ESSURE
Report
- Report Number
- 2951250-2018-03743
- Event Type
- Injury
- Date Received
- August 28, 2018
- Date of Event
- May 1, 2008
- Report Date
- June 6, 2023
- Manufacturer
- BAYER PHARMA AG
- Product Code
- HHS
- UDI-DI
- 10888853003051
- PMA / PMN Number
- P020014
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OH, US
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF ALLERGY TO METALS ("NICKEL ALLERGY") AND HERNIA REPAIR ("HERNIA REPAIR") IN A 22-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 626152, 526152-INV) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S PAST MEDICAL HISTORY INCLUDED DEPRESSION, ASTHMA, BRONCHITIS AND PSYCHIATRIC DISORDER NOS. CONCURRENT CONDITIONS INCLUDED ANESTHESIA AND BODY MASS INDEX NORMAL. CONCOMITANT PRODUCTS INCLUDED IBUPROFEN. ON (B)(6) 2008, THE PATIENT HAD ESSURE INSERTED. ON (B)(6) 2008, 28 DAYS AFTER INSERTION OF ESSURE, THE PATIENT EXPERIENCED ALLERGY TO METALS (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED) WITH RASH, PELVIC PAIN ("SEVERE PELVIC PAIN/ PAIN"), DYSMENORRHOEA ("ABNORMAL MENSTRUATION PAIN/ DYSMENORRHEA (CRAMPING)"), FATIGUE ("FATIGUE"), DYSPAREUNIA ("PAIN DURING INTERCOURSE/ DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE)"), MIGRAINE ("MIGRAINES"), MOOD SWINGS ("MOOD SWINGS"), VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL)"), THE FIRST EPISODE OF MENORRHAGIA ("ABNORMAL BLEEDING ( MENORRHAGIA)"), VAGINAL INFECTION ("CONSTANT VAGINITIS"), HEADACHE ("HEADACHES"), NAUSEA ("NAUSEA") AND ALOPECIA ("HAIR LOSS"). IN (B)(6) 2016, THE PATIENT UNDERWENT HERNIA REPAIR (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED THE SECOND EPISODE OF MENORRHAGIA ("ABNORMAL, HEAVY, MENSTRUAL BLEEDING"), ABDOMINAL PAIN LOWER ("SEVERE ABDOMINAL CRAMPING"), WEIGHT INCREASED ("WEIGHT GAIN"), VAGINAL DISCHARGE ("VAGINAL DISCHARGE") AND ABDOMINAL PAIN ("ABDOMINAL PAIN"). THE PATIENT WAS TREATED WITH ANTIBIOTICS, SURGERY (ESSURE REMOVAL) AND SURGERY (HERNIA REPAIR SURGERY). ESSURE WAS REMOVED ON (B)(6) 2018. AT THE TIME OF THE REPORT, THE ALLERGY TO METALS, VAGINAL HAEMORRHAGE, VAGINAL INFECTION, HEADACHE, NAUSEA, HERNIA REPAIR, VAGINAL DISCHARGE AND ALOPECIA OUTCOME WAS UNKNOWN, THE PELVIC PAIN, DYSMENORRHOEA, THE LAST EPISODE OF MENORRHAGIA, FATIGUE AND WEIGHT INCREASED HAD NOT RESOLVED, THE DYSPAREUNIA, ABDOMINAL PAIN LOWER, MIGRAINE AND ABDOMINAL PAIN HAD RESOLVED AND THE MOOD SWINGS WAS RESOLVING. THE REPORTER CONSIDERED ABDOMINAL PAIN, ABDOMINAL PAIN LOWER, ALLERGY TO METALS, ALOPECIA, DYSMENORRHOEA, DYSPAREUNIA, FATIGUE, HEADACHE, HERNIA REPAIR, MIGRAINE, MOOD SWINGS, NAUSEA, PELVIC PAIN, VAGINAL DISCHARGE, VAGINAL HAEMORRHAGE, VAGINAL INFECTION, WEIGHT INCREASED, THE FIRST EPISODE OF MENORRHAGIA AND THE SECOND EPISODE OF MENORRHAGIA TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: SHE HAD NOT YET BEEN ABLE TO UNDERGO SURGERY TO REMOVE THE ESSURE MICRO-INSERTS, AND STILL SUFFERS TO THIS DAY FROM THE ABOVE SYMPTOMS. