MENTOR MemoryGel Breast Implant 3505590BCRecalls & reported problems

Summary

The FDA's MAUDE database contains 274 adverse event reports that list this exact device (DI 00081317006992), received between May 10, 2019 and Sep 8, 2026 — classified as 271 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (105 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 274 reports, in the reporter's own words as published by the FDA.

• InjurySep 8, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that a patient implanted with two 590cc MENTOR MemoryGel Breast Implant experienced peripheral neuropathy post-operatively. At the time of this report, Mentor has received no information regarding explantation or an expected explantation date.

  Patient problems: Autoimmune Disorder

  MAUDE report 50672175 ↗
• InjurySep 8, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that a patient implanted with two 590cc MENTOR MemoryGel Breast Implant experienced peripheral neuropathy post-operatively. At the time of this report, Mentor has received no information regarding explantation or an expected explantation date.

  Patient problems: Autoimmune Disorder

  MAUDE report 50672169 ↗
• InjuryJun 3, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT IMPLANTED WITH TWO MENTOR MEMORYGEL BREAST IMPLANT EXPERIENCED BREAST IMPLANT ILLNESSES SYMPTOMS INCLUDING SWELLING, PAIN, BREAST PAIN, AND HEART PROBLEMS POST-OPERATIVELY. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON (B)(6) 2026.

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

  MAUDE report 25375184 ↗
• InjuryJun 2, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A BREAST AUGMENTATION REVISION SURGERY WITH IMPLANTATION OF A 590CC MENTOR MEMORYGEL BREAST IMPLANT PROSTHESIS. POST-OPERATIVELY, THE PATIENT REPORTED EXPERIENCING A HARD RIGHT BREAST WITH SOME CHANGES. SHE DESIRED A SIZE REDUCTION AND AN IMPLANT PLANE CHANGE FROM SUBMUSCULAR TO SUBGLANDULAR AS SHE HAD ANIMATION ISSUES WITH THE BREASTS. AN ULTRASOUND WAS CONDUCTED AND CONFIRMED A RUPTURED RIGHT IMPLANT. A CONSULTATION WITH A MEDICAL PROFESSIONAL WAS CONDUCTED. AS A RESULT, THE PATIENT UNDERWENT BILATERAL EXCHANGE WITH MOTIVA (NON-MENTOR) IMPLANTS ON (B)(6) 2026. THIS REPORT IS FOR THE LEFT BREAST PROSTHESIS.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 25368175 ↗
• InjuryMay 15, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT PRIMARY BREAST AUGMENTATION WITH TWO MENTOR MEMORYGEL BREAST IMPLANTS. POST-OPERATIVELY, THE PATIENT DEVELOPED BILATERAL BREAST CAPSULAR CONTRACTURES (BAKER GRADE III ON THE RIGHT AND BAKER GRADE II ON THE LEFT) AND BILATERAL BREAST PTOSIS. THE LEFT BREAST INCISION ALSO BEGAN TO OPEN UP DURING THE CAPSULAR CONTRACTURE. AS A RESULT, THE PATIENT UNDERWENT BREAST IMPLANT REMOVAL SURGERY ON (B)(6) 2026. THIS MEDWATCH FORM IS FOR THE LEFT BREAST PROSTHESIS.

  Patient problems: Capsular Contracture; Impaired Healing

  MAUDE report 25194110 ↗
• InjuryMay 15, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT IMPLANTED WITH A 590CC MENTOR MEMORYGEL BREAST IMPLANT EXPERIENCED CAPSULAR CONTRACTURE BAKER GRADE 4 ON THE LEFT 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 25185677 ↗
• InjuryMay 5, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A PRIMARY BREAST RECONSTRUCTION SURGERY WITH IMPLANTATION OF A 590CC MENTOR MEMORYGEL BREAST IMPLANT PROSTHESIS. POST-OPERATIVELY, THE PATIENT REPORTED THE RIGHT IMPLANT WAS CAVING IN AND SHE HAD CONCERNS REGARDING PRODUCT EXPIRATION. 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 25085369 ↗
• 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 590CC MENTOR MEMORYGEL BREAST IMPLANT PROSTHESIS. POST-OPERATIVELY, THE PATIENT INQUIRED ON THE RECALL STATUS OF THE IMPLANTS AND REPORTED RIPPLING OF THE BREASTS, BILATERALLY. 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: Wrinkling

