ESSURE
Report
- Report Number
- 2951250-2020-14452
- Event Type
- Injury
- Date Received
- September 17, 2020
- Report Date
- January 12, 2021
- Manufacturer
- BAYER PHARMA AG
- Product Code
- HHS
- UDI-DI
- 10888853003051
- PMA / PMN Number
- P020014
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NL
- Reporter Occupation
- OTHER
Narratives
THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF BACK PAIN ('BACK PAIN') IN A FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 810877) INSERTED. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S CONCURRENT CONDITIONS INCLUDED NICKEL SENSITIVITY. IN 2011, THE PATIENT EXPERIENCED PRURITUS ("ITCHING") AND PERIPHERAL SWELLING ("SWOLLEN HANDS AND FEET"). ON (B)(6) 2011, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED BACK PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), ABDOMINAL PAIN UPPER ("STOMACH PAIN"), MOOD SWINGS ("MOOD SWINGS"), INSOMNIA ("INSOMNIA"), HYPERHIDROSIS ("HEAVY PERSPIRATION"), DISTURBANCE IN ATTENTION ("PROBLEMS CONCENTRATING"), FATIGUE ("SEVERE FATIGUE"), CYSTITIS ("BLADDER INFECTION TWICE A MONTH"), MYALGIA ("A LOT OF MUSCLE PAIN") AND CYSTITIS NONINFECTIVE ("CHRONIC BLADDER INFLAMMATION"). THE PATIENT WAS TREATED WITH SURGERY (ESSURE AND FALLOPIAN TUBES REMOVED). ESSURE WAS REMOVED ON (B)(6) 2012. AT THE TIME OF THE REPORT, THE BACK PAIN, PRURITUS, PERIPHERAL SWELLING, ABDOMINAL PAIN UPPER, MOOD SWINGS, INSOMNIA, HYPERHIDROSIS, DISTURBANCE IN ATTENTION, FATIGUE, CYSTITIS, MYALGIA AND CYSTITIS NONINFECTIVE OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL PAIN UPPER, BACK PAIN, CYSTITIS, CYSTITIS NONINFECTIVE, DISTURBANCE IN ATTENTION, FATIGUE, HYPERHIDROSIS, INSOMNIA, MOOD SWINGS, MYALGIA, PERIPHERAL SWELLING AND PRURITUS TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: AFTER ESSURE REMOVAL MANY OF THE SYMPTOMS DISAPPEARED. SHE NO LONGER HAD ITCHING, ABDOMINAL PAIN, BACK PAIN, HEAVY PERSPIRATION OR INSOMNIA. DESPITE REMOVAL OF THE ESSURE, SHE STILL HAS PROBLEMS CONCENTRATING, AND SUFFERS FROM SEVERE FATIGUE, CHRONIC BLADDER INFLAMMATION AND MUSCLE PAIN IN HER BODY. LOT NUMBER: 810877 MANUFACTURING DATE: 2010-12 EXPIRATION DATE: 2013-12. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 16-DEC-2020: REPORTER, MEDICAL HISTORY, ESSURE REMOVAL DATE AND EVENTS ITCHING, SWOLLEN HANDS AND FEET, STOMACH PAIN, BACK PAIN, MOOD SWINGS, INSOMNIA, HEAVY PERSPIRATION, PROBLEMS CONCENTRATING, SEVERE FATIGUE, BLADDER INFECTION TWICE A MONTH, A LOT OF MUSCLE PAIN AND CHRONIC BLADDER INFLAMMATION ADDED. EVENT MEDICAL DEVICE REMOVAL DELETED. A TECHNICAL INVESTIGATION WAS 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 BACK PAIN ('BACK PAIN') IN A FEMALE PATIENT WHO HAD ESSURE (BATCH NO: 810877) INSERTED. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S CONCURRENT CONDITIONS INCLUDED NICKEL SENSITIVITY. IN 2011, THE PATIENT EXPERIENCED PRURITUS ("ITCHING") AND PERIPHERAL SWELLING ("SWOLLEN HANDS AND FEET"). ON (B)(6) 2011, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED BACK PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), ABDOMINAL PAIN UPPER ("STOMACH PAIN"), MOOD SWINGS ("MOOD SWINGS"), INSOMNIA ("INSOMNIA"), HYPERHIDROSIS ("HEAVY PERSPIRATION"), DISTURBANCE IN ATTENTION ("PROBLEMS CONCENTRATING"), FATIGUE ("SEVERE FATIGUE"), CYSTITIS ("BLADDER INFECTION TWICE A MONTH"), MYALGIA ("A LOT OF MUSCLE PAIN") AND CYSTITIS NONINFECTIVE ("CHRONIC BLADDER INFLAMMATION"). THE PATIENT WAS TREATED WITH SURGERY (ESSURE AND FALLOPIAN TUBES REMOVED). ESSURE WAS REMOVED ON (B)(6) 2012. AT THE TIME OF THE REPORT, THE BACK PAIN, PRURITUS, ABDOMINAL PAIN UPPER, INSOMNIA AND HYPERHIDROSIS HAD RESOLVED, THE PERIPHERAL SWELLING, MOOD SWINGS AND CYSTITIS OUTCOME WAS UNKNOWN AND THE DISTURBANCE IN ATTENTION, FATIGUE, MYALGIA AND CYSTITIS NONINFECTIVE HAD NOT RESOLVED. THE REPORTER CONSIDERED ABDOMINAL PAIN UPPER, BACK PAIN, CYSTITIS, CYSTITIS NONINFECTIVE, DISTURBANCE IN ATTENTION, FATIGUE, HYPERHIDROSIS, INSOMNIA, MOOD SWINGS, MYALGIA, PERIPHERAL SWELLING AND PRURITUS TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: AFTER ESSURE REMOVAL MANY OF THE SYMPTOMS DISAPPEARED. SHE NO LONGER HAD ITCHING, ABDOMINAL PAIN, BACK PAIN, HEAVY PERSPIRATION OR INSOMNIA. DESPITE REMOVAL OF THE ESSURE, SHE STILL HAS PROBLEMS CONCENTRATING, AND SUFFERS FROM SEVERE FATIGUE, CHRONIC BLADDER INFLAMMATION AND MUSCLE PAIN IN HER BODY. LOT NUMBER: 810877, MANUFACTURING DATE: 2010-12, EXPIRATION DATE: 2013-12. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 31-DEC-2020: AFTER THE REMOVAL SURGERY ON (B)(6) 2012, WHERE ALSO HER FALLOPIAN TUBES NEEDED TO BE REMOVED, MANY OF HER COMPLAINTS DISAPPEARED. SHE HAD NO MORE ITCHING, PAIN IN HER ABDOMEN AND BACK, HEAVY TRANSPIRATION AND INSOMNIA. DESPITE THE REMOVAL OF THE ESSURE SHE CONTINUES TO SUFFER FROM PROBLEMS WITH CONCENTRATION, EXTREME FATIGUE, CHRONIC BLADDER INFLAMMATION AND MUSCLE PAIN IN HER BODY. AMENDMENT: DUE TO INTERNAL REVIEW LAST FOLLOW UP WAS NOT RECEIVED ON 31-DEC-2020 BUT ON 16-DEC-2020. A TECHNICAL INVESTIGATION WAS 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 MEDICAL DEVICE REMOVAL ('FOREIGN-BODY MATERIAL HAS BEEN REMOVED') IN A FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 810877) INSERTED. ON (B)(6) 2011, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT UNDERWENT MEDICAL DEVICE REMOVAL (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED). THE PATIENT WAS TREATED WITH SURGERY. ESSURE WAS REMOVED. AT THE TIME OF THE REPORT, THE MEDICAL DEVICE REMOVAL OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED MEDICAL DEVICE REMOVAL TO BE RELATED TO ESSURE. LOT NUMBER: 810877. MANUFACTURING DATE: 2010-12. EXPIRATION DATE: 2013-12. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON (B)(6) 2020: QUALITY SAFETY EVALUATION OF PTC. A TECHNICAL INVESTIGATION WAS 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 BACK PAIN ('BACK PAIN') IN A FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 810877) INSERTED. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S CONCURRENT CONDITIONS INCLUDED NICKEL SENSITIVITY. IN 2011, THE PATIENT EXPERIENCED PRURITUS ("ITCHING") AND PERIPHERAL SWELLING ("SWOLLEN HANDS AND FEET"). ON (B)(6) 2011, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED BACK PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), ABDOMINAL PAIN UPPER ("STOMACH PAIN"), MOOD SWINGS ("MOOD SWINGS"), INSOMNIA ("INSOMNIA"), HYPERHIDROSIS ("HEAVY PERSPIRATION"), DISTURBANCE IN ATTENTION ("PROBLEMS CONCENTRATING"), FATIGUE ("SEVERE FATIGUE"), CYSTITIS ("BLADDER INFECTION TWICE A MONTH"), MYALGIA ("A LOT OF MUSCLE PAIN") AND CYSTITIS NONINFECTIVE ("CHRONIC BLADDER INFLAMMATION"). THE PATIENT WAS TREATED WITH SURGERY (ESSURE AND FALLOPIAN TUBES REMOVED). ESSURE WAS REMOVED ON (B)(6) 2012. AT THE TIME OF THE REPORT, THE BACK PAIN, PRURITUS, ABDOMINAL PAIN UPPER, INSOMNIA AND HYPERHIDROSIS HAD RESOLVED, THE PERIPHERAL SWELLING, MOOD SWINGS AND CYSTITIS OUTCOME WAS UNKNOWN AND THE DISTURBANCE IN ATTENTION, FATIGUE, MYALGIA AND CYSTITIS NONINFECTIVE HAD NOT RESOLVED. THE REPORTER CONSIDERED ABDOMINAL PAIN UPPER, BACK PAIN, CYSTITIS, CYSTITIS NONINFECTIVE, DISTURBANCE IN ATTENTION, FATIGUE, HYPERHIDROSIS, INSOMNIA, MOOD SWINGS, MYALGIA, PERIPHERAL SWELLING AND PRURITUS TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: AFTER ESSURE REMOVAL MANY OF THE SYMPTOMS DISAPPEARED. SHE NO LONGER HAD ITCHING, ABDOMINAL PAIN, BACK PAIN, HEAVY PERSPIRATION OR INSOMNIA. DESPITE REMOVAL OF THE ESSURE, SHE STILL HAS PROBLEMS CONCENTRATING, AND SUFFERS FROM SEVERE FATIGUE, CHRONIC BLADDER INFLAMMATION AND MUSCLE PAIN IN HER BODY. LOT NUMBER: 810877, MANUFACTURING DATE: 2010-12, EXPIRATION DATE: 2013-12 . QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 31-DEC-2020: AFTER THE REMOVAL SURGERY ON (B)(6) 2012, WHERE ALSO HER FALLOPIAN TUBES NEEDED TO BE REMOVED, MANY OF HER COMPLAINTS DISAPPEARED. SHE HAD NO MORE ITCHING, PAIN IN HER ABDOMEN AND BACK, HEAVY TRANSPIRATION AND INSOMNIA.DESPITE THE REMOVAL OF THE ESSURE SHE CONTINUES TO SUFFER FROMPROBLEMS WITH CONCENTRATION, EXTREME FATIGUE, CHRONIC BLADDER INFLAMMATION AND MUSCLE PAIN IN HER BODY. A TECHNICAL INVESTIGATION WAS 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 MEDICAL DEVICE REMOVAL ('FOREIGN-BODY MATERIAL HAS BEEN REMOVED') IN A FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 810877) INSERTED. ON (B)(6) 2011, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT UNDERWENT MEDICAL DEVICE REMOVAL (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED). THE PATIENT WAS TREATED WITH SURGERY. ESSURE WAS REMOVED. AT THE TIME OF THE REPORT, THE MEDICAL DEVICE REMOVAL OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED MEDICAL DEVICE REMOVAL TO BE RELATED TO ESSURE. LOT NUMBER: 810877, MANUFACTURING DATE: 2010-12, EXPIRATION DATE: 2013-12. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 16-SEP-2020: CASE UPGRADED TO SERIOUS INCIDENT. PATIENT INITIALS UPDATED AND EVENT FOREIGN-BODY MATERIAL HAS BEEN REMOVED ADDED. A TECHNICAL INVESTIGATION WAS 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.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1010661 | ESSURE | TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE | HHS | BAYER PHARMA AG | ESS305 | 810877 | 10888853003051 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other| R |