MENTOR MemoryGel Breast Implant 3507300BCRecalls & reported problems

Summary

The FDA's MAUDE database contains 455 adverse event reports that list this exact device (DI 00081317000099), received between Jan 23, 2018 and Sep 21, 2026 — classified as 453 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (374 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 455 reports, in the reporter's own words as published by the FDA.

• InjurySep 21, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that a 48-year-old female patient underwent primary breast augmentation with 250cc MENTOR MemoryGel Breast Implant and experienced breast implant rupture on her left side postoperatively; diagnosed after physical exam. The patient has consulted with the healthcare professional. As a result, the patient is scheduled for replacement surgery on (b)(6)2026. On September 16, 2026, Mentor became aware that the patient also experienced bilateral Capsular Contracture; Baker Grade unknown in addition to left side rupture.This MedWatch report is for the patient¿s right-sided device.

  Patient problems: Capsular Contracture

  MAUDE report 50842961 ↗
• InjurySep 14, 2026Material Rupture

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50759311 ↗
• InjuryJun 9, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT IMPLANTED WITH TWO MENTOR GEL BREAST PROSTHESES EXPERIENCED BILATERAL CAPSULAR CONTRACTURE (BAKER GRADE 4) AND A RUPTURE 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 25449137 ↗
• InjuryMar 17, 2026Material Rupture

  IT WAS REPORTED THAT A PATIENT UNDERWENT A PRIMARY BREAST AUGMENTATION SURGERY WITH IMPLANTATION OF AN UNDISCLOSED MENTOR GEL IMPLANT PROSTHESIS. POST-OPERATIVELY, THE PATIENT UNDERWENT BILATERAL IMPLANT EXCHANGE WITH MENTOR GEL IMPLANTS ON (B)(6) 2026, FOR AN UNDISCLOSED REASON. HOWEVER, DURING THE SURGERY, BILATERALLY RUPTURED IMPLANTS WERE DISCOVERED. THERE WERE NO REPORTED PROCEDURAL DELAYS OR PATIENT CONSEQUENCES/HARMS DUE TO THE FINDINGS. THE DATE OF IMPLANTATION WAS PROVIDED TO MENTOR AS A BEST ESTIMATE. 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 24617861 ↗
• InjuryMar 16, 2026Adverse Event Without Identified Device or Use Problem

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

  Patient problems: Capsular Contracture

  MAUDE report 24608086 ↗
• InjuryMar 16, 2026Material Rupture

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

  Patient problems: Capsular Contracture

  MAUDE report 24608083 ↗
• InjuryFeb 13, 2026Material Rupture

  IT WAS REPORTED THAT A PATIENT UNDERWENT PRIMARY BREAST AUGMENTATION WITH TWO 300CC MENTOR MEMORYGEL BREAST IMPLANTS. POST-OPERATIVELY, THE PATIENT WAS DIAGNOSED, VIA PHYSICAL EXAMINATION, 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 24340122 ↗
• InjuryFeb 13, 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: Deformity/ Disfigurement

  MAUDE report 24337991 ↗
• InjuryFeb 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 UNDERWENT BILATERAL EXCHANGE WITH MENTOR GEL IMPLANTS ON (B)(6) 2026, FOR AN UNDISCLOSED REASON. HOWEVER, DURING THE SURGERY, A RUPTURED LEFT IMPLANT WAS DISCOVERED. THERE WERE NO REPORTED PROCEDURAL DELAYS OR PATIENT HARMS/CONSEQUENCES DUE TO THE FINDINGS.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 24310040 ↗
• InjuryJan 29, 2026Material Rupture

  IT WAS REPORTED THAT A 50-YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT A PRIMARY BREAST AUGMENTATION WITH A 300CC MENTOR MEMORYGEL BREAST IMPLANT AND 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: Deformity/ Disfigurement

  MAUDE report 24210747 ↗
• InjuryJan 22, 2026Material Rupture

  IT WAS REPORTED THAT A PATIENT WITH MENTOR MEMORYGEL BREAST IMPLANTS EXPERIENCED BILATERAL BREAST PAIN AND BILATERAL RUPTURE 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. THIS REPORT IS FOR THE RIGHT BREAST PROSTHESIS.