  MAUDE report 24877775 ↗
• InjuryFeb 24, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A PRIMARY BREAST AUGMENTATION SURGERY WITH IMPLANTATION OF A 590CC MENTOR MEMORYGEL BREAST IMPLANT PROSTHESIS. POST-OPERATIVELY, THE PATIENT WAS DIAGNOSED WITH RIGHT BREAST BAKER GRADE IV CAPSULAR CONTRACTURE DURING A PHYSICAL EXAM. 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 24433287 ↗
• InjuryFeb 19, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A BREAST AUGMENTATION SURGERY WITH IMPLANTATION OF A 590CC MENTOR MEMORYGEL BREAST IMPLANT PROSTHESIS. POST-OPERATIVELY, THE PATIENT EXPERIENCED SWOLLEN PAINFUL LYMPH NODES ON THE RIGHT SIDE WHICH WAS RESOLVED USING ANTIBIOTICS. HOWEVER, THE PATIENT EXPERIENCED PERSISTENT RIGHT AXILLARY PAIN AND AS A RESULT, MAMMOGRAM IMAGING WAS PERFORMED. IMAGING FINDINGS INDICATED NORMAL AXILLARY LYMPH NODES AND A LEFT IMPLANT SUSPICIOUS OF RUPTURE. ON PHYSICAL EXAM, SHE WAS NOTED TO HAVE BILATERAL GLANDULAR PTOSIS AND SNOOPY DEFORMITY. AS A RESULT, THE PATIENT UNDERWENT BILATERAL EXCHANGE WITH NATRELLE (NON-MENTOR) IMPLANTS ON (B)(6) 2026. FURTHERMORE, DURING THE SURGERY, THE BOTH IMPLANTS WERE REMOVED INTACT AND THE RUPTURE WAS NOT CONFIRMED. THIS REPORT IS FOR THE RIGHT BREAST PROSTHESIS.

  Patient problems: Swollen Lymph Nodes/Glands

  MAUDE report 24390715 ↗
• InjuryFeb 19, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A BREAST AUGMENTATION SURGERY WITH IMPLANTATION OF A 590CC MENTOR MEMORYGEL BREAST IMPLANT PROSTHESIS. POST-OPERATIVELY, THE PATIENT EXPERIENCED SWOLLEN PAINFUL LYMPH NODES ON THE RIGHT SIDE WHICH WAS RESOLVED USING ANTIBIOTICS. HOWEVER, THE PATIENT EXPERIENCED PERSISTENT RIGHT AXILLARY PAIN AND AS A RESULT, MAMMOGRAM IMAGING WAS PERFORMED. IMAGING FINDINGS INDICATED NORMAL AXILLARY LYMPH NODES AND A LEFT IMPLANT SUSPICIOUS OF RUPTURE. ON PHYSICAL EXAM, SHE WAS NOTED TO HAVE BILATERAL GLANDULAR PTOSIS AND SNOOPY DEFORMITY. AS A RESULT, THE PATIENT UNDERWENT BILATERAL EXCHANGE WITH NATRELLE (NON-MENTOR) IMPLANTS ON (B)(6) 2026. FURTHERMORE, DURING THE SURGERY, THE BOTH IMPLANTS WERE REMOVED INTACT AND THE RUPTURE WAS NOT CONFIRMED. THIS REPORT IS FOR THE LEFT BREAST PROSTHESIS.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 24390695 ↗
• InjuryFeb 6, 2026Material Rupture

  IT WAS REPORTED THAT A PATIENT UNDERWENT BREAST AUGMENTATION REVISION WITH TWO 590CC MENTOR MEMORYGEL BREAST IMPLANTS. POST-OPERATIVELY, THE PATIENT WAS DIAGNOSED, VIA MRI, WITH LEFT BREAST IMPLANT RUPTURE AND BILATERAL BREAST CAPSULAR CONTRACTURES (BAKER GRADES III). AS A RESULT, THE PATIENT HAS BEEN SCHEDULED FOR BREAST IMPLANT REMOVAL SURGERY ON (B)(6) 2026. THIS MEDWATCH FORM IS FOR THE LEFT BREAST PROSTHESIS.

