ESSURE
Report
- Report Number
- 2951250-2020-08384
- Event Type
- Injury
- Date Received
- June 8, 2020
- Report Date
- June 17, 2020
- Manufacturer
- BAYER PHARMA AG
- Product Code
- HHS
- UDI-DI
- 10888853003051
- PMA / PMN Number
- P020014
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FR
- Reporter Occupation
- OTHER
Narratives
THIS LITERATURE CASE DESCRIBES THE OCCURRENCE OF MEDICAL DEVICE REMOVAL ('MEDICAL DEVICE REMOVAL') IN A 49-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE INSERTED. LITERATURE REFERENCE: CATINON M, ROUX E, AUROUX A, BALTER V, FELLAH C, TRUNFIO-SFARGHIU A-M, ET. AL., IDENTIFICATION OF INORGANIC PARTICLES RESULTING FROM DEGRADATION OF ESSURE® IMPLANTS: STUDY OF 10 CASES, EUROPEAN JOURNAL OF OBSTETRICS AND GYNECOLOGY AND REPRODUCTIVE BIOLOGY, 2020, 250:162-170. OTHER PRODUCT OR PRODUCT USE ISSUES IDENTIFIED: DEVICE MATERIAL ISSUE "IMPLANT SHOWED DARK AND LIGHT AREAS (DARK AREAS APPEAR TO BE MAINLY COMPOSED OF ORGANIC COMPOUNDS, AND THE LIGHTAREAS ARE MAINLY COMPOSED OF TIN,SOMETIMES ASSOCIATED WITH SILVER". ON AN UNKNOWN DATE, 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. THE REPORTER COMMENTED: PATIENT 1: THE ARTICLE DESCRIBED THAT MINERALOGICAL ANALYSIS OF BIOPSY DONE FORM TWO FALLOPIAN TUBES, TWO UTERINE HORNS SAMPLES, SHOWED TIN-BASED PARTICLES WERE DETECTED. OTHER METALLIC PARTICLES, SUCH AS STEEL, GOLD METAL, ALUMINIUM METAL, PLATINUM METAL, FEO AND ZRPT, WERE FOUND IN SMALLER PROPORTIONS. IN PATIENT 1, MINERALOGICAL ANALYSIS REVEALED THE PRESENCE OF A SIGNIFICANT ACCUMULATION OF PARTICLES ON OPTICAL AND ELECTRON MICROSCOPY. ON THIS FALLOPIAN TUBE BIOPSY (SAMPLE 1A), A PARTICLE CLUSTER >1 MM IN DIAMETER WAS OBSERVED. IT WAS ALSO DESCRIBED THAT AN UNUSED IMPLANT AND THE IMPLANTS OF PATIENTS 1 WAS OBSERVED BY SCANNING ELECTRON MICROSCOPY AT THE WELD ZONE. ON THE UNUSED IMPLANT, THE WELD, THE OUTER COIL AND THE INNER COIL WERE CLEARLY VISIBLE. THE IMPLANT FROM PATIENT 1 SHOWED DARK AND LIGHT AREAS. THE DARK AREAS APPEARED TO BE MAINLY COMPOSED OF ORGANIC COMPOUNDS, AND THE LIGHT AREAS ARE MAINLY COMPOSED OF TIN, SOMETIMES ASSOCIATED WITH SILVER. TEN PATIENTS, WHO REQUESTED REMOVAL OF THEIR ESSURE IMPLANT AND UNDERWENT SALPINGECTOMY OR HYSTERECTOMY WERE INCLUDED IN THIS STUDY. EIGHT PATIENTS UNDERWENT TOTAL HYSTERECTOMY AND TWO PATIENTS UNDERWENT SALPINGECTOMY AFTER A MEAN EXPOSURE TIME OF 85.5 MONTHS (STANDARD DEVIATION 26.8 MONTHS, RANGE 34-105 MONTHS). A MINERALOGICAL ANALYSIS WAS PERFORMED ON 13 BIOPSIES (EIGHT FALLOPIAN TUBES, FIVE UTERINE HORNS) AND FOUR IMPLANTS. THIS ANALYSIS OF IMPLANTS AND UTERINE BIOPSIES SHOWS THAT TIN PARTICLES WERE FOUND MOST FREQUENTLY IN THE SAMPLES. HOWEVER, OTHER