MENTOR MemoryGel Breast Implant 3502501BCRecalls & reported problems

Summary

The FDA's MAUDE database contains 1,044 adverse event reports that list this exact device (DI 00081317000266), received between May 6, 2019 and Sep 29, 2026 — classified as 1,019 injuries, 25 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (418 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 25 most recent of 1,044 reports, in the reporter's own words as published by the FDA.

• InjurySep 29, 2026Material Rupture

  It was reported that a patient underwent breast augmentation revision with two 250cc MENTOR MemoryGel Breast Implants. Post-operatively, the patient experienced right breast implant rupture. At the time of this report, Mentor has received no information regarding explantation or an expected explantation date.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50927118 ↗
• InjurySep 25, 2026Material Rupture

  It was reported that a patient with MENTOR MemoryGel Breast Implants experienced rupture on the left side post-operatively, which was confirmed during a physical exam. As a result, the patient is scheduled for removal on (b)(6), 2026.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50898196 ↗
• InjurySep 14, 2026Material Rupture

  It was reported that a 64-year-old Caucasian female patient underwent a breast augmentation revision with a 250cc MENTOR MemoryGel Breast Implant and experienced a rupture, capsular contracture (baker grade unknown), and wound dehiscence on the right side post-operatively. As a result, the patient underwent explantation on (b)(6) 2026, and replaced with a Mentor breast prosthesis.

  Patient problems: Capsular Contracture; Impaired Healing

  MAUDE report 50748059 ↗
• InjurySep 11, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that a patient with MENTOR MemoryGel Breast Implants experienced infection on the left side post-operatively, which was confirmed during a physical exam. As a result, the patient underwent device removal and replacement.

  Patient problems: Post Operative Wound Infection

  MAUDE report 50735572 ↗
• InjuryAug 5, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that a patient who underwent Breast Reconstruction Revision with a 130cc MENTOR MemoryGel Breast Implant (left) and a 250cc MENTOR MemoryGel Breast Implant (right) experienced bilateral hematoma post procedure. As a result, device replacement was performed.

  Patient problems: Hematoma

  MAUDE report 50146948 ↗
• InjuryJul 30, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that a patient with MENTOR MemoryGel Breast Implants experienced capsular contracture Baker Grade III on the right side post-operatively, which was confirmed during a physical exam. As a result, the patient underwent device removal and replacement.

  Patient problems: Capsular Contracture

  MAUDE report 50085001 ↗
• InjuryJun 1, 2026Material Rupture

  IT WAS REPORTED THAT A PATIENT WITH MENTOR MEMORYGEL BREAST IMPLANTS EXPERIENCED RUPTURE ON THE RIGHT SIDE POST-OPERATIVELY, WHICH WAS CONFIRMED DURING A PHYSICAL EXAM. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 25348000 ↗
• InjuryMay 28, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A 45-YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT A PRIMARY BREAST AUGMENTATION WITH A 250CC MENTOR MEMORYGEL BREAST IMPLANT AND EXPERIENCED CAPSULAR CONTRACTURE (BAKER GRADE 2) ON THE RIGHT SIDE POST-OPERATIVELY. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE.

  Patient problems: Capsular Contracture

  MAUDE report 25318258 ↗
• InjuryMay 20, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT WHO UNDERWENT A PRIMARY BREAST AUGMENTATION PROCEDURE WITH MENTOR MEMORYGEL BREAST IMPLANT GEL BREAST PROSTHESES DEVELOPED BAKER GRADE IV CAPSULAR CONTRACTURE IN BOTH BREASTS POST IMPLANTATION. BILATERAL CAPSULAR CONTRACTURE WAS DIAGNOSED DURING AN OFFICE VISIT. AS A RESULT, THE PATIENT UNDERWENT BILATERAL EXPLANTATION. THIS MEDWATCH REPORT IS FOR THE PATIENT¿S RIGHT BREAST PROSTHESIS.

  Patient problems: Capsular Contracture

  MAUDE report 25236941 ↗
• InjuryMay 18, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT WITH MENTOR MEMORYGEL BREAST IMPLANTS EXPERIENCED CAPSULAR CONTRACTURE BAKER GRADE IV ON THE LEFT SIDE POST-OPERATIVELY, WHICH WAS CONFIRMED DURING A PHYSICAL EXAM. AS A RESULT, THE PATIENT UNDERWENT DEVICE REMOVAL AND REPLACEMENT ON THE LEFT SIDE. THE PATIENT ALSO REPORTEDLY EXPERIENCED SCARRING UNDERWENT A SUBSEQUENT SCAR REVISION ON THE RIGHT SIDE WITHOUT EXPLANTATION. THIS REPORT IS FOR THE RIGHT BREAST PROSTHESIS.

