MENTOR MEMORYGEL BREAST IMPLANT
Report
- Report Number
- 1645337-2019-23645
- Event Type
- Injury
- Date Received
- November 12, 2019
- Date of Event
- September 23, 2019
- Report Date
- October 15, 2019
- Manufacturer
- MENTOR TEXAS
- Product Code
- FTR
- UDI-DI
- 00081317000082
- PMA / PMN Number
- P030053
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- LA, US
- Reporter Occupation
- OTHER
Narratives
ON 12/9/2019, THE PRODUCT INVESTIGATION WAS COMPLETED. DEVICE INVESTIGATION SUMMARY: DURING EVALUATION OF THE DEVICE A TEAR WAS OBSERVED IN THE POSTERIOR VIEW, MEASURING APPROXIMATELY 2 CM. 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. NO ADDITIONAL ANOMALIES WERE OBSERVED. THE SECOND PRODUCT RECEIVED IS RELATED TO A CONCOMITANT DEVICE, THERE ARE NEITHER DEFICIENCIES ALLEGED NOR PATIENT INJURIES. THEREFORE NO FURTHER INVESTIGATION IS REQUIRED. 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. IT IS POSSIBLE THE RUPTURE WAS CAUSED BY THE STRESS OCCASIONED TO THE SHELL BY THE 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. MANUFACTURER¿S REFERENCE NUMBER: (B)(4).
ON JULY 8, 2020, THE PRODUCT INVESTIGATION WAS UPDATED AND THE FOLLOWING STATEMENT HAS BEEN REMOVED TO CAPTURE THE EVENT MORE ACCURATELY: THE SECOND PRODUCT RECEIVED IS RELATED TO A CONCOMITANT DEVICE, THERE ARE NEITHER DEFICIENCIES ALLEGED NOR PATIENT INJURIES. THEREFORE NO FURTHER INVESTIGATION IS REQUIRED. MANUFACTURER¿S REFERENCE NUMBER: (B)(4).
ON MAY 1, 2020, MENTOR BECAME AWARE THAT THE PATIENT ALSO EXPERIENCED CAPSULAR CONTRACTURE; BAKER GRADE UNKNOWN ON THE RIGHT BREAST. THE COMPLICATION ON THE RIGHT BREAST WILL BE REPORTED UNDER MRN: 1645337-2020-06272 IN ADDITION, MENTOR ALSO BECAME AWARE THAT THE INCORRECT SENTENCE WAS INCLUDED IN THE INITIAL REPORT SENT ON NOVEMBER 12, 2019, "AS A RESULT, THE PATIENT UNDERWENT IMPLANT EXPLANTATION WITHOUT REMOVAL ON (B)(6) 2019." THE CORRECT STATEMENT IS " AS A RESULT, THE PATIENT UNDERWENT IMPLANT EXPLANTATION WITHOUT REPLACEMENT ON (B)(6) 2019." MANUFACTURER¿S REFERENCE NUMBER: (B)(4). THIS MEDWATCH FORM IS FOR THE LEFT BREAST PROSTHESIS.
ON JULY 13, 2020, THE PRODUCT INVESTIGATION WAS UPDATED. DEVICE INVESTIGATION SUMMARY: DURING THE EVALUATION OF THE DEVICE,¿ A TEAR WAS OBSERVED IN THE POSTERIOR VIEW, MEASURING APPROXIMATELY 2 CM. ADDITIONALLY, AN ANOMALY WITHIN THE RUPTURE WAS OBSERVED 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, BREAST IMPLANTS MAY ALSO WEAR OUT OVER TIME. 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. 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. MANUFACTURER¿S REFERENCE NUMBER: (B)(4).
ON 12/10/2019, MENTOR BECAME AWARE THAT THE LOT NUMBER WAS ERRONEOUSLY OMITTED FROM THE INITIAL REPORT SUBMITTED ON 11/12/2019. THE FOLLOWING FIELD HAS BEEN FILLED ACCORDINGLY. MANUFACTURER REFERENCE NUMBER: (B)(4).
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. 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. REASON FOR DEVICE EXPLANT AND/OR REOPERATION: RUPTURE, CAPSULAR CONTRACTURE. CONCOMITANT PRODUCTS: (RIGHT) 275CC MENTOR MEMORYGEL BREAST IMPLANT CATALOG: 3507275BC LOT: 5954584 SN: (B)(4).
IT WAS REPORTED THAT A (B)(6)-YEAR OLD FEMALE PATIENT WHO UNDERWENT PRIMARY BREAST AUGMENTATION WITH TWO 275CC MENTOR MEMORYGEL BREAST IMPLANTS, SUFFERED LEFT BREAST IMPLANT RUPTURE AND LEFT BREAST HARDENING POST-OPERATIVELY. AS A RESULT, THE PATIENT UNDERWENT IMPLANT EXPLANTATION WITHOUT REMOVAL ON (B)(6) 2019.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1102905 | MENTOR MEMORYGEL BREAST IMPLANT | PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED | FTR | MENTOR TEXAS | 3507275BC | 5929871 | 00081317000082 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 38 YR | Required Intervention |