ESSURE
Report
- Report Number
- 2951250-2018-02453
- Event Type
- Injury
- Date Received
- June 4, 2018
- Date of Event
- March 1, 2012
- Report Date
- June 22, 2020
- Manufacturer
- BAYER PHARMA AG
- Product Code
- HHS
- PMA / PMN Number
- P020014
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CO, US
- Reporter Occupation
- OTHER
Narratives
NTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ("SEVERE PELVIC PAIN, PAIN") AND GENITAL HAEMORRHAGE ("ABNORMAL BLEEDING (GENERAL)") IN A 38-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 871978) INSERTED FOR FEMALE STERILIZATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S PAST MEDICAL HISTORY INCLUDED CAROTID ARTERY ANEURYSM, STENT PLACEMENT AND VERTIGO. PREVIOUSLY ADMINISTERED PRODUCTS INCLUDED FOR AN UNREPORTED INDICATION: WELBUTRIN, PROZAC, ASPIRINE AND XANAX. CONCURRENT CONDITIONS INCLUDED MORBID OBESITY. CONCOMITANT PRODUCTS INCLUDED ACETYLSALICYLIC ACID (ASPIRINE) SINCE 2008 AND FLUOXETINE HYDROCHLORIDE (PROZAC) SINCE 2013. IN (B)(6) 2012, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL)"), ANXIETY ("ANXIETY"), FATIGUE ("FATIGUE"), MOOD SWINGS ("MOOD SWINGS"), DRY SKIN ("DULL DRY SKIN"), DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING)"), VAGINAL DISCHARGE ("VAGINAL DISCHARGE") AND WEIGHT INCREASED ("WEIGHT GAIN"). ON (B)(6) 2012, THE PATIENT HAD ESSURE INSERTED. IN (B)(6) 2012, THE PATIENT EXPERIENCED ARTHRITIS ("ARTHRITIS"). IN 2012, THE PATIENT EXPERIENCED GENITAL HAEMORRHAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT). IN 2013, THE PATIENT EXPERIENCED LID SULCUS DEEPENED ("SUNKEN EYES"). IN (B)(6) 2017, THE PATIENT EXPERIENCED ALOPECIA ("ALOPECIA"), ARTHRALGIA ("GENERALIZED JOINT PAIN/ RIGHT LEFT HIP PAIN") AND GASTROOESOPHAGEAL REFLUX DISEASE ("ACID REFLUX"). ON (B)(6) 2017, 5 YEARS 6 MONTHS AFTER INSERTION OF ESSURE, THE PATIENT EXPERIENCED ENDOMETRIOSIS ("ENDOMETRIOSIS"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED MENORRHAGIA ("ABNORMAL (MENORRHAGIA)"), HEADACHE ("HEADACHES"), INFECTION ("INFECTIONS"), MENSTRUAL DISORDER ("MENSTRUATION ISSUES"), DEPRESSION ("DEPRESSION") AND BACK PAIN ("LOWER BACK PAIN"). THE PATIENT WAS TREATED WITH SURGERY (TOTAL LAPAROSCOPIC HYSTERECTOMY, BILATERAL SALPINGECTOMY WITH REMOVAL OF ESSURE COILS). ESSURE WAS REMOVED ON (B)(6) 2017. AT THE TIME OF THE REPORT, THE PELVIC PAIN, GENITAL HAEMORRHAGE, VAGINAL HAEMORRHAGE, MENORRHAGIA, ALOPECIA, HEADACHE, INFECTION, MENSTRUAL DISORDER, ARTHRITIS, LID SULCUS DEEPENED, DYSMENORRHOEA, ENDOMETRIOSIS, ARTHRALGIA, WEIGHT INCREASED, GASTROOESOPHAGEAL REFLUX DISEASE AND BACK PAIN OUTCOME WAS UNKNOWN, THE ANXIETY, MOOD SWINGS, DEPRESSION AND VAGINAL DISCHARGE HAD RESOLVED AND THE FATIGUE AND DRY SKIN WAS RESOLVING. THE REPORTER CONSIDERED ALOPECIA, ANXIETY, ARTHRALGIA, ARTHRITIS, BACK PAIN, DEPRESSION, DRY SKIN, DYSMENORRHOEA, ENDOMETRIOSIS, FATIGUE, GASTROOESOPHAGEAL REFLUX DISEASE, GENITAL HAEMORRHAGE, HEADACHE, INFECTION, LID SULCUS DEEPENED, MENORRHAGIA, MENSTRUAL DISORDER, MOOD SWINGS, PELVIC PAIN, VAGINAL DISCHARGE, VAGINAL HAEMORRHAGE AND WEIGHT INCREASED TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: CURRENT WEIGHT 280 LBS APPROXIMATE WEIGHT AT THE TIME OF ESSURE PLACEMENT 270 LBS. COILS VISUALIZED LEFT 3 AND RIGHT NO. DECSCIPANCIES IN DATE OF INSERTION.(B)(6) 2010, (B)(6) 2012. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 43.8 KG/SQM. HYSTEROSALPINGOGRAM - ON (B)(6) 2011: ESSURE DEVICE WAS SUCCESSFULLY OCCLUDED; ON (B)(6) 2012: TOTAL BILATERAL OCCLUSION; ON (B)(6) 2012: QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT . MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 4-AUG-2018: QUALITY-SAFETY EVALUATION OF PRODUCT TECHNICAL COMPLAINT. INCIDENT: AT THE TIME OF REPORTING, 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.
THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ('SEVERE PELVIC PAIN, PAIN') IN A 38-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 871978) INSERTED FOR FEMALE STERILIZATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S MEDICAL HISTORY INCLUDED CAROTID ARTERY ANEURYSM, STENT PLACEMENT AND VERTIGO. PREVIOUSLY ADMINISTERED PRODUCTS INCLUDED FOR AN UNREPORTED INDICATION: WELBUTRIN, PROZAC, ASPIRINE AND XANAX. CONCURRENT CONDITIONS INCLUDED MORBID OBESITY. CONCOMITANT PRODUCTS INCLUDED ACETYLSALICYLIC ACID (ASPIRINE) SINCE 2008 AND FLUOXETINE HYDROCHLORIDE (PROZAC) SINCE 2013. IN (B)(6)2012, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL)"), ANXIETY ("ANXIETY"), FATIGUE ("FATIGUE"), MOOD SWINGS ("MOOD SWINGS"), DRY SKIN ("DULL DRY SKIN"), DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING)") AND VAGINAL DISCHARGE ("VAGINAL DISCHARGE") AND WAS FOUND TO HAVE WEIGHT INCREASED ("WEIGHT GAIN"). ON (B)(6)2012, THE PATIENT HAD ESSURE INSERTED. IN (B)(6)2012, THE PATIENT EXPERIENCED ARTHRITIS ("ARTHRITIS"). IN 2012, THE PATIENT EXPERIENCED GENITAL HAEMORRHAGE ("ABNORMAL BLEEDING (GENERAL)"). IN 2013, THE PATIENT EXPERIENCED LID SULCUS DEEPENED ("SUNKEN EYES"). IN (B)(6)2017, THE PATIENT EXPERIENCED ALOPECIA ("ALOPECIA/I LOST HAIR STARTED TO GROW BACK AFTER HYSTERECTOMY BUT STILL THIN"), ARTHRALGIA ("GENERALIZED JOINT PAIN/ RIGHT LEFT HIP PAIN") AND GASTROOESOPHAGEAL REFLUX DISEASE ("ACID REFLUX"). ON (B)(6)2017, THE PATIENT EXPERIENCED ENDOMETRIOSIS ("ENDOMETRIOSIS"), 5 YEARS 6 MONTHS AFTER INSERTION OF ESSURE. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED MENORRHAGIA ("ABNORMAL (MENORRHAGIA)"), HEADACHE ("HEADACHES"), INFECTION ("INFECTIONS"), MENSTRUAL DISORDER ("MENSTRUATION ISSUES"), DEPRESSION ("DEPRESSION") AND BACK PAIN ("LOWER BACK PAIN"). THE PATIENT WAS TREATED WITH SURGERY (TOTAL LAPAROSCOPIC HYSTERECTOMY, BILATERAL SALPINGECTOMY WITH REMOVAL OF ESSURE COILS). ESSURE WAS REMOVED ON (B)(6)2017. AT THE TIME OF THE REPORT, THE PELVIC PAIN, GENITAL HAEMORRHAGE, VAGINAL HAEMORRHAGE, MENORRHAGIA, HEADACHE, INFECTION, MENSTRUAL DISORDER, ARTHRITIS, LID SULCUS DEEPENED, DYSMENORRHOEA, ENDOMETRIOSIS, ARTHRALGIA, WEIGHT INCREASED, GASTROOESOPHAGEAL REFLUX DISEASE AND BACK PAIN OUTCOME WAS UNKNOWN, THE ALOPECIA, FATIGUE AND DRY SKIN WAS RESOLVING AND THE ANXIETY, MOOD SWINGS, DEPRESSION AND VAGINAL DISCHARGE HAD RESOLVED. THE REPORTER CONSIDERED ALOPECIA, ANXIETY, ARTHRALGIA, ARTHRITIS, BACK PAIN, DEPRESSION, DRY SKIN, DYSMENORRHOEA, ENDOMETRIOSIS, FATIGUE, GASTROOESOPHAGEAL REFLUX DISEASE, GENITAL HAEMORRHAGE, HEADACHE, INFECTION, LID SULCUS DEEPENED, MENORRHAGIA, MENSTRUAL DISORDER, MOOD SWINGS, PELVIC PAIN, VAGINAL DISCHARGE, VAGINAL HAEMORRHAGE AND WEIGHT INCREASED TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: CURRENT WEIGHT 280 LBS. APPROXIMATE WEIGHT AT THE TIME OF ESSURE PLACEMENT 270 LBS. COILS VISUALIZED LEFT 3 AND RIGHT NO. DECSCIPANCIES IN DATE OF INSERTION. (B)(6)2010, (B)(6) 2012. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 43.8 KG/SQM. HYSTEROSALPINGOGRAM - ON (B)(6)2011: RESULTS: ESSURE DEVICE WAS SUCCESSFULLY OCCLUDED; ON (B)(6)2012: RESULTS: TOTAL BILATERAL OCCLUSION; ON (B)(6)2012: . QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 23-MAR-2020: SOCIAL MEDIA RECEIVED : OUTCOME FOR ALOPECIA WAS UPDATED. REPORTER INFORMATION 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 ('SEVERE PELVIC PAIN, PAIN') IN A 38-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 871978) INSERTED FOR FEMALE STERILIZATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S MEDICAL HISTORY INCLUDED CAROTID ARTERY ANEURYSM, STENT PLACEMENT AND VERTIGO. PREVIOUSLY ADMINISTERED PRODUCTS INCLUDED FOR AN UNREPORTED INDICATION: WELBUTRIN, PROZAC, ASPIRINE AND XANAX. CONCURRENT CONDITIONS INCLUDED MORBID OBESITY. CONCOMITANT PRODUCTS INCLUDED ACETYLSALICYLIC ACID (ASPIRINE) SINCE 2008 AND FLUOXETINE HYDROCHLORIDE (PROZAC) SINCE 2013. ON (B)(6) 2012, THE PATIENT HAD ESSURE INSERTED. IN (B)(6) 2012, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL)"), ANXIETY ("ANXIETY"), FATIGUE ("FATIGUE"), MOOD SWINGS ("MOOD SWINGS"), DRY SKIN ("DULL DRY SKIN"), DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING)") AND VAGINAL DISCHARGE ("VAGINAL DISCHARGE") AND WAS FOUND TO HAVE WEIGHT INCREASED ("WEIGHT GAIN"). IN (B)(6) 2012, THE PATIENT EXPERIENCED ARTHRITIS ("ARTHRITIS"). IN 2012, THE PATIENT EXPERIENCED GENITAL HAEMORRHAGE ("ABNORMAL BLEEDING (GENERAL)"). IN 2013, THE PATIENT EXPERIENCED LID SULCUS DEEPENED ("SUNKEN EYES"). IN (B)(6) 2017, THE PATIENT EXPERIENCED ALOPECIA ("ALOPECIA/I LOST HAIR STARTED TO GROW BACK AFTER HYSTERECTOMY BUT STILL THIN"), ARTHRALGIA ("GENERALIZED JOINT PAIN/ RIGHT LEFT HIP PAIN") AND GASTROOESOPHAGEAL REFLUX DISEASE ("ACID REFLUX"). ON (B)(6) 2017, THE PATIENT EXPERIENCED ENDOMETRIOSIS ("ENDOMETRIOSIS"), 5 YEARS 6 MONTHS AFTER INSERTION OF ESSURE. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED MENORRHAGIA ("ABNORMAL (MENORRHAGIA)"), HEADACHE ("HEADACHES"), INFECTION ("INFECTIONS"), MENSTRUAL DISORDER ("MENSTRUATION ISSUES"), DEPRESSION ("DEPRESSION") AND BACK PAIN ("LOWER BACK PAIN"). THE PATIENT WAS TREATED WITH SURGERY (TOTAL LAPAROSCOPIC HYSTERECTOMY, BILATERAL SALPINGECTOMY WITH REMOVAL OF ESSURE COILS). ESSURE WAS REMOVED ON (B)(6) 2017. AT THE TIME OF THE REPORT, THE PELVIC PAIN, GENITAL HAEMORRHAGE, VAGINAL HAEMORRHAGE, MENORRHAGIA, ANXIETY, MOOD