ESSURE
Report
- Report Number
- 2951250-2016-02690
- Event Type
- Injury
- Date Received
- December 13, 2016
- Date of Event
- January 1, 2012
- Report Date
- August 2, 2018
- Manufacturer
- BAYER PHARMA AG
- Product Code
- HHS
- PMA / PMN Number
- P020014
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GA, US
- Reporter Occupation
- OTHER
Narratives
NTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF DEVICE DISLOCATION ("ONE OF THE COILS HAD MIGRATED OUT OF HER FALLOPIAN TUBE"), GENITAL HAEMORRHAGE ("ABNORMAL BLEEDING"), MENORRHAGIA ("EXCESSIVE BLEEDING DURING MENSTRUATION /ABNORMAL BLEEDING (MENORRHAGIA)"), ABDOMINAL ADHESIONS ("ADHESIONS") AND SEIZURE ("SEIZURES") IN AN ADULT FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 822374) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S PAST MEDICAL HISTORY INCLUDED BACK PAIN, CERVICAL DYSPLASIA, IRON DEFICIENCY ANEMIA, URINE ANALYSIS ABNORMAL, DYSURIA, DYSFUNCTIONAL UTERINE BLEEDING, ADENOMYOSIS, CHOLECYSTECTOMY AND OVARIAN CYST. CONCURRENT CONDITIONS INCLUDED PARAESTHESIA, MIGRAINE, CERVICAL CORD COMPRESSION AND NECK PAIN. CONCOMITANT PRODUCTS INCLUDED RIZATRIPTAN FROM (B)(6) 2013 TO (B)(6) 2014 FOR MIGRAINE, HYDROCODONE FROM (B)(6) 2013 TO (B)(6) 2014 FOR NECK PAIN, GABAPENTIN FROM (B)(6) 2013 TO (B)(6) 2014 FOR PARESTHESIA, TOPIRAMATE (TOPAMAX) FROM (B)(6) 2013 TO 9-JAN-2014 FOR SEIZURES AS WELL AS ALPRAZOLAM (XANAX) FROM (B)(6) 2011 TO (B)(6) 2012, AMOXICILLIN, BUPROPION HYDROCHLORIDE (WELLBUTRIN XL) FROM (B)(6) 2011 TO (B)(6) 2012, CYCLOBENZAPRINE HYDROCHLORIDE (FLEXERIL), ESCITALOPRAM OXALATE (LEXAPRO), FERROUS SULFATE SINCE (B)(6) 2012, KETOROLAC TROMETHAMINE FROM (B)(6) 2012 TO (B)(6) 2012, MEDROXYPROGESTERONE ACETATE (PROVERA) FROM (B)(6) 2012 TO (B)(6) 2012, PERCOCET-5 FROM (B)(6) 2012 TO (B)(6) 2012, PREVPAC FROM (B)(6) 2012 TO (B)(6) 2012, SERTRALINE (ZOLOFT) FROM (B)(6) 2011 TO (B)(6) 2011 AND VICODIN (LORCET PLUS) FROM (B)(6) 2011 TO (B)(6) 2012. ON (B)(6) 2011, THE PATIENT HAD ESSURE INSERTED. IN (B)(6) 2011, THE PATIENT EXPERIENCED URINARY TRACT INFECTION ("INFECTION (URINARY TRACT INFECTION)"), BLADDER DISORDER ("BLADDER PROBLEMS") AND URINARY TRACT DISORDER ("URINARY PROBLEMS"). IN (B)(6) 2012, THE PATIENT EXPERIENCED GENITAL HAEMORRHAGE (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), MENORRHAGIA (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED) AND VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL)"). IN (B)(6) 2012, THE PATIENT EXPERIENCED PELVIC PAIN ("CHRONIC PELVIC PAIN/PAIN") AND DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING)"). IN (B)(6) 2012, THE PATIENT EXPERIENCED NAUSEA ("NAUSEA") AND ABDOMINAL PAIN LOWER ("LOWER ABDOMEN PAIN/ PAIN"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED DEVICE DISLOCATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), ABDOMINAL ADHESIONS (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT) AND SEIZURE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT). THE PATIENT WAS TREATED WITH CIPROFLOXACIN (CIPRO), ANTIBIOTICS, DOXYCYCLINE, AZITHROMYCIN, ONDANSETRON (ZOFRAN), ESOMEPRAZOLE MAGNESIUM (NEXIUM), IBUPROFEN, PARACETAMOL (TYLENOL), SURGERY (PARTIAL HYSTERECTOMY ON (B)(6) 2012), SURGERY (ABLATION ON (B)(6) 2012, DILATION AND CURETTAGE), SURGERY (ABLATION) AND SURGERY (LYSIS SURGERY OF ADHESIONS ON (B)(6) 2012). ESSURE WAS REMOVED ON (B)(6) 2012. AT THE TIME OF THE REPORT, THE DEVICE DISLOCATION, MENORRHAGIA, ABDOMINAL ADHESIONS, SEIZURE, VAGINAL HAEMORRHAGE, URINARY TRACT INFECTION, URINARY TRACT DISORDER AND ABDOMINAL PAIN LOWER OUTCOME WAS UNKNOWN AND THE GENITAL HAEMORRHAGE, PELVIC PAIN, BLADDER DISORDER, NAUSEA AND DYSMENORRHOEA HAD RESOLVED. THE REPORTER CONSIDERED ABDOMINAL ADHESIONS, ABDOMINAL PAIN LOWER, BLADDER DISORDER, DEVICE DISLOCATION, DYSMENORRHOEA, GENITAL HAEMORRHAGE, MENORRHAGIA, NAUSEA, PELVIC PAIN, SEIZURE, URINARY TRACT DISORDER, URINARY TRACT INFECTION AND VAGINAL HAEMORRHAGE TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: BLADDER TRAINING, TENSION - FREE VAGINAL TAPE OBTURATOR USED AS TREATMENT FOR BLADDER OR URINARY PROBLEMS OR CHANGES. PATIENT TOOK PAIN MEDICATION FOR PAIN. NORMAL APPEARING ENDOMETRIAL CAVITY. THE LEFT ESSURE COIL COULD BE VISUALIZED. THE RIGHT COIL COULD NOT. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): HYSTEROSALPINGOGRAM - ON (B)(6) 2011: SATISFACTORY PLACEMENT OF BOTH COILS, OCCLUSION. CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONES WERE DESCRIBED IN PATIENT¿S MEDICAL RECORD CONFIRMING EVENT DYSMENORRHEA, LOWER ABDOMINAL PAIN, MENORRHAGIA, PELVIC PAIN AND NAUSEA. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 25-JUL-2018: QUALITY-SAFETY EVALUATION OF PTC. 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 IN A SUPPLEMENTAL REPORT.
THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF DEVICE DISLOCATION ("ONE OF THE COILS HAD MIGRATED OUT OF HER FALLOPIAN TUBE"), GENITAL HAEMORRHAGE ("ABNORMAL BLEEDING"), ABDOMINAL ADHESIONS ("ADHESIONS"), SEIZURE ("SEIZURES") AND MENORRHAGIA ("EXCESSIVE BLEEDING DURING MENSTRUATION /ABNORMAL BLEEDING (MENORRHAGIA)") IN AN ADULT FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 822374) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S CONCURRENT CONDITIONS INCLUDED PARAESTHESIA, MIGRAINE, CERVICAL CORD COMPRESSION AND NECK PAIN. CONCOMITANT PRODUCTS INCLUDED RIZATRIPTAN FROM (B)(6)2013 TO (B)(6)2014 FOR MIGRAINE, HYDROCODONE FROM (B)(6)2013 TO(B)(6)2014 FOR NECK PAIN, GABAPENTIN FROM (B)(6)2013 TO(B)(6)2014 FOR PARESTHESIA, TOPIRAMATE (TOPAMAX) FROM (B)(6)2013 TO(B)(6) 2014 FOR SEIZURES AS WELL AS ALPRAZOLAM (XANAX) FROM (B)(6)2011 TO (B)(6)2012, BUPROPION HYDROCHLORIDE (WELLBUTRIN XL) FROM (B)(6)2011 TO(B)(6)2012, CYCLOBENZAPRINE HYDROCHLORIDE (FLEXERIL), ESCITALOPRAM OXALATE (LEXAPRO), FERROUS SULFATE SINCE (B)(6)2012, KETOROLAC TROMETHAMINE FROM (B)(6)2012 TO(B)(6)2012, MEDROXYPROGESTERONE ACETATE (PROVERA) FROM (B)(6)2012 TO (B)(6)2012, PERCOCET-5 FROM(B)(6)2012 TO (B)(6)2012, PREVPAC FROM (B)(6)2012 TO(B)(6) 2012, SERTRALINE (ZOLOFT) FROM (B)(6)2011 TO (B)(6)2011 AND VICODIN (LORCET PLUS) FROM (B)(6) 2011 TO (B)(6)2012. ON (B)(6)2011, THE PATIENT HAD ESSURE INSERTED. IN SEPTEMBER 2011, THE PATIENT EXPERIENCED URINARY TRACT INFECTION ("INFECTION (URINARY TRACT INFECTION)"), BLADDER DISORDER ("BLADDER PROBLEMS") AND URINARY TRACT DISORDER ("URINARY PROBLEMS "). IN MARCH 2012, THE PATIENT EXPERIENCED MENORRHAGIA (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), PELVIC PAIN ("CHRONIC PELVIC PAIN/PAIN"), VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL)") AND DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING)"). IN APRIL 2012, THE PATIENT EXPERIENCED NAUSEA ("NAUSEA"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED DEVICE DISLOCATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), GENITAL HAEMORRHAGE (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), ABDOMINAL ADHESIONS (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), SEIZURE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT) AND ABDOMINAL PAIN LOWER ("LOWER ABDOMEN PAIN"). THE PATIENT WAS TREATED WITH CIPROFLOXACIN (CIPRO), ANTIBIOTICS, DOXYCYCLINE, AZITHROMYCIN, ONDANSETRON (ZOFRAN), ESOMEPRAZOLE MAGNESIUM (NEXIUM), SURGERY (PARTIAL HYSTERECTOMY ON (B)(6)2012), SURGERY (ABLATION ON (B)(6)2012, DILATION AND CURETTAGE), SURGERY (LYSIS SURGERY OF ADHESIONS ON (B)(6)2012). ESSURE WAS REMOVED ON (B)(6)2012. AT THE TIME OF THE REPORT, THE DEVICE DISLOCATION, ABDOMINAL ADHESIONS, SEIZURE, MENORRHAGIA, VAGINAL HAEMORRHAGE, URINARY TRACT INFECTION, BLADDER DISORDER, URINARY TRACT DISORDER, NAUSEA AND ABDOMINAL PAIN LOWER OUTCOME WAS UNKNOWN AND THE GENITAL HAEMORRHAGE, PELVIC PAIN AND DYSMENORRHOEA HAD RESOLVED. THE REPORTER CONSIDERED ABDOMINAL ADHESIONS, ABDOMINAL PAIN LOWER, BLADDER DISORDER, DEVICE DISLOCATION, DYSMENORRHOEA, GENITAL HAEMORRHAGE, MENORRHAGIA, NAUSEA, PELVIC PAIN, SEIZURE, URINARY TRACT DISORDER, URINARY TRACT INFECTION AND VAGINAL HAEMORRHAGE TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: BLADDER TRAINING, TENSION - FREE VAGINAL TAPE OBTURATOR USED AS TREATMENT FOR BLADDER OR URINARY PROBLEMS OR CHANGES. PATIENT TOOK PAIN MEDICATION FOR PAIN. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): HYSTEROSALPINGOGRAM - ON (B)(6)2011: SATISFACTORY PLACEMENT OF BOTH COILS, OCCLUSION MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON (B)(6)2018: PLAINTIFF FACT SHEET WAS RECEIVED. REPORTERS, PATIENT DETAILS, CONCOMITANT DISEASE, CONCOMITANT DRUGS, AND TREATMENT DRUGS WERE ADDED. ABNORMAL BLEEDING (VAGINAL), INFECTION (URINARY TRACT INFECTION), BLADDER OR URINARY PROBLEMS OR CHANGES, NAUSEA, SEIZURES, DYSMENORRHEA (CRAMPING), ADHESIONS, LOWER ABDOMEN PAIN AND ABNORMAL BLEEDING WERE ADDED AS EVENTS. ESSURE LOT NUMBER WAS ADDED. ESSURE LEGAL MANUFACTURER HAS CHANGED FROM BAYER HEALTHCARE, LLC, MILPITAS TO BAYER PHARMA AG, BERLIN, AND THIS REPORT IS BEING SUBMITTED AS A FOLLOW UP TO A PREVIOUS REPORT SUBMITTED UNDER THE FORMER LEGAL MANUFACTURER. REPORT TYPE ¿INITIAL¿ INDICATES HERE INITIAL SUBMISSION BY THE NEW LEGAL MANUFACTURER ONLY. 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 IN A SUPPLEMENTAL REPORT.
THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF DEVICE DISLOCATION ("ONE OF THE COILS HAD MIGRATED OUT OF HER FALLOPIAN TUBE"), GENITAL HAEMORRHAGE ("ABNORMAL BLEEDING"), MENORRHAGIA ("EXCESSIVE BLEEDING DURING MENSTRUATION /ABNORMAL BLEEDING (MENORRHAGIA)"), ABDOMINAL ADHESIONS ("ADHESIONS") AND SEIZURE ("SEIZURES") IN AN ADULT FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 822374) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S PAST MEDICAL HISTORY INCLUDED BACK PAIN, CERVICAL DYSPLASIA, IRON DEFICIENCY ANEMIA, URINE ANALYSIS ABNORMAL, DYSURIA, DYSFUNCTIONAL UTERINE BLEEDING, ADENOMYOSIS, CHOLECYSTECTOMY AND OVARIAN CYST. CONCURRENT CONDITIONS INCLUDED PARAESTHESIA, MIGRAINE, CERVICAL CORD COMPRESSION AND NECK PAIN. CONCOMITANT PRODUCTS INCLUDED RIZATRIPTAN FROM (B)(6) 2013 TO (B)(6) 2014 FOR MIGRAINE, HYDROCODONE FROM (B)(6) 2013 TO(B)(6) 2014 FOR NECK PAIN, GABAPENTIN FROM (B)(6) 2013 TO (B)(6) 2014 FOR PARESTHESIA, TOPIRAMATE (TOPAMAX) FROM (B)(6) 2013 TO (B)(6) 2014 FOR SEIZURES AS WELL AS ALPRAZOLAM (XANAX) FROM (B)(6)2011 TO (B)(6) 2012, AMOXICILLIN, BUPROPION HYDROCHLORIDE (WELLBUTRIN XL) FROM (B)(6)2011 TO 2-(B)(6)2012, CYCLOBENZAPRINE HYDROCHLORIDE (FLEXERIL), ESCITALOPRAM OXALATE (LEXAPRO), FERROUS SULFATE SINCE (B)(6)2012, KETOROLAC TROMETHAMINE FROM (B)(6)2012 TO (B)(6) 2012, MEDROXYPROGESTERONE ACETATE (PROVERA) FROM (B)(6)2012 TO (B)(6)2012, PERCOCET-5 FROM (B)(6)2012 TO (B)(6)2012, PREVPAC FROM (B)(6)2012 TO (B)(6)2012, SERTRALINE (ZOLOFT) FROM (B)(6)2011 TO (B)(6) 2011 AND VICODIN (LORCET PLUS) FROM (B)(6)2011 TO (B)(6) 2012. ON (B)(6)2011, THE PATIENT HAD ESSURE INSERTED. IN (B)(6) 2011, THE PATIENT EXPERIENCED URINARY TRACT INFECTION ("INFECTION (URINARY TRACT INFECTION)"), BLADDER DISORDER ("BLADDER PROBLEMS") AND