTCOME WAS UNKNOWN. THE REPORTER PROVIDED NO CAUSALITY ASSESSMENT FOR ABDOMINAL DISTENSION, ADVERSE EVENT, ALOPECIA, PAIN IN EXTREMITY AND RASH WITH ESSURE. THE REPORTER CONSIDERED ACNE, ACNE CYSTIC, AMNESIA, BACK PAIN, BLADDER DISORDER, DYSGEUSIA, DYSMENORRHOEA, DYSPAREUNIA, FATIGUE, FURUNCLE, HEADACHE, HYPERSENSITIVITY, HYPERTENSION, INFECTION, MENORRHAGIA, MENSTRUAL DISORDER, MIGRAINE, PELVIC PAIN, SKIN DISORDER, TOOTH DISORDER, URINARY TRACT DISORDER, WEIGHT INCREASED, THE FIRST EPISODE OF GASTROINTESTINAL DISORDER AND THE SECOND EPISODE OF GASTROINTESTINAL DISORDER TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: INSERTION DETAILS: THE RIGHT TUBAL OSTIA WAS EASILY VISUALIZED. THE ESSURE WAS PLACED WITH FOUR COILS NOTED. LEFT FALLOPIAN TUBAL OSTIA WAS IDENTIFIED. THE SECOND ESSURE CATHETER WAS PLACED WITHOUT DIFFICULTY. THERE WAS ONE TRAILING COIL. REMOVAL DETAILS: PREOPERATIVE DIAGNOSES: MENORRHAGIA AND DYSMENORRHEA. POSTOPERATIVE DIAGNOSES: MENORRHAGIA AND DYSMENORRHEA. HEMORRHAGIC RIGHT OVARIAN CYST. PROCEDURE: TOTAL ABDOMINAL HYSTERECTOMY, BILATERAL SALPINGECTOMY, AND RIGHT OOPHORECTOMY. BOTH ESSURE CATHETERS COULD BE PALPATED IN THE FALLOPIAN TUBE. THERE IS NO PERFORATION OF THE UTERUS FROM THE COILS OR ANY OTHER ABNORMALITIES. OPTED TO PERFORM THE BILATERAL SALPINGECTOMY AT THE COMPLETION OF THE PROCEDURE. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 33.2 KG/SQM. HYSTEROSALPINGOGRAM - ON (B)(6) 2012: TOTAL BILATERAL OCCLUSION . CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONE/ONES WERE DESCRIBED IN PATIENT¿S MEDICAL RECORDS: MENORRHAGIA, DYSMENORRHEA AND PELVIC PAIN. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. FURTHER COMPANY FOLLOW-UP WITH THE REGULATORY AUTHORITY IS NOT POSSIBLE. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 11-JUL-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 ON A SUPPLEMENTAL REPORT.
NTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ("SEVERE PELVIC PAIN/PAIN: PELVIC AREA"), MENORRHAGIA ("HEAVY PERIODS / ABNORMAL BLEEDING (MENORRHAGIA)"), DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING)") AND RASH ("RASH") IN A 33-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 880425) INSERTED FOR FEMALE STERILIZATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S PAST MEDICAL HISTORY INCLUDED MULTIGRAVIDA, PARITY 4, C-SECTION, MISSED ABORTION AND UTERINE DILATION AND CURETTAGE. CONCURRENT CONDITIONS INCLUDED OBESITY, HYPERTENSION, HYPOTHYROIDISM SINCE 1999, ANXIETY AND DEPRESSION. CONCOMITANT PRODUCTS INCLUDED COLECALCIFEROL (VITAMIN D) SINCE 2015, LEVOTHYROXINE SINCE 1999 AND MULTIVITAMINS SINCE 2015. ON (B)(6) 2012, THE PATIENT HAD ESSURE INSERTED. ON (B)(6) 2012, 9 DAYS AFTER INSERTION OF ESSURE, THE PATIENT EXPERIENCED DYSMENORRHOEA (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED). ON (B)(6) 2012, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED). ON (B)(6) 2012, THE PATIENT EXPERIENCED MENORRHAGIA (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED) AND VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL)"). ON (B)(6) 2012, THE PATIENT EXPERIENCED FATIGUE ("FATIGUE"). ON (B)(6) 2013, THE PATIENT EXPERIENCED MIGRAINE ("MIGRAINES") AND HEADACHE ("HEADACHE"). ON (B)(6) 2013, THE PATIENT EXPERIENCED WEIGHT INCREASED ("WEIGHT GAIN"). ON (B)(6) 2013, THE PATIENT EXPERIENCED CYSTITIS ("INFECTION: BLADDER") AND VAGINAL INFECTION ("INFECTION: VAGINAL"). ON (B)(6) 2014, THE PATIENT EXPERIENCED FURUNCLE ("BOILS APPEAR ALL OVER AREAS OF MY BODY/BOILS"), ACNE ("PIMPLES ON CHEST AND BACK") AND URINARY TRACT INFECTION ("INFECTION: URINARY"). ON (B)(6) 2014, THE PATIENT EXPERIENCED DYSPAREUNIA ("DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE)"). ON (B)(6) 2015, THE PATIENT EXPERIENCED HYPERTENSION ("HIGH BLOOD PRESSURE"). ON (B)(6) 2015, THE PATIENT EXPERIENCED ALOPECIA ("HAIR LOSS"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED RASH (SERIOUSNESS CRITERION DISABILITY), PAIN IN EXTREMITY ("LEG PAIN/PAIN: LEGS"), ABDOMINAL DISTENSION ("BLOATING / BIG BELLY LOOK"), ADVERSE EVENT ("THE LIST GOES ON AND ON"), BACK PAIN ("PAIN IN MY LOWER BACK/PAIN: LOWER BACK"), SKIN DISORDER ("SKIN LOOKS AWFUL"), ACNE CYSTIC ("ACNE CYSTS APPEAR ALL OVER AREAS OF MY BODY"), HYPERSENSITIVITY ("ALLERGIC REACTION"), AMNESIA ("MEMORY LOSS"), MENSTRUAL DISORDER ("MENSTRUATION ISSUES"), INFECTION ("INFECTION"), BLADDER DISORDER ("BLADDER PROBLEMS"), URINARY TRACT DISORDER ("URINARY PROBLEMS"), TOOTH DISORDER ("DENTAL PROBLEMS"), THE FIRST EPISODE OF GASTROINTESTINAL DISORDER ("GASTROINTESTINAL SYSTEM CONDITION"), THE SECOND EPISODE OF GASTROINTESTINAL DISORDER ("DIGESTIVE SYSTEM CONDITION") AND DYSGEUSIA ("METAL TASTE IN THE MOUTH"). THE PATIENT WAS TREATED WITH SURGERY (TOTAL ABDOMINAL HYSTERECTOMY WITH BILATERAL SALPINGECTOMY, RIGHT OOPHORECTOMY), SURGERY (TOTAL ABDOMINAL HYSTERECTOMY WITH BILATERAL SALPINGECTOMY, RIGHT OOPHORECTOMY) AND SURGERY (TOTAL ABDOMINAL HYSTERECTOMY WITH BILATERAL SALPINGECTOMY, RIGHT OOPHORECTOMY). ESSURE WAS REMOVED ON (B)(6) 2016. AT THE TIME OF THE REPORT, THE PELVIC