ESSURE
Report
- Report Number
- 2951250-2017-05199
- Event Type
- Injury
- Date Received
- October 20, 2017
- Date of Event
- January 1, 2013
- Report Date
- September 24, 2019
- Manufacturer
- BAYER PHARMA AG
- Product Code
- HHS
- PMA / PMN Number
- P020014
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- OTHER
Narratives
NTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ("PERSISTENT PELVIC PAIN") AND GENITAL HAEMORRHAGE ("ABNORMAL BLEEDING (GENERAL)") IN A 35-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 735707) INSERTED FOR FEMALE STERILIZATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S PAST MEDICAL HISTORY INCLUDED GRAVES' DISEASE, PROLONGED MENSES, CANDIDA VAGINAL AND MENSES IRREGULAR WITH EXCESSIVE BLEEDING. PREVIOUSLY ADMINISTERED PRODUCTS INCLUDED FOR AN UNREPORTED INDICATION: MIRENA. CONCOMITANT PRODUCTS INCLUDED PARACETAMOL (ACETAMINOPHEN). ON (B)(6) 2011, THE PATIENT HAD ESSURE INSERTED. ON (B)(6) 2011, 29 DAYS AFTER INSERTION OF ESSURE, THE PATIENT EXPERIENCED DYSPAREUNIA ("DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE)"). ON (B)(6) 2011, THE PATIENT EXPERIENCED DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING),") AND FATIGUE ("FATIGUE"). ON (B)(6) 2013, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), GENITAL HAEMORRHAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), DEPRESSION ("DEPRESSION") AND ANXIETY ("MENTAL ANGUISH"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED MENSTRUAL DISORDER ("MENSTRUAL BLEEDING"), ABDOMINAL PAIN ("ABDOMINAL PAIN") AND BACK PAIN ("BACK PAIN"). THE PATIENT WAS TREATED WITH SURGERY (HYSTERECTOMY (FULL) AND SALPINGECTOMY (BILATERAL)). ESSURE WAS REMOVED ON (B)(6) 2016. AT THE TIME OF THE REPORT, THE PELVIC PAIN, GENITAL HAEMORRHAGE, DYSMENORRHOEA, ABDOMINAL PAIN AND BACK PAIN WAS RESOLVING AND THE MENSTRUAL DISORDER, DEPRESSION, ANXIETY, DYSPAREUNIA AND FATIGUE OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL PAIN, ANXIETY, BACK PAIN, DEPRESSION, DYSMENORRHOEA, DYSPAREUNIA, FATIGUE, GENITAL HAEMORRHAGE, MENSTRUAL DISORDER AND PELVIC PAIN TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: 3 COILS VISIBLE ON RIGHT SIDE AND 3 VISIBLE ON LEFT SIDE. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): HYSTEROSALPINGOGRAM - ON (B)(6) 2011: TOTAL BILATERAL OCCLUSION ULTRASOUND SCAN - ON (B)(6) 2016: CONSISTENT WITH A FIBROID OR POLYP ON (B)(6) 2011, FINDINGS REVEALED LEFT TUBAL OSTIA SLIGHTLY OBSCURED BY THIN ENDOMETRIUM, BOTH IMPLANTS PLACED WITHOUT DIFFICULTY. 3 COILS VISIBLE ON R AND 3 VISIBLE ON L. ON (B)(6) 2016, PATHOLOGY REVEALED HIGHLY CELLULAR LEIOMYOMA WITH INFARCT-TYPE NECROSIS. CELLULAR LEIOMYOMA (3.5CM). SECRETORY ENDOMETRIUM WITH ENDOMETRIAL POLYP. ADENOMYOSIS. CERVIX WITH NO SIGNIFICANT HISTOPATHOLOGY. FALLOPIAN TUBE WITH NO SIGNIFICANT HISTOPATHOLOGY, RIGHT. FINDINGS REVEALED ABSENT LEFT OVARY AND FALLOPIAN TUBE (APPEARED SURGICALLY ABSENT WITH ADHESIONS BETWEEN THE LEFT ADNEXAL REGION AND PELVIC SIDE WALL). QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 27-SEP-2018: PFS RECEIVED- NEW EVENT DYSMENORRHEA (CRAMPING), DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE), FATIGUE, ABDOMINAL PAIN, BACK PAIN WERE ADDED. OUTCOME OF GENITAL HAEMORRHAGE UPDATE TO RECOVERING / RESOLVING. 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.
SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ("PERSISTENT PELVIC PAIN") AND GENITAL HAEMORRHAGE ("ABNORMAL BLEEDING (GENERAL)") IN AN ADULT FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 735707) INSERTED FOR FEMALE STERILIZATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S PAST MEDICAL HISTORY INCLUDED GRAVES' DISEASE, PROLONGED MENSES, CANDIDA VAGINAL AND MENSES IRREGULAR WITH EXCESSIVE BLEEDING. PREVIOUSLY ADMINISTERED PRODUCTS INCLUDED FOR AN UNREPORTED INDICATION: MIRENA. CONCOMITANT PRODUCTS INCLUDED PARACETAMOL (ACETAMINOPHEN). ON (B)(6) 2011, THE PATIENT HAD ESSURE INSERTED. IN (B)(6) 2013, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), GENITAL HAEMORRHAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), DEPRESSION ("DEPRESSION") AND ANXIETY ("MENTAL ANGUISH"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED MENSTRUAL DISORDER ("MENSTRUAL BLEEDING"). THE PATIENT WAS TREATED WITH SURGERY (HYSTERECTOMY (FULL) AND SALPINGECTOMY (BILATERAL)). ESSURE WAS REMOVED ON (B)(6) 2016. AT THE TIME OF THE REPORT, THE PELVIC PAIN WAS RESOLVING AND THE GENITAL HAEMORRHAGE, MENSTRUAL DISORDER, DEPRESSION AND ANXIETY OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ANXIETY, DEPRESSION, GENITAL HAEMORRHAGE, MENSTRUAL DISORDER AND PELVIC PAIN TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: 3 COILS VISIBLE ON RIGHT SIDE AND 3 VISIBLE ON LEFT SIDE. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): HYSTEROSALPINGOGRAM - ON (B)(6) 2011: ALL WITHIN NORMAL AT 2ND EXAM. ULTRASOUND SCAN - ON (B)(6) 2016: CONSISTENT WITH A FIBROID OR POLYP ON (B)(6) 2011, FINDINGS REVEALED LEFT TUBAL OSTIA SLIGHTLY OBSCURED BY THIN ENDOMETRIUM, BOTH IMPLANTS PLACED WITHOUT DIFFICULTY. 3 COILS VISIBLE ON R AND 3 VISIBLE ON L. ON (B)(6) 2016, PATHOLOGY REVEALED HIGHLY CELLULAR LEIOMYOMA WITH INFARCT-TYPE NECROSIS. CELLULAR LEIOMYOMA (3.5CM). SECRETORY ENDOMETRIUM WITH ENDOMETRIAL POLYP. ADENOMYOSIS. CERVIX WITH NO SIGNIFICANT HISTOPATHOLOGY. FALLOPIAN TUBE WITH NO SIGNIFICANT HISTOPATHOLOGY, RIGHT. FINDINGS REVEALED ABSENT LEFT OVARY AND FALLOPIAN TUBE (APPEARED SURGICALLY ABSENT WITH ADHESIONS BETWEEN THE LEFT ADNEXAL REGION AND PELVIC SIDE WALL). QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON (B)(6) 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 ("PERSISTENT PELVIC PAIN") AND GENITAL HAEMORRHAGE ("ABNORMAL BLEEDING (GENERAL)") IN A FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 735707) INSERTED FOR FEMALE STERILIZATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S PAST MEDICAL HISTORY INCLUDED GRAVES' DISEASE, PROLONGED MENSES, CANDIDA VAGINAL AND GENITAL BLEEDING. PREVIOUSLY ADMINISTERED PRODUCTS INCLUDED FOR AN UNREPORTED INDICATION: MIRENA. CONCOMITANT PRODUCTS INCLUDED PARACETAMOL (ACETAMINOPHEN). ON (B)(6) 2011, THE PATIENT HAD ESSURE INSERTED. IN (B)(6) 2013, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), GENITAL HAEMORRHAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), DEPRESSION ("DEPRESSION") AND ANXIETY ("MENTAL ANGUISH"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED MENSTRUAL DISORDER ("MENSTRUAL BLEEDING"). THE PATIENT WAS TREATED WITH SURGERY (HYSTERECTOMY (FULL) AND SALPINGECTOMY (BILATERAL)). ESSURE WAS REMOVED ON (B)(6) 2016. AT THE TIME OF THE REPORT, THE PELVIC PAIN WAS RESOLVING AND THE MENSTRUAL DISORDER, GENITAL HAEMORRHAGE, DEPRESSION AND ANXIETY OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ANXIETY, DEPRESSION, GENITAL HAEMORRHAGE, MENSTRUAL DISORDER, AND PELVIC PAIN TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: 3 COILS VISIBLE ON RIGHT SIDE AND 3 VISIBLE ON LEFT SIDE. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): HYSTEROSALPINGOGRAM - ON (B)(6) 2011: ALL WITHIN NORMAL AT 2ND EXAM. ULTRASOUND SCAN - ON (B)(6) 2016: CONSISTENT WITH A FIBROID OR POLYP. ON (B)(6) 2011, FINDINGS REVEALED LEFT TUBAL OSTIA SLIGHTLY OBSCURED BY THIN ENDOMETRIUM, BOTH IMPLANTS PLACED WITHOUT DIFFICULTY. 3 COILS VISIBLE ON R AND 3 VISIBLE ON L. ON (B)(6) 2016, PATHOLOGY REVEALED HIGHLY CELLULAR LEIOMYOMA WITH INFARCT-TYPE NECROSIS. CELLULAR LEIOMYOMA (3.5CM). SECRETORY ENDOMETRIUM WITH ENDOMETRIAL POLYP. ADENOMYOSIS. CERVIX WITH NO SIGNIFICANT HISTOPATHOLOGY. FALLOPIAN TUBE WITH NO SIGNIFICANT HISTOPATHOLOGY, RIGHT. FINDINGS REVEALED ABSENT LEFT OVARY AND FALLOPIAN TUBE (APPEARED SURGICALLY ABSENT WITH ADHESIONS BETWEEN THE LEFT ADNEXAL REGION AND PELVIC SIDE WALL). MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON (B)(6) 2018: PFS RECEIVED. NEW EVENTS ADDED- ABNORMAL BLEEDING (GENERAL), DEPRESSION AND MENTAL ANGUISH. EVENT OUTCOME OF PERSISTENT PELVIC PAIN WAS UPDATED AS RECOVERING/RESOLVING. 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 SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ("PERSISTENT PELVIC PAIN") AND GENITAL HAEMORRHAGE ("ABNORMAL BLEEDING (GENERAL)") IN A 39-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO: 735707) INSERTED FOR FEMALE STERILIZATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S MEDICAL HISTORY INCLUDED GRAVES' DISEASE, PROLONGED MENSES, CANDIDA VAGINAL AND MENSES IRREGULAR WITH EXCESSIVE BLEEDING. PREVIOUSLY ADMINISTERED PRODUCTS INCLUDED FOR PREVENT PREGNANCY: MIRENA FROM ON (B)(6) 2009 TO ON (B)(6) 2011. CONCOMITANT PRODUCTS INCLUDED ETHINYLESTRADIOL; ETONOGESTREL (NUVARING) FROM ON (B)(6)2011 FOR CONTRACEPTION AS WELL AS ASCORBIC ACID; CALCIUM GLUCONATE; CALCIUM PANTOTHENATE; CALCIUM PHOSPHATE; CYANOCOBALAMIN; ERGOCALCIFEROL; FERROUS FUMARATE;FOLIC ACID; MAGNESIUM PHOSPHATE; NICOTINAMIDE; PYRIDOXINE HYDROCHLORIDE; RETINOL; RIBOFLAVIN;THIAMINE HYDROCHLORIDE; TOCOPHEROL (VITAMIN 15) SINCE 2016, HYDROCODONE BITARTRATE; PARACETAMOL (NORCO) FROM ON (B)(6) 2010, IBUPROFEN (MOTRIN) AND PARACETAMOL (ACETAMINOPHEN). ON (B)(6) 2011, THE PATIENT HAD ESSURE INSERTED. ON (B)(6) 2011, THE PATIENT EXPERIENCED DYSPAREUNIA ("DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE)"), 