ESSURE
Report
- Report Number
- 2951250-2019-05515
- Event Type
- Injury
- Date Received
- September 6, 2019
- Date of Event
- February 1, 2013
- Report Date
- October 4, 2019
- Manufacturer
- BAYER PHARMA AG
- Product Code
- HHS
- UDI-DI
- 10888853003051
- PMA / PMN Number
- P020014
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- OTHER
Narratives
THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ('PAIN - PELVIC/LEFT PELVIC PAIN/ RIGHT PELVIC PAIN') IN A 36-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 841531) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S MEDICAL HISTORY INCLUDED TRACHELECTOMY. PREVIOUSLY ADMINISTERED PRODUCTS INCLUDED FOR BIRTH CONTROL: MIRENA FROM 2008 TO 2012. CONCURRENT CONDITIONS INCLUDED FLANK PAIN. CONCOMITANT PRODUCTS INCLUDED BUPROPION HYDROCHLORIDE (WELLBUTRIN), LEVOTHYROXINE SODIUM (SYNTHROID) AND PRAVASTATIN. ON (B)(6) 2013, THE PATIENT HAD ESSURE INSERTED. IN (B)(6) 2013, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED) AND ABDOMINAL PAIN ("PAIN (ABDOMINAL)"). IN (B)(6) 2013, THE PATIENT EXPERIENCED OVARIAN CYST ("HORMONAL CHANGES DESCRIBE: OVARIAN CYSTS"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED DYSMENORRHOEA ("PAIN: DYSMENORRHEA (CRAMPING)"), DYSPAREUNIA ("DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE)") AND MENORRHAGIA ("MENORRHAGIA (HEAVY MENSTRUAL BLEEDING)") AND WAS FOUND TO HAVE WEIGHT INCREASED ("WEIGHT GAIN"). THE PATIENT WAS TREATED WITH SURGERY (ON (B)(6) 2013 (HYSTERECTOMY (PARTIAL), SALPINGECTOMY (BILATERAL)). ESSURE WAS REMOVED ON (B)(6) 2013. AT THE TIME OF THE REPORT, THE PELVIC PAIN AND ABDOMINAL PAIN WAS RESOLVING, THE DYSMENORRHOEA AND DYSPAREUNIA HAD RESOLVED AND THE MENORRHAGIA, WEIGHT INCREASED AND OVARIAN CYST OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL PAIN, DYSMENORRHOEA, DYSPAREUNIA, MENORRHAGIA, OVARIAN CYST, PELVIC PAIN AND WEIGHT INCREASED TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: PATIENT RECEIVED TREATMENT FOR PAIN AND BLEEDING. CURRENT WEIGHT 185 LBS DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): HYSTEROSALPINGOGRAM - ON (B)(6) 2013: TOTAL BILATERAL OCCLUSION. ¿CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONE/ONES WERE DESCRIBED IN PATIENT¿S MEDICAL RECORDS: PELVIC PAIN, MENORRHAGIA". MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 3-SEP-2019: PLAINTIFF FACT SHEET AND MEDICAL RECORD WAS RECEIVED. LOT NUMBER WERE ADDED. EVENTS ADDED FROM PFS: OVARIAN CYSTS. REPORTER INFORMATION, MEDICAL HISTORY, CONCOMITANT DRUG, EVENTS ONSET DATE WERE 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.
THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ('PAIN - PELVIC/LEFT PELVIC PAIN/ RIGHT PELVIC PAIN') IN A 36-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 841531) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S MEDICAL HISTORY INCLUDED TRACHELECTOMY. PREVIOUSLY ADMINISTERED PRODUCTS INCLUDED FOR BIRTH CONTROL: MIRENA FROM 2008 TO 2012. CONCURRENT CONDITIONS INCLUDED FLANK PAIN. CONCOMITANT PRODUCTS INCLUDED BUPROPION HYDROCHLORIDE (WELLBUTRIN), LEVOTHYROXINE SODIUM (SYNTHROID) AND PRAVASTATIN. ON (B)(6) 2013, THE PATIENT HAD ESSURE INSERTED. IN (B)(6) 2013, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED) AND ABDOMINAL PAIN ("PAIN (ABDOMINAL)"). IN (B)(6) 2013, THE PATIENT EXPERIENCED OVARIAN CYST ("HORMONAL CHANGES DESCRIBE: OVARIAN CYSTS"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED DYSMENORRHOEA ("PAIN: DYSMENORRHEA (CRAMPING)"), DYSPAREUNIA ("DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE)") AND MENORRHAGIA ("MENORRHAGIA (HEAVY MENSTRUAL BLEEDING)") AND WAS FOUND TO HAVE WEIGHT INCREASED ("WEIGHT GAIN"). THE PATIENT WAS TREATED WITH SURGERY (ON (B)(6) 2013 (HYSTERECTOMY (PARTIAL),SALPINGECTOMY (BILATERAL)). ESSURE WAS REMOVED ON (B)(6) 2013. AT THE TIME OF THE REPORT, THE PELVIC PAIN AND ABDOMINAL PAIN WAS RESOLVING, THE DYSMENORRHOEA AND DYSPAREUNIA HAD RESOLVED AND THE MENORRHAGIA, WEIGHT INCREASED AND OVARIAN CYST OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL PAIN, DYSMENORRHOEA, DYSPAREUNIA, MENORRHAGIA, OVARIAN CYST, PELVIC PAIN AND WEIGHT INCREASED TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: PATIENT RECEIVED TREATMENT FOR PAIN AND BLEEDING. CURRENT WEIGHT 185 LBS. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): HYSTEROSALPINGOGRAM - ON (B)(6) 2013: TOTAL BILATERAL OCCLUSION.. ¿CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONE/ONES WERE DESCRIBED IN PATIENT¿S MEDICAL RECORDS: PELVIC PAIN, MENORRHAGIA". QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON (B)(6) 2019: QUALITY-SAFETY EVALUATION OF PRODUCT TECHNICAL COMPLAINT. 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 - PELVIC') IN AN ADULT FEMALE PATIENT WHO HAD ESSURE INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. ON (B)(6) 2013, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), DYSMENORRHOEA ("PAIN: DYSMENORRHEA (CRAMPING)"), DYSPAREUNIA ("DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE)"), ABDOMINAL PAIN ("PAIN (ABDOMINAL)") AND MENORRHAGIA ("MENORRHAGIA (HEAVY MENSTRUAL BLEEDING)") AND WAS FOUND TO HAVE WEIGHT INCREASED ("WEIGHT GAIN"). THE PATIENT WAS TREATED WITH SURGERY (ON (B)(6)2013 (HYSTERECTOMY (PARTIAL),SALPINGECTOMY (BILATERAL)). ESSURE WAS REMOVED ON (B)(6) 2013. AT THE TIME OF THE REPORT, THE PELVIC PAIN, DYSMENORRHOEA, DYSPAREUNIA AND ABDOMINAL PAIN HAD RESOLVED AND THE MENORRHAGIA AND WEIGHT INCREASED OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL PAIN, DYSMENORRHOEA, DYSPAREUNIA, MENORRHAGIA, PELVIC PAIN AND WEIGHT INCREASED TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: PATIENT RECEIVED TREATMENT FOR PAIN AND BLEEDING. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): IMAGING PROCEDURE - ON (B)(6) 2013: BILATERAL OCCLUSION. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 30-AUG-2019: PLAINTIFF FACT SHEET RECEIVED. EVENT "INJURY" NOS WAS REPLACED WITH THE NEW EVENTS: PAIN: DYSMENORRHEA (CRAMPING), DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE), PELVIC/ ABDOMINAL, BLEEDING: MENORRHAGIA (HEAVY MENSTRUAL BLEEDING), WEIGHT GAIN. LAB DATA AND REPORTER'S INFORMATION WAS ADDED. NO 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.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 762947 | ESSURE | TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE | HHS | BAYER PHARMA AG | ESS305 | 841531 | 10888853003051 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 36 YR | Other| R | PRAVASTATIN| PRAVASTATIN| SYNTHROID| SYNTHROID| WELLBUTRIN| WELLBUTRIN |