PAIN, DYSMENORRHOEA, FATIGUE AND MIGRAINE HAD RESOLVED AND THE MENORRHAGIA, RASH, ALOPECIA, PAIN IN EXTREMITY, ABDOMINAL DISTENSION, ADVERSE EVENT, BACK PAIN, SKIN DISORDER, ACNE CYSTIC, FURUNCLE, HYPERTENSION, HYPERSENSITIVITY, AMNESIA, MENSTRUAL DISORDER, INFECTION, ACNE, BLADDER DISORDER, URINARY TRACT DISORDER, TOOTH DISORDER, DYSPAREUNIA, THE LAST EPISODE OF GASTROINTESTINAL DISORDER, HEADACHE, WEIGHT INCREASED, DYSGEUSIA, VAGINAL HAEMORRHAGE, CYSTITIS, VAGINAL INFECTION AND URINARY TRACT INFECTION OUTCOME WAS UNKNOWN. THE REPORTER PROVIDED NO CAUSALITY ASSESSMENT FOR ABDOMINAL DISTENSION, ADVERSE EVENT, ALOPECIA, PAIN IN EXTREMITY AND RASH WITH ESSURE. THE REPORTER CONSIDERED ACNE, ACNE CYSTIC, AMNESIA, BACK PAIN, BLADDER DISORDER, CYSTITIS, DYSGEUSIA, DYSMENORRHOEA, DYSPAREUNIA, FATIGUE, FURUNCLE, HEADACHE, HYPERSENSITIVITY, HYPERTENSION, INFECTION, MENORRHAGIA, MENSTRUAL DISORDER, MIGRAINE, PELVIC PAIN, SKIN DISORDER, TOOTH DISORDER, URINARY TRACT DISORDER, URINARY TRACT INFECTION, VAGINAL HAEMORRHAGE, VAGINAL INFECTION, WEIGHT INCREASED, THE FIRST EPISODE OF GASTROINTESTINAL DISORDER AND THE SECOND EPISODE OF GASTROINTESTINAL DISORDER TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: INSERTION DETAILS: THE RIGHT TUBAL OSTIA WAS EASILY VISUALIZED. THE ESSURE WAS PLACED WITH FOUR COILS NOTED. LEFT FALLOPIAN TUBAL OSTIA WAS IDENTIFIED. THE SECOND ESSURE CATHETER WAS PLACED WITHOUT DIFFICULTY. THERE WAS ONE TRAILING COIL. REMOVAL DETAILS: PREOPERATIVE DIAGNOSES: MENORRHAGIA AND DYSMENORRHEA. POSTOPERATIVE DIAGNOSES: MENORRHAGIA AND DYSMENORRHEA. HEMORRHAGIC RIGHT OVARIAN CYST. PROCEDURE: TOTAL ABDOMINAL HYSTERECTOMY, BILATERAL SALPINGECTOMY, AND RIGHT OOPHORECTOMY. BOTH ESSURE CATHETERS COULD BE PALPATED IN THE FALLOPIAN TUBE. THERE IS NO PERFORATION OF THE UTERUS FROM THE COILS OR ANY OTHER ABNORMALITIES. OPTED TO PERFORM THE BILATERAL SALPINGECTOMY AT THE COMPLETION OF THE PROCEDURE. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 33.2 KG/SQM. HYSTEROSALPINGOGRAM - ON (B)(6) 2012: TOTAL BILATERAL OCCLUSION. "CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONES WERE DESCRIBED IN PATIENT¿S MEDICAL RECORDS: MENORRHAGIA, DYSMENORRHEA AND PELVIC PAIN." QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT . FURTHER COMPANY FOLLOW-UP WITH THE REGULATORY AUTHORITY IS NOT POSSIBLE. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 22-JUN-2018: REPORTER INFORMATION WAS ADDED. HER CONCOMITANT MEDICATIONS WERE ADDED. PLAINTIFF FACT SHEET FOLLOWING EVENTS: ABNORMAL BLEEDING (VAGINAL); INFECTION: BLADDER/URINARY/VAGINAL) TYPE: UNSPECIFIED 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.
THIS CASE WAS INITIALLY RECEIVED VIA REGULATORY AUTHORITY (FOOD AND DRUG ADMINISTRATION, REFERENCE NUMBER: MW5037305) ON 24-SEP-2014. THE MOST RECENT INFORMATION WAS RECEIVED ON 26-SEP-2018. THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ("SEVERE PELVIC PAIN/PAIN: PELVIC AREA"), MENORRHAGIA ("HEAVY PERIODS / ABNORMAL BLEEDING (MENORRHAGIA)"), DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING)") AND RASH ("RASH") IN A 33-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 880425) INSERTED FOR FEMALE STERILIZATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S PAST MEDICAL HISTORY INCLUDED MULTIGRAVIDA, PARITY 4, C-SECTION, MISSED ABORTION AND UTERINE DILATION AND CURETTAGE. CONCURRENT CONDITIONS INCLUDED OBESITY, HYPERTENSION, HYPOTHYROIDISM SINCE 1999, ANXIETY AND DEPRESSION. CONCOMITANT PRODUCTS INCLUDED CHOLECALCIFEROL (VITAMIN D) SINCE 2015, LEVOTHYROXINE SINCE 1999 AND MULTIVITAMINS SINCE 2015. ON (B)(6) 2012, THE PATIENT HAD ESSURE INSERTED. ON (B)(6) 2012, 9 DAYS AFTER INSERTION OF ESSURE, THE PATIENT EXPERIENCED DYSMENORRHOEA (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED). ON (B)(6) 2012, THE PATIENT EXPERIENCED DEPRESSION ("PSYCHOLOGICAL OR PSYCHIATRIC PROBLEMS: DEPRESSION") AND ANXIETY ("PSYCHOLOGICAL OR PSYCHIATRIC PROBLEMS: MENTAL ANGUISH"). ON (B)(6) 2012, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED). ON (B)(6) 2012, THE PATIENT EXPERIENCED MENORRHAGIA (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED) AND VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL)"). ON (B)(6) 2012, THE PATIENT EXPERIENCED FATIGUE ("FATIGUE"). ON (B)(6) 2013, THE PATIENT EXPERIENCED MIGRAINE ("MIGRAINES") AND HEADACHE ("HEADACHE"). ON (B)(6) 2013, THE PATIENT EXPERIENCED WEIGHT INCREASED ("WEIGHT GAIN"). ON (B)(6) 2013, THE PATIENT EXPERIENCED CYSTITIS ("INFECTION: BLADDER") AND VAGINAL INFECTION ("INFECTION: VAGINAL"). ON (B)(6) 2014, THE PATIENT EXPERIENCED FURUNCLE ("BOILS APPEAR ALL OVER AREAS OF MY BODY/BOILS"), ACNE ("PIMPLES ON CHEST AND BACK") AND URINARY TRACT INFECTION ("INFECTION: URINARY"). ON (B)(6) 2014, THE PATIENT EXPERIENCED DYSPAREUNIA ("DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE)"). ON (B)(6) 2015, THE PATIENT EXPERIENCED HYPERTENSION ("HIGH BLOOD PRESSURE"). ON (B)(6) 2015, THE PATIENT EXPERIENCED ALOPECIA ("HAIR LOSS"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED RASH (SERIOUSNESS CRITERION DISABILITY), PAIN IN