ESSURE

Report

Report Number: 2951250-2016-01976
Event Type: Injury
Date Received: September 19, 2016
Report Date: March 19, 2021
Manufacturer: BAYER PHARMA AG
Product Code: HHS
PMA / PMN Number: P020014
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: TX, US
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 0

THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ('CHRONIC PELVIC PAIN') IN AN ADULT FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 882191) INSERTED FOR FEMALE STERILIZATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. CONCOMITANT PRODUCTS INCLUDED CLINDAMYCIN, GENTAMICIN AND METRONIDAZOLE (FLAGYL 250). ON (B)(6) 2011, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), MENORRHAGIA ("HEAVY MENSTRUAL BLEEDING"), BACK PAIN ("CHRONIC BACK PAIN"), ABDOMINAL PAIN ("ABDOMINAL PAIN"), ABDOMINAL DISTENSION ("ABDOMINAL BLOATING"), ALOPECIA ("EXCESSIVE HAIR LOSS"), ABNORMAL WEIGHT GAIN ("EXCESSIVE WEIGHT GAIN"), ENDOMETRIOSIS ("ENDOMETRIOSIS "), FATIGUE ("CHRONIC FATIGUE"), DYSMENORRHOEA ("DYSMENORRHEA") AND ANAEMIA ("SYMPTOMATIC ANEMIA") AND WAS FOUND TO HAVE UTERINE LEIOMYOMA ("UTERINE FIBROIDS"). THE PATIENT WAS TREATED WITH SURGERY (ROBOTIC-ASSISTED TOTAL LAPAROSCOPIC HYSTERECTOMY WITH BILATERAL SALPINGECTOMIES,). ESSURE WAS REMOVED ON (B)(6) 2015. AT THE TIME OF THE REPORT, THE PELVIC PAIN, MENORRHAGIA, BACK PAIN, ABDOMINAL PAIN, ABDOMINAL DISTENSION, ALOPECIA, ABNORMAL WEIGHT GAIN, ENDOMETRIOSIS AND FATIGUE OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL DISTENSION, ABDOMINAL PAIN, ABNORMAL WEIGHT GAIN, ALOPECIA, ANAEMIA, BACK PAIN, DYSMENORRHOEA, ENDOMETRIOSIS, FATIGUE, MENORRHAGIA, PELVIC PAIN AND UTERINE LEIOMYOMA TO BE RELATED TO ESSURE. 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. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 19-MAR-2021: QUALITY SAFETY EVALUATION OF PTC. 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.

Additional Manufacturer Narrative · 0

THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ('CHRONIC PELVIC PAIN') IN AN ADULT FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 882191) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. CONCOMITANT PRODUCTS INCLUDED CLINDAMYCIN, GENTAMICIN AND METRONIDAZOLE (FLAGYL 250). ON (B)(6) 2011, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), MENORRHAGIA ("HEAVY MENSTRUAL BLEEDING"), BACK PAIN ("CHRONIC BACK PAIN"), ABDOMINAL PAIN ("ABDOMINAL PAIN"), ABDOMINAL DISTENSION ("ABDOMINAL BLOATING"), ALOPECIA ("EXCESSIVE HAIR LOSS"), ABNORMAL WEIGHT GAIN ("EXCESSIVE WEIGHT GAIN"), ENDOMETRIOSIS ("ENDOMETRIOSIS "), FATIGUE ("CHRONIC FATIGUE"), DYSMENORRHOEA ("DYSMENORRHEA") AND ANAEMIA ("SYMPTOMATIC ANEMIA") AND WAS FOUND TO HAVE UTERINE LEIOMYOMA ("UTERINE FIBROIDS"). THE PATIENT WAS TREATED WITH SURGERY (ROBOTIC-ASSISTED TOTAL LAPAROSCOPIC HYSTERECTOMY WITH BILATERAL SALPINGECTOMIES,). ESSURE WAS REMOVED ON (B)(6) 2015. AT THE TIME OF THE REPORT, THE PELVIC PAIN, MENORRHAGIA, BACK PAIN, ABDOMINAL PAIN, ABDOMINAL DISTENSION, ALOPECIA, ABNORMAL WEIGHT GAIN, ENDOMETRIOSIS AND FATIGUE OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL DISTENSION, ABDOMINAL PAIN, ABNORMAL WEIGHT GAIN, ALOPECIA, ANAEMIA, BACK PAIN, DYSMENORRHOEA, ENDOMETRIOSIS, FATIGUE, MENORRHAGIA, PELVIC PAIN AND UTERINE LEIOMYOMA TO BE RELATED TO ESSURE. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 5-MAR-2021: MEDICAL RECORDS RECEIVED- LOT NUMBER ADDED. NEW REPORTER, MEDICAL HISTORY, REMOVAL PROCEDURE , CONCOMITANT DRUGS WERE 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. PELVIC PAIN MAY OCCUR WITHIN CONSUMERS UNDER ESSURE USE. THUS, BASED ON A POSITIVE TEMPORAL RELATIONSHIP, LACK OF ALTERNATIVE EXPLANATION, AND ESSURE SAFETY PROFILE, CAUSALITY BETWEEN THE EVENT CHRONIC PELVIC PAIN AND SUSPECT INSERT CANNOT BE EXCLUDED. THIS CASE WAS REGARDED AS INCIDENT, SINCE DEVICE REMOVAL WAS REQUIRED (INTERVENTION REQUIRED). OTHER NONSERIOUS EVENTS WERE REPORTED. ACCORDING TO THE PRODUCT TECHNICAL ANALYSIS, A PRODUCT QUALITY DEFECT COULD NOT BE CONFIRMED BUT IS CONSIDERED PLAUSIBLE. NO ACTIVE FOLLOW-UP IS ALLOWED AND FURTHER INFORMATION IS EXPECTED ONLY THROUGH LITIGATION PROCESS.