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 18.7 KG/SQM. HYSTEROSALPINGOGRAM - ON (B)(6) 2008: FULL OCCLUSION OF FALLOPIAN TUBES. LOT NUMBERS AND EXP/MFG DATES: BATCH NO. 526152 IS INVALID. LOT NUMBER: 626152, MANUFACTURE DATE: 2007-10, EXPIRATION DATE: 2009-09. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 5-SEP-2018: QUALITY-SAFETY EVALUATION OF PRODUCT TECHNICAL COMPLAINT. INCIDENT: AT THE TIME OF REPORTING, 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 ORIGINALLY REPORTED BY A LAWYER ON BEHALF OF A CONSUMER AND DESCRIBES THE OCCURRENCE OF ALLERGY TO METALS ("NICKEL ALLERGY") AND HERNIA REPAIR ("HERNIA REPAIR") IN A 22 YEAR-OLD FEMALE PATIENT WHO HAD ESSURE INSERTED (LOT NO. 626152) FOR FEMALE STERILISATION. ADDITIONAL NON-SERIOUS EVENTS ARE DETAILED BELOW. THE PATIENT HAD A MEDICAL HISTORY OF LEG PAIN, BLURRED VISION, PSYCHIATRIC DISORDER NOS, BRONCHITIS, ASTHMA AND DEPRESSION. PREVIOUSLY ADMINISTERED PRODUCTS INCLUDED: VANCOMYCIN. CONCURRENT CONDITIONS WERE LISTED AS EDEMA, CONSTIPATION, OVARIAN CYST, SHOULDER PAIN, JOINT PAIN, TINGLING, CERVICALGIA, PAIN IN HIP, FLANK PAIN, ACUTE SINUSITIS, HEADACHE, EAR PAIN, MYDRIASIS, ANKLE SPRAIN, PUPILS UNEQUAL, PERIUMBILICAL PAIN, BODY MASS INDEX NORMAL AND ANESTHESIA. CONCOMITANT PRODUCTS INCLUDED HYDROCODONE, ACETAMINOPHEN (PARACETAMOL) AND IBUPROFEN. ON (B)(6) 2008, THE PATIENT HAD ESSURE INSERTED. ON (B)(6) 2008, 27 DAYS AFTER ESSURE INSERTION, SHE EXPERIENCED ALLERGY TO METALS (SERIOUSNESS CRITERIA MEDICALLY IMPORTANT AND INTERVENTION REQUIRED), PELVIC PAIN ("SEVERE PELVIC PAIN/ PAIN"), DYSMENORRHOEA ("ABNORMAL MENSTRUATION PAIN/ DYSMENORRHEA (CRAMPING)"), FATIGUE ("FATIGUE"), DYSPAREUNIA ("PAIN DURING INTERCOURSE/ DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE)"), MIGRAINE ("MIGRAINES"), MOOD SWINGS ("MOOD SWINGS"), VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL)"), MENORRHAGIA ("ABNORMAL BLEEDING ( MENORRHAGIA)"), VAGINAL INFECTION ("CONSTANT VAGINITIS"), HEADACHE ("HEADACHES"), NAUSEA ("NAUSEA"), VAGINAL DISCHARGE ("VAGINAL DISCHARGE") AND ALOPECIA ("HAIR LOSS"). IN (B)(6) 2016 SHE UNDERWENT HERNIA REPAIR (SERIOUSNESS CRITERION MEDICALLY IMPORTANT). ESSURE WAS REMOVED ON (B)(6) 2018. AN UNKNOWN TIME LATER SHE EXPERIENCED RASH ("RASHES OR SKIN : GENEARL RASHES"), BLEEDING MENSTRUAL HEAVY ("ABNORMAL, HEAVY, MENSTRUAL BLEEDING"), ABDOMINAL PAIN LOWER ("SEVERE ABDOMINAL CRAMPING") AND ABDOMINAL PAIN ("ABDOMINAL PAIN") AND WAS FOUND TO HAVE WEIGHT INCREASED ("WEIGHT GAIN"). THE PATIENT WAS TREATED WITH ANTIBIOTICS AS WELL AS SURGERY (ESSURE REMOVAL WITH HYSTERECTOMY AND HERNIA REPAIR SURGERY). AT THE TIME OF THE REPORT, THE MOOD SWINGS WAS RESOLVING, THE DYSPAREUNIA, ABDOMINAL PAIN LOWER, MIGRAINE AND ABDOMINAL PAIN HAD RESOLVED AND THE PELVIC PAIN, DYSMENORRHOEA, BLEEDING MENSTRUAL HEAVY, FATIGUE AND WEIGHT INCREASED HAD NOT RESOLVED. THE OUTCOMES FOR ALLERGY TO METALS, HERNIA REPAIR, VAGINAL HAEMORRHAGE, HEAVY MENSTRUAL BLEEDING, VAGINAL INFECTION, HEADACHE, NAUSEA, VAGINAL DISCHARGE AND ALOPECIA WERE UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL PAIN, ABDOMINAL PAIN LOWER, ALLERGY TO METALS, ALOPECIA, DYSMENORRHOEA, DYSPAREUNIA, FATIGUE, HEADACHE, MENORRHAGIA, BLEEDING MENSTRUAL HEAVY, HERNIA REPAIR, MIGRAINE, MOOD SWINGS, NAUSEA, PELVIC PAIN, RASH, VAGINAL DISCHARGE, VAGINAL HAEMORRHAGE, VAGINAL INFECTION AND WEIGHT INCREASED TO BE RELATED TO ESSURE ADMINISTRATION. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX: 18.651 KG/SQM. [HYSTEROSALPINGOGRAM] ON (B)(6) 2008: RESULTS: FULL OCCLUSION OF FALLOPIAN TUBES. LOT NUMBER: 626152 MANUFACTURE DATE: 2007-10 EXPIRATION DATE: 2009-09. (LOT NUMBER 526152 INVALID). ¿CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONES WERE DESCRIBED IN PATIENT¿S MEDICAL RECORD; CONFIRMING- EVENTS WHICH ARE SAME IN PFS & MR.¿ ABDOMINAL PAIN, HERNIA. QUALITY-SAFETY EVALUATION OF PTC: FOR ESSURE: UNABLE TO CONFIRM COMPLAINT. THE MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES DATA RECEIVED ON: 02-MAY-2023: REPORT VIA LAWYER. ESSURE REMOVAL SURGERY SPECIFIED. IMDRF-FDA SYNCHRONIZATION. 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.
THIS SPONTANEOUS CASE WAS ORIGINALLY REPORTED BY A LAWYER ON BEHALF OF A CONSUMER AND DESCRIBES THE OCCURRENCE OF ALLERGY TO METALS ("NICKEL ALLERGY") AND HERNIA REPAIR ("HERNIA REPAIR") IN A 22 YEAR-OLD FEMALE PATIENT WHO HAD ESSURE INSERTED (LOT NO. 626152) FOR FEMALE STERILISATION. ADDITIONAL NON-SERIOUS EVENTS ARE DETAILED BELOW. THE PATIENT HAD A MEDICAL HISTORY OF LEG PAIN, BLURRED VISION, PSYCHIATRIC DISORDER NOS, BRONCHITIS, ASTHMA AND DEPRESSION. PREVIOUSLY ADMINISTERED PRODUCTS INCLUDED: VANCOMYCIN. CONCURRENT CONDITIONS WERE LISTED AS EDEMA, CONSTIPATION, OVARIAN CYST, SHOULDER PAIN, JOINT PAIN, TINGLING, CERVICALGIA, PAIN IN HIP, FLANK PAIN, ACUTE SINUSITIS, HEADACHE, EAR PAIN, MYDRIASIS, ANKLE SPRAIN, PUPILS UNEQUAL, PERIUMBILICAL PAIN, BODY MASS INDEX NORMAL AND ANESTHESIA. CONCOMITANT PRODUCTS INCLUDED