MENTOR MemoryGel Breast Implant 3543257Recalls & reported problems

Summary

The FDA's MAUDE database contains 160 adverse event reports that list this exact device (DI 00081317000686), received between Feb 23, 2018 and Mar 30, 2026 — classified as 160 injuries.

The most frequently reported specific device problem is “Material Rupture” (130 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 160 reports, in the reporter's own words as published by the FDA.

• InjuryMar 30, 2026Material Rupture

  IT WAS REPORTED THAT A PATIENT UNDERWENT A PRIMARY BREAST AUGMENTATION PROCEDURE WITH A MENTOR MEMORYGEL BREAST IMPLANT GEL BREAST PROSTHESES THAT BOTH RUPTURED POST IMPLANTATION. BILATERAL RUPTURE WAS DIAGNOSED VIA MRI. ADDITIONALLY, MRI RESULTS INDICATED SILICONE IMPREGNATED INTERNAL MAMMARY LYMPH NODES. AS A RESULT, THE PATIENT UNDERWENT BILATERAL EXPLANTATION WITH NO REPLACEMENT BREAST PROSTHESES. THIS MEDWATCH REPORT IS FOR THE PATIENT¿S RIGHT BREAST PROSTHESIS.

  Patient problems: Granuloma

  MAUDE report 24736321 ↗
• InjuryMar 30, 2026Material Rupture

  IT WAS REPORTED THAT A PATIENT UNDERWENT A PRIMARY BREAST AUGMENTATION PROCEDURE WITH A MENTOR MEMORYGEL BREAST IMPLANT GEL BREAST PROSTHESES THAT BOTH RUPTURED POST IMPLANTATION. BILATERAL RUPTURE WAS DIAGNOSED VIA MRI. ADDITIONALLY, MRI RESULTS INDICATED SILICONE IMPREGNATED INTERNAL MAMMARY LYMPH NODES. AS A RESULT, THE PATIENT UNDERWENT BILATERAL EXPLANTATION WITH NO REPLACEMENT BREAST PROSTHESES. THIS MEDWATCH REPORT IS FOR THE PATIENT¿S LEFT BREAST PROSTHESIS.

  Patient problems: Granuloma; Paresthesia

  MAUDE report 24736053 ↗
• InjurySep 4, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT A 73-YEAR-OLD FEMALE PATIENT UNDERWENT BREAST AUGMENTATION WITH 325CC MENTOR MEMORYGEL BREAST IMPLANT AND EXPERIENCED BREAST IMPLANT RUPTURE ON HER RIGHT SIDE POSTOPERATIVELY; DIAGNOSED VIA MAMMOGRAM. THE PATIENT HAS CONSULTED WITH THE HEALTHCARE PROFESSIONAL. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 22964918 ↗
• InjuryJul 29, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A 62-YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT A PRIMARY BREAST AUGMENTATION WITH TWO 325CC MENTOR MEMORYGEL BREAST IMPLANTS AND EXPERIENCED BILATERAL CAPSULAR CONTRACTURE (BAKER GRADE 3-4) AND A RUPTURE ON THE RIGHT SIDE POST-OPERATIVELY, WHICH WAS DIAGNOSED DURING A PHYSICAL EXAM. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON (B)(6) 2025 AND REPLACED WITH TWO MENTOR MEMORYGEL BREAST IMPLANTS (CATALOG NUMBER: 3504215MC). THIS REPORT IS FOR THE LEFT SIDE DEVICE.

  Patient problems: Capsular Contracture

  MAUDE report 22659565 ↗
• InjuryJul 29, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT A 62-YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT A PRIMARY BREAST AUGMENTATION WITH TWO 325CC MENTOR MEMORYGEL BREAST IMPLANTS AND EXPERIENCED BILATERAL CAPSULAR CONTRACTURE (BAKER GRADE 3-4) AND A RUPTURE ON THE RIGHT SIDE POST-OPERATIVELY, WHICH WAS DIAGNOSED DURING A PHYSICAL EXAM. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON (B)(6) 2025 AND REPLACED WITH TWO MENTOR MEMORYGEL BREAST IMPLANTS (CATALOG NUMBER 3504215MC). THIS REPORT IS FOR THE RIGHT-SIDE DEVICE.

