MENTOR MemoryGel Breast Implant 3507275MCRecalls & reported problems

Summary

The FDA's MAUDE database contains 250 adverse event reports that list this exact device (DI 00081317004134), received between May 9, 2019 and Sep 22, 2026 — classified as 244 injuries, 6 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (104 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 250 reports, in the reporter's own words as published by the FDA.

• InjurySep 22, 2026Material Rupture

  It was reported that a patient underwent a Primary Breast Augmentation Surgery with implantation of a 275cc MENTOR MemoryGel Breast Implant prosthesis. Post-operatively, the patient was diagnosed with left breast Baker Grade III Capsular Contracture and a ruptured left implant by a medical professional using the patient's symptoms. As a result, the patient underwent bilateral exchange with Mentor gel implants on (b)(6) 2026.

  Patient problems: Capsular Contracture

  MAUDE report 50855397 ↗
• InjurySep 18, 2026Material Rupture

  It was reported that a female patient underwent an unspecified Breast Augmentation with MENTOR MemoryGel, 275cc Silicone implants, subsequently the patient experienced right sided silent ruptures. The rupture was diagnosed through physical examination and confirmed through MRI examinations. At the time of this report, Mentor received no information regarding explantation or an expected explantation date.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50821466 ↗
• InjurySep 17, 2026Material Rupture

  It was reported that a patient with MENTOR MemoryGel Breast Implants experienced bilateral rupture post-operatively, which was confirmed during a physical exam. As a result, the patient underwent device removal.This report is for the left breast prosthesis.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50805238 ↗
• InjurySep 17, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that a 44-year-old Asian female patient underwent a primary breast augmentation with two 275cc MENTOR MemoryGel Breast Implants and experienced bilateral capsular contracture (baker grade 4) post-operatively, which was diagnosed with 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 side device.

  Patient problems: Capsular Contracture

  MAUDE report 50805229 ↗
• InjurySep 17, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that a 44-year-old Asian female patient underwent a primary breast augmentation with two 275cc MENTOR MemoryGel Breast Implants and experienced bilateral capsular contracture (baker grade 4) post-operatively, which was diagnosed with 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 side device.

  Patient problems: Capsular Contracture

  MAUDE report 50805227 ↗
• InjurySep 14, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Post Operative Wound Infection

  MAUDE report 50765051 ↗
• InjurySep 10, 2026Material Rupture

  Patient problems: Capsular Contracture; Granuloma

  MAUDE report 50721084 ↗
• InjurySep 9, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that a patient underwent breast augmentation revision with two 275cc MENTOR MemoryGel Breast Implants. Post-operatively, the patient was diagnosed, via physical examination, with right breast capsular contracture (baker grade III). As a result, the patient has been scheduled for breast implant removal surgery on (b)(6)2026.

  Patient problems: Capsular Contracture

  MAUDE report 50698467 ↗
• InjuryJul 29, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that a 42-year-old female patient underwent a primary breast augmentation with a 275cc MENTOR MemoryGel Breast Implant and experienced capsular contracture (baker grade 3) on the left side post-operatively, which was diagnosed with a physical exam. As a result, the patient underwent explantation on (b)(6) 4 2026.

  Patient problems: Capsular Contracture

  MAUDE report 50076017 ↗
• InjuryMay 15, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A 41-YEAR-OLD ASIAN FEMALE PATIENT UNDERWENT A PRIMARY BREAST AUGMENTATION WITH TWO 275CC MENTOR MEMORYGEL BREAST IMPLANT AND EXPERIENCED BILATERAL CAPSULAR CONTRACTURE (BAKER GRADE UNKNOWN) POST-OPERATIVELY. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON (B)(6), 2026. THIS REPORT IS FOR THE RIGHT SIDE DEVICE.

  Patient problems: Capsular Contracture

  MAUDE report 25194216 ↗
• InjuryApr 23, 2026Material Rupture

  IT WAS REPORTED THAT A 75-YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT A BREAST AUGMENTATION REVISION WITH TWO 275CC MENTOR MEMORYGEL BREAST IMPLANTS AND EXPERIENCED A RUPTURE ON THE LEFT SIDE POST-OPERATIVELY, WHICH WAS DIAGNOSED WITH A MAMMOGRAM. IT WAS REPORTED THAT THE LEFT SIDE WAS MISHAPPEN AND SCATTERED BENIGN APPEARING CALCIFICATIONS WERE NOTED BILATERALLY. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON (B)(6) 2026 AND REPLACED WITH MENTOR BREAST PROSTHESES. THIS REPORT IS FOR THE LEFT SIDE DEVICE.