URINARY TRACT DISORDER ("URINARY PROBLEMS"). IN (B)(6) 2012, THE PATIENT EXPERIENCED GENITAL HAEMORRHAGE (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), MENORRHAGIA (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED) AND VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL)"). IN (B)(6) 2012, THE PATIENT EXPERIENCED PELVIC PAIN ("CHRONIC PELVIC PAIN/PAIN") AND DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING)"). IN (B)(6) 2012, THE PATIENT EXPERIENCED NAUSEA ("NAUSEA") AND ABDOMINAL PAIN LOWER ("LOWER ABDOMEN PAIN/ PAIN"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED DEVICE DISLOCATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), ABDOMINAL ADHESIONS (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT) AND SEIZURE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT). THE PATIENT WAS TREATED WITH CIPROFLOXACIN (CIPRO), ANTIBIOTICS, DOXYCYCLINE, AZITHROMYCIN, ONDANSETRON (ZOFRAN), ESOMEPRAZOLE MAGNESIUM (NEXIUM), IBUPROFEN, PARACETAMOL (TYLENOL), SURGERY (PARTIAL HYSTERECTOMY ON (B)(6) 2012), SURGERY (ABLATION ON (B)(6)2012, DILATION AND CURETTAGE), SURGERY (ABLATION) AND SURGERY (LYSIS SURGERY OF ADHESIONS ON (B)(6)2012). ESSURE WAS REMOVED ON (B)(6)2012. AT THE TIME OF THE REPORT, THE DEVICE DISLOCATION, MENORRHAGIA, ABDOMINAL ADHESIONS, SEIZURE, VAGINAL HAEMORRHAGE, URINARY TRACT INFECTION, URINARY TRACT DISORDER AND ABDOMINAL PAIN LOWER OUTCOME WAS UNKNOWN AND THE GENITAL HAEMORRHAGE, PELVIC PAIN, BLADDER DISORDER, NAUSEA AND DYSMENORRHOEA HAD RESOLVED. THE REPORTER CONSIDERED ABDOMINAL ADHESIONS, ABDOMINAL PAIN LOWER, BLADDER DISORDER, DEVICE DISLOCATION, DYSMENORRHOEA, GENITAL HAEMORRHAGE, MENORRHAGIA, NAUSEA, PELVIC PAIN, SEIZURE, URINARY TRACT DISORDER, URINARY TRACT INFECTION AND VAGINAL HAEMORRHAGE TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: BLADDER TRAINING, TENSION - FREE VAGINAL TAPE OBTURATOR USED AS TREATMENT FOR BLADDER OR URINARY PROBLEMS OR CHANGES. PATIENT TOOK PAIN MEDICATION FOR PAIN. NORMAL APPEARING ENDOMETRIAL CAVITY. THE LEFT ESSURE COIL COULD BE VISUALIZED. THE RIGHT COIL COULD NOT. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): HYSTEROSALPINGOGRAM - ON (B)(6) 2011: SATISFACTORY PLACEMENT OF BOTH COILS, OCCLUSION CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONES WERE DESCRIBED IN PATIENT¿S MEDICAL RECORD CONFIRMING EVENT DYSMENORRHEA, LOWER ABDOMINAL PAIN, MENORRHAGIA, PELVIC PAIN AND NAUSEA MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON (B)(6) 2018: PFS RECEIVED. THE ONSET DATE OF EVENT ABNORMAL BLEEDING (VAGINAL) AND ABNORMAL BLEEDING (MENORRHAGIA) WERE UPDATED TO (B)(6) 2012. THE ONSET DATE OF PAIN IS (B)(6) 2012 AND PATIENT RECEIVED LORCET, HYDROCODONE, OTC TYLENOL AND IBUPROFEN TO TREAT EVENT. THE PAIN IS LOCATED IN LOWER ABDOMEN AND PELVIC AREA, WITH INTENSITY CONSIDERED MILD TO SEVERE AND DAILY FREQUENCY (ABOUT 6 TIMES A DAY). PLAINTIFF HAS RECOVERED FROM NAUSEA 1 WEEK AFTER ESSURE REMOVAL AND HAS RECOVERED FROM BLADDER PROBLEMS 3 WEEKS AFTER REMOVAL. 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 IN A SUPPLEMENTAL REPORT.
