MENTOR MemoryShape Breast Implant 3341509Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00081317005131), received between May 7, 2019 and Feb 28, 2024 — classified as 6 injuries.

The most frequently reported specific device problem is “Material Rupture” (2 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 28, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT UNDERWENT A BREAST SURGERY WITH A 680CC MENTOR MEMORYSHAPE BREAST IMPLANT. POST-OPERATIVELY, THE PATIENT WAS IN A CAR ACCIDENT. A COMPUTERIZED TOMOGRAPHY SCAN WAS PERFORMED AND IDENTIFIED A RUPTURE OF THE PATIENT¿S RIGHT PROSTHESIS. AT THE TIME OF THIS REPORT, MENTOR HAS NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE. SEVERAL FOLLOW-UPS HAVE BEEN CONDUCTED, AND NO ADDITIONAL INFORMATION HAS BEEN RECEIVED. IF MORE INFORMATION BECOMES AVAILABLE, MENTOR WILL SUBMIT A SUPPLEMENTAL REPORT ACCORDINGLY.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 18797887 ↗
• InjuryFeb 26, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT IMPLANTED WITH A 680CC MENTOR MEMORYSHAPE BREAST IMPLANT EXPERIENCED A RUPTURE ON THE LEFT SIDE POST-OPERATIVELY. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON (B)(6) 2024.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 18781477 ↗
• InjuryNov 11, 2020Migration; Migration

  IT WAS REPORTED THAT A (B)(6)-YEAR-OLD CAUCASIAN FEMALE WHO UNDERWENT PRIMARY BREAST RECONSTRUCTION SURGERY WITH A MENTOR MEMORYSHAPE 680CC SILICONE PROSTHESIS EXPERIENCED BILATERAL PAIN, LEFT SIDED WRINKLING, RIGHT SIDED CAPSULAR CONTRACTURE, UNKNOWN GRADE, AND DEVICE MIGRATION POST PROCEDURE. THE PATIENT STATED THAT THE LEFT SIDE IMPLANT POPPED BY THE AREA OF NIPPLE, EXTREME PAIN ON BOTH SIDES, RIGHT IMPLANT SITS HIGH AND HARD AND NOT ALIGN, IT APPEARS LIKE THE IMPLANT TURNED AND MAKES IT PAINFUL, PATIENT CAN'T SLEEP. PATIENT STATED IN 2016 DOCTOR MADE ADJUSTMENT FOR RIGHT SIDE, TOOK SKIN OF THE SIDES, AND SECURE IT. AS A RESULT, PATIENT SCHEDULED FOR EXPLANT ON (B)(6) 2021. THIS REPORT RELATES TO THE RIGHT PROSTHESIS.

  Patient problems: Capsular Contracture; No Code Available

  MAUDE report 10826250 ↗
• InjuryNov 11, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A (B)(6) YEAR-OLD CAUCASIAN FEMALE WHO UNDERWENT PRIMARY BREAST RECONSTRUCTION SURGERY WITH A MENTOR MEMORYSHAPE 680CC SILICONE PROSTHESIS EXPERIENCED BILATERAL PAIN, LEFT SIDED WRINKLING, RIGHT SIDED CAPSULAR CONTRACTURE, UNKNOWN GRADE, AND DEVICE MIGRATION POST PROCEDURE. THE PATIENT STATED THAT THE LEFT SIDE IMPLANT POPPED BY THE AREA OF NIPPLE, EXTREME PAIN ON BOTH SIDES, RIGHT IMPLANT SITS HIGH AND HARD AND NOT ALIGN, IT APPEARS LIKE THE IMPLANT TURNED AND MAKES IT PAINFUL, PATIENT CAN'T SLEEP. PATIENT STATED IN 2016 DOCTOR MADE ADJUSTMENT FOR RIGHT SIDE, TOOK SKIN OF THE SIDES, AND SECURE IT. AS A RESULT, PATIENT SCHEDULED FOR EXPLANT ON (B)(6) 2021. THIS REPORT RELATES TO THE LEFT PROSTHESIS.

  Patient problems: No Code Available; Pain; Wrinkling

  MAUDE report 10826216 ↗
• InjuryDec 19, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AN (B)(6) YEAR-OLD FEMALE PATIENT UNDERWENT A BREAST RECONSTRUCTION REVISION WITH A 680CC GEL MENTOR MEMORYSHAPE BREAST IMPLANT AND EXPERIENCED POSTOPERATIVE RIGHT-SIDED BREAST PAIN AND BREAST CYST. PATIENT REPORTED THAT SHE HAS HAD CANCER BEFORE AND NOTICED A BUMP ON HER RIGHT SIDE. PATIENT HAD ULTRASOUND AND MAMMOGRAM PERFORMED AND A CYST WAS FOUND, DOCTOR CONFIRMED IT WAS SMALL AND FREE OF CANCER. PATIENT ALSO REPORTED PAIN ON THE RIGHT SIDE AND THAT THE BREAST APPEARS SEVERELY DIMPLED. AS A RESULT, THE PATIENT IS PLANNING ON EXPLANTATION, BUT AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING AN EXPECTED EXPLANTATION DATE.

  Patient problems: Cyst(s); Pain

  MAUDE report 9499763 ↗
• InjuryMay 7, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A (B)(6) PATIENT WHO UNDERWENT PRIMARY BREAST RECONSTRUCTION WITH MENTOR GEL IMPLANTS ON (B)(6) 2016 DEVELOPED RIGHT BREAST SWELLING. THE PATIENT HAD A LATE SEROMA IN THE RIGHT BREAST AND RUPTURE PER MRI ON (B)(6) 2019. THE PATIENT UNDERWENT DRAINAGE, PARTIAL CAPSULECTOMY, EXPLANTATION AND REPLACEMENT WITH NON MENTOR IMPLANTS ON (B)(6) 2019. UPON EXPLANTATION, IT WAS NOTED THAT THE DEVICE WAS NOT RUPTURED. THE SEROMA FLUID WAS TESTED AND RETURNED NEGATIVE FOR ALCL. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS CASE WILL BE RE-ASSESSED AND NOTES WILL BE UPDATED.

  Patient problems: No Code Available; Seroma

  MAUDE report 8588621 ↗