MENTOR MEMORYGEL BREAST IMPLANT
Report
- Report Number
- 1645337-2019-12163
- Event Type
- Injury
- Date Received
- May 17, 2019
- Date of Event
- March 14, 2019
- Report Date
- April 26, 2019
- Manufacturer
- MENTOR TEXAS
- Product Code
- FTR
- UDI-DI
- 00081317000679
- PMA / PMN Number
- P030053
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- OTHER
Narratives
ON 4/16/2020, DURING VISUAL EVALUATION OF THE DEVICE, IT WAS OBSERVED CLOUDY. LEAK TESTING WAS PERFORMED IN ACCORDANCE WITH MENTOR PROCEDURES AND NO LEAK SITES WERE DETECTED. DISCOLORATION OF THE IMPLANTS IN SOME CASES HAVE BEING ATTRIBUTED TO ADHERENCE OF TRIGLYCERIDES OR FATTY ACIDS IN THE BREAST IMPLANT GEL AFTER SOME TIME OF BEING INSIDE THE BODY. POSTOPERATIVE FORMATION OF A FIBROUS TISSUE CAPSULE AROUND A MAMMARY PROSTHESIS IS A NORMAL PHYSIOLOGIC RESPONSE TO THE IMPLANTATION OF A FOREIGN OBJECT AND OCCURS IN ALL PATIENTS IN VARYING DEGREES. IN SOME CASES, CONTRACTURE OF THE FIBROUS CAPSULE MAY OCCUR. THIS PHENOMENON IS REFERRED TO AS CAPSULAR CONTRACTURE. THE MANUFACTURING RECORDS WERE REVIEWED, AND THE MANUFACTURING CRITERIA WERE MET PRIOR TO THE RELEASE OF THIS LOT. 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. COMPLAINT INFORMATION WILL BE INCLUDED IN COMPLAINT TRENDING THAT IS REVIEWED AND MONITOR BY QUALITY ASSURANCE ON A REGULAR BASIS TO DETERMINE IF FURTHER ACTION IS NECESSARY. MANUFACTURER¿S REFERENCE NUMBER: (B)(4).
ON 5/27/2019, A MANUFACTURING RECORD EVALUATION (MRE) WAS PERFORMED FOR THE FINISHED DEVICE NUMBER (B)(4), AND NO NON-CONFORMANCES RELATED TO THE REPORTED COMPLAINT WERE IDENTIFIED. MANUFACTURER¿S REFERENCE NUMBER: (B)(4).
ON 11/7/2019, IT WAS REPORTED TO MENTOR THAT THE CAPSULAR CONTRACTURE WAS BILATERAL BAKER GRADE III. MANUFACTURER'S REFERENCE NUMBER: (B)(4).
ON 11/25/19, 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. MANUFACTURER¿S REFERENCE NUMBER: (B)(4).
ON (B)(6) 2019, IT WAS REPORTED TO MENTOR THAT THE DATE PROBLEM OBSERVED WAS (B)(6) 2019 FOR RUPTURE. THE CAPSULAR CONTRACTURE WAS BAKER GRADE III. THE DATE OF EXPLANTATION IS (B)(6) 2019. NOTE: ACCT NAME: (B)(6). ADDRESS: (B)(6). CONTACT PERSON: (B)(6). CONTACT PHONE: (B)(6). CONTACT FAX: (B)(6). CONTACT EMAIL: (B)(6). 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 REVIEW IS IN PROGRESS. ONCE COMPLETED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. FACILITY INFORMATION: (B)(4). REASON FOR DEVICE EXPLANT AND/OR REOPERATION: CAPSULAR CONTRACTURE. CONCOMITANT PRODUCTS: A GEL MENTOR MEMORYGEL BREAST IMPLANT 300CC , CATALOG NUMBER: 3543007, SERIAL NUMBER: (B)(4), LOT NUMBER: 5579414. MANUFACTURER¿S REFERENCE NUMBER: (B)(4).
IT WAS REPORTED THAT A (B)(6) YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT A BREAST AUGMENTATION REVISION WITH A GEL MENTOR MEMORYGEL BREAST IMPLANT 300CC AND EXPERIENCED CAPSULAR CONTRACTURE BAKER GRADE UNKNOWN, PAIN AND DISTORTION ON THE RIGHT BREAST IMPLANT. AS A RESULT, THE PATIENT HAD UNDERGONE REMOVAL ON (B)(6) 2019.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 413578 | MENTOR MEMORYGEL BREAST IMPLANT | PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED | FTR | MENTOR TEXAS | 3543007 | 5579414 | 00081317000679 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 69 YR | Other| R |