ESSURE
Report
- Report Number
- 2951250-2016-01484
- Event Type
- Injury
- Date Received
- August 23, 2016
- Report Date
- October 30, 2019
- Manufacturer
- BAYER PHARMA AG
- Product Code
- HHS
- PMA / PMN Number
- P020014
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NL
- Reporter Occupation
- OTHER
Narratives
THIS CASE WAS INITIALLY RECEIVED VIA REGULATORY AUTHORITY (IGZ, REFERENCE NUMBER: 1032349) ON 04-AUG-2016. THE MOST RECENT INFORMATION WAS RECEIVED ON 28-OCT-2019. THIS SPONTANEOUS CASE WAS REPORTED BY A CONSUMER AND DESCRIBES THE OCCURRENCE OF MENORRHAGIA ('INCREASE OR HEAVY BLOOD LOSS DURING MENSTRUATION') IN A 40-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE INSERTED. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. OTHER PRODUCT OR PRODUCT USE ISSUES IDENTIFIED: DEVICE DIFFICULT TO USE "PLACEMENT RIGHT SIDE VERY DIFFICULT" ON (B)(6) 2013. ON (B)(6) 2013, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED MENORRHAGIA (SERIOUSNESS CRITERIA DISABILITY, MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), PAIN IN EXTREMITY ("PAIN IN LEGS AND ARMS"), DYSMENORRHOEA ("PAIN DURING MENSTRUATION"), EYE ALLERGY ("ALLERGIC COMPLAINTS IN EYES"), LIVER DISORDER ("LIVER PROBLEMS"), DYSURIA ("PROBLEMS WITH URINATING"), ARTHRALGIA ("ARTHRALGIA"), MYALGIA ("MUSCLE PAIN"), DEPRESSED MOOD ("DEPRESSIVE FEELINGS"), ABDOMINAL DISTENSION ("SWOLLEN ABDOMEN"), INFLAMMATION ("INFLAMED FINGERS") AND SUPRAPUBIC PAIN ("PUBIC AREA SOMETIMES FEELS FEVERISH") AND WAS FOUND TO HAVE WEIGHT ABNORMAL ("INCREASE/DECREASE OF WEIGHT"). THE PATIENT WAS TREATED WITH SURGERY (UTERUS AND ESSURE WERE REMOVED). ESSURE WAS REMOVED. AT THE TIME OF THE REPORT, THE MENORRHAGIA, PAIN IN EXTREMITY, DYSMENORRHOEA, EYE ALLERGY, LIVER DISORDER, DYSURIA, ARTHRALGIA, MYALGIA, DEPRESSED MOOD, WEIGHT ABNORMAL, ABDOMINAL DISTENSION, INFLAMMATION AND SUPRAPUBIC PAIN HAD NOT RESOLVED. THE REPORTER CONSIDERED ABDOMINAL DISTENSION, ARTHRALGIA, DEPRESSED MOOD, DYSMENORRHOEA, DYSURIA, EYE ALLERGY, INFLAMMATION, LIVER DISORDER, MENORRHAGIA, MYALGIA, PAIN IN EXTREMITY, SUPRAPUBIC PAIN AND WEIGHT ABNORMAL TO BE RELATED TO ESSURE. 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 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. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 28-OCT-2019: "UTERUS REMOVED" WAS ALSO CONSIDERED AS A TREATMENT FOR THE EVENT MENORRHAGIA. 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 01-NOV-2016 FROM A CONSUMER: AROUND (B)(6) 2013 THE PATIENT UNDERWENT A MEDICAL TREATMENT IN THE HOSPITAL, KNOWN AS THE ESSURE STERILIZATION METHOD. AFTER THIS TREATMENT SEVERAL PHYSICAL COMPLAINTS DEVELOPED. IN THE MEANTIME PATIENT HAS HAD FOLLOW-UP TREATMENTS AND THE XENOBIOTIC MATERIAL HAS BEEN REMOVED. HOWEVER SHE HAD NOT RECOVERED. BECAUSE OF THE COMPLAINTS PATIENT IS BEING IMPEDED IN HER NORMAL DAILY FUNCTIONING AND PATIENT IS SUFFERING FROM INJURY. SHE HOLDS BAYER LIABLE FOR THE DAMAGE CAUSED. DEVICE SIMILAR INCIDENT