ESSURE
Report
- Report Number
- 2951250-2019-10207
- Event Type
- Injury
- Date Received
- October 14, 2019
- Report Date
- March 16, 2020
- Manufacturer
- BAYER PHARMA AG
- Product Code
- HHS
- UDI-DI
- 10888853003051
- PMA / PMN Number
- P020014
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CO, US
- Reporter Occupation
- OTHER
Narratives
THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ('PAIN: OTHER'), DIABETES INSIPIDUS ('DIABETES INSIPIDUS') AND TOOTH EXTRACTION ('TEETH PULLED') IN A 37-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 852529) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S CONCURRENT CONDITIONS INCLUDED BODY MASS INDEX NORMAL AND HYPERALIMENTATION PARENTERAL. CONCOMITANT PRODUCTS INCLUDED DROSPIRENONE + ETHINYLESTRADIOL (YAZ) SINCE 2010 FOR BIRTH CONTROL. ON (B)(6) 2011, THE PATIENT HAD ESSURE INSERTED. IN (B)(6) OF 2013, THE PATIENT EXPERIENCED GENITAL HAEMORRHAGE ("GEN.ABNORM.BLEED"), DIABETES INSIPIDUS (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), SKIN IRRITATION ("RASH/SKIN CONDITION:SKIN IRRITATION"), MOOD SWINGS ("PSYCH INJURY:MOOD SWINGS"), ALOPECIA ("HAIR LOSS"), DERMATITIS ALLERGIC ("ALLERGIC OR HYPERSENSITIVITY REACTION TYPE: RASH"), DEPRESSION ("DEPRESSION/PSYCH INJURY"), AMENORRHOEA ("AMENORRHEA"), MENSTRUATION IRREGULAR ("IRREGULAR MENSES"), MENORRHAGIA ("SEVERE BLEEDING") AND PAIN IN EXTREMITY ("FOOT PAIN") AND WAS FOUND TO HAVE HORMONE LEVEL ABNORMAL ("HORMONAL CHANGES/HORMONAL IMBALANCE"). IN (B)(6) OF 2013, THE PATIENT WAS FOUND TO HAVE WEIGHT INCREASED ("WEIGHT GAIN") AND EXPERIENCED FATIGUE ("FATIGUE"). IN (B)(6) OF 2015, THE PATIENT EXPERIENCED TOOTH DISORDER ("DENTAL PROBLEMS/PERIDONTAL DISEASE"). ON (B)(6) OF 2018, THE PATIENT EXPERIENCED ALLERGY TO METALS ("NICKEL ALLERGY"), 6 YEARS 5 MONTHS AFTER INSERTION OF ESSURE. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), BLADDER DISORDER ("BLADDER/ URINARY PROBLEMS"), URINARY TRACT DISORDER ("BLADDER/ URINARY PROBLEMS"), GASTROINTESTINAL DISORDER ("GI CONDITIONS"), ARTHRALGIA ("HIP AND JOINT/JOINT PAIN/ELBOW PAIN/HIP PAIN") AND INFLAMMATION ("INFLAMMATION") AND UNDERWENT TOOTH EXTRACTION (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT). THE PATIENT WAS TREATED WITH CAFFEINE, ESTRADIOL (ESTRACE), ESTRADIOL (ESTROGEN), ETHINYLESTRADIOL;NORGESTIMATE (ORTHO-CYCLEN), MEDROXYPROGESTERONE ACETATE (PROVERA) AND SURGERY (HYSTERECTOMY WITH BILATERAL SALPINGECTOMY AND SURGERY (OTHER) TYPE OF SURGERY: ORAL). ESSURE WAS REMOVED ON (B)(6) OF 2018. AT THE TIME OF THE REPORT, THE PELVIC PAIN, GENITAL HAEMORRHAGE, SKIN IRRITATION, ALLERGY TO METALS, BLADDER DISORDER, URINARY TRACT DISORDER, ALOPECIA, TOOTH DISORDER, GASTROINTESTINAL DISORDER, HORMONE LEVEL ABNORMAL, WEIGHT INCREASED, DERMATITIS ALLERGIC AND ARTHRALGIA HAD RESOLVED, THE DIABETES INSIPIDUS, MOOD SWINGS, DEPRESSION, AMENORRHOEA, MENSTRUATION IRREGULAR, MENORRHAGIA, PAIN IN EXTREMITY AND INFLAMMATION OUTCOME WAS UNKNOWN AND THE TOOTH EXTRACTION AND FATIGUE WAS RESOLVING. THE REPORTER CONSIDERED ALLERGY TO METALS, ALOPECIA, AMENORRHOEA, ARTHRALGIA, BLADDER DISORDER, DEPRESSION, DERMATITIS ALLERGIC, DIABETES INSIPIDUS, FATIGUE, GASTROINTESTINAL DISORDER, GENITAL HAEMORRHAGE, HORMONE LEVEL