MENTOR MemoryGel Breast Implant 3548007Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00081317000778), received between Apr 12, 2018 and Oct 28, 2024 — classified as 8 injuries.

The most frequently reported specific device problem is “Material Rupture” (8 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• InjuryOct 28, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT UNDERWENT A PRIMARY BREAST AUGMENTATION PROCEDURE WITH AN UNSPECIFIED MENTOR SALINE BREAST PROSTHESIS (LEFT DEVICE) AND A MENTOR MEMORYGEL BREAST IMPLANT 800CC GEL BREAST PROSTHESIS (RIGHT DEVICE) WHEN THE DEVICES RUPTURED POST IMPLANTATION. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE. THIS MEDWATCH REPORT IS FOR THE PATIENT¿S RIGHT BREAST PROSTHESIS.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 20547046 ↗
• InjuryOct 13, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT A 67-YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT A BREAST SURGERY WITH AN 800CC MENTOR MEMORYGEL BREAST IMPLANT AND EXPERIENCED A RUPTURE ON THE LEFT SIDE POST-OPERATIVELY . AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON (B)(6) 2022.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 15599041 ↗
• InjurySep 11, 2020Material Rupture; Material Rupture

  IT WAS REPORTED VIA (FDA MW5095028) THAT A FEMALE PATIENT WHO UNDERWENT BREAST AUGMENTATION REVISION AS PART OF AN UNSPECIFIED MENTOR STUDY WITH TWO 800CC MENTOR MEMORYGEL BREAST IMPLANTS, EXPERIENCED POSTOPERATIVE BILATERAL BREAST IMPLANT RUPTURES. THE PATIENT REPORTED SHE UNDERWENT AN MRI WHICH IDENTIFIED THAT SILICONE FROM THE RUPTURE MIGRATED TO THEIR LYMPH NODES. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE. THIS MEDWATCH FORM IS FOR THE LEFT BREAST PROSTHESIS.

  Patient problems: Granuloma

  MAUDE report 10522280 ↗
• InjuryApr 2, 2020Material Rupture; Material Rupture

  IT WAS REPORTED THAT A FEMALE PATIENT UNDERWENT A BREAST AUGMENTATION REVISION WITH 800CC MENTOR MEMORYGEL BREAST IMPLANTS AND EXPERIENCED POSTOPERATIVE RIGHT-SIDED RUPTURE. THE PATIENT REPORTED SHE UNDERWENT A SONOGRAM AND MRI WHICH IDENTIFIED THAT LOOSE SILICONE FROM THE RUPTURE MIGRATED TO THE LYMPH NODES. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE.

  Patient problems: Granuloma

  MAUDE report 9917072 ↗
• InjuryMay 29, 2018Material Rupture; Material Rupture

  IT WAS REPORTED THAT A (B)(6) FEMALE PATIENT UNDERWENT A BREAST AUGMENTATION REVISION PROCEDURE WITH MENTOR MEMORYGEL BREAST IMPLANT 800 CC GEL BREAST PROSTHESES THAT BOTH RUPTURED AFTER IMPLANTATION. AS A RESULT, THE PATIENT WILL UNDERGO BILATERAL EXPLANTATION ON (B)(6) 2018. THIS MEDWATCH REPORT IS FOR THE 2ND OF TWO BREAST PROSTHESES.

  Patient problems: No Code Available

  MAUDE report 7550170 ↗
• InjuryMay 29, 2018Material Rupture; Material Rupture

  IT WAS REPORTED THAT A (B)(6) -YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT A BREAST AUGMENTATION REVISION PROCEDURE WITH MENTOR MEMORYGEL BREAST IMPLANT 800CC GEL BREAST PROSTHESES THAT BOTH RUPTURED AFTER IMPLANTATION. AS A RESULT, THE PATIENT WILL UNDERGO BILATERAL EXPLANTATION ON (B)(6) 2018. THIS MEDWATCH REPORT IS FOR THE 1ST OF TWO BREAST PROSTHESES.

  Patient problems: No Code Available

  MAUDE report 7550120 ↗
• InjuryApr 12, 2018Material Rupture; Material Rupture

  IT WAS REPORTED THAT A (B)(6) -YEAR-OLD FEMALE PATIENT UNDERWENT A BREAST AUGMENTATION REVISION WITH A GEL MENTOR MEMORYGEL BREAST IMPLANT 800CC AND EXPERIENCED BILATERAL RUPTURE ON THE LEFT AND RIGHT BREAST IMPLANTS. AS A RESULT, THE PATIENT WILL UNDERGO EXPLANTATION ON (B)(6) 2018. THIS MEDWATCH REPORT IS FOR THE LEFT BREAST IMPLANT.

  Patient problems: No Code Available

  MAUDE report 7426929 ↗
• InjuryApr 12, 2018Material Rupture; Material Rupture

  IT WAS REPORTED THAT A (B)(6) -YEAR-OLD FEMALE PATIENT UNDERWENT A BREAST AUGMENTATION REVISION WITH A GEL MENTOR MEMORYGEL BREAST IMPLANT 800CC AND EXPERIENCED BILATERAL RUPTURE ON THE LEFT AND RIGHT BREAST IMPLANTS. AS A RESULT, THE PATIENT WILL UNDERGO EXPLANTATION ON (B)(6) 2018. THIS MEDWATCH REPORT IS FOR THE RIGHT BREAST IMPLANT.

  Patient problems: No Code Available

  MAUDE report 7426927 ↗