ESSURE
Report
- Report Number
- 2951250-2018-00787
- Event Type
- Injury
- Date Received
- February 23, 2018
- Date of Event
- May 1, 2008
- Report Date
- July 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 /PELVIC AREA CONSTANT PAIN") AND MENORRHAGIA ("ABNORMAL BLEEDING (MENORRHAGIA)") IN A 34-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (ESS205) (BATCH NO. 620737,0712021, 3976163-INV) INSERTED. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S CONCURRENT CONDITIONS INCLUDED HIVES, ANKLE SWELLING, DIARRHEA AND COLONIC POLYP. FAMILY HISTORY INCLUDED POLYPOSIS GASTRIC. CONCOMITANT PRODUCTS INCLUDED BETADINE [ETHANOL,POVIDONE-IODINE], BUPROPION HYDROCHLORIDE (WELLBUTRIN), BUPROPION HYDROCHLORIDE (ZYBAN), DOXYCYCLINE, ETHINYLESTRADIOL;NORETHISTERONE (OVCON), IBUPROFEN FROM 2010 TO 2016 AND PANTOPRAZOLE (PROTONIX) FROM 2012 TO 2016. ON 14-NOV-2006, THE PATIENT HAD ESSURE (ESS205) INSERTED. IN MAY 2008, THE PATIENT EXPERIENCED MENORRHAGIA (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED) AND VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL)"). IN 2008, THE PATIENT EXPERIENCED FURUNCLE ("BOILS") AND CYST ("CYSTS"). IN 2009, THE PATIENT WAS FOUND TO HAVE WEIGHT INCREASED ("WEIGHT GAIN"). IN 2010, THE PATIENT EXPERIENCED DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING)"). IN 2012, THE PATIENT EXPERIENCED NAUSEA ("NAUSEA") AND ABDOMINAL PAIN ("ABDOMINAL PAIN"). IN 2014, THE PATIENT EXPERIENCED VAGINAL DISCHARGE ("VAGINAL DISCHARGE"). IN 2015, THE PATIENT EXPERIENCED VISION BLURRED ("VISION BLURRY/DIFFICULTY FOCUSING"), GASTROINTESTINAL MOTILITY DISORDER ("GASTROINTESTINAL OR DIGESTIVE SYSTEM CONDITION TYPE:DIFFICULTY HAVING BOWEL MOVEMENTS") AND HAEMORRHOIDS ("HEMORRHOIDS"). IN MARCH 2016, THE PATIENT EXPERIENCED MIGRAINE ("MIGRAINES/HEADACHES / DAILY HEADACHE"). IN MAY 2017, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), ADENOMYOSIS ("ADENOMYOSIS") AND FATIGUE ("FATIGUE"). IN JUNE 2017, THE PATIENT EXPERIENCED DYSURIA ("PAINFUL URINATION"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED ABDOMINAL DISTENSION ("FEELING OF FULLNESS IN LOWER ABDOMEN"), BACK PAIN ("LOWER BACK PAIN"), DYSPEPSIA ("HEARTBURN"), ABDOMINAL PAIN LOWER ("LOWER ABDOMINAL PAIN"), DISTURBANCE IN ATTENTION ("ABILITY TO FOCUS") AND MEMORY IMPAIRMENT ("FOGGY MEMORY"). THE PATIENT WAS TREATED WITH SURGERY (HYSTERECTOMY (FULL) AND SALPINGECTOMY (BILATERAL REMOVAL OF FALLOPIAN TUBES) AND ABLATION). ESSURE (ESS205) WAS REMOVED ON 16-OCT-2017. AT THE TIME OF THE REPORT, THE PELVIC PAIN, MENORRHAGIA, VAGINAL HAEMORRHAGE, FURUNCLE, CYST, DYSURIA, DYSMENORRHOEA, ADENOMYOSIS, NAUSEA, VAGINAL DISCHARGE, WEIGHT INCREASED, GASTROINTESTINAL MOTILITY DISORDER, HAEMORRHOIDS, DYSPEPSIA AND ABDOMINAL PAIN OUTCOME WAS UNKNOWN AND THE MIGRAINE, VISION BLURRED, FATIGUE, ABDOMINAL DISTENSION, BACK PAIN, ABDOMINAL PAIN LOWER, DISTURBANCE