ABNORMAL, INFLAMMATION, MENORRHAGIA, MENSTRUATION IRREGULAR, MOOD SWINGS, PAIN IN EXTREMITY, PELVIC PAIN, SKIN IRRITATION, TOOTH DISORDER, TOOTH EXTRACTION, URINARY TRACT DISORDER AND WEIGHT INCREASED TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: PLAINTIFF RECEIVED TREATMENT GEN.ABNORM.BLEED, RASH/SKIN CONDITION, NICKEL ALLERGY, PSYCH INJURY, BLADDER/ URINARY PROBLEMS, HAIR LOSS, DENTAL PROBLEMS, GI CONDITIONS, HORMONAL CHANGES, WEIGHT GAIN, PELVIC PAIN INSERTION DETAILS: LEFT -3, RIGHT- 1COIL. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 21.7 KG/SQM. HYSTEROSALPINGOGRAM - ON (B)(6) OF 2012: TOTAL BILATERAL OCCLUSION. CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONES WERE CONFIRMED IN PATIENTS MEDICAL RECORDS: AMENORRHEA, WEIGHT LOSS, HAIR LOSS, JOINT PAIN, NICKEL ALLERGY. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT . MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 28-FEB-2020: SOCIAL MEDIA RECEIVED. REPORTER ADDED. ADDED EVENT INFLAMMATION.PREVIOUSLY REPORTED EVENT "GENITAL HEMORRHAGE" SERIOUSNESS CRITERIA (MEDICALLY SIGNIFICANT) WAS REMOVED 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 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: OTHER'), GENITAL HAEMORRHAGE ('GEN.ABNORM.BLEED'), DIABETES INSIPIDUS ('DIABETES INSIPIDUS') AND TOOTH EXTRACTION ('TEETH PULLED') IN A 37-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 852529) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S CONCURRENT CONDITIONS INCLUDED BODY MASS INDEX NORMAL AND HYPERALIMENTATION PARENTERAL. CONCOMITANT PRODUCTS INCLUDED DROSPIRENONE + ETHINYLESTRADIOL (YAZ) SINCE 2010 FOR BIRTH CONTROL. ON (B)(6) 2011, THE PATIENT HAD ESSURE INSERTED. IN (B)(6) 2013, THE PATIENT EXPERIENCED GENITAL HAEMORRHAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), DIABETES INSIPIDUS (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), SKIN IRRITATION ("RASH/SKIN CONDITION:SKIN IRRITATION"), MOOD SWINGS ("PSYCH INJURY:MOOD SWINGS"), ALOPECIA ("HAIR LOSS"), DERMATITIS ALLERGIC ("ALLERGIC OR HYPERSENSITIVITY REACTION TYPE: RASH"), DEPRESSION ("DEPRESSION/PSYCH INJURY"), AMENORRHOEA ("AMENORRHEA"), MENSTRUATION IRREGULAR ("IRREGULAR MENSES"), MENORRHAGIA ("SEVERE BLEEDING") AND PAIN IN EXTREMITY ("FOOT PAIN") AND WAS FOUND TO HAVE HORMONE LEVEL ABNORMAL ("HORMONAL CHANGES/HORMONAL IMBALANCE"). IN (B)(6) 2013, THE PATIENT WAS FOUND TO HAVE WEIGHT INCREASED ("WEIGHT GAIN") AND EXPERIENCED FATIGUE ("FATIGUE"). IN (B)(6) 2015, THE PATIENT EXPERIENCED TOOTH DISORDER ("DENTAL PROBLEMS/PERIDONTAL DISEASE"). ON (B)(6) 2018, THE PATIENT EXPERIENCED ALLERGY TO METALS ("NICKEL ALLERGY"), 6 YEARS 5 MONTHS AFTER INSERTION OF ESSURE. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), BLADDER DISORDER ("BLADDER/ URINARY PROBLEMS"), URINARY TRACT DISORDER ("BLADDER/ URINARY PROBLEMS"), GASTROINTESTINAL DISORDER ("GI CONDITIONS") AND ARTHRALGIA ("HIP AND JOINT/JOINT PAIN/ELBOW PAIN/HIP PAIN") AND UNDERWENT TOOTH EXTRACTION (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT). THE PATIENT WAS TREATED WITH CAFFEINE, ESTRADIOL (ESTRACE), ESTRADIOL (ESTROGEN), ETHINYLESTRADIOL;NORGESTIMATE (ORTHO-CYCLEN), MEDROXYPROGESTERONE ACETATE (PROVERA) AND SURGERY (HYSTERECTOMY WITH BILATERAL SALPINGECTOMY