MENTOR MemoryGel Breast Implant 3507200BCRecalls & reported problems

Summary

The FDA's MAUDE database contains 123 adverse event reports that list this exact device (DI 00081317000051), received between Mar 7, 2018 and Mar 26, 2026 — classified as 123 injuries.

The most frequently reported specific device problem is “Material Rupture” (102 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 123 reports, in the reporter's own words as published by the FDA.

• InjuryMar 26, 2026Material Rupture

  IT WAS REPORTED THAT A 66-YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT A BREAST AUGMENTATION REVISION WITH TWO 200CC MENTOR MEMORYGEL BREAST IMPLANTS AND EXPERIENCED BILATERAL RUPTURES POST-OPERATIVELY, WHICH WAS DIAGNOSED WITH AN MRI. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON (B)(6) 2026 AND REPLACED WITH A 170CC MENTOR MEMORYGEL BREAST IMPLANTS. THIS REPORT IS FOR THE LEFT SIDE DEVICE.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 24708547 ↗
• InjuryMar 26, 2026Material Rupture

  IT WAS REPORTED THAT A 66-YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT A BREAST AUGMENTATION REVISION WITH TWO 200CC MENTOR MEMORYGEL BREAST IMPLANTS AND EXPERIENCED BILATERAL RUPTURES POST-OPERATIVELY, WHICH WAS DIAGNOSED WITH AN MRI. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON (B)(6) 2026 AND REPLACED WITH A 170CC MENTOR MEMORYGEL BREAST IMPLANTS. THIS REPORT IS FOR THE RIGHT SIDE DEVICE.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 24708544 ↗
• InjuryFeb 19, 2026Material Rupture

  IT WAS REPORTED THAT A PATIENT IMPLANTED WITH A 225CC MENTOR MEMORYGEL BREAST IMPLANT EXPERIENCED BILATERAL CAPSULAR CONTRACTURE AND RUPTURE POST-OPERATIVELY. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON (B)(6) 2025.

  Patient problems: Capsular Contracture

  MAUDE report 24390105 ↗
• InjuryDec 11, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT UNDERWENT A PRIMARY BREAST AUGMENTATION SURGERY WITH IMPLANTATION OF A 200CC MENTOR MEMORYGEL BREAST IMPLANT PROSTHESIS. POST-OPERATIVELY, THE PATIENT WAS DIAGNOSED WITH BILATERAL BREAST CAPSULAR CONTRACTURE (BAKER GRADE RATINGS WERE NOT PROVIDED) BY A MEDICAL PROFESSIONAL. AS A RESULT, THE PATIENT UNDERWENT BILATERAL EXCHANGE WITH MENTOR GEL IMPLANTS ON (B)(6) 2025. FURTHERMORE, THE EXPLANTED RIGHT DEVICE WAS FOUND TO BE RUPTURED. THERE WERE NO REPORTED PROCEDURAL DELAYS OR PATIENT CONSEQUENCES/HARMS DUE TO THE FINDINGS. FOLLOW-UPS ARE BEING CONDUCTED. IF MORE INFORMATION BECOMES AVAILABLE, MENTOR WILL SUBMIT A SUPPLEMENTAL REPORT ACCORDINGLY. THIS REPORT IS FOR THE RIGHT BREAST PROSTHESIS.

  Patient problems: Capsular Contracture

  MAUDE report 23783287 ↗
• InjuryDec 11, 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 200CC MENTOR MEMORYGEL BREAST IMPLANT PROSTHESIS. POST-OPERATIVELY, THE PATIENT WAS DIAGNOSED WITH BILATERAL BREAST CAPSULAR CONTRACTURE (BAKER GRADE RATINGS WERE NOT PROVIDED) BY A MEDICAL PROFESSIONAL. AS A RESULT, THE PATIENT UNDERWENT BILATERAL EXCHANGE WITH MENTOR GEL IMPLANTS ON (B)(6) 2025. FURTHERMORE, THE EXPLANTED RIGHT DEVICE WAS FOUND TO BE RUPTURED. THERE WERE NO REPORTED PROCEDURAL DELAYS OR PATIENT CONSEQUENCES/HARMS DUE TO THE FINDINGS. FOLLOW-UPS ARE BEING CONDUCTED. IF MORE INFORMATION BECOMES AVAILABLE, MENTOR WILL SUBMIT A SUPPLEMENTAL REPORT ACCORDINGLY. THIS REPORT IS FOR THE LEFT BREAST PROSTHESIS.

