ESSURE
Report
- Report Number
- 2951250-2017-07227
- Event Type
- Injury
- Date Received
- November 23, 2017
- Report Date
- April 23, 2020
- Manufacturer
- BAYER PHARMA AG
- Product Code
- HHS
- PMA / PMN Number
- P020014
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- OTHER
Narratives
THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ("PAIN") AND AUTOIMMUNE DISORDER ("AUTOIMMUNE ISSUES") IN AN ADULT FEMALE PATIENT WHO HAD ESSURE (BATCH NO: 628314) INSERTED FOR FEMALE STERILIZATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S MEDICAL HISTORY INCLUDED OVERWEIGHT, FOOT FRACTURE AND MASTITIS. PREVIOUSLY ADMINISTERED PRODUCTS INCLUDED FOR TO REGULATE HORMONES: YAZ IN 2011; FOR CONTRACEPTION: YAZ 28 FROM 1998 TO 2001; FOR AN UNREPORTED INDICATION: ERGOCALCIFEROL IN JANUARY 2009. CONCOMITANT PRODUCTS INCLUDED BUPROPION HYDROCHLORIDE (WELLBUTRIN) FROM 2009 TO 2013, CELECOXIB (CELEXA) FROM 2009 TO 2013 AND FERRITIN SINCE 2009. IN 2009, THE PATIENT EXPERIENCED HEADACHE ("HEADACHES"), DEPRESSION ("DEPRESSION") AND MIGRAINE ("MIGRAINES"). ON (B)(6) 2009, THE PATIENT HAD ESSURE INSERTED. IN 2010, THE PATIENT EXPERIENCED NAUSEA ("NAUSEA") AND FATIGUE ("FATIGUE"). IN 2011, THE PATIENT EXPERIENCED PREMENSTRUAL DYSPHORIC DISORDER ("PMDD GOT WORSE") AND DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING)"). IN 2012, THE PATIENT EXPERIENCED DYSPAREUNIA ("PAINFUL INTERCOURSE"), VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL)"), MENORRHAGIA ("ABNORMAL BLEEDING (MENORRHAGIA)"), CONTUSION ("BRUISING ALL OVER BODY EASILY"), ALOPECIA ("HAIR LOSS, HAIR STARTED THINNING OUT"), MENSTRUATION IRREGULAR ("PERIODS WERE NEVER CONSISTENT"), OVULATION PAIN ("PAINFUL OVULATION") AND ARTHRALGIA ("HIP JOINT PAIN, WRIST JOINT PAIN"). IN 2013, THE PATIENT WAS FOUND TO HAVE THE FIRST EPISODE OF WEIGHT INCREASED ("WEIGHT GAIN"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), AUTOIMMUNE DISORDER (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), ANXIETY ("ANXIETY"), SCAR ("ABNORMAL SCARRING") AND PREMENSTRUAL SYNDROME ("PMS") AND WAS FOUND TO HAVE THE SECOND EPISODE OF WEIGHT INCREASED ("WEIGHT GAIN"). THE PATIENT WAS TREATED WITH SURGERY (HYSTERECTOMY WITH BILATERAL SALPINGECTOMY). ESSURE WAS REMOVED ON (B)(6) 2014. AT THE TIME OF THE REPORT, THE PELVIC PAIN, AUTOIMMUNE DISORDER, HEADACHE, ANXIETY, SCAR, THE LAST EPISODE OF WEIGHT INCREASED, VAGINAL HAEMORRHAGE, MENORRHAGIA, MIGRAINE, NAUSEA, FATIGUE, CONTUSION, ALOPECIA, MENSTRUATION IRREGULAR, OVULATION PAIN AND PREMENSTRUAL SYNDROME OUTCOME WAS UNKNOWN, THE DEPRESSION, DYSPAREUNIA, DYSMENORRHOEA AND ARTHRALGIA HAD RESOLVED AND THE PREMENSTRUAL DYSPHORIC DISORDER WAS RESOLVING. THE REPORTER CONSIDERED ALOPECIA, ANXIETY, ARTHRALGIA, AUTOIMMUNE DISORDER, CONTUSION, DEPRESSION, DYSMENORRHOEA, DYSPAREUNIA, FATIGUE, HEADACHE, MENORRHAGIA, MENSTRUATION IRREGULAR, MIGRAINE, NAUSEA, OVULATION PAIN, PELVIC PAIN, PREMENSTRUAL DYSPHORIC DISORDER, PREMENSTRUAL SYNDROME, SCAR, VAGINAL HAEMORRHAGE, THE FIRST EPISODE OF WEIGHT INCREASED AND THE SECOND EPISODE OF WEIGHT INCREASED TO BE RELATED TO ESSURE. