ESSURE
Report
- Report Number
- 2951250-2019-04321
- Event Type
- Injury
- Date Received
- July 31, 2019
- Date of Event
- February 1, 2012
- Report Date
- April 14, 2021
- Manufacturer
- BAYER PHARMA AG
- Product Code
- HHS
- UDI-DI
- 10888853003051
- PMA / PMN Number
- P020014
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AR, US
- Reporter Occupation
- OTHER
Narratives
THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF DEVICE EXPULSION ('PROXIMAL END OF LEFT COIL ADJ TO ENDOMETRIUM/ESSURE COILS VISABLE WITHIN FUNDUS'), PELVIC INFLAMMATORY DISEASE ('PID(PELVIC INFLAMMATORY DISEASE)'), VAGINAL HAEMORRHAGE ('ABNORMAL BLEEDING (VAGINAL)') AND MENORRHAGIA ('ABNORMAL BLEEDING (MENORRHAGIA)/ABNORMAL MENTSRUAL BLEEDING') IN A 32-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S MEDICAL HISTORY INCLUDED BACTERIAL VAGINOSIS ON (B)(6) 2013, POLYCYSTIC OVARIES ON (B)(6) 2013, SPONTANEOUS ABORTION IN (B)(6) 2010, VAGINAL MUCOSAL DAMAGE, VULVAL CANDIDA, LIGAMENT PAIN, HEADACHE, IRRITABILITY, FAINTING (SYMPTOMS DURING PREGNANCY: OTHER FAINTING SPELLS.), HEAVY PERIODS (EXCESSIVE OR FREQUENT MENSTRUATION), ENDOMETRIAL BIOPSY, UTERINE CRAMPS, BLEEDING MENSTRUAL HEAVY, HYPERTENSION, OBESITY AND URINARY TRACT INFECTION. CONCURRENT CONDITIONS INCLUDED HYPERTENSION SINCE (B)(6). CONCOMITANT PRODUCTS INCLUDED FLUCONAZOLE, MEDROXYPROGESTERONE ACETATE (DEPO PROVERA) SINCE (B)(6) TO (B)(6) 2013 AND METOPROLOL SINCE (B)(6). ON (B)(6) 2012, THE PATIENT HAD ESSURE INSERTED. IN (B)(6) 2012, THE PATIENT EXPERIENCED VAGINAL HAEMORRHAGE (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), MENORRHAGIA (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING)"), ANXIETY ("PSYCHOLOGICAL OR PSYCHIATRIC PROBLEMS CONDITION: MENTAL ANGUISH/ PSYCHOLOGY INJURY") AND DEPRESSION ("PSYCHOLOGICAL OR PSYCHIATRIC PROBLEMS CONDITION: DEPRESSION") AND WAS FOUND TO HAVE WEIGHT INCREASED ("WEIGHT GAIN / LOSS SPECIFY WHICH ONE: WEIGHT GAIN."). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED DEVICE EXPULSION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), PELVIC INFLAMMATORY DISEASE (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), PELVIC PAIN ("PHYSICAL PAIN/PAIN"), VAGINAL INFECTION ("INFECTION (BLADDER/URINARY TRACT/VAGINAL)-TYPE: VAGINAL"), MENSTRUAL DISORDER ("ABNORMAL MENTSRUAL BLEEDING") AND ABDOMINAL PAIN ("ABDOMINAL PAIN"). THE PATIENT WAS TREATED WITH SURGERY (HYSTERECTOMY AND ON (B)(6) 2008 UNDERWENT THERMACHOICE ABLATION). ESSURE TREATMENT WAS ONGOING AT THE TIME OF THE REPORT. AT THE TIME OF THE REPORT, THE DEVICE EXPULSION, PELVIC INFLAMMATORY DISEASE, VAGINAL HAEMORRHAGE, MENORRHAGIA, PELVIC PAIN, DYSMENORRHOEA, ANXIETY, DEPRESSION, WEIGHT INCREASED, VAGINAL INFECTION, MENSTRUAL DISORDER AND ABDOMINAL PAIN OUTCOME WAS UNKNOWN. THE REPORTER PROVIDED NO CAUSALITY ASSESSMENT FOR DEVICE EXPULSION AND PELVIC INFLAMMATORY DISEASE