MENTOR MemoryGel Breast Implant 3507300MCRecalls & reported problems

Summary

The FDA's MAUDE database contains 231 adverse event reports that list this exact device (DI 00081317004141), received between Oct 12, 2018 and Sep 22, 2026 — classified as 227 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (99 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 231 reports, in the reporter's own words as published by the FDA.

• InjurySep 22, 2026Material Rupture

  It was reported that a patient with MENTOR MemoryGel Breast Implants experienced rupture on the right side confirmed by ultrasound and complicated by the silicone granuloma formation in the righty axillary region. As a result, the patient underwent device removal.

  Patient problems: Granuloma

  MAUDE report 50856431 ↗
• InjurySep 21, 2026Material Rupture

  It was reported that a patient underwent a primary breast augmentation procedure with a MENTOR MemoryGel Breast Implant gel breast prosthesis that ruptured post implantation. Rupture of the patient¿s right breast prosthesis was diagnosed via mammogram and ultrasound. 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 50845192 ↗
• InjuryAug 28, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that a female patient underwent a breast reconstruction revision with a 300cc MENTOR MemoryGel Breast Implant and experienced inflammation on the left side post-operatively. As a result, the patient underwent explantation on (b)(6) 2026, and replaced with a 360cc MENTOR MemoryGel Breast Implant.

  Patient problems: Local Reaction

  MAUDE report 50502254 ↗
• InjuryAug 12, 2026Material Rupture

  It was reported that a patient implanted with a 300cc MENTOR MemoryGel Breast Implant experienced a rupture 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: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50223034 ↗
• InjuryMay 12, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A PRIMARY BREAST AUGMENTATION SURGERY WITH IMPLANTATION OF A 300CC MENTOR MEMORYGEL BREAST IMPLANT PROSTHESIS. POST-OPERATIVELY, THE PATIENT REPORTED EXPERIENCING BILATERAL CAPSULAR CONTRACTURE AFTER CONSULTING WITH A MEDICAL PROFESSIONAL. NO FURTHER INFORMATION WAS PROVIDED. 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: Capsular Contracture

  MAUDE report 25150777 ↗
• InjuryMay 12, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A PRIMARY BREAST AUGMENTATION SURGERY WITH IMPLANTATION OF A 300CC MENTOR MEMORYGEL BREAST IMPLANT PROSTHESIS. POST-OPERATIVELY, THE PATIENT REPORTED EXPERIENCING BILATERAL CAPSULAR CONTRACTURE AFTER CONSULTING WITH A MEDICAL PROFESSIONAL. NO FURTHER INFORMATION WAS PROVIDED. 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: Capsular Contracture

  MAUDE report 25150659 ↗
• InjuryMar 12, 2026Material Rupture

  IT WAS REPORTED THAT A PATIENT UNDERWENT A PRIMARY BREAST AUGMENTATION PROCEDURE WITH A MENTOR MEMORYGEL BREAST IMPLANT GEL BREAST PROSTHESIS THAT RUPTURED POST IMPLANTATION. RUPTURE OF THE PATIENT¿S LEFT BREAST PROSTHESIS WAS DIAGNOSED VIA A PHYSICAL EXAM. AS A RESULT, THE PATIENT UNDERWENT BILATERAL EXPLANTATION AND REPLACEMENT WITH MENTOR SMOOTH ROUND HIGH PROFILE GEL BREAST PROSTHESES.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 24583858 ↗
• InjuryMar 10, 2026Material Rupture

  IT WAS REPORTED THAT A PATIENT UNDERWENT A PRIMARY BREAST AUGMENTATION SURGERY WITH IMPLANTATION OF A 300CC MENTOR MEMORYGEL BREAST IMPLANT PROSTHESIS. POST-OPERATIVELY, THE PATIENT WAS DIAGNOSED WITH A RUPTURED RIGHT IMPLANT USING MAMMOGRAM 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 24563107 ↗
• MalfunctionMar 5, 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. AS A RESULT, THE PATIENT UNDERWENT DEVICE REMOVAL.

