ESSURE
Report
- Report Number
- 2951250-2018-01405
- Event Type
- Injury
- Date Received
- April 3, 2018
- Date of Event
- June 1, 2011
- Report Date
- July 15, 2020
- Manufacturer
- BAYER PHARMA AG
- Product Code
- HHS
- PMA / PMN Number
- P020014
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WI, US
- Reporter Occupation
- OTHER
Narratives
THIS CASE WAS INITIALLY RECEIVED VIA REGULATORY AUTHORITY (FOOD AND DRUG ADMINISTRATION, REFERENCE NUMBER: MW5035249) ON 21-APR-2014. THE MOST RECENT INFORMATION WAS RECEIVED ON 16-APR-2019. THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ("CONSTANT PELVIC PAIN AND PRESSURE, PAIN"), MENORRHAGIA ("PERIODS HAVE BECOME INCREASING IN FLOW WITH LARGE CLOTS / EXCESSIVE BLEEDING /VERY HEAVY FLOW OF BLOOD FOR 2-3 DAYS, ABNORMAL BLEEDING (VAGINAL/MENORRHAGIA)") AND UTERINE HAEMORRHAGE ("HEAVY ABNORMAL UTERINE BLEEDING") IN A 26-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 774396) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S MEDICAL HISTORY INCLUDED OBESITY, HYPERTENSION, PREGNANCY AND CESAREAN SECTION. ON UNSPECIFIED DATE: UNSPECIFIED TESTS TO DETERMINE THE CAUSE OF EXCESSIVE BLEEDING: NONE OF THE RESULTS HAVE CONCLUDED ANY CAUSES. CONCURRENT CONDITIONS INCLUDED OBESITY, CHRONIC CERVICITIS, MENOMETRORRHAGIA, BLOOD PRESSURE HIGH (200/170.) SINCE 2004, PHOTOPHOBIA, NUMBNESS OF EXTREMITIES (WHOLE BODY FELT NUMB), PARESTHESIA, MULTIPLE SCLEROSIS, SKIN LESION, LYMPHADENOPATHY, PIMPLE (LITTLE PIMPLE SHE HAD ON HER EARLOBE.), DYSPLASTIC NEVUS, TEMPOROMANDIBULAR JOINT DISORDER, GERD, PELVIC DISCOMFORT AND ANXIETY. CONCOMITANT PRODUCTS INCLUDED BENZOCAINE, ETHINYLESTRADIOL;NORGESTIMATE (ORTHO TRI-CYCLEN) SINCE (B)(6) 2013, MEDROXYPROGESTERONE ACETATE (DEPO-PROVERA) FROM (B)(6) 2011 TO (B)(6) 2011, METOPROLOL SINCE 2004, OMEPRAZOLE SINCE 2008, POVIDONE-IODINE, RIZATRIPTAN SINCE (B)(6) 2014 AND TOPIRAMATE SINCE (B)(6) 2014. IN (B)(6) 2011, THE PATIENT EXPERIENCED MENORRHAGIA (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT) AND HEADACHE ("MIGRAINES / HEADACHES"). ON (B)(6) 2011, THE PATIENT HAD ESSURE INSERTED. IN 2011, THE PATIENT EXPERIENCED DERMATITIS ALLERGIC ("RANDOM RASH THAT POPS UP ON BACK, SHOULDERS AND STOMACH, ALLERGIC OR HYPERSENSITIVITY REACTION INCLUDING SKIN RASHES") AND WAS FOUND TO HAVE WEIGHT INCREASED ("WEIGHT GAIN"). IN (B)(6) 2011, THE PATIENT EXPERIENCED DYSMENORRHOEA ("SEVERE PAIN WITH PERIODS/HORRIBLE CRAMPING DURING MY PERIODS, DYSMENORRHEA (CRAMPING)"), ALLERGY TO METALS ("RASHES WHEN EXPOSED TO ALLERGENS SUCH AS NICKEL, NICKEL ALLERGY") AND ABDOMINAL PAIN ("SEVERE AND PERSISTENT ABDOMINAL PAIN"). IN (B)(6) 2011, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), 2 YEARS 11 MONTHS AFTER INSERTION OF ESSURE. IN (B)(6) 2011, THE PATIENT EXPERIENCED DYSMENORRHOEA ("SEVERE PAIN WITH PERIODS/HORRIBLE CRAMPING DURING MY PERIODS, DYSMENORRHEA (CRAMPING)"), ALLERGY TO METALS ("RASHES WHEN EXPOSED TO ALLERGENS SUCH AS NICKEL, NICKEL ALLERGY") AND ABDOMINAL PAIN ("SEVERE AND PERSISTENT ABDOMINAL PAIN"). IN 2011, THE PATIENT EXPERIENCED DERMATITIS ALLERGIC ("RANDOM RASH THAT POPS UP ON BACK, SHOULDERS AND STOMACH, ALLERGIC OR HYPERSENSITIVITY REACTION INCLUDING SKIN RASHES") AND WAS FOUND TO HAVE WEIGHT INCREASED ("WEIGHT GAIN"). IN (B)(6) 2011, THE PATIENT EXPERIENCED TOOTH DISORDER ("DENTAL PROBLEMS"). IN (B)(6) 2012, THE PATIENT EXPERIENCED BLADDER PROLAPSE ("BLADDER OR URINARY PROBLEMS OR CHANGES, STAGE 1 PROLAPSED BLADDER") AND URINARY TRACT DISORDER ("BLADDER OR URINARY PROBLEMS OR CHANGES"). IN (B)(6) 2012, THE PATIENT EXPERIENCED MIGRAINE ("MIGRAINES, EVERY DAY AT LEAST ONE MILD EPISODE OF HEADACHE, BUT A COUPLE DAYS BEFORE AND DURING HER PERIODS INTENSE AND OFTEN, MIGRAINES / HEADACHES") WITH MIGRAINE WITH AURA, VOMITING, NAUSEA AND TREMOR. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED UTERINE HAEMORRHAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), ABDOMINAL PAIN LOWER ("STABBING PAIN IN LOWER ABDOMEN/CRAMPING"), PELVIC DISCOMFORT ("CONSTANT PELVIC PAIN AND PRESSURE"), BACK PAIN ("CHRONIC LOWER BACK PAIN"), DECREASED APPETITE ("LACK OF APPETITE"), DYSPAREUNIA ("DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE)") AND RASH ("ALLERGIC OR HYPERSENSITIVITY REACTION TYPE RASHES"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED FATIGUE ("FATIGUE") AND VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL/MENORRHAGIA)"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED UTERINE HAEMORRHAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), ABDOMINAL PAIN LOWER ("STABBING PAIN IN LOWER ABDOMEN/CRAMPING"), PELVIC DISCOMFORT ("CONSTANT PELVIC PAIN AND PRESSURE"), BACK PAIN ("CHRONIC LOWER BACK PAIN"), DECREASED APPETITE ("LACK OF APPETITE"), DYSPAREUNIA ("DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE)") AND RASH ("ALLERGIC OR HYPERSENSITIVITY REACTION TYPE RASHES"). THE PATIENT WAS TREATED WITH I.V. SOLUTIONS AND SURGERY (HYSTERECTOMY WITH BILATERAL SALPINGECTOMY - LAPAROSCOPIC ASSISTED TOTAL VAGINAL HYSTERECTOMY AND BIL). ESSURE WAS REMOVED ON (B)(6) 2014. AT THE TIME OF THE REPORT, THE PELVIC PAIN, MIGRAINE, FATIGUE, WEIGHT INCREASED AND RASH HAD RESOLVED, THE MENORRHAGIA, DYSMENORRHOEA, ABDOMINAL PAIN LOWER, PELVIC DISCOMFORT AND BACK PAIN HAD NOT RESOLVED, THE UTERINE HAEMORRHAGE AND ABDOMINAL PAIN WAS RESOLVING AND THE HEADACHE, DERMATITIS ALLERGIC, DECREASED APPETITE, VAGINAL HAEMORRHAGE, ALLERGY TO METALS, BLADDER PROLAPSE, URINARY TRACT DISORDER, TOOTH DISORDER AND DYSPAREUNIA OUTCOME WAS UNKNOWN. THE REPORTER PROVIDED NO CAUSALITY ASSESSMENT FOR ABDOMINAL PAIN LOWER, BACK PAIN, DECREASED APPETITE, DERMATITIS ALLERGIC, DYSMENORRHOEA, FATIGUE, HEADACHE, MENORRHAGIA, MIGRAINE, PELVIC DISCOMFORT AND PELVIC PAIN WITH ESSURE. THE REPORTER CONSIDERED ABDOMINAL PAIN, ALLERGY TO METALS, BLADDER PROLAPSE, DYSPAREUNIA, RASH, TOOTH DISORDER, URINARY TRACT DISORDER, UTERINE HAEMORRHAGE, VAGINAL HAEMORRHAGE AND WEIGHT INCREASED TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: PLACED THE HYSTEROSCOPE WITH NORMAL SALINE DISTENTION MEDIA. FIRST THE LEFT FALLOPIAN TUBE WAS NOTED, EASILY CANNULATED WITH 4 TRAILING COILS AFTER I WAS DONE DEPLOYING THE ESSURE COIL. THE RIGHT SIDE, I THEN REPEATED THIS PROCEDURE. I HAD 5 TRAILING COILS. THE PATIENT TOLERATED THE PROCEDURE WELL. THE LEFT BLADDER PILLAR WAS TAKEN, CLAMPED, CRUSHED, AND TIED, THEN THE RIGHT BLADDER PILLAR AS WELL. ON THE RIGHT SIDE, THERE WAS 1 FURTHER BROAD LIGAMENT PEDICLE, AND THE LEFT SIDE NO FURTHER BROAD LIGAMENT PEDICLES REQUIRED. I REMOVED THE UTERUS, CERVIX, AND FALLOPIAN TUBES IN THEIR ENTIRETY. BLEEDING WAS CONTROLLED. THE UTEROSACRAL LIGAMENTS WERE TIED TOGETHER. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 31.9 KG/SQM. HYSTEROSALPINGOGRAM - ON (B)(6) 2011: RESULTS: TUBES BLOCKED AT THE TIME OF PROCEDURE.. NUCLEAR MAGNETIC RESONANCE IMAGING BRAIN - ON AN UNKNOWN DATE: SHOWED NONSPECIFIC AREAS OF INCREASED SIGNAL IN THE WHITE MATTER ON THE T2-WEIGHTED IMAGES, 2 TINY AREAS ON THE RIGHT AND 2 TINY AREAS ON THE LEFT THAT WERE NONSPECIFIC.. QUALITY-SAFETY EVALUATION OF PTC: SAMPLE NOT AVAILABLE. WE CONDUCTED A REVIEW OF THE MANUFACTURING BATCH RECORD AND CONFIRMED THAT FINAL PRODUCT TESTING FOR THIS LOT WAS PERFORMED PER REQUIREMENTS AND THE PRODUCT MET ALL RELEASE REQUIREMENTS. 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 NOT INDICATIVE OF A QUALITY DEFICIT PER SE. NO SIMILAR AE CASE REPORTS HAVE BEEN RECEIVED TO DATE IN RELATION TO THE REPORTED BATCH . NO SPECIFIC QUALITY ISSUE WAS DEFINED, THEREFORE NO MEDDRA LLT CAN BE PROVIDED. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 16-APR-2019: PLAINTIFF FACT SHEET AND MEDICAL RECEIVED, CONCOMITANT MEDICATION ,CONCURRENT CONDITION LAB DATA, AND EVENT ALLERGIC OR HYPERSENSITIVITY REACTION TYPE RASHES WERE ADDED. 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 CASE WAS INITIALLY RECEIVED VIA REGULATORY AUTHORITY (FOOD AND DRUG ADMINISTRATION, REFERENCE NUMBER: MW5035249) ON 21-APR-2014. THE MOST RECENT INFORMATION WAS RECEIVED ON 02-DEC-2019. THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ('CONSTANT PELVIC PAIN AND PRESSURE, PAIN'), RESPIRATORY DISTRESS ('I¿VE DEVELOPED THRUSH AFTER MY SURGERY AN THE BREATHING TUBES AND SUCH') AND MEDICAL DEVICE REMOVAL ('I HAD A HYSTO') IN A 26-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 774396) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S MEDICAL HISTORY INCLUDED PARITY 2 IN (B)(6) 2010, OBESITY, HYPERTENSION, GRAVIDA II AND MULTIPLE CESAREAN SECTIONS. ON UNSPECIFIED DATE: UNSPECIFIED TESTS TO DETERMINE THE CAUSE OF EXCESSIVE BLEEDING: NONE OF THE RESULTS HAVE CONCLUDED ANY CAUSES. CONCURRENT CONDITIONS INCLUDED BLOOD PRESSURE HIGH (200/170.) SINCE 2004, OBESITY, CHRONIC CERVICITIS, MENOMETRORRHAGIA, PHOTOPHOBIA, NUMBNESS OF EXTREMITIES (WHOLE BODY FELT NUMB), PARESTHESIA, MULTIPLE SCLEROSIS, SKIN LESION, LYMPHADENOPATHY, PIMPLE (LITTLE PIMPLE SHE HAD ON HER EARLOBE.), DYSPLASTIC