ESSURE
Report
- Report Number
- 2951250-2019-09529
- Event Type
- Injury
- Date Received
- October 4, 2019
- Date of Event
- October 17, 2013
- Report Date
- March 4, 2020
- Manufacturer
- BAYER PHARMA AG
- Product Code
- HHS
- UDI-DI
- 10888853003051
- PMA / PMN Number
- P020014
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MA, US
- Reporter Occupation
- OTHER
Narratives
THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ('PAIN: PELVIC PAIN') IN A 37-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. C900803-INV) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S MEDICAL HISTORY INCLUDED BODY MASS INDEX NORMAL, HORMONAL IMBALANCE, OVARIAN CYST, HSIL, PITUITARY ADENOMA, UTERINE BLEEDING, ASTHMA AND UTERINE POLYP. CURRENT WEIGHT 175 LBS. PREVIOUSLY ADMINISTERED PRODUCTS INCLUDED FOR AN UNREPORTED INDICATION: NUVARING FROM 2003 TO 2004. CONCURRENT CONDITIONS INCLUDED BACTERIAL VAGINOSIS SINCE (B)(6)2014, HUMAN PAPILLOMA VIRUS INFECTION, VAGINAL IRRITATION, FREQUENCY URINARY, NOCTURIA, CONSTIPATION, NAUSEA, VOMITING AND PARATUBAL CYST. CONCOMITANT PRODUCTS INCLUDED CABERGOLINE (DOSTINEX) AND LEVOTHYROXINE SINCE 2005. ON (B)(6)2013, THE PATIENT HAD ESSURE INSERTED. ON (B)(6)2013, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), ABDOMINAL PAIN ("VIBRATION FEELING IN ABDOMEN/ PINCHING") AND DISCOMFORT ("PAIN: DISCOMFORT"), 1 DAY AFTER INSERTION OF ESSURE. ON (B)(6)2013, THE PATIENT EXPERIENCED AUTOIMMUNE HYPOTHYROIDISM ("AUTOIMMUNE DISORDER TYPE OF DISORDER: HYPOTHYROID"), AUTOIMMUNE THYROIDITIS ("AUTOIMMUNE DISORDER TYPE OF DISORDER: EXACERBATED HASHIMOTO'S DISEASE"), AUTOIMMUNE DISORDER ("GENERAL AUTO IMMUNE ISSUES AND SENSITIVITY FLARED"), POLLAKIURIA ("BLADDER OR URINARY PROBLEMS OR CHANGES"), DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING)"), ANXIETY ("PSYCHOLOGICAL OR PSYCHIATRIC PROBLEMS CONDITION: ANXIETY"), DEPRESSION ("PSYCHOLOGICAL OR PSYCHIATRIC PROBLEMS CONDITION:DEPRESSION") AND FATIGUE ("FATIGUE"). IN (B)(6)2013, THE PATIENT EXPERIENCED VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL)"), MENORRHAGIA ("ABNORMAL BLEEDING(MENORRHAGIA)/PERIOD WERE ALWAYS VERY HEAVY"), ABDOMINAL DISTENSION ("GASTROINTESTINAL OR DIGESTIVE SYSTEM CONDITION TYPE:BLOATING") AND CONSTIPATION ("GASTROINTESTINAL OR DIGESTIVE SYSTEM CONDITION TYPE:CONSTIPATION"). IN (B)(6)2013, THE PATIENT EXPERIENCED DYSPAREUNIA ("DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE)"). IN (B)(6)2014, THE PATIENT EXPERIENCED FEELING ABNORMAL ("NEUROLOGICAL CONDITIONS OR PROBLEMS TYPE:BRAIN FOG"), AMNESIA ("NEUROLOGICAL CONDITIONS OR PROBLEMS TYPE: MEMORY LOSS") AND DIZZINESS ("NEUROLOGICAL