IN ATTENTION AND MEMORY IMPAIRMENT HAD RESOLVED. THE REPORTER CONSIDERED ABDOMINAL DISTENSION, ABDOMINAL PAIN, ABDOMINAL PAIN LOWER, ADENOMYOSIS, BACK PAIN, CYST, DISTURBANCE IN ATTENTION, DYSMENORRHOEA, DYSPEPSIA, DYSURIA, FATIGUE, FURUNCLE, GASTROINTESTINAL MOTILITY DISORDER, HAEMORRHOIDS, MEMORY IMPAIRMENT, MENORRHAGIA, MIGRAINE, NAUSEA, PELVIC PAIN, VAGINAL DISCHARGE, VAGINAL HAEMORRHAGE, VISION BLURRED AND WEIGHT INCREASED TO BE RELATED TO ESSURE (ESS205). THE REPORTER COMMENTED: ALL LOT NUMBERS (620737,0712021, 3976163 ) ARE INVALIDS DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): HYSTEROSALPINGOGRAM - ON 01-MAR-2007: RESULTS: TOTAL BILATERAL OCCLUSION. CONCERNING THE INJURIES REPORTED IN THIS CASE,THE FOLLOWING ONE/ONES WERE DESCRIBED IN PATIENTS MEDICAL RECORD CONFIRMING :NAUSEA AND HEART BURN, ABDOMINAL PAIN. 620737-INVALID LOT, 0712021-INVALID LOT, 3976163-INVALID LOT MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 27-NOV-2018: UPDATE OF INFORMATION (BATCH IS INVALID) 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 /PELVIC AREA CONSTANT PAIN'), MENORRHAGIA ('ABNORMAL BLEEDING (MENORRHAGIA)'), LYMPHADENECTOMY ('LYMPH NODE REMOVAL/LYMPH NODE BIOPSY'), ADENOMYOSIS ('ADENOMYOSIS'), BIOPSY ENDOMETRIUM ('ENDOMETRIAL BIOPSY') AND MULTIPLE EPISODES OF HAEMORRHOIDS ('HEMORRHOID', 'HEMORRHOIDS') IN A 34-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (ESS205) (BATCH NO. 620737,0712021,3976163-ALL INV) INSERTED FOR FEMALE STERILIZATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S MEDICAL HISTORY INCLUDED OVERWEIGHT AND GASTROESOPHAGEAL REFLUX DISEASE. PREVIOUSLY ADMINISTERED PRODUCTS INCLUDED FOR BIRTH CONTROL: MIRENA. CONCURRENT CONDITIONS INCLUDED HIVES, ANKLE SWELLING, DIARRHEA, COLONIC POLYP AND OVERWEIGHT. FAMILY HISTORY INCLUDED POLYPOSIS GASTRIC. CONCOMITANT PRODUCTS INCLUDED BUPROPION HYDROCHLORIDE (WELLBUTRIN), BUPROPION HYDROCHLORIDE (ZYBAN), DOXYCYCLINE, ETHANOL;POVIDONE-IODINE, ETHINYLESTRADIOL;NORETHISTERONE (OVCON), IBUPROFEN FROM 2010 TO 2016 AND PROTON PUMP INHIBITORS FROM 2012 TO 2016. ON (B)(6) 2006, THE PATIENT HAD ESSURE (ESS205) INSERTED. IN (B)(6) 2008, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), MENORRHAGIA (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL)"), FURUNCLE ("BOILS"), CYST ("CYSTS"), DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING)"), BACK PAIN ("LOWER BACK PAIN") AND FLANK PAIN ("FLANK PAIN"). ON (B)(6) 2009, THE PATIENT UNDERWENT LYMPHADENECTOMY (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), 2 YEARS 2 MONTHS AFTER INSERTION OF ESSURE (ESS205). IN 2009, THE PATIENT WAS FOUND TO HAVE WEIGHT INCREASED ("WEIGHT GAIN / WEIGHT GAIN OF 45 LBS WHILE MAINTAINING SAME ACTIVITY"). IN (B)(6) 2012, THE PATIENT EXPERIENCED NAUSEA ("NAUSEA"), DYSPEPSIA ("HEARTBURN") AND ABDOMINAL PAIN ("ABDOMINAL PAIN"). IN (B)(6) 2013, THE PATIENT