29 DAYS AFTER INSERTION OF ESSURE. ON (B)(6) 2011, THE PATIENT EXPERIENCED DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING)") AND FATIGUE ("FATIGUE"). ON (B)(6) 2013, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), GENITAL HAEMORRHAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), DEPRESSION ("PSYCHOLOGICAL OR PSYCHIATRIC PROBLEMS - CONDITIONS: DEPRESSION") AND ANXIETY ("PSYCHOLOGICAL OR PSYCHIATRIC PROBLEMS - CONDITIONS: MENTAL ANGUISH"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED MENSTRUAL DISORDER ("MENSTRUAL BLEEDING"), ABDOMINAL PAIN ("ABDOMINAL PAIN"), BACK PAIN ("BACK PAIN"), VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL)") AND MENORRHAGIA ("MENORRHAGIA"). THE PATIENT WAS TREATED WITH SURGERY (HYSTERECTOMY (FULL) AND SALPINGECTOMY (BILATERAL), DILATION AND CURETTAGE ON (B)(6) 2016). ESSURE WAS REMOVED ON (B)(6) 2016. AT THE TIME OF THE REPORT, THE PELVIC PAIN, GENITAL HAEMORRHAGE, DYSMENORRHOEA, ABDOMINAL PAIN AND BACK PAIN WAS RESOLVING AND THE MENSTRUAL DISORDER, DEPRESSION, ANXIETY, DYSPAREUNIA, FATIGUE, VAGINAL HAEMORRHAGE AND MENORRHAGIA OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL PAIN, ANXIETY, BACK PAIN, DEPRESSION, DYSMENORRHOEA, DYSPAREUNIA, FATIGUE, GENITAL HAEMORRHAGE, MENORRHAGIA, MENSTRUAL DISORDER, PELVIC PAIN AND VAGINAL HAEMORRHAGE TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: 3 COILS VISIBLE ON RIGHT SIDE AND 3 VISIBLE ON LEFT SIDE. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): HYSTEROSALPINGOGRAM: ON (B)(6) 2011: RESULTS: TOTAL BILATERAL OCCLUSION. ULTRASOUND SCAN: ON (B)(6) 2016: RESULTS: CONSISTENT WITH A FIBROID OR POLYP. DIAGNOSTIC RESULTS: ON (B)(6) 2011, FINDINGS REVEALED LEFT TUBAL OSTIA SLIGHTLY OBSCURED BY THIN ENDOMETRIUM, BOTH IMPLANTS PLACED WITHOUT DIFFICULTY. 3 COILS VISIBLE ON R AND 3 VISIBLE ON L. ON (B)(6) 2016, PATHOLOGY REVEALED HIGHLY CELLULAR LEIOMYOMA WITH INFARCT-TYPE NECROSIS. CELLULAR LEIOMYOMA (3.5CM). SECRETORY ENDOMETRIUM WITH ENDOMETRIAL POLYP. ADENOMYOSIS. CERVIX WITH NO SIGNIFICANT HISTOPATHOLOGY. FALLOPIAN TUBE WITH NO SIGNIFICANT HISTOPATHOLOGY, RIGHT. FINDINGS REVEALED ABSENT LEFT OVARY AND FALLOPIAN TUBE (APPEARED SURGICALLY ABSENT WITH ADHESIONS BETWEEN THE LEFT ADNEXAL REGION AND PELVIC SIDE WALL). QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 9-JAN-2019: PFS RECEIVED: PLAINTIFFS DATE OF BIRTH WAS UPDATED. EVENTS: ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA) WERE ADDED. SURGERY WAS ADDED. INDICATION OF HISTORICAL DRUG MIRENA WAS ADDED. CONCOMITANT DRUGS WERE ADDED. REPORTED TERM OF DEPRESSION AND ANXIETY WERE UPDATED. INCIDENT: WE RECEIVED A LOT NUMBER IN THIS CASE. A TECHNICAL INVESTIGATION WILL BE CONDUCTED, INCLUDING A BATCH REVIEW, AND A REVIEW OF COMPLAINT RECORDS AND OTHER NON-CONFORMANCES DATA; SHOULD ANY NEW AND REPORTABLE INFORMATION BECOME AVAILABLE AS A RESULT, THIS WILL BE PROVIDED IN A SUPPLEMENTARY REPORT.
THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ('PERSISTENT PELVIC PAIN') AND GENITAL HAEMORRHAGE ('ABNORMAL BLEEDING (GENERAL)/ GEN. ABNORM. BLEED') IN A 39-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 735707) INSERTED FOR FEMALE STERILIZATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S MEDICAL HISTORY INCLUDED GRAVES' DISEASE, PROLONGED MENSES, CANDIDA VAGINAL AND MENSES IRREGULAR WITH EXCESSIVE BLEEDING. PREVIOUSLY ADMINISTERED PRODUCTS INCLUDED FOR PREVENT PREGNANCY: MIRENA FROM (B)(6) 2009 TO (B)(6) 2011. CONCOMITANT PRODUCTS INCLUDED ETHINYLESTRADIOL;ETONOGESTREL (NUVARING) FROM 3-JUN-2011 TO (B)(6) 2011 FOR CONTRACEPTION AS WELL AS ASCORBIC ACID;CALCIUM GLUCONATE;CALCIUM PANTOTHENATE;CALCIUM PHOSPHATE;CYANOCOBALAMIN;ERGOCALCIFEROL;FERROUS FUMARATE;FOLIC ACID;MAGNESIUM PHOSPHATE;NICOTINAMIDE;PYRIDOXINE HYDROCHLORIDE;RETINOL;RIBOFLAVIN;THIAMINE HYDROCHLORIDE;TOCOPHEROL (VITAMIN 15) SINCE 2016, HYDROCODONE BITARTRATE;PARACETAMOL (NORCO) FROM (B)(6) 2010 TO (B)(6) 2010, IBUPROFEN (MOTRIN) AND PARACETAMOL (ACETAMINOPHEN). ON (B)(6) 2011, THE PATIENT HAD ESSURE INSERTED. ON (B)(6) 2011, THE PATIENT EXPERIENCED DYSPAREUNIA ("DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE)"), 29 DAYS AFTER INSERTION OF ESSURE. ON (B)(6) 2011, THE PATIENT EXPERIENCED DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING)") AND FATIGUE ("FATIGUE"). ON (B)(6) 2013, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), GENITAL HAEMORRHAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), DEPRESSION ("PSYCHOLOGICAL OR PSYCHIATRIC PROBLEMS - CONDITIONS: DEPRESSION") AND ANXIETY ("PSYCHOLOGICAL OR PSYCHIATRIC PROBLEMS - CONDITIONS: MENTAL ANGUISH"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED MENSTRUAL DISORDER ("MENSTRUAL BLEEDING"), ABDOMINAL PAIN ("ABDOMINAL PAIN"), BACK PAIN ("BACK PAIN"), VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL)") AND MENORRHAGIA ("MENORRHAGIA"). THE PATIENT WAS TREATED WITH SURGERY (HYSTERECTOMY (FULL) AND SALPINGECTOMY (BILATERAL), DILATION AND CURETTAGE ON (B)(6) 2016). ESSURE WAS REMOVED ON (B)(6) 2016. AT THE TIME OF THE REPORT, THE PELVIC PAIN, GENITAL HAEMORRHAGE, DYSMENORRHOEA AND ABDOMINAL PAIN HAD RESOLVED, THE MENSTRUAL DISORDER, DEPRESSION, ANXIETY, DYSPAREUNIA, FATIGUE, VAGINAL HAEMORRHAGE AND MENORRHAGIA OUTCOME WAS UNKNOWN AND THE BACK PAIN WAS RESOLVING. THE REPORTER CONSIDERED ABDOMINAL PAIN, ANXIETY, BACK PAIN, DEPRESSION, DYSMENORRHOEA, DYSPAREUNIA, FATIGUE, GENITAL HAEMORRHAGE, MENORRHAGIA, MENSTRUAL DISORDER, PELVIC PAIN AND VAGINAL HAEMORRHAGE TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: 3 COILS VISIBLE ON RIGHT SIDE AND 3 VISIBLE ON LEFT SIDE. PATIENT RECEIVED TREATMENT FOR PELVIC PAIN, ABDOMINAL PAIN, DYSMENORRHEA (CRAMPING), GEN. ABNORM. BLEED DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): HYSTEROSALPINGOGRAM - ON (B)(6) 2011: RESULTS: TOTAL BILATERAL OCCLUSION. ULTRASOUND SCAN - ON (B)(6) 2016: RESULTS: CONSISTENT WITH A FIBROID OR POLYP. DIAGNOSTIC RESULTS: ON (B)(6) 2011, FINDINGS REVEALED LEFT TUBAL OSTIA SLIGHTLY OBSCURED BY THIN ENDOMETRIUM, BOTH IMPLANTS PLACED WITHOUT DIFFICULTY. 3 COILS VISIBLE ON R AND 3 VISIBLE ON L. ON (B)(6) 2016, PATHOLOGY REVEALED HIGHLY CELLULAR LEIOMYOMA WITH INFARCT-TYPE NECROSIS. CELLULAR LEIOMYOMA (3.5CM). SECRETORY ENDOMETRIUM WITH ENDOMETRIAL POLYP. ADENOMYOSIS. CERVIX WITH NO SIGNIFICANT HISTOPATHOLOGY. FALLOPIAN TUBE WITH NO SIGNIFICANT HISTOPATHOLOGY, RIGHT. FINDINGS REVEALED ABSENT LEFT OVARY AND FALLOPIAN TUBE (APPEARED SURGICALLY ABSENT WITH ADHESIONS BETWEEN THE LEFT ADNEXAL REGION AND PELVIC SIDE WALL). QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON (B)(6) 2019: PFS RECEIVED. OUTCOME FOR PRECIOUSLY REPORTED EVENTS -"PELVIC PAIN, ABDOMINAL PAIN, DYSMENORRHEA (CRAMPING), GEN. ABNORM. BLEED" IS UPDATED TO "RECOVERED / RESOLVED" INCIDENT WE RECEIVED A LOT NUMBER IN THIS CASE. A TECHNICAL INVESTIGATION WILL BE CONDUCTED, INCLUDING A BATCH REVIEW, AND A REVIEW OF COMPLAINT RECORDS AND OTHER NON-CONFORMANCES DATA; SHOULD ANY NEW AND REPORTABLE INFORMATION BECOME AVAILABLE AS A RESULT, THIS WILL BE PROVIDED IN A SUPPLEMENTARY REPORT.
THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ("PERSISTENT PELVIC PAIN") IN A FEMALE PATIENT WHO HAD ESSURE INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. ON (B)(6) 2009, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED) AND MENSTRUAL DISORDER ("MENSTRUAL BLEEDING"). THE PATIENT WAS TREATED WITH SURGERY (UNDERWENT PARTIAL HYSTERECTOMY). AT THE TIME OF THE REPORT, THE PELVIC PAIN HAD NOT RESOLVED AND THE MENSTRUAL DISORDER OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED MENSTRUAL DISORDER AND PELVIC PAIN TO BE RELATED TO ESSURE. 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 |
|---|---|---|---|---|---|---|---|
| 744876 | ESSURE | TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE | HHS | BAYER PHARMA AG | ESS305 | 735707 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 39 YR | Other| R | ACETAMINOPHEN| ACETAMINOPHEN| ACETAMINOPHEN| ACETAMINOPHEN| ACETAMINOPHEN| MOTRIN [IBUPROFEN]| MOTRIN [IBUPROFEN]| NORCO| NORCO| NUVARING| NUVARING| VITAMIN 15| VITAMIN 15 |