WITH ESSURE. THE REPORTER CONSIDERED ABDOMINAL PAIN, ANXIETY, DEPRESSION, DYSMENORRHOEA, MENORRHAGIA, MENSTRUAL DISORDER, PELVIC PAIN, VAGINAL HAEMORRHAGE, VAGINAL INFECTION AND WEIGHT INCREASED TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: CURRENT WEIGHT 216LBS. PLAINTIFF REPORTED TOOK LEAVE AND THE REASON: DATE LEAVE BEGAN: (B)(6) 2018. DATE LEAVE ENDED: (B)(6) 2018. REASON: HYSTERECTOMY. SHE RECEIVED TREATMENT FOR PSYCHOLOGY INJURY AND WEIGHT GAIN. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 30.8 KG/SQM. HYSTEROSALPINGOGRAM - ON (B)(6) 2012: ESSURE DEVICE WAS SUCCESSFULLY OCCLUDED. PREGNANCY TEST URINE - ON (B)(6) 2012: NEGATIVE. CONCERNING THE INJURIES REPORTED IN THIS CASE THE FOLLOWING EVENTS WERE REPORTED VIA MEDICAL RECORD: DEVICE EXPULSION, PELVIC INFLAMMATORY DISEASE AND EXPULSION DEVICE. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 13-NOV-2019: PFS RECEIVED. EVENT : ABDOMINAL PAIN WERE ADDED. NO LOT NUMBER OR DEVICE SAMPLE WAS RECEIVED IN THIS CASE. AT THIS TIME, WE HAVE NO INFORMATION SUGGESTING THAT THE DEVICE FAILED TO MEET ITS SPECIFICATIONS. WE WILL CONDUCT A REVIEW OF OUR COMPLAINT RECORDS AND OTHER NON-CONFORMANCES DATA; SHOULD ANY NEW AND REPORTABLE INFORMATION BECOME AVAILABLE FROM OUR INVESTIGATION, THIS WILL BE PROVIDED IN A SUPPLEMENTARY REPORT.
THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF DEVICE EXPULSION ('PROXIMAL END OF LEFT COIL ADJ TO ENDOMETRIUM/ESSURE COILS VISABLE WITHIN FUNDUS'), PELVIC INFLAMMATORY DISEASE ('PID(PELVIC INFLAMMATORY DISEASE)'), VAGINAL HAEMORRHAGE ('ABNORMAL BLEEDING (VAGINAL)') AND MENORRHAGIA ('ABNORMAL BLEEDING (MENORRHAGIA)/ABNORMAL MENTSRUAL BLEEDING') IN A (B)(6) FEMALE PATIENT WHO HAD ESSURE INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S MEDICAL HISTORY INCLUDED BACTERIAL VAGINOSIS ON (B)(6) 2013, POLYCYSTIC OVARIES ON (B)(6) 2013, SPONTANEOUS ABORTION IN (B)(6) 2010, VAGINAL MUCOSAL DAMAGE, VULVAL CANDIDA, LIGAMENT PAIN, HEADACHE, IRRITABILITY, FAINTING (SYMPTOMS DURING PREGNANCY: OTHER FAINTING SPELLS.), HEAVY PERIODS (EXCESSIVE OR FREQUENT MENSTRUATION), ENDOMETRIAL BIOPSY, UTERINE CRAMPS, BLEEDING MENSTRUAL HEAVY, HYPERTENSION, OBESITY AND URINARY TRACT INFECTION. CONCURRENT CONDITIONS INCLUDED HYPERTENSION SINCE 2010. CONCOMITANT PRODUCTS INCLUDED FLUCONAZOLE, MEDROXYPROGESTERONE ACETATE (DEPO PROVERA) SINCE 2008 TO (B)(6) 2013 AND METOPROLOL SINCE 2010. ON (B)(6) 2012, THE PATIENT HAD ESSURE INSERTED. IN (B)(6) 2012, THE PATIENT EXPERIENCED VAGINAL HAEMORRHAGE (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), MENORRHAGIA (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING)"), ANXIETY ("PSYCHOLOGICAL OR PSYCHIATRIC PROBLEMS CONDITION: MENTAL ANGUISH/ PSYCHOLOGY INJURY") AND DEPRESSION ("PSYCHOLOGICAL OR PSYCHIATRIC PROBLEMS CONDITION: DEPRESSION") AND WAS FOUND TO HAVE WEIGHT INCREASED ("WEIGHT GAIN / LOSS SPECIFY WHICH ONE: WEIGHT GAIN."). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED DEVICE EXPULSION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), PELVIC INFLAMMATORY DISEASE (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), PELVIC PAIN ("PHYSICAL PAIN/PAIN"), THE FIRST EPISODE OF VAGINAL INFECTION ("INFECTION (BLADDER/URINARY TRACT/VAGINAL)-TYPE: VAGINAL"), MENSTRUAL DISORDER ("ABNORMAL MENTSRUAL BLEEDING"), ABDOMINAL PAIN ("ABDOMINAL PAIN"), GENITAL HAEMORRHAGE ("ABNORMAL BLEEDING"), BLADDER DISORDER ("BLADDER PROBLEM"), URINARY TRACT DISORDER ("URINARY PROBLEM"), CYSTITIS ("BLADDER INFECTION"), URINARY TRACT INFECTION ("UTI"), THE SECOND EPISODE OF VAGINAL INFECTION ("VAGINAL INFECTION") AND VAGINAL DISCHARGE ("VAGINAL DISCHARGE"). THE PATIENT WAS TREATED WITH SURGERY (HYSTERECTOMY AND ON (B)(6) 2008 UNDERWENT THERMACHOICE ABLATION). ESSURE TREATMENT WAS ONGOING AT THE TIME OF THE REPORT. AT THE TIME OF THE REPORT, THE DEVICE EXPULSION, PELVIC INFLAMMATORY DISEASE, VAGINAL HAEMORRHAGE, MENORRHAGIA, PELVIC PAIN, DYSMENORRHOEA, ANXIETY, DEPRESSION, WEIGHT INCREASED, MENSTRUAL DISORDER, ABDOMINAL PAIN, GENITAL HAEMORRHAGE, BLADDER DISORDER, URINARY TRACT DISORDER, CYSTITIS, URINARY TRACT INFECTION, THE LAST EPISODE OF VAGINAL INFECTION AND VAGINAL DISCHARGE OUTCOME WAS UNKNOWN. THE REPORTER PROVIDED NO CAUSALITY ASSESSMENT FOR DEVICE EXPULSION AND PELVIC INFLAMMATORY DISEASE WITH ESSURE. THE REPORTER CONSIDERED ABDOMINAL PAIN, ANXIETY, BLADDER DISORDER, CYSTITIS, DEPRESSION, DYSMENORRHOEA, GENITAL HAEMORRHAGE, MENORRHAGIA, MENSTRUAL DISORDER, PELVIC PAIN, URINARY TRACT DISORDER, URINARY TRACT INFECTION, VAGINAL DISCHARGE, VAGINAL HAEMORRHAGE, WEIGHT INCREASED, THE FIRST EPISODE OF VAGINAL INFECTION AND THE SECOND EPISODE OF VAGINAL INFECTION TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: CURRENT WEIGHT (B)(6) . PLAINTIFF REPORTED TOOK LEAVE AND THE REASON: DATE LEAVE BEGAN: (B)(6) 2018 DATE LEAVE ENDED: (B)(6) 2018 REASON: HYSTERECTOMY. SHE RECEIVED TREATMENT FOR PSYCHOLOGY INJURY AND WEIGHT GAIN. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS (B)(6) . HYSTEROSALPINGOGRAM - ON (B)(6) 2012: ESSURE DEVICE WAS SUCCESSFULLY OCCLUDED. PREGNANCY TEST URINE - ON (B)(6) 2012: NEGATIVE. CONCERNING THE INJURIES REPORTED IN THIS CASE THE FOLLOWING EVENTS WERE REPORTED VIA MEDICAL RECORD: DEVICE EXPULSION, PELVIC INFLAMMATORY DISEASE AND EXPULSION DEVICE. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON (B)(6) 2020: PFS RECEIVED- NEW EVENTS ABNORMAL BLEEDING, BLADDER PROBLEM, URINARY PROBLEM, BLADDER INFECTION, UTI, VAGINAL INFECTION, VAGINAL DISCHARGE WERE ADDED WERE ADDED. BASED ON THE AVAILABLE INFORMATION, A REVIEW OF OUR COMPLAINT RECORDS AND OTHER RELEVANT DATA WAS CONDUCTED; ANY NEW AND REPORTABLE INFORMATION THAT BECOMES AVAILABLE FROM OUR INVESTIGATION WILL BE PROVIDED IN A SUPPLEMENTARY REPORT.
THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF DEVICE EXPULSION ('PROXIMAL END OF LEFT COIL ADJ TO ENDOMETRIUM/ESSURE COILS VISABLE WITHIN FUNDUS'), PELVIC INFLAMMATORY DISEASE ('PID(PELVIC INFLAMMATORY DISEASE)'), VAGINAL HAEMORRHAGE ('ABNORMAL BLEEDING (VAGINAL)') AND MENORRHAGIA ('ABNORMAL BLEEDING (MENORRHAGIA)/ABNORMAL MENTSRUAL BLEEDING') IN A 32-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S MEDICAL HISTORY INCLUDED BACTERIAL VAGINOSIS ON (B)(6) 2013, POLYCYSTIC OVARIES ON (B)(6) 2013, SPONTANEOUS ABORTION IN (B)(6) 2010, VAGINAL MUCOSAL DAMAGE, VULVAL CANDIDA, LIGAMENT PAIN, HEADACHE, IRRITABILITY, FAINTING (SYMPTOMS DURING PREGNANCY: OTHER FAINTING SPELLS.), HEAVY PERIODS (EXCESSIVE OR FREQUENT MENSTRUATION), ENDOMETRIAL BIOPSY, UTERINE CRAMPS, BLEEDING MENSTRUAL HEAVY, HYPERTENSION, OBESITY, URINARY TRACT INFECTION, PENICILLIN ALLERGY, WEIGHT GAIN, POLLEN ALLERGY, SMOKE SENSITIVITY, FIBROIDS, BACTERIAL VAGINOSIS, POLYCYSTIC OVARIES AND FUNGAL INFECTION. CONCURRENT CONDITIONS INCLUDED HYPERTENSION SINCE 2010. CONCOMITANT PRODUCTS INCLUDED FLUCONAZOLE, MEDROXYPROGESTERONE ACETATE (DEPO PROVERA) SINCE 2008 TO (B)(6) 2013 AND METOPROLOL SINCE 2010. ON (B)(6) 2012, THE PATIENT HAD ESSURE INSERTED. IN (B)(6) 2012, THE PATIENT EXPERIENCED VAGINAL HAEMORRHAGE (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), MENORRHAGIA (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING)"), ANXIETY ("PSYCHOLOGICAL OR PSYCHIATRIC PROBLEMS CONDITION: MENTAL ANGUISH/ PSYCHOLOGY INJURY") AND DEPRESSION ("PSYCHOLOGICAL OR PSYCHIATRIC PROBLEMS CONDITION: DEPRESSION") AND WAS FOUND TO HAVE WEIGHT INCREASED ("WEIGHT GAIN / LOSS SPECIFY WHICH ONE: WEIGHT GAIN."). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED DEVICE EXPULSION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), PELVIC INFLAMMATORY DISEASE (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), PELVIC PAIN ("PHYSICAL PAIN/PAIN"), THE FIRST EPISODE OF VAGINAL INFECTION ("INFECTION (BLADDER/URINARY TRACT/VAGINAL)-TYPE: VAGINAL"), MENSTRUAL DISORDER ("ABNORMAL MENTSRUAL BLEEDING"), ABDOMINAL PAIN ("ABDOMINAL PAIN"), GENITAL HAEMORRHAGE ("ABNORMAL BLEEDING"), BLADDER DISORDER ("BLADDER PROBLEM"), URINARY TRACT DISORDER ("URINARY PROBLEM"), CYSTITIS ("BLADDER INFECTION"), URINARY TRACT INFECTION ("UTI"), THE SECOND EPISODE OF VAGINAL INFECTION ("VAGINAL INFECTION") AND VAGINAL DISCHARGE ("VAGINAL DISCHARGE"). THE