MENTOR MemoryGel Breast Implant 3544750Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 00081317003953), received between Aug 30, 2019 and Mar 7, 2025 — classified as 10 injuries, 1 malfunction.

The most frequently reported specific device problem is “Material Rupture” (7 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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• InjuryMar 7, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT WHO UNDERWENT PRIMARY BREAST AUGMENTATION WITH A 750CC MENTOR MEMORYGEL BREAST IMPLANT EXPERIENCED LEFT SIDED RUPTURE POST PROCEDURE. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 21549153 ↗
• InjuryJul 16, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT A FEMALE WHO UNDERWENT A BREAST RECONSTRUCTION REVISION WITH A MENTOR MEMORYGEL, 750CC SILICONE PROSTHESIS EXPERIENCED LEFT-SIDED SILENT RUPTURE POST OPERATION. PHYSICAL AND MAMMOGRAM EXAMINATION DIAGNOSED AND CONFIRMED THE ISSUE. AS A RESULT, PATIENT SCHEDULED FOR REMOVAL ON (B)(6) 2024.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 19753007 ↗
• InjuryJan 3, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A FEMALE PATIENT UNDERWENT REVISION BREAST RECONSTRUCTION SURGERY WITH 750CC MENTOR MEMORYGEL BREAST IMPLANT AND EXPERIENCED RIGHT SIDE PAIN. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE.

  Patient problems: Breast Discomfort/Pain

  MAUDE report 16090167 ↗
• InjuryDec 6, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT A 32-YEAR-OLD FEMALE PATIENT UNDERWENT A BREAST AUGMENTATION SURGERY WITH TWO 750CC MENTOR MEMORYGEL BREAST IMPLANTS AND EXPERIENCED GENERALIZED ILLNESS PROBLEMS INCLUDING PAIN, FATIGUE, LYMPHADENOPATHY, AND ABNORMAL PANCREATIC LESION POST-OPERATIVELY. THE PATIENT ALSO REPORTED SHE HAD A RUPTURE ON THE LEFT BREAST PROSTHESIS. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON (B)(6) 2022. THIS REPORT IS FOR THE LEFT SIDE DEVICE.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 15928239 ↗
• InjuryDec 6, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A 32-YEAR-OLD FEMALE PATIENT UNDERWENT A BREAST AUGMENTATION SURGERY WITH TWO 750CC MENTOR MEMORYGEL BREAST IMPLANTS AND EXPERIENCED GENERALIZED ILLNESS PROBLEMS INCLUDING PAIN, FATIGUE, LYMPHADENOPATHY, AND ABNORMAL PANCREATIC LESION POST-OPERATIVELY. THE PATIENT ALSO REPORTED SHE HAD A RUPTURE ON THE LEFT BREAST PROSTHESIS. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON (B)(6) 2022. THIS REPORT IS FOR THE RIGHT SIDE DEVICE.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 15927663 ↗
• InjuryOct 19, 2022Use of Device Problem; Adverse Event Without Identified Device or Use Problem; Use of Device Problem; Adverse Event Without Identified Device or Use Problem

  THIS EVENT IS ASSOCIATED WITH THE GLOW CLINICAL TRIAL. IT WAS REPORTED THAT A FEMALE PATIENT WHO UNDERWENT BREAST AUGMENTATION SURGERY WITH TWO 750CC MENTOR MEMORYGEL BREAST IMPLANTS EXPERIENCED RIGHT SIDED CONTOUR DEFORMITY (A FLAT SPOT), WHICH REQUIRED BREAST POCKET ADJUSTMENT. IT WAS ALSO REPORTED BY PATIENT THAT THE RIGHT SIDED IMPLANT WAS REIMPLANTED DURING THE POCKET ADJUSTMENT SURGERY. IN A YEAR AFTER THE IMPLANT SURGERY, PATIENT EXPERIENCED PERSISTENT JOINT STIFFNESS, PERSISTENT NON-TRAUMATIC JOINT PAIN, PERSISTENT MUSCLE PAIN, FINGERS BECOMING UNUSUALLY PALE, NUMB, OR UNCOMFORTABLE IN THE COLD, UNUSUAL HAIR LOSS, RECURRENT TINGLING OR NUMBNESS , RECURRENT DIZZINESS AND PERSISTENT MEMORY PROBLEMS POST PROCEDURE. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE. PER MENTOR IFU, THESE DEVICES ARE FOR SINGLE USE ONLY AND SHOULD NOT BE RE-IMPLANTED. THEREFORE, THESE DEVICES WERE USED IN USER ERROR. THIS MEDWATCH FORM IS FOR THE RIGHT BREAST PROSTHESIS.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Wrinkling