NEVUS, TEMPOROMANDIBULAR JOINT DISORDER, GERD, PELVIC DISCOMFORT AND ANXIETY. CONCOMITANT PRODUCTS INCLUDED BENZOCAINE, ETHINYLESTRADIOL;NORGESTIMATE (ORTHO TRI-CYCLEN) SINCE (B)(6) 2013, MEDROXYPROGESTERONE ACETATE (DEPO-PROVERA) FROM (B)(6)2011, METOPROLOL SINCE 2004, OMEPRAZOLE SINCE 2008, POVIDONE-IODINE, RIZATRIPTAN AND TOPIRAMATE SINCE (B)(6) 2014. IN (B)(6) 2011, THE PATIENT EXPERIENCED MENORRHAGIA ("PERIODS HAVE BECOME INCREASING IN FLOW WITH LARGE CLOTS / EXCESSIVE BLEEDING /VERY HEAVY FLOW OF BLOOD FOR 2-3 DAYS, ABNORMAL BLEEDING (VAGINAL/MENORRHAGIA), MY CYCLE BECOME INTENSELY HEAVY WITH LOTS OF LARGE CLOTTING") AND HEADACHE ("MIGRAINES / HEADACHES"). ON (B)(6)2011, THE PATIENT HAD ESSURE INSERTED. IN (B)(6) 2011, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), 2 YEARS 11 MONTHS AFTER INSERTION OF ESSURE. IN (B)(6)2011, THE PATIENT EXPERIENCED DYSMENORRHOEA ("SEVERE PAIN WITH PERIODS/HORRIBLE CRAMPING DURING MY PERIODS, DYSMENORRHEA (CRAMPING) , I CRAMP SO BAD"), ALLERGY TO METALS ("RASHES WHEN EXPOSED TO ALLERGENS SUCH AS NICKEL, NICKEL ALLERGY") AND ABDOMINAL PAIN ("SEVERE AND PERSISTENT ABDOMINAL PAIN"). IN 2011, THE PATIENT EXPERIENCED DERMATITIS ALLERGIC ("RANDOM RASH THAT POPS UP ON BACK, SHOULDERS AND STOMACH, ALLERGIC OR HYPERSENSITIVITY REACTION INCLUDING SKIN RASHES") AND WAS FOUND TO HAVE WEIGHT INCREASED ("WEIGHT GAIN"). IN (B)(6) 2011, THE PATIENT EXPERIENCED TOOTH DISORDER ("DENTAL PROBLEMS"). IN (B)(6) 2012, THE PATIENT EXPERIENCED BLADDER PROLAPSE ("BLADDER OR URINARY PROBLEMS OR CHANGES, STAGE 1 PROLAPSED BLADDER") AND URINARY TRACT DISORDER ("BLADDER OR URINARY PROBLEMS OR CHANGES"). IN (B)(6) 2012, THE PATIENT EXPERIENCED MIGRAINE ("MIGRAINES, EVERY DAY AT LEAST ONE MILD EPISODE OF HEADACHE, BUT A COUPLE DAYS BEFORE AND DURING HER PERIODS INTENSE AND OFTEN, MIGRAINES / HEADACHES, I HAVE DEVELOPED SEVER MIGRAINS") WITH VOMITING AND TREMOR. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED UTERINE HAEMORRHAGE ("HEAVY ABNORMAL UTERINE BLEEDING"), MIGRAINE WITH AURA ("AURAS/AURAS ARE SO BAD MOST OF THE TIME THAT I CANNOT SEE"), NAUSEA ("NAUSEA, BUT THE NAUSEA WAS HORRIBLE AFTER THEY GAVE"), ABDOMINAL PAIN LOWER ("STABBING PAIN IN LOWER ABDOMEN/CRAMPING , SHARP STABBING PAINS MOSTLY ON MY RIGHT SIDE, SUCH SHARP BURRING PAINS IN MY LOWER RIGHT ABDOMEN TO BACK"), PELVIC DISCOMFORT ("CONSTANT PELVIC PAIN AND PRESSURE"), BACK PAIN ("CHRONIC LOWER BACK PAIN,SHARP SHARP BURRNIG PAINS IN MY LOWER RIGHT ABDOMEN TO BACK PAINS IN MY LOWER RIGHT ABDOMEN TO BACK"), DECREASED APPETITE ("LACK OF APPETITE"), DYSPAREUNIA ("DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE)"), RASH ERYTHEMATOUS ("ALLERGIC OR HYPERSENSITIVITY REACTION TYPE RASHES, SKIN PROBLEMS RASHES AN REDNESS"), ANGINA PECTORIS ("BUT IT STILL BECOMES A NUISANCE , I FELT I WAS HAVING A HEART ATTACK WITH SEVERE CHEST AND BACK PAIN"), LIBIDO INCREASED ("I HAVE ALWAYS HAD A HIGH SEX DRIVE EVEN WITH ESSURE"), RASH MACULAR ("MY CHEEKS WERE NORMALLY RED AN BLOTCHY AND VAINY SINCE ESSURE 2011"), EYE DISORDER ("VISION ISSUES , VISION CHANGES , BAWLING MY EYES "), GENITAL INJURY ("PULL THEM OUT VIRGINALLY THEN SURGICALLY REMOVE THE DAMAGED TUBES"), RESPIRATORY DISTRESS (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), DYSPHAGIA ("SWALLOW HORRIBLE STUFF"), SCAR ("I HAD MASSIVE SCAR TISSUE BUILD UP BEHIND MY BELLY BUTTON AREA"), VULVOVAGINAL PAIN ("STABBING PAINS IN MY VAGINAL AREA"), NERVOUSNESS ("MORE NERVOUS THAN I THOUGHT I WOULD BE ") AND CONTUSION ("I¿VE REALLY GOT TO GET HURT HARD TO BRUISE AT ALL"), WAS FOUND TO HAVE BLOOD POTASSIUM DECREASED ("I'M VERY LOW IN POTASSIUM") AND UNDERWENT MEDICAL DEVICE REMOVAL (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED FATIGUE ("FATIGUE") AND VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL/MENORRHAGIA)"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED UTERINE HAEMORRHAGE ("HEAVY ABNORMAL UTERINE BLEEDING"), MIGRAINE WITH AURA ("AURAS/AURAS ARE SO BAD MOST OF THE TIME THAT I CANNOT SEE"), NAUSEA ("NAUSEA, BUT THE NAUSEA WAS HORRIBLE AFTER THEY GAVE"), ABDOMINAL PAIN LOWER ("STABBING PAIN IN LOWER ABDOMEN/CRAMPING , SHARP STABBING PAINS MOSTLY ON MY RIGHT SIDE, SUCH SHARP BURRING PAINS IN MY LOWER RIGHT ABDOMEN TO BACK"), PELVIC DISCOMFORT ("CONSTANT PELVIC PAIN AND PRESSURE"), BACK PAIN ("CHRONIC LOWER BACK PAIN,SHARP SHARP BURRNIG PAINS IN MY LOWER RIGHT ABDOMEN TO BACK PAINS IN MY LOWER RIGHT ABDOMEN TO BACK"), DECREASED APPETITE ("LACK OF APPETITE"), DYSPAREUNIA ("DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE)"), RASH ERYTHEMATOUS ("ALLERGIC OR HYPERSENSITIVITY REACTION TYPE RASHES, SKIN PROBLEMS RASHES AN REDNESS"), ANGINA PECTORIS ("BUT IT STILL BECOMES A NUISANCE , I FELT I WAS HAVING A HEART ATTACK WITH SEVERE CHEST AND BACK PAIN"), LIBIDO INCREASED ("I HAVE ALWAYS HAD A HIGH SEX DRIVE EVEN WITH ESSURE"), RASH MACULAR ("MY CHEEKS WERE NORMALLY RED AN BLOTCHY AND VAINY SINCE ESSURE 2011"), EYE DISORDER ("VISION ISSUES , VISION CHANGES , BAWLING MY EYES "), GENITAL INJURY ("PULL THEM OUT VIRGINALLY THEN SURGICALLY REMOVE THE DAMAGED TUBES"), RESPIRATORY DISTRESS (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), DYSPHAGIA ("SWALLOW HORRIBLE STUFF"), SCAR ("I HAD MASSIVE SCAR TISSUE BUILD UP BEHIND MY BELLY BUTTON AREA"), VULVOVAGINAL PAIN ("STABBING PAINS IN MY VAGINAL AREA"), NERVOUSNESS ("MORE NERVOUS THAN I THOUGHT I WOULD BE ") AND CONTUSION ("I¿VE REALLY GOT TO GET HURT HARD TO BRUISE AT ALL"), WAS FOUND TO HAVE BLOOD POTASSIUM DECREASED ("I'M VERY LOW IN POTASSIUM") AND UNDERWENT MEDICAL DEVICE REMOVAL (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED). THE PATIENT WAS TREATED WITH I.V. SOLUTIONS AND SURGERY (HYSTERECTOMY AND HYSTERECTOMY WITH BILATERAL SALPINGECTOMY - LAPAROSCOPIC ASSISTED TOTAL VAGINAL HYSTERECTOMY AND BIL). ESSURE WAS REMOVED ON (B)(6)2014. AT THE TIME OF THE REPORT, THE PELVIC PAIN, MIGRAINE, FATIGUE, WEIGHT INCREASED AND RASH ERYTHEMATOUS HAD RESOLVED, THE MENORRHAGIA, DYSMENORRHOEA, ABDOMINAL PAIN LOWER, PELVIC DISCOMFORT AND BACK PAIN HAD NOT RESOLVED, THE UTERINE HAEMORRHAGE AND ABDOMINAL PAIN WAS RESOLVING AND THE NAUSEA, HEADACHE, DERMATITIS ALLERGIC, DECREASED APPETITE, VAGINAL HAEMORRHAGE, ALLERGY TO METALS, BLADDER PROLAPSE, URINARY TRACT DISORDER, TOOTH DISORDER, DYSPAREUNIA, ANGINA PECTORIS, LIBIDO INCREASED, RASH MACULAR, EYE DISORDER, GENITAL INJURY, RESPIRATORY DISTRESS, DYSPHAGIA, SCAR, VULVOVAGINAL PAIN, BLOOD POTASSIUM DECREASED, NERVOUSNESS, CONTUSION AND MEDICAL DEVICE REMOVAL OUTCOME WAS UNKNOWN. THE REPORTER PROVIDED NO CAUSALITY ASSESSMENT FOR ABDOMINAL PAIN LOWER, BACK PAIN, DECREASED APPETITE, DERMATITIS ALLERGIC, DYSMENORRHOEA, FATIGUE, HEADACHE, MENORRHAGIA, MIGRAINE, PELVIC DISCOMFORT AND PELVIC PAIN WITH ESSURE. THE REPORTER CONSIDERED ABDOMINAL PAIN, ALLERGY TO METALS, ANGINA PECTORIS, BLADDER PROLAPSE, BLOOD POTASSIUM DECREASED, CONTUSION, DYSPAREUNIA, DYSPHAGIA, EYE DISORDER, GENITAL INJURY, LIBIDO INCREASED, MEDICAL DEVICE REMOVAL, MIGRAINE WITH AURA, NAUSEA, NERVOUSNESS, RASH ERYTHEMATOUS, RASH MACULAR, RESPIRATORY DISTRESS, SCAR, TOOTH DISORDER, URINARY TRACT DISORDER, UTERINE HAEMORRHAGE, VAGINAL HAEMORRHAGE, VULVOVAGINAL PAIN AND WEIGHT INCREASED TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: PLACED THE HYSTEROSCOPE WITH NORMAL SALINE DISTENTION MEDIA. FIRST THE LEFT FALLOPIAN TUBE WAS NOTED, EASILY CANNULATED WITH 4 TRAILING COILS AFTER I WAS DONE DEPLOYING THE ESSURE COIL. THE RIGHT SIDE, I THEN REPEATED THIS PROCEDURE. I HAD 5 TRAILING COILS. THE PATIENT TOLERATED THE PROCEDURE WELL. THE LEFT BLADDER PILLAR WAS TAKEN, CLAMPED, CRUSHED, AND TIED, THEN THE RIGHT BLADDER PILLAR AS WELL. ON THE RIGHT SIDE, THERE WAS 1 FURTHER BROAD LIGAMENT PEDICLE, AND THE LEFT SIDE NO FURTHER BROAD LIGAMENT PEDICLES REQUIRED. I REMOVED THE UTERUS, CERVIX, AND FALLOPIAN TUBES IN THEIR ENTIRETY. BLEEDING WAS CONTROLLED. THE UTEROSACRAL LIGAMENTS WERE TIED TOGETHER. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 31.9 KG/SQM. HYSTEROSALPINGOGRAM - ON (B)(6)2011: RESULTS: TUBES BLOCKED AT THE TIME OF PROCEDURE.. MAGNETIC RESONANCE IMAGING BRAIN - ON AN UNKNOWN DATE: SHOWED NONSPECIFIC AREAS OF INCREASED SIGNAL IN THE WHITE MATTER ON THE T2-WEIGHTED IMAGES, 2 TINY AREAS ON THE RIGHT AND 2 TINY AREAS ON THE LEFT THAT WERE NONSPECIFIC. 4 FLARES ON MY BRAIN. CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONES WERE REPORTED VIA SOCIAL MEDIA: BUT IT STILL BECOMES A NUISANCE , I FELT I WAS HAVING A HEART ATTACK WITH SEVERE CHEST AND BACK PAIN, I HAVE ALWAYS HAD A HIGH SEX DRIVE EVEN WITH ESSURE, MY CHEEKS WERE NORMALLY RED AN BLOTCHY AND VAINY SINCE ESSURE 2011, VISION ISSUES , VISION CHANGES, BAWLING MY EYES, PULL THEM OUT VIRGINALLY THEN SURGICALLY REMOVE THE DAMAGED TUBES, I¿VE DEVELOPED THRUSH AFTER MY SURGERY AN THE BREATHING TUBES AND SUCH, SWALLOW HORRIBLE STUFF , I HAD MASSIVE SCAR TISSUE BUILD UP BEHIND MY BELLY BUTTON AREA, STABBING PAINS IN MY VAGINAL AREA , I'M VERY LOW IN POTASSIUM , MORE NERVOUS THAN I THOUGHT I WOULD BE , I¿VE REALLY GOT TO GET HURT HARD TO BRUISE AT ALL. QUALITY-SAFETY EVALUATION OF PTC: SAMPLE NOT AVAILABLE. WE CONDUCTED A REVIEW OF THE MANUFACTURING BATCH RECORD AND CONFIRMED THAT FINAL PRODUCT TESTING FOR THIS LOT WAS PERFORMED PER REQUIREMENTS AND THE PRODUCT MET ALL RELEASE REQUIREMENTS. 