MENTOR MEMORYGEL BREAST IMPLANT
Report
- Report Number
- 1645337-2019-12326
- Event Type
- Injury
- Date Received
- May 20, 2019
- Date of Event
- January 1, 2019
- Report Date
- April 24, 2019
- Manufacturer
- MENTOR TEXAS
- Product Code
- FTR
- UDI-DI
- 00081317000525
- PMA / PMN Number
- P030053
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IL, US
- Reporter Occupation
- OTHER
Narratives
ON 5/23/2019, THE MENTOR FAILURE ANALYSIS LAB HAS 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. MENTOR BECAME AWARE THAT THE SUSPECT MEDICAL DEVICE'S LOT NUMBER AND SERIAL NUMBER WERE THE FOLLOWING: LOT: 5991845 SN: (B)(4). MENTOR ALSO BECAME AWARE OF THE CONCOMITANT DEVICE: 450CC MENTOR MEMORYGEL BREAST IMPLANT CATALOG: 3504504BC LOT: 5930371 SN: (B)(4). ON 6/17/2019, A MANUFACTURING RECORD EVALUATION (MRE) WAS PERFORMED FOR THE COMPLAINT DEVICE. AS A RESULT, THE MANUFACTURING DATE AND EXPIRATION DATE FIELDS HAVE BEEN UPDATED. THE MANUFACTURING RECORD EVALUATION (MRE) WAS REVIEWED, 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, MENTOR BECAME AWARE OF THE FOLLOWING INFORMATION: THE PRODUCT LOCATION OF THE SUSPECT MEDICAL DEVICE WAS THE LEFT SIDE, INSTEAD OF RIGHT SIDE. MENTOR ALSO BECAME AWARE THAT THE INITIAL PROCEDURE WAS A BREAST RECONSTRUCTION AND THAT THE CORRECT DATE OF IMPLANT EXPLANTATION WAS (B)(6) 2019. THE PATIENT ALSO SUFFERED DISCOMFORT AND THE PATIENT DATE OF BIRTH AND AGE AT THE TIME OF THE EVENT WERE ALSO PROVIDED AND UPDATED IN THE APPROPRIATE FIELDS. IN ADDITION, MENTOR BECAME AWARE THAT THE PATIENT HAD UNDERGONE BILATERAL REPLACEMENT WITH THE FOLLOWING DEVICES ON (B)(6) 2019: (LEFT) 480CC MENTOR MEMORYGEL BREAST IMPLANT CATALOG: 3505480BC LOT: 7642051 SN: (B)(4) AND (RIGHT) 535CC MENTOR MEMORYGEL BREAST IMPLANT CATALOG: 3505535BC LOT: 7550118 SN: (B)(4). MANUFACTURER¿S REFERENCE NUMBER: (B)(4).
ON APRIL 30, 2020, THE PRODUCT INVESTIGATION WAS UPDATED. DEVICE INVESTIGATION SUMMARY: DURING VISUAL INSPECTION, THE SAMPLE WAS FOUND TO BE RUPTURED AND RECEIVED IN TWO PARTS. ADDITIONALLY AN ANOMALY WAS OBSERVED ON THE DEVICE CONSISTENT WITH SHELL ABRASION. THE EVALUATION DETERMINED THAT THE LOSS OF SHELL INTEGRITY IS CONSISTENT WITH A RUPTURE CAUSED BY WEAR. SHELL ABRASION SUGGESTS IN-VIVO FOLDING OR CREASING OF THE DEVICE. THIS MAY BE THE RESULT OF THE FOLLOWING FACTORS: CONTINUOUS AND SUSTAINED STRESSES TO THE DEVICE SUCH AS TOO SMALL BREAST POCKET AND FOLDING OR WRINKLING OF THE SHELL IN THE BREAST POCKET. IN SOME CASES, THE BREAST IMPLANTS MAY ALSO 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. PAIN IS A KNOWN COMPLICATION ASSOCIATED WITH THESE DEVICES AND IS REFERENCED IN OUR CURRENT PRODUCT INSERT DATA SHEET. AS PART OF OUR QUALITY PROCESS, THE MANUFACTURING RECORDS OF THIS LOT-SERIAL NUMBER WERE REVIEWED AND THE MANUFACTURING STANDARDS WERE MET PRIOR TO THE RELEASE OF THIS LOT. EACH DEVICE IS VISUALLY INSPECTED DURING MANUFACTURING TO ENSURE THE DEVICE MEETS THE REQUIRED SPECIFICATIONS PRIOR TO SHIPMENT. RUPTURE AND PAIN COMPLAINT INFORMATION IS CONSISTENTLY ANALYZED AND MONITORED BY QUALITY ASSURANCE TO DETERMINE WHEN FURTHER ACTION IS NECESSARY. MANUFACTURER¿S REFERENCE NUMBER: (B)(4).