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 29 KG/SQM. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 5-DEC-2018: PLAINTIFF FACT SHEET RECEIVED. NEW REPORTERS ADDED. PATIENT DEMOGRAPHIC INFORMATION AD RELEVANT HISTORY ADDED. INDICATION (PERMANENT BIRTH CONTROL BY BILATERAL OCCLUSION OF THE FALLOPIAN TUBES) ADDED. LOT NUMBER: (628314) ADDED. ESSURE REMOVAL DATE UPDATED TO ON (B)(6) 2014. CONCOMITANT MEDICATIONS ADDED. EVENT OUTCOMES UPDATED. EVENT ONSET DATES ADDED. NEW EVENTS PMDD GOT WORSE, ABNORMAL BLEEDING (VAGINAL), ABNORMAL BLEEDING (MENORRHAGIA), MIGRAINES, NAUSEA, DYSMENORRHEA (CRAMPING), FATIGUE, WEIGHT GAIN, BRUISING ALL OVER BODY EASILY, HAIR LOSS, HAIR STARTED THINNING OUT, PERIODS WERE NEVER CONSISTENT, PAINFUL OVULATION, HIP JOINT PAIN, WRIST JOINT PAIN AND PMS ADDED. INCIDENT: WE RECEIVED A LOT NUMBER. 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 SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ('PAIN') AND AUTOIMMUNE DISORDER ('AUTOIMMUNE ISSUES') IN AN ADULT FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 628314) INSERTED FOR FEMALE STERILIZATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S MEDICAL HISTORY INCLUDED OVERWEIGHT, FOOT FRACTURE, MASTITIS, CERVICAL PAP SMEAR ABNORMAL, REDNESS OF EXTERNAL EAR, NUMBNESS, COLD EXPOSURE INJURY, GRAVIDA I, PARITY 1, RASH OVER ARMS, JAW SPASM, VITAMIN D DEFICIENCY, DYSURIA, FREQUENCY URINARY, DIZZINESS, ACNE, SORE THROAT, STREPTOCOCCAL SORE THROAT, ABDOMINAL DISCOMFORT, GENITAL BLEEDING, HEAVY PERIODS, MOOD SWINGS, BLOATING, BACK PAIN, PAIN IN HIP, ALLERGY TO METALS, EMOTIONAL REACTION, BIOPSY ENDOMETRIUM, BIOPSY OVARY, OVARIAN LESION EXCISION AND BREAST PAIN. PREVIOUSLY ADMINISTERED PRODUCTS INCLUDED FOR TO REGULATE HORMONES: YAZ IN 2011; FOR CONTRACEPTION: YAZ 28 FROM 1998 TO 2001; FOR AN UNREPORTED INDICATION: ERGOCALCIFEROL IN (B)(6)2009. CONCOMITANT PRODUCTS INCLUDED BUPROPION HYDROCHLORIDE (WELLBUTRIN) FROM 2009 TO 2013, CELECOXIB (CELEXA) FROM 2009 TO 2013, DROSPIRENONE;ETHINYLESTRADIOL BETADEX CLATHRATE (YAZ) AND FERRITIN SINCE 2009. IN 2009, THE PATIENT EXPERIENCED HEADACHE ("HEADACHES"), DEPRESSION ("DEPRESSION") AND MIGRAINE ("MIGRAINES"). ON (B)(6)2009, THE PATIENT HAD ESSURE INSERTED. IN 2010, THE PATIENT EXPERIENCED NAUSEA ("NAUSEA") AND FATIGUE ("FATIGUE"). IN 2011, THE PATIENT EXPERIENCED PREMENSTRUAL DYSPHORIC DISORDER ("PMDD GOT WORSE") AND DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING)"). IN 2012, THE PATIENT EXPERIENCED DYSPAREUNIA ("PAINFUL INTERCOURSE"), VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL)"), MENORRHAGIA ("ABNORMAL BLEEDING (MENORRHAGIA)"), INCREASED TENDENCY TO BRUISE ("BRUISING ALL OVER BODY EASILY"), ALOPECIA ("HAIR LOSS, HAIR STARTED THINNING OUT"), MENSTRUATION IRREGULAR ("PERIODS WERE NEVER CONSISTENT"), OVULATION PAIN ("PAINFUL OVULATION") AND ARTHRALGIA ("HIP JOINT PAIN, WRIST JOINT PAIN"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), AUTOIMMUNE