ELEMENT CONSTITUENTS OF THE IMPLANT WERE ALSO IDENTIFIED (SILVER, NICKEL, GOLD, CHROMIUM, PLATINUM AND TITANIUM). IT IS THEREFORE POSSIBLE THAT SUPPLEMENTARY TOXICITY COULD BE ADDED TO TIN TOXICITY. ABSTRACT QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT OBJECTIVE: APPROXIMATELY 750,000 WOMEN WORLDWIDE HAVE UNDERGONE ESSURE HYSTEROSCOPIC STERILIZATION SINCE 2002. IN 2015, AN INCREASE IN ADVERSE EFFECTS WAS NOTED, WITH GYNAECOLOGICAL AND SYSTEMIC SYMPTOMS REPORTED. SCANNING ELECTRON MICROSCOPY (SEM) ANALYSIS OF FALLOPIAN TUBE AND UTERINE HORN TISSUES AND IMPLANTS, AFTER HYSTERECTOMY OR SALPINGECTOMY, REVEALED THE PRESENCE OF INORGANIC PARTICLES RESULTING FROM IMPLANT DEGRADATION. STUDY DESIGN: TEN PATIENTS (AGE 42?53 YEARS) WERE INCLUDED IN THIS STUDY. OF THESE, EIGHT PATIENTS HAD UNDERGONE HYSTERECTOMY AND TWO PATIENTS HAD UNDERGONE SALPINGECTOMY. MEAN EXPOSURE TIME WAS 85.5 MONTHS (STANDARD DEVIATION 26.8 MONTHS, RANGE 34?105 MONTHS). MINERALOGICAL ANALYSES WERE PERFORMED ON 13 TISSUE BIOPSIES AND FOUR IMPLANTS BY SEM COUPLED WITH ENERGY DISPERSIVE X-RAY SPECTROMETRY. RESULTS: IN FIVE OF THE 10 PATIENTS, TIN PARTICLES WERE OBSERVED IN FALLOPIAN TUBE OR UTERINE HORN TISSUES WITH INFLAMMATORY CELL REACTIONS. IN THE OTHER FIVE CASES, IRON, CHROMIUM, NICKEL OR PLATINUM PARTICLES WERE OBSERVED. FOR IMPLANTS, MAJOR DETERIORATION OF THE WELD ZONE WAS OBSERVED WITH EITHER DESTROYED APPEARANCE OR THE PRESENCE OF AN ORGANIC COATING CONTAINING NUMEROUS PARTICLES. DISCUSSION AND CONCLUSION: ANALYSIS OF THE PRECLINICAL STUDIES PERFORMED BY THE MANUFACTURER SUGGESTS THAT DEGRADATION OF THE TIN WELD PLAYS A MAJOR ROLE IN THESE ADVERSE EVENTS, WITH INCREASING LEACHING AND CORROSION BETWEEN 3 AND 6 MONTHS FOR AN INTRATUBAL INSERT THAT SI DESIGNED TO REMAIN IN AN WOMAN'S BODY FOR HER ENTIRE LIFE. FOR PATIENTS WITH GYNAECOLOGICAL SYMPTOMS (E.G. PAIN, METRORRAGIES) NEEDING EXPLANTATION, THESE FINDINGS RAISE THE QUESTION OF A CAUSAL RELATIONSHIP BETWEEN TIN PARTICLES FROM IMPLANT DEGRADATION AND THE INFLAMMATORY TISSUE RESPONSE. FOR PATIENTS WITH SYSTEMIC SYMPTOMS (E.G. BLURRED VISION, HEADACHE, ASTHENIA, MYALGIA), THE HYPOTHESIS THAT THESE SYMPTOMS MAY BE RELATED TO THE FORMATION OF ORGANOTIN. AMENDMENT: THE REPORT WAS AMENDED FOR THE FOLLOWING REASON: THIS CASE WILL BE DELETED FROM BAYER PV DATABASE. NULLIFICATION REASON: IT WAS IDENTIFIED AS DUPLICATE OF CASE (B)(4). NO NEW FOLLOW-UP INFORMATION WAS RECEIVED FROM THE REPORTER. BASED ON THE AVAILABLE INFORMATION, A REVIEW OF OUR COMPLAINT RECORDS AND OTHER RELEVANT DATA WAS CONDUCTED; ANY NEW AND REPORTABLE INFORMATION THAT BECOMES AVAILABLE FROM OUR INVESTIGATION WILL BE PROVIDED IN A SUPPLEMENTARY REPORT.
