MENTOR SMOOTH ROUND MODERATE PROFILE
Report
- Report Number
- 1645337-2022-03442
- Event Type
- Injury
- Date Received
- March 29, 2022
- Date of Event
- March 5, 2022
- Manufacturer
- MENTOR TEXAS
- Product Code
- FWM
- UDI-DI
- 00081317001270
- PMA / PMN Number
- P990075
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
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. SINCE NO LOT NUMBER WAS PROVIDED, NO MANUFACTURING RECORD EVALUATION COULD BE PERFORMED. REASON FOR DEVICE EXPLANT AND/OR REOPERATION: BREAST PAIN AND DEFLATION. EXPLANTATION DATE: (B)(6) 2022. MANUFACTURER¿S REFERENCE NUMBER: (B)(4).
ON MAY 24, 2022, MENTOR RECEIVED ADDITIONAL INFORMATION REGARDING THE IMPACTED DEVICE. THE IMPACTED DEVICE WAS REPORTED TO BE A 375CC MENTOR SMOOTH ROUND MODERATE PROFILE SALINE BREAST PROSTHESIS. CATALOG NUMBER: 3501660, LOT NUMBER: 5801122. 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. ON JUNE 01, 2022, THE MENTOR FAILURE ANALYSIS LAB HAS RECEIVED THE DEVICE FOR EVALUATION. ON JUNE 09, 2022, THE EVALUATION FOR THE DEVICE WAS COMPLETED. DEVICE EVALUATION SUMMARY: VISUAL ANALYSIS OF THE RETURNED SAMPLE REVEALED THAT THE SAL SMOOTH RND DIAP 375CC BREAST IMPLANT HAD A CREASE/FOLD EXTENDED FROM THE ANTERIOR TO THE POSTERIOR VIEW. LEAK TESTING WAS PERFORMED, ACCORDING TO THE MENTOR PROCEDURE, AND IT IDENTIFIED A TEAR WITHIN THE CREASE/FOLD ON THE ANTERIOR VIEW, MEASURING APPROXIMATELY 0.3 CM. THE EVALUATION DETERMINED THAT THE CAUSE OF THE RUPTURE IS CONSISTENT WITH NORMAL WEAR. DEFLATION CAN OCCUR AT ANY TIME AFTER IMPLANTATION, BUT IT IS MORE LIKELY TO OCCUR THE LONGER THE IMPLANT IS IMPLANTED. CREATING WRINKLES OR FOLDS SHOULD BE AVOIDED DURING IMPLANTATION OR OTHER PROCEDURES AS IT CAN RESULT IN DEFLATION AT A LATER TIME. BREAST IMPLANTS MAY ALSO SIMPLY WEAR OUT OVER TIME. MOST WOMEN UNDERGOING AUGMENTATION OR RECONSTRUCTION WITH A MAMMARY PROSTHESIS WILL EXPERIENCE SOME PAIN POSTOPERATIVELY. WHILE PAIN NORMALLY SUBSIDES IN MOST WOMEN AS THEY HEAL FROM SURGERY, IT CAN BECOME A CHRONIC PROBLEM IN OTHER WOMEN. CHRONIC PAIN CAN BE ASSOCIATED WITH A VARIETY OF FACTORS. SURGEONS SHOULD INSTRUCT THEIR PATIENTS TO INFORM THEM IF THERE IS SIGNIFICANT PAIN OR IF PAIN PERSISTS. PAIN IS A KNOWN COMPLICATION ASSOCIATED WITH THESE DEVICES AND IS REFERENCED IN OUR CURRENT PRODUCT INSERT DATA SHEET. IT SHOULD BE NOTED THAT AS PART OF THE MENTOR¿S QUALITY PROCESS ALL DEVICES ARE MANUFACTURED, INSPECTED, AND RELEASED TO APPROVED SPECIFICATIONS. ADDITIONAL COMPLAINT INFORMATION MONITORING FOR POTENTIAL SAFETY SIGNALS WILL BE CONDUCTED THROUGH COMPLAINT TRENDING AS PART OF POST-MARKET SURVEILLANCE. MANUFACTURER¿S REFERENCE NUMBER: (B)(4).
IT WAS REPORTED THAT A (B)(6) CAUCASIAN FEMALE PATIENT UNDERWENT A PRIMARY BREAST AUGMENTATION WITH AN UNSPECIFIED SMOOTH MENTOR SALINE BREAST PROSTHESIS AND EXPERIENCED BREAST PAIN AND DEFLATION ON THE RIGHT SIDE POST-OPERATIVELY. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON (B)(6) 2022.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 647111 | MENTOR SMOOTH ROUND MODERATE PROFILE | PROSTHESIS, BREAST, INFLATABLE, INTERNAL, SALINE | FWM | MENTOR TEXAS | 3501660 | 5801122 | 00081317001270 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 54 YR | Female | Required Intervention |