MENTOR MemoryGel Breast Implant 3544325Recalls & reported problems

Summary

The FDA's MAUDE database contains 64 adverse event reports that list this exact device (DI 00081317001058), received between Jun 12, 2018 and Mar 30, 2026 — classified as 63 injuries, 1 malfunction.

The most frequently reported specific device problem is “Material Rupture” (31 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 64 reports, in the reporter's own words as published by the FDA.

• InjuryMar 30, 2026Material Rupture

  IT WAS REPORTED THAT A PATIENT UNDERWENT A BREAST AUGMENTATION REVISION PROCEDURE WITH A MENTOR MEMORYGEL BREAST IMPLANT GEL BREAST PROSTHESIS THAT RUPTURED POST IMPLANTATION. AS A RESULT, THE PATIENT UNDERWENT BILATERAL EXPLANTATION AND REPLACEMENT WITH MENTOR MEMORYGEL BREAST IMPLANTGEL BREAST PROSTHESES.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 24718066 ↗
• InjuryFeb 13, 2026Material Rupture

  IT WAS REPORTED THAT A PATIENT UNDERWENT BREAST AUGMENTATION REVISION WITH TWO 325CC MENTOR MEMORYGEL BREAST IMPLANTS. POST-OPERATIVELY, THE PATIENT WAS DIAGNOSED WITH RIGHT BREAST IMPLANT RUPTURE. AS A RESULT, THE PATIENT UNDERWENT BREAST IMPLANT REMOVAL SURGERY ON (B)(6) 2026.

  Patient problems: Deformity/ Disfigurement; Seroma

  MAUDE report 24330364 ↗
• InjuryJan 21, 2026Material Rupture

  IT WAS REPORTED THAT A PATIENT UNDERWENT A BREAST AUGMENTATION REVISION PROCEDURE WITH A MENTOR MEMORYGEL BREAST IMPLANT GEL BREAST PROSTHESIS THAT POSSIBLY RUPTURED POST IMPLANTATION. THE PATIENT NOTICED LUMPS ON HER LEFT BREAST. MAMMOGRAM AND ULTRASOUND RESULTS INDICATED POSSIBLE LEFT BREAST PROSTHESIS 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 24133775 ↗
• InjuryDec 1, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT IMPLANTED WITH A 325CC MENTOR MEMORYGEL BREAST IMPLANT EXPERIENCED A RUPTURE AND A GRANULOMA ON THE LEFT SIDE POST-OPERATIVELY. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON (B)(6) 2025.

  Patient problems: Granuloma

  MAUDE report 23682533 ↗
• InjuryOct 31, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT A FEMALE PATIENT UNDERWENT A BREAST AUGMENTATION REVISION WITH A 325CC MENTOR MEMORYGEL BREAST IMPLANT AND EXPERIENCED CAPSULAR CONTRACTURE (BAKER GRADE 3) AND A RUPTURE ON THE RIGHT SIDE POST-OPERATIVELY. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON (B)(6) 2025 AND REPLACED WITH A 200CC MENTOR MEMORYGEL BREAST IMPLANT.

  Patient problems: Capsular Contracture

  MAUDE report 23438832 ↗
• InjuryFeb 12, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT IMPLANTED WITH A 325CC MENTOR MEMORYGEL BREAST IMPLANT EXPERIENCED BREAST PAIN AND A RUPTURE ON THE LEFT SIDE POST-OPERATIVELY. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON (B)(6) 2025.

  Patient problems: Breast Discomfort/Pain; Granuloma

  MAUDE report 21365515 ↗
• InjuryJan 24, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT WHO UNDERWENT PRIMARY BREAST AUGMENTATION WITH A 325CC MENTOR MEMORYGEL BREAST IMPLANT EXPERIENCED RIGHT SIDED RUPTURE POST PROCEDURE. AS A RESULT, EXPLANT IS PLANNED FOR (B)(6) 2025.