EXPERIENCED VAGINAL DISCHARGE ("VAGINAL DISCHARGE"). ON (B)(6) 2015, THE PATIENT WAS FOUND TO HAVE BIOPSY ENDOMETRIUM (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT). IN 2015, THE PATIENT EXPERIENCED VISION BLURRED ("VISION BLURRY/DIFFICULTY FOCUSING"), GASTROINTESTINAL MOTILITY DISORDER ("GASTROINTESTINAL OR DIGESTIVE SYSTEM CONDITION TYPE:DIFFICULTY HAVING BOWEL MOVEMENTS") AND THE FIRST EPISODE OF HAEMORRHOIDS ("HEMORRHOIDS"). IN (B)(6) 2015, THE PATIENT EXPERIENCED THE SECOND EPISODE OF HAEMORRHOIDS (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), ABDOMINAL DISTENSION ("FEELING OF FULLNESS IN LOWER ABDOMEN/BLOATING"), ASTIGMATISM ("ASTIGMATISM"), GASTROOESOPHAGEAL REFLUX DISEASE ("GERD") AND CONSTIPATION ("CONSTIPATION"). IN (B)(6) 2016, THE PATIENT EXPERIENCED MIGRAINE ("MIGRAINES/HEADACHES / DAILY HEADACHE/, MIGRAINES/HEADACHES FREQUENT HEADACHE"). IN (B)(6) 2017, THE PATIENT EXPERIENCED ADENOMYOSIS (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT) AND FATIGUE ("FATIGUE"). IN (B)(6) 2017, THE PATIENT EXPERIENCED DYSURIA ("PAINFUL URINATION"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED ABDOMINAL PAIN LOWER ("LOWER ABDOMINAL PAIN"), DISTURBANCE IN ATTENTION ("ABILITY TO FOCUS") AND MEMORY IMPAIRMENT ("FOGGY MEMORY"). THE PATIENT WAS TREATED WITH SURGERY (HYSTERECTOMY (FULL) AND SALPINGECTOMY (BILATERAL REMOVAL OF FALLOPIAN TUBES), ON (B)(6) 2015 UNDERWENT ABLATION, ENDOMETRIAL BIOPSY, ENDOMETRIAL BIOPSY AND HAD COLONOSCOPY AND UPPER GI SCOPE). ESSURE (ESS205) WAS REMOVED ON (B)(6) 2017. AT THE TIME OF THE REPORT, THE PELVIC PAIN, MENORRHAGIA, LYMPHADENECTOMY, ADENOMYOSIS, THE LAST EPISODE OF HAEMORRHOIDS, VAGINAL HAEMORRHAGE, FURUNCLE, CYST, DYSURIA, DYSMENORRHOEA, NAUSEA, VAGINAL DISCHARGE, WEIGHT INCREASED, GASTROINTESTINAL MOTILITY DISORDER, DYSPEPSIA, ABDOMINAL PAIN, ASTIGMATISM, GASTROOESOPHAGEAL REFLUX DISEASE, CONSTIPATION AND FLANK PAIN OUTCOME WAS UNKNOWN AND THE MIGRAINE, VISION BLURRED, FATIGUE, ABDOMINAL DISTENSION, BACK PAIN, ABDOMINAL PAIN LOWER, DISTURBANCE IN ATTENTION AND MEMORY IMPAIRMENT HAD RESOLVED. THE REPORTER CONSIDERED ABDOMINAL DISTENSION, ABDOMINAL PAIN, ABDOMINAL PAIN LOWER, ADENOMYOSIS, ASTIGMATISM, BACK PAIN, BIOPSY ENDOMETRIUM, CONSTIPATION, CYST, DISTURBANCE IN ATTENTION, DYSMENORRHOEA, DYSPEPSIA, DYSURIA, FATIGUE, FLANK PAIN, FURUNCLE, GASTROINTESTINAL MOTILITY DISORDER, GASTROOESOPHAGEAL REFLUX DISEASE, LYMPHADENECTOMY, MEMORY IMPAIRMENT, MENORRHAGIA, MIGRAINE, NAUSEA, PELVIC PAIN, VAGINAL DISCHARGE, VAGINAL HAEMORRHAGE, VISION BLURRED, WEIGHT INCREASED, THE FIRST EPISODE OF HAEMORRHOIDS AND THE SECOND EPISODE OF HAEMORRHOIDS TO BE RELATED TO ESSURE (ESS205). THE REPORTER COMMENTED: ALL LOT NUMBERS (620737,0712021, 3976163 ) ARE INVALIDS CURRENT WEIGHT 197 LBS. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 27.2 KG/SQM. HYSTEROSALPINGOGRAM - ON (B)(6) 2007: RESULTS: TOTAL BILATERAL OCCLUSION. PATHOLOGY TEST - ON (B)(6) 2017: CLINICAL INFORMATION: PRE-OP AND POSTOP DIAGNOSIS: PELVIC PAIN, FOREIGN BODY OF UTERUS, ADENOMYOSIS. TISSUE REMOVED: UTERUS, CERVIX, BILATERAL FALLOPIAN TUBES. GROSS DESCRIPTION: CERVIX WITH ATTACHED BILATERAL FIMBRIATED FALLOPIAN TUBES. THE RIGHT FIMBRIATED FALLOPIAN TUBE IS 6.5 CM IN LENGTH X 0.7 CM IN DIAMETER WITH DARK RED, GLISTENING SEROSA AND A FEW PARATUBAL CYSTS ARE UP TO 0.7 CM IN GREATEST DIMENSION. THERE IS A METALLIC COIL IN THE PROXIMAL LUMEN THAT FOCALLY APPEARS TO ATTENUATE THE SEROSA AT THE CORNU. THE LEFT FIMBRIATED FALLOPIAN TUBE IS 7.0 CM IN LENGTH X 0.6 CM IN DIAMETER. WITHIN THE PROXIMAL LUMEN IS A METALLIC COIL. DIAGNOSIS: RIGHT FALLOPIAN TUBE: BENIGN FALLOPIAN TUBE CONTAINING AN INTRALUMINAL ESSURE COIL. BENIGN PARATUBAL CYSTS. LEFT FALLOPIAN TUBE: BENIGN FALLOPIAN TUBE CONTAINING AN INTRALUMINAL ESSURE COIL.. CONCERNING THE INJURIES REPORTED IN THIS CASE,THE FOLLOWING ONE/ONES WERE DESCRIBED IN PATIENTS MEDICAL RECORD CONFIRMING :NAUSEA AND HEART BURN, ABDOMINAL PAIN. 620737-INVALID LOT, 0712021-INVALID LOT, 3976163-INVALID LOT . MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 17-JUL-2019: PFS AND SOCIAL MEDIA RECEIVED. MEDICAL HISTORY WERE ADDED. EVENTS : GERD, CONSTIPATION, LYMPH NODE REMOVAL/LYMPH NODE BIOPSY, FLANK PAIN, ENDOMETRIAL BIOPSY WERE ADDED. EVENT VERBATIM WERE UPDATED AS FEELING OF FULLNESS IN LOWER ABDOMEN/BLOATING, MIGRAINES/HEADACHES / DAILY HEADACHE/, MIGRAINES/HEADACHES FREQUENT HEADACHE. ONSET DATE OF EVENTS WERE UPDATED. 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 /PELVIC AREA CONSTANT PAIN") AND MENORRHAGIA ("ABNORMAL BLEEDING (MENORRHAGIA)") IN A 34-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (ESS205) (BATCH NO. 620737, 0712021, 3976163) INSERTED. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S CONCURRENT CONDITIONS INCLUDED HIVES, ANKLE SWELLING, DIARRHEA AND COLONIC POLYP. FAMILY HISTORY INCLUDED POLYPOSIS GASTRIC. CONCOMITANT PRODUCTS INCLUDED BETADINE [ETHANOL,POVIDONE-IODINE], BUPROPION (WELLBUTRIN), BUPROPION HYDROCHLORIDE (ZYBAN), DOXYCYCLINE, IBUPROFEN FROM 2010 TO 2016, NORMENSAL (OVCON) AND PANTOPRAZOLE (PROTONIX) FROM 2012 TO 2016. ON (B)(6) 2006, THE PATIENT HAD ESSURE (ESS205) INSERTED. IN (B)(6) 2008, THE PATIENT EXPERIENCED MENORRHAGIA (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED) AND VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL)"). IN 2008, THE PATIENT EXPERIENCED FURUNCLE ("BOILS") AND CYST ("CYSTS"). IN 2009, THE PATIENT EXPERIENCED WEIGHT INCREASED ("WEIGHT GAIN"). IN 2010, THE PATIENT EXPERIENCED DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING)"). IN 2012, THE PATIENT EXPERIENCED NAUSEA ("NAUSEA") AND ABDOMINAL PAIN ("ABDOMINAL PAIN"). IN 2014, THE PATIENT EXPERIENCED VAGINAL DISCHARGE ("VAGINAL DISCHARGE"). IN 2015, THE PATIENT