MENTOR MemoryGel Breast Implant 3505535BCRecalls & reported problems

Summary

The FDA's MAUDE database contains 325 adverse event reports that list this exact device (DI 00081317006985), received between May 8, 2019 and Sep 15, 2026 — classified as 315 injuries, 10 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (133 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 325 reports, in the reporter's own words as published by the FDA.

• InjurySep 15, 2026Material Rupture

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50781360 ↗
• InjurySep 15, 2026Gel Leak; Adverse Event Without Identified Device or Use Problem

  Patient problems: Capsular Contracture

  MAUDE report 50779888 ↗
• InjurySep 15, 2026Gel Leak; Adverse Event Without Identified Device or Use Problem

  Patient problems: Capsular Contracture

  MAUDE report 50779887 ↗
• InjurySep 6, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Capsular Contracture

  MAUDE report 50640852 ↗
• MalfunctionAug 20, 2026Insufficient Device Problem Information

  It was originally reported that a 535cc MENTOR MemoryGel Breast Implant was discovered to be "defective" out of the box. The report provided limited details; there was no specific product malfunction or fault indicated. Thereafter, the breast prosthesis received by the Mentor analysis lab where it was determined to have a reportable failure mode.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50353256 ↗
• InjuryJul 27, 2026Migration

  It was reported that a patient implanted with two 535cc MENTOR MemoryGel Breast Implant experienced bilateral device migrations and burning sensations post-operatively. The patient noticed these symptoms follow a motor vehicle accident. At the time of this report, Mentor has received no information regarding explantation or an expected explantation date.

  Patient problems: Paresthesia

  MAUDE report 50043163 ↗
• InjuryJul 27, 2026Migration

  It was reported that a patient implanted with two 535cc MENTOR MemoryGel Breast Implant experienced bilateral device migrations and burning sensations post-operatively. The patient noticed these symptoms follow a motor vehicle accident. At the time of this report, Mentor has received no information regarding explantation or an expected explantation date.

  Patient problems: Paresthesia

  MAUDE report 50043160 ↗
• InjuryJun 11, 2026Migration

  IT WAS REPORTED THAT A PATIENT IMPLANTED WITH A 535CC MENTOR MEMORYGEL BREAST IMPLANT EXPERIENCED A DEVICE MIGRATION ON THE RIGHT SIDE POST-OPERATIVELY. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON (B)(6) 2026.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 25471015 ↗
• InjuryJun 3, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT IMPLANTED WITH TWO MENTOR MEMORYGEL BREAST IMPLANT EXPERIENCED BREAST IMPLANT ILLNESSES SYMPTOMS INCLUDING SWELLING, PAIN, BREAST PAIN, AND HEART PROBLEMS POST-OPERATIVELY. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON (B)(6) 2026.

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

  MAUDE report 25375180 ↗
• InjuryMay 21, 2026Migration

  A FEMALE PATIENT UNDERWENT A BREAST AUGMENTATION PRIMARY WITH A MENTOR MEMORYGEL, 535CC SILICONE PROSTHESIS DEVELOPED LEFT SIDED DEVICE MIGRATION POSTOPERATIVE. DURING A ROUTINE MAMMOGRAM, PRESSURE FROM THE EXAM PUSHED THE IMPLANT OUT OF ITS POCKET. THE MAMMOGRAM CONFIRMED THAT THE IMPLANT HAD MIGRATED. AS A RESULT, THE PATIENT SCHEDULED FOR REMOVAL SURGERY ON (B)(6) 2026.

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

  MAUDE report 25247930 ↗
• InjuryMay 11, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT WHO UNDERWENT A PRIMARY BREAST AUGMENTATION PROCEDURE WITH A MENTOR MEMORYGEL BREAST IMPLANT GEL BREAST PROSTHESIS DEVELOPED BAKER GRADE IV CAPSULAR CONTRACTURE IN HER RIGHT BREAST POST IMPLANTATION. THE CAPSULAR CONTRACTURE WAS DIAGNOSED VIA AP HYSICAL EXAM. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE.