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 NOT INDICATIVE OF A QUALITY DEFICIT PER SE. NO SIMILAR AE CASE REPORTS HAVE BEEN RECEIVED TO DATE IN RELATION TO THE REPORTED BATCH . NO SPECIFIC QUALITY ISSUE WAS DEFINED, THEREFORE NO MEDDRA LLT CAN BE PROVIDED. AMENDMENT: THE REPORT WAS AMENDED FOR THE FOLLOWING REASON: THIS IS A RETENTION CASE. ALL THE INFORMATION HAS BEEN TRANSFERED FROM DELETION CASE (B)(4), INFORMATION INCLUDES REFERENCES AND SOURCE DOCUMENT. NO NEW FOLLOW-UP INFORMATION WAS RECEIVED FROM THE REPORTER. 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 CASE WAS INITIALLY RECEIVED VIA REGULATORY AUTHORITY (FOOD AND DRUG ADMINISTRATION, REFERENCE NUMBER: MW5035249) ON 21-APR-2014. THE MOST RECENT INFORMATION WAS RECEIVED ON 02-DEC-2019. THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ('CONSTANT PELVIC PAIN AND PRESSURE, PAIN'), MENORRHAGIA ('PERIODS HAVE BECOME INCREASING IN FLOW WITH LARGE CLOTS / EXCESSIVE BLEEDING /VERY HEAVY FLOW OF BLOOD FOR 2-3 DAYS, ABNORMAL BLEEDING (VAGINAL/MENORRHAGIA), MY CYCLE BECOME INTENSELY HEAVY WITH LOTS OF LARGE CLOTTING'), UTERINE HAEMORRHAGE ('HEAVY ABNORMAL UTERINE BLEEDING') AND RESPIRATORY DISTRESS ('I¿VE DEVELOPED THRUSH AFTER MY SURGERY AN THE BREATHING TUBES AND SUCH') IN A 26-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 774396) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S MEDICAL HISTORY INCLUDED NORMAL DELIVERY (LIVE CHILD) IN (B)(6) 2010, OBESITY, HYPERTENSION, PREGNANCY AND CESAREAN SECTION. ON UNSPECIFIED DATE: UNSPECIFIED TESTS TO DETERMINE THE CAUSE OF EXCESSIVE BLEEDING: NONE OF THE RESULTS HAVE CONCLUDED ANY CAUSES. CONCURRENT CONDITIONS INCLUDED BLOOD PRESSURE HIGH (200/170.) SINCE 2004, OBESITY, CHRONIC CERVICITIS, MENOMETRORRHAGIA, PHOTOPHOBIA, NUMBNESS OF EXTREMITIES (WHOLE BODY FELT NUMB), PARESTHESIA, MULTIPLE SCLEROSIS, SKIN LESION, LYMPHADENOPATHY, PIMPLE (LITTLE PIMPLE SHE HAD ON HER EARLOBE.), DYSPLASTIC NEVUS, TEMPOROMANDIBULAR JOINT DISORDER, GERD, PELVIC DISCOMFORT AND ANXIETY. CONCOMITANT PRODUCTS INCLUDED BENZOCAINE, ETHINYLESTRADIOL;NORGESTIMATE (ORTHO TRI-CYCLEN) SINCE (B)(6) 2013, MEDROXYPROGESTERONE ACETATE (DEPO-PROVERA) FROM (B)(6) 2011 TO (B)(6) 2011, METOPROLOL SINCE 2004, OMEPRAZOLE SINCE 2008, POVIDONE-IODINE, RIZATRIPTAN SINCE (B)(6) 2014 AND TOPIRAMATE SINCE (B)(6) 2014. IN (B)(6) 2011, THE PATIENT EXPERIENCED MENORRHAGIA (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT) AND HEADACHE ("MIGRAINES / HEADACHES"). ON (B)(6) 2011, THE PATIENT HAD ESSURE INSERTED. IN 2011, THE PATIENT EXPERIENCED DERMATITIS ALLERGIC ("RANDOM RASH THAT POPS UP ON BACK, SHOULDERS AND STOMACH, ALLERGIC OR HYPERSENSITIVITY REACTION INCLUDING SKIN RASHES") AND WAS FOUND TO HAVE WEIGHT INCREASED ("WEIGHT GAIN"). IN (B)(6) 2011, THE PATIENT EXPERIENCED DYSMENORRHOEA ("SEVERE PAIN WITH PERIODS/HORRIBLE CRAMPING DURING MY PERIODS, DYSMENORRHEA (CRAMPING), I CRAMP SO BAD"), ALLERGY TO METALS ("RASHES WHEN EXPOSED TO ALLERGENS SUCH AS NICKEL, NICKEL ALLERGY") AND ABDOMINAL PAIN ("SEVERE AND PERSISTENT ABDOMINAL PAIN"). IN (B)(6) 2011, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), 2 YEARS 11 MONTHS AFTER INSERTION OF ESSURE. IN (B)(6) 2011, THE PATIENT EXPERIENCED DYSMENORRHOEA ("SEVERE PAIN WITH PERIODS/HORRIBLE CRAMPING DURING MY PERIODS, DYSMENORRHEA (CRAMPING), I CRAMP SO BAD"), ALLERGY TO METALS ("RASHES WHEN EXPOSED TO ALLERGENS SUCH AS NICKEL, NICKEL ALLERGY") AND ABDOMINAL PAIN ("SEVERE AND PERSISTENT ABDOMINAL PAIN"). IN 2011, THE PATIENT EXPERIENCED DERMATITIS ALLERGIC ("RANDOM RASH THAT POPS UP ON BACK, SHOULDERS AND STOMACH, ALLERGIC OR HYPERSENSITIVITY REACTION INCLUDING SKIN RASHES") AND WAS FOUND TO HAVE WEIGHT INCREASED ("WEIGHT GAIN"). IN (B)(6) 2011, THE PATIENT EXPERIENCED TOOTH DISORDER ("DENTAL PROBLEMS"). IN (B)(6) 2012, THE PATIENT EXPERIENCED BLADDER PROLAPSE ("BLADDER OR URINARY PROBLEMS OR CHANGES, STAGE 1 PROLAPSED BLADDER") AND URINARY TRACT DISORDER ("BLADDER OR URINARY PROBLEMS OR CHANGES"). IN (B)(6) 2012, THE PATIENT EXPERIENCED MIGRAINE ("MIGRAINES, EVERY DAY AT LEAST ONE MILD EPISODE OF HEADACHE, BUT A COUPLE DAYS BEFORE AND DURING HER PERIODS INTENSE AND OFTEN, MIGRAINES / HEADACHES, I HAVE DEVELOPED SEVERE MIGRAINES") WITH VOMITING AND TREMOR. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED UTERINE HAEMORRHAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), MIGRAINE WITH AURA ("AURAS/AURAS ARE SO BAD MOST OF THE TIME THAT I CANNOT SEE"), NAUSEA ("NAUSEA, BUT THE NAUSEA WAS HORRIBLE AFTER THEY GAVE"), ABDOMINAL PAIN LOWER ("STABBING PAIN IN LOWER ABDOMEN/CRAMPING , SHARP STABBING PAINS MOSTLY ON MY RIGHT SIDE, SUCH SHARP BURRING PAINS IN MY LOWER RIGHT ABDOMEN TO BACK"), PELVIC DISCOMFORT ("CONSTANT PELVIC PAIN AND PRESSURE"), BACK PAIN ("CHRONIC LOWER BACK PAIN,SHARP BURNING PAINS IN MY LOWER RIGHT ABDOMEN TO BACK PAINS IN MY LOWER RIGHT ABDOMEN TO BACK"), DECREASED APPETITE ("LACK OF APPETITE"), DYSPAREUNIA ("DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE)"), RASH ERYTHEMATOUS ("ALLERGIC OR HYPERSENSITIVITY REACTION TYPE RASHES, SKIN PROBLEMS RASHES AN REDNESS"), FEELING ABNORMAL ("BUT IT STILL BECOMES A NUISANCE , I FELT I WAS HAVING A HEART ATTACK WITH SEVERE CHEST AND BACK PAIN"), HIGH RISK SEXUAL BEHAVIOUR ("I HAVE ALWAYS HAD A HIGH SEX DRIVE EVEN WITH ESSURE"), RASH MACULAR ("MY CHEEKS WERE NORMALLY RED AN BLOTCHY AND VEINY SINCE ESSURE 2011"), EYE DISORDER ("VISION ISSUES , VISION CHANGES , BAWLING MY EYES "), GENITAL INJURY ("PULL THEM OUT VIRGINALLY THEN SURGICALLY REMOVE THE DAMAGED TUBES"), RESPIRATORY DISTRESS (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), DYSPHAGIA ("SWALLOW HORRIBLE STUFF"), SKIN LESION INFLAMMATION ("I HAD MASSIVE SCAR TISSUE BUILD UP BEHIND MY BELLY BUTTON AREA"), VULVOVAGINAL PAIN ("STABBING PAINS IN MY VAGINAL AREA"), NERVOUSNESS ("MORE NERVOUS THAN I THOUGHT I WOULD BE ") AND CONTUSION ("I¿VE REALLY GOT TO GET HURT HARD TO BRUISE AT ALL") AND WAS FOUND TO HAVE BLOOD POTASSIUM DECREASED ("I'M VERY LOW IN POTASSIUM"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED FATIGUE ("FATIGUE") AND VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL/MENORRHAGIA)"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED UTERINE HAEMORRHAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), MIGRAINE WITH AURA ("AURAS/AURAS ARE SO BAD MOST OF THE TIME THAT I CANNOT SEE"), NAUSEA ("NAUSEA, BUT THE NAUSEA WAS HORRIBLE AFTER THEY GAVE"), ABDOMINAL PAIN LOWER ("STABBING PAIN IN LOWER ABDOMEN/CRAMPING , SHARP STABBING PAINS MOSTLY ON MY RIGHT SIDE, SUCH SHARP BURRING PAINS IN MY LOWER RIGHT ABDOMEN TO BACK"), PELVIC DISCOMFORT ("CONSTANT PELVIC PAIN AND PRESSURE"), BACK PAIN ("CHRONIC LOWER BACK PAIN,SHARP BURNING PAINS IN MY LOWER RIGHT ABDOMEN TO BACK PAINS IN MY LOWER RIGHT ABDOMEN TO BACK"), DECREASED APPETITE ("LACK OF APPETITE"), DYSPAREUNIA ("DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE)"), RASH ERYTHEMATOUS ("ALLERGIC OR HYPERSENSITIVITY REACTION TYPE RASHES, SKIN PROBLEMS RASHES AN REDNESS"), FEELING ABNORMAL ("BUT IT STILL BECOMES A NUISANCE , I FELT I WAS HAVING A HEART ATTACK WITH SEVERE CHEST AND BACK PAIN"), HIGH RISK SEXUAL BEHAVIOUR ("I HAVE ALWAYS HAD A HIGH SEX DRIVE EVEN WITH ESSURE"), RASH MACULAR ("MY CHEEKS WERE NORMALLY RED AN BLOTCHY AND VEINY SINCE ESSURE 2011"), EYE DISORDER ("VISION ISSUES , VISION CHANGES , BAWLING MY EYES "), GENITAL INJURY ("PULL THEM OUT VIRGINALLY THEN SURGICALLY REMOVE THE DAMAGED TUBES"), RESPIRATORY DISTRESS (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), DYSPHAGIA ("SWALLOW HORRIBLE STUFF"), SKIN LESION INFLAMMATION ("I HAD MASSIVE SCAR TISSUE BUILD UP BEHIND MY BELLY BUTTON AREA"), VULVOVAGINAL PAIN ("STABBING PAINS IN MY VAGINAL AREA"), NERVOUSNESS ("MORE NERVOUS THAN I THOUGHT I WOULD BE ") AND CONTUSION ("I¿VE REALLY GOT TO GET HURT HARD TO BRUISE AT ALL") AND WAS FOUND TO HAVE BLOOD POTASSIUM DECREASED ("I'M VERY LOW IN POTASSIUM"). THE PATIENT WAS TREATED WITH I.V. SOLUTIONS AND SURGERY (HYSTERECTOMY WITH BILATERAL SALPINGECTOMY - LAPAROSCOPIC ASSISTED TOTAL VAGINAL HYSTERECTOMY AND BIL). ESSURE WAS REMOVED ON (B)(6) 2014. AT THE TIME OF THE REPORT, THE PELVIC PAIN, MIGRAINE, FATIGUE, WEIGHT INCREASED AND RASH ERYTHEMATOUS HAD RESOLVED, THE MENORRHAGIA, DYSMENORRHOEA, ABDOMINAL PAIN LOWER, PELVIC DISCOMFORT AND BACK PAIN HAD NOT RESOLVED, THE UTERINE HAEMORRHAGE AND ABDOMINAL PAIN WAS RESOLVING AND THE NAUSEA, HEADACHE, DERMATITIS ALLERGIC, DECREASED APPETITE, VAGINAL HAEMORRHAGE, ALLERGY TO METALS, BLADDER PROLAPSE, URINARY TRACT