ESSURE
Report
- Report Number
- 2951250-2016-02325
- Event Type
- Injury
- Date Received
- October 27, 2016
- Date of Event
- February 12, 2013
- Report Date
- March 21, 2019
- Manufacturer
- BAYER PHARMA AG
- Product Code
- HHS
- PMA / PMN Number
- P020014
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NC, US
- Reporter Occupation
- OTHER
Narratives
THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF FALLOPIAN TUBE PERFORATION ("THE ESSURE DEVICE PUNCTURED BOTH FALLOPIAN TUBES"), PELVIC PAIN ("PELVIC PAINS, PAIN"), MENORRHAGIA ("INCREASED BLEEDING DURING MENSTRUATION, BLEEDING/ ABNORMAL BLEEDING(MENORRHAGIA)") AND BLADDER PERFORATION ("BLADDER WAS CUT ON ACCIDENT") IN A 32-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE INSERTED FOR FEMALE STERILIZATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S CONCURRENT CONDITIONS INCLUDED DYSMENORRHEA, GENITAL BLEEDING, MENSES IRREGULAR AND HEAVY PERIODS. CONCOMITANT PRODUCTS INCLUDED IBUPROFEN AND IRON. ON (B)(6)2012, THE PATIENT HAD ESSURE INSERTED. ON (B)(6) 2013, THE PATIENT EXPERIENCED MENORRHAGIA (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED) AND VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL)"). IN (B)(6) 2013, THE PATIENT EXPERIENCED TOOTH DISORDER ("DENTAL PROBLEMS"). IN (B)(6) 2013, THE PATIENT WAS FOUND TO HAVE WEIGHT INCREASED ("WEIGHT GAIN") AND EXPERIENCED ALOPECIA ("HAIR LOSS"). IN 2013, THE PATIENT EXPERIENCED DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING)"). ON (B)(6) 2013, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED) AND BLADDER PERFORATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED FALLOPIAN TUBE PERFORATION (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT) AND ABDOMINAL PAIN LOWER ("LOWER ABDOMEN PAIN"). THE PATIENT WAS TREATED WITH SURGERY (ESSURE AND NOVASURE ENDOMETRIAL ABLATION (B)(6) 2012, HYSTERECTOMY (FULL), SALPINGECTOMY (BILATERAL REMOVAL OF FALLOPIAN TUBES), HYSTERECTOMY (FULL), SALPINGECTOMY (BILATERAL REMOVAL OF FALLOPIAN TUBES), AND YSTERECTOMY (FULL), SALPINGECTOMY (BILATERAL REMOVAL OF FALLOPIAN TUBES),). ESSURE WAS REMOVED ON (B)(6) 2013. AT THE TIME OF THE REPORT, THE FALLOPIAN TUBE PERFORATION, BLADDER PERFORATION AND DYSMENORRHOEA OUTCOME WAS UNKNOWN AND THE PELVIC PAIN, MENORRHAGIA, VAGINAL HAEMORRHAGE, TOOTH DISORDER, WEIGHT INCREASED, ALOPECIA AND ABDOMINAL PAIN LOWER HAD RESOLVED. THE REPORTER CONSIDERED ABDOMINAL PAIN LOWER, ALOPECIA, BLADDER PERFORATION, DYSMENORRHOEA, FALLOPIAN TUBE PERFORATION, MENORRHAGIA, PELVIC PAIN, TOOTH DISORDER, VAGINAL HAEMORRHAGE AND WEIGHT INCREASED TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: CURRENT WEIGHT AS OF (B)(6) 2018: 185 LBS. APPROXIMATE WEIGHT AT THE TIME OF ESSURE PLACEMENT 150-165 LBS. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): HYSTEROSALPINGOGRAM - ON (B)(6)2013: TOTAL BILATERAL OCCLUSION. AS PER MR: (B)(6)2013: HYSTEROSALPINGOGRAM (HSG) IMPRESSION: BILATERAL TUBAL LIGATION DEVICES ARE NOTED. THERE IS NO FREE SPILLAGE OF CONTRAST INTO THE PELVIS VIA THE FALLOPIAN TUBES. THE FALLOPIAN TUBES ARE NOT PATENT.. PATHOLOGY TEST - ON (B)(6) 2012: FINAL PATHOLOGIC DIAGNOSIS: ENDOMETRIAL CURETTINGS.. QUALITY-SAFETY EVALUATION OF PTC: NO SAMPLE AVAILABLE FOR THIS INVESTIGATION. 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 OF 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 DETECT 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 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. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 18-MAR-2019: PFS RECEIVED- NEW EVENT DYSMENORRHEA (CRAMPING) 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-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 FALLOPIAN TUBE PERFORATION ("THE ESSURE DEVICE PUNCTURED BOTH FALLOPIAN TUBES"), PELVIC PAIN ("PELVIC PAINS, PAIN"), MENORRHAGIA ("INCREASED BLEEDING DURING MENSTRUATION, BLEEDING/ ABNORMAL BLEEDING(MENORRHAGIA)") AND BLADDER PERFORATION ("BLADDER WAS CUT ON ACCIDENT") 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 CONCURRENT CONDITIONS INCLUDED DYSMENORRHEA, GENITAL BLEEDING, MENSES IRREGULAR AND HEAVY PERIODS. CONCOMITANT PRODUCTS INCLUDED IBUPROFEN AND IRON. ON (B)(6) 2012, THE PATIENT HAD ESSURE INSERTED. ON (B)(6) 2013, THE PATIENT EXPERIENCED MENORRHAGIA (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED) AND VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL)"). IN (B)(6) 2013, THE PATIENT EXPERIENCED TOOTH DISORDER ("DENTAL PROBLEMS"). IN (B)(6) 2013, THE PATIENT WAS FOUND TO HAVE WEIGHT INCREASED ("WEIGHT GAIN") AND EXPERIENCED ALOPECIA ("HAIR LOSS"). ON (B)(6) 2013, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED) AND BLADDER PERFORATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED FALLOPIAN TUBE PERFORATION (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT) AND ABDOMINAL PAIN LOWER ("LOWER ABDOMEN PAIN"). THE PATIENT WAS TREATED WITH SURGERY (ESSURE AND NOVASURE ENDOMETRIAL ABLATION (B)(6) 2012, HYSTERECTOMY (FULL), SALPINGECTOMY (BILATERAL REMOVAL OF FALLOPIAN TUBES), HYSTERECTOMY (FULL), SALPINGECTOMY (BILATERAL REMOVAL OF FALLOPIAN TUBES), AND YSTERECTOMY (FULL), SALPINGECTOMY (BILATERAL REMOVAL OF FALLOPIAN TUBES),). ESSURE WAS REMOVED ON (B)(6) 2013. AT THE TIME OF THE REPORT, THE FALLOPIAN TUBE PERFORATION AND BLADDER PERFORATION OUTCOME WAS UNKNOWN AND THE PELVIC PAIN, MENORRHAGIA, VAGINAL HAEMORRHAGE, TOOTH DISORDER, WEIGHT INCREASED, ALOPECIA AND ABDOMINAL PAIN LOWER HAD RESOLVED. THE REPORTER CONSIDERED ABDOMINAL PAIN LOWER, ALOPECIA, BLADDER PERFORATION, FALLOPIAN TUBE PERFORATION, MENORRHAGIA, PELVIC PAIN, TOOTH DISORDER, VAGINAL HAEMORRHAGE AND WEIGHT INCREASED TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: CURRENT WEIGHT AS OF (B)(6) 2018: 185 LBS. APPROXIMATE WEIGHT AT THE TIME OF ESSURE PLACEMENT 150-165 LBS. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): HYSTEROSALPINGOGRAM - ON (B)(6) 2013: TOTAL BILATERAL OCCLUSION. AS PER MR: (B)(6) 2013: HYSTEROSALPINGOGRAM (HSG). IMPRESSION: BILATERAL TUBAL LIGATION DEVICES ARE NOTED. THERE IS NO FREE SPILLAGE OF CONTRAST INTO THE PELVIS VIA THE FALLOPIAN TUBES. THE FALLOPIAN TUBES ARE NOT PATENT.. PATHOLOGY TEST - ON (B)(6) 2012: FINAL PATHOLOGIC DIAGNOSIS: ENDOMETRIAL CURETTINGS.. QUALITY-SAFETY EVALUATION OF PTC: NO SAMPLE AVAILABLE FOR THIS INVESTIGATION. 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 OF 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 DETECT 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 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. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 7-DEC-2018: PLAINTIFF FACT SHEET AND MEDICAL RECORD RECEIVED. EVENT ADDED: ABNORMAL BLEEDING (VAGINAL), DENTAL PROBLEMS, WEIGHT GAIN, HAIR LOSS, LOWER ABDOMEN PAIN.EVENT ADDED FROM ESSURE REMOVAL INFORMATION: THE ESSURE DEVICE PUNCTURED BOTH FALLOPIAN TUBES AND BLADDER WAS CUT ON ACCIDENT. EVENT OUTCOME WAS UPDATED FOR THE EVENT: ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA), PELVIC PAIN, LOWER ABDOMINAL PAIN, HAIR LOSS, DENTAL PROBLEMS, WEIGHT GAIN. LAB TEST WAS ADDED. REPORTER INFORMATION WAS ADDED. CONCOMITANT CONDITIONS AND DRUGS WERE ADDED. ABLATION SURGERY WAS ADDED TO THE EVENT: MENORRHAGIA. 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.