  Patient problems: Scar Tissue

  MAUDE report 25204193 ↗
• InjuryMay 12, 2026Material Rupture

  IT WAS REPORTED THAT A PATIENT UNDERWENT A PRIMARY BREAST AUGMENTATION SURGERY WITH IMPLANTATION OF A 250CC MENTOR MEMORYGEL BREAST IMPLANT PROSTHESIS. POST-OPERATIVELY, THE PATIENT WAS DIAGNOSED WITH A RUPTURED LEFT IMPLANT USING MAGNETIC RESONANCE IMAGING. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE. 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 25156711 ↗
• InjuryApr 29, 2026Adverse Event Without Identified Device or Use Problem

  A FEMALE PATIENT UNDERWENT AN UNSPECIFIED BREAST SURGERY PROCEDURE UTILIZING MENTOR MEMORYGEL, XTR 650CC SILICONE PROSTHESIS. POSTOPERATIVELY, SHE EXPERIENCED BILATERAL CAPSULAR CONTRACTURES, GRADE III GRADE. THE PHYSICAL EXAMINATION DIAGNOSED THE ISSUES. AT THE TIME OF THIS REPORT, MENTOR RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE. THIS REPORT RELATES TO THE RIGHT SIDE.

  Patient problems: Capsular Contracture

  MAUDE report 25036010 ↗
• InjuryApr 14, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A BREAST AUGMENTATION REVISION SURGERY WITH IMPLANTATION OF A 250CC PROSTHESIS. POST-OPERATIVELY, THE PATIENT WAS DIAGNOSED WITH BILATERAL BAKER GRADE IV (LEFT BREAST) AND III (RIGHT BREAST) BY A MEDICAL PROFESSIONAL. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE. FOLLOW-UPS HAVE BEEN CONDUCTED, AND NO ADDITIONAL INFORMATION HAS BEEN RECEIVED. IF MORE INFORMATION BECOMES AVAILABLE, MENTOR WILL SUBMIT A SUPPLEMENTAL REPORT ACCORDINGLY. THIS REPORT IS FOR THE RIGHT BREAST PROSTHESIS.

  Patient problems: Capsular Contracture

  MAUDE report 24879144 ↗
• MalfunctionApr 9, 2026Material Rupture

  IT WAS REPORTED THAT A 250CC MENTOR MEMORYGEL BREAST IMPLANT BEING USED IN A BREAST SURGERY WAS RUPTURED DURING THE OPERATION. THE SURGEON USED BACKUP DEVICES, AND THERE WERE NO REPORTED PATIENT CONSEQUENCES. PROCEDURAL DELAY WAS DESCRIBED AS MINOR, HOWEVER, IT HAD NO ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24834599 ↗
• InjuryApr 9, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT BREAST AUGMENTATION REVISION, AS PART OF A CLINICAL STUDY, WITH TWO 250CC MENTOR MEMORYGEL BREAST IMPLANTS. POST-OPERATIVELY, THE PATIENT DEVELOPED BILATERAL BREAST ASYMMETRIES. 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: Deformity/ Disfigurement

  MAUDE report 24832225 ↗
• InjuryApr 9, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT BREAST AUGMENTATION REVISION, AS PART OF A CLINICAL STUDY, WITH TWO 250CC MENTOR MEMORYGEL BREAST IMPLANTS. POST-OPERATIVELY, THE PATIENT DEVELOPED BILATERAL BREAST ASYMMETRIES. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE. THIS MEDWATCH FORM IS FOR THE RIGHT BREAST PROSTHESIS.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 24832223 ↗
• InjuryMar 25, 2026Material Rupture

  IT WAS REPORTED THAT A PATIENT IMPLANTED WITH TWO 250CC MENTOR MEMORYGEL BREAST IMPLANT EXPERIENCED BILATERAL RUPTURE POST-OPERATIVELY. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON (B)(6) 2026.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 24690753 ↗
• InjuryMar 25, 2026Material Rupture