DISORDER, TOOTH DISORDER, DYSPAREUNIA, FEELING ABNORMAL, HIGH RISK SEXUAL BEHAVIOUR, RASH MACULAR, EYE DISORDER, GENITAL INJURY, RESPIRATORY DISTRESS, DYSPHAGIA, SKIN LESION INFLAMMATION, VULVOVAGINAL PAIN, BLOOD POTASSIUM DECREASED, NERVOUSNESS AND CONTUSION OUTCOME WAS UNKNOWN. THE REPORTER PROVIDED NO CAUSALITY ASSESSMENT FOR ABDOMINAL PAIN LOWER, BACK PAIN, DECREASED APPETITE, DERMATITIS ALLERGIC, DYSMENORRHOEA, FATIGUE, HEADACHE, MENORRHAGIA, MIGRAINE, PELVIC DISCOMFORT AND PELVIC PAIN WITH ESSURE. THE REPORTER CONSIDERED ABDOMINAL PAIN, ALLERGY TO METALS, BLADDER PROLAPSE, BLOOD POTASSIUM DECREASED, CONTUSION, DYSPAREUNIA, DYSPHAGIA, EYE DISORDER, FEELING ABNORMAL, GENITAL INJURY, HIGH RISK SEXUAL BEHAVIOUR, MIGRAINE WITH AURA, NAUSEA, NERVOUSNESS, RASH ERYTHEMATOUS, RASH MACULAR, RESPIRATORY DISTRESS, SKIN LESION INFLAMMATION, TOOTH DISORDER, URINARY TRACT DISORDER, UTERINE HAEMORRHAGE, VAGINAL HAEMORRHAGE, VULVOVAGINAL PAIN AND WEIGHT INCREASED TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: PLACED THE HYSTEROSCOPE WITH NORMAL SALINE DISTENTION MEDIA. FIRST THE LEFT FALLOPIAN TUBE WAS NOTED, EASILY CANNULATED WITH 4 TRAILING COILS AFTER I WAS DONE DEPLOYING THE ESSURE COIL. THE RIGHT SIDE, I THEN REPEATED THIS PROCEDURE. I HAD 5 TRAILING COILS. THE PATIENT TOLERATED THE PROCEDURE WELL. THE LEFT BLADDER PILLAR WAS TAKEN, CLAMPED, CRUSHED, AND TIED, THEN THE RIGHT BLADDER PILLAR AS WELL. ON THE RIGHT SIDE, THERE WAS 1 FURTHER BROAD LIGAMENT PEDICLE, AND THE LEFT SIDE NO FURTHER BROAD LIGAMENT PEDICLES REQUIRED. I REMOVED THE UTERUS, CERVIX, AND FALLOPIAN TUBES IN THEIR ENTIRETY. BLEEDING WAS CONTROLLED. THE UTEROSACRAL LIGAMENTS WERE TIED TOGETHER. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 31.9 KG/SQM. HYSTEROSALPINGOGRAM - ON (B)(6) 2011: RESULTS: TUBES BLOCKED AT THE TIME OF PROCEDURE.. MAGNETIC RESONANCE IMAGING BRAIN - ON AN UNKNOWN DATE: SHOWED NONSPECIFIC AREAS OF INCREASED SIGNAL IN THE WHITE MATTER ON THE T2-WEIGHTED IMAGES, 2 TINY AREAS ON THE RIGHT AND 2 TINY AREAS ON THE LEFT THAT WERE NONSPECIFIC. 4 FLARES ON MY BRAIN. CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONES WERE REPORTED VIA SOCIAL MEDIA: BUT IT STILL BECOMES A NUISANCE , I FELT I WAS HAVING A HEART ATTACK WITH SEVERE CHEST AND BACK PAIN, I HAVE ALWAYS HAD A HIGH SEX DRIVE EVEN WITH ESSURE, MY CHEEKS WERE NORMALLY RED AN BLOTCHY AND VEINY SINCE ESSURE 2011, VISION ISSUES , VISION CHANGES, BAWLING MY EYES, PULL THEM OUT VIRGINALLY THEN SURGICALLY REMOVE THE DAMAGED TUBES, I¿VE DEVELOPED THRUSH AFTER MY SURGERY AN THE BREATHING TUBES AND SUCH, SWALLOW HORRIBLE STUFF , I HAD MASSIVE SCAR TISSUE BUILD UP BEHIND MY BELLY BUTTON AREA, STABBING PAINS IN MY VAGINAL AREA , I'M VERY LOW IN POTASSIUM , MORE NERVOUS THAN I THOUGHT I WOULD BE , I¿VE REALLY GOT TO GET HURT HARD TO BRUISE AT ALL. QUALITY-SAFETY EVALUATION OF PTC: SAMPLE NOT AVAILABLE. WE CONDUCTED A REVIEW OF THE MANUFACTURING BATCH RECORD AND CONFIRMED THAT FINAL PRODUCT TESTING FOR THIS LOT WAS PERFORMED PER REQUIREMENTS AND THE PRODUCT MET ALL RELEASE REQUIREMENTS. 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 NOT INDICATIVE OF A QUALITY DEFICIT PER SE. NO SIMILAR AE CASE REPORTS HAVE BEEN RECEIVED TO DATE IN RELATION TO THE REPORTED BATCH. NO SPECIFIC QUALITY ISSUE WAS DEFINED, THEREFORE NO MEDDRA LLT CAN BE PROVIDED. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 2-DEC-2019: CONTENT FROM SOCIAL MEDIA,NEW REPORTER NEW EVENT BUT IT STILL BECOMES A NUISANCE , I FELT I WAS HAVING A HEART ATTACK WITH SEVERE CHEST AND BACK PAIN, I HAVE ALWAYS HAD A HIGH SEX DRIVE EVEN WITH ESSURE, MY CHEEKS WERE NORMALLY RED AN BLOTCHY AND VEINY SINCE ESSURE 2011, VISION ISSUES , VISION CHANGES, BAWLING MY EYES, PULL THEM OUT VIRGINALLY THEN SURGICALLY REMOVE THE DAMAGED TUBES, I¿VE DEVELOPED THRUSH AFTER MY SURGERY AN THE BREATHING TUBES AND SUCH, SWALLOW HORRIBLE STUFF , I HAD MASSIVE SCAR TISSUE BUILD UP BEHIND MY BELLY BUTTON AREA, STABBING PAINS IN MY VAGINAL AREA , I'M VERY LOW IN POTASSIUM , MORE NERVOUS THAN I THOUGHT I WOULD BE , I¿VE REALLY GOT TO GET HURT HARD TO BRUISE AT ALL , LAB DATA UPDATED AND PATIENT CONCOMITANT CONDITION WERE ADDED AND EVENT ALLERGIC OR HYPERSENSITIVITY REACTION TYPE RASHES UPDATED TO SKIN PROBLEMS RASHES AN REDNESS. 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-CONFORMANT DATA; SHOULD ANY NEW AND REPORTABLE INFORMATION BECOME AVAILABLE AS A RESULT, THIS WILL BE PROVIDED IN A SUPPLEMENTARY REPORT.