  Patient problems: Capsular Contracture

  MAUDE report 25144513 ↗
• InjuryApr 9, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A FEMALE PATIENT UNDERWENT A BREAST SURGERY WITH TWO 535CC MENTOR MEMORYGEL BREAST IMPLANTS AND EXPERIENCED BILATERAL CAPSULAR CONTRACTURE (BAKER GRADE 3) POST-OPERATIVELY. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON (B)(6) 2026 AND REPLACED WITH A 480CC MENTOR MEMORYGEL BREAST IMPLANTS. THIS REPORT IS FOR THE LEFT SIDE DEVICE.

  Patient problems: Capsular Contracture

  MAUDE report 24833016 ↗
• InjuryApr 9, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A FEMALE PATIENT UNDERWENT A BREAST SURGERY WITH TWO 535CC MENTOR MEMORYGEL BREAST IMPLANTS AND EXPERIENCED BILATERAL CAPSULAR CONTRACTURE (BAKER GRADE 3) POST-OPERATIVELY. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON (B)(6) 2026, AND REPLACED WITH A 480CC MENTOR MEMORYGEL BREAST IMPLANTS. THIS REPORT IS FOR THE RIGHT SIDE DEVICE.

  Patient problems: Capsular Contracture

  MAUDE report 24833008 ↗
• InjuryApr 1, 2026Material Rupture

  IT WAS REPORTED THAT A PATIENT UNDERWENT PRIMARY BREAST AUGMENTATION WITH A 535CC MENTOR MEMORYGEL BREAST IMPLANT ON THE RIGHT BREAST. POST-OPERATIVELY, THE PATIENT SUFFERED RIGHT BREAST IMPLANT RUPTURE. AS A RESULT, THE PATIENT UNDERWENT BREAST IMPLANT REMOVAL SURGERY ON (B)(6) 2026.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 24757887 ↗
• InjuryFeb 26, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT IMPLANTED WITH TWO 535CC MENTOR MEMORYGEL BREAST IMPLANTS EXPERIENCED SORENESS UNDER ARMS, BACK PAIN, HEADACHES, FEET PAIN, AND EYE PAIN POST-OPERATIVELY. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE.

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

  MAUDE report 24457307 ↗
• InjuryFeb 26, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT IMPLANTED WITH TWO 535CC MENTOR MEMORYGEL BREAST IMPLANTS EXPERIENCED SORENESS UNDER ARMS, BACK PAIN, HEADACHES, FEET PAIN, AND EYE PAIN POST-OPERATIVELY. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE.

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

  MAUDE report 24457300 ↗
• InjuryJan 21, 2026Material 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. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 24139472 ↗
• InjuryJan 16, 2026Material Rupture

  IT WAS REPORTED THAT A PATIENT IMPLANTED WITH A 535CC MENTOR MEMORYGEL BREAST IMPLANT EXPERIENCED A RUPTURE ON THE RIGHT SIDE POST-OPERATIVELY. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON (B)(6) 2026.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 24102915 ↗
• MalfunctionDec 25, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT A 535CC MENTOR MEMORYGEL BREAST IMPLANT BEING USED IN A PRIMARY BREAST AUGMENTATION PROCEDURE WAS FOUND TO BE RUPTURED DURING THE OPERATION. NO ADVERSE EVENT WAS EXPERIENCED BY THE PATIENT. THE SURGEON USED A BACKUP DEVICE, AND THERE WERE NO REPORTED PATIENT CONSEQUENCES OR PROCEDURAL DELAYS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23891864 ↗
• InjuryDec 24, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT UNDERWENT A PRIMARY BREAST AUGMENTATION SURGERY WITH IMPLANTATION OF A 535CC MENTOR MEMORYGEL BREAST IMPLANT PROSTHESIS. POST-OPERATIVELY, THE PATIENT REPORTED EXPERIENCING A RUPTURED LEFT BREAST IMPLANT. MAMMOGRAM, ULTRASOUND, AND MAGNETIC RESONANCE IMAGING WERE PERFORMED. ADDITIONALLY, THE PATIENT STATED A BREAST BIOPSY IS NEEDED TO RULE OUT BREAST CANCER. MAGNETIC RESONANCE IMAGING INDICATED A SMALL AMOUNT OF FLUID COLLECTION IN THE LEFT BREAST WITHOUT CONCERN. ADDITIONALLY, THE PATIENT WAS DIAGNOSED WITH BILATERALLY RUPTURED IMPLANTS AND BREAST PTOSIS BY A MEDICAL PROFESSIONAL. AS A RESULT, THE PATIENT UNDERWENT BILATERAL EXCHANGE WITH MENTOR SALINE IMPLANTS ON (B)(6) 2025. A POST-OPERATIVE DIAGNOSIS OF BILATERALLY RUPTURED IMPLANTS WAS PROVIDED; HOWEVER, THE LEFT IMPLANT WAS DESCRIBED AS RUPTURED WHILE THE RIGHT WAS DESCRIBED AS "APPEARED TO BE UNRUPTURED". THE RIGHT-SIDE RUPTURE WAS NOT CONFIRMED BY THE INFORMATION PROVIDED, BUT THE DESCRIPTION INDICATES THE SURGEON WAS UNSURE IF THE RIGHT IMPLANT WAS TRULY RUPTURED. THIS REPORT IS FOR THE RIGHT BREAST PROSTHESIS.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 23888401 ↗
• InjuryDec 9, 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 535CC MENTOR MEMORYGEL BREAST IMPLANTS. POST-OPERATIVELY, THE PATIENT WAS DIAGNOSED, VIA PHYSICAL EXAMINATION, WITH RIGHT BREAST CAPSULAR CONTRACTURE (BAKER GRADE III). AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE.