SWINGS, DEPRESSION, DYSMENORRHOEA, VAGINAL DISCHARGE AND BACK PAIN HAD RESOLVED, THE ALOPECIA, FATIGUE AND DRY SKIN WAS RESOLVING AND THE HEADACHE, INFECTION, MENSTRUAL DISORDER, ARTHRITIS, LID SULCUS DEEPENED, ENDOMETRIOSIS, ARTHRALGIA, WEIGHT INCREASED AND GASTROOESOPHAGEAL REFLUX DISEASE OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ALOPECIA, ANXIETY, ARTHRALGIA, ARTHRITIS, BACK PAIN, DEPRESSION, DRY SKIN, DYSMENORRHOEA, ENDOMETRIOSIS, FATIGUE, GASTROOESOPHAGEAL REFLUX DISEASE, GENITAL HAEMORRHAGE, HEADACHE, INFECTION, LID SULCUS DEEPENED, MENORRHAGIA, MENSTRUAL DISORDER, MOOD SWINGS, PELVIC PAIN, VAGINAL DISCHARGE, VAGINAL HAEMORRHAGE AND WEIGHT INCREASED TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: CURRENT WEIGHT 280 LBS. APPROXIMATE WEIGHT AT THE TIME OF ESSURE PLACEMENT 270 LBS. COILS VISUALIZED LEFT 3 AND RIGHT NO. ""DISCREPANCIES"" IN DATE OF INSERTION.(B)(6) 2010, (B)(6) 2012. PATIENT RECEIVED TREATMENT FOR PAIN AND BLEEDING. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 43.8 KG/SQM. HYSTEROSALPINGOGRAM - ON (B)(6) 2011: RESULTS: ESSURE DEVICE WAS SUCCESSFULLY OCCLUDED; ON (B)(6) 2012: RESULTS: TOTAL BILATERAL OCCLUSION; ON (B)(6) 2012: THE ENDOMETRIAL CAVITY IS NORMAL IN CONTOUR WITHOUT ANY FILLING DEFECTS. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 9-JAN-2020: PLAINTIFF FACT SHEET WAS RECEIVED. OUTCOME OF EVENTS SEVERE PELVIC PAIN, PAIN, ABNORMAL BLEEDING (GENERAL), ABNORMAL BLEEDING (VAGINAL), ABNORMAL (MENORRHAGIA), DYSMENORRHEA (CRAMPING) AND LOWER BACK PAIN WAS UPDATED TO RECOVERED/RESOLVED. REPORTER CAUSALITY COMMENT 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 ("SEVERE PELVIC PAIN, PAIN") AND GENITAL HAEMORRHAGE ("ABNORMAL BLEEDING (GENERAL)") IN AN ADULT FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 871978) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S PAST MEDICAL HISTORY INCLUDED CAROTID ARTERY ANEURYSM, STENT PLACEMENT AND VERTIGO. PREVIOUSLY ADMINISTERED PRODUCTS INCLUDED FOR AN UNREPORTED INDICATION: WELBUTRIN, PROZAC, ASPIRIN AND XANAX. CONCURRENT CONDITIONS INCLUDED MORBID OBESITY. ON (B)(6) 2012, THE PATIENT HAD ESSURE INSERTED. IN (B)(6) 2012, THE PATIENT EXPERIENCED ARTHRITIS ("ARTHRITIS"). IN 2012, THE PATIENT EXPERIENCED GENITAL HAEMORRHAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT). IN 2013, THE PATIENT EXPERIENCED DRY SKIN ("DULL DRY SKIN") AND LID SULCUS DEEPENED ("SUNKEN EYES"). IN 2016, THE PATIENT EXPERIENCED FATIGUE ("FATIGUE"), MOOD SWINGS ("MOOD SWINGS") AND DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING)"). IN (B)(6) 2017, THE PATIENT EXPERIENCED ALOPECIA ("ALOPECIA"), ARTHRALGIA ("GENERALIZED JOINT PAIN/ RIGHT LEFT HIP PAIN") AND GASTROOESOPHAGEAL REFLUX DISEASE ("ACID