FOLLOW UP INFORMATION RECEIVED ON 14-NOV-2016: QUALITY-SAFETY EVALUATION OF PRODUCT TECHNICAL COMPLAINT (PTC). THIS ADVERSE EVENT REPORT IS RELATED TO A PTC AND THE BAYER REFERENCE NUMBER FOR THE PTC REPORT IS (B)(4). NO SAMPLE AVAILABLE FOR THIS INVESTIGATION. 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 OF 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 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 SPONTANEOUS CASE REPORT IS UNDER LITIGATION. IT REFERS TO A FEMALE CONSUMER WHO HAD ESSURE (FALLOPIAN TUBE OCCLUSION INSERT) PLACED AND BEGAN TO EXPERIENCE PELVIC PAINS AND BLEEDING DURING MENSTRUATION (INTERPRETED AS MENORRHAGIA). A YEAR LATER, SHE UNDERWENT A LAPAROSCOPIC ASSISTED VAGINAL HYSTERECTOMY AND PARTIAL BILATERAL SALPINGECTOMY AS A DEFINITIVE SOLUTION TO THE PAIN AND BLEEDING. PELVIC PAIN AND MENORRHAGIA ARE ANTICIPATED EVENTS IN THE REFERENCE SAFETY INFORMATION FOR ESSURE. CONSIDERING THAT ESSURE THERAPY MAY CAUSE PELVIC PAIN AND CHANGE IN BLEEDING PATTERNS AND THAT IN THIS CASE THERE IS NO ALTERNATIVE EXPLANATION, A CAUSAL RELATIONSHIP WITH ESSURE CANNOT BE EXCLUDED. THIS CASE IS REGARDED AS INCIDENT SINCE DEVICE REMOVAL WAS REQUIRED (IMPLIED). A PRODUCT QUALITY DEFECT COULD NOT BE CONFIRMED BUT IS CONSIDERED PLAUSIBLE. FURTHER INFORMATION WILL BE OBTAINED THROUGH LITIGATION PROCESS.
THIS IS A SPONTANEOUS CASE REPORT RECEIVED FROM A LAWYER IN THE UNITED STATES, ON BEHALF OF A PLAINTIFF IN UNITED STATES ON 03-OCT-2016 WHICH REFERS TO A FEMALE CONSUMER OF UNSPECIFIED AGE WHO HAD ESSURE (FALLOPIAN TUBE OCCLUSION INSERT) IMPLANTED ON OR ABOUT (B)(6) 2012 FOR PERMANENT BIRTH CONTROL. ON AN UNSPECIFIED DATE, HSG PROCEDURE WAS PERFORMED. UPON INFORMATION AND BELIEF, AFTER THE IMPLANT PROCEDURE SHE BEGAN TO EXPERIENCE PELVIC PAINS AND INCREASED BLEEDING DURING MENSTRUATION. THESE SYMPTOMS STARTED OUT MINOR AND GRADUALLY INCREASED IN INTENSITY. DURING THIS TIME, SHE UNDERWENT AN ABLATION THAT WAS UNSUCCESSFUL IN ALLEVIATING THE PAIN AND BLEEDING. ON OR ABOUT (B)(6) 2013, SHE UNDERWENT A LAPAROSCOPIC ASSISTED VAGINAL HYSTERECTOMY AND PARTIAL BILATERAL SALPINGECTOMY AS A DEFINITIVE SOLUTION TO THE PAIN AND BLEEDING. COMPANY CAUSALITY COMMENT: THIS NON-MEDICALLY CONFIRMED SPONTANEOUS CASE REPORT IS UNDER LITIGATION. IT REFERS TO A FEMALE CONSUMER WHO HAD ESSURE (FALLOPIAN TUBE OCCLUSION INSERT) PLACED AND BEGAN TO EXPERIENCE PELVIC PAINS AND BLEEDING DURING MENSTRUATION (INTERPRETED AS MENORRHAGIA). A YEAR LATER, SHE UNDERWENT A LAPAROSCOPIC ASSISTED VAGINAL HYSTERECTOMY AND PARTIAL BILATERAL SALPINGECTOMY AS A DEFINITIVE SOLUTION TO THE PAIN AND BLEEDING. PELVIC PAIN AND MENORRHAGIA ARE ANTICIPATED EVENTS IN THE REFERENCE SAFETY INFORMATION FOR ESSURE. CONSIDERING THAT ESSURE THERAPY MAY CAUSE PELVIC PAIN AND CHANGE IN BLEEDING PATTERNS AND THAT IN THIS CASE THERE IS NO ALTERNATIVE EXPLANATION, A CAUSAL RELATIONSHIP WITH ESSURE CANNOT BE EXCLUDED. THIS CASE IS REGARDED AS INCIDENT SINCE DEVICE REMOVAL WAS REQUIRED (IMPLIED). A PRODUCT TECHNICAL COMPLAINT ANALYSIS IS BEING SOUGHT. FURTHER INFORMATION WILL BE OBTAINED THROUGH LITIGATION PROCESS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 711997 | ESSURE | TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE | HHS | BAYER PHARMA AG | ESS305 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 32 YR | Other| R | IBUPROFEN,| IBUPROFEN.| IRON,| IRON, |