DISORDER (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), ANXIETY ("ANXIETY"), SCAR ("ABNORMAL SCARRING"), PREMENSTRUAL SYNDROME ("PMS"), DIZZINESS ("DIZZINESS"), ABDOMINAL PAIN ("ABDOMINAL PAIN/ ACHE IN MY ABDOMEN"), WEIGHT FLUCTUATION ("WEIGHT GOES UP AND DOWN"), ABDOMINAL DISTENSION ("BLOATING"), MOOD SWINGS ("MOOD SWINGS"), ALLERGY TO METALS ("NICKEL ALLERGY"), INFLAMMATION ("INFLAMMED"), FOOT FRACTURE ("FRACTURED ON MY FOOT"), PAIN IN EXTREMITY ("ALOT PAIN IN BETWEEN FOOT AND INWARDS"), OROPHARYNGEAL PAIN ("SORE THROAT"), PYREXIA ("SLIGHT FEVER") AND HYPERSOMNIA ("SLEEPING A LOT") AND WAS FOUND TO HAVE WEIGHT INCREASED ("WEIGHT GAIN"), WEIGHT DECREASED ("LOST A LOT OF WEIGHT") AND HORMONE LEVEL ABNORMAL ("HORMONES FLUCTUATE"). THE PATIENT WAS TREATED WITH SURGERY (HYSTERECTOMY WITH BILATERAL SALPINGECTOMY (B)(6)2014). ESSURE WAS REMOVED ON (B)(6)2014. AT THE TIME OF THE REPORT, THE PELVIC PAIN, AUTOIMMUNE DISORDER, HEADACHE, ANXIETY, SCAR, WEIGHT INCREASED, VAGINAL HAEMORRHAGE, MENORRHAGIA, MIGRAINE, NAUSEA, FATIGUE, INCREASED TENDENCY TO BRUISE, ALOPECIA, MENSTRUATION IRREGULAR, OVULATION PAIN, PREMENSTRUAL SYNDROME, WEIGHT DECREASED, DIZZINESS, ABDOMINAL PAIN, WEIGHT FLUCTUATION, ABDOMINAL DISTENSION, MOOD SWINGS, HORMONE LEVEL ABNORMAL, ALLERGY TO METALS, INFLAMMATION, FOOT FRACTURE, PAIN IN EXTREMITY, OROPHARYNGEAL PAIN AND HYPERSOMNIA OUTCOME WAS UNKNOWN, THE DEPRESSION, DYSPAREUNIA, DYSMENORRHOEA AND ARTHRALGIA HAD RESOLVED AND THE PREMENSTRUAL DYSPHORIC DISORDER WAS RESOLVING. THE REPORTER CONSIDERED ABDOMINAL DISTENSION, ABDOMINAL PAIN, ALLERGY TO METALS, ALOPECIA, ANXIETY, ARTHRALGIA, AUTOIMMUNE DISORDER, DEPRESSION, DIZZINESS, DYSMENORRHOEA, DYSPAREUNIA, FATIGUE, FOOT FRACTURE, HEADACHE, HORMONE LEVEL ABNORMAL, HYPERSOMNIA, INCREASED TENDENCY TO BRUISE, INFLAMMATION, MENORRHAGIA, MENSTRUATION IRREGULAR, MIGRAINE, MOOD SWINGS, NAUSEA, OROPHARYNGEAL PAIN, OVULATION PAIN, PAIN IN EXTREMITY, PELVIC PAIN, PREMENSTRUAL DYSPHORIC DISORDER, PREMENSTRUAL SYNDROME, PYREXIA, SCAR, VAGINAL HAEMORRHAGE, WEIGHT DECREASED, WEIGHT FLUCTUATION AND WEIGHT INCREASED TO BE RELATED TO ESSURE. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 29 KG/SQM. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 11-DEC-2019: SOCIAL MEDIA RECEIVED: NEWLY ADDED EVENTS- LOST WEIGHT, DIZZINESS, PAIN IN HIP, ABDOMINAL PAIN, WEIGHT FLUCTUATION, BLOATING, MOOD SWINGS, HORMONAL IMBALANCE, NICKEL SENSITIVITY, INFLAMMATION NOS, FOOT FRACTURE, FOOT PAIN, SORE THROAT, SLEEP EXCESSIVE, REPORTER WAS ADDED. 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 ('PAIN') IN AN ADULT FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 628314) INSERTED FOR FEMALE STERILIZATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S MEDICAL HISTORY INCLUDED OVERWEIGHT, FOOT FRACTURE, MASTITIS, CERVICAL PAP SMEAR ABNORMAL, REDNESS OF EXTERNAL EAR, NUMBNESS, COLD EXPOSURE INJURY, GRAVIDA I, PARITY 1, RASH OVER ARMS, JAW SPASM, VITAMIN D DEFICIENCY, DYSURIA, FREQUENCY URINARY, DIZZINESS, ACNE, SORE