PATIENT WAS TREATED WITH SURGERY (ON (B)(6) 2008 UNDERWENT THERMACHOICE ABLATION AND TOTAL LAPAROSCOPIC HYSTERECTOMY AND BILATERAL SALPINGECTOMY WITH DA VINCI ROBOTIC ASSISTANCE). ESSURE WAS REMOVED ON (B)(6) 2018. AT THE TIME OF THE REPORT, THE DEVICE EXPULSION, PELVIC INFLAMMATORY DISEASE, VAGINAL HAEMORRHAGE, MENORRHAGIA, PELVIC PAIN, DYSMENORRHOEA, ANXIETY, DEPRESSION, WEIGHT INCREASED, MENSTRUAL DISORDER, ABDOMINAL PAIN, GENITAL HAEMORRHAGE, BLADDER DISORDER, URINARY TRACT DISORDER, CYSTITIS, URINARY TRACT INFECTION, THE LAST EPISODE OF VAGINAL INFECTION AND VAGINAL DISCHARGE OUTCOME WAS UNKNOWN. THE REPORTER PROVIDED NO CAUSALITY ASSESSMENT FOR DEVICE EXPULSION AND PELVIC INFLAMMATORY DISEASE WITH ESSURE. THE REPORTER CONSIDERED ABDOMINAL PAIN, ANXIETY, BLADDER DISORDER, CYSTITIS, DEPRESSION, DYSMENORRHOEA, GENITAL HAEMORRHAGE, MENORRHAGIA, MENSTRUAL DISORDER, PELVIC PAIN, URINARY TRACT DISORDER, URINARY TRACT INFECTION, VAGINAL DISCHARGE, VAGINAL HAEMORRHAGE, WEIGHT INCREASED, THE FIRST EPISODE OF VAGINAL INFECTION AND THE SECOND EPISODE OF VAGINAL INFECTION TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: 04 ON LEFT CORNUA AND 03 ON RIGHT CORNUA CURRENT WEIGHT 216LBS. PLAINTIFF REPORTED TOOK LEAVE AND THE REASON: DATE LEAVE BEGAN: (B)(6) 2018. DATE LEAVE ENDED: (B)(6) 2018. REASON: HYSTERECTOMY. SHE RECEIVED TREATMENT FOR PSYCHOLOGY INJURY AND WEIGHT GAIN. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 30.8 KG/SQM. HYSTEROSALPINGOGRAM - ON (B)(6) 2012: ESSURE DEVICE WAS SUCCESSFULLY OCCLUDED. PREGNANCY TEST URINE - ON (B)(6) 2012: NEGATIVE. CONCERNING THE INJURIES REPORTED IN THIS CASE THE FOLLOWING EVENTS WERE REPORTED VIA MEDICAL RECORD: DEVICE EXPULSION, PELVIC INFLAMMATORY DISEASE AND EXPULSION DEVICE. QUALITY-SAFETY EVALUATION OF PTC: NO DEFECT COULD BE CONFIRMED BY THE MANUFACTURER. ALL PRODUCT BATCHES HAVE MET THE SPECIFICATIONS REGARDING LABELING, MATERIAL, AND PROCESS CONTROLS AT TIME OF RELEASE. 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 AND BATCH RECORD REVIEW COULD NOT BE CONDUCTED, AS NO SAMPLE OR BATCH NUMBER WERE AVAILABLE. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 14-APR-2021: QUALITY SAFETY EVALUATION OF PTC. BASED ON THE AVAILABLE INFORMATION, A REVIEW OF OUR COMPLAINT RECORDS AND OTHER RELEVANT DATA WAS CONDUCTED; ANY NEW AND REPORTABLE INFORMATION THAT BECOMES AVAILABLE FROM OUR INVESTIGATION WILL BE PROVIDED IN A SUPPLEMENTARY REPORT.
THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER, AND DESCRIBES THE OCCURRENCE OF DEVICE EXPULSION ('PROXIMAL END OF LEFT COIL ADJ TO ENDOMETRIUM/ESSURE COILS VISABLE WITHIN FUNDUS'), PELVIC INFLAMMATORY DISEASE ('PID(PELVIC INFLAMMATORY DISEASE)'), VAGINAL HAEMORRHAGE ('ABNORMAL BLEEDING (VAGINAL)') AND MENORRHAGIA ('ABNORMAL BLEEDING (MENORRHAGIA)/ABNORMAL MENSTRUAL BLEEDING'). IN A 32-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S MEDICAL HISTORY INCLUDED: BACTERIAL VAGINOSIS ON (B)(6) 2013, POLYCYSTIC OVARIES ON (B)(6) 2013, SPONTANEOUS ABORTION IN (B)(6) 2010, VAGINAL MUCOSAL DAMAGE, VULVAL CANDIDA, LIGAMENT PAIN, HEADACHE, IRRITABILITY, FAINTING (SYMPTOMS DURING PREGNANCY: OTHER FAINTING SPELLS), HEAVY PERIODS (EXCESSIVE OR FREQUENT MENSTRUATION), ENDOMETRIAL BIOPSY, UTERINE CRAMPS, BLEEDING MENSTRUAL HEAVY, HYPERTENSION, OBESITY, URINARY TRACT INFECTION, PENICILLIN ALLERGY, WEIGHT GAIN, POLLEN ALLERGY, SMOKE SENSITIVITY, FIBROIDS, BACTERIAL VAGINOSIS, POLYCYSTIC OVARIES AND FUNGAL INFECTION. CONCURRENT CONDITIONS INCLUDED: HYPERTENSION SINCE 2010. CONCOMITANT PRODUCTS INCLUDED: FLUCONAZOLE, MEDROXYPROGESTERONE ACETATE (DEPO PROVERA) SINCE 2008 TO (B)(6) 2013 AND METOPROLOL SINCE 2010. ON (B)(6) 2012, THE PATIENT HAD ESSURE INSERTED. IN (B)(6) 2012, THE PATIENT EXPERIENCED VAGINAL HAEMORRHAGE (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), MENORRHAGIA (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING)"), ANXIETY ("PSYCHOLOGICAL OR PSYCHIATRIC PROBLEMS, CONDITION: MENTAL ANGUISH/PSYCHOLOGY INJURY") AND DEPRESSION ("PSYCHOLOGICAL OR PSYCHIATRIC PROBLEMS, CONDITION: DEPRESSION"). AND WAS FOUND TO HAVE WEIGHT INCREASED ("WEIGHT GAIN/LOSS, SPECIFY WHICH ONE: WEIGHT GAIN"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED DEVICE EXPULSION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), PELVIC INFLAMMATORY DISEASE (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), PELVIC PAIN ("PHYSICAL PAIN/PAIN"). THE FIRST EPISODE OF VAGINAL INFECTION ("INFECTION (BLADDER/URINARY TRACT/VAGINAL),TYPE: VAGINAL"), MENSTRUAL DISORDER ("ABNORMAL MENSTRUAL BLEEDING"), ABDOMINAL PAIN ("ABDOMINAL PAIN"), GENITAL HAEMORRHAGE ("ABNORMAL BLEEDING"), BLADDER DISORDER ("BLADDER PROBLEM"), URINARY TRACT DISORDER ("URINARY PROBLEM"), CYSTITIS ("BLADDER INFECTION"), URINARY TRACT INFECTION ("UTI"). THE SECOND EPISODE OF VAGINAL INFECTION ("VAGINAL INFECTION") AND VAGINAL DISCHARGE ("VAGINAL DISCHARGE"). THE PATIENT WAS TREATED WITH SURGERY (ON (B)(6) 2008 UNDERWENT THERMACHOICE ABLATION AND TOTAL LAPAROSCOPIC HYSTERECTOMY, AND BILATERAL SALPINGECTOMY WITH DA VINCI ROBOTIC ASSISTANCE). ESSURE WAS REMOVED ON (B)(6) 2018. AT THE TIME OF THE REPORT, THE DEVICE EXPULSION, PELVIC INFLAMMATORY DISEASE, VAGINAL HAEMORRHAGE, MENORRHAGIA, PELVIC PAIN, DYSMENORRHOEA, ANXIETY, DEPRESSION, WEIGHT INCREASED, MENSTRUAL DISORDER, ABDOMINAL PAIN, GENITAL HAEMORRHAGE, BLADDER DISORDER, URINARY TRACT DISORDER, CYSTITIS, URINARY TRACT INFECTION, THE LAST EPISODE OF VAGINAL INFECTION AND VAGINAL DISCHARGE OUTCOME WAS UNKNOWN. THE REPORTER PROVIDED