ESSURE
Report
- Report Number
- 2951250-2021-03316
- Event Type
- Injury
- Date Received
- October 11, 2021
- Date of Event
- May 1, 2012
- Report Date
- October 14, 2021
- Manufacturer
- BAYER PHARMA AG
- Product Code
- HHS
- UDI-DI
- 10888853003051
- PMA / PMN Number
- P020014
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- OTHER
Narratives
THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF ABDOMINAL PAIN LOWER ('PAIN LOWER ABDOMINAL') IN AN ADULT FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 841534) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S CONCURRENT CONDITIONS INCLUDED ABNORMAL UTERINE BLEEDING, GERD, IRON DEFICIENCY ANEMIA, POST COITAL BLEEDING, PULMONARY EMBOLISM AND TOOTH PAIN. ON (B)(6) 2011, THE PATIENT HAD ESSURE INSERTED. IN (B)(6) 2012, THE PATIENT EXPERIENCED ABDOMINAL PAIN LOWER (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), MUSCLE SPASMS ("MUSCLE SPASMS/ MUSCLE SPASMS IN FEET. LEGS AND BACK"), DEPRESSION ("PSYCHOLOGICAL OR PSYCHIATRIC PROBLEMS CONDITION: ANXIETY/DEPRESSION") AND ANXIETY ("PSYCHOLOGICAL OR PSYCHIATRIC PROBLEMS CONDITION: ANXIETY/DEPRESSION"). IN (B)(6) 2012, THE PATIENT EXPERIENCED DYSPAREUNIA ("DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE)") AND ABDOMINAL DISTENSION ("GASTROINTESTINAL OR DIGESTIVE SYSTEM CONDITION TYPE: BLOATING") AND WAS FOUND TO HAVE WEIGHT INCREASED ("WEIGHT GAIN"). IN (B)(6) 2012, THE PATIENT EXPERIENCED ALOPECIA ("HAIR LOSS"). IN (B)(6) 2013, THE PATIENT EXPERIENCED DENTAL CARIES ("DENTAL PROBLEMS/ DECAYING TEETH"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED DEVICE EXPULSION ("THE ONE ON THE LEFT EXTENDS QUITE FAR INTO THE FUNDAL ENDOMETRIUM"), HYPERSENSITIVITY ("ALLERGY"), FATIGUE ("FATIGUE") AND NAUSEA ("NAUSEA,"). THE PATIENT WAS TREATED WITH SURGERY (ROBOTIC SALPINGECTOMY AND HYSTERECTOMY). ESSURE WAS REMOVED ON (B)(6) 2021. AT THE TIME OF THE REPORT, THE ABDOMINAL PAIN LOWER, DEVICE EXPULSION, DYSPAREUNIA, HYPERSENSITIVITY, ABDOMINAL DISTENSION, FATIGUE, ALOPECIA, DENTAL CARIES, NAUSEA, MUSCLE SPASMS, DEPRESSION, ANXIETY AND WEIGHT INCREASED OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL DISTENSION, ABDOMINAL PAIN LOWER, ALOPECIA, ANXIETY, DENTAL CARIES, DEPRESSION, DEVICE EXPULSION, DYSPAREUNIA, FATIGUE, HYPERSENSITIVITY, MUSCLE SPASMS, NAUSEA AND WEIGHT INCREASED TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: DISCREPANCY NOTED IN INSERTION DATE- (B)(6) 2011. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 23.3 KG/SQM. HYSTEROSALPINGOGRAM - IN (B)(6) 2012: TOTAL BILATERAL OCCLUSION.. IMAGING PROCEDURE - ON (B)(6) 2013: ESSURE CONFIRMATION TEST WAS UNSPECIFIED, RESULT WAS UNKNOWN. ULTRASOUND SCAN VAGINA - ON (B)(6) 2021: THE ENDOMETRIUM IS PARTICULARLY VERY POORLY SEEN. THERE DOES APPEAR TO BE A TUBAL OCCLUSION DEVICES. A TUBAL OCCLUSION DEVICE ENTERING FROM THE LEFT MAY EXTEND INTO THE REGION OF THE FUNDAL ENDOMETRIUM. THE MYOMETRIUM AND OVARIES ARE POORLY VISUALIZED.. LOT NUMBER: 841534 MANUFACTURE DATE: 2011-03 EXPIRATION DATE: 2014-03. 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 12-OCT-2021: QUALITY SAFETY EVALUATION OF PTC. WE RECEIVED A LOT NUMBER IN THIS CASE. A TECHNICAL INVESTIGATION WAS 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.
THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF ABDOMINAL PAIN LOWER ('PAIN LOWER ABDOMINAL') IN AN ADULT FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 841534) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S CONCURRENT CONDITIONS INCLUDED ABNORMAL UTERINE BLEEDING, GERD, IRON DEFICIENCY ANEMIA, POST COITAL BLEEDING, PULMONARY EMBOLISM AND TOOTH PAIN. ON (B)(6) 2011, THE PATIENT HAD ESSURE INSERTED. IN (B)(6) 2012, THE PATIENT EXPERIENCED ABDOMINAL PAIN LOWER (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), MUSCLE SPASMS ("MUSCLE SPASMS/ MUSCLE SPASMS IN FEET. LEGS AND BACK"), DEPRESSION ("PSYCHOLOGICAL OR PSYCHIATRIC PROBLEMS CONDITION: ANXIETY/ DEPRESSION") AND ANXIETY ("PSYCHOLOGICAL OR PSYCHIATRIC PROBLEMS CONDITION: ANXIETY/ DEPRESSION"). IN (B)(6) 2012, THE PATIENT EXPERIENCED DYSPAREUNIA ("DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE)") AND ABDOMINAL DISTENSION ("GASTROINTESTINAL OR DIGESTIVE SYSTEM CONDITION TYPE: BLOATING") AND WAS FOUND TO HAVE WEIGHT INCREASED ("WEIGHT GAIN"). IN (B)(6) 2012, THE PATIENT EXPERIENCED ALOPECIA ("HAIR LOSS"). IN (B)(6) 2013, THE PATIENT EXPERIENCED DENTAL CARIES ("DENTAL PROBLEMS/ DECAYING TEETH"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED DEVICE EXPULSION ("THE ONE ON THE LEFT EXTENDS QUITE FAR INTO THE FUNDAL ENDOMETRIUM"), HYPERSENSITIVITY ("ALLERGY"), FATIGUE ("FATIGUE") AND NAUSEA ("NAUSEA,"). THE PATIENT WAS TREATED WITH SURGERY (ROBOTIC SALPINGECTOMY AND HYSTERECTOMY). ESSURE WAS REMOVED ON (B)(6) 2021. AT THE TIME OF THE REPORT, THE ABDOMINAL PAIN LOWER, DEVICE EXPULSION, DYSPAREUNIA, HYPERSENSITIVITY, ABDOMINAL DISTENSION, FATIGUE, ALOPECIA, DENTAL CARIES, NAUSEA, MUSCLE SPASMS, DEPRESSION, ANXIETY AND WEIGHT INCREASED OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL DISTENSION, ABDOMINAL PAIN LOWER, ALOPECIA, ANXIETY, DENTAL CARIES, DEPRESSION, DEVICE EXPULSION, DYSPAREUNIA, FATIGUE, HYPERSENSITIVITY, MUSCLE SPASMS, NAUSEA AND WEIGHT INCREASED TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: DISCREPANCY NOTED IN INSERTION DATE- (B)(6) 2011. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 23.3 KG/SQM. HYSTEROSALPINGOGRAM - IN (B)(6) 2012: TOTAL BILATERAL OCCLUSION. IMAGING PROCEDURE - ON (B)(6) 2013: ESSURE CONFIRMATION TEST WAS UNSPECIFIED, RESULT WAS UNKNOWN. ULTRASOUND SCAN VAGINA - ON (B)(6) 2021: THE ENDOMETRIUM IS PARTICULARLY VERY POORLY SEEN. THERE DOES APPEAR TO BE A TUBAL OCCLUSION DEVICES. A TUBAL OCCLUSION DEVICE ENTERING FROM THE LEFT MAY EXTEND INTO THE REGION OF THE FUNDAL ENDOMETRIUM. THE MYOMETRIUM AND OVARIES ARE POORLY VISUALIZED. LOT NUMBER: 841534, MANUFACTURE DATE: 2011-03, EXPIRATION DATE: 2014-03. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 01-OCT-2021: MR RECEIVED. CASE CATEGORY UPDATED TO SERIOUS INCIDENT. ESSURE REMOVAL WAS DONE. REPORTER, LAB DATA AND MEDICAL HISTORY ADDED. NEW EVENT ADDED- PARTIAL EXPULSION OF DEVICE. 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.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1508151 | ESSURE | TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE | HHS | BAYER PHARMA AG | ESS305 | 841534 | 10888853003051 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 24 YR | Other| R |