MENTOR MemoryGel Breast Implant 3507250BCRecalls & reported problems

Summary

The FDA's MAUDE database contains 212 adverse event reports that list this exact device (DI 00081317000075), received between Mar 27, 2018 and Sep 10, 2026 — classified as 212 injuries.

The most frequently reported specific device problem is “Material Rupture” (142 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 212 reports, in the reporter's own words as published by the FDA.

• InjurySep 10, 2026Material Rupture

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50722863 ↗
• InjurySep 10, 2026Gel Leak

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50721087 ↗
• InjuryMar 4, 2026Material Rupture

  IT WAS REPORTED THAT A PATIENT IMPLANTED WITH TWO MENTOR MEMORYGEL BREAST IMPLANT EXPERIENCED BILATERAL RUPTURES, CAPSULAR CONTRACTURE, AND A BREAST CYST ON THE LEFT SIDE POST-OPERATIVELY. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON (B)(6) 2026.

  Patient problems: Breast Mass; Capsular Contracture

  MAUDE report 24508000 ↗
• InjuryFeb 23, 2026Material Rupture

  IT WAS REPORTED THAT A PATIENT WITH MENTOR MEMORYGEL BREAST IMPLANTS EXPERIENCED BILATERAL RUPTURE POST-OPERATIVELY, WHICH WAS CONFIRMED VIA ULTRASOUND. 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 24415815 ↗
• InjuryFeb 23, 2026Material Rupture

  IT WAS REPORTED THAT A PATIENT WITH MENTOR MEMORYGEL BREAST IMPLANTS EXPERIENCED BILATERAL RUPTURE POST-OPERATIVELY, WHICH WAS CONFIRMED VIA ULTRASOUND. 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 24415804 ↗
• InjuryJan 30, 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 WAS DIAGNOSED, VIA ULTRASOUND, WITH BILATERAL BREAST CAPSULAR CONTRACTURES (BAKER GRADE III). AS A RESULT, THE PATIENT UNDERWENT BREAST IMPLANT REMOVAL AND REPLACEMENT SURGERY ON (B)(6) 2025. THE REPLACEMENT DEVICES WERE TWO MENTOR GEL IMPLANTS. THIS MEDWATCH FORM IS FOR THE RIGHT BREAST PROSTHESIS.

  Patient problems: Capsular Contracture

  MAUDE report 24223228 ↗
• InjuryJan 30, 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 WAS DIAGNOSED, VIA ULTRASOUND, WITH BILATERAL BREAST CAPSULAR CONTRACTURES (BAKER GRADE III). AS A RESULT, THE PATIENT UNDERWENT BREAST IMPLANT REMOVAL AND REPLACEMENT SURGERY ON (B)(6) 2025. THE REPLACEMENT DEVICES WERE TWO MENTOR GEL IMPLANTS. THIS MEDWATCH FORM IS FOR THE LEFT BREAST PROSTHESIS.

  Patient problems: Capsular Contracture

  MAUDE report 24223223 ↗
• InjuryNov 25, 2025Material Rupture; Material 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 AND REPLACEMENT. 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 23647949 ↗
• InjuryNov 10, 2025Adverse Event Without Identified Device or Use Problem; Adverse 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 WAS DIAGNOSED, VIA PHYSICAL EXAMINATION, WITH BILATERAL BREAST CAPSULAR CONTRACTURES (BAKER GRADE III). AS A RESULT, THE PATIENT HAS BEEN SCHEDULED FOR BREAST IMPLANT REMOVAL SURGERY ON (B)(6) 2025. THIS MEDWATCH FORM IS FOR THE RIGHT BREAST PROSTHESIS.

  Patient problems: Capsular Contracture

  MAUDE report 23510026 ↗
• InjuryJul 21, 2025Material Rupture; Material 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 BILATERAL CAPSULAR CONTRACTURE (BAKER GRADE RATINGS WERE NOT PROVIDED) AND A RUPTURED RIGHT BREAST IMPLANT DURING A PHYSICAL EXAM. MAGNETIC RESONANCE IMAGING WAS PERFORMED. AS A RESULT, THE PATIENT WAS SCHEDULED FOR BILATERAL IMPLANT REMOVAL ON (B)(6) 2025. THIS REPORT IS FOR THE RIGHT BREAST PROSTHESIS.

  Patient problems: Capsular Contracture

  MAUDE report 22557383 ↗
• InjuryJul 21, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  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 BILATERAL CAPSULAR CONTRACTURE (BAKER GRADE RATINGS WERE NOT PROVIDED) AND A RUPTURED RIGHT BREAST IMPLANT DURING A PHYSICAL EXAM. MAGNETIC RESONANCE IMAGING WAS PERFORMED. AS A RESULT, THE PATIENT WAS SCHEDULED FOR BILATERAL IMPLANT REMOVAL ON (B)(6) 2025. THIS REPORT IS FOR THE LEFT BREAST PROSTHESIS.

