ESSURE
Report
- Report Number
- 2951250-2016-02773
- Event Type
- Injury
- Date Received
- December 22, 2016
- Date of Event
- April 1, 2014
- Report Date
- December 17, 2018
- Manufacturer
- BAYER PHARMA AG
- Product Code
- HHS
- PMA / PMN Number
- P020014
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- OTHER
Narratives
NTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF DEVICE EXPULSION ("MIGRATION/MALPOSITION OF ESSURE DEVICE - LOCATION OF DEVICE: UTERINE CAVITY"), PELVIC PAIN ("LOWER LEFT-SIDED PELVIC PAIN / PELVIC PAIN (SEVERE)") AND UTERINE HAEMORRHAGE ("ABNORMAL UTERINE BLEEDING") IN AN ADULT FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 8882479-INVALID) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. OTHER PRODUCT OR PRODUCT USE ISSUES IDENTIFIED: DEVICE DIFFICULT TO USE "DIFFICULTY WITH INSERTING COILS IN LEFT TUBE". THE PATIENT'S PAST MEDICAL HISTORY INCLUDED MULTIGRAVIDA, PARITY 3 (((B)(6) 2003, (B)(6) 2012, (B)(6)2010)), GALLBLADDER DISORDER (SURGERY AND MEDICATION) FROM 2009 TO 2010, ANXIETY IN 2007 AND DEPRESSION IN 2007. PREVIOUSLY ADMINISTERED PRODUCTS INCLUDED FOR BIRTH CONTROL: DEPO-PROVERA FROM 2009 TO 2014; FOR AN UNREPORTED INDICATION: ADOXA FROM 2007 TO (B)(6) 2018, MOTRIN IN 2009, ADVIL IN 2009 AND NORCO. CONCURRENT CONDITIONS INCLUDED OBESITY, DIZZINESS, WEIGHT LOSS, STRESS, TOBACCO USER, NONSMOKER, CHILLS, HOT FLASHES, BLOATING, NAUSEA AND VOMITING. CONCOMITANT PRODUCTS INCLUDED IBUPROFEN FROM 2014 TO 2015. ON (B)(6) 2014, THE PATIENT HAD ESSURE INSERTED. IN (B)(6) 2014, THE PATIENT EXPERIENCED DEVICE EXPULSION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), ABDOMINAL PAIN ("ABDOMINAL PAIN"), VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL,MENORRHAGIA)"), MENORRHAGIA ("ABNORMAL BLEEDING (VAGINAL,MENORRHAGIA)"), DYSPAREUNIA ("DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE)"), WEIGHT INCREASED ("WEIGHT GAIN") AND DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING)"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED UTERINE HAEMORRHAGE (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), CONSTIPATION ("CONSTIPATION"), MENSTRUAL DISORDER ("DISORDER OF MENSTRUATION ABNORMAL BLEEDING"), ANXIETY ("ANXIETY"), DEPRESSION ("DEPRESSION") AND COMPLICATION ASSOCIATED WITH DEVICE ("MECHANICAL COMPLICATION OF INTRAUTERINE CONTRACEPTIVE DEVICE"). THE PATIENT WAS TREATED WITH SURGERY (LAPAROSCOPIC BILATERAL SALPINGECTOMY, HYSTEROSCOPIC SURGICAL REMOVAL OF COIL), SURGERY (LAPAROSCOPIC BILATERAL SALPINGECTOMY, HYSTEROSCOPIC SURGICAL REMOVAL OF COIL) AND SURGERY (LAPAROSCOPIC BILATERAL SALPINGECTOMY, HYSTEROSCOPIC SURGICAL REMOVAL OF COIL). ESSURE WAS REMOVED ON (B)(6) 2015. AT THE TIME OF THE REPORT, THE DEVICE EXPULSION, UTERINE HAEMORRHAGE, ABDOMINAL PAIN, VAGINAL HAEMORRHAGE, MENORRHAGIA, DYSPAREUNIA, WEIGHT INCREASED, DYSMENORRHOEA, CONSTIPATION, MENSTRUAL DISORDER AND COMPLICATION ASSOCIATED WITH DEVICE OUTCOME