CONDITIONS OR PROBLEMS TYPE:DIZZY SPELLS/ DIZZINESS"). IN (B)(6)2014, THE PATIENT WAS FOUND TO HAVE WEIGHT INCREASED ("WEIGHT GAIN/ LOSS (SPECIFY WHICH ONE) WEIGHT GAIN"). IN (B)(6)2014, THE PATIENT EXPERIENCED VAGINAL DISCHARGE ("VAGINAL DISCHARGE"). IN (B)(6)2017, THE PATIENT WAS FOUND TO HAVE UTERINE FIBROIDS ("REPRODUCTIVE SYSTEM DISORDER OR CONDITION TYPE OF DISORDER OR CONDITION: UTERINE FIBROIDS") AND EXPERIENCED POLYCYSTIC OVARIES ("REPRODUCTIVE SYSTEM DISORDER OR CONDITION TYPE OF DISORDER OR CONDITION:OVARIAN CYSTS"). IN (B)(6)2017, THE PATIENT EXPERIENCED ARTHRALGIA ("OTHER INJURY(IES) OR COMPLICATION PLEASE DESCRIBE: JOINT PAIN"). IN (B)(6)2018, THE PATIENT EXPERIENCED RASH MACULAR ("RASHES OR SKIN CONDITIONS TYPE: RED SPOTS/PATCHES ON MY LEGS"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED ADNEXA UTERI PAIN ("SENSATION IN MY OVARIES ON BOTH SIDES/TWINGES DURING OVULATION"), PANIC ATTACK ("PANIC ATTACKS"), DYSPNOEA ("SHORT OF BREATH"), MYALGIA ("MUSCLE ACHE IN MY KNEE FELLS OUT OF JOINT"), UTERINE POLYP ("POLYPS IN MY UTERUS"), OVARIAN CYST ("CYST ON OVARY"), ALOPECIA ("HAIR LOSS"), DIARRHOEA ("DIARRHEA") AND HOT FLUSH ("HOT FLASHES ") AND WAS FOUND TO HAVE UTERINE FIBROID ("FIBROID"). THE PATIENT WAS TREATED WITH TRANEXAMIC ACID (LYSTEDA) AND SURGERY (BILATERAL SALPINGECTOMY). ESSURE WAS REMOVED ON (B)(6)2018. AT THE TIME OF THE REPORT, THE PELVIC PAIN, FATIGUE, ABDOMINAL PAIN AND DISCOMFORT HAD RESOLVED, THE AUTOIMMUNE HYPOTHYROIDISM, AUTOIMMUNE THYROIDITIS AND AUTOIMMUNE DISORDER WAS RESOLVING AND THE VAGINAL HAEMORRHAGE, MENORRHAGIA, POLLAKIURIA, DYSMENORRHOEA, DYSPAREUNIA, FEELING ABNORMAL, AMNESIA, DIZZINESS, ANXIETY, DEPRESSION, RASH MACULAR, UTERINE FIBROIDS, POLYCYSTIC OVARIES, VAGINAL DISCHARGE, ABDOMINAL DISTENSION, CONSTIPATION, ARTHRALGIA, WEIGHT INCREASED, ADNEXA UTERI PAIN, PANIC ATTACK, DYSPNOEA, MYALGIA, UTERINE POLYP, OVARIAN CYST, ALOPECIA, DIARRHOEA, HOT FLUSH AND UTERINE FIBROID OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL DISTENSION, ABDOMINAL PAIN, ADNEXA UTERI PAIN, ALOPECIA, AMNESIA, ANXIETY, ARTHRALGIA, AUTOIMMUNE DISORDER, AUTOIMMUNE HYPOTHYROIDISM, AUTOIMMUNE THYROIDITIS, CONSTIPATION, DEPRESSION, DIARRHOEA, DISCOMFORT, DIZZINESS, DYSMENORRHOEA, DYSPAREUNIA, DYSPNOEA, FATIGUE, FEELING ABNORMAL, HOT FLUSH, MENORRHAGIA, MYALGIA, OVARIAN CYST, PANIC ATTACK, PELVIC PAIN, POLLAKIURIA, POLYCYSTIC OVARIES, RASH MACULAR, UTERINE FIBROIDS, UTERINE POLYP, VAGINAL DISCHARGE, VAGINAL HAEMORRHAGE, WEIGHT INCREASED AND UTERINE FIBROID TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: CURRENT WEIGHT 175 LBS. SHE RECEIVED TREATMENT FOR: DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE), PELVIC PAIN, ABDOMINAL PAIN AND DYSMENORRHEA (CRAMPING). DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 23.4 KG/SQM. HYSTEROSALPINGOGRAM - ON (B)(6)2014: RESULT: TOTAL BILATERAL OCCLUSION.. PREGNANCY TEST - ON (B)(6)2013: URINE HCG NEGATIVE; ON (B)(6)2018: NEGATIVE. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 20-FEB-2020: SOCIAL MEDIA RECEIVED. NEW EVENTS SENSATION IN MY OVARIES ON BOTH SIDES, PANIC ATTACKS, SHORT OF BREATH, MUSCLE ACHE IN MY KNEE FELLS OUT OF JOINT, POLYPS IN MY UTERUS, CYST ON OVARY, HAIR LOSS, DIARRHEA, HOT FLASHES, FIBROID WAS ADDED. REPORTER, LAB DATA WAS ADDED. BASED ON THE AVAILABLE INFORMATION, A REVIEW OF OUR COMPLAINT RECORDS AND OTHER RELEVANT DATA WILL BE CONDUCTED; ANY NEW AND REPORTABLE INFORMATION THAT BECOMES AVAILABLE FROM OUR INVESTIGATION WILL BE PROVIDED IN A SUPPLEMENTARY REPORT.
THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ('PAIN: PELVIC PAIN'), AUTOIMMUNE THYROIDITIS ('AUTOIMMUNE DISORDER TYPE OF DISORDER: EXACERBATED HASHIMOTO'S DISEASE'), AUTOIMMUNE DISORDER ('GENERAL AUTO IMMUNE ISSUES AND SENSITIVITY FLARED') AND AUTOIMMUNE HYPOTHYROIDISM ('AUTOIMMUNE DISORDER TYPE OF DISORDER: HYPOTHYROID') IN A 37-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. C900803-NOT VALID) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S MEDICAL HISTORY INCLUDED BODY MASS INDEX NORMAL AND HORMONAL IMBALANCE. CURRENT WEIGHT (B)(6) . PREVIOUSLY ADMINISTERED PRODUCTS INCLUDED FOR AN UNREPORTED INDICATION: NUVARING FROM 2003 TO 2004. CONCOMITANT PRODUCTS INCLUDED CABERGOLINE (DOSTINEX) AND LEVOTHYROXINE SINCE 2005. ON (B)(6) 2013, THE PATIENT HAD ESSURE INSERTED. ON (B)(6) 2013, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), ABDOMINAL PAIN ("VIBRATION FEELING IN ABDOMEN/ PINCHING") AND DISCOMFORT ("PAIN: DISCOMFORT"), 1 DAY AFTER INSERTION OF ESSURE. ON (B)(6) 2013, THE PATIENT EXPERIENCED AUTOIMMUNE THYROIDITIS (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), AUTOIMMUNE DISORDER (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), AUTOIMMUNE HYPOTHYROIDISM (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), POLLAKIURIA ("BLADDER OR URINARY PROBLEMS OR CHANGES"), DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING)"), ANXIETY ("PSYCHOLOGICAL OR PSYCHIATRIC PROBLEMS CONDITION: ANXIETY"), DEPRESSION ("PSYCHOLOGICAL OR PSYCHIATRIC PROBLEMS CONDITION:DEPRESSION") AND FATIGUE ("FATIGUE"). IN (B)(6) 2013, THE PATIENT EXPERIENCED VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL)"), MENORRHAGIA ("ABNORMAL BLEEDING(MENORRHAGIA)"), ABDOMINAL DISTENSION ("GASTROINTESTINAL OR DIGESTIVE SYSTEM