  Patient problems: Breast Discomfort/Pain

  MAUDE report 24148687 ↗
• InjuryJan 22, 2026Material Rupture

  IT WAS REPORTED THAT A PATIENT WITH MENTOR MEMORYGEL BREAST IMPLANTS EXPERIENCED BILATERAL BREAST PAIN AND BILATERAL RUPTURE 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. THIS REPORT IS FOR THE LEFT BREAST PROSTHESIS.

  Patient problems: Breast Discomfort/Pain

  MAUDE report 24148660 ↗
• InjuryDec 11, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT UNDERWENT A BREAST RECONSTRUCTION SURGERY WITH IMPLANTATION OF A 300CC MENTOR MEMORYGEL BREAST IMPLANT PROSTHESIS. POST-OPERATIVELY, THE PATIENT UNDERWENT RIGHT-SIDED EXCHANGE WITH A MENTOR GEL IMPLANT ON (B)(6) 2025. THE EXPLANTED DEVICE WAS RUPTURED. NO FURTHER INFORMATION WAS PROVIDED 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 23785529 ↗
• InjuryDec 5, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT A 62-YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT PRIMARY BREAST AUGMENTATION WITH 300CC UNKNOWN GEL IMPLANT ON THE LEFT SIDE, AND WITH 300CC MENTOR MEMORYGEL BREAST IMPLANT ON THE RIGHT SIDE AND BILATERAL BREAST IMPLANT RUPTURES AND BILATERAL CAPSULAR CONTRACTURE; BAKER GRADE UNKNOWN WERE FOUND DURING BILATERAL REMOVAL ONLY SURGERY ON (B)(6) 2025. THE PATIENT HAS CONSULTED WITH THE HEALTHCARE PROFESSIONAL. THIS MEDWATCH REPORT IS FOR THE PATIENT¿S RIGHT-SIDED DEVICE.

  Patient problems: Calcium Deposits/Calcification; Capsular Contracture

  MAUDE report 23728204 ↗
• InjuryDec 2, 2025Material Rupture; Material 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. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 23697712 ↗
• InjuryNov 4, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT BREAST PROSTHESIS IMPLANTATION SURGERY WITH TWO 300CC MENTOR MEMORYGEL BREAST IMPLANTS. POST-OPERATIVELY, THE PATIENT DEVELOPED RIGHT BREAST CAPSULAR CONTRACTURE (BAKER GRADE III) AND SUFFERED LEFT BREAST IMPLANT RUPTURE. AS A RESULT, THE PATIENT UNDERWENT BILATERAL BREAST IMPLANT REMOVAL SURGERY ON (B)(6) 2025. THIS MEDWATCH FORM IS FOR THE RIGHT BREAST PROSTHESIS.

  Patient problems: Capsular Contracture

  MAUDE report 23472136 ↗
• InjuryNov 4, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT UNDERWENT BREAST PROSTHESIS IMPLANTATION SURGERY WITH TWO 300CC MENTOR MEMORYGEL BREAST IMPLANTS. POST-OPERATIVELY, THE PATIENT DEVELOPED RIGHT BREAST CAPSULAR CONTRACTURE (BAKER GRADE III) AND SUFFERED LEFT BREAST IMPLANT RUPTURE. AS A RESULT, THE PATIENT UNDERWENT BILATERAL BREAST IMPLANT REMOVAL SURGERY ON (B)(6) 2025. THIS MEDWATCH FORM IS FOR THE LEFT BREAST PROSTHESIS.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 23472135 ↗
• InjuryAug 27, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT UNDERWENT BREAST AUGMENTATION REVISION WITH TWO 300CC MENTOR MEMORYGEL BREAST IMPLANTS. POST-OPERATIVELY, THE PATIENT WAS DIAGNOSED, VIA MRI, WITH BILATERAL BREAST IMPLANT RUPTURES. 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: Deformity/ Disfigurement

  MAUDE report 22906496 ↗
• InjuryAug 27, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT UNDERWENT BREAST AUGMENTATION REVISION WITH TWO 300CC MENTOR MEMORYGEL BREAST IMPLANTS. POST-OPERATIVELY, THE PATIENT WAS DIAGNOSED, VIA MRI, WITH BILATERAL BREAST IMPLANT RUPTURES. 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: Deformity/ Disfigurement