EXPERIENCED VISION BLURRED ("VISION BLURRY/DIFFICULTY FOCUSING"), GASTROINTESTINAL MOTILITY DISORDER ("GASTROINTESTINAL OR DIGESTIVE SYSTEM CONDITION TYPE: DIFFICULTY HAVING BOWEL MOVEMENTS") AND HAEMORRHOIDS ("HEMORRHOIDS"). IN (B)(6) 2016, THE PATIENT EXPERIENCED MIGRAINE ("MIGRAINES/HEADACHES / DAILY HEADACHE"). IN (B)(6) 2017, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), ADENOMYOSIS ("ADENOMYOSIS") AND FATIGUE ("FATIGUE"). IN (B)(6) 2017, THE PATIENT EXPERIENCED DYSURIA ("PAINFUL URINATION"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED ABDOMINAL DISTENSION ("FEELING OF FULLNESS IN LOWER ABDOMEN"), BACK PAIN ("LOWER BACK PAIN"), DYSPEPSIA ("HEARTBURN"), ABDOMINAL PAIN LOWER ("LOWER ABDOMINAL PAIN"), DISTURBANCE IN ATTENTION ("ABILITY TO FOCUS") AND MEMORY IMPAIRMENT ("FOGGY MEMORY"). THE PATIENT WAS TREATED WITH SURGERY (HYSTERECTOMY (FULL) AND SALPINGECTOMY (BILATERAL REMOVAL OF FALLOPIAN TUBES)) AND SURGERY (ABLATION). ESSURE (ESS205) WAS REMOVED ON (B)(6) 2017. AT THE TIME OF THE REPORT, THE PELVIC PAIN, MENORRHAGIA, VAGINAL HAEMORRHAGE, FURUNCLE, CYST, DYSURIA, DYSMENORRHOEA, ADENOMYOSIS, NAUSEA, VAGINAL DISCHARGE, WEIGHT INCREASED, GASTROINTESTINAL MOTILITY DISORDER, HAEMORRHOIDS, DYSPEPSIA AND ABDOMINAL PAIN OUTCOME WAS UNKNOWN AND THE MIGRAINE, VISION BLURRED, FATIGUE, ABDOMINAL DISTENSION, BACK PAIN, ABDOMINAL PAIN LOWER, DISTURBANCE IN ATTENTION AND MEMORY IMPAIRMENT HAD RESOLVED. THE REPORTER CONSIDERED ABDOMINAL DISTENSION, ABDOMINAL PAIN, ABDOMINAL PAIN LOWER, ADENOMYOSIS, BACK PAIN, CYST, DISTURBANCE IN ATTENTION, DYSMENORRHOEA, DYSPEPSIA, DYSURIA, FATIGUE, FURUNCLE, GASTROINTESTINAL MOTILITY DISORDER, HAEMORRHOIDS, MEMORY IMPAIRMENT, MENORRHAGIA, MIGRAINE, NAUSEA, PELVIC PAIN, VAGINAL DISCHARGE, VAGINAL HAEMORRHAGE, VISION BLURRED AND WEIGHT INCREASED TO BE RELATED TO ESSURE (ESS205). DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): HYSTEROSALPINGOGRAM - ON (B)(6) 2007: TOTAL BILATERAL OCCLUSION. CONCERNING THE INJURIES REPORTED IN THIS CASE,THE FOLLOWING ONE/ONES WERE DESCRIBED IN PATIENTS MEDICAL RECORD CONFIRMING: NAUSEA AND HEART BURN, ABDOMINAL PAIN. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 8-NOV-2018: PFS & MR RECEIVED. LOT NUMBER WAS ADDED. DATE OF INSERTION WAS UPDATED. PATIENT'S DEMOGRAPHIC DATA WAS ADDED. CONCOMITANT CONDITION, CONCOMITANT DRUG WAS ADDED. ADDED EVENTS: ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA), BOILS, CYSTS, PAINFUL URINATION, DYSMENORRHEA (CRAMPING), MIGRAINES, HEADACHES, ADENOMYOSIS, NAUSEA, VAGINAL DISCHARGE, VISION BLURRY/DIFFICULTY FOCUSING, FATIGUE, WEIGHT GAIN, DIFFICULTY HAVING BOWEL MOVEMENTS, FEELING OF FULLNESS IN LOWER ABDOMEN, HEMORRHOIDS, ABDOMINAL PAIN LOWER, BACK PAIN, FEELING OF FULLNESS IN ABDOMEN, FOGGY MEMORY, ABILITY TO FOCUS, HEARTBURN. UPDATED OUTCOME OF EVENTS. UPDATED DATE OF EVENTS. 