LISTING: THE LIST OF SIMILAR CASES CONTAINS ESSURE REPORTS RECEIVED BY BAYER AND OLDER CASES RECEIVED BY CONCEPTUS WITH SIMILAR EVENTS CODED IN MEDDRA. IN THIS PARTICULAR CASE A SEARCH IN THE DATABASE WAS PERFORMED ON 03-NOV-2016 FOR THE FOLLOWING MEDDRA PREFERRED TERMS: MENORRHAGIA: THE ANALYSIS IN THE GLOBAL SAFETY DATABASE REVEALED (B)(4) CASES. BAYER IS CLOSELY MONITORING THE BENEFIT-RISK PROFILE OF ESSURE. A RECENT CUMULATIVE REVIEW OF ALL AVAILABLE DATA ON ESSURE HAS NOT YIELDED ANY NEW SAFETY SIGNAL WITH REGARD TO THESE MEDDRA PT. COMPANY CAUSALITY COMMENT: THIS IS A POTENTIAL LEGAL NON-MEDICALLY CONFIRMED SPONTANEOUS CASE REPORT. IT REFERS TO A (B)(6) FEMALE CONSUMER IN NETHERLANDS WHO HAD ESSURE (FALLOPIAN TUBE OCCLUSION INSERT) INSERTED AND INCREASE OR HEAVY BLOOD LOSS DURING MENSTRUATION. THE XENOBIOTIC MATERIAL WAS REMOVED. THIS BLEEDING, INTERPRETED AS MENORRHAGIA IS ANTICIPATED IN THE REFERENCE SAFETY INFORMATION FOR ESSURE. CONSIDERING THAT ESSURE MAY CAUSE CHANGES IN BLEEDING PATTERNS AND CONSIDERING THAT IN THIS CASE THERE IS NO ALTERNATIVE EXPLANATION, A CAUSAL RELATIONSHIP WITH ESSURE INSERTS CANNOT BE EXCLUDED. THIS CASE IS REGARDED AS INCIDENT SINCE DEVICE REMOVAL WAS REQUIRED. NO SAMPLE AVAILABLE FOR THIS INVESTIGATION AND NO VALID LOT NUMBER. THEREFORE, A PRODUCT QUALITY DEFECT COULD NOT BE CONFIRMED BUT IS CONSIDERED PLAUSIBLE. NO FURTHER INFORMATION WILL BE OBTAINED.
FOLLOW-UP ON 05-SET-2016. QUALITY-SAFETY EVALUATION OF PTC: (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. THE LIST OF SIMILAR CASES CONTAINS ESSURE REPORTS RECEIVED BY BAYER AND OLDER CASES RECEIVED BY CONCEPTUS WITH SIMILAR EVENTS CODED IN MEDDRA. IN THIS PARTICULAR CASE A SEARCH IN THE DATABASE WAS PERFORMED ON 08-SEP-2016 FOR THE FOLLOWING MEDDRA PREFERRED TERM: MENORRHAGIA. THE ANALYSIS IN THE GLOBAL SAFETY DATABASE REVEALED 276 CASES. BAYER IS CLOSELY MONITORING THE BENEFIT-RISK PROFILE OF ESSURE. A RECENT CUMULATIVE REVIEW OF ALL AVAILABLE DATA ON ESSURE HAS NOT YIELDED ANY NEW SAFETY SIGNAL WITH REGARD TO THIS MEDDRA PT. COMPANY CAUSALITY COMMENT: THIS NON-MEDICALLY CONFIRMED SPONTANEOUS CASE REPORT RECEIVED VIA REGULATORY AUTHORITY REFERS TO A (B)(6) FEMALE CONSUMER IN (B)(6) WHO HAD ESSURE (FALLOPIAN TUBE OCCLUSION INSERT) INSERTED AND INCREASE OR HEAVY BLOOD LOSS DURING MENSTRUATION. SHE CONTACTED A PHYSICIAN RECEIVED MEDICATION AND WAS PLANNING TO HAVE ESSURE REMOVED. THIS BLEEDING, INTERPRETED AS MENORRHAGIA IS LISTED IN THE REFERENCE SAFETY INFORMATION FOR ESSURE. CONSIDERING THAT ESSURE MAY CAUSE CHANGES IN BLEEDING PATTERNS AND CONSIDERING THAT IN THIS CASE THERE IS NO ALTERNATIVE EXPLANATION, A CAUSAL RELATIONSHIP WITH ESSURE INSERTS CANNOT BE EXCLUDED. THIS CASE IS REGARDED AS INCIDENT SINCE DEVICE REMOVAL WILL BE REQUIRED. ACCORDING TO PRODUCT TECHNICAL ANALYSIS, SINCE NO BATCH NUMBER WAS REPORTED, A BATCH INVESTIGATION WITH RESPECT TO SIMILAR AE CASES IS NOT APPLICABLE. NO FURTHER INFORMATION WILL BE OBTAINED.