THROAT, STREPTOCOCCAL SORE THROAT, ABDOMINAL DISCOMFORT, GENITAL BLEEDING, HEAVY PERIODS, MOOD SWINGS, BLOATING, BACK PAIN, PAIN IN HIP, ALLERGY TO METALS, EMOTIONAL REACTION, BIOPSY ENDOMETRIUM, BIOPSY OVARY, OVARIAN LESION EXCISION AND BREAST PAIN. PREVIOUSLY ADMINISTERED PRODUCTS INCLUDED FOR TO REGULATE HORMONES: YAZ IN 2011; FOR CONTRACEPTION: YAZ 28 FROM 1998 TO 2001; FOR AN UNREPORTED INDICATION: ERGOCALCIFEROL IN (B)(6)2009. CONCOMITANT PRODUCTS INCLUDED BUPROPION HYDROCHLORIDE (WELLBUTRIN) FROM 2009 TO 2013, CELECOXIB (CELEXA) FROM 2009 TO 2013, DROSPIRENONE;ETHINYLESTRADIOL BETADEX CLATHRATE (YAZ) AND FERRITIN SINCE 2009. IN 2009, THE PATIENT EXPERIENCED HEADACHE ("HEADACHES"), DEPRESSION ("DEPRESSION") AND MIGRAINE ("MIGRAINES"). ON (B)(6)-2009, THE PATIENT HAD ESSURE INSERTED. IN 2010, THE PATIENT EXPERIENCED NAUSEA ("NAUSEA") AND FATIGUE ("FATIGUE"). IN 2011, THE PATIENT EXPERIENCED PREMENSTRUAL DYSPHORIC DISORDER ("PMDD GOT WORSE") AND DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING)"). IN 2012, THE PATIENT EXPERIENCED DYSPAREUNIA ("PAINFUL INTERCOURSE"), VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL)"), MENORRHAGIA ("ABNORMAL BLEEDING (MENORRHAGIA)"), INCREASED TENDENCY TO BRUISE ("BRUISING ALL OVER BODY EASILY"), ALOPECIA ("HAIR LOSS, HAIR STARTED THINNING OUT"), MENSTRUATION IRREGULAR ("PERIODS WERE NEVER CONSISTENT"), OVULATION PAIN ("PAINFUL OVULATION") AND ARTHRALGIA ("HIP JOINT PAIN, WRIST JOINT PAIN"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), AUTOIMMUNE DISORDER ("AUTOIMMUNE ISSUES"), ANXIETY ("ANXIETY"), SCAR ("ABNORMAL SCARRING"), PREMENSTRUAL SYNDROME ("PMS"), DIZZINESS ("DIZZINESS"), ABDOMINAL PAIN ("ABDOMINAL PAIN/ ACHE IN MY ABDOMEN"), WEIGHT FLUCTUATION ("WEIGHT GOES UP AND DOWN"), ABDOMINAL DISTENSION ("BLOATING"), MOOD SWINGS ("MOOD SWINGS"), ALLERGY TO METALS ("NICKEL ALLERGY"), INFLAMMATION ("INFLAMED"), FOOT FRACTURE ("FRACTURED ON MY FOOT"), PAIN IN EXTREMITY ("ALOT PAIN IN BETWEEN FOOT AND INWARDS"), OROPHARYNGEAL PAIN ("SORE THROAT"), PYREXIA ("SLIGHT FEVER"), HYPERSOMNIA ("SLEEPING A LOT"), ACNE ("ACNE"), FLATULENCE ("GAS PAIN") AND FEELING ABNORMAL ("BRAIN FOG") AND WAS FOUND TO HAVE WEIGHT INCREASED ("WEIGHT GAIN"), WEIGHT DECREASED ("LOST A LOT OF WEIGHT") AND HORMONE LEVEL ABNORMAL ("HORMONES FLUCTUATE"). THE PATIENT WAS TREATED WITH SURGERY (HYSTERECTOMY WITH BILATERAL SALPINGECTOMY (B)(6)2014). ESSURE WAS REMOVED ON (B)(6)2014. AT THE TIME OF THE REPORT, THE PELVIC PAIN, AUTOIMMUNE DISORDER, HEADACHE, ANXIETY, SCAR, WEIGHT INCREASED, VAGINAL HAEMORRHAGE, MENORRHAGIA, MIGRAINE, NAUSEA, FATIGUE, INCREASED TENDENCY TO BRUISE, ALOPECIA, MENSTRUATION IRREGULAR, OVULATION PAIN, PREMENSTRUAL SYNDROME, WEIGHT DECREASED, DIZZINESS, ABDOMINAL PAIN, WEIGHT FLUCTUATION, ABDOMINAL DISTENSION, MOOD SWINGS, HORMONE LEVEL ABNORMAL, ALLERGY TO METALS, INFLAMMATION, FOOT FRACTURE, PAIN IN EXTREMITY, OROPHARYNGEAL PAIN, HYPERSOMNIA, ACNE, FLATULENCE AND FEELING ABNORMAL OUTCOME WAS UNKNOWN, THE DEPRESSION, DYSPAREUNIA, DYSMENORRHOEA