MENTOR SILTEX ROUND MODERATE PROFILE
Report
- Report Number
- 1645337-2019-12612
- Event Type
- Injury
- Date Received
- May 28, 2019
- Date of Event
- April 30, 2019
- Report Date
- May 1, 2019
- Manufacturer
- MENTOR TEXAS
- Product Code
- FWM
- UDI-DI
- 00081317001829
- PMA / PMN Number
- P990075
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OH, US
- Reporter Occupation
- OTHER
Narratives
A MANUFACTURING RECORD EVALUATION (MRE) WAS PERFORMED, AND NO ANOMALIES WERE FOUND RELATED TO THIS COMPLAINT. IN ADDITION, THE MRE VERIFIES THAT THE DEVICE WAS MANUFACTURED IN ACCORDANCE WITH DOCUMENTED SPECIFICATION AND PROCEDURES. MANUFACTURER¿S REFERENCE NUMBER: (B)(4).
ON (B)(6) 2020, DEVICE EVALUATION WAS COMPLETED. DEVICE EVALUATION SUMMARY: DURING THE VISUAL EVALUATION OF THE DEVICE, AN AREA OF SILTEX CRACKING WAS OBSERVED ON THE POSTERIOR ASPECT. ADDITIONALLY, IT WAS REVEALED A TEAR WITHIN THE SILTEX CRACKING MEASURING APPROXIMATELY 0.5 CM. IT IS POSSIBLE THE RUPTURE WAS CAUSED BY THE STRESS OCCASIONED TO THE SHELL BY THE CAPSULAR CONTRACTURE. MENTOR CONCLUDED THAT THE CAPSULAR CONTRACTURE IN THE PATIENT´S BREAST WAS THE RESULT OF THE BODY´S INDIVIDUAL PHYSIOLOGICAL RESPONSE TO THE IMPLANTATION OF A FOREIGN OBJECT IN SOFT TISSUE. CAPSULAR CONTRACTURE IS A KNOWN COMPLICATION ASSOCIATED WITH THESE DEVICES AND IS REFERENCED IN OUR CURRENT PRODUCT INSERT DATA SHEET. THE AMERICAN SOCIETY OF PLASTIC SURGEONS RECOMMENDS AND ENCOURAGES MEMBER SURGEONS TO ALWAYS SUBMIT BREAST IMPLANTS, CAPSULE, AND EFFUSION TO PATHOLOGY FOR EXAMINATION. EACH DEVICE IS VISUALLY INSPECTED DURING MANUFACTURING TO ENSURE THE DEVICE MEETS THE REQUIRED SPECIFICATIONS PRIOR TO SHIPMENT. THIS SUPPLEMENTAL REPORT IS FOR PATIENT'S LEFT SIDE DEVICE. MANUFACTURER¿S REFERENCE NUMBER: (B)(4).
ON 6/3/2020, THE MENTOR FAILURE ANALYSIS LAB RECEIVED THE DEVICE FOR EVALUATION. THE ANALYSIS HAS BEGUN, BUT IS NOT COMPLETE AT THIS TIME. WHEN THE INVESTIGATIONAL ANALYSIS HAS BEEN COMPLETED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. THIS SUPPLEMENTAL REPORT IS FOR PATIENT'S LEFT SIDE DEVICE. MANUFACTURER¿S REFERENCE NUMBER: (B)(4).
ON (B)(6) 2020, MENTOR BECAME AWARE THAT CAUCASIAN PATIENT EXPERIENCED BILATERAL CAPSULAR CONTRACTURE; BAKER GRADE III AND LEFT SIDE BREAST IMPLANT RUPTURE. ALSO, MENTOR BECAME AWARE THAT PATIENT UNDERWENT BILATERAL EXPLANTATION AND REPLACEMENT WITH CATALOG NUMBER 3504754BC ON (B)(6) 202. HENCE, FIELD D7 ON THIS FORM HAS BEEN UPDATED FROM (B)(6) 2019 TO (B)(6) 2020. PATIENT CODE CAPSULAR CONTRACTURE HAS BEEN ADDED ON THIS FORM. THIS SUPPLEMENTAL REPORT IS FOR PATIENT'S LEFT SIDE DEVICE. MANUFACTURER¿S REFERENCE NUMBER: (B)(4).
SINCE THE DEVICE HAS NOT BEEN RETURNED FOR ANALYSIS, NO PRODUCT FAILURE ANALYSIS CAN BE CONDUCTED, AND NO DETERMINATION OF POSSIBLE CONTRIBUTING FACTORS CAN BE MADE. AS SUCH, THE INVESTIGATION WILL BE CLOSED. IF THE COMPLAINT DEVICE IS RECEIVED IN THE FUTURE, THE INVESTIGATION WILL BE REOPENED AND CONDUCTED AS APPROPRIATE. A MANUFACTURING RECORD EVALUATION IS IN PROGRESS. ONCE COMPLETED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. REASON FOR DEVICE EXPLANT AND/OR REOPERATION: BILATERAL DEFLATION. MANUFACTURER¿S REFERENCE NUMBER: (B)(4).
IT WAS REPORTED THAT A (B)(6) YEAR-OLD FEMALE PATIENT UNDERWENT PRIMARY BREAST AUGMENTATION WITH A 425CC MENTOR SILTEX ROUND MODERATE PROFILE AND WAS PRESENTED WITH BILATERAL BREAST IMPLANT DEFLATION CONFIRMED BY THE DOCTOR UPON EXAMINATION ON (B)(6) 2019. AS A RESULT, THE DEVICES WILL BE EXPLANTED ON (B)(6) 2019. THIS REPORT IS FOR ONE OF THE TWO EFFECTED SIDES.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 441381 | MENTOR SILTEX ROUND MODERATE PROFILE | PROSTHESIS, BREAST, INFLATABLE, INTERNAL, SALINE | FWM | MENTOR TEXAS | 3542670 | 226240 | 00081317001829 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 56 YR | Required Intervention |