THIS LITERATURE CASE DESCRIBES THE OCCURRENCE OF MEDICAL DEVICE REMOVAL ('MEDICAL DEVICE REMOVAL') IN A 49-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE INSERTED. LITERATURE REFERENCE: CATINON M, ROUX E, AUROUX A, BALTER V, FELLAH C, TRUNFIO-SFARGHIU A-M, ET. AL., IDENTIFICATION OF INORGANIC PARTICLES RESULTING FROM DEGRADATION OF ESSURE® IMPLANTS: STUDY OF 10 CASES, EUROPEAN JOURNAL OF OBSTETRICS AND GYNECOLOGY AND REPRODUCTIVE BIOLOGY, 2020, 250:162-170. OTHER PRODUCT OR PRODUCT USE ISSUES IDENTIFIED: DEVICE MATERIAL ISSUE "IMPLANT SHOWED DARK AND LIGHT AREAS (DARK AREAS APPEAR TO BE MAINLY COMPOSED OF ORGANIC COMPOUNDS, AND THE LIGHTAREAS ARE MAINLY COMPOSED OF TIN,SOMETIMES ASSOCIATED WITH SILVER". ON AN UNKNOWN DATE, 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. THE REPORTER COMMENTED: PATIENT 1: THE ARTICLE DESCRIBED THAT MINERALOGICAL ANALYSIS OF BIOPSY DONE FORM TWO FALLOPIAN TUBES, TWO UTERINE HORNS SAMPLES, SHOWED TIN-BASED PARTICLES WERE DETECTED. OTHER METALLIC PARTICLES, SUCH AS STEEL, GOLD METAL, ALUMINIUM METAL, PLATINUM METAL, FEO AND ZRPT, WERE FOUND IN SMALLER PROPORTIONS. IN PATIENT 1, MINERALOGICAL ANALYSIS REVEALED THE PRESENCE OF A SIGNIFICANT ACCUMULATION OF PARTICLES ON OPTICAL AND ELECTRON MICROSCOPY. ON THIS FALLOPIAN TUBE BIOPSY (SAMPLE 1A), A PARTICLE CLUSTER >1 MM IN DIAMETER WAS OBSERVED. IT WAS ALSO DESCRIBED THAT AN UNUSED IMPLANT AND THE IMPLANTS OF PATIENTS 1 WAS OBSERVED BY SCANNING ELECTRON MICROSCOPY AT THE WELD ZONE. ON THE UNUSED IMPLANT, THE WELD, THE OUTER COIL AND THE INNER COIL WERE CLEARLY VISIBLE. THE IMPLANT FROM PATIENT 1 SHOWED DARK AND LIGHT AREAS. THE DARK AREAS APPEARED TO BE MAINLY COMPOSED OF ORGANIC COMPOUNDS, AND THE LIGHT AREAS ARE MAINLY COMPOSED OF TIN, SOMETIMES ASSOCIATED WITH SILVER. TEN PATIENTS, WHO REQUESTED REMOVAL OF THEIR ESSURE IMPLANT AND UNDERWENT SALPINGECTOMY OR HYSTERECTOMY WERE INCLUDED IN THIS STUDY. EIGHT PATIENTS UNDERWENT TOTAL HYSTERECTOMY AND TWO PATIENTS UNDERWENT SALPINGECTOMY AFTER A MEAN EXPOSURE TIME OF 85.5 MONTHS (STANDARD DEVIATION 26.8 MONTHS, RANGE 34-105 MONTHS). A MINERALOGICAL ANALYSIS WAS PERFORMED ON 13 BIOPSIES (EIGHT FALLOPIAN TUBES, FIVE UTERINE HORNS) AND FOUR IMPLANTS. THIS ANALYSIS OF IMPLANTS AND UTERINE BIOPSIES SHOWS THAT TIN PARTICLES WERE FOUND MOST FREQUENTLY IN THE SAMPLES. HOWEVER, OTHER ELEMENT CONSTITUENTS OF THE IMPLANT WERE ALSO IDENTIFIED (SILVER, NICKEL, GOLD, CHROMIUM, PLATINUM AND