ESSURE
Report
- Report Number
- 2951250-2017-10279
- Event Type
- Injury
- Date Received
- December 8, 2017
- Report Date
- February 22, 2019
- Manufacturer
- BAYER PHARMA AG
- Product Code
- HHS
- PMA / PMN Number
- P020014
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OH, US
- Reporter Occupation
- OTHER
Narratives
THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ("PAIN") IN A 38-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO: 841631 (L ) , 841631 ( R )) INSERTED FOR FEMALE STERILIZATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S CONCURRENT CONDITIONS INCLUDED OVERWEIGHT. CONCOMITANT PRODUCTS INCLUDED IBUPROFEN AND PARACETAMOL (TYLENOL 8 HOUR). IN APRIL 2011, THE PATIENT HAD ESSURE INSERTED. IN MAY 2011, THE PATIENT WAS FOUND TO HAVE WEIGHT INCREASED ("WEIGHT GAIN"). IN NOVEMBER 2011, THE PATIENT EXPERIENCED VAGINAL HAEMORRHAGE ("ABNORMAL VAGINAL BLEEDING"), MENORRHAGIA ("MENORRHAGIA"), ABDOMINAL PAIN UPPER ("STOMACH PAIN/ APIN IN MY STOMACH"), DYSPAREUNIA ("DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE).") AND DYSMENORRHOEA ("DYSMENORRHEA(CRAMPING)"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED) AND ABDOMINAL PAIN ("ABDOMINAL PAIN"). THE PATIENT WAS TREATED WITH SURGERY (TOTAL LAPAROSCOPIC HYSTERECTOMY WITH BILATERAL SALPINGECTOMY). ESSURE WAS REMOVED ON (B)(6) 2014. AT THE TIME OF THE REPORT, THE PELVIC PAIN, VAGINAL HAEMORRHAGE, MENORRHAGIA, WEIGHT INCREASED, ABDOMINAL PAIN UPPER, DYSPAREUNIA AND DYSMENORRHOEA OUTCOME WAS UNKNOWN AND THE ABDOMINAL PAIN WAS RESOLVING. THE REPORTER CONSIDERED ABDOMINAL PAIN, ABDOMINAL PAIN UPPER, DYSMENORRHOEA, DYSPAREUNIA, MENORRHAGIA, PELVIC PAIN, VAGINAL HAEMORRHAGE AND WEIGHT INCREASED TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: NEED FOR ADDITIONAL SURGERY. DISCREPANCY NOTED IN DATE OF INSERTION- PREVIOUS INSERTION DATE WAS ,OCT-2011, APR-2011 AND IN CURRENT F/U (B)(6) 2011 IS MENTIONED. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 35.3 KG/SQM. HYSTEROSALPINGOGRAM: ON (B)(6) 2012: TOTAL BILATERAL OCCLUSION. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 18-DEC-2018: MEDICAL RECORD RECEIVED. REPORTER ADDED. LOT NUMBER ADDED. INCIDENT: WE RECEIVED A LOT NUMBER. A TECHNICAL INVESTIGATION WILL BE CONDUCTED, INCLUDING A BATCH REVIEW, AND A REVIEW OF COMPLAINT RECORDS AND OTHER NON-CONFORMANCES DATA; SHOULD ANY NEW AND REPORTABLE INFORMATION BECOME AVAILABLE AS A RESULT, THIS WILL BE PROVIDED IN A SUPPLEMENTARY REPORT.
THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ("PAIN") IN A 38-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 841631-INVALID,841531-VALID) INSERTED FOR FEMALE STERILIZATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S CONCURRENT CONDITIONS INCLUDED OVERWEIGHT. CONCOMITANT PRODUCTS INCLUDED IBUPROFEN AND PARACETAMOL (TYLENOL 8 HOUR). IN (B)(6) 2011, THE PATIENT HAD ESSURE INSERTED. IN (B)(6) 2011, THE PATIENT WAS FOUND TO HAVE WEIGHT INCREASED ("WEIGHT GAIN"). IN (B)(6) 2011, THE PATIENT EXPERIENCED VAGINAL HAEMORRHAGE ("ABNORMAL VAGINAL BLEEDING"), MENORRHAGIA ("MENORRHAGIA"), ABDOMINAL PAIN UPPER ("STOMACH PAIN/ PAIN IN MY STOMACH"), DYSPAREUNIA ("DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE).") AND DYSMENORRHOEA ("DYSMENORRHEA(CRAMPING)"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED) AND ABDOMINAL PAIN ("ABDOMINAL PAIN"). THE PATIENT WAS TREATED WITH SURGERY (TOTAL LAPAROSCOPIC HYSTERECTOMY WITH BILATERAL SALPINGECTOMY). ESSURE WAS REMOVED ON (B)(6)2014. AT THE TIME OF THE REPORT, THE PELVIC PAIN, VAGINAL HAEMORRHAGE, MENORRHAGIA, WEIGHT INCREASED, ABDOMINAL PAIN UPPER, DYSPAREUNIA AND DYSMENORRHOEA OUTCOME WAS UNKNOWN AND THE ABDOMINAL PAIN WAS RESOLVING. THE REPORTER CONSIDERED ABDOMINAL PAIN, ABDOMINAL PAIN UPPER, DYSMENORRHOEA, DYSPAREUNIA, MENORRHAGIA, PELVIC PAIN, VAGINAL HAEMORRHAGE AND WEIGHT INCREASED TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: NEED FOR ADDITIONAL SURGERY DISCREPANCY NOTED IN DATE OF INSERTION- PREVIOUS INSERTION DATE WAS (B)(6)2011, (B)(6)2011 AND IN CURRENT F/U (B)(6)2011 IS MENTIONED. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 35.3 KG/SQM. HYSTEROSALPINGOGRAM - ON (B)(6)2012: TOTAL BILATERAL OCCLUSION. 841631- NOT A VALID. LOT NUMBER: 841531 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 22-FEB-2019: QUALITY SAFETY EVALUATION OF PTC. INCIDENT 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 NON-CONFORMANCES DATA; SHOULD ANY NEW AND REPORTABLE INFORMATION BECOME AVAILABLE AS A RESULT, THIS WILL BE PROVIDED IN A SUPPLEMENTARY REPORT.
NTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ("PAIN") IN A 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 OVERWEIGHT. IN (B)(6) 2011, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), VAGINAL HAEMORRHAGE ("ABNORMAL VAGINAL BLEEDING"), MENORRHAGIA ("MENORRHAGIA"), WEIGHT INCREASED ("WEIGHT GAIN"), ABDOMINAL PAIN UPPER ("STOMACH PAIN") AND ABDOMINAL PAIN ("ABDOMINAL PAIN"). THE PATIENT WAS TREATED WITH SURGERY (TOTAL LAPAROSCOPIC HYSTERECTOMY WITH BILATERAL SALPINGECTOMY). ESSURE WAS REMOVED IN (B)(6) 2014. AT THE TIME OF THE REPORT, THE PELVIC PAIN, VAGINAL HAEMORRHAGE, MENORRHAGIA, WEIGHT INCREASED AND ABDOMINAL PAIN UPPER OUTCOME WAS UNKNOWN AND THE ABDOMINAL PAIN WAS RESOLVING. THE REPORTER CONSIDERED ABDOMINAL PAIN, ABDOMINAL PAIN UPPER, MENORRHAGIA, PELVIC PAIN, VAGINAL HAEMORRHAGE AND WEIGHT INCREASED TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: NEED FOR ADDITIONAL SURGERY PREVIOUS INSERTION DATE WAS (B)(6) 2011. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 35.3 KG/SQM. HYSTEROSALPINGOGRAM - ON AN UNKNOWN DATE: DOES NOT RECALL RESULT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 7-SEP-2018: PFS AND MR RECEIVED:EVENT ABNORMAL VAGINAL BLEEDING, MENORRHAGIA, WEIGHT GAIN, STOMACH PAIN, ABDOMINAL PAIN ADDED. REPORTER,DEMOGRAPHIC INFORMATION,CONCURRENT CONDITION ADDED. INCIDENT: NO 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 PELVIC PAIN ("PAIN") IN A 38-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 OVERWEIGHT. CONCOMITANT PRODUCTS INCLUDED IBUPROFEN AND PARACETAMOL (TYLENOL 8 HOUR). IN (B)(6)2011, THE PATIENT HAD ESSURE INSERTED. IN (B)(6)2011, THE PATIENT WAS FOUND TO HAVE WEIGHT INCREASED ("WEIGHT GAIN"). IN (B)(6)2011, THE PATIENT EXPERIENCED VAGINAL HAEMORRHAGE ("ABNORMAL VAGINAL BLEEDING"), MENORRHAGIA ("MENORRHAGIA"), ABDOMINAL PAIN UPPER ("STOMACH PAIN/ A PAIN IN MY STOMACH"), DYSPAREUNIA ("DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE).") AND DYSMENORRHOEA ("DYSMENORRHEA(CRAMPING)"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED) AND ABDOMINAL PAIN ("ABDOMINAL PAIN"). THE PATIENT WAS TREATED WITH SURGERY (TOTAL LAPAROSCOPIC HYSTERECTOMY WITH BILATERAL SALPINGECTOMY). ESSURE WAS REMOVED ON (B)(6)2014. AT THE TIME OF THE REPORT, THE PELVIC PAIN, VAGINAL HAEMORRHAGE, MENORRHAGIA, WEIGHT INCREASED, ABDOMINAL PAIN UPPER, DYSPAREUNIA AND DYSMENORRHOEA OUTCOME WAS UNKNOWN AND THE ABDOMINAL PAIN WAS RESOLVING. THE REPORTER CONSIDERED ABDOMINAL PAIN, ABDOMINAL PAIN UPPER, DYSMENORRHOEA, DYSPAREUNIA, MENORRHAGIA, PELVIC PAIN, VAGINAL HAEMORRHAGE AND WEIGHT INCREASED TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: NEED FOR ADDITIONAL SURGERY DISCREPANCY NOTED IN DATE OF INSERTION- PREVIOUS INSERTION DATE WAS (B)(6)2011, (B)(6)2011 AND IN CURRENT F/U (B)(6)2011 IS MENTIONED . DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 35.3 KG/SQM. HYSTEROSALPINGOGRAM - ON (B)(6)2012: TOTAL BILATERAL OCCLUSION. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 14-DEC-2018: PFS RECEIVED- NEW EVENT DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE), DYSMENORRHEA(CRAMPING) WERE ADDED. CONCOMITANT DRUG 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 PELVIC PAIN ("PAIN") IN A FEMALE PATIENT WHO HAD ESSURE INSERTED. IN (B)(6) 2011, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED). THE PATIENT WAS TREATED WITH SURGERY (PATIENT HAD SURGERY TO REMOVE THE ESSURE IMPLANT). ESSURE WAS REMOVED IN (B)(6) 2017. AT THE TIME OF THE REPORT, THE PELVIC PAIN OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED PELVIC PAIN TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: NEED FOR ADDITIONAL SURGERY. NO 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.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 878692 | ESSURE | TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE | HHS | BAYER PHARMA AG | ESS305 | 841631-INVALID,841531-VALID |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 38 YR | Other| R | IBUPROFEN| IBUPROFEN| IBUPROFEN| TYLENOL 8 HOUR| TYLENOL 8 HOUR| TYLENOL 8 HOUR |