WAS UNKNOWN, THE PELVIC PAIN HAD RESOLVED AND THE ANXIETY AND DEPRESSION HAD NOT RESOLVED. THE REPORTER CONSIDERED ABDOMINAL PAIN, ANXIETY, COMPLICATION ASSOCIATED WITH DEVICE, CONSTIPATION, DEPRESSION, DEVICE EXPULSION, DYSMENORRHOEA, DYSPAREUNIA, MENORRHAGIA, MENSTRUAL DISORDER, PELVIC PAIN, UTERINE HAEMORRHAGE, VAGINAL HAEMORRHAGE AND WEIGHT INCREASED TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: BILATERAL ESSURE CHOLECYSTECTOMY. BILATERAL ESSURE CONTRACEPTIVE COILS NOTED. THE LEFT SIDED COIL PARTIALLY EXTENDS IN TO THE ENDOMETRIAL CAVITY WITH ENDOMETRIAL CUL-DE-SAC HEMORRHAGE. THE LEFT TUBE INSERTION WAS INCOMPLETE AND THE MLORO INSERT IS HANGING IN THE UTERINE CAVITY. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 36.7 KG/SQM. ¿CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONES WERE DESCRIBED IN PATIENT¿S MEDICAL RECORDS:DEVICE EXPULSION AND EVENT UTERINE HAEMORRHAGE CONFIRMING EVENTS VAGINAL HAEMORRHAGE & MENORRHAGIA ". MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 20-AUG-2018: QUALITY SAFETY EVALUATION OF PRODUCT TECHNICAL COMPLAINT. FU PTC DECLINED BY QA (NO VALID BATCH, NO NEW PTC INFORMATION) INCIDENT NO VALID 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.
THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF DEVICE EXPULSION ("MIGRATION/MALPOSITION OF ESSURE DEVICE - LOCATION OF DEVICE: UTERINE CAVITY"), PELVIC PAIN ("LOWER LEFT-SIDED PELVIC PAIN / PELVIC PAIN (SEVERE)") AND UTERINE HAEMORRHAGE ("ABNORMAL UTERINE BLEEDING") IN AN ADULT FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 8882479,882479-INV) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. OTHER PRODUCT OR PRODUCT USE ISSUES IDENTIFIED: DEVICE DIFFICULT TO USE "DIFFICULTY WITH INSERTING COILS IN LEFT TUBE". THE PATIENT'S MEDICAL HISTORY INCLUDED MULTIGRAVIDA, PARITY 3 (((B)(6) 2003, (B)(6) 2012, (B)(6) 2010)) AND GALLBLADDER DISORDER (SURGERY AND MEDICATION) FROM 2009 TO 2010. PREVIOUSLY ADMINISTERED PRODUCTS INCLUDED FOR BIRTH CONTROL: DEPO-PROVERA FROM 2009 TO 2014; FOR AN UNREPORTED INDICATION: ADOXA FROM 2007 TO (B)(6) 2018, MOTRIN, ADVIL AND NORCO. CONCURRENT CONDITIONS INCLUDED OBESITY, DIZZINESS, WEIGHT LOSS, STRESS, TOBACCO USER, NONSMOKER, CHILLS, HOT FLASHES, BLOATING, NAUSEA, VOMITING, ANXIETY SINCE 2007 AND DEPRESSION SINCE 2007. CONCOMITANT PRODUCTS INCLUDED IBUPROFEN FROM 2014 TO 2015. ON (B)(6) 2014, THE PATIENT HAD ESSURE INSERTED. IN (B)(6) 2014, THE PATIENT EXPERIENCED DEVICE EXPULSION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), ABDOMINAL PAIN ("ABDOMINAL PAIN"), VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL,MENORRHAGIA)"), MENORRHAGIA ("ABNORMAL BLEEDING (VAGINAL,MENORRHAGIA)"), DYSPAREUNIA ("DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE)") AND DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING)") AND WAS FOUND TO HAVE WEIGHT INCREASED ("WEIGHT GAIN"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED UTERINE HAEMORRHAGE (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), CONSTIPATION ("CONSTIPATION"), MENSTRUAL DISORDER ("DISORDER OF MENSTRUATION ABNORMAL BLEEDING"), ANXIETY ("ANXIETY"), DEPRESSION ("DEPRESSION") AND COMPLICATION ASSOCIATED WITH DEVICE ("MECHANICAL COMPLICATION OF INTRAUTERINE CONTRACEPTIVE DEVICE"). THE PATIENT WAS TREATED WITH MEDICATION AND POSSIBLE SLEEVE SURGERY AND SURGERY (LAPAROSCOPIC BILATERAL SALPINGECTOMY, HYSTEROSCOPIC SURGICAL REMOVAL OF COIL). ESSURE WAS REMOVED ON (B)(6) 2015. AT THE TIME OF THE REPORT, THE DEVICE EXPULSION, UTERINE HAEMORRHAGE, ABDOMINAL PAIN, VAGINAL HAEMORRHAGE, MENORRHAGIA, DYSPAREUNIA, WEIGHT INCREASED, DYSMENORRHOEA, CONSTIPATION, MENSTRUAL DISORDER AND COMPLICATION ASSOCIATED WITH DEVICE OUTCOME WAS UNKNOWN, THE PELVIC PAIN HAD RESOLVED AND THE ANXIETY AND DEPRESSION HAD NOT RESOLVED. THE REPORTER CONSIDERED ABDOMINAL PAIN, ANXIETY, COMPLICATION ASSOCIATED WITH DEVICE, CONSTIPATION, DEPRESSION, DEVICE EXPULSION, DYSMENORRHOEA, DYSPAREUNIA, MENORRHAGIA, MENSTRUAL DISORDER, PELVIC PAIN, UTERINE HAEMORRHAGE, VAGINAL HAEMORRHAGE AND WEIGHT INCREASED TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: BILATERAL ESSURE CHOLECYSTECTOMY. BILATERAL ESSURE CONTRACEPTIVE COILS NOTED. THE LEFT SIDED COIL PARTIALLY EXTENDS IN TO THE ENDOMETRIAL CAVITY WITH ENDOMETRIAL CUL-DE-SAC HEMORRHAGE. THE LEFT TUBE INSERTION WAS INCOMPLETE AND THE MLORO INSERT IS HANGING IN THE UTERINE CAVITY. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 36.7 KG/SQM. ¿CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONES WERE DESCRIBED IN PATIENT¿S MEDICAL RECORDS:DEVICE EXPULSION AND EVENT UTERINE HAEMORRHAGE CONFIRMING EVENTS VAGINAL HAEMORRHAGE & MENORRHAGIA ". LOT NUMBERS 8882479 AND 882479 ARE INVALID. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 29-NOV-2018: UPDATE OF INFORMATION (BATCH IS INVALID). 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-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 ("MIGRATION/MALPOSITION OF ESSURE DEVICE - LOCATION OF DEVICE: UTERINE CAVITY"), PELVIC PAIN ("LOWER LEFT-SIDED PELVIC PAIN / PELVIC PAIN (SEVERE)") AND UTERINE HAEMORRHAGE ("ABNORMAL UTERINE BLEEDING") IN AN ADULT FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 8882479) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. OTHER PRODUCT OR PRODUCT USE ISSUES IDENTIFIED: DEVICE DIFFICULT TO USE "DIFFICULTY WITH INSERTING COILS IN LEFT TUBE". THE PATIENT'S PAST MEDICAL HISTORY INCLUDED GRAVIDA II, PARITY 3 (((B)(6) 2003, (B)(6) 2012, (B)(6) 2010)), GALLBLADDER DISORDER (SURGERY AND MEDICATION) FROM 2009 TO 2010, ANXIETY IN 2007 AND DEPRESSION IN 2007. PREVIOUSLY ADMINISTERED PRODUCTS INCLUDED FOR BIRTH CONTROL: DEPO-PROVERA FROM 2009 TO 2014; FOR AN UNREPORTED INDICATION: ADOXA FROM 2007 TO (B)(6) 2018, MOTRIN IN 2009, ADVIL IN 2009 AND NORCO. CONCURRENT CONDITIONS INCLUDED OBESITY, DIZZINESS, WEIGHT LOSS, STRESS, TOBACCO