Additional Manufacturer Narrative · 1

FOLLOW-UP RECEIVED ON 21-SEP-2016: QUALITY-SAFETY EVALUATION: THIS ADVERSE EVENT REPORT IS RELATED TO A PRODUCT TECHNICAL COMPLAINT. 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 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 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 SPONTANEOUS CASE REPORT REFERS TO A FEMALE CONSUMER WHO HAD ESSURE (FALLOPIAN TUBE OCCLUSION INSERTS) INSERTED AND EXPERIENCED CHRONIC PELVIC PAIN. THIS EVENT IS LISTED IN THE REFERENCE SAFETY INFORMATION FOR ESSURE. PELVIC PAIN MAY OCCUR WITHIN CONSUMERS UNDER ESSURE USE. THUS, BASED ON A POSITIVE TEMPORAL RELATIONSHIP, LACK OF ALTERNATIVE EXPLANATION, AND ESSURE SAFETY PROFILE, CAUSALITY BETWEEN THE EVENT CHRONIC PELVIC PAIN AND SUSPECT INSERT CANNOT BE EXCLUDED. THIS CASE WAS REGARDED AS INCIDENT, SINCE DEVICE REMOVAL WAS REQUIRED (INTERVENTION REQUIRED). OTHER NONSERIOUS EVENTS WERE REPORTED. ACCORDING TO THE PRODUCT TECHNICAL ANALYSIS, A PRODUCT QUALITY DEFECT COULD NOT BE CONFIRMED BUT IS CONSIDERED PLAUSIBLE. NO ACTIVE FOLLOW-UP IS ALLOWED AND FURTHER INFORMATION IS EXPECTED ONLY THROUGH LITIGATION PROCESS.

Description of Event or Problem · 1

THIS IS A SPONTANEOUS CASE REPORT RECEIVED FROM A LAWYER IN THE UNITED STATES ON 22-AUG-2016 ON BEHALF OF AN ADULT (>=18Y & <65Y) FEMALE CONSUMER WHO HAD ESSURE (FALLOPIAN TUBE OCCLUSION INSERT) INSERTED ON (B)(6) 2011 FOR PERMANENT STERILIZATION. SHORTLY AFTER UNDERGOING THE ESSURE PROCEDURE, AN HSG TEST WAS PERFORMED AND COILS WERE PROPERLY PLACED. HOWEVER, HER POST-PROCEDURE PERIOD HAS BEEN MARKED BY INCREASINGLY SEVERE PAIN AND DISCOMFORT, INCLUDING HEAVY MENSTRUAL BLEEDING, CHRONIC PELVIC PAIN, CHRONIC BACK PAIN, ABDOMINAL PAIN, ABDOMINAL BLOATING, EXCESSIVE HAIR LOSS, EXCESSIVE WEIGHT GAIN, ENDOMETRIOSIS DIAGNOSIS, AND CHRONIC FATIGUE. SHE NEVER EXPERIENCED ANY OF THESE CONDITIONS PRIOR TO UNDERGOING THE ESSURE PROCEDURE. ON (B)(6) 2015, SHE UNDERWENT SURGERY TO REMOVE HER ESSURE COILS. COMPANY CAUSALITY COMMENT: THIS SPONTANEOUS CASE REPORT REFERS TO A FEMALE CONSUMER WHO HAD ESSURE (FALLOPIAN TUBE OCCLUSION INSERTS) INSERTED AND EXPERIENCED CHRONIC PELVIC PAIN. THIS EVENT IS LISTED IN THE REFERENCE SAFETY INFORMATION FOR ESSURE. PELVIC PAIN MAY OCCUR WITHIN CONSUMERS UNDER ESSURE USE. THUS, BASED ON A POSITIVE TEMPORAL RELATIONSHIP, LACK OF ALTERNATIVE EXPLANATION, AND ESSURE SAFETY PROFILE, CAUSALITY BETWEEN THE EVENT CHRONIC PELVIC PAIN AND SUSPECT INSERT CANNOT BE EXCLUDED. THIS CASE WAS REGARDED AS INCIDENT, SINCE DEVICE REMOVAL WAS REQUIRED (INTERVENTION REQUIRED). OTHER NONSERIOUS EVENTS WERE REPORTED. A PRODUCT TECHNICAL ANALYSIS IS BEING SOUGHT. NO ACTIVE FOLLOW-UP IS ALLOWED AND FURTHER INFORMATION IS EXPECTED ONLY THROUGH LITIGATION PROCESS.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
612078	ESSURE	TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE	HHS	BAYER PHARMA AG	ESS305	882191

Patients

Seq	Age	Sex	Outcome	Treatment
1			Other\| R	CLINDAMYCIN\| CLINDAMYCIN\| FLAGYL 250\| FLAGYL 250\| GENTAMICIN\| GENTAMICIN