  Patient problems: Capsular Contracture

  MAUDE report 22659562 ↗
• InjuryDec 19, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A FEMALE PATIENT UNDERWENT AN UNSPECIFIED BREAST SURGERY WITH AN UNSPECIFIED GEL MENTOR BREAST IMPLANT EXPERIENCED RIGHT SIDED SYMPTOMATIC RUPTURE, AND UNEXPLAINED SYMPTOMATIC SYMPTOMS POST OPERATION INCLUDING BREAST IMPLANT ILLNESSES, THYROID ISSUES, ABNORMAL BLOODWORK, WEIGHT GAIN, AND ASYMMETRY ISSUE. AS A RESULT PATIENT UNDERWENT BILATERAL REMOVAL WITHOUT REPLACEMENTS ON (B)(6) 2022. THE PATIENT INDICATED THAT HER SYMPTOMS IMPROVED AFTER THE REMOVAL. THIS REPORT RELATES TO THE LEFT SIDE.

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

  MAUDE report 20978014 ↗
• InjurySep 25, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT A 57-YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT PRIMARY BREAST AUGMENTATION WITH 325CC MENTOR MEMORYGEL BREAST IMPLANT AND EXPERIENCED BREAST IMPLANT RUPTURE ON HER RIGHT SIDE POSTOPERATIVELY; DIAGNOSED VIA ULTRASOUND. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 20304553 ↗
• InjurySep 24, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT IMPLANTED WITH A 325CC MENTOR MEMORYGEL BREAST IMPLANT EXPERIENCED CAPSULAR CONTRACTURE ON THE LEFT SIDE POST-OPERATIVELY. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON (B)(6) 2024.

  Patient problems: Capsular Contracture; Deformity/ Disfigurement

  MAUDE report 20292494 ↗
• InjurySep 20, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT INVOLVED IN A CLINICAL STUDY UNDERWENT A BREAST AUGMENTATION REVISION SURGERY WITH IMPLANTATION OF A 325CC MENTOR MEMORYGEL BREAST IMPLANT PROSTHESIS. POST-OPERATIVELY, THE PATIENT WAS DIAGNOSED WITH A RUPTURED RIGHT BREAST IMPLANT USING MAMMOGRAM AND 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. 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: Deformity/ Disfigurement

  MAUDE report 20273386 ↗
• InjurySep 4, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT IMPLANTED WITH A 325CC MENTOR MEMORYGEL BREAST IMPLANT EXPERIENCED A RUPTURE ON THE RIGHT SIDE POST-OPERATIVELY. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON (B)(6) 2024.

  Patient problems: Breast Mass; Capsular Contracture; Deformity/ Disfigurement; No Clinical Signs, Symptoms or Conditions; Swollen Lymph Nodes/Glands

  MAUDE report 20140432 ↗
• InjurySep 3, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT IMPLANTED WITH TWO 325CC MENTOR MEMORYGEL BREAST IMPLANTS EXPERIENCED BILATERAL RUPTURES POST-OPERATIVELY. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON (B)(6) 2024.

  Patient problems: Capsular Contracture; Deformity/ Disfigurement

  MAUDE report 20128283 ↗
• InjurySep 3, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT IMPLANTED WITH TWO 325CC MENTOR MEMORYGEL BREAST IMPLANTS EXPERIENCED BILATERAL RUPTURES POST-OPERATIVELY. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON (B)(6) 2024.

  Patient problems: Capsular Contracture; Deformity/ Disfigurement

  MAUDE report 20128229 ↗
• InjuryJun 7, 2024Adverse 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 325CC MENTOR MEMORYGEL BREAST IMPLANT PROSTHESIS. POST-OPERATIVELY, THE PATIENT WAS DIAGNOSED WITH BAKER GRADE IV CAPSULAR CONTRACTURE OF THE RIGHT BREAST DURING A PHYSICAL EXAM WITH A MEDICAL PROFESSIONAL. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE.