USER, NONSMOKER, CHILLS, HOT FLASHES, BLOATING, NAUSEA AND VOMITING. CONCOMITANT PRODUCTS INCLUDED IBUPROFEN FROM 2014 TO 2015. ON (B)(6) 2014, THE PATIENT HAD ESSURE INSERTED. IN (B)(6) 2014, THE PATIENT EXPERIENCED DEVICE EXPULSION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), ABDOMINAL PAIN ("ABDOMINAL PAIN"), VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL,MENORRHAGIA)"), MENORRHAGIA ("ABNORMAL BLEEDING (VAGINAL,MENORRHAGIA)"), DYSPAREUNIA ("DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE)"), WEIGHT INCREASED ("WEIGHT GAIN") AND DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING)"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED UTERINE HAEMORRHAGE (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), CONSTIPATION ("CONSTIPATION"), MENSTRUAL DISORDER ("DISORDER OF MENSTRUATION ABNORMAL BLEEDING"), ANXIETY ("ANXIETY"), DEPRESSION ("DEPRESSION") AND COMPLICATION ASSOCIATED WITH DEVICE ("MECHANICAL COMPLICATION OF INTRAUTERINE CONTRACEPTIVE DEVICE"). THE PATIENT WAS TREATED WITH SURGERY (LAPAROSCOPIC BILATERAL SALPINGECTOMY, HYSTEROSCOPIC SURGICAL REMOVAL OF COIL). ESSURE WAS REMOVED ON (B)(6) 2015. AT THE TIME OF THE REPORT, THE DEVICE EXPULSION, UTERINE HAEMORRHAGE, ABDOMINAL PAIN, VAGINAL HAEMORRHAGE, MENORRHAGIA, DYSPAREUNIA, WEIGHT INCREASED, DYSMENORRHOEA, CONSTIPATION, MENSTRUAL DISORDER AND COMPLICATION ASSOCIATED WITH DEVICE OUTCOME WAS UNKNOWN, THE PELVIC PAIN HAD RESOLVED AND THE ANXIETY AND DEPRESSION HAD NOT RESOLVED. THE REPORTER CONSIDERED ABDOMINAL PAIN, ANXIETY, COMPLICATION ASSOCIATED WITH DEVICE, CONSTIPATION, DEPRESSION, DEVICE EXPULSION, DYSMENORRHOEA, DYSPAREUNIA, MENORRHAGIA, MENSTRUAL DISORDER, PELVIC PAIN, UTERINE HAEMORRHAGE, VAGINAL HAEMORRHAGE AND WEIGHT INCREASED TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: BILATERAL ESSURE CHOLECYSTECTOMY. BILATERAL ESSURE CONTRACEPTIVE COILS NOTED. THE LEFT SIDED COIL PARTIALLY EXTENDS IN TO THE ENDOMETRIAL CAVITY WITH ENDOMETRIAL CUL-DE-SAC HEMORRHAGE. THE LEFT TUBE INSERTION WAS INCOMPLETE AND THE MLORO INSERT IS HANGING IN THE UTERINE CAVITY. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 36.7 KG/SQM. CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONES WERE DESCRIBED IN PATIENT¿S MEDICAL RECORDS:DEVICE EXPULSION AND EVENT UTERINE HAEMORRHAGE CONFIRMING EVENTS VAGINAL HAEMORRHAGE & MENORRHAGIA ". MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 2-FEB-2018: PFS RECEIVED - NEW EVENTS, "ABNORMAL BLEEDING (VAGINAL), ABNORMAL BLEEDING (MENORRHAGIA), MIGRATION OF ESSURE DEVICE - LOCATION OF DEVICE: UTERINE CAVITY, DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE), WEIGHT GAIN, CONSTIPATION, DISORDER OF MENSTRUATION ABNORMAL BLEEDING, OBESITY / BODY MASS INDEX OF 31-31.9 IN ADULT, DIFFICULTY WITH INSERTING COILS IN LEFT TUBE, ANXIETY, DEPRESSION,MECHANICAL COMPLICATION OF INTRAUTERINE CONTRACEPTIVE DEVICE, EVENT ABNORMAL UTERINE BLEEDING " WERE ADDED. LOT NUMBER