AND ARTHRALGIA HAD RESOLVED AND THE PREMENSTRUAL DYSPHORIC DISORDER WAS RESOLVING. THE REPORTER CONSIDERED ABDOMINAL DISTENSION, ABDOMINAL PAIN, ACNE, ALLERGY TO METALS, ALOPECIA, ANXIETY, ARTHRALGIA, AUTOIMMUNE DISORDER, DEPRESSION, DIZZINESS, DYSMENORRHOEA, DYSPAREUNIA, FATIGUE, FEELING ABNORMAL, FLATULENCE, FOOT FRACTURE, HEADACHE, HORMONE LEVEL ABNORMAL, HYPERSOMNIA, INCREASED TENDENCY TO BRUISE, INFLAMMATION, MENORRHAGIA, MENSTRUATION IRREGULAR, MIGRAINE, MOOD SWINGS, NAUSEA, OROPHARYNGEAL PAIN, OVULATION PAIN, PAIN IN EXTREMITY, PELVIC PAIN, PREMENSTRUAL DYSPHORIC DISORDER, PREMENSTRUAL SYNDROME, PYREXIA, SCAR, VAGINAL HAEMORRHAGE, WEIGHT DECREASED, WEIGHT FLUCTUATION AND WEIGHT INCREASED TO BE RELATED TO ESSURE. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 29 KG/SQM. CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONE WERE REPORTED VIA SOCIAL MEDIA: ACNE, FLATULENCE AND FEELING ABNORMAL. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 10-JAN-2020: SOCIAL MEDIA RECEIVED. NEW EVENT ACNE, GAS PAIN AND BRAIN FOG WERE ADDED. 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 ('PAIN') IN AN ADULT FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 628314) INSERTED FOR FEMALE STERILIZATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S MEDICAL HISTORY INCLUDED OVERWEIGHT, FOOT FRACTURE, MASTITIS, CERVICAL PAP SMEAR ABNORMAL, REDNESS OF EXTERNAL EAR, NUMBNESS, COLD EXPOSURE INJURY, GRAVIDA I, PARITY 1, RASH OVER ARMS, JAW SPASM, VITAMIN D DEFICIENCY, DYSURIA, FREQUENCY URINARY, DIZZINESS, ACNE, SORE THROAT, STREPTOCOCCAL SORE THROAT, ABDOMINAL DISCOMFORT, GENITAL BLEEDING, HEAVY PERIODS, MOOD SWINGS, BLOATING, BACK PAIN, PAIN IN HIP, ALLERGY TO METALS, EMOTIONAL REACTION, BIOPSY ENDOMETRIUM, BIOPSY OVARY, OVARIAN LESION EXCISION AND BREAST PAIN. PREVIOUSLY ADMINISTERED PRODUCTS INCLUDED FOR TO REGULATE HORMONES: YAZ IN 2011; FOR CONTRACEPTION: YAZ 28 FROM 1998 TO 2001; FOR AN UNREPORTED INDICATION: ERGOCALCIFEROL IN (B)(6) 2009. CONCOMITANT PRODUCTS INCLUDED BUPROPION HYDROCHLORIDE (WELLBUTRIN) FROM 2009 TO 2013, CELECOXIB (CELEXA) FROM 2009 TO 2013, DROSPIRENONE;ETHINYLESTRADIOL BETADEX CLATHRATE (YAZ) AND FERRITIN SINCE 2009. IN 2009, THE PATIENT EXPERIENCED HEADACHE ("HEADACHES"), DEPRESSION ("DEPRESSION") AND MIGRAINE ("MIGRAINES"). ON (B)(6) 2009, THE PATIENT HAD ESSURE INSERTED. IN 2010, THE PATIENT EXPERIENCED NAUSEA ("NAUSEA") AND FATIGUE ("FATIGUE"). IN 2011, THE PATIENT EXPERIENCED PREMENSTRUAL DYSPHORIC DISORDER ("PMDD GOT WORSE") AND DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING)"). IN 2012, THE PATIENT EXPERIENCED DYSPAREUNIA ("PAINFUL INTERCOURSE"), VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL)"), MENORRHAGIA ("ABNORMAL BLEEDING (MENORRHAGIA)"), INCREASED TENDENCY TO BRUISE ("BRUISING ALL OVER BODY EASILY"), ALOPECIA ("HAIR LOSS, HAIR STARTED THINNING OUT"), MENSTRUATION IRREGULAR ("PERIODS WERE NEVER CONSISTENT"), OVULATION PAIN ("PAINFUL OVULATION") AND ARTHRALGIA ("HIP JOINT PAIN, WRIST JOINT