TITANIUM). IT IS THEREFORE POSSIBLE THAT SUPPLEMENTARY TOXICITY COULD BE ADDED TO TIN TOXICITY. ABSTRACT : QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT . OBJECTIVE: APPROXIMATELY 750,000 WOMEN WORLDWIDE HAVE UNDERGONE ESSURE HYSTEROSCOPIC STERILIZATION SINCE 2002. IN 2015, AN INCREASE IN ADVERSE EFFECTS WAS NOTED, WITH GYNAECOLOGICAL AND SYSTEMIC SYMPTOMS REPORTED. SCANNING ELECTRON MICROSCOPY (SEM) ANALYSIS OF FALLOPIAN TUBE AND UTERINE HORN TISSUES AND IMPLANTS, AFTER HYSTERECTOMY OR SALPINGECTOMY, REVEALED THE PRESENCE OF INORGANIC PARTICLES RESULTING FROM IMPLANT DEGRADATION. STUDY DESIGN: TEN PATIENTS (AGE 42?53 YEARS) WERE INCLUDED IN THIS STUDY. OF THESE, EIGHT PATIENTS HAD UNDERGONE HYSTERECTOMY AND TWO PATIENTS HAD UNDERGONE SALPINGECTOMY. MEAN EXPOSURE TIME WAS 85.5 MONTHS (STANDARD DEVIATION 26.8 MONTHS, RANGE 34?105 MONTHS). MINERALOGICAL ANALYSES WERE PERFORMED ON 13 TISSUE BIOPSIES AND FOUR IMPLANTS BY SEM COUPLED WITH ENERGY DISPERSIVE X-RAY SPECTROMETRY. RESULTS: IN FIVE OF THE 10 PATIENTS, TIN PARTICLES WERE OBSERVED IN FALLOPIAN TUBE OR UTERINE HORN TISSUES WITH INFLAMMATORY CELL REACTIONS. IN THE OTHER FIVE CASES, IRON, CHROMIUM, NICKEL OR PLATINUM PARTICLES WERE OBSERVED. FOR IMPLANTS, MAJOR DETERIORATION OF THE WELD ZONE WAS OBSERVED WITH EITHER DESTROYED APPEARANCE OR THE PRESENCE OF AN ORGANIC COATING CONTAINING NUMEROUS PARTICLES. DISCUSSION AND CONCLUSION: ANALYSIS OF THE PRECLINICAL STUDIES PERFORMED BY THE MANUFACTURER SUGGESTS THAT DEGRADATION OF THE TIN WELD PLAYS A MAJOR ROLE IN THESE ADVERSE EVENTS, WITH INCREASING LEACHING AND CORROSION BETWEEN 3 AND 6 MONTHS FOR AN INTRATUBAL INSERT THAT SI DESIGNED TO REMAIN IN AN WOMAN'S BODY FOR HER ENTIRE LIFE. FOR PATIENTS WITH GYNAECOLOGICAL SYMPTOMS (E.G. PAIN, METRORRAGIES) NEEDING EXPLANTATION, THESE FINDINGS RAISE THE QUESTION OF A CAUSAL RELATIONSHIP BETWEEN TIN PARTICLES FROM IMPLANT DEGRADATION AND THE INFLAMMATORY TISSUE RESPONSE. FOR PATIENTS WITH SYSTEMIC SYMPTOMS (E.G. BLURRED VISION, HEADACHE, ASTHENIA, MYALGIA), THE HYPOTHESIS THAT THESE SYMPTOMS MAY BE RELATED TO THE FORMATION OF ORGANOTIN. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 9-JUN-2020: QUALITY SAFETY EVALUATION OF PTC. BASED ON THE AVAILABLE INFORMATION, A REVIEW OF OUR COMPLAINT RECORDS AND OTHER RELEVANT DATA WAS CONDUCTED; ANY NEW AND REPORTABLE INFORMATION THAT BECOMES AVAILABLE FROM OUR INVESTIGATION WILL BE PROVIDED IN A SUPPLEMENTARY REPORT.