  Patient problems: Autoimmune Disorder; Capsular Contracture

  MAUDE report 24275422 ↗
• InjuryFeb 5, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A PRIMARY BREAST AUGMENTATION SURGERY WITH IMPLANTATION OF A 590CC MENTOR MEMORYGEL BREAST IMPLANT PROSTHESIS. POST-OPERATIVELY, THE PATIENT WAS DIAGNOSED WITH BAKER GRADE III CAPSULAR CONTRACTURE OF AN UNDISCLOSED BREAST DURING A PHONE CONSULTATION USING THE PATIENT'S SYMPTOMS. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE. THE DATE OF EVENT WAS PROVIDED TO MENTOR AS A BEST ESTIMATE. AS THE AFFECTED SIDE WAS NOT PROVIDED, THE SERIAL NUMBERS FOR BOTH PRODUCTS ARE BEING PROVIDED AS LEFT IMPLANT - SERIAL NUMBER: (B)(6) AND RIGHT IMPLANT - SERIAL NUMBER: (B)(6). THE CATALOG AND LOT NUMBERS ARE THE SAME FOR BOTH DEVICES. 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 24273695 ↗
• InjuryFeb 2, 2026Material Rupture; Adverse 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 III CAPSULAR CONTRACTURE IN BOTH BREASTS POST IMPLANTATION. BILATERAL CAPSULAR CONTRACTURE WAS DIAGNOSED VIA A HEALTHCARE PROFESSIONAL¿S EXAM. 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: Capsular Contracture

  MAUDE report 24242362 ↗
• InjuryJan 21, 2026Material Rupture

  IT WAS REPORTED THAT A PATIENT IMPLANTED WITH A 590CC MENTOR MEMORYGEL BREAST IMPLANT EXPERIENCED A RUPTURE AND BREAST PAIN ON THE RIGHT SIDE POST-OPERATIVELY. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON (B)(6) 2025.

  Patient problems: Pain

  MAUDE report 24134437 ↗
• InjuryJan 13, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A FEMALE PATIENT UNDERWENT A BREAST AUGMENTATION REVISION WITH TWO 590CC MENTOR MEMORYGEL BREAST IMPLANTS AND EXPERIENCED BILATERAL BREAST PTOSIS AND CAPSULAR CONTRACTURE (BAKER GRADE UNKNOWN) ON THE LEFT SIDE POST-OPERATIVELY. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON (B)(6) 2025 FOR THE LEFT SIDE AND REPLACED WITH A 590CC MENTOR MEMORYGEL BREAST IMPLANT. THE RIGHT SIDE WAS NOT EXPLANTED; IT WAS ADDRESSED BY SURGICAL INTERVENTION ONLY. THIS REPORT IS FOR THE LEFT SIDE DEVICE.

  Patient problems: Capsular Contracture

  MAUDE report 24059696 ↗
• InjuryJan 13, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A FEMALE PATIENT UNDERWENT A BREAST AUGMENTATION REVISION WITH TWO 590CC MENTOR MEMORYGEL BREAST IMPLANTS AND EXPERIENCED BILATERAL BREAST PTOSIS AND CAPSULAR CONTRACTURE (BAKER GRADE UNKNOWN) ON THE LEFT SIDE POST-OPERATIVELY. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON (B)(6) 2025 FOR THE LEFT SIDE, AND REPLACED WITH A 590CC MENTOR MEMORYGEL BREAST IMPLANT. THE RIGHT SIDE WAS NOT EXPLANTED; IT WAS ADDRESSED BY SURGICAL INTERVENTION ONLY. THIS REPORT IS FOR THE RIGHT SIDE DEVICE.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 24059693 ↗
• InjuryDec 24, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT UNDERWENT PRIMARY BREAST AUGMENTATION WITH TWO 590CC MENTOR MEMORYGEL BREAST IMPLANTS. POST-OPERATIVELY, THE PATIENT DEVELOPED BILATERAL BREAST PAIN AND WAS DIAGNOSED WITH BILATERAL BREAST IMPLANT RUPTURES. 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: Breast Discomfort/Pain

