MENTOR MemoryShape Breast Implant 3541458Recalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 00081317005506), received between Sep 11, 2019 and Mar 6, 2026 — classified as 15 injuries.

The most frequently reported specific device problem is “Material Rupture” (6 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 15 most recent of 15 reports, in the reporter's own words as published by the FDA.

• InjuryMar 6, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A 61-YEAR-OLD FEMALE PATIENT UNDERWENT A PRIMARY BREAST WITH TWO 480CC MENTOR MEMORYSHAPE BREAST IMPLANTS AND WAS DIAGNOSED WITH SUSPECTED BREAST IMPLANT-ASSOCIATED ANAPLASTIC LARGE CELL LYMPHOMA (BIA-ALCL) POST-OPERATIVELY. AT THE TIME OF DIAGNOSIS, THE PATIENT WAS IMPLANTED WITH MENTOR DEVICES, BUT THE PATIENT¿S BREAST IMPLANT HISTORY IS UNKNOWN. NO OTHER INFORMATION WAS PROVIDED AT THE TIME. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE. THIS REPORT IS FOR THE LEFT SIDE DEVICE.

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

  MAUDE report 24533753 ↗
• InjuryMar 6, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A 61-YEAR-OLD FEMALE PATIENT UNDERWENT A PRIMARY BREAST WITH TWO 480CC MENTOR MEMORYSHAPE BREAST IMPLANTS AND WAS DIAGNOSED WITH SUSPECTED BREAST IMPLANT-ASSOCIATED ANAPLASTIC LARGE CELL LYMPHOMA (BIA-ALCL) POST-OPERATIVELY. AT THE TIME OF DIAGNOSIS, THE PATIENT WAS IMPLANTED WITH MENTOR DEVICES, BUT THE PATIENT¿S BREAST IMPLANT HISTORY IS UNKNOWN. NO OTHER INFORMATION WAS PROVIDED AT THE TIME. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE. THIS REPORT IS FOR THE RIGHT SIDE DEVICE.

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

  MAUDE report 24533735 ↗
• InjuryDec 16, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT UNDERWENT A BREAST AUGMENTATION REVISION SURGERY WITH IMPLANTATION OF A 480CC MENTOR MEMORYSHAPE 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 23817920 ↗
• InjuryJun 23, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT UNDERWENT BREAST AUGMENTATION REVISION WITH TWO MENTOR MEMORYSHAPE BREAST IMPLANTS. POST-OPERATIVELY, THE PATIENT DEVELOPED BILATERAL BREAST PTOSIS (GRADE II). AS A RESULT, THE PATIENT UNDERWENT BILATERAL BREAST IMPLANT REMOVAL SURGERY ON (B)(6) 2025. DURING THE SURGERY, THE RIGHT BREAST IMPLANT WAS DISCOVERED TO HAVE RUPTURED. SUBSEQUENTLY, BOTH THE IMPLANTS WERE REPLACED WITH MENTOR GEL IMPLANTS. THIS MEDWATCH FORM IS FOR THE RIGHT BREAST PROSTHESIS.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 22309445 ↗
• InjuryMar 20, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT WHO UNDERWENT A BREAST AUGMENTATION REVISION PROCEDURE MENTOR MEMORYSHAPE BREAST IMPLANT 480CC BREAST PROSTHESES HAS SILICONE IN HER RIGHT LYMPH NODES POST IMPLANTATION. MAMMOGRAM RESULTS INDICATED THAT THERE WAS NO RUPTURE OF THE BREAST PROSTHESIS. IT WAS LATER REPORTED THAT BILATERAL RUPTURE OF THE BREAST PROSTHESES WAS DIAGNOSED BY A HEALTHCARE PROFESSIONAL. 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 1645337-2024-02338 FOR THE REPORT FOR THE PATIENT¿S RIGHT BREAST PROSTHESIS.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 18946879 ↗
• InjuryFeb 26, 2024Gel Leak; Material Rupture; Gel Leak; Material Rupture