THIS LITERATURE CASE DESCRIBES THE OCCURRENCE OF MEDICAL DEVICE REMOVAL ('MEDICAL DEVICE REMOVAL') IN A (B)(6) YEAR-OLD FEMALE PATIENT WHO HAD ESSURE INSERTED. LITERATURE REFERENCE: CATINON M, ROUX E, AUROUX A, BALTER V, FELLAH C, TRUNFIO-SFARGHIU A-M, ET. AL., IDENTIFICATION OF INORGANIC PARTICLES RESULTING FROM DEGRADATION OF ESSURE® IMPLANTS: STUDY OF 10 CASES, EUROPEAN JOURNAL OF OBSTETRICS AND GYNECOLOGY AND REPRODUCTIVE BIOLOGY, 2020, 250:162-170. OTHER PRODUCT OR PRODUCT USE ISSUES IDENTIFIED: DEVICE MATERIAL ISSUE "IMPLANT SHOWED DARK AND LIGHT AREAS (DARK AREAS APPEAR TO BE MAINLY COMPOSED OF ORGANIC COMPOUNDS, AND THE LIGHT AREAS ARE MAINLY COMPOSED OF TIN, SOMETIMES ASSOCIATED WITH SILVER". ON AN UNKNOWN DATE, 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. THE REPORTER COMMENTED: PATIENT 1: THE ARTICLE DESCRIBED THAT MINERALOGICAL ANALYSIS OF BIOPSY DONE FORM TWO FALLOPIAN TUBES, TWO UTERINE HORNS SAMPLES, SHOWED TIN-BASED PARTICLES WERE DETECTED. OTHER METALLIC PARTICLES, SUCH AS STEEL, GOLD METAL, ALUMINIUM METAL, PLATINUM METAL, FEO AND ZRPT, WERE FOUND IN SMALLER PROPORTIONS. IN PATIENT 1, MINERALOGICAL ANALYSIS REVEALED THE PRESENCE OF A SIGNIFICANT ACCUMULATION OF PARTICLES ON OPTICAL AND ELECTRON MICROSCOPY. ON THIS FALLOPIAN TUBE BIOPSY (SAMPLE 1A), A PARTICLE CLUSTER >1 MM IN DIAMETER WAS OBSERVED. IT WAS ALSO DESCRIBED THAT AN UNUSED IMPLANT AND THE IMPLANTS OF PATIENTS 1 WAS OBSERVED BY SCANNING ELECTRON MICROSCOPY AT THE WELD ZONE. ON THE UNUSED IMPLANT, THE WELD, THE OUTER COIL AND THE INNER COIL WERE CLEARLY VISIBLE. THE IMPLANT FROM PATIENT 1 SHOWED DARK AND LIGHT AREAS. THE DARK AREAS APPEARED TO BE MAINLY COMPOSED OF ORGANIC COMPOUNDS, AND THE LIGHT AREAS ARE MAINLY COMPOSED OF TIN, SOMETIMES ASSOCIATED WITH SILVER. TEN PATIENTS, WHO REQUESTED REMOVAL OF THEIR ESSURE IMPLANT AND UNDERWENT SALPINGECTOMY OR HYSTERECTOMY WERE INCLUDED IN THIS STUDY. EIGHT PATIENTS UNDERWENT TOTAL HYSTERECTOMY AND TWO PATIENTS UNDERWENT SALPINGECTOMY AFTER A MEAN EXPOSURE TIME OF 85.5 MONTHS (STANDARD DEVIATION 26.8 MONTHS, RANGE 34-105 MONTHS). A MINERALOGICAL ANALYSIS WAS PERFORMED ON 13 BIOPSIES (EIGHT FALLOPIAN TUBES, FIVE UTERINE HORNS) AND FOUR IMPLANTS. THIS ANALYSIS OF IMPLANTS AND UTERINE BIOPSIES SHOWS THAT TIN PARTICLES WERE FOUND MOST FREQUENTLY IN THE SAMPLES. HOWEVER, OTHER ELEMENT CONSTITUENTS OF THE IMPLANT WERE ALSO IDENTIFIED (SILVER, NICKEL, GOLD, CHROMIUM, PLATINUM AND TITANIUM). IT IS THEREFORE POSSIBLE THAT SUPPLEMENTARY