CONDITION TYPE:BLOATING") AND CONSTIPATION ("GASTROINTESTINAL OR DIGESTIVE SYSTEM CONDITION TYPE:CONSTIPATION"). IN (B)(6) 2013, THE PATIENT EXPERIENCED DYSPAREUNIA ("DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE)"). IN (B)(6) 2014, THE PATIENT EXPERIENCED FEELING ABNORMAL ("NEUROLOGICAL CONDITIONS OR PROBLEMS TYPE:BRAIN FOG"), AMNESIA ("NEUROLOGICAL CONDITIONS OR PROBLEMS TYPE: MEMORY LOSS") AND DIZZINESS ("NEUROLOGICAL CONDITIONS OR PROBLEMS TYPE:DIZZY SPELLS/ DIZZINESS"). IN (B)(6) 2014, THE PATIENT WAS FOUND TO HAVE WEIGHT INCREASED ("WEIGHT GAIN/ LOSS (SPECIFY WHICH ONE) WEIGHT GAIN"). IN (B)(6) 2014, THE PATIENT EXPERIENCED VAGINAL DISCHARGE ("VAGINAL DISCHARGE"). IN (B)(6) 2017, THE PATIENT WAS FOUND TO HAVE UTERINE LEIOMYOMA ("REPRODUCTIVE SYSTEM DISORDER OR CONDITION TYPE OF DISORDER OR CONDITION: UTERINE FIBROIDS") AND EXPERIENCED POLYCYSTIC OVARIES ("REPRODUCTIVE SYSTEM DISORDER OR CONDITION TYPE OF DISORDER OR CONDITION:OVARIAN CYSTS"). IN (B)(6) 2017, THE PATIENT EXPERIENCED ARTHRALGIA ("OTHER INJURY(IES) OR COMPLICATION PLEASE DESCRIBE: JOINT PAIN"). IN (B)(6) 2018, THE PATIENT EXPERIENCED RASH MACULAR ("RASHES OR SKIN CONDITIONS TYPE: RED SPOTS/PATCHES ON MY LEGS"). THE PATIENT WAS TREATED WITH TRANEXAMIC ACID (LYSTEDA) AND SURGERY (BILATERAL SALPINGECTOMY). ESSURE WAS REMOVED ON (B)(6) 2018. AT THE TIME OF THE REPORT, THE PELVIC PAIN, FATIGUE, ABDOMINAL PAIN AND DISCOMFORT HAD RESOLVED, THE AUTOIMMUNE THYROIDITIS, AUTOIMMUNE DISORDER AND AUTOIMMUNE HYPOTHYROIDISM WAS RESOLVING AND THE VAGINAL HAEMORRHAGE, MENORRHAGIA, POLLAKIURIA, DYSMENORRHOEA, DYSPAREUNIA, FEELING ABNORMAL, AMNESIA, DIZZINESS, ANXIETY, DEPRESSION, RASH MACULAR, UTERINE LEIOMYOMA, POLYCYSTIC OVARIES, VAGINAL DISCHARGE, ABDOMINAL DISTENSION, CONSTIPATION, ARTHRALGIA AND WEIGHT INCREASED OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL DISTENSION, ABDOMINAL PAIN, AMNESIA, ANXIETY, ARTHRALGIA, AUTOIMMUNE DISORDER, AUTOIMMUNE HYPOTHYROIDISM, AUTOIMMUNE THYROIDITIS, CONSTIPATION, DEPRESSION, DISCOMFORT, DIZZINESS, DYSMENORRHOEA, DYSPAREUNIA, FATIGUE, FEELING ABNORMAL, MENORRHAGIA, PELVIC PAIN, POLLAKIURIA, POLYCYSTIC OVARIES, RASH MACULAR, UTERINE LEIOMYOMA, VAGINAL DISCHARGE, VAGINAL HAEMORRHAGE AND WEIGHT INCREASED TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: CURRENT WEIGHT (B)(6) . DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS (B)(6) . HYSTEROSALPINGOGRAM - IN (B)(6) 2014: RESULT: TOTAL BILATERAL OCCLUSION.. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 5-OCT-2019: UPDATE OF INFORMATION (BATCH IS NOT VALID) INCIDENT NO VALID LOT NUMBER 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 PAIN'), AUTOIMMUNE THYROIDITIS ('AUTOIMMUNE DISORDER TYPE OF DISORDER: EXACERBATED HASHIMOTO'S DISEASE') AND AUTOIMMUNE DISORDER ('GENERAL AUTO IMMUNE ISSUES AND SENSITIVITY FLARED') IN A (B)(6) FEMALE PATIENT WHO HAD ESSURE (BATCH NO. C900803) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S MEDICAL HISTORY INCLUDED BODY MASS INDEX NORMAL AND HORMONAL IMBALANCE. CURRENT WEIGHT (B)(6). PREVIOUSLY ADMINISTERED PRODUCTS INCLUDED FOR AN UNREPORTED INDICATION: NUVARING FROM 2003 TO 2004. CONCOMITANT PRODUCTS INCLUDED CABERGOLINE (DOSTINEX) AND LEVOTHYROXINE SINCE 2005. ON (B)(6) 2013, THE PATIENT HAD ESSURE INSERTED. ON (B)(6) 2013, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), ABDOMINAL PAIN ("VIBRATION FEELING IN ABDOMEN/ PINCHING") AND DISCOMFORT ("PAIN: DISCOMFORT"), 1 DAY AFTER INSERTION OF ESSURE. ON (B)(6) 2013, THE PATIENT EXPERIENCED AUTOIMMUNE THYROIDITIS (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), AUTOIMMUNE DISORDER (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), HYPOTHYROIDISM ("AUTOIMMUNE DISORDER TYPE OF DISORDER: HYPOTHYROID"), POLLAKIURIA ("BLADDER OR URINARY PROBLEMS OR CHANGES"), DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING)"), ANXIETY ("PSYCHOLOGICAL OR PSYCHIATRIC PROBLEMS CONDITION: ANXIETY"), DEPRESSION ("PSYCHOLOGICAL OR PSYCHIATRIC PROBLEMS CONDITION: DEPRESSION") AND FATIGUE ("FATIGUE"). IN (B)(6) 2013, THE PATIENT EXPERIENCED VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL)"), MENORRHAGIA ("ABNORMAL BLEEDING(MENORRHAGIA)"), ABDOMINAL DISTENSION ("GASTROINTESTINAL OR DIGESTIVE SYSTEM CONDITION TYPE: BLOATING") AND CONSTIPATION ("GASTROINTESTINAL OR DIGESTIVE SYSTEM CONDITION TYPE: CONSTIPATION"). IN (B)(6) 2013, THE PATIENT EXPERIENCED DYSPAREUNIA ("DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE)"). IN (B)(6) 2014, THE PATIENT EXPERIENCED FEELING ABNORMAL ("NEUROLOGICAL CONDITIONS OR PROBLEMS TYPE: BRAIN FOG"), AMNESIA ("NEUROLOGICAL CONDITIONS OR PROBLEMS TYPE: MEMORY LOSS") AND DIZZINESS ("NEUROLOGICAL CONDITIONS OR PROBLEMS TYPE: DIZZY SPELLS/ DIZZINESS"). IN (B)(6) 2014, THE PATIENT WAS FOUND TO HAVE WEIGHT INCREASED ("WEIGHT GAIN/ LOSS (SPECIFY WHICH ONE) WEIGHT GAIN"). IN (B)(6) 2014, THE PATIENT EXPERIENCED VAGINAL DISCHARGE ("VAGINAL DISCHARGE"). IN (B)(6) 2017, THE PATIENT WAS FOUND TO HAVE UTERINE LEIOMYOMA ("REPRODUCTIVE SYSTEM DISORDER OR CONDITION TYPE OF DISORDER OR CONDITION: UTERINE FIBROIDS") AND EXPERIENCED POLYCYSTIC OVARIES ("REPRODUCTIVE SYSTEM DISORDER OR CONDITION TYPE OF DISORDER OR CONDITION: OVARIAN CYSTS"). IN (B)(6) 2017, THE PATIENT EXPERIENCED ARTHRALGIA ("OTHER INJURY(IES) OR