  Patient problems: Capsular Contracture; Deformity/ Disfigurement

  MAUDE report 21233026 ↗
• InjuryJun 7, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT A FEMALE PATIENT UNDERWENT PRIMARY BREAST AUGMENTATION WITH 325CC MENTOR MEMORYGEL BREAST IMPLANT AND EXPERIENCED BREAST IMPLANT RUPTURE, AND CAPSULAR CONTRACTURE; BAKER GRADE III ON HER RIGHT SIDE POSTOPERATIVELY. AS A RESULT, THE PATIENT IS SCHEDULED FOR SURGERY ON (B)(6), 2024.

  Patient problems: Capsular Contracture

  MAUDE report 19490739 ↗
• InjuryMay 8, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

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

  Patient problems: Seroma

  MAUDE report 19270571 ↗
• InjuryMay 8, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

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

  Patient problems: Seroma

  MAUDE report 19270570 ↗
• InjuryJan 3, 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 3225CC MENTOR MEMORYGEL BREAST IMPLANT EXPERIENCED CAPSULAR CONTRACTURE BAKER GRADE 4 AND A RUPTURE ON THE LEFT SIDE POST-OPERATIVELY. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON (B)(6) 2023.

  Patient problems: Capsular Contracture

  MAUDE report 18440084 ↗
• InjuryJan 3, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT UNDERWENT BREAST PROSTHESIS IMPLANTATION WITH TWO MENTOR MEMORYGEL BREAST IMPLANTS. POST-OPERATIVELY, THE PATIENT WAS DIAGNOSED, VIA MRI, WITH BILATERAL BREAST IMPLANT LEAKS/RUPTURES. AS A RESULT, THE PATIENT HAS BEEN SCHEDULED FOR BILATERAL BREAST IMPLANT REMOVAL SURGERY ON (B)(6) 2024. THIS MEDWATCH FORM IS FOR THE LEFT BREAST PROSTHESIS.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 18439617 ↗
• InjuryDec 5, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT WHO UNDERWENT A PRIMARY BREAST RECONSTRUCTION PROCEDURE WITH MENTOR MEMORYGEL BREAST IMPLANT 325CC GEL BREAST PROSTHESES NOTICED THAT HER ARMS WERE BREAKING OUT AND THAT HER SCALP IS ITCHING. THE PATIENT DEVELOPED HIVES AND RASHES. THE PATIENT¿S DOCTOR STATED THAT THEY CANNOT TELL IF THE DEVICES ARE RUPTURED OR NOT AND WOULD NEED TO DO SURGERY TO CONFIRM. 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.

  Patient problems: Skin Inflammation/ Irritation

  MAUDE report 18268284 ↗
• InjuryDec 5, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT WHO UNDERWENT A PRIMARY BREAST RECONSTRUCTION PROCEDURE WITH MENTOR MEMORYGEL BREAST IMPLANT 325CC GEL BREAST PROSTHESES NOTICED THAT HER ARMS WERE BREAKING OUT AND THAT HER SCALP IS ITCHING. THE PATIENT DEVELOPED HIVES AND RASHES. THE PATIENT¿S DOCTOR STATED THAT THEY CANNOT TELL IF THE DEVICES ARE RUPTURED OR NOT AND WOULD NEED TO DO SURGERY TO CONFIRM. 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: Skin Inflammation/ Irritation

  MAUDE report 18268272 ↗
• InjurySep 18, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT UNDERWENT A BREAST AUGMENTATION REVISION WITH MENTOR MEMORYGEL BREAST IMPLANTS 325CC AND EXPERIENCED RUPTURE ON THE RIGHT SIDE POST-OPERATIVELY, WHICH WAS CONFIRMED VIA MAMMOGRAM. AS A RESULT, THE PATIENT IS SCHEDULED FOR REMOVAL ON (B)(6) 2023.