TOXICITY COULD BE ADDED TO TIN TOXICITY. ABSTRACT. OBJECTIVE: APPROXIMATELY 750,000 WOMEN WORLDWIDE HAVE UNDERGONE ESSURE HYSTEROSCOPIC STERILIZATION SINCE 2002. IN 2015, AN INCREASE IN ADVERSE EFFECTS WAS NOTED, WITH GYNAECOLOGICAL AND SYSTEMIC SYMPTOMS REPORTED. SCANNING ELECTRON MICROSCOPY (SEM) ANALYSIS OF FALLOPIAN TUBE AND UTERINE HORN TISSUES AND IMPLANTS, AFTER HYSTERECTOMY OR SALPINGECTOMY, REVEALED THE PRESENCE OF INORGANIC PARTICLES RESULTING FROM IMPLANT DEGRADATION. STUDY DESIGN: TEN PATIENTS (AGE 42?53 YEARS) WERE INCLUDED IN THIS STUDY. OF THESE, EIGHT PATIENTS HAD UNDERGONE HYSTERECTOMY AND TWO PATIENTS HAD UNDERGONE SALPINGECTOMY. MEAN EXPOSURE TIME WAS 85.5 MONTHS (STANDARD DEVIATION 26.8 MONTHS, RANGE 34?105 MONTHS). MINERALOGICAL ANALYSES WERE PERFORMED ON 13 TISSUE BIOPSIES AND FOUR IMPLANTS BY SEM COUPLED WITH ENERGY DISPERSIVE X-RAY SPECTROMETRY. RESULTS: IN FIVE OF THE 10 PATIENTS, TIN PARTICLES WERE OBSERVED IN FALLOPIAN TUBE OR UTERINE HORN TISSUES WITH INFLAMMATORY CELL REACTIONS. IN THE OTHER FIVE CASES, IRON, CHROMIUM, NICKEL OR PLATINUM PARTICLES WERE OBSERVED. FOR IMPLANTS, MAJOR DETERIORATION OF THE WELD ZONE WAS OBSERVED WITH EITHER DESTROYED APPEARANCE OR THE PRESENCE OF AN ORGANIC COATING CONTAINING NUMEROUS PARTICLES. DISCUSSION AND CONCLUSION: ANALYSIS OF THE PRECLINICAL STUDIES PERFORMED BY THE MANUFACTURER SUGGESTS THAT DEGRADATION OF THE TIN WELD PLAYS A MAJOR ROLE IN THESE ADVERSE EVENTS, WITH INCREASING LEACHING AND CORROSION BETWEEN 3 AND 6 MONTHS FOR AN INTRATUBAL INSERT THAT SI DESIGNED TO REMAIN IN AN WOMAN'S BODY FOR HER ENTIRE LIFE. FOR PATIENTS WITH GYNAECOLOGICAL SYMPTOMS (E.G. PAIN, METRORRHAGIAS) NEEDING EXPLANTATION, THESE FINDINGS RAISE THE QUESTION OF A CAUSAL RELATIONSHIP BETWEEN TIN PARTICLES FROM IMPLANT DEGRADATION AND THE INFLAMMATORY TISSUE RESPONSE. FOR PATIENTS WITH SYSTEMIC SYMPTOMS (E.G. BLURRED VISION, HEADACHE, ASTHENIA, MYALGIA), THE HYPOTHESIS THAT THESE SYMPTOMS MAY BE RELATED TO THE FORMATION OF ORGANOTIN. BASED ON THE AVAILABLE INFORMATION, A REVIEW OF OUR COMPLAINT RECORDS AND OTHER RELEVANT DATA WILL BE CONDUCTED; ANY NEW AND REPORTABLE INFORMATION THAT BECOMES AVAILABLE FROM OUR INVESTIGATION WILL BE PROVIDED IN A SUPPLEMENTARY REPORT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 592862 | ESSURE | TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE | HHS | BAYER PHARMA AG | ESS305 | 10888853003051 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 49 YR | Other| R |