  MAUDE report 15635709 ↗
• InjuryOct 19, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS EVENT IS ASSOCIATED WITH THE GLOW CLINICAL TRIAL. IT WAS REPORTED THAT A FEMALE PATIENT WHO UNDERWENT BREAST AUGMENTATION SURGERY WITH TWO 750CC MENTOR MEMORYGEL BREAST IMPLANTS EXPERIENCED RIGHT SIDED CONTOUR DEFORMITY (A FLAT SPOT), WHICH REQUIRED BREAST POCKET ADJUSTMENT. IT WAS ALSO REPORTED BY PATIENT THAT THE RIGHT SIDED IMPLANT WAS REIMPLANTED DURING THE POCKET ADJUSTMENT SURGERY. IN A YEAR AFTER THE IMPLANT SURGERY, PATIENT EXPERIENCED PERSISTENT JOINT STIFFNESS, PERSISTENT NON-TRAUMATIC JOINT PAIN, PERSISTENT MUSCLE PAIN, FINGERS BECOMING UNUSUALLY PALE, NUMB, OR UNCOMFORTABLE IN THE COLD, UNUSUAL HAIR LOSS, RECURRENT TINGLING OR NUMBNESS , RECURRENT DIZZINESS AND PERSISTENT MEMORY PROBLEMS POST PROCEDURE. 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: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 15635452 ↗
• InjuryDec 4, 2020Material Rupture; Adverse Event Without Identified Device or Use Problem; Material Rupture; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A (B)(6) YEAR-OLD CAUCASIAN FEMALE PATIENT WHO UNDERWENT A PRIMARY BREAST AUGMENTATION WITH 750CC TEXTURED MENTOR MEMORYGEL BREAST IMPLANTS EXPERIENCED BILATERAL RUPTURE OF IMPLANTS POST-OPERATIVELY. RUPTURE WAS CONFIRMED BY MRI. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON (B)(6) 2020. THIS MEDWATCH REPORT IS FOR THE LEFT-SIDED IMPLANT.

  Patient problems: Deformity/ Disfigurement; Swollen Lymph Nodes/Glands

  MAUDE report 10946321 ↗
• InjuryDec 4, 2020Material Rupture; Material Rupture

  IT WAS REPORTED THAT A (B)(6) YEAR-OLD CAUCASIAN FEMALE PATIENT WHO UNDERWENT A PRIMARY BREAST AUGMENTATION WITH 750CC TEXTURED MENTOR MEMORYGEL BREAST IMPLANTS EXPERIENCED BILATERAL RUPTURE OF IMPLANTS POST-OPERATIVELY. RUPTURE WAS CONFIRMED BY MRI. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON (B)(6) 2020. THIS MEDWATCH REPORT IS FOR THE RIGHT-SIDED IMPLANT.

  Patient problems: Deformity/ Disfigurement; Granuloma

  MAUDE report 10946293 ↗
• MalfunctionAug 30, 2019Gel Leak; Material Rupture; Gel Leak; Material Rupture

  IT WAS REPORTED THAT A (B)(6) YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT A BREAST AUGMENTATION PRIMARY WITH A MENTOR MEMORYGEL BREAST IMPLANT 750CC AND EXPERIENCED ¿BAD PAIN IN BOTH BREAST, PUSHING ON HER NERVES AND ARE NOT THE SAME SHAPE THEY USE TO BE. SWELLING AND BURNING SENSATION, NUMBNESS, TIGHTNESS IN HER CHEST. THEY HAVE GOTTEN SEVERELY WORSE SINCE HER SURGERY. SHE IS SLEEPING A LOT TO GET OUT OF THE PAIN. EVERY TIME SHE MOVES HER ARMS HER MUSCLES FLEX AND IT IS PAINFUL IN HER ARMS. IN ADDITION, THERE IS POSSIBLE BILATERAL RUPTURE. AS A RESULT, THE PATIENT HAD UNDERGONE REMOVAL ON (B)(6) 2019. THIS MEDWATCH IS FOR THE RIGHT BREAST IMPLANT.

  Patient problems: Neurological Deficit/Dysfunction; No Code Available

  MAUDE report 8950013 ↗
• InjuryAug 30, 2019Gel Leak; Material Rupture; Gel Leak; Material Rupture

  IT WAS REPORTED THAT A (B)(6) YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT A BREAST AUGMENTATION PRIMARY WITH A MENTOR MEMORYGEL BREAST IMPLANT 750CC AND EXPERIENCED ¿BAD PAIN IN BOTH BREAST, PUSHING ON HER NERVES AND ARE NOT THE SAME SHAPE THEY USE TO BE. SWELLING AND BURNING SENSATION, NUMBNESS, TIGHTNESS IN HER CHEST. THEY HAVE GOTTEN SEVERELY WORSE SINCE HER SURGERY. SHE IS SLEEPING A LOT TO GET OUT OF THE PAIN. EVERY TIME SHE MOVES HER ARMS HER MUSCLES FLEX AND IT IS PAINFUL IN HER ARMS. IN ADDITION, THERE IS POSSIBLE BILATERAL RUPTURE. AS A RESULT, THE PATIENT HAD UNDERGONE REMOVAL ON (B)(6) 2019. THIS MEDWATCH IS FOR THE LEFT BREAST IMPLANT.

  Patient problems: Neurological Deficit/Dysfunction; No Code Available

  MAUDE report 8950003 ↗