NO CAUSALITY ASSESSMENT FOR DEVICE EXPULSION AND PELVIC INFLAMMATORY DISEASE WITH ESSURE. THE REPORTER CONSIDERED ABDOMINAL PAIN, ANXIETY, BLADDER DISORDER, CYSTITIS, DEPRESSION, DYSMENORRHOEA, GENITAL HAEMORRHAGE, MENORRHAGIA, MENSTRUAL DISORDER, PELVIC PAIN, URINARY TRACT DISORDER, URINARY TRACT INFECTION, VAGINAL DISCHARGE, VAGINAL HAEMORRHAGE, WEIGHT INCREASED, THE FIRST EPISODE OF VAGINAL INFECTION AND THE SECOND EPISODE OF VAGINAL INFECTION TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: 04 ON LEFT CORNUA AND 03 ON RIGHT CORNUA. CURRENT WEIGHT: 216 LBS. PLAINTIFF REPORTED TOOK LEAVE AND THE REASON: DATE LEAVE BEGAN: (B)(6) 2018; DATE LEAVE ENDED: (B)(6) 2018. REASON: HYSTERECTOMY. SHE RECEIVED TREATMENT FOR PSYCHOLOGY INJURY AND WEIGHT GAIN. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS: INDEX WAS 30.8 KG/SQM. HYSTEROSALPINGOGRAM: ON (B)(6) 2012, ESSURE DEVICE WAS SUCCESSFULLY OCCLUDED. PREGNANCY TEST URINE: ON (B)(6) 2012, NEGATIVE. CONCERNING THE INJURIES REPORTED IN THIS CASE THE FOLLOWING EVENTS WERE REPORTED VIA MEDICAL RECORD: DEVICE EXPULSION, PELVIC INFLAMMATORY DISEASE AND EXPULSION DEVICE. QUALITY SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON (B)(6) 2021, MR RECEIVED: MEDICAL HISTORY, ESSURE REMOVAL DATE AND RCC ADDED. BASED ON THE AVAILABLE INFORMATION. A REVIEW OF OUR COMPLAINT RECORDS AND OTHER RELEVANT DATA WAS CONDUCTED. ANY NEW AND REPORTABLE INFORMATION THAT BECOMES AVAILABLE FROM OUR INVESTIGATION, WILL BE PROVIDED IN A SUPPLEMENTARY REPORT.
THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF DEVICE EXPULSION ('PROXIMAL END OF LEFT COIL ADJ TO ENDOMETRIUM/ESSURE COILS VISABLE WITHIN FUNDUS'), PELVIC INFLAMMATORY DISEASE ('PID (PELVIC INFLAMMATORY DISEASE)'), VAGINAL HAEMORRHAGE ('ABNORMAL BLEEDING (VAGINAL)') AND MENORRHAGIA ('ABNORMAL BLEEDING (MENORRHAGIA)/ABNORMAL MENSTRUAL BLEEDING') IN A (B)(6) YEAR-OLD FEMALE PATIENT WHO HAD ESSURE INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S MEDICAL HISTORY INCLUDED BACTERIAL VAGINOSIS ON (B)(6) 2013, POLYCYSTIC OVARIES ON (B)(6) 2013, SPONTANEOUS ABORTION IN (B)(6) 2010, VAGINAL MUCOSAL DAMAGE, VULVAL CANDIDA, LIGAMENT PAIN, HEADACHE, IRRITABILITY, FAINTING (SYMPTOMS DURING PREGNANCY: OTHER FAINTING SPELLS.), HEAVY PERIODS (EXCESSIVE OR FREQUENT MENSTRUATION), ENDOMETRIAL BIOPSY, UTERINE CRAMPS, BLEEDING MENSTRUAL HEAVY, HYPERTENSION, OBESITY AND URINARY TRACT INFECTION. CONCURRENT CONDITIONS INCLUDED HYPERTENSION SINCE 2010. CONCOMITANT PRODUCTS INCLUDED FLUCONAZOLE, MEDROXYPROGESTERONE ACETATE (DEPO PROVERA) SINCE 2008 TO (B)(6) 2013 AND METOPROLOL SINCE 2010. ON (B)(6) 2012, THE PATIENT HAD ESSURE INSERTED. IN (B)(6) 2012, THE PATIENT EXPERIENCED VAGINAL HAEMORRHAGE (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), MENORRHAGIA (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING)"), ANXIETY ("PSYCHOLOGICAL OR PSYCHIATRIC PROBLEMS CONDITION: MENTAL ANGUISH,") AND DEPRESSION ("PSYCHOLOGICAL OR PSYCHIATRIC PROBLEMS CONDITION: DEPRESSION") AND WAS FOUND TO HAVE WEIGHT INCREASED ("WEIGHT GAIN / LOSS SPECIFY WHICH ONE: WEIGHT GAIN."). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED DEVICE EXPULSION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), PELVIC INFLAMMATORY DISEASE (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), PELVIC PAIN ("PHYSICAL PAIN/PAIN"), VAGINAL INFECTION ("INFECTION (BLADDER/URINARY TRACT/VAGINAL)-TYPE: VAGINAL") AND MENSTRUAL DISORDER ("ABNORMAL MENSTRUAL BLEEDING"). THE PATIENT WAS TREATED WITH SURGERY (HYSTERECTOMY AND ON (B)(6) 2008 UNDERWENT THERMACHOICE ABLATION). ESSURE TREATMENT WAS ONGOING AT THE TIME OF THE REPORT. AT THE TIME OF THE REPORT, THE DEVICE EXPULSION, PELVIC INFLAMMATORY DISEASE, VAGINAL HAEMORRHAGE, MENORRHAGIA, PELVIC PAIN, DYSMENORRHOEA, ANXIETY, DEPRESSION, WEIGHT INCREASED, VAGINAL INFECTION AND MENSTRUAL DISORDER OUTCOME WAS UNKNOWN. THE REPORTER PROVIDED NO CAUSALITY ASSESSMENT FOR DEVICE EXPULSION AND PELVIC INFLAMMATORY DISEASE WITH ESSURE. THE REPORTER CONSIDERED ANXIETY, DEPRESSION, DYSMENORRHOEA, MENORRHAGIA, MENSTRUAL DISORDER, PELVIC PAIN, VAGINAL HAEMORRHAGE, VAGINAL INFECTION AND WEIGHT INCREASED TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: CURRENT WEIGHT (B)(6) LBS. PLAINTIFF REPORTED TOOK LEAVE AND THE REASON: DATE LEAVE BEGAN: (B)(6) 2018, DATE LEAVE ENDED: (B)(6) 2018. REASON: HYSTERECTOMY. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 30.8 KG/SQM. HYSTEROSALPINGOGRAM - ON (B)(6) 2012: ESSURE DEVICE WAS SUCCESSFULLY OCCLUDED. PREGNANCY TEST URINE - ON (B)(6) 2012: NEGATIVE. CONCERNING THE INJURIES REPORTED IN THIS CASE THE FOLLOWING EVENTS WERE REPORTED VIA MEDICAL RECORD: DEVICE EXPULSION, PELVIC INFLAMMATORY DISEASE AND EXPULSION DEVICE. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 24-JUL-2019: PFS AND MR RECEIVED: EVENT ¿ ¿ABNORMAL BLEEDING (VAGINAL), ABNORMAL BLEEDING (MENORRHAGIA), DYSMENORRHEA (CRAMPING), PSYCHOLOGICAL OR PSYCHIATRIC PROBLEMS CONDITION: DEPRESSION , PSYCHOLOGICAL OR PSYCHIATRIC PROBLEMS CONDITION: MENTAL ANGUISH, WEIGHT GAIN / LOSS SPECIFY WHICH ONE: WEIGHT GAIN, PELVIC INFLAMMATORY DISEASE, ESSURE COIL VISIBLE WITHIN FUNDUS AND PROXIMAL END OF LEFT COIL ADJ TO ENDOMETRIUM¿ AND ABNORMAL MENSTRUAL BLEEDING, PATIENT DEMOGRAPHIC, CONCOMITANT DRUG AND MEDICAL HISTORY ADDED WERE ADDED. INCIDENT: NO LOT NUMBER OR DEVICE SAMPLE WAS RECEIVED IN THIS CASE. AT THIS TIME, WE HAVE NO INFORMATION SUGGESTING THAT THE DEVICE FAILED TO MEET ITS SPECIFICATIONS. WE WILL CONDUCT A REVIEW OF OUR COMPLAINT RECORDS AND OTHER NON-CONFORMANCE'S DATA; SHOULD ANY NEW AND REPORTABLE INFORMATION BECOME AVAILABLE FROM OUR INVESTIGATION, THIS WILL BE PROVIDED IN A SUPPLEMENTARY REPORT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 640671 | ESSURE | TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE | HHS | BAYER PHARMA AG | ESS305 | 10888853003051 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 32 YR | Other| R | DEPO PROVERA| DEPO PROVERA| DEPO PROVERA| DEPO PROVERA| DEPO PROVERA| FLUCONAZOLE| FLUCONAZOLE| FLUCONAZOLE| FLUCONAZOLE| FLUCONAZOLE| METOPROLOL| METOPROLOL| METOPROLOL| METOPROLOL| METOPROLOL| DEPO PROVERA| FLUCONAZOLE| METOPROLOL |