PAIN"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), AUTOIMMUNE DISORDER ("AUTOIMMUNE ISSUES"), ANXIETY ("ANXIETY"), SCAR ("ABNORMAL SCARRING"), PREMENSTRUAL SYNDROME ("PMS"), DIZZINESS ("DIZZINESS"), ABDOMINAL PAIN ("ABDOMINAL PAIN/ ACHE IN MY ABDOMEN"), WEIGHT FLUCTUATION ("WEIGHT GOES UP AND DOWN"), ABDOMINAL DISTENSION ("BLOATING"), MOOD SWINGS ("MOOD SWINGS"), ALLERGY TO METALS ("NICKEL ALLERGY"), INFLAMMATION ("INFLAMMED"), FOOT FRACTURE ("FRACTURED ON MY FOOT"), PAIN IN EXTREMITY ("ALOT PAIN IN BETWEEN FOOT AND INWARDS"), OROPHARYNGEAL PAIN ("SORE THROAT"), PYREXIA ("SLIGHT FEVER"), HYPERSOMNIA ("SLEEPING A LOT"), ACNE ("ACNE"), FLATULENCE ("GAS PAIN"), FEELING ABNORMAL ("BRAIN FOG") AND VITAMIN D DEFICIENCY ("VITAMIN D DEFICIENCY") AND WAS FOUND TO HAVE WEIGHT INCREASED ("WEIGHT GAIN"), WEIGHT DECREASED ("LOST A LOT OF WEIGHT") AND HORMONE LEVEL ABNORMAL ("HORMONES FLUCTUATE"). THE PATIENT WAS TREATED WITH SURGERY (HYSTERECTOMY WITH BILATERAL SALPINGECTOMY (B)(6) 2014). ESSURE WAS REMOVED ON (B)(6) 2014. AT THE TIME OF THE REPORT, THE PELVIC PAIN, AUTOIMMUNE DISORDER, HEADACHE, ANXIETY, SCAR, WEIGHT INCREASED, VAGINAL HAEMORRHAGE, MENORRHAGIA, MIGRAINE, NAUSEA, FATIGUE, INCREASED TENDENCY TO BRUISE, ALOPECIA, MENSTRUATION IRREGULAR, OVULATION PAIN, PREMENSTRUAL SYNDROME, WEIGHT DECREASED, DIZZINESS, ABDOMINAL PAIN, WEIGHT FLUCTUATION, ABDOMINAL DISTENSION, MOOD SWINGS, HORMONE LEVEL ABNORMAL, ALLERGY TO METALS, INFLAMMATION, FOOT FRACTURE, PAIN IN EXTREMITY, OROPHARYNGEAL PAIN, HYPERSOMNIA, ACNE, FLATULENCE AND FEELING ABNORMAL OUTCOME WAS UNKNOWN, THE DEPRESSION, DYSPAREUNIA, DYSMENORRHOEA, ARTHRALGIA AND VITAMIN D DEFICIENCY HAD RESOLVED AND THE PREMENSTRUAL DYSPHORIC DISORDER WAS RESOLVING. THE REPORTER CONSIDERED ABDOMINAL DISTENSION, ABDOMINAL PAIN, ACNE, ALLERGY TO METALS, ALOPECIA, ANXIETY, ARTHRALGIA, AUTOIMMUNE DISORDER, DEPRESSION, DIZZINESS, DYSMENORRHOEA, DYSPAREUNIA, FATIGUE, FEELING ABNORMAL, FLATULENCE, FOOT FRACTURE, HEADACHE, HORMONE LEVEL ABNORMAL, HYPERSOMNIA, INCREASED TENDENCY TO BRUISE, INFLAMMATION, MENORRHAGIA, MENSTRUATION IRREGULAR, MIGRAINE, MOOD SWINGS, NAUSEA, OROPHARYNGEAL PAIN, OVULATION PAIN, PAIN IN EXTREMITY, PELVIC PAIN, PREMENSTRUAL DYSPHORIC DISORDER, PREMENSTRUAL SYNDROME, PYREXIA, SCAR, VAGINAL HAEMORRHAGE, VITAMIN D DEFICIENCY, WEIGHT DECREASED, WEIGHT FLUCTUATION AND WEIGHT INCREASED TO BE RELATED TO ESSURE. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 29 KG/SQM. CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONE WERE REPORTED VIA SOCIAL MEDIA: ACNE, FLATULENCE AND FEELING ABNORMAL. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 20-MAR-2020: SOCIAL MEDIA RECEIVED: EVENT WAS ADDED- VITAMIN D DEFICIENCY. REPORTER INFORMATION ADDED. 