REFLUX"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL)"), MENORRHAGIA ("ABNORMAL (MENORRHAGIA)"), ANXIETY ("ANXIETY"), HEADACHE ("HEADACHES"), INFECTION ("INFECTIONS"), MENSTRUAL DISORDER ("MENSTRUATION ISSUES"), DEPRESSION ("DEPRESSION"), VAGINAL DISCHARGE ("VAGINAL DISCHARGE"), ENDOMETRIOSIS ("ENDOMETRIOSIS"), WEIGHT INCREASED ("WEIGHT GAIN") AND BACK PAIN ("LOWER BACK PAIN"). THE PATIENT WAS TREATED WITH SURGERY (TOTAL LAPAROSCOPIC HYSTERECTOMY, BILATERAL SALPINGECTOMY WITH REMOVAL OF ESSURE COILS). ESSURE WAS REMOVED ON (B)(6) 2017. AT THE TIME OF THE REPORT, THE PELVIC PAIN, GENITAL HAEMORRHAGE, VAGINAL HAEMORRHAGE, MENORRHAGIA, ALOPECIA, ANXIETY, HEADACHE, INFECTION, MENSTRUAL DISORDER, DEPRESSION, ARTHRITIS, LID SULCUS DEEPENED, DYSMENORRHOEA, ENDOMETRIOSIS, ARTHRALGIA, WEIGHT INCREASED, GASTROOESOPHAGEAL REFLUX DISEASE AND BACK PAIN OUTCOME WAS UNKNOWN, THE FATIGUE AND DRY SKIN WAS RESOLVING AND THE MOOD SWINGS AND VAGINAL DISCHARGE HAD RESOLVED. THE REPORTER CONSIDERED ALOPECIA, ANXIETY, ARTHRALGIA, ARTHRITIS, BACK PAIN, DEPRESSION, DRY SKIN, DYSMENORRHOEA, ENDOMETRIOSIS, FATIGUE, GASTROOESOPHAGEAL REFLUX DISEASE, GENITAL HAEMORRHAGE, HEADACHE, INFECTION, LID SULCUS DEEPENED, MENORRHAGIA, MENSTRUAL DISORDER, MOOD SWINGS, PELVIC PAIN, VAGINAL DISCHARGE, VAGINAL HAEMORRHAGE AND WEIGHT INCREASED TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: CURRENT WEIGHT (B)(6). APPROXIMATE WEIGHT AT THE TIME OF ESSURE PLACEMENT (B)(6). COILS VISUALIZED LEFT 3 AND RIGHT NO. DISCREPANCIES IN DATE OF INSERTION. (B)(6) 2010, (B)(6) 2012. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 43.8 KG/SQM. HYSTEROSALPINGOGRAM - ON (B)(6) 2011: ESSURE DEVICE WAS SUCCESSFULLY OCCLUDED; ON (B)(6) 2012: TOTAL BILATERAL OCCLUSION; ON (B)(6) 2012: MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 17-APR-2018: PLAINTIFF FACT SHEET AND MEDICAL RECORDS RECEIVED:NEW REPORTERS ADDED. PATIENT DEMOGRAPHIC INFORMATION AND PATIENT RELEVANT HISTORY ADDED. LOT NUMBER ADDED. INSERTION DATE UPDATED TO 2012 AND REMOVAL DATE (B)(6) 2017 ADDED. EVENTS MOOD SWINGS, ABNORMAL BLEEDING (VAGINAL), DEPRESSION, ARTHRITIS, DULL DRY SKIN, SUNKEN EYES, DYSMENORRHEA (CRAMPING), VAGINAL DISCHARGE, ACID REFLUX, ENDOMETRIOSIS, ABNORMAL BLEEDING (GENERAL), GENERALIZED JOINT PAIN, WEIGHT GAIN, ACID REFLUX, LOWER BACK PAIN AND RIGHT LEFT HIP PAIN ADDED. INCIDENT: AT THE TIME OF REPORTING, 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 |
|---|---|---|---|---|---|---|---|
| 407472 | ESSURE | TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE | HHS | BAYER PHARMA AG | ESS305 | 871978 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 38 YR | Other| R | ASPIRINE| ASPIRINE| ASPIRINE| PROZAC| PROZAC| PROZAC |