  Patient problems: Capsular Contracture

  MAUDE report 22557353 ↗
• InjuryJul 18, 2025Material Rupture; Material Rupture

  A FEMALE PATIENT WHO UNDERWENT A BREAST AUGMENTATION REVISION WITH A MENTOR MEMORYGEL, 250CC SILICONE PROSTHESIS EXPERIENCE BILATERAL SILENT RUPTURES POST PROCEDURE. THE MRI/ CT SCREENING EXAMINATIONS CONFIRMED THE ISSUE. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE. THIS REPORT RELATES TO THE LEFT SIDE.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 22543265 ↗
• InjuryJul 18, 2025Material Rupture; Material Rupture

  A FEMALE PATIENT WHO UNDERWENT A BREAST AUGMENTATION REVISION WITH A MENTOR MEMORYGEL, 250CC SILICONE PROSTHESIS EXPERIENCE BILATERAL SILENT RUPTURES POST PROCEDURE. THE MRI/ CT SCREENING EXAMINATIONS CONFIRMED THE ISSUE. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE. THIS REPORT RELATES TO THE RIGHT SIDE.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 22543070 ↗
• InjuryJul 8, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT A FEMALE PATIENT UNDERWENT A BREAST AUGMENTATION REVISION WITH 250 CC (LEFT) MENTOR MEMORYGEL BREAST IMPLANT AND A 300 CC (RIGHT) MENTOR MEMORYGEL BREAST IMPLANT AND EXPERIENCED BILATERAL RUPTURES POST-OPERATIVELY. AS A RESULT, THE PATIENT UNDERWENT BILATERAL DEVICE EXPLANTATION ON (B)(6) 2025. THIS REPORT IS FOR THE LEFT SIDE DEVICE.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 22439834 ↗
• InjuryJun 12, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT A FEMALE PATIENT UNDERWENT A BREAST AUGMENTATION REVISION WITH 250CC 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 190CC MENTOR MEMORYGEL BREAST IMPLANT (CATALOG NUMBER 3507190MC).

  Patient problems: Deformity/ Disfigurement

  MAUDE report 22195598 ↗
• InjuryMar 26, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT UNDERWENT A BREAST AUGMENTATION PRIMARY WITH MENTOR MEMORYGEL BREAST IMPLANTS 250CC AND EXPERIENCED BILATERAL RUPTURE POST-OPERATIVELY, WHICH WAS CONFIRMED VIA MAMMOGRAM. AS A RESULT, THE PATIENT UNDERWENT REMOVAL ON (B)(6) 2025. THIS REPORT IS FOR THE SECOND OF TWO DEVICES. THE REPORTED LOT NUMBER DOES NOT CORRESPOND TO ANY CURRENT MENTOR DEVICES. MULTIPLE ATTEMPTS WERE MADE TO GET CLARIFICATION ABOUT THE LOT NUMBER; HOWEVER, NO FURTHER INFORMATION IS AVAILABLE. IF ADDITIONAL INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

  Patient problems: Calcium Deposits/Calcification; Deformity/ Disfigurement

  MAUDE report 21698343 ↗
• InjuryMar 26, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT UNDERWENT A BREAST AUGMENTATION PRIMARY WITH MENTOR MEMORYGEL BREAST IMPLANTS 250CC AND EXPERIENCED BILATERAL RUPTURE POST-OPERATIVELY, WHICH WAS CONFIRMED VIA MAMMOGRAM. AS A RESULT, THE PATIENT UNDERWENT REMOVAL ON (B)(6) 2025. THIS REPORT IS FOR THE FIRST OF TWO DEVICES. THE REPORTED LOT NUMBER DOES NOT CORRESPOND TO ANY CURRENT MENTOR DEVICES. MULTIPLE ATTEMPTS WERE MADE TO GET CLARIFICATION ABOUT THE LOT NUMBER, HOWEVER NO FURTHER INFORMATION IS AVAILABLE. IF ADDITIONAL INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