AND SURGERY (OTHER) TYPE OF SURGERY: ORAL). ESSURE WAS REMOVED ON (B)(6) 2018. AT THE TIME OF THE REPORT, THE PELVIC PAIN, GENITAL HAEMORRHAGE, SKIN IRRITATION, ALLERGY TO METALS, BLADDER DISORDER, URINARY TRACT DISORDER, ALOPECIA, TOOTH DISORDER, GASTROINTESTINAL DISORDER, HORMONE LEVEL ABNORMAL, WEIGHT INCREASED, DERMATITIS ALLERGIC AND ARTHRALGIA HAD RESOLVED, THE DIABETES INSIPIDUS, MOOD SWINGS, DEPRESSION, AMENORRHOEA, MENSTRUATION IRREGULAR, MENORRHAGIA AND PAIN IN EXTREMITY OUTCOME WAS UNKNOWN AND THE TOOTH EXTRACTION AND FATIGUE WAS RESOLVING. THE REPORTER CONSIDERED ALLERGY TO METALS, ALOPECIA, AMENORRHOEA, ARTHRALGIA, BLADDER DISORDER, DEPRESSION, DERMATITIS ALLERGIC, DIABETES INSIPIDUS, FATIGUE, GASTROINTESTINAL DISORDER, GENITAL HAEMORRHAGE, HORMONE LEVEL ABNORMAL, MENORRHAGIA, MENSTRUATION IRREGULAR, MOOD SWINGS, PAIN IN EXTREMITY, PELVIC PAIN, SKIN IRRITATION, TOOTH DISORDER, TOOTH EXTRACTION, URINARY TRACT DISORDER AND WEIGHT INCREASED TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: PLAINTIFF RECEIVED TREATMENT GEN.ABNORM.BLEED, RASH/SKIN CONDITION, NICKEL ALLERGY, PSYCH INJURY, BLADDER/ URINARY PROBLEMS, HAIR LOSS, DENTAL PROBLEMS, GI CONDITIONS, HORMONAL CHANGES, WEIGHT GAIN, PELVIC PAIN INSERTION DETAILS: LEFT -3, RIGHT- 1COIL. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 21.7 KG/SQM. HYSTEROSALPINGOGRAM - ON (B)(6) 2012: TOTAL BILATERAL OCCLUSION. CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONES WERE CONFIRMED IN PATIENTS MEDICAL RECORDS: AMENORRHEA, WEIGHT LOSS, HAIR LOSS, JOINT PAIN, NICKEL ALLERGY QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 16-OCT-2019: QUALITY SAFETY EVALUATION OF PTC. 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 SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ('PAIN: OTHER'), GENITAL HAEMORRHAGE ('GEN. ABNORM. BLEED'), DIABETES INSIPIDUS ('DIABETES INSIPIDUS') AND TOOTH EXTRACTION ('TEETH PULLED') IN A (B)(6) FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 852529) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S CONCURRENT CONDITIONS INCLUDED BODY MASS INDEX NORMAL AND HYPERALIMENTATION PARENTERAL. CONCOMITANT PRODUCTS INCLUDED DROSPIRENONE + ETHINYLESTRADIOL (YAZ) SINCE 2010 FOR BIRTH CONTROL. ON (B)(6) 2011, THE PATIENT HAD ESSURE INSERTED. IN (B)(6) 2013, THE PATIENT EXPERIENCED GENITAL HAEMORRHAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), DIABETES INSIPIDUS (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), SKIN IRRITATION ("RASH/SKIN CONDITION:SKIN IRRITATION"), MOOD SWINGS ("PSYCH INJURY:MOOD SWINGS"), ALOPECIA ("HAIR LOSS"), RASH ("ALLERGIC OR HYPERSENSITIVITY REACTION TYPE: RASH"), DEPRESSION ("DEPRESSION/PSYCH INJURY"), AMENORRHOEA ("AMENORRHEA"), MENSTRUATION IRREGULAR ("IRREGULAR MENSES"), MENORRHAGIA ("SEVERE BLEEDING") AND PAIN IN EXTREMITY ("FOOT PAIN") AND WAS FOUND TO HAVE HORMONE LEVEL ABNORMAL ("HORMONAL CHANGES/HORMONAL IMBALANCE"). IN (B)(6) 2013, THE PATIENT WAS FOUND TO HAVE WEIGHT INCREASED ("WEIGHT GAIN") AND EXPERIENCED FATIGUE ("FATIGUE"). IN (B)(6) 2015, THE PATIENT EXPERIENCED TOOTH DISORDER ("DENTAL PROBLEMS/PERIODONTAL DISEASE"). ON (B)(6) 2018, THE PATIENT EXPERIENCED ALLERGY TO METALS ("NICKEL ALLERGY"), 6 YEARS 5 MONTHS AFTER INSERTION OF ESSURE. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), BLADDER DISORDER ("BLADDER/ URINARY PROBLEMS"), URINARY TRACT DISORDER ("BLADDER/ URINARY PROBLEMS"), GASTROINTESTINAL DISORDER ("GI CONDITIONS") AND ARTHRALGIA ("HIP AND JOINT/JOINT PAIN/ELBOW PAIN/HIP PAIN") AND UNDERWENT TOOTH EXTRACTION (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT). THE PATIENT WAS TREATED WITH CAFFEINE, ESTRADIOL (ESTRACE), ESTRADIOL (ESTROGEN), ETHINYLESTRADIOL;NORGESTIMATE (ORTHO-CYCLEN), MEDROXYPROGESTERONE ACETATE (PROVERA) AND SURGERY (HYSTERECTOMY WITH BILATERAL SALPINGECTOMY AND SURGERY (OTHER) TYPE OF SURGERY: ORAL). ESSURE WAS REMOVED ON (B)(6) 2018. AT THE TIME OF THE REPORT, THE PELVIC PAIN, GENITAL HAEMORRHAGE, SKIN IRRITATION, ALLERGY TO METALS, BLADDER DISORDER, URINARY TRACT DISORDER, ALOPECIA, TOOTH DISORDER, GASTROINTESTINAL DISORDER, HORMONE LEVEL ABNORMAL, WEIGHT INCREASED, RASH AND ARTHRALGIA HAD RESOLVED, THE DIABETES INSIPIDUS, MOOD SWINGS, DEPRESSION, AMENORRHOEA, MENSTRUATION IRREGULAR, MENORRHAGIA AND PAIN IN EXTREMITY OUTCOME WAS UNKNOWN AND THE TOOTH EXTRACTION AND FATIGUE WAS RESOLVING. THE REPORTER CONSIDERED ALLERGY TO METALS, ALOPECIA, AMENORRHOEA, ARTHRALGIA, BLADDER DISORDER, DEPRESSION, DIABETES INSIPIDUS, FATIGUE, GASTROINTESTINAL DISORDER, GENITAL HAEMORRHAGE, HORMONE LEVEL ABNORMAL, MENORRHAGIA, MENSTRUATION IRREGULAR, MOOD SWINGS, PAIN IN EXTREMITY, PELVIC PAIN, RASH, SKIN IRRITATION, TOOTH DISORDER, TOOTH EXTRACTION, URINARY TRACT DISORDER AND WEIGHT INCREASED TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: PLAINTIFF RECEIVED TREATMENT GEN.ABNORM.BLEED, RASH/SKIN CONDITION, NICKEL ALLERGY, PSYCH INJURY, BLADDER/ URINARY PROBLEMS, HAIR LOSS, DENTAL PROBLEMS, GI CONDITIONS, HORMONAL CHANGES, WEIGHT GAIN, PELVIC PAIN INSERTION DETAILS: LEFT -3, RIGHT- 1 COIL. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 21.7 KG/SQM. HYSTEROSALPINGOGRAM - ON (B)(6) 2012: TOTAL BILATERAL OCCLUSION. CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONES WERE CONFIRMED IN PATIENTS MEDICAL RECORDS: AMENORRHEA, WEIGHT LOSS, HAIR LOSS, JOINT PAIN, NICKEL ALLERGY QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 18-SEP-2019: FU1 &FU2 PROCEED TOGETHER: PFS RECEIVED. INJURY NOS REPLACED WITH NEW EVENT GEN. ABNORM. BLEED. NEW EVENTS RASH/SKIN CONDITION, NICKEL ALLERGY, PSYCH INJURY, BLADDER/ URINARY PROBLEMS, HAIR LOSS, DENTAL PROBLEMS, GI CONDITIONS, HORMONAL CHANGES, WEIGHT GAIN, PAIN WERE ADDED. LAB DATA, REPORTER¿S INFORMATION, PATIENT¿S DEMOGRAPHICS WERE ADDED. ON 20-SEP-2019: FU1 &FU2 PROCEED TOGETHER:PFS RECEIVED. NEW EVENTS RASH, DEPRESSION, FATIGUE, DIABETES INSIPIDUS, AMENORRHEA, IRREGULAR MENSES, SEVERE BLEEDING, JOINT PAIN, HIP PAIN, ANXIETY, FOOT PAIN, TEETH PULLED WERE ADDED. LAB DATA UPDATED, LOT NUMBER TREATMENT DRUGS, CONCOMITANT DRUGS, CONCOMITANT CONDITIONS,REPORTER¿S INFORMATION, PATIENT¿S DEMOGRAPHICS WERE ADDED. 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 |
|---|---|---|---|---|---|---|---|
| 982364 | ESSURE | TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE | HHS | BAYER PHARMA AG | ESS305 | 852529 | 10888853003051 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 37 YR | Other| R | YAZ.| YAZ.| YAZ. |