  MAUDE report 23889503 ↗
• InjuryDec 24, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT UNDERWENT PRIMARY BREAST AUGMENTATION WITH TWO 590 CC MENTOR MEMORYGEL BREAST IMPLANTS. POST-OPERATIVELY, THE PATIENT DEVELOPED BILATERAL BREAST PAIN AND WAS DIAGNOSED WITH BILATERAL BREAST IMPLANT RUPTURES. 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: Breast Discomfort/Pain

  MAUDE report 23889502 ↗
• InjuryDec 10, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT UNDERWENT BREAST AUGMENTATION WITH A 590CC MENTOR MEMORYGEL BREAST IMPLANT ON THE RIGHT BREAST. POST-OPERATIVELY, THE PATIENT WAS DIAGNOSED, VIA MRI, WITH RIGHT BREAST IMPLANT RUPTURE. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 23774005 ↗
• InjuryDec 9, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT UNDERWENT A BREAST AUGMENTATION SURGERY WITH IMPLANTATION OF A 590CC MENTOR MEMORYGEL BREAST IMPLANT PROSTHESIS. POST-OPERATIVELY, THE PATIENT HAD ROUTINE MAMMOGRAM IMAGING PERFORMED AND RESULTS INDICATED A SMALL CLUSTER OF BENIGN CYSTS IN THE LEFT BREAST WITH EVIDENCE OF A RUPTURED LEFT IMPLANT. DURING A PHYSICAL EXAM, SHE WAS DIAGNOSED WITH ASYMMETRY BETWEEN THE BREASTS AND BILATERALLY RUPTURED IMPLANTS. AS A RESULT, THE PATIENT UNDERWENT BILATERAL EXCHANGE WITH MENTOR GEL IMPLANTS ON (B)(6) 2025. THIS REPORT IS FOR THE RIGHT BREAST PROSTHESIS.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 23759541 ↗
• InjuryNov 25, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT UNDERWENT A BREAST AUGMENTATION REVISION SURGERY WITH IMPLANTATION OF A 590CC MENTOR MEMORYGEL BREAST IMPLANT PROSTHESIS. POST-OPERATIVELY, THE PATIENT WAS DIAGNOSED WITH A RUPTURED LEFT IMPLANT USING ULTRASOUND IMAGING. AS A RESULT, THE PATIENT WAS SCHEDULED FOR IMPLANT REMOVAL ON (B)(6) 2026.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 23646261 ↗
• InjuryNov 13, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT A FEMALE PATIENT UNDERWENT A BREAST SURGERY WITH A 590CC MENTOR MEMORYGEL BREAST IMPLANT AND EXPERIENCED A RUPTURE ON THE LEFT SIDE POST-OPERATIVELY. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON (B)(6) 2025 AND REPLACED WITH A 635CC MENTOR MEMORYGEL BOOST BREAST IMPLANT.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 23547560 ↗
• InjuryNov 12, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A 45-YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT A PRIMARY BREAST AUGMENTATION REVISION WITH A 590CC MENTOR MEMORYGEL BREAST IMPLANT AND EXPERIENCED CAPSULAR CONTRACTURE (BAKER GRADE 3) AND BREAST PTOSIS ON THE LEFT SIDE POST-OPERATIVELY. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON (B)(6) 2025.

  Patient problems: Capsular Contracture

  MAUDE report 23534453 ↗
• InjuryOct 28, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT UNDERWENT A BREAST AUGMENTATION SURGERY WITH IMPLANTATION OF A 590CC MENTOR MEMORYGEL BREAST IMPLANT PROSTHESIS. POST-OPERATIVELY, THE PATIENT HAD ROUTINE MAMMOGRAM IMAGING PERFORMED AND RESULTS INDICATED A SMALL CLUSTER OF BENIGN CYSTS IN THE LEFT BREAST WITH EVIDENCE OF A RUPTURED LEFT IMPLANT. AS A RESULT, THE PATIENT WAS SCHEDULED FOR BREAST IMPLANT EXCHANGE ON (B)(6) 2025. THE CYSTS WERE AN INCIDENTAL FINDING, WITHOUT CONCERNING RESULTS AS THEY ARE BENIGN, AND NO PLANNED OR PERFORMED INTERVENTION WAS INDICATED.

  Patient problems: Cyst(s)

  MAUDE report 23405929 ↗