HYDROCODONE, ACETAMINOPHEN (PARACETAMOL) AND IBUPROFEN. ON (B)(6) 2008, THE PATIENT HAD ESSURE INSERTED. ON (B)(6) 2008, 27 DAYS AFTER ESSURE INSERTION, SHE EXPERIENCED ALLERGY TO METALS (SERIOUSNESS CRITERIA MEDICALLY IMPORTANT AND INTERVENTION REQUIRED), PELVIC PAIN ("SEVERE PELVIC PAIN/ PAIN"), DYSMENORRHOEA ("ABNORMAL MENSTRUATION PAIN/ DYSMENORRHEA (CRAMPING)"), FATIGUE ("FATIGUE"), DYSPAREUNIA ("PAIN DURING INTERCOURSE/ DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE)"), MIGRAINE ("MIGRAINES"), MOOD SWINGS ("MOOD SWINGS"), VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL)"), MENORRHAGIA ("ABNORMAL BLEEDING ( MENORRHAGIA)"), VAGINAL INFECTION ("CONSTANT VAGINITIS"), HEADACHE ("HEADACHES"), NAUSEA ("NAUSEA"), VAGINAL DISCHARGE ("VAGINAL DISCHARGE") AND ALOPECIA ("HAIR LOSS"). IN (B)(6) 2016 SHE UNDERWENT HERNIA REPAIR (SERIOUSNESS CRITERION MEDICALLY IMPORTANT). ESSURE WAS REMOVED ON (B)(6) 2018. AN UNKNOWN TIME LATER SHE EXPERIENCED RASH ("RASHES OR SKIN : GENEARL RASHES"), BLEEDING MENSTRUAL HEAVY ("ABNORMAL, HEAVY, MENSTRUAL BLEEDING"), ABDOMINAL PAIN LOWER ("SEVERE ABDOMINAL CRAMPING") AND ABDOMINAL PAIN ("ABDOMINAL PAIN") AND WAS FOUND TO HAVE WEIGHT INCREASED ("WEIGHT GAIN"). THE PATIENT WAS TREATED WITH ANTIBIOTICS AS WELL AS SURGERY (ESSURE REMOVAL WITH HYSTERECTOMY AND HERNIA REPAIR SURGERY). AT THE TIME OF THE REPORT, THE MOOD SWINGS WAS RESOLVING, THE DYSPAREUNIA, ABDOMINAL PAIN LOWER, MIGRAINE AND ABDOMINAL PAIN HAD RESOLVED AND THE PELVIC PAIN, DYSMENORRHOEA, BLEEDING MENSTRUAL HEAVY, FATIGUE AND WEIGHT INCREASED HAD NOT RESOLVED. THE OUTCOMES FOR ALLERGY TO METALS, HERNIA REPAIR, VAGINAL HAEMORRHAGE, HEAVY MENSTRUAL BLEEDING, VAGINAL INFECTION, HEADACHE, NAUSEA, VAGINAL DISCHARGE AND ALOPECIA WERE UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL PAIN, ABDOMINAL PAIN LOWER, ALLERGY TO METALS, ALOPECIA, DYSMENORRHOEA, DYSPAREUNIA, FATIGUE, HEADACHE, MENORRHAGIA, BLEEDING MENSTRUAL HEAVY, HERNIA REPAIR, MIGRAINE, MOOD SWINGS, NAUSEA, PELVIC PAIN, RASH, VAGINAL DISCHARGE, VAGINAL HAEMORRHAGE, VAGINAL INFECTION AND WEIGHT INCREASED TO BE RELATED TO ESSURE ADMINISTRATION. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX: 18.651 KG/SQM. [HYSTEROSALPINGOGRAM] ON (B)(6) 2008: RESULTS: FULL OCCLUSION OF FALLOPIAN TUBES. LOT NUMBER: 626152, MANUFACTURE DATE: 2007-10 AND EXPIRATION DATE: 2009-09. (LOT NUMBER 526152 INVALID). QUALITY-SAFETY EVALUATION OF PTC: FOR ESSURE: 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. THE MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES DATA RECEIVED ON: 02-JUN-2023: 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.
SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF ALLERGY TO METALS ("NICKEL ALLERGY") AND HERNIA REPAIR ("HERNIA REPAIR") IN A (B)(6) FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 526152, 626152) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S PAST MEDICAL HISTORY INCLUDED DEPRESSION, ASTHMA, BRONCHITIS AND PSYCHIATRIC DISORDER NOS. CONCURRENT CONDITIONS INCLUDED ANESTHESIA AND BODY MASS INDEX NORMAL. CONCOMITANT PRODUCTS INCLUDED IBUPROFEN. ON (B)(6) 2008, THE PATIENT HAD ESSURE INSERTED. ON (B)(6) 2008, 28 DAYS AFTER INSERTION OF ESSURE, THE PATIENT EXPERIENCED ALLERGY TO METALS (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED) WITH RASH, PELVIC PAIN ("SEVERE PELVIC PAIN/ PAIN"), DYSMENORRHOEA ("ABNORMAL MENSTRUATION PAIN/ DYSMENORRHEA (CRAMPING)"), FATIGUE ("FATIGUE"), DYSPAREUNIA ("PAIN DURING INTERCOURSE/ DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE)"), MIGRAINE ("MIGRAINES"), MOOD SWINGS ("MOOD SWINGS"), VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL)"), THE FIRST EPISODE OF MENORRHAGIA ("ABNORMAL BLEEDING ( MENORRHAGIA)"), VAGINAL INFECTION ("CONSTANT VAGINITIS"), HEADACHE ("HEADACHES"), NAUSEA ("NAUSEA") AND ALOPECIA ("HAIR LOSS"). IN (B)(6) 2016, THE PATIENT UNDERWENT HERNIA REPAIR (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED THE SECOND EPISODE OF MENORRHAGIA ("ABNORMAL, HEAVY, MENSTRUAL BLEEDING"), ABDOMINAL PAIN LOWER ("SEVERE ABDOMINAL CRAMPING"), WEIGHT INCREASED ("WEIGHT GAIN"), VAGINAL DISCHARGE ("VAGINAL DISCHARGE") AND ABDOMINAL PAIN ("ABDOMINAL PAIN"). THE PATIENT WAS TREATED WITH ANTIBIOTICS, SURGERY (ESSURE REMOVAL) AND SURGERY (HERNIA REPAIR SURGERY). ESSURE WAS REMOVED ON (B)(6) 2018. AT THE TIME OF THE REPORT, THE ALLERGY TO METALS, VAGINAL HAEMORRHAGE, VAGINAL INFECTION, HEADACHE, NAUSEA, HERNIA REPAIR, VAGINAL DISCHARGE AND ALOPECIA OUTCOME WAS UNKNOWN, THE PELVIC PAIN, DYSMENORRHOEA, THE LAST EPISODE OF MENORRHAGIA, FATIGUE AND WEIGHT INCREASED HAD NOT RESOLVED, THE DYSPAREUNIA, ABDOMINAL PAIN LOWER, MIGRAINE AND ABDOMINAL PAIN HAD RESOLVED AND THE MOOD SWINGS WAS RESOLVING. THE REPORTER CONSIDERED ABDOMINAL PAIN, ABDOMINAL PAIN LOWER, ALLERGY TO METALS, ALOPECIA, DYSMENORRHOEA, DYSPAREUNIA, FATIGUE, HEADACHE, HERNIA REPAIR, MIGRAINE, MOOD SWINGS, NAUSEA, PELVIC PAIN, VAGINAL DISCHARGE, VAGINAL HAEMORRHAGE, VAGINAL INFECTION, WEIGHT INCREASED, THE FIRST EPISODE OF MENORRHAGIA AND THE SECOND EPISODE OF MENORRHAGIA TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: SHE HAD NOT YET BEEN ABLE TO UNDERGO SURGERY TO REMOVE THE ESSURE MICRO-INSERTS, AND STILL SUFFERS TO THIS DAY FROM THE ABOVE SYMPTOMS. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 18.7 KG/SQM. HYSTEROSALPINGOGRAM - ON (B)(6) 2008: FULL OCCLUSION OF FALLOPIAN TUBES. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 24-AUG-2018: PLAINTIFF FACT SHEET AND MEDICAL RECORD RECEIVED. EVENTS ADDED: MOOD SWINGS, ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA), CONSTANT VAGINITIS, RASHES, HEADACHES, NAUSEA, NICKEL ALLERGY, HERNIA REPAIR, VAGINAL DISCHARGE, HAIR LOSS. LOT NO WAS ADDED. HISTORICAL CONDITIONS WERE ADDED. INCIDENT: AT THE TIME OF REPORTING, 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 |
|---|---|---|---|---|---|---|---|
| 662865 | ESSURE | TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE | HHS | BAYER PHARMA AG | ESS305 | 626152 | 10888853003051 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 22 YR | Female | Required Intervention| O | ACETAMINOPHEN| ACETAMINOPHEN| HYDROCODONE| HYDROCODONE| IBUPROFEN| IBUPROFEN| IBUPROFEN| IBUPROFEN| IBUPROFEN |