ON 6/24/2019, THE PRODUCT INVESTIGATION WAS COMPLETED. DEVICE INVESTIGATION SUMMARY: DURING ANALYSIS OF THE SAMPLE IT WAS RECEIVED IN TWO PARTS. NO OTHER ANOMALIES WERE OBSERVED. SINCE THE AUTHORIZATION FOR RETURN AND EXAMINATION OF MEDICAL DEVICE FORM WAS NOT SIGNED AND/OR RETURNED, MENTOR PRODUCT ANALYSIS LAB WAS PRECLUDED FROM FURTHER EVALUATING THE DEVICE. THE MANUFACTURING RECORDS WERE REVIEWED AND THE MANUFACTURING CRITERIA WERE MET PRIOR TO THE RELEASE OF THIS LOT. RUPTURE, AS INDICATED IN THE PRODUCT INSERT DATA SHEET (PIDS), IS A KNOWN COMPLICATION ASSOCIATED WITH MENTOR MAMMARY PROSTHESES. CAUSES OF RUPTURE OF GEL-FILLED IMPLANTS INCLUDE, BUT ARE NOT LIMITED TO THE FOLLOWING EVENTS: DAMAGE FROM SURGICAL INSTRUMENTS, INTRAOPERATIVE OR POSTOPERATIVE TRAUMA,EXCESSIVE STRESSES OR MANIPULATIONS AS MAY OCCUR DURING NORMAL, DAILY ROUTINES INCLUDING CUSTOMARY AND PURPOSEFUL TRAUMA TO THE BREAST. THE REPORTED COMPLAINT WAS CONFIRMED. IT SHOULD BE NOTED THAT AS PART OF OUR QUALITY PROCESS, EACH DEVICE IS VISUALLY INSPECTED DURING MANUFACTURING TO ENSURE THE DEVICE MEETS THE REQUIRED SPECIFICATIONS PRIOR TO SHIPMENT. BASED ON THE INFORMATION REPORTED AND/OR THE PRODUCT INVESTIGATION, THERE IS NO EVIDENCE THAT THE ISSUE IS RELATED WITH THE MANUFACTURING PROCESS. 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. SINCE NO LOT NUMBER WAS PROVIDED, NO MANUFACTURING RECORD EVALUATION COULD BE PERFORMED. REASON FOR DEVICE EXPLANT AND/OR REOPERATION: RUPTURE. MANUFACTURER¿S REFERENCE NUMBER: (B)(4).
IT WAS REPORTED THAT A FEMALE PATIENT OF UNKNOWN AGE WHO UNDERWENT AN UNSPECIFIED BREAST PROSTHESIS IMPLANTATION PROCEDURE WITH A 450CC MENTOR MEMORYGEL BREAST IMPLANT ON AN UNSPECIFIED SIDE, EXPERIENCED RUPTURE POST-OPERATIVELY. AS A RESULT, THE PATIENT UNDERWENT REMOVAL ON (B)(6) 2019.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 416362 | MENTOR MEMORYGEL BREAST IMPLANT | PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED | FTR | MENTOR TEXAS | 3504504BC | 5991845 | 00081317000525 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 42 YR | Required Intervention |