EXTREMITY ("LEG PAIN/PAIN: LEGS"), ABDOMINAL DISTENSION ("BLOATING / BIG BELLY LOOK"), ADVERSE EVENT ("THE LIST GOES ON AND ON"), BACK PAIN ("PAIN IN MY LOWER BACK/PAIN: LOWER BACK"), SKIN DISORDER ("SKIN LOOKS AWFUL"), ACNE CYSTIC ("ACNE CYSTS APPEAR ALL OVER AREAS OF MY BODY"), HYPERSENSITIVITY ("ALLERGIC REACTION"), AMNESIA ("MEMORY LOSS"), MENSTRUAL DISORDER ("MENSTRUATION ISSUES"), INFECTION ("INFECTION"), BLADDER DISORDER ("BLADDER PROBLEMS"), URINARY TRACT DISORDER ("URINARY PROBLEMS"), TOOTH DISORDER ("DENTAL PROBLEMS"), THE FIRST EPISODE OF GASTROINTESTINAL DISORDER ("GASTROINTESTINAL SYSTEM CONDITION"), THE SECOND EPISODE OF GASTROINTESTINAL DISORDER ("DIGESTIVE SYSTEM CONDITION") AND DYSGEUSIA ("METAL TASTE IN THE MOUTH"). THE PATIENT WAS TREATED WITH SURGERY (TOTAL ABDOMINAL HYSTERECTOMY WITH BILATERAL SALPINGECTOMY, RIGHT OOPHORECTOMY), SURGERY (TOTAL ABDOMINAL HYSTERECTOMY WITH BILATERAL SALPINGECTOMY, RIGHT OOPHORECTOMY) AND SURGERY (TOTAL ABDOMINAL HYSTERECTOMY WITH BILATERAL SALPINGECTOMY, RIGHT OOPHORECTOMY). ESSURE WAS REMOVED ON (B)(6) 2016. AT THE TIME OF THE REPORT, THE PELVIC PAIN, DYSMENORRHOEA, FATIGUE AND MIGRAINE HAD RESOLVED AND THE MENORRHAGIA, RASH, ALOPECIA, PAIN IN EXTREMITY, ABDOMINAL DISTENSION, ADVERSE EVENT, BACK PAIN, SKIN DISORDER, ACNE CYSTIC, FURUNCLE, HYPERTENSION, HYPERSENSITIVITY, AMNESIA, MENSTRUAL DISORDER, INFECTION, ACNE, BLADDER DISORDER, URINARY TRACT DISORDER, TOOTH DISORDER, DYSPAREUNIA, THE LAST EPISODE OF GASTROINTESTINAL DISORDER, HEADACHE, WEIGHT INCREASED, DYSGEUSIA, VAGINAL HAEMORRHAGE, CYSTITIS, VAGINAL INFECTION, URINARY TRACT INFECTION, DEPRESSION AND ANXIETY OUTCOME WAS UNKNOWN. THE REPORTER PROVIDED NO CAUSALITY ASSESSMENT FOR ABDOMINAL DISTENSION, ADVERSE EVENT, ALOPECIA, PAIN IN EXTREMITY AND RASH WITH ESSURE. THE REPORTER CONSIDERED ACNE, ACNE CYSTIC, AMNESIA, ANXIETY, BACK PAIN, BLADDER DISORDER, CYSTITIS, DEPRESSION, DYSGEUSIA, DYSMENORRHOEA, DYSPAREUNIA, FATIGUE, FURUNCLE, HEADACHE, HYPERSENSITIVITY, HYPERTENSION, INFECTION, MENORRHAGIA, MENSTRUAL DISORDER, MIGRAINE, PELVIC PAIN, SKIN DISORDER, TOOTH DISORDER, URINARY TRACT DISORDER, URINARY TRACT INFECTION, VAGINAL HAEMORRHAGE, VAGINAL INFECTION, WEIGHT INCREASED, THE FIRST EPISODE OF GASTROINTESTINAL DISORDER AND THE SECOND EPISODE OF GASTROINTESTINAL DISORDER TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: INSERTION DETAILS: THE RIGHT TUBAL OSTIA WAS EASILY VISUALIZED. THE ESSURE WAS PLACED WITH FOUR COILS NOTED. LEFT FALLOPIAN TUBAL OSTIA WAS IDENTIFIED. THE SECOND ESSURE CATHETER WAS PLACED WITHOUT DIFFICULTY. THERE WAS ONE TRAILING COIL. REMOVAL DETAILS: PREOPERATIVE DIAGNOSES: MENORRHAGIA AND DYSMENORRHEA. POSTOPERATIVE DIAGNOSES: MENORRHAGIA AND DYSMENORRHEA. HEMORRHAGIC RIGHT OVARIAN CYST. PROCEDURE: TOTAL ABDOMINAL HYSTERECTOMY, BILATERAL SALPINGECTOMY, AND RIGHT OOPHORECTOMY. BOTH ESSURE CATHETERS COULD BE PALPATED IN THE FALLOPIAN TUBE. THERE IS NO PERFORATION OF THE UTERUS FROM THE COILS OR ANY OTHER ABNORMALITIES. OPTED TO PERFORM THE BILATERAL SALPINGECTOMY AT THE COMPLETION OF THE PROCEDURE. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 32.2 KG/SQM. HYSTEROSALPINGOGRAM - ON (B)(6) 2012: TOTAL BILATERAL OCCLUSION. "CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONES WERE DESCRIBED IN PATIENT¿S MEDICAL RECORDS: MENORRHAGIA, DYSMENORRHEA AND PELVIC PAIN." QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. FURTHER COMPANY FOLLOW-UP WITH THE REGULATORY AUTHORITY IS NOT POSSIBLE. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 26-SEP-2018: PLAINTIFF FACT SHEET: EVENTS DEPRESSION AND MENTAL ANGUISH WERE ADDED. HISTORICAL & CONCOMITANT CONDITIONS DRUGS WERE ADDED. PRODUCT, PATIENT & REPORTER INFORMATION UPDATED. 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.
THIS CASE WAS INITIALLY RECEIVED VIA REGULATORY AUTHORITY (FOOD AND DRUG ADMINISTRATION, REFERENCE NUMBER: MW5037305) ON 24-SEP-2014. THE MOST RECENT INFORMATION WAS RECEIVED ON 09-APR-2018. THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ("SEVERE PELVIC PAIN"), MENORRHAGIA ("HEAVY PERIODS / ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA)"), DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING)") AND RASH ("RASH") IN A 33-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 880425) INSERTED FOR FEMALE STERILIZATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S PAST MEDICAL HISTORY INCLUDED MULTIGRAVIDA, PARITY 4, C-SECTION, ABORTION AND UTERINE DILATION AND CURETTAGE. CONCURRENT CONDITIONS INCLUDED OBESITY, HYPERTENSION, HYPOTHYROIDISM, ANXIETY AND DEPRESSION. ON (B)(6) 2012, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), MENORRHAGIA (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), DYSMENORRHOEA (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), RASH (SERIOUSNESS CRITERION DISABILITY), ALOPECIA ("HAIR LOSS"), PAIN IN EXTREMITY ("LEG PAIN"), ABDOMINAL DISTENSION ("BLOATING / BIG BELLY LOOK"), ADVERSE EVENT ("THE LIST GOES ON AND ON"), BACK PAIN ("PAIN IN MY LOWER BACK"), SKIN DISORDER ("SKIN LOOKS AWFUL"), ACNE CYSTIC ("ACNE CYSTS