  Patient problems: Calcium Deposits/Calcification; Deformity/ Disfigurement

  MAUDE report 24971908 ↗
• InjuryApr 22, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT WHO UNDERWENT A PRIMARY BREAST AUGMENTATION PROCEDURE WITH MENTOR MEMORYGEL BREAST IMPLANT GEL BREAST PROSTHESES DEVELOPED BAKER GRADE IV CAPSULAR CONTRACTURE IN HER RIGHT BREAST POST IMPLANTATION. ADDITIONALLY, THE PATIENT DEVELOPED PTOSIS IN HER LEFT BREAST. AS A RESULT, THE PATIENT UNDERWENT BILATERAL EXPLANTATION. THIS MEDWATCH REPORT IS FOR THE PATIENT¿S LEFT BREAST PROSTHESIS. REFER TO MANUFACTURER REPORT NUMBER 1645337-2026-03034 FOR THE REPORT FOR THE PATIENT¿S RIGHT BREAST PROSTHESIS.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 24961202 ↗
• InjuryApr 6, 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. RUPTURE OF THE PATIENT¿S LEFT BREAST PROSTHESIS WAS DIAGNOSED VIA A PHYSICAL EXAM. AS A RESULT, THE PATIENT IS SCHEDULED TO UNDERGO EXPLANTATION.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 24795845 ↗
• InjuryMar 31, 2026Material Rupture

  IT WAS REPORTED THAT A FEMALE PATIENT UNDERWENT A BREAST SURGERY WITH TWO 275CC MENTOR MEMORYGEL BREAST IMPLANTS AND EXPERIENCED BILATERAL CAPSULAR CONTRACTURE (BAKER GRADE UNKNOWN) AND BILATERAL RUPTURE POST-OPERATIVELY. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON (B)(6) 2026 AND REPLACED WITH TWO 225CC MENTOR MEMORYGEL BREAST IMPLANTS. THIS REPORT IS FOR THE RIGHT-SIDE DEVICE.

  Patient problems: Capsular Contracture

  MAUDE report 24745012 ↗
• InjuryMar 31, 2026Material Rupture

  IT WAS REPORTED THAT A FEMALE PATIENT UNDERWENT A BREAST SURGERY WITH TWO 275 CC MENTOR MEMORYGEL BREAST IMPLANTS AND EXPERIENCED BILATERAL CAPSULAR CONTRACTURE (BAKER GRADE UNKNOWN) AND BILATERAL RUPTURE POST-OPERATIVELY. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON (B)(6) 2026 AND REPLACED WITH TWO 225 CC MENTOR MEMORYGEL BREAST IMPLANTS. THIS REPORT IS FOR THE LEFT SIDE DEVICE.

  Patient problems: Capsular Contracture

  MAUDE report 24744922 ↗
• InjuryMar 11, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT PRIMARY BREAST AUGMENTATION WITH TWO 275CC MENTOR MEMORYGEL BREAST IMPLANTS. POST-OPERATIVELY, THE PATIENT WAS DIAGNOSED, VIA, IMAGING, WITH BILATERAL BREAST IMPLANT RUPTURES. THE PATIENT ALSO DEVELOPED BILATERAL BREAST CAPSULAR CONTRACTURES (BAKER GRADE III-IV ON THE RIGHT AND UNSPECIFIED ON THE LEFT) AS A RESULT, PATIENT UNDERWENT BREAST IMPLANT REMOVAL AND REPLACEMENT SURGERY ON (B)(6), 2026. DURING THE SURGERY, THE LEFT BREAST IMPLANT WAS IDENTIFIED TO BE INTACT. THE REPLACEMENT DEVICES WERE MENTOR GEL IMPLANTS. THIS MEDWATCH FORM IS FOR THE LEFT BREAST PROSTHESIS.

  Patient problems: Capsular Contracture

  MAUDE report 24570535 ↗
• InjuryMar 6, 2026Material Rupture

  A FEMALE PATIENT WHO UNDERWENT A BREAST RECONSTRUCTION REVISION WITH MENTOR MEMORYGEL 275CC, SILICONE PROSTHESIS EXPERIENCED LEFT SIDED SILENT RUPTURE POSTOPERATIVELY. THE ISSUE WAS CONFIRMED THROUGH MRI EXAMINATION. AS A RESULT, THE PATIENT UNDERWENT UNILATERAL REPLACEMENT WITH REF 3507275MC SN ON (B)(6), 2026.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 24532473 ↗
• MalfunctionFeb 26, 2026Material Rupture

  IT WAS REPORTED THAT A 275CC MENTOR MEMORYGEL BREAST IMPLANT BEING USED IN A BREAST RECONSTRUCTION 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 24456355 ↗
• InjuryFeb 25, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A 38-YEAR-OLD FEMALE PATIENT UNDERWENT A PRIMARY BREAST AUGMENTATION WITH A 300CC (RIGHT) MENTOR MEMORYGEL BREAST IMPLANT AND A 275CC (LEFT) MENTOR MEMORYGEL BREAST IMPLANT AND EXPERIENCED BILATERAL CAPSULAR CONTRACTURE (BAKER GRADE 3) POST-OPERATIVELY, WHICH WAS DIAGNOSED WITH AN OFFICE VISIT. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON (B)(6) 2026. THIS REPORT IS FOR THE LEFT SIDE DEVICE.