  IT WAS REPORTED THAT A PATIENT WHO UNDERWENT A BREAST AUGMENTATION REVISION PROCEDURE WITH AN UNSPECIFIED MENTOR GEL BREAST PROSTHESIS HAS SILICONE IN HER RIGHT LYMPH NODES POST IMPLANTATION. MAMMOGRAM RESULTS INDICATED THAT THERE WAS NO RUPTURE OF THE BREAST PROSTHESIS. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE. A CATALOG NUMBER (354-148G) WAS REPORTED FOR THE SUSPECT MEDICAL DEVICE. HOWEVER, MENTOR CANNOT CONFIRM THAT THIS BELONGS TO A MENTOR PRODUCT. IF CLARIFICATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

  Patient problems: Granuloma

  MAUDE report 18778769 ↗
• InjuryJan 16, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT WHO UNDERWENT PRIMARY BREAST AUGMENTATION WITH A 480CC MENTOR MEMORYSHAPE BREAST IMPLANT EXPERIENCED LEFT SIDED BAKER GRADE III CAPSULAR CONTRACTURE POST PROCEDURE. THIS WAS DIAGNOSED THROUGH A PHYSICAL EXAMINATION. AS A RESULT, EXPLANT WAS PERFORMED ON (B)(6) 2023.

  Patient problems: Capsular Contracture

  MAUDE report 18522596 ↗
• InjuryJun 21, 2023Material Rupture; Migration; Air/Gas in Device; Material Rupture; Migration; Air/Gas in Device

  IT WAS REPORTED THAT A 48-YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT A BREAST AUGMENTATION REVISION WITH TWO 480CC MENTOR MEMORYSHAPE BREAST IMPLANTS AND EXPERIENCED SWOLLEN LYMPH NODES AND DEVICE MIGRATIONS BILATERALLY, WRINKLING ON THE LEFT SIDE AND 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. THIS REPORT IS FOR THE RIGHT SIDE DEVICE.

  Patient problems: Deformity/ Disfigurement; Swollen Lymph Nodes/Glands

  MAUDE report 17171682 ↗
• InjuryJun 21, 2023Migration; Migration

  IT WAS REPORTED THAT A 48-YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT A BREAST AUGMENTATION REVISION WITH TWO 480CC MENTOR MEMORYSHAPE BREAST IMPLANTS AND EXPERIENCED SWOLLEN LYMPH NODES AND DEVICE MIGRATIONS BILATERALLY, WRINKLING ON THE LEFT SIDE AND 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. THIS REPORT IS FOR THE LEFT SIDE DEVICE.

  Patient problems: Deformity/ Disfigurement; Swollen Lymph Nodes/Glands; Wrinkling

  MAUDE report 17171679 ↗
• InjuryMar 3, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT A 33-YEAR-OLD CAUCASIAN FEMALE PATIENT WHO UNDERWENT AN UNSPECIFIED BREAST SURGERY WITH MENTOR MEMORYSHAPE BREAST IMPLANT 480CC GEL BREAST PROSTHESES DEVELOPED BREAST IMPLANT ILLNESS POST IMPLANTATION. AS A RESULT, THE PATIENT UNDERWENT BILATERAL EXPLANTATION WITH NO REPLACEMENT BREAST PROSTHESES ON (B)(6) 2023. DURING EXPLANT SURGERY, IT WAS OBSERVED THAT THE LEFT BREAST PROSTHESIS HAD RUPTURED. THIS MEDWATCH REPORT IS FOR THE PATIENT¿S LEFT BREAST PROSTHESIS.

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

  MAUDE report 16479303 ↗
• InjuryMar 3, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A 33-YEAR-OLD CAUCASIAN FEMALE PATIENT WHO UNDERWENT AN UNSPECIFIED BREAST SURGERY WITH MENTOR MEMORYSHAPE BREAST IMPLANT 480CC GEL BREAST PROSTHESES DEVELOPED BREAST IMPLANT ILLNESS POST IMPLANTATION. AS A RESULT, THE PATIENT UNDERWENT BILATERAL EXPLANTATION WITH NO REPLACEMENT BREAST PROSTHESES ON (B)(6) 2023. DURING EXPLANT SURGERY, IT WAS OBSERVED THAT THE LEFT BREAST PROSTHESIS HAD RUPTURED. THIS MEDWATCH REPORT IS FOR THE PATIENT¿S RIGHT BREAST PROSTHESIS.