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 REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ("PAIN /PELVIC AREA CONSTANT PAIN"), MENORRHAGIA ("ABNORMAL BLEEDING (MENORRHAGIA)") AND THE SECOND EPISODE OF HAEMORRHOIDS ("HEMORRHOID") IN A 34-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (ESS205) (BATCH NO. 620737,0712021,3976163-ALL INV) INSERTED. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S MEDICAL HISTORY INCLUDED BODY MASS INDEX NORMAL. PREVIOUSLY ADMINISTERED PRODUCTS INCLUDED FOR BIRTH CONTROL: MIRENA. CONCURRENT CONDITIONS INCLUDED HIVES, ANKLE SWELLING, DIARRHEA AND COLONIC POLYP. FAMILY HISTORY INCLUDED POLYPOSIS GASTRIC. CONCOMITANT PRODUCTS INCLUDED BUPROPION HYDROCHLORIDE (WELLBUTRIN), BUPROPION HYDROCHLORIDE (ZYBAN), DOXYCYCLINE, ETHANOL;POVIDONE-IODINE, ETHINYLESTRADIOL;NORETHISTERONE (OVCON), IBUPROFEN FROM 2010 TO 2016 AND PROTON PUMP INHIBITORS FROM 2012 TO 2016. ON (B)(6) 2006, THE PATIENT HAD ESSURE (ESS205) INSERTED. IN (B)(6) 2008, THE PATIENT EXPERIENCED MENORRHAGIA (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED) AND VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL)"). IN 2008, THE PATIENT EXPERIENCED FURUNCLE ("BOILS") AND CYST ("CYSTS"). IN 2009, THE PATIENT WAS FOUND TO HAVE WEIGHT INCREASED ("WEIGHT GAIN / WEIGHT GAIN OF 45 LBS WHILE MAINTAINING SAME ACTIVITY"). IN 2010, THE PATIENT EXPERIENCED DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING)"). IN 2012, THE PATIENT EXPERIENCED NAUSEA ("NAUSEA") AND ABDOMINAL PAIN ("ABDOMINAL PAIN"). IN (B)(6) 2014, THE PATIENT EXPERIENCED VAGINAL DISCHARGE ("VAGINAL DISCHARGE"). IN 2015, THE PATIENT EXPERIENCED VISION BLURRED ("VISION BLURRY/DIFFICULTY FOCUSING"), GASTROINTESTINAL MOTILITY DISORDER ("GASTROINTESTINAL OR DIGESTIVE SYSTEM CONDITION TYPE:DIFFICULTY HAVING BOWEL MOVEMENTS") AND THE FIRST EPISODE OF HAEMORRHOIDS ("HEMORRHOIDS"). IN SEPTEMBER 2015, THE PATIENT EXPERIENCED ASTIGMATISM ("ASTIGMATISM"). IN (B)(6) 2016, THE PATIENT EXPERIENCED MIGRAINE ("MIGRAINES/HEADACHES / DAILY HEADACHE"). IN (B)(6) 2016, THE PATIENT EXPERIENCED THE SECOND EPISODE OF HAEMORRHOIDS (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT). IN MAY 2017, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), ADENOMYOSIS ("ADENOMYOSIS") AND FATIGUE ("FATIGUE"). IN (B)(6) 2017, THE PATIENT EXPERIENCED DYSURIA ("PAINFUL URINATION"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED ABDOMINAL DISTENSION ("FEELING OF FULLNESS IN LOWER ABDOMEN"), BACK PAIN ("LOWER BACK PAIN"), DYSPEPSIA ("HEARTBURN"), ABDOMINAL PAIN LOWER ("LOWER ABDOMINAL PAIN"), DISTURBANCE IN ATTENTION ("ABILITY TO FOCUS") AND MEMORY IMPAIRMENT ("FOGGY MEMORY"). THE PATIENT WAS TREATED WITH SURGERY (HYSTERECTOMY (FULL) AND SALPINGECTOMY (BILATERAL REMOVAL OF FALLOPIAN TUBES), ON (B)(6) 2015 UNDERWENT ABLATION, ENDOMETRIAL BIOPSY AND HAD COLONOSCOPY AND UPPER GI SCOPE). ESSURE (ESS205) WAS