  MAUDE report 22906382 ↗
• InjuryAug 26, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNSPECIFIED BREAST SURGERY WITH A MENTOR MEMORYGEL BREAST IMPLANT 300CC GEL BREAST PROSTHESIS (LEFT DEVICE) AND A MENTOR MEMORYGEL BREAST IMPLANT 375CC GEL BREAST PROSTHESIS (RIGHT DEVICE) WHEN THE LEFT BREAST PROSTHESIS RUPTURED POST IMPLANTATION. THE RUPTURE WAS DIAGNOSED VIA MAMMOGRAM. ADDITIONALLY, THE PATIENT DEVELOPED CAPSULAR CONTRACTURE (BAKER GRADE UNKNOWN) IN HER RIGHT BREAST. AS A RESULT, THE PATIENT UNDERWENT BILATERAL EXPLANTATION ON (B)(6) 2024. THIS MEDWATCH REPORT IS FOR THE PATIENT¿S LEFT BREAST PROSTHESIS.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 22897690 ↗
• InjuryAug 19, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT WITH MENTOR MEMORYGEL BREAST IMPLANTS EXPERIENCED CAPSULAR CONTRACTURE BAKER GRADE UNKNOWN ALONG WITH RUPTURE 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 22842994 ↗
• InjuryAug 19, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT A 43-YEAR-OLD FEMALE PATIENT UNDERWENT PRIMARY BREAST AUGMENTATION WITH 300CC MENTOR MEMORYGEL BREAST IMPLANT AND EXPERIENCED BREAST PAIN, AND BREAST IMPLANT RUPTURE ON HER LEFT SIDE POSTOPERATIVELY; DIAGNOSED IN THE OFFICE. THE PATIENT HAS CONSULTED WITH THE HEALTHCARE PROFESSIONAL. AS A RESULT, THE PATIENT IS SCHEDULED FOR REPLACEMENT SURGERY WITH NON-MENTOR DEVICE ON (B)(6) 2025 MENTOR IS AWARE THAT THE DATE OF IMPLANT ((B)(6) 2005) IS PRIOR TO THE MANUFACTURING DATE (5/26/2005) OF LOT 5607694. FOLLOW UPS WERE CONDUCTED; HOWEVER, NO CLARIFICATION WAS RECEIVED REGARDING THE DATES. IF THE INFORMATION IS RECEIVED IN THE FUTURE, IT WILL BE UPDATED AND SUPPLEMENTAL REPORT WILL BE SUBMITTED.

  Patient problems: Breast Discomfort/Pain

  MAUDE report 22839261 ↗
• InjuryAug 7, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT UNDERWENT A BREAST AUGMENTATION REVISION PROCEDURE WITH A MENTOR MEMORYGEL BREAST IMPLANT 300CC GEL BREAST PROSTHESIS WHEN THE LEFT BREAST PROSTHESIS RUPTURED POST IMPLANTATION. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION AND REPLACEMENT WITH A MENTOR MEMORYGEL BREAST IMPLANT 350CC GEL BREAST PROSTHESIS ON (B)(6) 2025.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 22745760 ↗
• InjuryJul 30, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT UNDERWENT A BREAST SURGERY WITH IMPLANTATION OF A 300CC MENTOR MEMORYGEL BREAST IMPLANT PROSTHESIS. POST-OPERATIVELY, THE PATIENT WAS DIAGNOSED WITH BILATERALLY RUPTURED BREAST IMPLANTS USING AN UNDISCLOSED IMAGING METHODOLOGY. 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; Deformity/ Disfigurement

  MAUDE report 22669066 ↗
• InjuryJul 30, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT UNDERWENT A BREAST SURGERY WITH IMPLANTATION OF A 300CC MENTOR MEMORYGEL BREAST IMPLANT PROSTHESIS. POST-OPERATIVELY, THE PATIENT WAS DIAGNOSED WITH BILATERALLY RUPTURED BREAST IMPLANTS USING AN UNDISCLOSED IMAGING METHODOLOGY. 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; Deformity/ Disfigurement

  MAUDE report 22669063 ↗