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 ('PAIN') IN AN ADULT FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 628314) INSERTED FOR FEMALE STERILIZATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S MEDICAL HISTORY INCLUDED OVERWEIGHT, FOOT FRACTURE, MASTITIS, CERVICAL PAP SMEAR ABNORMAL, REDNESS OF EXTERNAL EAR, NUMBNESS, COLD EXPOSURE INJURY, GRAVIDA I, PARITY 1, RASH OVER ARMS, JAW SPASM, VITAMIN D DEFICIENCY, DYSURIA, FREQUENCY URINARY, DIZZINESS, ACNE, SORE THROAT, STREPTOCOCCAL SORE THROAT, ABDOMINAL DISCOMFORT, GENITAL BLEEDING, HEAVY PERIODS, MOOD SWINGS, BLOATING, BACK PAIN, PAIN IN HIP, ALLERGY TO METALS, EMOTIONAL REACTION, BIOPSY ENDOMETRIUM, BIOPSY OVARY, OVARIAN LESION EXCISION AND BREAST PAIN. PREVIOUSLY ADMINISTERED PRODUCTS INCLUDED FOR TO REGULATE HORMONES: YAZ IN 2011; FOR CONTRACEPTION: YAZ 28 FROM 1998 TO 2001; FOR AN UNREPORTED INDICATION: ERGOCALCIFEROL IN JANUARY 2009. CONCOMITANT PRODUCTS INCLUDED BUPROPION HYDROCHLORIDE (WELLBUTRIN) FROM 2009 TO 2013, CELECOXIB (CELEXA) FROM 2009 TO 2013, DROSPIRENONE;ETHINYLESTRADIOL BETADEX CLATHRATE (YAZ) AND FERRITIN SINCE 2009. IN 2009, THE PATIENT EXPERIENCED HEADACHE ("HEADACHES"), DEPRESSION ("DEPRESSION") AND MIGRAINE ("MIGRAINES"). ON (B)(6) 2009, THE PATIENT HAD ESSURE INSERTED. IN 2010, THE PATIENT EXPERIENCED NAUSEA ("NAUSEA") AND FATIGUE ("FATIGUE"). IN 2011, THE PATIENT EXPERIENCED PREMENSTRUAL DYSPHORIC DISORDER ("PMDD GOT WORSE") AND DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING)"). IN 2012, THE PATIENT EXPERIENCED DYSPAREUNIA ("PAINFUL INTERCOURSE"), VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL)"), MENORRHAGIA ("ABNORMAL BLEEDING (MENORRHAGIA)"), INCREASED TENDENCY TO BRUISE ("BRUISING ALL OVER BODY EASILY"), ALOPECIA ("HAIR LOSS, HAIR STARTED THINNING OUT"), MENSTRUATION IRREGULAR ("PERIODS WERE NEVER CONSISTENT"), OVULATION PAIN ("PAINFUL OVULATION") AND ARTHRALGIA ("HIP JOINT PAIN, WRIST JOINT PAIN"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), AUTOIMMUNE DISORDER ("AUTOIMMUNE ISSUES"), ANXIETY ("ANXIETY"), SCAR ("ABNORMAL SCARRING"), PREMENSTRUAL SYNDROME ("PMS"), DIZZINESS ("DIZZINESS"), ABDOMINAL PAIN ("ABDOMINAL PAIN/ ACHE IN MY ABDOMEN"), WEIGHT FLUCTUATION ("WEIGHT GOES UP AND DOWN"), ABDOMINAL DISTENSION ("BLOATING"), MOOD SWINGS ("MOOD SWINGS"), ALLERGY TO METALS ("NICKEL ALLERGY"), INFLAMMATION ("INFLAMMED"), FOOT FRACTURE ("FRACTURED ON MY FOOT"), PAIN IN EXTREMITY ("ALOT PAIN IN BETWEEN FOOT AND INWARDS"), OROPHARYNGEAL PAIN ("SORE THROAT"), PYREXIA ("SLIGHT FEVER"), HYPERSOMNIA ("SLEEPING A LOT"), ACNE ("ACNE"), FLATULENCE ("GAS PAIN"), FEELING ABNORMAL ("BRAIN FOG"), VITAMIN D DEFICIENCY ("VITAMIN D DEFICIENCY") AND PAINFUL HIPS ("ACHY HIP JOINTS") AND WAS FOUND TO HAVE WEIGHT INCREASED ("WEIGHT GAIN"), WEIGHT DECREASED ("LOST A LOT OF WEIGHT") AND HORMONE LEVEL ABNORMAL ("HORMONES FLUCTUATE"). THE PATIENT WAS TREATED WITH SURGERY (HYSTERECTOMY WITH BILATERAL SALPINGECTOMY (B)(6) 2014). ESSURE WAS REMOVED ON (B)(6) 2014. AT THE TIME OF THE REPORT, THE PELVIC PAIN, AUTOIMMUNE DISORDER, HEADACHE, ANXIETY, SCAR, WEIGHT INCREASED, VAGINAL HAEMORRHAGE, MENORRHAGIA, MIGRAINE, NAUSEA, FATIGUE, INCREASED TENDENCY TO BRUISE, ALOPECIA, MENSTRUATION IRREGULAR, OVULATION PAIN, PREMENSTRUAL SYNDROME, WEIGHT DECREASED, DIZZINESS, ABDOMINAL