  Patient problems: Deformity/ Disfigurement; No Clinical Signs, Symptoms or Conditions

  MAUDE report 24521009 ↗
• InjuryFeb 25, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT WHO UNDERWENT A BREAST RECONSTRUCTION REVISION PROCEDURE WITH A MENTOR MEMORYGEL BREAST IMPLANT GEL BREAST PROSTHESIS DEVELOPED AN INFECTION IN HER LEFT BREAST POST IMPLANTATION. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION AND REPLACEMENT WITH A MENTOR MEMORYGEL BREAST IMPLANT GEL BREAST PROSTHESIS.

  Patient problems: Post Operative Wound Infection

  MAUDE report 24446152 ↗
• InjuryFeb 25, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A 38-YEAR-OLD FEMALE PATIENT UNDERWENT A PRIMARY BREAST AUGMENTATION WITH A 300CC (RIGHT) MENTOR MEMORYGEL BREAST IMPLANT AND A 275CC (LEFT) MENTOR MEMORYGEL BREAST IMPLANT AND EXPERIENCED BILATERAL CAPSULAR CONTRACTURE (BAKER GRADE 3) POST-OPERATIVELY, WHICH WAS DIAGNOSED WITH AN OFFICE VISIT. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON (B)(6) 2026. THIS REPORT IS FOR THE RIGHT SIDE DEVICE.

  Patient problems: Capsular Contracture

  MAUDE report 24444996 ↗
• InjuryJan 26, 2026Material Rupture

  IT WAS REPORTED THAT A PATIENT IMPLANTED WITH A 300CC MENTOR MEMORYGEL BREAST IMPLANT EXPERIENCED A RUPTURE ON THE RIGHT SIDE POST-OPERATIVELY. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON (B)(6) 2026.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 24179990 ↗
• InjuryJan 23, 2026Material Rupture

  IT WAS REPORTED THAT A PATIENT UNDERWENT A PRIMARY BREAST AUGMENTATION SURGERY WITH IMPLANTATION OF A 300CC MENTOR MEMORYGEL BREAST IMPLANT PROSTHESIS. POST-OPERATIVELY, THE PATIENT WAS DIAGNOSED WITH A RUPTURED RIGHT IMPLANT USING ULTRASOUND IMAGING. A CONSULTATION WITH A MEDICAL PROFESSIONAL HAS BEEN CONDUCTED. 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 24163927 ↗
• InjuryJan 22, 2026Material Rupture

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

  Patient problems: Deformity/ Disfigurement

  MAUDE report 24148996 ↗
• InjuryJan 13, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT BREAST AUGMENTATION REVISION WITH TWO 300CC MENTOR MEMORYGEL BREAST IMPLANTS. POST-OPERATIVELY, THE PATIENT WAS DIAGNOSED, VIA PHYSICAL EXAMINATION, WITH BILATERAL BREAST CAPSULAR CONTRACTURES (BAKER GRADES III). 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: Capsular Contracture

  MAUDE report 24059589 ↗
• InjuryJan 13, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT BREAST AUGMENTATION REVISION WITH TWO 300CC MENTOR MEMORYGEL BREAST IMPLANTS. POST-OPERATIVELY, THE PATIENT WAS DIAGNOSED, VIA PHYSICAL EXAMINATION, WITH BILATERAL BREAST CAPSULAR CONTRACTURES (BAKER GRADES III). 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: Capsular Contracture

  MAUDE report 24059585 ↗
• InjuryDec 23, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT IMPLANTED WITH TWO 300CC MENTOR MEMORYGEL BREAST IMPLANT EXPERIENCED BILATERAL CAPSULAR CONTRACTURE (BAKER GRADE 4) POST-OPERATIVELY. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON (B)(6) 2025.

  Patient problems: Capsular Contracture

  MAUDE report 23881286 ↗
• InjuryDec 23, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT IMPLANTED WITH TWO 300CC MENTOR MEMORYGEL BREAST IMPLANT EXPERIENCED BILATERAL CAPSULAR CONTRACTURE (BAKER GRADE 4) POST-OPERATIVELY. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON (B)(6) 2025.