APPEAR ALL OVER AREAS OF MY BODY"), FURUNCLE ("BOILS APPEAR ALL OVER AREAS OF MY BODY"), HYPERTENSION ("HIGH BLOOD PRESSURE"), HYPERSENSITIVITY ("ALLERGIC REACTION"), AMNESIA ("MEMORY LOSS"), MENSTRUAL DISORDER ("MENSTRUATION ISSUES"), INFECTION ("INFECTION"), ACNE ("PIMPLES ON CHEST AND BACK"), BLADDER DISORDER ("BLADDER PROBLEMS"), URINARY TRACT DISORDER ("URINARY PROBLEMS"), TOOTH DISORDER ("DENTAL PROBLEMS"), DYSPAREUNIA ("DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE)"), FATIGUE ("FATIGUE"), GASTROINTESTINAL DISORDER ("GASTROINTESTINAL SYSTEM CONDITION"), DYSPEPSIA ("DIGESTIVE SYSTEM CONDITION"), MIGRAINE ("MIGRAINES"), HEADACHE ("HEADACHE"), WEIGHT INCREASED ("WEIGHT GAIN") AND DYSGEUSIA ("METAL TASTE IN THE MOUTH"). THE PATIENT WAS TREATED WITH SURGERY (HYSTERECTOMY WITH BILATERAL SALPINGECTOMY, RIGHT OOPHORECTOMY), SURGERY (HYSTERECTOMY WITH BILATERAL SALPINGECTOMY, RIGHT OOPHORECTOMY) AND SURGERY (HYSTERECTOMY WITH BILATERAL SALPINGECTOMY, RIGHT OOPHORECTOMY). ESSURE WAS REMOVED ON 26-FEB-2016. AT THE TIME OF THE REPORT, THE PELVIC PAIN HAD RESOLVED AND THE MENORRHAGIA, DYSMENORRHOEA, RASH, ALOPECIA, PAIN IN EXTREMITY, ABDOMINAL DISTENSION, ADVERSE EVENT, BACK PAIN, SKIN DISORDER, ACNE CYSTIC, FURUNCLE, HYPERTENSION, HYPERSENSITIVITY, AMNESIA, MENSTRUAL DISORDER, INFECTION, ACNE, BLADDER DISORDER, URINARY TRACT DISORDER, TOOTH DISORDER, DYSPAREUNIA, FATIGUE, GASTROINTESTINAL DISORDER, DYSPEPSIA, MIGRAINE, HEADACHE, WEIGHT INCREASED AND DYSGEUSIA OUTCOME WAS UNKNOWN. THE REPORTER PROVIDED NO CAUSALITY ASSESSMENT FOR ABDOMINAL DISTENSION, ADVERSE EVENT, ALOPECIA, PAIN IN EXTREMITY AND RASH WITH ESSURE. THE REPORTER CONSIDERED ACNE, ACNE CYSTIC, AMNESIA, BACK PAIN, BLADDER DISORDER, DYSGEUSIA, DYSMENORRHOEA, DYSPAREUNIA, DYSPEPSIA, FATIGUE, FURUNCLE, GASTROINTESTINAL DISORDER, HEADACHE, HYPERSENSITIVITY, HYPERTENSION, INFECTION, MENORRHAGIA, MENSTRUAL DISORDER, MIGRAINE, PELVIC PAIN, SKIN DISORDER, TOOTH DISORDER, URINARY TRACT DISORDER AND WEIGHT INCREASED TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: INSERTION DETAILS: THE RIGHT TUBAL OSTIA WAS EASILY VISUALIZED. THE ESSURE WAS PLACED WITH FOUR COILS NOTED. LEFT FALLOPIAN TUBAL OSTIA WAS IDENTIFIED. THE SECOND ESSURE CATHETER WAS PLACED WITHOUT DIFFICULTY. THERE WAS ONE TRAILING COIL. REMOVAL DETAILS: PREOPERATIVE DIAGNOSES: MENORRHAGIA AND DYSMENORRHEA. POSTOPERATIVE DIAGNOSES: MENORRHAGIA AND DYSMENORRHEA. HEMORRHAGIC RIGHT OVARIAN CYST. PROCEDURE: TOTAL ABDOMINAL HYSTERECTOMY, BILATERAL SALPINGECTOMY, AND RIGHT OOPHORECTOMY. BOTH ESSURE CATHETERS COULD BE PALPATED IN THE FALLOPIAN TUBE. THERE IS NO PERFORATION OF THE UTERUS FROM THE COILS OR ANY OTHER ABNORMALITIES. OPTED TO PERFORM THE BILATERAL SALPINGECTOMY AT THE COMPLETION OF THE PROCEDURE. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 33.2 KG/SQM. HYSTEROSALPINGOGRAM - ON 14-JUN-2012: TOTAL BILATERAL OCCLUSION. CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONE/ONES WERE DESCRIBED IN PATIENT¿S MEDICAL RECORDS: MENORRHAGIA, DYSMENORRHEA AND PELVIC PAIN. FURTHER COMPANY FOLLOW-UP WITH THE REGULATORY AUTHORITY IS NOT POSSIBLE. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 9-APR-2018: PLAINTIFF FACT SHEET WAS RECEIVED AND THE FOLLOWING INFORMATION WERE PROVIDED: NEW REPORTER (MEDICALLY CONFIRMED) ADDED; PATIENT¿S DEMOGRAPHIC DETAILS; ESSURE INSERTION DATE WAS CHANGED FROM SEP-2011 TO 21-MAR-2012, REMOVAL DATE 26-FEB-2016 AND LOT NUMBER 880425; INFECTION, PIMPLES ON CHEST AND BACK, BLADDER PROBLEMS, URINARY PROBLEMS, DENTAL PROBLEMS, DYSMENORRHEA (CRAMPING), DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE), FATIGUE, GASTROINTESTINAL SYSTEM CONDITION, DIGESTIVE SYSTEM CONDITION, MIGRAINES, HEADACHE, WEIGHT GAIN, METAL TASTE IN THE MOUTH WERE ADDED AS EVENT; PELVIC PAIN OUTCOME WAS UPDATED TO RESOLVED . MEDICAL RECORDS WERE ALSO RECEIVED AND THE FOLLOWING INFORMATION WAS PROVIDED: INSERTION AND REMOVAL DETAILS. 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.
THIS CASE WAS INITIALLY RECEIVED VIA REGULATORY AUTHORITY (FOOD AND DRUG ADMINISTRATION, REFERENCE NUMBER: MW5037305) ON 24-SEP-2014. THE MOST RECENT INFORMATION WAS RECEIVED ON 18-MAY-2021. THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ('SEVERE PELVIC PAIN/PAIN: PELVIC AREA'), HEAVY MENSTRUAL BLEEDING ('HEAVY PERIODS / ABNORMAL BLEEDING (MENORRHAGIA)'), DYSMENORRHOEA ('DYSMENORRHEA (CRAMPING)') AND RASH ('RASH') IN A 33-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 880425) INSERTED FOR FEMALE STERILIZATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S MEDICAL HISTORY INCLUDED MULTIGRAVIDA, PARITY 4, C-SECTION, MISSED ABORTION AND UTERINE DILATION AND CURETTAGE. CONCURRENT CONDITIONS INCLUDED HYPOTHYROIDISM SINCE 1999, OBESITY, HYPERTENSION, ANXIETY AND DEPRESSION. CONCOMITANT PRODUCTS INCLUDED LEVOTHYROXINE SINCE 1999, PARACETAMOL (ACETAMINOPHEN) FROM 2012 TO 2016, VITAMIN D NOS (VITAMIN D) SINCE 2015 AND VITAMINS NOS (MULTIVITAMINS) SINCE 2015. ON (B)(6) 2012, THE PATIENT HAD ESSURE INSERTED. ON (B)(6) 2012, THE PATIENT EXPERIENCED DYSMENORRHOEA (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), 9 DAYS AFTER INSERTION OF ESSURE. ON (B)(6) 2012, THE PATIENT EXPERIENCED DEPRESSION ("PSYCHOLOGICAL OR PSYCHIATRIC PROBLEMS: DEPRESSION") AND ANXIETY ("PSYCHOLOGICAL OR PSYCHIATRIC PROBLEMS: MENTAL ANGUISH"). ON (B)(6) 2012, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED). ON (B)(6) 2012, THE PATIENT EXPERIENCED HEAVY MENSTRUAL BLEEDING (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED) AND VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL)"). ON (B)(6) 2012, THE PATIENT EXPERIENCED FATIGUE ("FATIGUE"). ON (B)(6) 2013, THE PATIENT EXPERIENCED MIGRAINE ("MIGRAINES") AND HEADACHE ("HEADACHE"). ON (B)(6) 2013, THE PATIENT WAS FOUND TO HAVE WEIGHT INCREASED ("WEIGHT GAIN"). ON (B)(6) 2013, THE PATIENT EXPERIENCED CYSTITIS ("INFECTION: BLADDER") AND VAGINAL INFECTION ("INFECTION: VAGINAL"). ON (B)(6) 2014, THE PATIENT EXPERIENCED FURUNCLE ("BOILS APPEAR ALL OVER AREAS OF MY BODY/BOILS"), ACNE ("PIMPLES ON CHEST AND BACK") AND URINARY TRACT INFECTION ("INFECTION: URINARY / INFECTION (BLADDER/URINARY TRACT/ VAGINAL)-TYPE: URINARY"). ON (B)(6) 2014, THE PATIENT EXPERIENCED DYSPAREUNIA ("DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE)"). ON (B)(6) 2015, THE PATIENT EXPERIENCED HYPERTENSION ("HIGH BLOOD PRESSURE"). ON (B)(6) 2015, THE PATIENT EXPERIENCED ALOPECIA ("HAIR LOSS"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED RASH (SERIOUSNESS CRITERION DISABILITY), PAIN IN EXTREMITY ("LEG PAIN/PAIN: LEGS"), ABDOMINAL DISTENSION ("BLOATING / BIG BELLY LOOK"), ADVERSE EVENT ("THE LIST GOES ON AND ON"), BACK PAIN ("PAIN IN MY LOWER BACK/PAIN: LOWER BACK"), SKIN DISORDER ("SKIN LOOKS AWFUL"), ACNE CYSTIC ("ACNE CYSTS APPEAR ALL OVER AREAS OF MY BODY"), HYPERSENSITIVITY ("ALLERGIC REACTION"), AMNESIA ("MEMORY LOSS"), MENSTRUAL DISORDER ("MENSTRUATION ISSUES"), INFECTION ("INFECTION"), BLADDER DISORDER ("BLADDER PROBLEMS"), URINARY TRACT DISORDER ("URINARY PROBLEMS"), TOOTH DISORDER ("DENTAL PROBLEMS"), GASTROINTESTINAL DISORDER ("GASTROINTESTINAL SYSTEM CONDITION"), DISORDER GASTROINTESTINAL ("DIGESTIVE SYSTEM CONDITION") AND DYSGEUSIA ("METAL TASTE IN THE MOUTH"). THE PATIENT WAS TREATED WITH SURGERY (TOTAL ABDOMINAL HYSTERECTOMY WITH BILATERAL SALPINGECTOMY, RIGHT OOPHORECTOMY). ESSURE WAS REMOVED ON (B)(6) 2016. AT THE TIME OF THE REPORT, THE PELVIC PAIN, HEAVY MENSTRUAL BLEEDING, DYSMENORRHOEA, HYPERSENSITIVITY, BLADDER DISORDER, URINARY TRACT DISORDER, FATIGUE, MIGRAINE, VAGINAL HAEMORRHAGE, CYSTITIS, VAGINAL INFECTION AND URINARY TRACT INFECTION HAD RESOLVED AND THE RASH, ALOPECIA, PAIN IN EXTREMITY, ABDOMINAL DISTENSION, ADVERSE EVENT, BACK PAIN, SKIN DISORDER, ACNE CYSTIC, FURUNCLE, HYPERTENSION, AMNESIA, MENSTRUAL DISORDER, INFECTION, ACNE, TOOTH DISORDER, DYSPAREUNIA, GASTROINTESTINAL DISORDER, DISORDER GASTROINTESTINAL, HEADACHE, WEIGHT INCREASED, DYSGEUSIA, DEPRESSION AND ANXIETY OUTCOME WAS UNKNOWN. THE REPORTER PROVIDED NO CAUSALITY ASSESSMENT FOR ABDOMINAL DISTENSION, ADVERSE EVENT, ALOPECIA, PAIN IN EXTREMITY AND RASH WITH ESSURE. THE REPORTER CONSIDERED ACNE, ACNE CYSTIC, AMNESIA, ANXIETY, BACK PAIN, BLADDER DISORDER, CYSTITIS, DEPRESSION, DYSGEUSIA, DYSMENORRHOEA, DYSPAREUNIA, FATIGUE, FURUNCLE, GASTROINTESTINAL DISORDER, HEADACHE, HEAVY MENSTRUAL BLEEDING, HYPERSENSITIVITY, HYPERTENSION, INFECTION, MENSTRUAL DISORDER, MIGRAINE, PELVIC PAIN, SKIN DISORDER, TOOTH DISORDER, URINARY TRACT DISORDER, URINARY TRACT INFECTION, VAGINAL HAEMORRHAGE, VAGINAL INFECTION, WEIGHT INCREASED AND DISORDER GASTROINTESTINAL TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: PLAINTIFF RECEIVED TREATMENT FOR PAIN, BLEEDING. INSERTION DETAILS: THE RIGHT TUBAL OSTIA WAS EASILY VISUALIZED. THE ESSURE WAS PLACED WITH FOUR COILS NOTED. LEFT FALLOPIAN TUBAL OSTIA WAS IDENTIFIED. THE SECOND ESSURE CATHETER WAS PLACED WITHOUT DIFFICULTY. THERE WAS ONE TRAILING COIL. REMOVAL DETAILS: PREOPERATIVE DIAGNOSES: MENORRHAGIA AND DYSMENORRHEA. POSTOPERATIVE DIAGNOSES: MENORRHAGIA AND DYSMENORRHEA. HEMORRHAGIC RIGHT OVARIAN CYST. PROCEDURE: TOTAL ABDOMINAL HYSTERECTOMY, BILATERAL SALPINGECTOMY, AND RIGHT OOPHORECTOMY. BOTH ESSURE CATHETERS COULD BE PALPATED IN THE FALLOPIAN TUBE. THERE IS NO PERFORATION OF THE UTERUS FROM THE COILS OR ANY OTHER ABNORMALITIES. OPTED TO PERFORM THE BILATERAL SALPINGECTOMY AT THE COMPLETION OF THE PROCEDURE. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 32.2 KG/SQM. HYSTEROSALPINGOGRAM - ON (B)(6) 2012: RESULTS: TOTAL BILATERAL OCCLUSION. "CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONES WERE DESCRIBED IN PATIENT¿S MEDICAL RECORDS: MENORRHAGIA, DYSMENORRHEA AND PELVIC PAIN." QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. FURTHER COMPANY FOLLOW-UP WITH THE REGULATORY AUTHORITY IS NOT POSSIBLE. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 18-MAY-2021: MR RECEIVED-NEW REPORTER 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 RELEVANT DATA; SHOULD ANY NEW AND REPORTABLE INFORMATION BECOME AVAILABLE FROM OUR INVESTIGATION, THIS WILL BE PROVIDED IN A SUPPLEMENTARY REPORT.