  IT WAS REPORTED THAT A PATIENT IMPLANTED WITH TWO 250CC MENTOR MEMORYGEL BREAST IMPLANT EXPERIENCED BILATERAL RUPTURE POST-OPERATIVELY. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON (B)(6) 2026.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 24690752 ↗
• MalfunctionMar 11, 2026Material Rupture

  IT WAS REPORTED THAT A MENTOR MEMORYGEL BREAST IMPLANTS BEING USED IN A BREAST IMPLANTATION PROCEDURE WAS FOUND TO BE RUPTURED DURING THE OPERATION. NO ADVERSE EVENT WAS EXPERIENCED BY THE PATIENT. THE SURGEON USED BACKUP DEVICES, AND THERE WERE NO REPORTED PATIENT CONSEQUENCES OR PROCEDURAL DELAYS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24575673 ↗
• InjuryMar 11, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A FEMALE PATIENT WHO UNDERWENT A BREAST AUGMENTATION PRIMARY WITH MENTOR MEMORYGEL, 250CC SILICONE PROSTHESIS EXPERIENCED RIGHT SIDED SYMPTOMATIC RUPTURE, CAPSULAR CONTRACTURE GRADE III, AND LEFT SIDED PTOSIS POSTOPERATIVE. A RECENT MRI DEMONSTRATED INTRA CAPSULAR RUPTURE. AS A RESULT, THE PATIENT UNDERWENT BILATERAL REPLACEMENT WITH 200CC MOD PLUS MENTOR SILICONE IMPLANTS, CAPSULOTOMY AND LIFT ON THE LEFT SIDE ON (B)(6) 2026. THIS REPORT RELATES TO THE LEFT SIDE.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 24568941 ↗
• InjuryMar 7, 2026Material Rupture

  IT WAS REPORTED THAT A PATIENT UNDERWENT A BREAST RECONSTRUCTION REVISION PROCEDURE WITH A MENTOR MEMORYGEL BREAST IMPLANT GEL BREAST PROSTHESIS THAT RUPTURED POST IMPLANTATION. RUPTURE OF THE PATIENT¿S RIGHT BREAST PROSTHESIS WAS REPORTED. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION AND REPLACEMENT WITH A MENTOR MEMORYGEL BREAST IMPLANT GEL BREAST PROSTHESIS.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 24540385 ↗
• InjuryMar 4, 2026Material Rupture

  IT WAS REPORTED THAT A PATIENT WITH MENTOR MEMORYGEL BREAST IMPLANTS EXPERIENCED RUPTURE ON THE LEFT SIDE POST-OPERATIVELY, WHICH WAS CONFIRMED VIA MRI. AS A RESULT, THE PATIENT UNDERWENT DEVICE REMOVAL. THE REPORTED IMPLANTATION DATE IS PRIOR TO THE DEVICE MANUFACTURE DATE. IF ADDITIONAL INFORMATION IS RECEIVED REGARDING THE CORRECT DATE OF IMPLANTATION OR DEVICE LOT NUMBER, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 24513315 ↗
• InjuryFeb 26, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT BREAST AUGMENTATION REVISION WITH TWO 250CC MENTOR MEMORYGEL BREAST IMPLANTS. POST-OPERATIVELY, THE PATIENT DEVELOPED RIGHT BREAST CAPSULAR CONTRACTURE (BAKER GRADE III). AS A RESULT, THE PATIENT UNDERWENT BREAST IMPLANT REMOVAL SURGERY ON (B)(6) 2026.

  Patient problems: Capsular Contracture

  MAUDE report 24463841 ↗
• InjuryFeb 25, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A FEMALE PATIENT UNDERWENT A BREAST RECONSTRUCTION REVISION WITH A 250CC MENTOR MEMORYGEL BREAST IMPLANT AND EXPERIENCED A WOUND INFECTION ON THE LEFT SIDE POST-OPERATIVELY. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON (B)(6) 2025, AND REPLACED WITH A 300CC MENTOR MEMORYGEL BREAST IMPLANT.

  Patient problems: Post Operative Wound Infection

  MAUDE report 24446432 ↗
• InjuryFeb 19, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT BREAST AUGMENTATION WITH TWO MENTOR MEMORYGEL BREAST IMPLANT. POST-OPERATIVELY, THE PATIENT EXPERIENCED MOLD IN THEIR BODY AND WAS ADVISED BY THEIR DOCTOR TO USE INFRARED SAUNA SEVERAL TIMES PER WEEK. 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: Post Operative Wound Infection

  MAUDE report 24393037 ↗