  Patient problems: Capsular Contracture

  MAUDE report 19488679 ↗
• InjuryMay 22, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT UNDERWENT A BREAST AUGMENTATION REVISION WITH MENTOR MEMORYGEL BREAST IMPLANTS 325CC AND EXPERIENCED BILATERAL RUPTURE ALONG WITH BILATERAL BREAST CYSTS AND PARESTHESIA POST-OPERATIVELY, WHICH WAS CONFIRMED DURING A PHYSICAL EXAM. THE PATIENT REPORTEDLY EXPERIENCED TRAUMA (ASSAULT) WHICH MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT. 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; Cyst(s); Paresthesia

  MAUDE report 19372962 ↗
• InjuryMay 22, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT UNDERWENT A BREAST AUGMENTATION REVISION WITH MENTOR MEMORYGEL BREAST IMPLANTS 325CC AND EXPERIENCED BILATERAL RUPTURE ALONG WITH BILATERAL BREAST CYSTS AND PARESTHESIA POST-OPERATIVELY, WHICH WAS CONFIRMED DURING A PHYSICAL EXAM. THE PATIENT REPORTEDLY EXPERIENCED TRAUMA (ASSAULT) WHICH MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT. 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: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Cyst(s); Paresthesia

  MAUDE report 19372961 ↗
• InjuryMar 11, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED, VIA A HEALTHCARE PROFESSIONAL (HCP), THAT A 45-YEAR-OLD FEMALE PATIENT WHO UNDERWENT PRIMARY BREAST AUGMENTATION SURGERY WITH MENTOR GEL SILTEX MOD-RND 325CC, AND 300CC GEL BREAST IMPLANTS (DEVICE INFORMATION NOT PROVIDED) IN 2005 WAS DIAGNOSED WITH "POSSIBLE" ANAPLASTIC LARGE CELL LYMPHOMA (BIA-ALCL). THE AFFECTED SIDE WAS NOT PROVIDED. PER THE INFORMATION PROVIDED BY THE HCP, THE PATIENT PRESENTED WITH A LATE SEROMA IN (B)(6) 2023, WHICH WORSENED OVER TIME TO THE POINT WHERE THE AFFECTED BREAST WAS TWICE THE SIZE OF THE CONTRALATERAL BREAST. THE PHYSICIAN SPECIFICALLY MENTIONED THAT THE PATIENT¿S LATE SEROMA REQUIRED DIAGNOSTIC TESTING TO RULE OUT POSSIBLE BIA-ALCL, BUT IT WAS UNCLEAR IF FLUID WAS COLLECTED AND SENT OUT FOR TESTING. IN ADDITION, THE PHYSICIAN MENTIONED THAT SURGERY WAS TO BE PERFORMED UNDER LOCAL ANESTHESIA IN HIS OFFICE, BUT HAS BEEN POSTPONED UNTIL FURTHER NOTICE. NO FURTHER DETAILS WERE PROVIDED. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE. AFFECTED SIDE HAS NOT BEEN CLARIFIED THEREFORE, THIS REPORT IS FOR PATIENT'S SIDE WITH ALCL, AND SEROMA UNTIL CLARIFICATION IS RECE

  Patient problems: Breast Implant Associated Anaplastic Large Cell Lymphoma (BIA ALCL); Seroma