REMOVED ON (B)(6) 2017. AT THE TIME OF THE REPORT, THE PELVIC PAIN, MENORRHAGIA, VAGINAL HAEMORRHAGE, FURUNCLE, CYST, DYSURIA, DYSMENORRHOEA, ADENOMYOSIS, NAUSEA, VAGINAL DISCHARGE, WEIGHT INCREASED, GASTROINTESTINAL MOTILITY DISORDER, DYSPEPSIA, ABDOMINAL PAIN, ASTIGMATISM AND THE LAST EPISODE OF HAEMORRHOIDS OUTCOME WAS UNKNOWN AND THE MIGRAINE, VISION BLURRED, FATIGUE, ABDOMINAL DISTENSION, BACK PAIN, ABDOMINAL PAIN LOWER, DISTURBANCE IN ATTENTION AND MEMORY IMPAIRMENT HAD RESOLVED. THE REPORTER CONSIDERED ABDOMINAL DISTENSION, ABDOMINAL PAIN, ABDOMINAL PAIN LOWER, ADENOMYOSIS, ASTIGMATISM, BACK PAIN, CYST, DISTURBANCE IN ATTENTION, DYSMENORRHOEA, DYSPEPSIA, DYSURIA, FATIGUE, FURUNCLE, GASTROINTESTINAL MOTILITY DISORDER, MEMORY IMPAIRMENT, MENORRHAGIA, MIGRAINE, NAUSEA, PELVIC PAIN, VAGINAL DISCHARGE, VAGINAL HAEMORRHAGE, VISION BLURRED, WEIGHT INCREASED, THE FIRST EPISODE OF HAEMORRHOIDS AND THE SECOND EPISODE OF HAEMORRHOIDS TO BE RELATED TO ESSURE (ESS205). THE REPORTER COMMENTED: ALL LOT NUMBERS (620737,0712021, 3976163 ) ARE INVALIDS CURRENT WEIGHT 197 LBS. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 25.5 KG/SQM. HYSTEROSALPINGOGRAM - ON (B)(6) 2007: RESULTS: TOTAL BILATERAL OCCLUSION. CONCERNING THE INJURIES REPORTED IN THIS CASE,THE FOLLOWING ONE/ONES WERE DESCRIBED IN PATIENTS MEDICAL RECORD CONFIRMING :NAUSEA AND HEART BURN, ABDOMINAL PAIN. 620737-INVALID LOT, 0712021-INVALID LOT, 3976163-INVALID LOT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON (B)(6) 2019: EVENTS- "ASTIGMATISM, HEMORRHOID", MEDICAL HISTORY, REPORTER ADDED FROM PFS. 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 (ESS205) INSERTED. IN 2006, THE PATIENT HAD ESSURE (ESS205) INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED). THE PATIENT WAS TREATED WITH SURGERY (TO REMOVE THE ESSURE IMPLANT). ESSURE (ESS205) 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 (ESS205). THE REPORTER COMMENTED: NEED FOR ADDITIONAL SURGERY. 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.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 136533 | ESSURE | TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE | HHS | BAYER PHARMA AG | ESS205 | 620737,0712021,3976163-ALL INV |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 34 YR | Other| R | BETADINE [ETHANOL,POVIDONE-IODINE]| BETADINE [ETHANOL,POVIDONE-IODINE]| DOXYCYCLINE| DOXYCYCLINE| DOXYCYCLINE| DOXYCYCLINE| DOXYCYCLINE| DOXYCYCLINE| ETHANOL,POVIDONE-IODINE| ETHANOL,POVIDONE-IODINE| ETHANOL,POVIDONE-IODINE| ETHANOL,POVIDONE-IODINE| IBUPROFEN| IBUPROFEN| IBUPROFEN| IBUPROFEN| IBUPROFEN| IBUPROFEN| OVCON| OVCON| OVCON| OVCON| OVCON| OVCON| PROTON PUMP INHIBITORS| PROTON PUMP INHIBITORS| PROTON PUMP INHIBITORS| PROTON PUMP INHIBITORS| PROTONIX| PROTONIX| WELLBUTRIN| WELLBUTRIN| WELLBUTRIN| WELLBUTRIN| WELLBUTRIN| WELLBUTRIN| ZYBAN| ZYBAN| ZYBAN| ZYBAN| ZYBAN| ZYBAN |