ESSURE
Report
- Report Number
- 2951250-2019-02005
- Event Type
- Injury
- Date Received
- May 21, 2019
- Date of Event
- August 1, 2018
- Report Date
- October 18, 2019
- Manufacturer
- BAYER PHARMA AG
- Product Code
- HHS
- UDI-DI
- 10888853003051
- PMA / PMN Number
- P020014
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AR, US
- Reporter Occupation
- OTHER
Narratives
THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF DEVICE BREAKAGE ('BREAKAGE/ EXPULSION: BREAKAGE'), PELVIC INFECTION ('INFECTION (OTHER) DESCRIBE: PELVIC BACTERIAL') AND PELVIC PAIN ('CHRONIC PELVIC PAIN/PAIN') IN AN ADULT FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 883568- NOT VALID) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S MEDICAL HISTORY INCLUDED OBESITY. ON (B)(6) 2011, THE PATIENT HAD ESSURE INSERTED. IN (B)(6) 2011, THE PATIENT EXPERIENCED DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING)"), ABDOMINAL PAIN LOWER ("LOWER ABDOMINAL PAIN") AND BACK PAIN ("LOWER BACK PAIN"). IN (B)(6) 2012, THE PATIENT EXPERIENCED MIGRAINE ("MIGRAINES") AND HEADACHE ("HEADACHES"). IN DECEMBER 2012, THE PATIENT EXPERIENCED WEIGHT FLUCTUATION ("WEIGHT FLUCTUATIONS (WEIGHT GAIN & LOSS)") AND ACNE ("ACNE"). IN (B)(6) 2013, THE PATIENT EXPERIENCED DYSPAREUNIA ("DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE)"). IN 2013, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT). IN (B)(6) 2015, THE PATIENT EXPERIENCED ALLERGY TO METALS ("NICKEL ALLERGY SINCE CHILDHOOD-NOONE TOLD ME DEVICE WAS MADE WITH NICKEL") AND RASH ("RASHES OR SKIN CONDITIONS TYPE: RASHES ON HAIRLINE AND NOSE"). IN (B)(6) 2015, THE PATIENT EXPERIENCED TOOTH FRACTURE ("DENTAL PROBLEMS: BRITTLE CRACKING"). IN (B)(6) 2015, THE PATIENT EXPERIENCED URINARY TRACT INFECTION ("INFECTION (BLADDER/ URINARY TRACT/VAGINAL) TYPE: URINARY TRACT"). IN (B)(6) 2016, THE PATIENT EXPERIENCED MOOD SWINGS ("HORMONAL CHANGES DESCRIBE: MOOD SWINGS"). IN (B)(6) 2018, THE PATIENT EXPERIENCED PELVIC INFECTION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED) AND BACTERIAL INFECTION ("INFECTION (OTHER): BACTERIAL"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED DEVICE BREAKAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), AMENORRHOEA ("OTHER INJURY(IES) OR COMPLICATION PLEASE DESCRIBE: AMENORRHEA DID NOT HAVE CYCLE FOR A YEAR"), RASH ERYTHEMATOUS ("RASHES OR SKIN CONDITION : HAIRLINE"), ARTHRALGIA ("JOINT PAIN"), VAGINAL DISCHARGE ("VAG. DISCHARGE") AND NAUSEA ("NAUSEA") AND WAS FOUND TO HAVE WEIGHT INCREASED ("WEIGHT GAIN"). ESSURE TREATMENT WAS NOT CHANGED. AT THE TIME OF THE REPORT, THE DEVICE BREAKAGE, PELVIC INFECTION, PELVIC PAIN, DYSPAREUNIA, MIGRAINE, WEIGHT FLUCTUATION, TOOTH FRACTURE, MOOD SWINGS, URINARY TRACT INFECTION, HEADACHE, ALLERGY TO METALS, RASH, ACNE, DYSMENORRHOEA, AMENORRHOEA, BACTERIAL INFECTION, ABDOMINAL PAIN LOWER, BACK PAIN, RASH ERYTHEMATOUS, ARTHRALGIA, VAGINAL