THIS CASE WAS INITIALLY RECEIVED VIA REGULATORY AUTHORITY (FOOD AND DRUG ADMINISTRATION, REFERENCE NUMBER: MW5037305) ON (B)(6) 2014. THE MOST RECENT INFORMATION WAS RECEIVED ON (B)(6) 2021. THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ('SEVERE PELVIC PAIN/PAIN: PELVIC AREA'), HEAVY MENSTRUAL BLEEDING ('HEAVY PERIODS / ABNORMAL BLEEDING (MENORRHAGIA)'), DYSMENORRHOEA ('DYSMENORRHEA (CRAMPING)') AND RASH ('RASH') IN A 33-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 880425) INSERTED FOR FEMALE STERILIZATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S MEDICAL HISTORY INCLUDED MULTIGRAVIDA, PARITY 4, C-SECTION, MISSED ABORTION AND UTERINE DILATION AND CURETTAGE. CONCURRENT CONDITIONS INCLUDED HYPOTHYROIDISM SINCE 1999, OBESITY, HYPERTENSION, ANXIETY AND DEPRESSION. CONCOMITANT PRODUCTS INCLUDED LEVOTHYROXINE SINCE 1999, PARACETAMOL (ACETAMINOPHEN) FROM 2012 TO 2016, VITAMIN D NOS (VITAMIN D) SINCE 2015 AND VITAMINS NOS (MULTIVITAMINS) SINCE 2015. ON (B)(6) 2012, THE PATIENT HAD ESSURE INSERTED. ON (B)(6) 2012, THE PATIENT EXPERIENCED DYSMENORRHOEA (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), 9 DAYS AFTER INSERTION OF ESSURE. ON (B)(6) 2012, THE PATIENT EXPERIENCED DEPRESSION ("PSYCHOLOGICAL OR PSYCHIATRIC PROBLEMS: DEPRESSION") AND ANXIETY ("PSYCHOLOGICAL OR PSYCHIATRIC PROBLEMS: MENTAL ANGUISH"). ON (B)(6) 2012, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED). ON (B)(6) 2012, THE PATIENT EXPERIENCED HEAVY MENSTRUAL BLEEDING (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED) AND VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL)"). ON (B)(6) 2012, THE PATIENT EXPERIENCED FATIGUE ("FATIGUE"). ON (B)(6) 2013, THE PATIENT EXPERIENCED MIGRAINE ("MIGRAINES") AND HEADACHE ("HEADACHE"). ON (B)(6) 2013, THE PATIENT WAS FOUND TO HAVE WEIGHT INCREASED ("WEIGHT GAIN"). ON (B)(6) 2013, THE PATIENT EXPERIENCED CYSTITIS ("INFECTION: BLADDER") AND VAGINAL INFECTION ("INFECTION: VAGINAL"). ON (B)(6) 2014, THE PATIENT EXPERIENCED FURUNCLE ("BOILS APPEAR ALL OVER AREAS OF MY BODY/BOILS"), ACNE ("PIMPLES ON CHEST AND BACK") AND URINARY TRACT INFECTION ("INFECTION: URINARY / INFECTION (BLADDER/URINARY TRACT/ VAGINAL)-TYPE: URINARY"). ON (B)(6) 2014, THE PATIENT EXPERIENCED DYSPAREUNIA ("DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE)"). ON (B)(6) 2015, THE PATIENT EXPERIENCED HYPERTENSION ("HIGH BLOOD PRESSURE"). ON (B)(6) 2015, THE PATIENT EXPERIENCED ALOPECIA ("HAIR LOSS"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED RASH (SERIOUSNESS CRITERION DISABILITY), PAIN IN EXTREMITY ("LEG PAIN/PAIN: LEGS"), ABDOMINAL DISTENSION ("BLOATING / BIG BELLY LOOK"), ADVERSE EVENT ("THE LIST GOES ON AND ON"), BACK PAIN ("PAIN IN MY LOWER BACK/PAIN: LOWER BACK"), SKIN DISORDER ("SKIN LOOKS AWFUL"), ACNE CYSTIC ("ACNE CYSTS APPEAR ALL OVER AREAS OF MY BODY"), HYPERSENSITIVITY ("ALLERGIC REACTION"), AMNESIA ("MEMORY LOSS"), MENSTRUAL DISORDER ("MENSTRUATION ISSUES"), INFECTION ("INFECTION"), BLADDER DISORDER ("BLADDER PROBLEMS"), URINARY TRACT DISORDER ("URINARY PROBLEMS"), TOOTH DISORDER ("DENTAL PROBLEMS"), GASTROINTESTINAL DISORDER ("GASTROINTESTINAL SYSTEM CONDITION"), DISORDER GASTROINTESTINAL ("DIGESTIVE SYSTEM CONDITION") AND DYSGEUSIA ("METAL TASTE IN THE MOUTH"). THE PATIENT WAS TREATED WITH SURGERY (TOTAL ABDOMINAL HYSTERECTOMY WITH BILATERAL SALPINGECTOMY, RIGHT OOPHORECTOMY). ESSURE WAS REMOVED ON (B)(6) 2016. AT THE TIME OF THE REPORT, THE PELVIC PAIN, HEAVY MENSTRUAL BLEEDING, DYSMENORRHOEA, HYPERSENSITIVITY, BLADDER DISORDER, URINARY TRACT DISORDER, FATIGUE, MIGRAINE, VAGINAL HAEMORRHAGE, CYSTITIS, VAGINAL INFECTION AND URINARY TRACT INFECTION HAD RESOLVED AND THE RASH, ALOPECIA, PAIN IN EXTREMITY, ABDOMINAL DISTENSION, ADVERSE EVENT, BACK PAIN, SKIN DISORDER, ACNE CYSTIC, FURUNCLE, HYPERTENSION, AMNESIA, MENSTRUAL DISORDER, INFECTION, ACNE, TOOTH DISORDER, DYSPAREUNIA, GASTROINTESTINAL DISORDER, DISORDER GASTROINTESTINAL, HEADACHE, WEIGHT INCREASED, DYSGEUSIA, DEPRESSION AND ANXIETY OUTCOME WAS UNKNOWN. THE REPORTER PROVIDED NO CAUSALITY ASSESSMENT FOR ABDOMINAL DISTENSION, ADVERSE EVENT, ALOPECIA, PAIN IN EXTREMITY AND RASH WITH ESSURE. THE REPORTER CONSIDERED ACNE, ACNE CYSTIC, AMNESIA, ANXIETY, BACK PAIN, BLADDER DISORDER, CYSTITIS, DEPRESSION, DYSGEUSIA, DYSMENORRHOEA, DYSPAREUNIA, FATIGUE, FURUNCLE, GASTROINTESTINAL DISORDER, HEADACHE, HEAVY MENSTRUAL BLEEDING, HYPERSENSITIVITY, HYPERTENSION, INFECTION, MENSTRUAL DISORDER, MIGRAINE, PELVIC PAIN, SKIN DISORDER, TOOTH DISORDER, URINARY TRACT DISORDER, URINARY TRACT INFECTION, VAGINAL HAEMORRHAGE, VAGINAL INFECTION, WEIGHT INCREASED AND DISORDER GASTROINTESTINAL TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: PLAINTIFF RECEIVED TREATMENT FOR PAIN, BLEEDING. INSERTION DETAILS: THE RIGHT TUBAL OSTIA WAS EASILY VISUALIZED. THE ESSURE WAS PLACED WITH FOUR COILS NOTED. LEFT FALLOPIAN TUBAL OSTIA WAS IDENTIFIED. THE SECOND ESSURE CATHETER WAS PLACED WITHOUT DIFFICULTY. THERE WAS ONE TRAILING COIL. REMOVAL DETAILS: PREOPERATIVE DIAGNOSES: MENORRHAGIA AND DYSMENORRHEA. POSTOPERATIVE DIAGNOSES: MENORRHAGIA AND DYSMENORRHEA. HEMORRHAGIC RIGHT OVARIAN CYST. PROCEDURE: TOTAL ABDOMINAL HYSTERECTOMY, BILATERAL SALPINGECTOMY, AND RIGHT OOPHORECTOMY. BOTH ESSURE CATHETERS COULD BE PALPATED IN THE FALLOPIAN TUBE. THERE IS NO PERFORATION OF THE UTERUS FROM THE COILS OR ANY OTHER ABNORMALITIES. OPTED TO PERFORM THE BILATERAL SALPINGECTOMY AT THE COMPLETION OF THE PROCEDURE. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 32.2 KG/SQM. HYSTEROSALPINGOGRAM - ON (B)(6) 2012: RESULTS: TOTAL BILATERAL OCCLUSION. "CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONES WERE DESCRIBED IN PATIENT¿S MEDICAL RECORDS: MENORRHAGIA, DYSMENORRHEA AND PELVIC PAIN." QUALITY-SAFETY EVALUATION OF PTC: NO DEFECT COULD BE CONFIRMED BY THE MANUFACTURER. ALL COMPONENT BATCHES USED FOR MANUFACTURING OF THIS PRODUCT BATCH FULFILLED THE SET SPECIFICATIONS. BATCH DOCUMENTATION DID NOT REVEAL ANY DEVIATIONS DURING THE MANUFACTURING PROCESS THAT COULD HAVE CAUSED THE DESCRIBED COMPLAINT REASON. TREND ANALYSES OF COMPLAINTS ARE REVIEWED REGULARLY, NO SIGNAL WAS OBSERVED WITH REGARD TO THE REPORTED COMPLAINT REASON. THE RISK MANAGEMENT FILE WAS REVIEWED AND AN UPDATE WAS NOT DEEMED REQUIRED. A TECHNICAL INVESTIGATION OF THE COMPLAINT SAMPLE COULD NOT BE CONDUCTED, AS NO SAMPLE WAS AVAILABLE. FURTHER COMPANY FOLLOW-UP WITH THE REGULATORY AUTHORITY IS NOT POSSIBLE. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON (B)(6) 2021: QUALITY SAFETY EVALUATION OF PTC WE RECEIVED A LOT NUMBER IN THIS CASE. 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 ('SEVERE PELVIC PAIN/PAIN: PELVIC AREA'), MENORRHAGIA ('HEAVY PERIODS / ABNORMAL BLEEDING (MENORRHAGIA)'), DYSMENORRHOEA ('DYSMENORRHEA (CRAMPING)') AND RASH ('RASH') IN A 33-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 880425) INSERTED FOR FEMALE STERILIZATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S MEDICAL HISTORY INCLUDED MULTIGRAVIDA, PARITY 4, C-SECTION, MISSED ABORTION AND UTERINE DILATION AND CURETTAGE. CONCURRENT CONDITIONS INCLUDED HYPOTHYROIDISM SINCE 1999, OBESITY, HYPERTENSION, ANXIETY AND DEPRESSION. CONCOMITANT PRODUCTS INCLUDED LEVOTHYROXINE SINCE 1999, PARACETAMOL (ACETAMINOPHEN) FROM 2012 TO 2016, VITAMIN D NOS (VITAMIN D) SINCE 2015 AND VITAMINS NOS (MULTIVITAMINS) SINCE 2015. ON (B)(6) 2012, THE PATIENT HAD ESSURE INSERTED. ON (B)(6) 2012, THE PATIENT EXPERIENCED DYSMENORRHOEA (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), 9 DAYS AFTER INSERTION OF ESSURE. ON (B)(6) 2012, THE PATIENT EXPERIENCED DEPRESSION ("PSYCHOLOGICAL OR PSYCHIATRIC PROBLEMS: DEPRESSION") AND ANXIETY ("PSYCHOLOGICAL OR PSYCHIATRIC PROBLEMS: MENTAL ANGUISH"). ON (B)(6) 2012, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED). ON (B)(6) 2012, THE PATIENT EXPERIENCED MENORRHAGIA (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED) AND VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL)"). ON (B)(6) 2012, THE PATIENT EXPERIENCED FATIGUE ("FATIGUE"). ON (B)(6) 2013, THE PATIENT EXPERIENCED MIGRAINE ("MIGRAINES") AND HEADACHE ("HEADACHE"). ON (B)(6) 2013, THE PATIENT WAS FOUND TO HAVE WEIGHT INCREASED ("WEIGHT GAIN"). ON (B)(6) 2013, THE PATIENT EXPERIENCED CYSTITIS ("INFECTION: BLADDER") AND VAGINAL INFECTION ("INFECTION: VAGINAL"). ON (B)(6) 2014, THE PATIENT EXPERIENCED FURUNCLE ("BOILS APPEAR ALL OVER AREAS OF MY BODY/BOILS"), ACNE ("PIMPLES ON CHEST AND BACK") AND URINARY TRACT INFECTION ("INFECTION: URINARY / INFECTION (BLADDER/URINARY TRACT/ VAGINAL)-TYPE: URINARY"). ON (B)(6) 2014, THE PATIENT EXPERIENCED DYSPAREUNIA ("DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE)"). ON (B)(6) 2015, THE PATIENT EXPERIENCED HYPERTENSION ("HIGH BLOOD PRESSURE"). ON (B)(6) 2015, THE PATIENT EXPERIENCED ALOPECIA ("HAIR LOSS"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED RASH (SERIOUSNESS CRITERION DISABILITY), PAIN IN EXTREMITY ("LEG PAIN/PAIN: LEGS"), ABDOMINAL DISTENSION ("BLOATING / BIG BELLY LOOK"), ADVERSE EVENT ("THE LIST GOES ON AND ON"), BACK PAIN ("PAIN IN MY LOWER BACK/PAIN: LOWER BACK"), SKIN DISORDER ("SKIN LOOKS AWFUL"), ACNE CYSTIC ("ACNE CYSTS APPEAR ALL OVER AREAS OF MY BODY"), HYPERSENSITIVITY ("ALLERGIC REACTION"), AMNESIA ("MEMORY LOSS"), MENSTRUAL DISORDER ("MENSTRUATION ISSUES"), INFECTION ("INFECTION"), BLADDER DISORDER ("BLADDER PROBLEMS"), URINARY TRACT DISORDER ("URINARY PROBLEMS"), TOOTH DISORDER ("DENTAL PROBLEMS"), GASTROINTESTINAL DISORDER ("GASTROINTESTINAL SYSTEM CONDITION"), DISORDER GASTROINTESTINAL ("DIGESTIVE SYSTEM CONDITION") AND DYSGEUSIA ("METAL TASTE IN THE MOUTH"). THE PATIENT WAS TREATED WITH SURGERY (TOTAL ABDOMINAL HYSTERECTOMY WITH BILATERAL SALPINGECTOMY, RIGHT OOPHORECTOMY). ESSURE WAS REMOVED ON (B)(6) 2016. AT THE TIME OF THE REPORT, THE PELVIC PAIN, MENORRHAGIA, DYSMENORRHOEA, HYPERSENSITIVITY, BLADDER DISORDER, URINARY TRACT DISORDER, FATIGUE, MIGRAINE, VAGINAL HAEMORRHAGE, CYSTITIS, VAGINAL INFECTION AND URINARY TRACT INFECTION HAD RESOLVED AND THE RASH, ALOPECIA, PAIN IN EXTREMITY, ABDOMINAL DISTENSION, ADVERSE EVENT, BACK PAIN, SKIN DISORDER, ACNE CYSTIC, FURUNCLE, HYPERTENSION, AMNESIA, MENSTRUAL DISORDER, INFECTION, ACNE, TOOTH DISORDER, DYSPAREUNIA, GASTROINTESTINAL DISORDER, DISORDER GASTROINTESTINAL, HEADACHE, WEIGHT INCREASED, DYSGEUSIA, DEPRESSION AND ANXIETY OUTCOME WAS UNKNOWN. THE REPORTER PROVIDED NO CAUSALITY ASSESSMENT FOR ABDOMINAL DISTENSION, ADVERSE EVENT, ALOPECIA, PAIN IN EXTREMITY AND RASH WITH ESSURE. THE REPORTER CONSIDERED ACNE, ACNE CYSTIC, AMNESIA, ANXIETY, BACK PAIN, BLADDER DISORDER, CYSTITIS, DEPRESSION, DYSGEUSIA, DYSMENORRHOEA, DYSPAREUNIA, FATIGUE, FURUNCLE, GASTROINTESTINAL DISORDER, HEADACHE, HYPERSENSITIVITY, HYPERTENSION, INFECTION, MENORRHAGIA, MENSTRUAL DISORDER, MIGRAINE, PELVIC PAIN, SKIN DISORDER, TOOTH DISORDER, URINARY TRACT DISORDER, URINARY TRACT INFECTION, VAGINAL HAEMORRHAGE, VAGINAL INFECTION, WEIGHT INCREASED AND DISORDER GASTROINTESTINAL TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: PLAINTIFF RECEIVED TREATMENT FOR PAIN, BLEEDING. INSERTION DETAILS: THE RIGHT TUBAL OSTIA WAS EASILY VISUALIZED. THE ESSURE WAS PLACED WITH FOUR COILS NOTED. LEFT FALLOPIAN TUBAL OSTIA WAS IDENTIFIED. THE SECOND ESSURE CATHETER WAS PLACED WITHOUT DIFFICULTY. THERE WAS ONE TRAILING COIL. REMOVAL DETAILS: PREOPERATIVE DIAGNOSES: MENORRHAGIA AND DYSMENORRHEA. POSTOPERATIVE DIAGNOSES: MENORRHAGIA AND DYSMENORRHEA. HEMORRHAGIC RIGHT OVARIAN CYST. PROCEDURE: TOTAL ABDOMINAL HYSTERECTOMY, BILATERAL SALPINGECTOMY, AND RIGHT OOPHORECTOMY. BOTH ESSURE CATHETERS COULD BE PALPATED IN THE FALLOPIAN TUBE. THERE IS NO PERFORATION OF THE UTERUS FROM THE COILS OR ANY OTHER ABNORMALITIES. OPTED TO PERFORM THE BILATERAL SALPINGECTOMY AT THE COMPLETION OF THE PROCEDURE. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 32.2 KG/SQM. HYSTEROSALPINGOGRAM - ON (B)(6) 2012: RESULTS: TOTAL BILATERAL OCCLUSION. "CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONES WERE DESCRIBED IN PATIENT¿S MEDICAL RECORDS: MENORRHAGIA, DYSMENORRHEA AND PELVIC PAIN." QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. FURTHER COMPANY FOLLOW-UP WITH THE REGULATORY AUTHORITY IS NOT POSSIBLE. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 9-JAN-2020: PIF RECEIVED. REPORTER INFORMATION ADDED. EVENTS OUTCOME WERE UPDATED. 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 PELVIC PAIN ("SEVERE PELVIC PAIN") AND RASH ("RASH") IN A (B)(6) YEAR-OLD FEMALE PATIENT WHO HAD ESSURE INSERTED FOR STERILIZATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. IN 2011, 92 DAYS BEFORE INSERTION OF ESSURE, THE PATIENT EXPERIENCED MENORRHAGIA ("HEAVY PERIODS"). IN (B)(6) 2011, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), RASH (SERIOUSNESS CRITERION DISABILITY), ALOPECIA ("HAIR LOSS"), PAIN IN EXTREMITY ("LEG PAIN"), ABDOMINAL DISTENSION ("BLOATING / BIG BELLY LOOK"), ADVERSE EVENT ("THE LIST GOES ON AND ON"), BACK PAIN ("PAIN IN MY LOWER BACK"), SKIN DISORDER ("SKIN LOOKS AWFUL"), ACNE CYSTIC ("ACNE CYSTS APPEAR ALL OVER AREAS OF MY BODY"), FURUNCLE ("BOILS APPEAR ALL OVER AREAS OF MY BODY"), HYPERTENSION ("HIGH BLOOD PRESSURE"), HYPERSENSITIVITY ("ALLERGIC REACTION"), AMNESIA ("MEMORY LOSS") AND MENSTRUAL DISORDER ("MENSTRUATION ISSUES"). THE PATIENT WAS TREATED WITH SURGERY (UNDERWENT REMOVAL DUE TO COMPLICATIONS FROM THE ESSURE). ESSURE WAS REMOVED. AT THE TIME OF THE REPORT, THE PELVIC PAIN, RASH, ALOPECIA, PAIN IN EXTREMITY, ABDOMINAL DISTENSION, ADVERSE EVENT, MENORRHAGIA, BACK PAIN, SKIN DISORDER, ACNE CYSTIC, FURUNCLE, HYPERTENSION, HYPERSENSITIVITY, AMNESIA AND MENSTRUAL DISORDER OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ACNE CYSTIC, AMNESIA, BACK PAIN, FURUNCLE, HYPERSENSITIVITY, HYPERTENSION, MENORRHAGIA, MENSTRUAL DISORDER, PELVIC PAIN AND SKIN DISORDER TO BE RELATED TO ESSURE. THE REPORTER PROVIDED NO CAUSALITY ASSESSMENT FOR ABDOMINAL DISTENSION, ADVERSE EVENT, ALOPECIA, PAIN IN EXTREMITY AND RASH WITH ESSURE. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): HYSTEROSALPINGOGRAM - ON (B)(6) 2011: ESSURE DEVICE WAS SUCCESSFULLY OCCLUDED. QUALITY-SAFETY EVALUATION OF PTC: FINAL ASSESSMENT: SINCE NO PRODUCT WAS RETURNED TO US FOR INVESTIGATION, WE WERE UNABLE TO PERFORM AN INVESTIGATION OF THE ACTUAL DEVICE INVOLVED IN THIS COMPLAINT. TYPICALLY, WE WOULD INSPECT THE MICRO-INSERT TO CONFIRM THAT ALL PARTS ARE ACCOUNTED FOR AND INSPECT THE DEVICE TO LOOK FOR ANY MANUFACTURING DEFICIENCIES. SINCE WE HAVE NO VALID LOT NUMBER FOR THIS CASE, WE WERE UNABLE TO CONDUCT A REVIEW OF THE MANUFACTURING BATCH RECORD. WE ARE UNABLE TO CONFIRM ANY QUALITY DEFECT OR DEVICE MALFUNCTION AT THIS TIME. MEDICAL ASSESSMENT: THIS PTC WAS INITIATED DUE TO A REQUEST FOR CONFIRMATION OF QUALITY. THE ADVERSE EVENTS CONSIDERED RELATED ARE KNOWN, POSSIBLE, UNDESIRABLE EVENTS AND NOT INDICATIVE OF A QUALITY DEFICIT PER SE. NO BATCH NUMBER WAS REPORTED. WITHOUT THIS INFORMATION, NO BATCH SIGNAL CLUSTER REVIEW IN THE GPV DATABASE FOR A MORE DETAILED STATISTICAL MEDICAL EVALUATION IS POSSIBLE. NO COMPLAINT SAMPLE WAS PROVIDED FOR FURTHER TECHNICAL INVESTIGATION. THE TECHNICAL ASSESSMENT CONCLUDED UNCONFIRMED QUALITY DEFECT. IN SUMMARY, THERE IS NO REASON TO SUSPECT A CAUSAL RELATIONSHIP TO A POTENTIAL QUALITY DEFICIT. FURTHER COMPANY FOLLOW-UP WITH THE REGULATORY AUTHORITY IS NOT POSSIBLE. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON (B)(6) 2017: CASE IS NOW A LEGAL CASE (SUMMONS RECEIVED). NEW EVENTS ADDED: ALLERGIC REACTION, MEMORY LOSS, MENSTRUATION ISSUES AND SEVERE PELVIC PAIN. ESSURE LEGAL MANUFACTURE HAS CHANGED FROM BAYER HEALTHCARE, LLC, MILPITAS TO BAYER PHARMA AG, BERLIN, AND THIS REPORT IS BEING SUBMITTED AS A FOLLOW UP TO A PREVIOUS REPORT SUBMITTED UNDER THE FORMER LEGAL MANUFACTURER. REPORT TYPE [?] INITIAL' INDICATES HERE INITIAL SUBMISSION BY THE NEW LEGAL MANUFACTURER ONLY. 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 |
|---|---|---|---|---|---|---|---|
| 735919 | ESSURE | TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE | HHS | BAYER PHARMA AG | ESS305 | 880425 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 33 YR | Other| R| S | ACETAMINOPHEN| ACETAMINOPHEN| ACETAMINOPHEN| LEVOTHYROXINE| LEVOTHYROXINE| LEVOTHYROXINE| LEVOTHYROXINE| LEVOTHYROXINE| MULTIVITAMINS| MULTIVITAMINS| MULTIVITAMINS [VITAMINS NOS]| MULTIVITAMINS [VITAMINS NOS]| MULTIVITAMINS [VITAMINS NOS]| VITAMIN D| VITAMIN D| VITAMIN D [VITAMIN D NOS]| VITAMIN D [VITAMIN D NOS]| VITAMIN D [VITAMIN D NOS] |