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

  MAUDE report 16479263 ↗
• InjuryFeb 20, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A (B)(6) YEAR-OLD CAUCASIAN FEMALE WHO UNDERWENT PRIMARY BREAST AUGMENTATION WITH 490CC MENTOR MEMORYSHAPE BREAST IMPLANTS EXPERIENCED BILATERAL CAPSULAR CONTRACTURE ACCOMPANIED BY PAIN POST PROCEDURE. THE PAIN WAS DESCRIBED AS BURNING WITH PRESSURE. IT WAS STATED TO BE MORE PRONOUNCED ON THE LEFT SIDE. THE CAPSULAR CONTRACTURE WAS BAKER GRADE II. THE PATIENT DEMONSTRATED CONCERN OVER BREAST IMPLANTS AND SOUGHT OUT THE OPINION OF TWO PHYSICIANS. ON (B)(6) 2019 A PHYSICIAN¿S EXAMINATION DETERMINED THAT SYMPTOMS THE PATIENT WAS DEMONSTRATING WAS DUE TO THE CAPSULAR CONTRACTURE. THE POSSIBILITY OF FUTURE EXPLANT IS INDICATED, HOWEVER, AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING AN EXPECTED EXPLANTATION DATE. SEE 1645337-2020-02702 FOR CONTRALATERAL PROSTHESIS REPORT.

  Patient problems: Capsular Contracture

  MAUDE report 9734070 ↗
• InjuryFeb 20, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A (B)(6) CAUCASIAN FEMALE WHO UNDERWENT PRIMARY BREAST AUGMENTATION WITH 490CC MENTOR MEMORYSHAPE BREAST IMPLANTS EXPERIENCED BILATERAL CAPSULAR CONTRACTURE ACCOMPANIED BY PAIN POST PROCEDURE. THE PAIN WAS DESCRIBED AS BURNING WITH PRESSURE. IT WAS STATED TO BE MORE PRONOUNCED ON THE LEFT SIDE. THE CAPSULAR CONTRACTURE WAS BAKER GRADE II. THE PATIENT DEMONSTRATED CONCERN OVER BREAST IMPLANTS AND SOUGHT OUT THE OPINION OF TWO PHYSICIANS. ON (B)(6) 2019 A PHYSICIAN¿S EXAMINATION DETERMINED THAT SYMPTOMS THE PATIENT WAS DEMONSTRATING WAS DUE TO THE CAPSULAR CONTRACTURE. THE POSSIBILITY OF FUTURE EXPLANT IS INDICATED, HOWEVER, AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING AN EXPECTED EXPLANTATION DATE. SEE 1645337-2020-02703 FOR CONTRALATERAL PROSTHESIS REPORT.

  Patient problems: Capsular Contracture

  MAUDE report 9734057 ↗
• InjuryOct 28, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A (B)(6) CAUCASIAN FEMALE WHO UNDERWENT PRIMARY BREAST RECONSTRUCTION WITH A 480CC MENTOR MEMORYSHAPE BREAST IMPLANT (LEFT) AND A 775CC MENTOR MEMORYSHAPE BREAST IMPLANT (RIGHT) EXPERIENCED SYMPTOMS CONSISTENT WITH BILATERAL CAPSULAR CONTRACTURE POST PROCEDURE. BILATERAL PAIN, HARDNESS OF THE IMPLANTS, AND MISSHAPEN IMPLANTS WERE ALL REPORTED. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE. SEE 1645337-2019-22677 FOR CONTRALATERAL PROSTHESIS REPORT.

  Patient problems: Capsular Contracture

  MAUDE report 9247077 ↗
• InjurySep 11, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A (B)(6) YEAR-OLD HISPANIC FEMALE PATIENT UNDERWENT AN UNSPECIFIED BREAST RECONSTRUCTION WITH A 480CC MENTOR MEMORYSHAPE BREAST IMPLANT (FOR RIGHT) AND AN UNKNOWN MENTOR GEL BREAST IMPLANT (FOR LEFT) AND EXPERIENCED POSTOPERATIVE RIGHT-SIDED HEMATOMA, AND THE LEFT BREAST HAD TO BE DRAINED. AS A RESULT, THE PATIENT UNDERWENT BILATERAL REMOVAL AND REPLACEMENT WITH UNKNOWN MENTOR BREAST IMPLANTS ON AROUND (B)(6) 2014. THIS MEDWATCH REPORT IS FOR THE RIGHT-SIDED IMPLANT.

  Patient problems: Hematoma; No Code Available

  MAUDE report 8994889 ↗