VICRYL POLYGLACTIN 910 MESH UNKNOWN PRODUCT
Report
- Report Number
- 2210968-2024-12519
- Event Type
- Injury
- Date Received
- November 26, 2024
- Date of Event
- March 15, 2023
- Manufacturer
- ETHICON INC.
- Product Code
- FTL
- PMA / PMN Number
- K810428
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- OTHER
Narratives
(B)(4). THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH HAS NOT BEEN INVESTIGATED OR VERIFIED PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY ETHICON INC, OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, ETHICON INC, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE. AN ATTEMPT HAS BEEN MADE TO OBTAIN THE FOLLOWING INFORMATION. TO DATE NO RESPONSE HAS BEEN PROVIDED. IF FURTHER DETAILS ARE RECEIVED AT A LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT. DOES THE SURGEON BELIEVE THAT ANY OF THE ETHICON PRODUCTS INVOLVED CAUSED AND/OR CONTRIBUTED TO THE POST-OPERATIVE COMPLICATIONS DESCRIBED IN THE ARTICLE? WHICH SPECIFIC ETHICON PRODUCTS HAVE BEEN USED DURING THE PROCEDURES (PRODUCT CODE, LOT NUMBER)? DOES THE SURGEON BELIEVE THERE WAS ANY DEFICIENCY WITH ANY OF THE ETHICON PRODUCTS USED IN THIS PROCEDURE? IF SO, PLEASE PROVIDE DETAILS. WERE THE CASES DISCUSSED IN THIS ARTICLE PREVIOUSLY REPORTED TO ETHICON? IF YES, PLEASE PROVIDE A COMPLAINT REFERENCE NUMBER. PATIENT DEMOGRAPHICS? D4: UDI: AS THE CATALOG/MODEL NUMBER WAS NOT PROVIDED, THE (01)GTIN IS NOT AVAILABLE. THIS REPORT IS RELATED TO A JOURNAL ARTICLE; THEREFORE, NO PRODUCT WILL BE RETURNED FOR ANALYSIS AND THE BATCH HISTORY RECORDS CANNOT BE REVIEWED AS THE LOT NUMBER HAS NOT BEEN PROVIDED. H6 COMPONENT CODE: G07002 ¿ DEVICE NOT RETURNED. THE SINGLE COMPLAINT WAS REPORTED WITH MULTIPLE EVENTS. THERE ARE NO ADDITIONAL DETAILS REGARDING THE ADDITIONAL EVENTS. CITATION: JOURNAL OF PLASTIC, RECONSTRUCTIVE & AESTHETIC SURGERY 80 (2023) 178¿181. PLEASE SEE ARTICLE ATTACHED.
TITLE : ADMS AND SYNTHETIC MESHES IMPROVE IMPLANT-BASED BREAST RECONSTRUCTION AESTHETICS, BUT AT WHAT COST? THE AIM OF THIS STUDY WAS TO REVIEW OUR EXPERIENCE AT A LARGE ACADEMIC CENTER IN IMPLANT-BASED RECONSTRUCTION FOR THE LAST 15 YEARS TO ASCERTAIN TRENDS IN ADM USE, COMPLICATION RATES BETWEEN DIFFERENT TYPES OF MESHES, DIFFERENCES IN AESTHETIC OUTCOMES, AS WELL AS INFECTION RATES IN PATIENTS UNDERGOING IBR WITH AND WITHOUT ADM OR MESH. WE CONDUCTED A RETROSPECTIVE REVIEW OF IMPLANT-BASED RECONSTRUCTION AT A TERTIARY CARE ACADEMIC MEDICAL CENTER BETWEEN 2007 AND 2021. 1643 PATIENTS (1379 SUBPECTORAL, 264 PREPECTORAL) UNDERWENT IMMEDIATE TISSUE EXPANDER OR PERMANENT IMPLANT-BASED RECONSTRUCTION FOLLOWING THERAPEUTIC OR PROPHYLACTIC MASTECTOMY. PATIENT CHARACTERISTICS, ONCOLOGIC VARIABLES, BREAST IRRADIATION STATUS AND TIMING, RECONSTRUCTIVE TIMING AND STAGE, IMPLANT LOCATION, TYPE OF IMPLANT, AND TYPE OF SURGICAL MESH USED (VICRYL®, ALLODERM®, FLEXHD®, AND SERI®) WERE COLLECTED. THE REPORTED COMPLICATIONS INCLUDED INFECTION (N=?) AND WOUND DEHISCENCE (N=?). IN CONCLUSION, OUR STUDY DEMONSTRATED THAT PREPECTORAL IBR WITH ADM OR MESH RESULTED IN THE FEWEST AESTHETIC REOPERATIONS AND THE LOWEST RATES OF CAPSULAR CONTRACTURE. INFECTION AND WOUND DEHISCENCE RATES WERE NOTABLY HIGHER FOR PATIENTS WHO HAD RECONSTRUCTION WITH ADM.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2441958 | VICRYL POLYGLACTIN 910 MESH UNKNOWN PRODUCT | MESH, SURGICAL, POLYMERIC | FTL | ETHICON INC. |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Other |