  Patient problems: Capsular Contracture

  MAUDE report 23881246 ↗
• InjuryNov 24, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A 42-YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT A BREAST AUGMENTATION REVISION WITH TWO 300CC MENTOR MEMORYGEL BREAST IMPLANT AND EXPERIENCED RUPTURE ON THE LEFT SIDE AND CAPSULAR CONTRACTURE (BAKER GRADE 3) ON THE RIGHT SIDE POST-OPERATIVELY, WHICH WAS DIAGNOSED WITH AN OFFICE VISIT. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON (B)(6) , 2025, AND REPLACED WITH TWO 240CC MENTOR MEMORYGEL XTRA BREAST IMPLANTS. THIS REPORT IS FOR THE RIGHT SIDE DEVICE.

  Patient problems: Capsular Contracture

  MAUDE report 23640292 ↗
• InjuryNov 24, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT A 42-YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT A BREAST AUGMENTATION REVISION WITH TWO 300CC MENTOR MEMORYGEL BREAST IMPLANT AND EXPERIENCED RUPTURE ON THE LEFT SIDE AND CAPSULAR CONTRACTURE (BAKER GRADE 3) ON THE RIGHT SIDE POST-OPERATIVELY, WHICH WAS DIAGNOSED WITH AN OFFICE VISIT. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON (B)(6) 2025, AND REPLACED WITH TWO 240CC MENTOR MEMORYGEL XTRA BREAST IMPLANTS. THIS REPORT IS FOR THE LEFT SIDE DEVICE.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 23640290 ↗
• InjuryNov 18, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A BREAST SURGERY WITH IMPLANTATION OF A 300CC MENTOR MEMORYGEL BREAST IMPLANT PROSTHESIS. POST-OPERATIVELY, THE PATIENT REPORTED EXPERIENCING UNSPECIFIED COMPLICATIONS. A CONSULTATION WITH HER PRIMARY CARE PROVIDER WAS CONDUCTED AND SHE WAS PROVIDED WITH A POSSIBLE DIAGNOSIS OF BREAST IMPLANT ILLNESS. A PLASTIC SURGEON REPORTED NO SPECIFIC SYMPTOMS AND NO OTHER AREAS OF CONCERN. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE. THIS REPORT IS FOR THE LEFT BREAST PROSTHESIS.

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

  MAUDE report 23586165 ↗
• InjurySep 17, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT IMPLANTED WITH A 300CC MENTOR MEMORYGEL BREAST IMPLANT EXPERIENCED A RUPTURE ON THE RIGHT SIDE POST-OPERATIVELY. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON (B)(6) 2025.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 23073953 ↗
• InjurySep 16, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT WITH MENTOR MEMORYGEL BREAST IMPLANTS EXPERIENCED BILATERAL RUPTURE POST-OPERATIVELY, WHICH WAS CONFIRMED VIA CT SCAN. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE. THIS REPORT IS FOR THE LEFT BREAST PROSTHESIS.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 23066173 ↗
• InjurySep 16, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT WITH MENTOR MEMORYGEL BREAST IMPLANTS EXPERIENCED BILATERAL RUPTURE POST-OPERATIVELY, WHICH WAS CONFIRMED VIA CT SCAN. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE. THIS REPORT IS FOR THE RIGHT BREAST PROSTHESIS.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 23066171 ↗
• InjuryAug 27, 2025Material Rupture; Adverse Event Without Identified Device or Use Problem; Material Rupture; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT BREAST AUGMENTATION REVISION WITH TWO 300CC MENTOR MEMORYGEL BREAST IMPLANTS. POST-OPERATIVELY, THE PATIENT WAS DIAGNOSED, VIA PHYSICAL EXAMINATION, WITH BILATERAL BREAST CAPSULAR CONTRACTURES (BAKER GRADE IV ON THE RIGHT AND BAKER GRADE III ON THE LEFT) AND POSSIBLE RIGHT BREAST IMPLANT RUPTURE. AS A RESULT, THE PATIENT HAS BEEN SCHEDULED FOR BREAST IMPLANT REMOVAL SURGERY ON (B)(6) 2025. THIS MEDWATCH FORM IS FOR THE LEFT BREAST PROSTHESIS.

  Patient problems: Capsular Contracture; No Clinical Signs, Symptoms or Conditions

  MAUDE report 22909591 ↗