COMPLICATION PLEASE DESCRIBE: JOINT PAIN"). IN (B)(6) 2018, THE PATIENT EXPERIENCED RASH MACULAR ("RASHES OR SKIN CONDITIONS TYPE: RED SPOTS/PATCHES ON MY LEGS"). THE PATIENT WAS TREATED WITH TRANEXAMIC ACID (LYSTEDA) AND SURGERY (BILATERAL SALPINGECTOMY). ESSURE WAS REMOVED ON (B)(6) 2018. AT THE TIME OF THE REPORT, THE PELVIC PAIN, FATIGUE, ABDOMINAL PAIN AND DISCOMFORT HAD RESOLVED, THE AUTOIMMUNE THYROIDITIS, AUTOIMMUNE DISORDER AND HYPOTHYROIDISM WAS RESOLVING AND THE VAGINAL HAEMORRHAGE, MENORRHAGIA, POLLAKIURIA, DYSMENORRHOEA, DYSPAREUNIA, FEELING ABNORMAL, AMNESIA, DIZZINESS, ANXIETY, DEPRESSION, RASH MACULAR, UTERINE LEIOMYOMA, POLYCYSTIC OVARIES, VAGINAL DISCHARGE, ABDOMINAL DISTENSION, CONSTIPATION, ARTHRALGIA AND WEIGHT INCREASED OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL DISTENSION, ABDOMINAL PAIN, AMNESIA, ANXIETY, ARTHRALGIA, AUTOIMMUNE DISORDER, AUTOIMMUNE THYROIDITIS, CONSTIPATION, DEPRESSION, DISCOMFORT, DIZZINESS, DYSMENORRHOEA, DYSPAREUNIA, FATIGUE, FEELING ABNORMAL, HYPOTHYROIDISM, MENORRHAGIA, PELVIC PAIN, POLLAKIURIA, POLYCYSTIC OVARIES, RASH MACULAR, UTERINE LEIOMYOMA, VAGINAL DISCHARGE, VAGINAL HAEMORRHAGE AND WEIGHT INCREASED TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: CURRENT WEIGHT (B)(6). DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS (B)(6). HYSTEROSALPINGOGRAM - IN (B)(6) 2014: RESULT: TOTAL BILATERAL OCCLUSION. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 12-SEP-2019: PFS WAS RECEIVE. LOT NUMBER WAS ADDED. PREVIOUSLY ADDED INJURY NOS WAS REPLACED WITH PELVIC PAIN AND NEW EVENTS ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA), EXACERBATED HASHIMOTO'S DISEASE - HYPOTHYROID, GENERAL AUTO IMMUNE ISSUES AND SENSITIVITY FLARED, FREQUENT URINATION, DYSMENORRHEA, DYSPAREUNIA, BRAIN FOG, MEMORY LOSS, DIZZY SPELLS, ANXIETY, DEPRESSION, RED SPOTS ON MY LEGS, UTERINE FIBROIDS, OVARIAN CYSTS, VAGINAL DISCHARGE, FATIGUE, BLOATING, CONSTIPATION, JOINT PAIN, WEIGHT GAIN, VIBRATION FEELING IN ABDOMEN, DISCOMFORT WERE ADDED. DATE OF INSERTION AND DATE OF REMOVAL WAS ADDED. NEW REPORTERS WERE ADDED. PATIENT DEMOGRAPHIC WAS ADDED. CONCOMITANT, HISTORICAL AND TREATMENT DRUGS WERE ADDED. EVENT OUTCOME WAS ADDED. EVENT ONSET DATES WERE ADDED. LAB DATA WAS 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.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 951942 | ESSURE | TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE | HHS | BAYER PHARMA AG | ESS305 | C900803-INV | 10888853003051 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 37 YR | Other| R | DOSTINEX| DOSTINEX| DOSTINEX| LEVOTHYROXINE| LEVOTHYROXINE| LEVOTHYROXINE |