FOLLOW-UP RECEIVED ON 07-DEC-2016 - QUALITY-SAFETY EVALUATION OF PTC: PTC GLOBAL NUMBER: (B)(4). 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 MEDDRA LLT CAN BE PROVIDED COMPANY CAUSALITY COMMENT: THIS SPONTANEOUS CASE REPORT REFERS TO A FEMALE PLAINTIFF WHO HAD ESSURE (FALLOPIAN TUBE OCCLUSION INSERT) INSERTED AND ONE OF THE COILS MIGRATED OUT OF HER FALLOPIAN TUBE (DEVICE DISLOCATION). SHE ALSO EXPERIENCED EXCESSIVE BLEEDING DURING MENSTRUATION (MENORRHAGIA). SHE UNDERWENT AN ABLATION ONE YEAR AFTER ESSURE INSERTION AND A TOTAL HYSTERECTOMY THREE MONTHS LATER. BOTH EVENTS ARE ANTICIPATED IN THE REFERENCE SAFETY INFORMATION FOR ESSURE. DURING THE ESSURE THERAPY, ABNORMAL GENITAL BLEEDING AND MENSES PATTERN CHANGES MAY OCCUR. ALSO DEVICE DISLOCATION MAY OCCUR. CONSIDERING THE INFORMATION PROVIDED AND THE NATURE OF REPORTED EVENTS, A CAUSAL RELATIONSHIP WITH ESSURE CANNOT BE EXCLUDED. THIS CASE WAS REGARDED AS INCIDENT, AS SURGICAL INTERVENTIONS WERE REQUIRED. IN ADDITION, A NON-SERIOUS EVENT WAS REPORTED. A PRODUCT TECHNICAL COMPLAINT ANALYSIS CONCLUDED THAT A QUALITY DEFECT COULD NOT BE CONFIRMED BUT IS CONSIDERED PLAUSIBLE AND A RELATIONSHIP WITH THE REPORTED MEDICAL EVENTS CANNOT BE TOTALLY EXCLUDED. FURTHER INFORMATION WILL BE OBTAINED THROUGH THE LITIGATION PROCESS.
