ESSURE
Report
- Report Number
- 2951250-2019-07759
- Event Type
- Injury
- Date Received
- September 23, 2019
- Date of Event
- January 1, 2011
- Report Date
- December 23, 2020
- Manufacturer
- BAYER PHARMA AG
- Product Code
- HHS
- UDI-DI
- 10888853003051
- PMA / PMN Number
- P020014
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- OTHER
Narratives
THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ('PELVIC PAIN') IN A FEMALE PATIENT WHO HAD ESSURE INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. ON (B)(6) 2011, THE PATIENT HAD ESSURE INSERTED. IN 2011, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), ABDOMINAL PAIN ("CRAMPING / ABDOMINAL PAIN"), DYSPAREUNIA ("PAINFUL INTERCOURSE") AND BACK PAIN ("BACK PAIN"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED GENITAL HAEMORRHAGE ("HEAVY BLEEDING"), DYSMENORRHOEA ("DYSMENORRHEA(CRAMPING)"), FEMALE SEXUAL DYSFUNCTION ("APAREUNIA"), MENORRHAGIA ("MENORRHAGIA (HEAVY MENSTRUAL BLEEDING)"), FATIGUE ("FATIGUE"), ALOPECIA ("HAIR LOSS"), MIGRAINE ("MIGRAINE") AND HAIR COLOUR CHANGES ("HAVE GREY HAIR") AND WAS FOUND TO HAVE HORMONE LEVEL ABNORMAL ("HORMONAL CHANGES"), WEIGHT INCREASED ("WEIGHT GAIN") AND WEIGHT DECREASED ("WEIGHT LOSS"). THE PATIENT WAS TREATED WITH SURGERY (SALPINGECTOMY(BILATERAL)). ESSURE WAS REMOVED ON (B)(6)2019. AT THE TIME OF THE REPORT, THE PELVIC PAIN, ABDOMINAL PAIN, BACK PAIN, DYSMENORRHOEA, FEMALE SEXUAL DYSFUNCTION, MENORRHAGIA, FATIGUE, ALOPECIA, HORMONE LEVEL ABNORMAL, MIGRAINE, WEIGHT INCREASED AND WEIGHT DECREASED HAD RESOLVED, THE GENITAL HAEMORRHAGE AND DYSPAREUNIA HAD NOT RESOLVED AND THE HAIR COLOUR CHANGES OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL PAIN, ALOPECIA, BACK PAIN, DYSMENORRHOEA, DYSPAREUNIA, FATIGUE, FEMALE SEXUAL DYSFUNCTION, GENITAL HAEMORRHAGE, HAIR COLOUR CHANGES, HORMONE LEVEL ABNORMAL, MENORRHAGIA, MIGRAINE, PELVIC PAIN, WEIGHT DECREASED AND WEIGHT INCREASED TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: PATIENT RECEIVED TREATMENT FOR- DYSMENORRHEA, APAREUNIA, PELVIC PAIN, ABDOMINAL PAIN, BACK PAIN, FATIGUE, HAIR LOSS, HORMONAL, CHANGES, MIGRAINE, WEIGHT GAIN AND WEIGHT LOSS. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): HYSTEROSALPINGOGRAM - ON AN UNKNOWN DATE: RESULTS: ESSURE IN PLACE, FUNCTIONING PROPERLY. IMAGING PROCEDURE - ON (B)(6)2011: ESSURE CONFIRMATION TEST (UNSPECIFIED) BILATERAL OCCLUSION. CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONES WERE REPORTED VIA SOCIAL MEDIA : HAIR COLOUR CHANGES. QUALITY-SAFETY EVALUATION OF PTC: SAMPLE NOT AVAILABLE. 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 KNOWN POSSIBLE UNDESIRABLE EVENTS AND 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 MED DRA LLT CAN BE PROVIDED. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON (B)(6)2020: SOCIAL MEDIA RECEIVED. REPORTER INFORMATION ADDED. EVENT : HAVE GREY HAIR ADDED. BASED ON THE AVAILABLE INFORMATION, A REVIEW OF OUR COMPLAINT RECORDS AND OTHER RELEVANT DATA WILL BE CONDUCTED; ANY NEW AND REPORTABLE INFORMATION THAT BECOMES AVAILABLE FROM OUR INVESTIGATION WILL BE PROVIDED IN A SUPPLEMENTARY REPORT.
THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ('PELVIC PAIN') AND MENORRHAGIA ('MENORRHAGIA (HEAVY MENSTRUAL BLEEDING)') IN AN ADULT FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 808913) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S MEDICAL HISTORY INCLUDED DEPRESSION, BIPOLAR DISORDER, POST-TRAUMATIC STRESS DISORDER, TOBACCO USE DISORDER, ACUTE VAGINITIS, GRAND MULTIPARITY, DYSFUNCTIONAL UTERINE BLEEDING AND OVARIAN CYST. CONCOMITANT PRODUCTS INCLUDED IBUPROFEN AND PARACETAMOL (TYLENOL). ON (B)(6) 2011, THE PATIENT HAD ESSURE INSERTED. IN 2011, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), ABDOMINAL PAIN ("CRAMPING / ABDOMINAL PAIN") AND BACK PAIN ("BACK PAIN"). IN (B)(6) 2011, THE PATIENT EXPERIENCED DYSMENORRHOEA ("DYSMENORRHEA(CRAMPING)") AND VAGINAL DISCHARGE ("VAGINAL DISCHARGE"). IN (B)(6) 2011, THE PATIENT EXPERIENCED MENORRHAGIA (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), DYSPAREUNIA ("PAINFUL INTERCOURSE"), FEMALE SEXUAL DYSFUNCTION ("APAREUNIA (INABILITY TO HAVE SEXUAL INTERCOURSE)"), FATIGUE ("FATIGUE") AND VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL)"). IN (B)(6) 2012, THE PATIENT EXPERIENCED ALOPECIA ("HAIR LOSS"), MOOD ALTERED ("HORMONAL CHANGES DESCRIBE: MOODINESS"), MIGRAINE ("MIGRAINE"), HOT FLUSH ("HOT FLASHES") AND HEADACHE ("HEADACHES"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED GENITAL HAEMORRHAGE ("HEAVY BLEEDING"), HAIR COLOUR CHANGES ("HAVE GREY HAIR"), ARTHRALGIA ("HIP PAIN") AND ABDOMINAL PAIN LOWER ("LOWER ABDOMEN PAIN") AND WAS FOUND TO HAVE WEIGHT INCREASED ("WEIGHT GAIN") AND WEIGHT DECREASED ("WEIGHT LOSS"). THE PATIENT WAS TREATED WITH SURGERY (ABLATION AND LAPAROSCOPIC BILATERAL SALPINGECTOMY , LAPAROSCOPIC REMOVAL OF ESSURE COILS). ESSURE WAS REMOVED ON (B)(6) 2019. AT THE TIME OF THE REPORT, THE PELVIC PAIN, MENORRHAGIA, ABDOMINAL PAIN, DYSPAREUNIA, BACK PAIN, DYSMENORRHOEA, FEMALE SEXUAL DYSFUNCTION, FATIGUE, ALOPECIA, MOOD ALTERED, MIGRAINE, WEIGHT INCREASED, WEIGHT DECREASED, VAGINAL HAEMORRHAGE, ARTHRALGIA AND ABDOMINAL PAIN LOWER HAD RESOLVED, THE GENITAL HAEMORRHAGE HAD NOT RESOLVED AND THE HAIR COLOUR CHANGES, HEADACHE AND VAGINAL DISCHARGE OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL PAIN, ABDOMINAL PAIN LOWER, ALOPECIA, ARTHRALGIA, BACK PAIN, DYSMENORRHOEA, DYSPAREUNIA, FATIGUE, FEMALE SEXUAL DYSFUNCTION, GENITAL HAEMORRHAGE, HAIR COLOUR CHANGES, HEADACHE, HOT FLUSH, MENORRHAGIA, MIGRAINE, MOOD ALTERED, PELVIC PAIN, VAGINAL DISCHARGE, VAGINAL HAEMORRHAGE, WEIGHT DECREASED AND WEIGHT INCREASED TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: PATIENT RECEIVED TREATMENT FOR- DYSMENORRHEA, APAREUNIA, PELVIC PAIN, ABDOMINAL PAIN, BACK PAIN, FATIGUE, HAIR LOSS, HORMONAL, CHANGES, MIGRAINE, WEIGHT GAIN AND WEIGHT LOSS. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 36.7 KG/SQM. HYSTEROSALPINGOGRAM - ON (B)(6) 2011: RESULTS: ESSURE IN PLACE, FUNCTIONING PROPERLY TOTAL BILATERAL OCCLUSION. SUCCESSFUL OCCLUSION OF BILATERAL FALLOPIAN TUBES FOLLOWING ESSURE PROCEDURE. CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONES WERE REPORTED VIA SOCIAL MEDIA : HAIR COLOUR CHANGES MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 3-DEC-2020: PFS RECEIVED LOT NUMBER WAS ADDED. EVENTS " HORMONAL CHANGES DESCRIBE: MOODINESS, HOT FLASHES, ABNORMAL BLEEDING (VAGINAL), HEADACHES, HIP PAIN, LOWER ABDOMINAL PAIN, VAGINAL DISCHARGE, HEADACHE" WERE ADDED. OUTCOME OF EVENT " ABNORMAL BLEEDING, MIGRAINE, PAIN" WERE UPDATED AS RECOVERED. MEDICAL HISTORY , PATIENT DEMOGRAPHICS, CONCOMITANT DRUGS AND LAB DATA WERE ADDED. 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 REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ('PELVIC PAIN') IN A FEMALE PATIENT WHO HAD ESSURE INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. ON (B)(6)2011, THE PATIENT HAD ESSURE INSERTED. IN 2011, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), ABDOMINAL PAIN ("CRAMPING / ABDOMINAL PAIN"), DYSPAREUNIA ("PAINFUL INTERCOURSE") AND BACK PAIN ("BACK PAIN"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED GENITAL HAEMORRHAGE ("HEAVY BLEEDING"), DYSMENORRHOEA ("DYSMENORRHEA(CRAMPING)"), FEMALE SEXUAL DYSFUNCTION ("APAREUNIA"), MENORRHAGIA ("MENORRHAGIA (HEAVY MENSTRUAL BLEEDING)"), FATIGUE ("FATIGUE"), ALOPECIA ("HAIR LOSS"), MIGRAINE ("MIGRAINE") AND HAIR COLOUR CHANGES ("HAVE GREY HAIR") AND WAS FOUND TO HAVE HORMONE LEVEL ABNORMAL ("HORMONAL CHANGES"), WEIGHT INCREASED ("WEIGHT GAIN") AND WEIGHT DECREASED ("WEIGHT LOSS"). THE PATIENT WAS TREATED WITH SURGERY (SALPINGECTOMY(BILATERAL)). ESSURE WAS REMOVED ON (B)(6) 2019. AT THE TIME OF THE REPORT, THE PELVIC PAIN, ABDOMINAL PAIN, BACK PAIN, DYSMENORRHOEA, FEMALE SEXUAL DYSFUNCTION, MENORRHAGIA, FATIGUE, ALOPECIA, HORMONE LEVEL ABNORMAL, MIGRAINE, WEIGHT INCREASED AND WEIGHT DECREASED HAD RESOLVED, THE GENITAL HAEMORRHAGE AND DYSPAREUNIA HAD NOT RESOLVED AND THE HAIR COLOUR CHANGES OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL PAIN, ALOPECIA, BACK PAIN, DYSMENORRHOEA, DYSPAREUNIA, FATIGUE, FEMALE SEXUAL DYSFUNCTION, GENITAL HAEMORRHAGE, HAIR COLOUR CHANGES, HORMONE LEVEL ABNORMAL, MENORRHAGIA, MIGRAINE, PELVIC PAIN, WEIGHT DECREASED AND WEIGHT INCREASED TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: PATIENT RECEIVED TREATMENT FOR- DYSMENORRHEA, APAREUNIA, PELVIC PAIN, ABDOMINAL PAIN, BACK PAIN, FATIGUE, HAIR LOSS, HORMONAL, CHANGES, MIGRAINE, WEIGHT GAIN AND WEIGHT LOSS. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): HYSTEROSALPINGOGRAM - ON AN UNKNOWN DATE: RESULTS: ESSURE IN PLACE, FUNCTIONING PROPERLY. IMAGING PROCEDURE - ON (B)(6) 2011: ESSURE CONFIRMATION TEST (UNSPECIFIED) BILATERAL OCCLUSION. CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONES WERE REPORTED VIA SOCIAL MEDIA : HAIR COLOUR CHANGES. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 15-JUN-2020: QUALITY SAFETY EVALUATION OF PTC(PRODUCT TECHNICAL COMPLAINT). BASED ON THE AVAILABLE INFORMATION, A REVIEW OF OUR COMPLAINT RECORDS AND OTHER RELEVANT DATA WAS CONDUCTED; ANY NEW AND REPORTABLE INFORMATION THAT BECOMES AVAILABLE FROM OUR INVESTIGATION WILL BE PROVIDED IN A SUPPLEMENTARY REPORT.
THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ('PELVIC PAIN') AND MENORRHAGIA ('MENORRHAGIA (HEAVY MENSTRUAL BLEEDING)') IN AN ADULT FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 808913) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S MEDICAL HISTORY INCLUDED DEPRESSION, BIPOLAR DISORDER, POST-TRAUMATIC STRESS DISORDER, TOBACCO USE DISORDER, ACUTE VAGINITIS, GRAND MULTIPARITY, DYSFUNCTIONAL UTERINE BLEEDING AND OVARIAN CYST. CONCOMITANT PRODUCTS INCLUDED IBUPROFEN AND PARACETAMOL (TYLENOL). ON (B)(6) 2011, THE PATIENT HAD ESSURE INSERTED. IN 2011, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), ABDOMINAL PAIN ("CRAMPING / ABDOMINAL PAIN") AND BACK PAIN ("BACK PAIN"). IN (B)(6) 2011, THE PATIENT EXPERIENCED DYSMENORRHOEA ("DYSMENORRHEA(CRAMPING)") AND VAGINAL DISCHARGE ("VAGINAL DISCHARGE"). IN (B)(6) 2011, THE PATIENT EXPERIENCED MENORRHAGIA (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), DYSPAREUNIA ("PAINFUL INTERCOURSE"), FEMALE SEXUAL DYSFUNCTION ("APAREUNIA (INABILITY TO HAVE SEXUAL INTERCOURSE)"), FATIGUE ("FATIGUE") AND VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL)"). IN (B)(6) 2012, THE PATIENT EXPERIENCED ALOPECIA ("HAIR LOSS"), MOOD ALTERED ("HORMONAL CHANGES DESCRIBE: MOODINESS"), MIGRAINE ("MIGRAINE"), HOT FLUSH ("HOT FLASHES") AND HEADACHE ("HEADACHES"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED GENITAL HAEMORRHAGE ("HEAVY BLEEDING"), HAIR COLOUR CHANGES ("HAVE GREY HAIR"), ARTHRALGIA ("HIP PAIN") AND ABDOMINAL PAIN LOWER ("LOWER ABDOMEN PAIN") AND WAS FOUND TO HAVE WEIGHT INCREASED ("WEIGHT GAIN") AND WEIGHT DECREASED ("WEIGHT LOSS"). THE PATIENT WAS TREATED WITH SURGERY (ABLATION AND LAPAROSCOPIC BILATERAL SALPINGECTOMY , LAPAROSCOPIC REMOVAL OF ESSURE COILS). ESSURE WAS REMOVED ON (B)(6) 2019. AT THE TIME OF THE REPORT, THE PELVIC PAIN, MENORRHAGIA, ABDOMINAL PAIN, DYSPAREUNIA, BACK PAIN, DYSMENORRHOEA, FEMALE SEXUAL DYSFUNCTION, FATIGUE, ALOPECIA, MOOD ALTERED, MIGRAINE, WEIGHT INCREASED, WEIGHT DECREASED, VAGINAL HAEMORRHAGE, ARTHRALGIA AND ABDOMINAL PAIN LOWER HAD RESOLVED, THE GENITAL HAEMORRHAGE HAD NOT RESOLVED AND THE HAIR COLOUR CHANGES, HEADACHE AND VAGINAL DISCHARGE OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL PAIN, ABDOMINAL PAIN LOWER, ALOPECIA, ARTHRALGIA, BACK PAIN, DYSMENORRHOEA, DYSPAREUNIA, FATIGUE, FEMALE SEXUAL DYSFUNCTION, GENITAL HAEMORRHAGE, HAIR COLOUR CHANGES, HEADACHE, HOT FLUSH, MENORRHAGIA, MIGRAINE, MOOD ALTERED, PELVIC PAIN, VAGINAL DISCHARGE, VAGINAL HAEMORRHAGE, WEIGHT DECREASED AND WEIGHT INCREASED TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: PATIENT RECEIVED TREATMENT FOR- DYSMENORRHEA, APAREUNIA, PELVIC PAIN, ABDOMINAL PAIN, BACK PAIN, FATIGUE, HAIR LOSS, HORMONAL, CHANGES, MIGRAINE, WEIGHT GAIN AND WEIGHT LOSS. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 36.7 KG/SQM. HYSTEROSALPINGOGRAM - ON (B)(6) 2011: RESULTS: ESSURE IN PLACE, FUNCTIONING PROPERLY TOTAL BILATERAL OCCLUSION. SUCCESSFUL OCCLUSION OF BILATERAL FALLOPIAN TUBES FOLLOWING ESSURE PROCEDURE. CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONES WERE REPORTED VIA SOCIAL MEDIA : HAIR COLOUR CHANGES. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 21-DEC-2020: QUALITY-SAFETY EVALUATION OF PTC (PRODUCT TECHNICAL COMPLAINT). 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 PELVIC PAIN ('PELVIC PAIN') AND GENITAL HAEMORRHAGE ('HEAVY BLEEDING') IN A FEMALE PATIENT WHO HAD ESSURE INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. ON (B)(6) 2011, THE PATIENT HAD ESSURE INSERTED. IN 2011, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), ABDOMINAL PAIN ("CRAMPING / ABDOMINAL PAIN"), DYSPAREUNIA ("PAINFUL INTERCOURSE") AND BACK PAIN ("BACK PAIN"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED GENITAL HAEMORRHAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), DYSMENORRHOEA ("DYSMENORRHEA(CRAMPING)"), FEMALE SEXUAL DYSFUNCTION ("APAREUNIA"), MENORRHAGIA ("MENORRHAGIA (HEAVY MENSTRUAL BLEEDING)"), FATIGUE ("FATIGUE"), ALOPECIA ("HAIR LOSS") AND MIGRAINE ("MIGRAINE") AND WAS FOUND TO HAVE HORMONE LEVEL ABNORMAL ("HORMONAL CHANGES"), WEIGHT INCREASED ("WEIGHT GAIN") AND WEIGHT DECREASED ("WEIGHT LOSS"). THE PATIENT WAS TREATED WITH SURGERY (SALPINGECTOMY(BILATERAL)). ESSURE WAS REMOVED ON (B)(6) 2019. AT THE TIME OF THE REPORT, THE PELVIC PAIN, ABDOMINAL PAIN, BACK PAIN, DYSMENORRHOEA, FEMALE SEXUAL DYSFUNCTION, MENORRHAGIA, FATIGUE, ALOPECIA, HORMONE LEVEL ABNORMAL, MIGRAINE, WEIGHT INCREASED AND WEIGHT DECREASED HAD RESOLVED AND THE GENITAL HAEMORRHAGE AND DYSPAREUNIA HAD NOT RESOLVED. THE REPORTER CONSIDERED ABDOMINAL PAIN, ALOPECIA, BACK PAIN, DYSMENORRHOEA, DYSPAREUNIA, FATIGUE, FEMALE SEXUAL DYSFUNCTION, GENITAL HAEMORRHAGE, HORMONE LEVEL ABNORMAL, MENORRHAGIA, MIGRAINE, PELVIC PAIN, WEIGHT DECREASED AND WEIGHT INCREASED TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: PATIENT RECEIVED TREATMENT FOR- DYSMENORRHEA, APAREUNIA, PELVIC PAIN, ABDOMINAL PAIN, BACK PAIN, FATIGUE, HAIR LOSS, HORMONAL, CHANGES, MIGRAINE, WEIGHT GAIN AND WEIGHT LOSS. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): HYSTEROSALPINGOGRAM ON AN UNKNOWN DATE: RESULTS: ESSURE IN PLACE, FUNCTIONING PROPERLY. IMAGING PROCEDURE ON (B)(6) 2011: ESSURE CONFIRMATION TEST (UNSPECIFIED) BILATERAL OCCLUSION. QUALITY-SAFETY EVALUATION OF PTC: SAMPLE NOT AVAILABLE. 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 KNOWN POSSIBLE UNDESIRABLE EVENTS AND 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 MED DRA LLT CAN BE PROVIDED. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 9-SEP-2019: PFS RECEIVED- NEW EVENTS DYSMENORRHEA (CRAMPING), APAREUNIA, MENORRHAGIA (HEAVY MENSTRUAL BLEEDING), FATIGUE, HAIR LOSS, HORMONAL CHANGES, MIGRAINE, WEIGHT GAIN AND WEIGHT LOSS WERE ADDED. REPORTER AND PATIENT DEMOGRAPHY ADDED. LAB DATA WAS 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 |
|---|---|---|---|---|---|---|---|
| 900702 | ESSURE | TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE | HHS | BAYER PHARMA AG | ESS305 | 808913 | 10888853003051 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 25 YR | Other| R | IBUPROFEN| IBUPROFEN| TYLENOL| TYLENOL |