THIS CASE WAS INITIALLY RECEIVED VIA REGULATORY AUTHORITY (FOOD AND DRUG ADMINISTRATION, REFERENCE NUMBER: MW5035249) ON 21-APR-2014. THE MOST RECENT INFORMATION WAS RECEIVED ON 27-FEB-2018. THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ("CONSTANT PELVIC PAIN AND PRESSURE, PAIN"), MENORRHAGIA ("PERIODS HAVE BECOME INCREASING IN FLOW WITH LARGE CLOTS / EXCESSIVE BLEEDING /VERY HEAVY FLOW OF BLOOD FOR 2-3 DAYS, ABNORMAL BLEEDING (VAGINAL/MENORRHAGIA)") AND UTERINE HAEMORRHAGE ("HEAVY ABNORMAL UTERINE BLEEDING") IN A FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 774396) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S CONCURRENT CONDITIONS INCLUDED OBESITY. CONCOMITANT PRODUCTS INCLUDED RIZATRIPTAN SINCE (B)(6) 2014 AND TOPIRAMATE SINCE (B)(6)2014. IN (B)(6) 2011, THE PATIENT EXPERIENCED MENORRHAGIA (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), DYSMENORRHOEA ("SEVERE PAIN WITH PERIODS/HORRIBLE CRAMPING DURING MY PERIODS, DYSMENORRHEA (CRAMPING)") AND HEADACHE ("MIGRAINES / HEADACHES"). ON (B)(6) 2011, THE PATIENT HAD ESSURE INSERTED. IN 2011, THE PATIENT EXPERIENCED RASH ("RANDOM RASH THAT POPS UP ON BACK, SHOULDERS AND STOMACH, ALLERGIC OR HYPERSENSITIVITY REACTION INCLUDING SKIN RASHES"), FATIGUE ("FATIGUE"), VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL/MENORRHAGIA)"), ALLERGY TO METALS ("RASHES WHEN EXPOSED TO ALLERGENS SUCH AS NICKEL, NICKEL ALLERGY"), TOOTH DISORDER ("DENTAL PROBLEMS"), WEIGHT INCREASED ("WEIGHT GAIN") AND ABDOMINAL PAIN ("SEVERE AND PERSISTENT ABDOMINAL PAIN"). IN (B)(6) 2015, THE PATIENT EXPERIENCED BLADDER PROLAPSE ("BLADDER OR URINARY PROBLEMS OR CHANGES, STAGE 1 PROLAPSED BLADDER") AND URINARY TRACT DISORDER ("BLADDER OR URINARY PROBLEMS OR CHANGES"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), UTERINE HAEMORRHAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), MIGRAINE ("MIGRAINES, EVERY DAY AT LEAST ONE MILD EPISODE OF HEADACHE, BUT A COUPLE DAYS BEFORE AND DURING HER PERIODS INTENSE AND OFTEN, MIGRAINES / HEADACHES") WITH MIGRAINE WITH AURA, VOMITING, NAUSEA AND TREMOR AND DYSPAREUNIA ("DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE)"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED ABDOMINAL PAIN LOWER ("STABBING PAIN IN LOWER ABDOMEN"), PELVIC DISCOMFORT ("CONSTANT PELVIC PAIN AND PRESSURE"), BACK PAIN ("CHRONIC LOWER BACK PAIN") AND DECREASED APPETITE ("LACK OF APPETITE"). THE PATIENT WAS TREATED WITH I.V. SOLUTIONS AND SURGERY (HYSTERECTOMY (FULL), SALPINGECTOMY (BILATERAL REMOVAL OF FALLOPIAN TUBES)). ESSURE WAS REMOVED ON (B)(6) 2014. AT THE TIME OF THE REPORT, THE PELVIC PAIN, MENORRHAGIA, DYSMENORRHOEA AND MIGRAINE HAD NOT RESOLVED, THE UTERINE HAEMORRHAGE AND ABDOMINAL PAIN WAS RESOLVING, THE HEADACHE, RASH, FATIGUE, VAGINAL HAEMORRHAGE, ALLERGY TO METALS, BLADDER PROLAPSE, URINARY TRACT DISORDER, TOOTH DISORDER AND DYSPAREUNIA OUTCOME WAS UNKNOWN, THE ABDOMINAL PAIN LOWER, PELVIC DISCOMFORT AND BACK PAIN HAD NOT RESOLVED, THE DECREASED APPETITE OUTCOME WAS UNKNOWN AND THE WEIGHT INCREASED HAD RESOLVED. THE REPORTER PROVIDED NO CAUSALITY ASSESSMENT FOR ABDOMINAL PAIN LOWER, BACK PAIN, DECREASED APPETITE, DYSMENORRHOEA, FATIGUE, HEADACHE, MENORRHAGIA, MIGRAINE, PELVIC DISCOMFORT, PELVIC PAIN AND RASH WITH ESSURE. THE REPORTER CONSIDERED ABDOMINAL PAIN, ALLERGY TO METALS, BLADDER PROLAPSE, DYSPAREUNIA, TOOTH DISORDER, URINARY TRACT DISORDER, UTERINE HAEMORRHAGE, VAGINAL HAEMORRHAGE AND WEIGHT INCREASED TO BE RELATED TO ESSURE. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS (B)(6). HYSTEROSALPINGOGRAM - ON (B)(6) 2011: TUBES BLOCKED AT THE TIME OF PROCEDURE. ON UNSPECIFIED DATE: UNSPECIFIED TESTS TO DETERMINE THE CAUSE OF EXCESSIVE BLEEDING: NONE OF THE RESULTS HAVE CONCLUDED ANY CAUSES. QUALITY-SAFETY EVALUATION OF PTC: SAMPLE NOT AVAILABLE. WE CONDUCTED A REVIEW OF THE MANUFACTURING BATCH RECORD AND CONFIRMED THAT FINAL PRODUCT TESTING FOR THIS LOT WAS PERFORMED PER REQUIREMENTS AND THE PRODUCT MET ALL RELEASE REQUIREMENTS. 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 NOT INDICATIVE OF A QUALITY DEFICIT PER SE. NO SIMILAR AE CASE REPORTS HAVE BEEN RECEIVED TO DATE IN RELATION TO THE REPORTED BATCH . NO SPECIFIC QUALITY ISSUE WAS DEFINED, THEREFORE NO MEDDRA LLT CAN BE PROVIDED. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 27-FEB-2018: PFS RECEIVED: REPORTER INFORMATION, PATIENT DEMOGRAPHIC INFORMATION, PRODUCT REMOVAL DATE, INDICATION, CONCOMITANT DISEASE AND MEDICATIONS, NEW EVENTS VAGINAL HAEMORRHAGE, BLADDER PROLAPSE, URINARY TRACT DISORDER, TOOTH DISORDER, DYSPAREUNIA, ALLERGY TO METALS, WEIGHT INCREASED, ABDOMINAL PAIN AND UTERINE HAEMORRHAGE ADDED. OUTCOME FOR THE EVENT WEIGHT INCREASED ADDED AS RECOVERED / RESOLVED AND FOR EVENTS ABDOMINAL PAIN AND UTERINE HAEMORRHAGE ADDED AS RECOVERING / RESOLVING. 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 |
|---|---|---|---|---|---|---|---|
| 234724 | ESSURE | TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE | HHS | BAYER PHARMA AG | ESS305 | 774396 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 26 YR | Other| R | BENZOCAINE| BENZOCAINE| BENZOCAINE| DEPO-PROVERA| DEPO-PROVERA| DEPO-PROVERA| METOPROLOL| METOPROLOL| METOPROLOL| OMEPRAZOLE| OMEPRAZOLE| OMEPRAZOLE| ORTHO TRI-CYCLEN| ORTHO TRI-CYCLEN| ORTHO TRI-CYCLEN| POVIDONE-IODINE| POVIDONE-IODINE| POVIDONE-IODINE| RIZATRIPTAN| RIZATRIPTAN| RIZATRIPTAN| RIZATRIPTAN| TOPIRAMATE| TOPIRAMATE| TOPIRAMATE| TOPIRAMATE| RIZATRIPTAN| TOPIRAMATE |