DISCHARGE, NAUSEA AND WEIGHT INCREASED OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL PAIN LOWER, ACNE, ALLERGY TO METALS, AMENORRHOEA, ARTHRALGIA, BACK PAIN, BACTERIAL INFECTION, DEVICE BREAKAGE, DYSMENORRHOEA, DYSPAREUNIA, HEADACHE, MIGRAINE, MOOD SWINGS, NAUSEA, PELVIC INFECTION, PELVIC PAIN, RASH, RASH ERYTHEMATOUS, TOOTH FRACTURE, URINARY TRACT INFECTION, VAGINAL DISCHARGE, WEIGHT FLUCTUATION AND WEIGHT INCREASED TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: CURRENT WEIGHT 220 LBS. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 28.8 KG/SQM. HYSTEROSALPINGOGRAM - ON (B)(6) 2012: RESULTS: TOTAL BILATERAL OCCLUSION. IMAGING PROCEDURE - ON (B)(6) 2012: BREAKAGE. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 11-SEP-2019: PFS RECEIVED : NEW EVENTS, "BREAKAGE/ EXPULSION: BREAKAGE, BLADDER/URINARY PROBLEMS: VAG. DISCHARGE, WEIGHT GAIN, NAUSEA " WERE ADDED. NEW REPORTER CONTACT INFORMATION WAS ADDED. LAB DATA WAS ADDED. INCIDENT: NO VALID LOT NUMBER OR DEVICE SAMPLE WAS RECEIVED IN THIS CASE. 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 DEVICE BREAKAGE ('BREAKAGE/ EXPULSION: BREAKAGE'), PELVIC INFECTION ('INFECTION (OTHER) DESCRIBE: PELVIC BACTERIAL') AND PELVIC PAIN ('CHRONIC PELVIC PAIN/PAIN') IN AN ADULT FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 883568- NOT VALID) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S MEDICAL HISTORY INCLUDED OBESITY. ON (B)(6) 2011, THE PATIENT HAD ESSURE INSERTED. IN (B)(6) 2011, THE PATIENT EXPERIENCED DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING)"), ABDOMINAL PAIN LOWER ("LOWER ABDOMINAL PAIN") AND BACK PAIN ("LOWER BACK PAIN"). IN (B)(6) 2012, THE PATIENT EXPERIENCED MIGRAINE ("MIGRAINES") AND HEADACHE ("HEADACHES"). IN (B)(6) 2012, THE PATIENT EXPERIENCED WEIGHT FLUCTUATION ("WEIGHT FLUCTUATIONS (WEIGHT GAIN & LOSS)") AND ACNE ("ACNE"). IN (B)(6) 2013, THE PATIENT EXPERIENCED DYSPAREUNIA ("DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE)"). IN 2013, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT). IN (B)(6) 2015, THE PATIENT EXPERIENCED ALLERGY TO METALS ("NICKEL ALLERGY SINCE CHILDHOOD-NO ONE TOLD ME DEVICE WAS MADE WITH NICKEL") AND RASH ("RASHES OR SKIN CONDITIONS TYPE: RASHES ON HAIRLINE AND NOSE"). IN (B)(6) 2015, THE PATIENT EXPERIENCED TOOTH FRACTURE ("DENTAL PROBLEMS: BRITTLE CRACKING"). IN (B)(6) 2015, THE PATIENT EXPERIENCED URINARY TRACT INFECTION ("INFECTION (BLADDER/ URINARY TRACT/VAGINAL) TYPE: URINARY TRACT"). IN (B)(6) 2016, THE PATIENT EXPERIENCED MOOD SWINGS ("HORMONAL CHANGES DESCRIBE: MOOD SWINGS"). IN (B)(6) 2018, THE PATIENT EXPERIENCED PELVIC INFECTION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED) AND BACTERIAL INFECTION ("INFECTION (OTHER): BACTERIAL"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED DEVICE BREAKAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), AMENORRHOEA ("OTHER INJURY(IES) OR COMPLICATION PLEASE DESCRIBE: AMENORRHEA DID NOT HAVE CYCLE FOR A YEAR"), RASH ERYTHEMATOUS ("RASHES OR SKIN CONDITION : HAIRLINE"), ARTHRALGIA ("JOINT PAIN"), VAGINAL DISCHARGE ("VAG. DISCHARGE"), NAUSEA ("NAUSEA"), ABDOMINAL PAIN ("ABDOMINAL PAIN"), MENORRHAGIA ("MENORRHAGIA (HEAVY MENSTRUAL BLEEDING)") AND BLADDER DISORDER ("BLADDER PROBLEMS") AND WAS FOUND TO HAVE WEIGHT INCREASED ("WEIGHT GAIN"). ESSURE TREATMENT WAS NOT CHANGED. AT THE TIME OF THE REPORT, THE DEVICE BREAKAGE, PELVIC INFECTION, PELVIC PAIN, DYSPAREUNIA, MIGRAINE, WEIGHT FLUCTUATION, TOOTH FRACTURE, MOOD SWINGS, URINARY TRACT INFECTION, HEADACHE, ALLERGY TO METALS, RASH, ACNE, DYSMENORRHOEA, AMENORRHOEA, BACTERIAL INFECTION, ABDOMINAL PAIN LOWER, BACK PAIN, RASH ERYTHEMATOUS, ARTHRALGIA, VAGINAL DISCHARGE, NAUSEA, WEIGHT INCREASED, ABDOMINAL PAIN, MENORRHAGIA AND BLADDER DISORDER OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL PAIN, ABDOMINAL PAIN LOWER, ACNE, ALLERGY TO METALS, AMENORRHOEA, ARTHRALGIA, BACK PAIN, BACTERIAL INFECTION, BLADDER DISORDER, DEVICE BREAKAGE, DYSMENORRHOEA, DYSPAREUNIA, HEADACHE, MENORRHAGIA, MIGRAINE, MOOD SWINGS, NAUSEA, PELVIC INFECTION, PELVIC PAIN, RASH, RASH ERYTHEMATOUS, TOOTH FRACTURE, URINARY TRACT INFECTION, VAGINAL DISCHARGE, WEIGHT FLUCTUATION AND WEIGHT INCREASED TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: CURRENT WEIGHT: 220 LBS. RECEIVED TREATMENT FOR PELVIC PAIN, ABDOMINAL PAIN, MENORRHAGIA (HEAVY MENSTRUAL BLEEDING), RASH/SKIN CONDITION, BLADDER PROBLEMS. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 28.8 KG/SQM. HYSTEROSALPINGOGRAM - ON (B)(6) 2012: RESULTS: TOTAL BILATERAL OCCLUSION. IMAGING PROCEDURE - ON (B)(6) 2012: BREAKAGE. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 13-SEP-2019: PFS RECEIVED. REPORTER INFORMATION UPDATED. NEW EVENTS: ABDOMINAL PAIN, MENORRHAGIA (HEAVY MENSTRUAL BLEEDING), BLADDER PROBLEMS WERE ADDED. ON 30-SEP-2019: QUALITY SAFETY EVALUATION OF PRODUCT TECHNICAL COMPLAINT. INCIDENT: NO VALID LOT NUMBER OR DEVICE SAMPLE WAS RECEIVED IN THIS CASE. 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 INFECTION ('INFECTION (OTHER) DESCRIBE: PELVIC BACTERIAL') AND PELVIC PAIN ('CHRONIC PELVIC PAIN/PAIN') IN AN ADULT FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 883568- INVALID) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S MEDICAL HISTORY INCLUDED OBESITY. ON (B)(6) 2011, THE PATIENT HAD ESSURE INSERTED. IN (B)(6) 2011, THE PATIENT EXPERIENCED DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING)"), ABDOMINAL PAIN LOWER ("LOWER ABDOMINAL PAIN") AND BACK PAIN ("LOWER BACK PAIN"). IN (B)(6) 2012, THE PATIENT EXPERIENCED MIGRAINE ("MIGRAINES") AND HEADACHE ("HEADACHES"). IN (B)(6) 2012, THE PATIENT EXPERIENCED WEIGHT FLUCTUATION ("WEIGHT FLUCTUATIONS (WEIGHT GAIN & LOSS)") AND ACNE ("ACNE"). IN (B)(6) 2013, THE PATIENT EXPERIENCED DYSPAREUNIA ("DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE)"). IN 2013, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT). IN (B)(6) 2015, THE PATIENT EXPERIENCED ALLERGY TO METALS ("NICKEL ALLERGY SINCE CHILDHOOD-NO ONE TOLD ME DEVICE WAS MADE WITH NICKEL") AND RASH ("RASHES OR SKIN CONDITIONS TYPE: RASHES ON HAIRLINE AND NOSE"). IN (B)(6) 2015, THE PATIENT EXPERIENCED TOOTH FRACTURE ("DENTAL PROBLEMS: BRITTLE CRACKING"). IN (B)(6) 2015, THE PATIENT EXPERIENCED URINARY TRACT INFECTION ("INFECTION (BLADDER/ URINARY TRACT/VAGINAL) TYPE: URINARY TRACT"). IN (B)(6) 2016, THE PATIENT EXPERIENCED MOOD SWINGS ("HORMONAL CHANGES DESCRIBE: MOOD SWINGS"). IN (B)(6) 2018, THE PATIENT EXPERIENCED PELVIC INFECTION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED) AND BACTERIAL INFECTION ("INFECTION (OTHER): BACTERIAL"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED AMENORRHOEA ("OTHER INJURY(IES) OR COMPLICATION PLEASE DESCRIBE: AMENORRHEA DID NOT HAVE CYCLE FOR A YEAR"), RASH ERYTHEMATOUS ("RASHES OR SKIN CONDITION : HAIRLINE") AND ARTHRALGIA ("JOINT PAIN"). ESSURE TREATMENT WAS NOT CHANGED. AT THE TIME OF THE REPORT, THE PELVIC INFECTION, PELVIC PAIN, DYSPAREUNIA, MIGRAINE, WEIGHT FLUCTUATION, TOOTH FRACTURE, MOOD SWINGS, URINARY TRACT INFECTION, HEADACHE, ALLERGY TO METALS, RASH, ACNE, DYSMENORRHOEA, AMENORRHOEA, BACTERIAL INFECTION, ABDOMINAL PAIN LOWER, BACK PAIN, RASH ERYTHEMATOUS AND ARTHRALGIA OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL PAIN LOWER, ACNE, ALLERGY TO METALS, AMENORRHOEA, ARTHRALGIA, BACK PAIN, BACTERIAL INFECTION, DYSMENORRHOEA, DYSPAREUNIA, HEADACHE, MIGRAINE, MOOD SWINGS, PELVIC INFECTION, PELVIC PAIN, RASH, RASH ERYTHEMATOUS, TOOTH FRACTURE, URINARY TRACT INFECTION AND WEIGHT FLUCTUATION 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 28.8 KG/SQM. HYSTEROSALPINGOGRAM - ON (B)(6) 2012: RESULTS: TOTAL BILATERAL OCCLUSION. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 16-MAY-2019: PFS RECEIVED EVENT " BRITTLE CRACKING, URINARY TRACT INFECTION, PELVIC INFECTION, BACTERIAL INFECTION, AMENORRHEA, LOWER BACK PAIN, LOWER ABDOMEN PAIN, RASH-HAIRLINE AND NOSE, ACNE, JOINT PAIN, HEADACHE" WERE ADDED. REPORTER, PRODUCT, AND PATIENT INFORMATION WERE ADDED. INCIDENT: NO VALID LOT NUMBER OR DEVICE SAMPLE WAS RECEIVED IN THIS CASE. AT THIS TIME, WE HAVE NO INFORMATION SUGGESTING THAT THE DEVICE FAILED TO MEET ITS SPECIFICATIONS. WE WILL CONDUCT A REVIEW OF OUR COMPLAINT RECORDS AND OTHER NON-CONFORMANCES DATA; SHOULD ANY NEW AND REPORTABLE INFORMATION BECOME AVAILABLE FROM OUR INVESTIGATION, THIS WILL BE PROVIDED IN A SUPPLEMENTARY REPORT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 420367 | ESSURE | TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE | HHS | BAYER PHARMA AG | ESS305 | 883568- NOT VALID | 10888853003051 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 29 YR | Other| R |