THIS SPONTANEOUS CASE REPORT WAS RECEIVED BY REGULATORY AUTHORITY IN (B)(6) ON (B)(6) 2016 FROM A FEMALE CONSUMER AND FORWARDED TO BAYER ON (B)(6) 2016. ON (B)(6) 2013, ESSURE (FALLOPIAN TUBE OCCLUSION INSERT) WAS PLACED WHEN SHE WAS (B)(6). THE PLACEMENT OF RIGHT SIDE WAS VERY DIFFICULT. OTHER SIDE WITHOUT PROBLEMS. SHE HAD THE CONTROL POSITION ESSURE PERFORMED THROUGH ECHO AND SMEARS. THREE MONTHS AFTER THE PLACEMENT PROCEDURE HER COMPLAINTS STARTED BUT SHE DID NOT SPECIFY WHICH COMPLAINTS. SHE HAD EXPERIENCED PAIN IN LEGS AND ARMS, PAIN DURING MENSTRUATION, ALLERGIC COMPLAINTS IN EYES, INCREASE OR HEAVY BLOOD LOSS DURING MENSTRUATION, LIVER PROBLEMS, PROBLEMS WITH URINATING, ARTHRALGIA, MUSCLE PAIN, DEPRESSIVE FEELINGS, INCREASE/DECREASE OF WEIGHT, SWOLLEN ABDOMEN, INFLAMED FINGERS, AND PUBIC AREA SOMETIMES FEELS FEVERISH. ESSURE INFLUENCE IN DAILY LIFE INCLUDED SOCIAL ACTIVITIES AND HAPPINESS COMPLAINTS, WORK-RELATED PROBLEMS, SHE WORKED LESS AND OFTEN LIES IN BED IN THE WEEKEND. SHE CONTACTED A DOCTOR FOR MEDICATION TREATMENT AND WAS PLANNING ESSURE REMOVAL. COMPANY CAUSALITY COMMENT: THIS NON-MEDICALLY CONFIRMED SPONTANEOUS CASE REPORT RECEIVED VIA REGULATORY AUTHORITY REFERS TO A (B)(6) FEMALE CONSUMER IN (B)(6) WHO HAD ESSURE (FALLOPIAN TUBE OCCLUSION INSERT) INSERTED AND INCREASE OR HEAVY BLOOD LOSS DURING MENSTRUATION. SHE CONTACTED A PHYSICIAN RECEIVED MEDICATION AND WAS PLANNING TO HAVE ESSURE REMOVED. THIS BLEEDING, INTERPRETED AS MENORRHAGIA IS LISTED IN THE REFERENCE SAFETY INFORMATION FOR ESSURE. CONSIDERING THAT ESSURE MAY CAUSE CHANGES IN BLEEDING PATTERNS AND CONSIDERING THAT IN THIS CASE THERE IS NO ALTERNATIVE EXPLANATION, A CAUSAL RELATIONSHIP WITH ESSURE INSERTS CANNOT BE EXCLUDED. THIS CASE IS REGARDED AS INCIDENT SINCE DEVICE REMOVAL WILL BE REQUIRED. A PRODUCT TECHNICAL COMPLAINT ANALYSIS IS BEING SOUGHT. NO FURTHER INFORMATION WILL BE OBTAINED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 549801 | ESSURE | TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE | HHS | BAYER PHARMA AG | ESS305 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 40 YR | Other| R| S |