THIS IS A SPONTANEOUS CASE REPORT RECEIVED FROM A LAWYER IN THE UNITED STATES, ON BEHALF OF A FEMALE PLAINTIFF OF UNSPECIFIED AGE IN UNITED STATES ON 18-NOV-2016 WHO HAD ESSURE (FALLOPIAN TUBE OCCLUSION INSERT) IMPLANTED ON (B)(6) 2011 FOR PERMANENT CONTRACEPTION. ON (B)(6) 2011 SHE HAD A HYSTEROSALPINGOGRAM (HSG) TEST THAT CONFIRMED SATISFACTORY PLACEMENT OF BOTH ESSURE COILS AND FULL OCCLUSION OF BOTH TUBES. SOMETIME AFTER IMPLANT OF THE ESSURE DEVICE, SHE BEGAN TO EXPERIENCE ONE OR MORE OF THE FOLLOWING SYMPTOMS, INCLUDING, BUT NOT LIMITED TO: SEVERE ABNORMAL MENSTRUAL PAIN, ABNORMAL MENSTRUAL CYCLE, EXCESSIVE BLEEDING, SEVERE PELVIC PAIN, BACK PAIN, ABDOMINAL PAIN, PAIN DURING INTERCOURSE, HEADACHES, ALLERGIC REACTION, MOOD SWINGS, MIGRATION OF THE DEVICE, UNWANTED PREGNANCY, AND FATIGUE. SHE REPORTED TO HER HEALTHCARE PROVIDER THAT SHE WAS EXPERIENCING EXCESSIVE BLEEDING DURING MENSTRUATION, AS WELL AS CHRONIC PELVIC PAIN. HER DOCTOR INFORMED HER THAT ONE OF THE COILS HAD MIGRATED OUT OF HER FALLOPIAN TUBE ON (B)(6) 2012, SHE SAW HER PHYSICIAN AND UNDERWENT AN ABLATION. ON (B)(6) 2012, SHE UNDERWENT A HYSTERECTOMY. COMPANY CAUSALITY COMMENT: THIS SPONTANEOUS CASE REPORT REFERS TO A FEMALE PLAINTIFF WHO HAD ESSURE (FALLOPIAN TUBE OCCLUSION INSERT) INSERTED AND ONE OF THE COILS MIGRATED OUT OF HER FALLOPIAN TUBE (DEVICE DISLOCATION). SHE ALSO EXPERIENCED EXCESSIVE BLEEDING DURING MENSTRUATION (MENORRHAGIA). SHE UNDERWENT AN ABLATION ONE YEAR AFTER ESSURE INSERTION AND A TOTAL HYSTERECTOMY THREE MONTHS LATER. BOTH EVENTS ARE ANTICIPATED IN THE REFERENCE SAFETY INFORMATION FOR ESSURE. DURING THE ESSURE THERAPY, ABNORMAL GENITAL BLEEDING AND MENSES PATTERN CHANGES MAY OCCUR. ALSO DEVICE DISLOCATION MAY OCCUR. CONSIDERING THE INFORMATION PROVIDED AND THE NATURE OF REPORTED EVENTS, A CAUSAL RELATIONSHIP WITH ESSURE CANNOT BE EXCLUDED. THIS CASE WAS REGARDED AS INCIDENT, AS SURGICAL INTERVENTIONS WERE REQUIRED. IN ADDITION, A NON SERIOUS EVENT WAS REPORTED. A PRODUCT TECHNICAL ANALYSIS IS EXPECTED. FURTHER INFORMATION WILL BE OBTAINED THROUGH THE LITIGATION PROCESS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 822898 | ESSURE | TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE | HHS | BAYER PHARMA AG | ESS305 | 822374 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 39 YR | Other| R | AMOXICILLIN| AMOXICILLIN| FERROUS SULFATE| FERROUS SULFATE| FERROUS SULFATE| FERROUS SULFATE| FERROUS SULFATE| FERROUS SULFATE| FLEXERIL| FLEXERIL| FLEXERIL| GABAPENTIN| GABAPENTIN| GABAPENTIN| HYDROCODONE| HYDROCODONE| HYDROCODONE| HYDROCODONE| HYDROCODONE| HYDROCODONE| KETOROLAC TROMETHAMINE| KETOROLAC TROMETHAMINE| KETOROLAC TROMETHAMINE| LEXAPRO| LEXAPRO| LEXAPRO| LORCET PLUS| LORCET PLUS| LORCET PLUS| PERCOCET-5| PERCOCET-5| PERCOCET-5| PREVPAC| PREVPAC| PREVPAC| PROVERA| PROVERA| PROVERA| RIZATRIPTAN| RIZATRIPTAN| RIZATRIPTAN| TOPAMAX| TOPAMAX| TOPAMAX| WELLBUTRIN XL| WELLBUTRIN XL| WELLBUTRIN XL| XANAX| XANAX| XANAX| ZOLOFT| ZOLOFT| ZOLOFT |