  Patient problems: Capsular Contracture

  MAUDE report 23758902 ↗
• InjuryNov 17, 2025Migration; Migration

  IT WAS REPORTED THAT A PATIENT UNDERWENT A PRIMARY BREAST AUGMENTATION PROCEDURE WITH MENTOR MEMORYGEL BREAST IMPLANT 535CC GEL BREAST PROSTHESES WHEN THE RIGHT BREAST PROSTHESIS RUPTURED POST IMPLANTATION. RUPTURE OF THE PATIENT¿S RIGHT BREAST PROSTHESIS WAS DIAGNOSED VIA MRI. ADDITIONALLY, THE PATIENT DEVELOPED BILATERAL BREAST ANIMATION DEFORMITY AND LATERAL DISPLACEMENT OF THE BREAST PROSTHESES. LASTLY, THE PATIENT WAS DIAGNOSED WITH LYMPHOMA IN LATE 2024. AS A RESULT, THE PATIENT UNDERWENT BILATERAL EXPLANTATION AND REPLACEMENT WITH MENTOR MEMORYGEL BOOST BREAST IMPLANT 480CC GEL BREAST PROSTHESES ON (B)(6) 2025. THIS MEDWATCH REPORT IS FOR THE PATIENT¿S LEFT BREAST PROSTHESIS. REFER TO MANUFACTURER REPORT NUMBER 1645337-2025-11806 FOR THE REPORT FOR THE PATIENT¿S RIGHT BREAST PROSTHESIS.

  Patient problems: Cancer; Deformity/ Disfigurement

  MAUDE report 23577922 ↗
• InjuryNov 17, 2025Migration; Migration

  IT WAS REPORTED THAT A PATIENT IMPLANTED WITH A 535CC MENTOR MEMORYGEL BREAST IMPLANT EXPERIENCED A DEVICE MIGRATION ON THE LEFT SIDE POST-OPERATIVELY. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON (B)(6) 2025.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 23572191 ↗
• InjuryNov 10, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT UNDERWENT A BREAST AUGMENTATION REVISION PROCEDURE WITH A MENTOR MEMORYGEL BREAST IMPLANT 535CC GEL BREAST PROSTHESIS THAT RUPTURED POST IMPLANTATION. RUPTURE OF THE PATIENT¿S RIGHT BREAST PROSTHESIS WAS OBSERVED DURING AN IMPLANT EXCHANGE SURGERY ON (B)(6) 2025. THE PATIENT¿S EXPLANTED BREAST PROSTHESES WERE REPLACED WITH MENTOR MEMORYGEL BREAST IMPLANT 750CC GEL BREAST PROSTHESES.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 23518936 ↗
• 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 A PRIMARY BREAST AUGMENTATION SURGERY WITH IMPLANTATION OF A 535CC MENTOR MEMORYGEL BREAST IMPLANT PROSTHESIS. POST-OPERATIVELY, THE PATIENT WAS DIAGNOSED WITH LEFT BREAST BAKER GRADE IV CAPSULAR CONTRACTURE DURING A PHYSICAL EXAM. 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

  MAUDE report 23514263 ↗