  Patient problems: Capsular Contracture

  MAUDE report 24444999 ↗
• InjuryFeb 13, 2026Material Rupture

  IT WAS REPORTED THAT A PATIENT UNDERWENT PRIMARY BREAST AUGMENTATION WITH TWO 275CC MENTOR MEMORYGEL BREAST IMPLANTS. POST-OPERATIVELY, THE PATIENT UNDERWENT BREAST IMPLANT REMOVAL AND REPLACEMENT SURGERY ON (B)(6) 2026. DURING THE SURGERY, THE RIGHT BREAST IMPLANT WAS IDENTIFIED TO HAVE RUPTURED. THE REPLACEMENT DEVICE WAS A MENTOR GEL IMPLANT.

  Patient problems: Capsular Contracture; Deformity/ Disfigurement

  MAUDE report 24340063 ↗
• InjuryJan 28, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A FEMALE PATIENT UNDERWENT A BREAST SURGERY WITH A 775CC (LEFT) MENTOR MEMORYGEL XTRA BREAST IMPLANT AND A 275CC (RIGHT) MENTOR MEMORYGEL BREAST IMPLANT AND EXPERIENCED BILATERAL ANISOMASTIA POST-OPERATIVELY. THE PATIENT UNDERWENT A BREAST LIFT. THE PATIENT UNDERWENT EXPLANTATION ON (B)(6) 2025,AND REPLACED WITH A 790CC MENTOR MEMORYGEL XTRA BREAST IMPLANT ON THE LEFT AND A 235CC MENTOR MEMORYGEL BREAST IMPLANT ON THE RIGHT SIDE. THIS REPORT IS FOR THE RIGHT SIDE DEVICE.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 24203495 ↗
• InjuryJan 21, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A 67-YEAR-OLD FEMALE PATIENT UNDERWENT A BREAST AUGMENTATION REVISION WITH A 275CC MENTOR MEMORYGEL BREAST IMPLANT AND EXPERIENCED CAPSULAR CONTRACTURE (BAKER GRADE 4) ON THE RIGHT SIDE POST-OPERATIVELY, WHICH WAS DIAGNOSED WITH AN EXAM. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON (B)(6) 2026.

  Patient problems: Capsular Contracture; Hematoma

  MAUDE report 24141172 ↗
• InjuryDec 22, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT BREAST AUGMENTATION REVISION WITH A 275CC MENTOR MEMORYGEL BREAST IMPLANT ON THE LEFT BREAST. POST-OPERATIVELY, THE PATIENT WAS DIAGNOSED, VIA ULTRASOUND, WITH LEFT BREAST CAPSULAR CONTRACTURE (BAKER GRADE III). AS A RESULT, THE PATIENT UNDERWENT BREAST IMPLANT REMOVAL AND REPLACEMENT SURGERY ON (B)(6) 2025. THE REPLACEMENT DEVICE WAS A MENTOR GEL IMPLANT.

  Patient problems: Capsular Contracture

  MAUDE report 23871207 ↗
• InjuryDec 15, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT IMPLANTED WITH A 275CC MENTOR MEMORYGEL BREAST IMPLANT EXPERIENCED CAPSULAR CONTRACTURE BAKER GRADE 4 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: Capsular Contracture

  MAUDE report 23804254 ↗
• InjuryDec 11, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT UNDERWENT A PRIMARY BREAST AUGMENTATION SURGERY WITH IMPLANTATION OF A 275CC MENTOR MEMORYGEL BREAST IMPLANT PROSTHESIS. POST-OPERATIVELY, THE PATIENT WAS DIAGNOSED WITH LEFT BREAST BAKER GRADE III CAPSULAR CONTRACTURE WITH DISTORTION DURING A PHYSICAL EXAM. AS A RESULT, THE PATIENT UNDERWENT BILATERAL EXCHANGE WITH A MENTOR GEL IMPLANT ON (B)(6) 2025. HOWEVER, THE RIGHT EXPLANTED IMPLANT WAS OBSERVED TO RUPTURED. THERE WERE NO REPORTED PROCEDURAL DELAYS OR PATIENT CONSEQUENCES/HARMS DUE TO THE FINDING. THIS REPORT IS FOR THE RIGHT BREAST PROSTHESIS.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 23783433 ↗