WAS ADDED. NEW REPORTER WERE ADDED. HISTORICAL AND CONCOMITANT CONDITIONS AND TREATMENT MEDICATION WERE ADDED. LAB DATA WAS UPDATED. ¿ESSURE LEGAL MANUFACTURE HAS CHANGED FROM BAYER HEALTHCARE, LLC, (B)(4) TO BAYER PHARMA (B)(4), 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: 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 ("LOWER LEFT-SIDED PELVIC PAIN") IN A FEMALE PATIENT WHO RECEIVED ESSURE FOR STERILIZATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. ON (B)(6) 2014, THE PATIENT STARTED ESSURE. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUS CRITERIA MEDICALLY SIGNIFICANT AND CLINICALLY SIGNIFICANT/INTERVENTION REQUIRED) AND ABDOMINAL PAIN ("ABDOMINAL PAIN"). THE PATIENT WAS TREATED WITH SURGERY (DEVICE REMOVAL). ESSURE WAS WITHDRAWN. AT THE TIME OF THE REPORT, THE PELVIC PAIN AND ABDOMINAL PAIN OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED PELVIC PAIN AND ABDOMINAL PAIN TO BE RELATED TO ESSURE. QUALITY SAFETY EVALUATION RECEIVED ON 19-DEC-2016: THIS ADVERSE EVENT REPORT IS RELATED TO A PRODUCT TECHNICAL COMPLAINT (PTC). (B)(4). SAMPLE NOT AVAILABLE. 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, ALTHOUGH WE WERE UNABLE TO CONFIRM THIS COMPLAINT, WE CANNOT EXCLUDE THE POSSIBILITY OF HAVING A TECHNICAL ISSUE INVOLVED IN THE COMPLAINT. THERE WAS NO EVENT REPORTED WHICH INDICATES A NEW TECHNICAL FAILURE MODE FOR THE DEVICE. AS A PRODUCT QUALITY DEFECT COULD NOT BE CONFIRMED BUT IS CONSIDERED PLAUSIBLE A RELATIONSHIP WITH THE REPORTED MEDICAL EVENTS CANNOT BE TOTALLY EXCLUDED. HOWEVER, THE REPORTED MEDICAL EVENTS ARE KNOWN POSSIBLE UNDESIRABLE EVENTS AND NOT INDICATIVE OF A QUALITY DEFICIT PER SE. SINCE NO BATCH NUMBER WAS REPORTED, A BATCH INVESTIGATION WITH RESPECT TO SIMILAR AE CASES IS NOT APPLICABLE. NO SPECIFIC QUALITY ISSUE WAS DEFINED, THEREFORE NO MEDDRA LLT CAN BE PROVIDED. COMPANY CAUSALITY COMMENT: THIS NON-MEDICALLY CONFIRMED CASE REFERS TO AN ADULT FEMALE PLAINTIFF WHO HAD ESSURE (FALLOPIAN TUBE OCCLUSION INSERT) INSERTED AND EXPERIENCED LOWER LEFT-SIDED PELVIC PAIN AND ABDOMINAL PAIN. APPROXIMATELY ONE YEAR AFTER PLACEMENT SHE UNDERWENT SURGERY TO REMOVE THE DEVICE (OUTCOME UNKNOWN). PELVIC PAIN, SERIOUS DUE TO MEDICAL SIGNIFICANCE, IS AN ANTICIPATED EVENT ACCORDING TO THE REFERENCE SAFETY INFORMATION OF ESSURE. GIVEN THE NATURE AND COURSE OF THE EVENTS, A CAUSALITY OF ESSURE DEVICE CANNOT BE EXCLUDED (RELATED). THE CASE WAS CLASSIFIED AS INCIDENT SINCE DEVICE REMOVAL WAS REQUIRED. A PRODUCT QUALITY DEFECT COULD NOT BE CONFIRMED BUT IS CONSIDERED PLAUSIBLE. FURTHER INFORMATION IS EXPECTED ONLY THROUGH THE LITIGATION PROCESS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 850606 | ESSURE | TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE | HHS | BAYER PHARMA AG | ESS305 | 8882479,882479-INV |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 28 YR | Other| R | IBUPROFEN| IBUPROFEN| IBUPROFEN| IBUPROFEN| IBUPROFEN |