PAIN, WEIGHT FLUCTUATION, ABDOMINAL DISTENSION, MOOD SWINGS, HORMONE LEVEL ABNORMAL, ALLERGY TO METALS, INFLAMMATION, FOOT FRACTURE, PAIN IN EXTREMITY, OROPHARYNGEAL PAIN, HYPERSOMNIA, ACNE, FLATULENCE, FEELING ABNORMAL AND PAINFUL HIPS OUTCOME WAS UNKNOWN, THE DEPRESSION, DYSPAREUNIA, DYSMENORRHOEA, ARTHRALGIA AND VITAMIN D DEFICIENCY HAD RESOLVED AND THE PREMENSTRUAL DYSPHORIC DISORDER WAS RESOLVING. THE REPORTER CONSIDERED ABDOMINAL DISTENSION, ABDOMINAL PAIN, ACNE, ALLERGY TO METALS, ALOPECIA, ANXIETY, ARTHRALGIA, AUTOIMMUNE DISORDER, DEPRESSION, DIZZINESS, DYSMENORRHOEA, DYSPAREUNIA, FATIGUE, FEELING ABNORMAL, FLATULENCE, FOOT FRACTURE, HEADACHE, HORMONE LEVEL ABNORMAL, HYPERSOMNIA, INCREASED TENDENCY TO BRUISE, INFLAMMATION, MENORRHAGIA, MENSTRUATION IRREGULAR, MIGRAINE, MOOD SWINGS, NAUSEA, OROPHARYNGEAL PAIN, OVULATION PAIN, PAIN IN EXTREMITY, PELVIC PAIN, PREMENSTRUAL DYSPHORIC DISORDER, PREMENSTRUAL SYNDROME, PYREXIA, SCAR, VAGINAL HAEMORRHAGE, VITAMIN D DEFICIENCY, WEIGHT DECREASED, WEIGHT FLUCTUATION, WEIGHT INCREASED AND PAINFUL HIPS TO BE RELATED TO ESSURE. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 29 KG/SQM. CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONE WERE REPORTED VIA SOCIAL MEDIA: ACNE, FLATULENCE AND FEELING ABNORMAL. LOT NUMBER: 628314 MANUFACTURING DATE: 2008-10 EXPIRATION DATE: 2011-10 . QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT . MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 23-MAR-2020: CONTENT FROM SOCIAL MEDIA RECEIVED. NEW EVENT ACHY HIP JOINTS WAS ADDED. 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 ("PAIN") AND AUTOIMMUNE DISORDER ("AUTOIMMUNE ISSUES") IN A FEMALE PATIENT WHO HAD ESSURE INSERTED. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. ON (B)(6) 2009, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), AUTOIMMUNE DISORDER (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), HEADACHE ("HEADACHES"), DEPRESSION ("DEPRESSION"), ANXIETY ("ANXIETY"), SCAR ("ABNORMAL SCARRING"), DYSPAREUNIA ("PAINFUL INTERCOURSE") AND WEIGHT INCREASED ("WEIGHT GAIN"). THE PATIENT WAS TREATED WITH SURGERY (SURGERY TO REMOVE THE ESSURE IMPLANT.). ESSURE WAS REMOVED IN (B)(6) 2014. AT THE TIME OF THE REPORT, THE PELVIC PAIN, AUTOIMMUNE DISORDER, HEADACHE, DEPRESSION, ANXIETY, SCAR, DYSPAREUNIA AND WEIGHT INCREASED OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ANXIETY, AUTOIMMUNE DISORDER, DEPRESSION, DYSPAREUNIA, HEADACHE, PELVIC PAIN, SCAR AND WEIGHT INCREASED TO BE RELATED TO ESSURE. 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 |
|---|---|---|---|---|---|---|---|
| 834617 | ESSURE | TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE | HHS | BAYER PHARMA AG | ESS305 | 628314 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other| R | CELEXA [CELECOXIB]| CELEXA [CELECOXIB]| CELEXA [CELECOXIB]| CELEXA [CELECOXIB]| CELEXA [CELECOXIB]| FERRITIN| FERRITIN| FERRITIN| FERRITIN| FERRITIN| WELLBUTRIN| WELLBUTRIN| WELLBUTRIN| WELLBUTRIN| WELLBUTRIN| YAZ| YAZ| YAZ| YAZ |