  Patient problems: Breast Discomfort/Pain; Deformity/ Disfigurement

  MAUDE report 17768334 ↗
• InjurySep 12, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A 59-YEAR-OLD CAUCASIAN FEMALE PATIENT WHO UNDERWENT A BREAST AUGMENTATION PRIMARY WITH A MENTOR MEMORYGEL, 300CC SILICONE IMPLANT EXPERIENCED LEFT-SIDED SILENT RUPTURE, AND BILATERAL PTOSIS POSTOPERATIVE. THE RUPTURE WAS DISCOVERED DURING MAMMOGRAM EXAMINATION. AS A RESULT, PATIENT UNDERWENT PARTIAL CAPSULECTOMY OF THE RIGHT SIDE, BILATERAL MASTOPEXY, AND BILATERAL REPLACEMENT WITH UNSPECIFIED MENTOR SILICONE PROSTHESIS ON (B)(6) 2023. THIS REPORT RELATES TO THE RIGHT SIDE.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 17729408 ↗
• InjuryJul 11, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT A 46-YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT A BREAST AUGMENTATION REVISION WITH TWO 325CC MENTOR MEMORYGEL BREAST IMPLANTS AND EXPERIENCED BILATERAL RUPTURES POST-OPERATIVELY. IT WAS ALSO REPORTED THAT THE LEFT SIDE SHOWED FLUID AROUND THE IMPLANT AND THAT SURGICAL INTERVENTION WAS GOING TO BE INITIATED TO TEST THE FLUID FOR BIA-ALCL. THE PATIENT UNDERWENT EXPLANTATION ON (B)(6) 2023. THIS REPORT IS FOR THE RIGHT SIDE DEVICE.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 17300225 ↗
• InjuryJun 21, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT A 61-YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT A BREAST AUGMENTATION REVISION WITH MENTOR MEMORYGEL BREAST IMPLANTS 325CC AND EXPERIENCED BILATERAL IMPLANT SITE CALCIFICATION ALONG WITH RUPTURE ON THE RIGHT SIDE POST-OPERATIVELY, WHICH WAS CONFIRMED DURING A PHYSICAL EXAM. AS A RESULT, THE PATIENT IS SCHEDULED FOR REMOVAL ON (B)(4) 2023. THIS REPORT IS FOR THE RIGHT BREAST PROSTHESIS. SEE MANUFACTURER REPORT NUMBER 1645337-2023-07401 FOR CONTRALATERAL SIDE.

  Patient problems: Calcium Deposits/Calcification

  MAUDE report 17175101 ↗
• InjuryJun 21, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A 61-YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT A BREAST AUGMENTATION REVISION WITH MENTOR MEMORYGEL BREAST IMPLANTS 325CC AND EXPERIENCED BILATERAL IMPLANT SITE CALCIFICATION ALONG WITH RUPTURE ON THE RIGHT SIDE POST-OPERATIVELY, WHICH WAS CONFIRMED DURING A PHYSICAL EXAM. AS A RESULT, THE PATIENT IS SCHEDULED FOR REMOVAL ON (B)(6) 2023. THIS REPORT IS FOR THE LEFT BREAST PROSTHESIS. SEE MANUFACTURER REPORT NUMBER 1645337-2023-07402 FOR CONTRALATERAL SIDE.

  Patient problems: Calcium Deposits/Calcification

  MAUDE report 17175100 ↗
• InjuryMay 17, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A FEMALE PATIENT UNDERWENT A BREAST AUGMENTATION WITH MENTOR MEMORYGEL BREAST IMPLANTS 325CC AND EXPERIENCED CAPSULAR CONTRACTURE BAKER GRADE III ON THE RIGHT SIDE POST-OPERATIVELY, WHICH WAS CONFIRMED DURING A PHYSICAL EXAM. AS A RESULT, THE PATIENT UNDERWENT REMOVAL AND REPLACEMENT WITH A SIMILAR DEVICE ON (B)(6) 2023.