  MAUDE report 18874184 ↗
• InjuryMar 6, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT IMPLANTED WITH A 325CC MENTOR MEMORYGEL BREAST IMPLANT EXPERIENCED BILATERAL RUPTURES POST-OPERATIVELY. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON (B)(6) 2024.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 18848018 ↗
• InjuryFeb 21, 2024Material Rupture; Appropriate Device Problem Term/Code Not Available; Material Rupture; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT A PATIENT IMPLANTED WITH A 325CC MENTOR MEMORYGEL BREAST IMPLANT EXPERIENCED BILATERAL RUPTURES POST-OPERATIVELY. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON (B)(6) 2024. THIS REPORT IS FOR THE RIGHT SIDE DEVICE.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 18754109 ↗
• InjuryFeb 21, 2024Material Rupture; Appropriate Device Problem Term/Code Not Available; Material Rupture; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT A PATIENT IMPLANTED WITH A 325CC MENTOR MEMORYGEL BREAST IMPLANT EXPERIENCED BILATERAL RUPTURES POST-OPERATIVELY. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON (B)(6) 2024. THIS REPORT IS FOR THE LEFT SIDE DEVICE.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 18754108 ↗
• InjuryJan 26, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT UNDERWENT A BREAST AUGMENTATION REVISION PROCEDURE WITH MENTOR MEMORYGEL BREAST IMPLANT 325CC GEL BREAST PROSTHESES THAT BOTH RUPTURED POST IMPLANTATION. BILATERAL RUPTURE WAS DIAGNOSED VIA IMAGING. 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 18590056 ↗
• InjuryJan 26, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT UNDERWENT A BREAST AUGMENTATION REVISION PROCEDURE WITH MENTOR MEMORYGEL BREAST IMPLANT 325CC GEL BREAST PROSTHESES THAT BOTH RUPTURED POST IMPLANTATION. BILATERAL RUPTURE WAS DIAGNOSED VIA IMAGING. AS A RESULT, THE PATIENT UNDERWENT BILATERAL EXPLANTATION ON (B)(6) 2024. THIS MEDWATCH REPORT IS FOR THE PATIENT¿S RIGHT BREAST PROSTHESIS.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 18590044 ↗
• InjuryJan 8, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT UNDERWENT A BREAST AUGMENTATION REVISION WITH MENTOR MEMORYGEL BREAST IMPLANTS 325CC AND EXPERIENCED BILATERAL RUPTURE POST-OPERATIVELY, WHICH WAS CONFIRMED VIA MRI. AS A RESULT, THE PATIENT UNDERWENT REMOVAL ON (B)(6) 2023. THIS REPORT IS FOR THE RIGHT BREAST PROSTHESIS. SEE MANUFACTURER REPORT NUMBER 1645337-2024-00300 FOR CONTRALATERAL SIDE.

  Patient problems: Capsular Contracture; Deformity/ Disfigurement; Granuloma

  MAUDE report 18465205 ↗
• InjuryJan 8, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT UNDERWENT A BREAST AUGMENTATION REVISION WITH MENTOR MEMORYGEL BREAST IMPLANTS 325CC AND EXPERIENCED BILATERAL RUPTURE POST-OPERATIVELY, WHICH WAS CONFIRMED VIA MRI. AS A RESULT, THE PATIENT UNDERWENT REMOVAL ON (B)(6) 2023. THIS REPORT IS FOR THE LEFT BREAST PROSTHESIS. SEE MANUFACTURER REPORT NUMBER 1645337-2024-00301 FOR CONTRALATERAL SIDE.

  Patient problems: Capsular Contracture; Deformity/ Disfigurement; Granuloma

  MAUDE report 18465201 ↗
• InjuryDec 28, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT A 61-YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT A PRIMARY BREAST AUGMENTATION WITH TWO 325CC MENTOR MEMORYGEL BREAST IMPLANTS AND EXPERIENCED BILATERAL RUPTURES AND BILATERAL CAPSULAR CONTRACTURE (BAKER GRADE 3) POST-OPERATIVELY, WHICH WAS DIAGNOSED WITH AN MRI. AS A RESULT, THE PATIENT IS TO UNDERGO DEVICE EXPLANTATION ON (B)(6) 2024. THIS REPORT IS FOR THE LEFT SIDE DEVICE.

  Patient problems: Capsular Contracture

  MAUDE report 18416098 ↗
• InjuryDec 28, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT A 61-YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT A PRIMARY BREAST AUGMENTATION WITH TWO 325CC MENTOR MEMORYGEL BREAST IMPLANTS AND EXPERIENCED BILATERAL RUPTURES AND BILATERAL CAPSULAR CONTRACTURE (BAKER GRADE 3) POST-OPERATIVELY, WHICH WAS DIAGNOSED WITH AN MRI. AS A RESULT, THE PATIENT IS TO UNDERGO DEVICE EXPLANTATION ON (B)(6) 2024. THIS REPORT IS FOR THE RIGHT SIDE DEVICE.

  Patient problems: Capsular Contracture

  MAUDE report 18416097 ↗