ESSURE
Report
- Report Number
- 2951250-2019-07813
- Event Type
- Injury
- Date Received
- September 23, 2019
- Report Date
- October 21, 2019
- Manufacturer
- BAYER PHARMA AG
- Product Code
- HHS
- UDI-DI
- 10888853003051
- PMA / PMN Number
- P020014
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- OTHER
Narratives
THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ('PELVIC PAINS') AND GENITAL HAEMORRHAGE ('HEAVY BLEEDING/ ABNORMAL BLEEDING (GENERAL)') IN A 26-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 901328) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S MEDICAL HISTORY INCLUDED BODY MASS INDEX NORMAL. CONCOMITANT PRODUCTS INCLUDED IBUPROFEN SINCE 2012 FOR MIGRAINE HEADACHE, LORATADINE AND PREDNISOLONE FOR RASH ALL OVER, LEVOTHYROXINE SINCE (B)(6) 2019 FOR THYROID DISORDER NOS AS WELL AS NORETHISTERONE (MINI-PILL) FROM 2007 TO 2012. IN (B)(6) 2012, THE PATIENT EXPERIENCED BACK PAIN ("BACK PAIN") AND DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING)"). ON (B)(6) 2012, THE PATIENT HAD ESSURE INSERTED. IN (B)(6) 2012, THE PATIENT EXPERIENCED DYSPAREUNIA ("PAIN DURING INTERCOURSE/DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE)") AND MIGRAINE ("MIGRAINE/ MIGRAINES / HEADACHES") AND WAS FOUND TO HAVE WEIGHT INCREASED ("WEIGHT GAIN"). IN (B)(6) 2013, THE PATIENT EXPERIENCED MENORRHAGIA ("MENORRHAGIA (HEAVY MENSTRUAL BLEEDING)/ ABNORMAL BLEEDING (MENORRHAGIA)"), VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL)") AND DYSGEUSIA ("METAL TASTE"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), GENITAL HAEMORRHAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), ABDOMINAL PAIN LOWER ("CRAMPING") AND ALLERGY TO METALS ("NICKEL ALLERGY"). THE PATIENT WAS TREATED WITH SURGERY (ESSURE REMOVAL). ESSURE WAS REMOVED ON (B)(6) 2016. AT THE TIME OF THE REPORT, THE PELVIC PAIN, ABDOMINAL PAIN LOWER AND DYSPAREUNIA HAD NOT RESOLVED, THE GENITAL HAEMORRHAGE, MENORRHAGIA AND VAGINAL HAEMORRHAGE HAD RESOLVED AND THE WEIGHT INCREASED, MIGRAINE, BACK PAIN, DYSMENORRHOEA, ALLERGY TO METALS AND DYSGEUSIA OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL PAIN LOWER, ALLERGY TO METALS, BACK PAIN, DYSGEUSIA, DYSMENORRHOEA, DYSPAREUNIA, GENITAL HAEMORRHAGE, MENORRHAGIA, MIGRAINE, PELVIC PAIN, VAGINAL HAEMORRHAGE AND WEIGHT INCREASED TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: SHE RECEIVED TREATMENT FOR WEIGHT GAIN AND MIGRAINE. ON (B)(6) 2016- SHE PERFORMED TUBAL REVERSAL AND REANASTOMOSIS SURGERY. CURRENT WEIGHT 130 LBS. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 22.7 KG/SQM. IMAGING PROCEDURE - ON (B)(6) 2012: ESSURE CONFIRMATION TEST(S) (UNSPECIFIED)- BILATERAL OCCLUSION. CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONE/ONES WERE DESCRIBED IN PATIENT¿S MEDICAL RECORDS: PELVIC PAIN. LOT NUMBER: 901328 MANUFACTURING DATE: 2011/09 EXPIRATION DATE: 2014/09. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON (B)(6) 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.
THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ('PELVIC PAINS') AND GENITAL HAEMORRHAGE ('HEAVY BLEEDING/ ABNORMAL BLEEDING (GENERAL)') IN A 26-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 901328) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S MEDICAL HISTORY INCLUDED BODY MASS INDEX NORMAL. CONCOMITANT PRODUCTS INCLUDED IBUPROFEN SINCE 2012 FOR MIGRAINE HEADACHE, LORATADINE AND PREDNISOLONE FOR RASH ALL OVER, LEVOTHYROXINE SINCE (B)(6) 2019 FOR THYROID DISORDER AS WELL AS NORETHISTERONE (MINI-PILL) FROM 2007 TO 2012. IN (B)(6) 2012, THE PATIENT EXPERIENCED BACK PAIN ("BACK PAIN") AND DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING)"). ON (B)(6) 2012, THE PATIENT HAD ESSURE INSERTED. IN (B)(6) 2012, THE PATIENT EXPERIENCED DYSPAREUNIA ("PAIN DURING INTERCOURSE/DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE)") AND MIGRAINE ("MIGRAINE/ MIGRAINES / HEADACHES") AND WAS FOUND TO HAVE WEIGHT INCREASED ("WEIGHT GAIN"). IN (B)(6) 2013, THE PATIENT EXPERIENCED MENORRHAGIA ("MENORRHAGIA (HEAVY MENSTRUAL BLEEDING)/ ABNORMAL BLEEDING (MENORRHAGIA)"), VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL)") AND DYSGEUSIA ("METAL TASTE"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), GENITAL HAEMORRHAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), ABDOMINAL PAIN LOWER ("CRAMPING") AND ALLERGY TO METALS ("NICKEL ALLERGY"). THE PATIENT WAS TREATED WITH SURGERY (ESSURE REMOVAL). ESSURE WAS REMOVED ON (B)(6) 2016. AT THE TIME OF THE REPORT, THE PELVIC PAIN, ABDOMINAL PAIN LOWER AND DYSPAREUNIA HAD NOT RESOLVED, THE GENITAL HAEMORRHAGE, MENORRHAGIA AND VAGINAL HAEMORRHAGE HAD RESOLVED AND THE WEIGHT INCREASED, MIGRAINE, BACK PAIN, DYSMENORRHOEA, ALLERGY TO METALS AND DYSGEUSIA OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL PAIN LOWER, ALLERGY TO METALS, BACK PAIN, DYSGEUSIA, DYSMENORRHOEA, DYSPAREUNIA, GENITAL HAEMORRHAGE, MENORRHAGIA, MIGRAINE, PELVIC PAIN, VAGINAL HAEMORRHAGE AND WEIGHT INCREASED TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: SHE RECEIVED TREATMENT FOR WEIGHT GAIN AND MIGRAINE. ON (B)(6) 2016- SHE PERFORMED TUBAL REVERSAL AND REANASTOMOSIS SURGERY. CURRENT WEIGHT 130 LBS. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 22.7 KG/SQM. IMAGING PROCEDURE - ON (B)(6) 2012: ESSURE CONFIRMATION TEST(S) (UNSPECIFIED)- BILATERAL OCCLUSION. CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONE/ONES WERE DESCRIBED IN PATIENT¿S MEDICAL RECORDS: PELVIC PAIN. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 12-SEP-2019: PLAINTIFF FACT SHEET AND MEDICAL RECORD WAS RECEIVED. LOT NUMBER WERE ADDED. EVENTS ADDED FROM PFS- ABNORMAL BLEEDING (VAGINAL), BACK PAIN, DYSMENORRHEA (CRAMPING), NICKEL ALLERGY, METAL TASTE. REPORTER INFORMATION, MEDICAL HISTORY, CONCOMITANT DRUG, EVENTS ONSET DATE WERE ADDED. EVENTS OUTCOME WERE UPDATED. 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-CONFORMANT 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 ('PELVIC PAINS') AND GENITAL HAEMORRHAGE ('HEAVY BLEEDING') IN AN ADULT FEMALE PATIENT WHO HAD ESSURE INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. ON (B)(6) 2012, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), GENITAL HAEMORRHAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), ABDOMINAL PAIN LOWER ("CRAMPING"), DYSPAREUNIA ("PAIN DURING INTERCOURSE/DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE)"), MENORRHAGIA ("MENORRHAGIA (HEAVY MENSTRUAL BLEEDING)") AND MIGRAINE ("MIGRAINE") AND WAS FOUND TO HAVE WEIGHT INCREASED ("WEIGHT GAIN"). THE PATIENT WAS TREATED WITH SURGERY (ESSURE REMOVAL). ESSURE WAS REMOVED ON (B)(6) 2016. AT THE TIME OF THE REPORT, THE PELVIC PAIN, GENITAL HAEMORRHAGE, ABDOMINAL PAIN LOWER AND DYSPAREUNIA HAD NOT RESOLVED, THE MENORRHAGIA HAD RESOLVED AND THE WEIGHT INCREASED AND MIGRAINE OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL PAIN LOWER, DYSPAREUNIA, GENITAL HAEMORRHAGE, MENORRHAGIA, MIGRAINE, PELVIC PAIN AND WEIGHT INCREASED TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: SHE RECEIVED TREATMENT FOR WEIGHT GAIN AND MIGRAINE. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): IMAGING PROCEDURE ON (B)(6) 2012: ESSURE CONFIRMATION TEST(S) (UNSPECIFIED) BILATERAL OCCLUSION. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 9-SEP-2019: PFS RECEIVED. PRODUCT INDICATION UPDATED. ESSURE EXPLANT DATE ADDED. EVENTS- MENORRHAGIA (HEAVY MENSTRUAL BLEEDING), WEIGHT GAIN AND MIGRAINE WERE ADDED. LAB DATA ADDED. 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.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 898646 | ESSURE | TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE | HHS | BAYER PHARMA AG | ESS305 | 901328 | 10888853003051 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 26 YR | Other| R | IBUPROFEN| IBUPROFEN| LEVOTHYROXINE| LEVOTHYROXINE| LORATADINE| LORATADINE| MINI-PILL| MINI-PILL| PREDNISOLONE| PREDNISOLONE |