  Patient problems: Capsular Contracture

  MAUDE report 16950460 ↗
• InjuryFeb 14, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT A 49-YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT A PRIMARY BREAST AUGMENTATION SURGERY WITH A 325CC MENTOR MEMORYGEL BREAST IMPLANT. POST-OPERATIVELY, THE PATIENT OBSERVED THAT HER LEFT BREAST WAS ENLARGED. AN ULTRASOUND CONFIRMED THAT HER LEFT BREAST PROSTHESIS WAS RUPTURED. AS A RESULT, THE PATIENT UNDERWENT REMOVAL ON (B)(6) 2023. 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: Local Reaction

  MAUDE report 16376312 ↗
• InjurySep 16, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT A 59-YEAR-OLD ASIAN FEMALE PATIENT UNDERWENT PRIMARY BREAST AUGMENTATION WITH UNKNOWN SIZE UNKNOWN GEL IMPLANTS AND EXPERIENCED BREAST IMPLANT RUPTURE ON HER LEFT SIDE POSTOPERATIVELY; DIAGNOSED UPON PHYSICAL EXAM. AS A RESULT, THE DEVICE WAS EXPLANTED AND REPLACED ON (B)(6) 2022.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 15439335 ↗
• InjuryMay 21, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A (B)(6)-YEAR-OLD FEMALE WHO UNDERWENT PRIMARY BREAST AUGMENTATION WITH A 325CC MENTOR MEMORYGEL BREAST IMPLANT EXPERIENCED RIGHT SIDED BAKER GRADE IV CAPSULAR CONTRACTURE POST PROCEDURE. THE CAPSULAR CONTRACTURE WAS DIAGNOSED THROUGH AN EXAMINATION IN THE PHYSICIAN¿S OFFICE. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE.

  Patient problems: Capsular Contracture

  MAUDE report 14466489 ↗
• InjuryMay 6, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT AN ASIAN FEMALE PATIENT UNDERWENT BREAST AUGMENTATION PROCEDURE WITH A 325CC MENTOR MEMORYGEL BREAST IMPLANT ON THE LEFT SIDE, AND WITH AN UNKNOWN SIZE, UNKNOWN GEL DEVICE ON THE RIGHT SIDE AND EXPERIENCED LEFT SIDE BREAST IMPLANT RUPTURE, LEFT BREAST CYST, LEFT SIDE DEFORMITY, BILATERAL SWOLLEN LYMPH NODES, AND BILATERAL IMPLANT SITE FLUID COLLECTION. AS A RESULT, THE DEVICES WAS EXPLANTED ON (B)(6) 2022. THIS MEDWATCH REPORT IS FOR THE PATIENT¿S LEFT-SIDED DEVICE.

  Patient problems: Cyst(s); Deformity/ Disfigurement; No Clinical Signs, Symptoms or Conditions; Swollen Lymph Nodes/Glands

  MAUDE report 14311499 ↗
• InjuryApr 1, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT A (B)(6)-YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT A BREAST AUGMENTATION PRIMARY WITH MENTOR MEMORYGEL BREAST IMPLANTS 350CC (R) AND 325CC (L) AND REPORTED RUPTURE ON THE RIGHT SIDE POST-OPERATIVELY, WHICH WAS CONFIRMED DURING A PHYSICAL EXAM. AS A RESULT, THE PATIENT UNDERWENT REMOVAL AND REPLACEMENT WITH SIMILAR DEVICES ON (B)(6) 2022. TWO DEVICES WERE RECEIVED DAMAGED. AS A RESULT, BOTH DEVICES WILL BE CONSERVATIVELY REPORTED FOR BILATERAL RUPTURE IN THE ABSENCE OF ADDITIONAL INFORMATION. THIS REPORT IS FOR THE LEFT BREAST PROSTHESIS. SEE MANUFACTURER REPORT NUMBER 1645337-2022-02408 FOR CONTRALATERAL DEVICE.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 13981034 ↗