  Patient problems: Calcium Deposits/Calcification; Deformity/ Disfigurement

  MAUDE report 21698313 ↗
• InjuryMar 25, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT A 78-YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT A PRIMARY BREAST AUGMENTATION WITH TWO 250CC MENTOR MEMORYGEL BREAST IMPLANTS AND EXPERIENCED BILATERAL RUPTURE POST-OPERATIVELY, WHICH WAS DIAGNOSED DURING SURGERY. THE PATIENT UNDERWENT EXPLANTATION ON (B)(6) 2025 AND REPLACED WITH A 320CC MENTOR MEMORYGEL BREAST IMPLANTS (CATALOG NUMBER 3507320MC). THIS REPORT IS FOR THE LEFT SIDE DEVICE.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 21690266 ↗
• InjuryMar 25, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT A 78-YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT A PRIMARY BREAST AUGMENTATION WITH TWO 250CC MENTOR MEMORYGEL BREAST IMPLANTS AND EXPERIENCED BILATERAL RUPTURE POST-OPERATIVELY, WHICH WAS DIAGNOSED DURING SURGERY. THE PATIENT UNDERWENT EXPLANTATION ON (B)(6) 2025 AND REPLACED WITH A 320CC MENTOR MEMORYGEL BREAST IMPLANTS (CATALOG NUMBER 3507320MC). THIS REPORT IS FOR THE RIGHT-SIDE DEVICE.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 21690264 ↗
• InjuryMar 21, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A FEMALE PATIENT WHO UNDERWENT BREAST AUGMENTATION WITH MENTOR MEMORYGEL 250CC SILICONE PROSTHESES DEVELOPED GRADE IV CAPSULAR CONTRACTURE ON THE RIGHT SIDE, AS DIAGNOSED THROUGH A CLINICAL EXAMINATION. THIS COMPLICATION NECESSITATED A SURGICAL INTERVENTION IN WHICH THE PATIENT UNDERWENT A RIGHT-SIDED CAPSULECTOMY AND SUBSEQUENT REPLACEMENT OF THE PROSTHESIS WITH AN UNSPECIFIED MENTOR GEL PROSTHESIS OF 233CC ON (B)(6) 2025.

  Patient problems: Capsular Contracture

  MAUDE report 21664323 ↗
• InjuryFeb 5, 2025Material Rupture; Material Rupture

  A FEMALE PATIENT UNDERWENT PRIMARY BREAST AUGMENTATION WITH MENTOR MEMORYGEL SILICONE PROSTHESES, RECEIVING 250CC ON THE RIGHT SIDE AND 200CC ON THE LEFT SIDE. SUBSEQUENTLY, MRI EXAMINATIONS REVEALED BILATERAL SILENT RUPTURES OF THE IMPLANTS, WHICH WERE ASYMPTOMATIC AT THE TIME OF DETECTION. AS A RESULT, THE PATIENT UNDERWENT A BILATERAL REMOVAL OF THE PROSTHESES ON (B)(6) 2025. THIS REPORT SPECIFICALLY FOCUSES ON THE RIGHT-SIDED IMPLANT.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 21315350 ↗
• InjuryJan 3, 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 AUGMENTATION PRIMARY WITH MENTOR MEMORYGEL BREAST IMPLANTS 275CC AND EXPERIENCED BILATERAL IMPLANT SITE FLUID COLLECTION ALONG WITH CAPSULAR CONTRACTURE BAKER GRADE UNKNOWN AND RUPTURE ON THE RIGHT SIDE POST-OPERATIVELY, WHICH WAS CONFIRMED DURING A PHYSICAL EXAM. AS A RESULT, THE PATIENT UNDERWENT REMOVAL ON (B)(6) 2024. THIS REPORT IS FOR THE LEFT BREAST PROSTHESIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21069763 ↗
• InjuryDec 3, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A BREAST AUGMENTATION PROCEDURE WITH A MENTOR MEMORYGEL BREAST IMPLANT 250CC GEL BREAST PROSTHESIS (LEFT DEVICE) AND A MENTOR MEMORYGEL BREAST IMPLANT 200CC GEL BREAST PROSTHESIS (RIGHT DEVICE) WHEN THE RIGHT BREAST PROSTHESIS RUPTURED POST IMPLANTATION. RUPTURE OF THE PATIENT¿S RIGHT BREAST PROSTHESIS WAS DIAGNOSED VIA MRI. ADDITIONALLY, THE PATIENT DEVELOPED BAKER GRADE III CAPSULAR CONTRACTURE IN HER RIGHT BREAST POST IMPLANTATION AND PAIN IN BOTH BREASTS. IT WAS REPORTED THAT THE PAIN IS WORSE IN THE LEFT BREAST. 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 LEFT BREAST PROSTHESIS. REFER TO MANUFACTURER REPORT NUMBER (B)(4) FOR THE REPORT FOR THE PATIENT¿S RIGHT BREAST PROSTHESIS.

  Patient problems: Breast Discomfort/Pain

  MAUDE report 20836529 ↗
• InjuryNov 22, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A BREAST AUGMENTATION SURGERY WITH IMPLANTATION OF A 250CC MENTOR MEMORYGEL BREAST IMPLANT PROSTHESIS. POST-OPERATIVELY, THE PATIENT WAS DIAGNOSED WITH RIGHT BREAST BAKER GRADE III CAPSULAR CONTRACTURE BY A MEDICAL PROFESSIONAL. AS A RESULT, THE PATIENT UNDERWENT BREAST IMPLANT REMOVAL ON (B)(6) 2024. SEVERAL 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 20759513 ↗
• InjuryNov 15, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT A FEMALE PATIENT UNDERWENT BREAST AUGMENTATION PROCEDURE WITH 250CC MENTOR MEMORYGEL BREAST IMPLANT AND EXPERIENCED BREAST IMPLANT RUPTURE ON HER LEFT SIDE. AS A RESULT, THE DEVICE WAS EXPLANTED ON (B)(6) 2024.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 20695551 ↗