  Patient problems: Capsular Contracture

  MAUDE report 23783146 ↗
• InjuryNov 23, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT UNDERWENT BREAST AUGMENTATION REVISION WITH TWO 200CC MENTOR MEMORYGEL BREAST IMPLANTS. POST-OPERATIVELY, THE PATIENT DEVELOPED BILATERAL BREAST CAPSULAR CONTRACTURES (BAKER GRADE II ON THE LEFT AND BAKER GRADE II-III ON THE RIGHT) AND WAS ALSO DIAGNOSED, VIA MRI, WITH BILATERAL BREAST IMPLANT RUPTURES AND ENLARGED ABNORMAL RIGHT AXILLARY LYMPH NODES. AS A RESULT, THE PATIENT UNDERWENT BREAST IMPLANT REMOVAL AND REPLACEMENT SURGERY ON (B)(6) 2025. THE REPLACEMENT DEVICES WERE TWO MENTOR GEL IMPLANTS. THIS MEDWATCH FORM IS FOR THE LEFT BREAST PROSTHESIS.

  Patient problems: Capsular Contracture

  MAUDE report 23627225 ↗
• InjuryNov 23, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT UNDERWENT BREAST AUGMENTATION REVISION WITH TWO 200CC MENTOR MEMORYGEL BREAST IMPLANTS. POST-OPERATIVELY, THE PATIENT DEVELOPED BILATERAL BREAST CAPSULAR CONTRACTURES (BAKER GRADE II ON THE LEFT AND BAKER GRADE II-III ON THE RIGHT) AND WAS ALSO DIAGNOSED, VIA MRI, WITH BILATERAL BREAST IMPLANT RUPTURES AND ENLARGED ABNORMAL RIGHT AXILLARY LYMPH NODES. AS A RESULT, THE PATIENT UNDERWENT BREAST IMPLANT REMOVAL AND REPLACEMENT SURGERY ON (B)(6) 2025. THE REPLACEMENT DEVICES WERE TWO MENTOR GEL IMPLANTS. THIS MEDWATCH FORM IS FOR THE RIGHT BREAST PROSTHESIS.

  Patient problems: Capsular Contracture; Swollen Lymph Nodes/Glands

  MAUDE report 23627223 ↗
• InjuryNov 7, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT A 55-YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT A BREAST AUGMENTATION REVISION WITH AN UNSPECIFIED GEL BREAST PROSTHESIS AND EXPERIENCED A RUPTURE ON AN UNSPECIFIED SIDE POST-OPERATIVELY, WHICH WAS DIAGNOSED WITH A CT SCAN. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 23503992 ↗
• InjuryOct 15, 2025Migration; Migration

  IT WAS REPORTED THAT A FEMALE PATIENT UNDERWENT A BREAST SURGERY WITH A 200CC MENTOR MEMORYGEL BREAST IMPLANT AND EXPERIENCED CUTANEOUS CONTOUR DEFORMITY AND DEVICE MIGRATION ON THE RIGHT SIDE POST-OPERATIVELY. IT WAS REPORTED THAT THE PATIENT HAD FOLD, WAVES, AND ROTATION. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON (B)(6) 2025. A LOT AND SERIAL NUMBERWAS PROVIDED THAT DOES NOT CORRESPOND TO A FINISHED BREAST PROSTHESIS. AS A RESULT, A DEVICE HISTORY RECORD REVIEW CANNOT BE COMPLETED. MENTOR HAS INITIATED FOLLOW UP ATTEMPTS TO CLARIFY THIS INFORMATION. SHOULD AN UPDATED/ACCURATE LOT OR SERIAL NUMBER BE RECEIVED, A SUPPLEMENTAL REPORT WILL BE SENT ACCORDINGLY.

  Patient problems: Wrinkling

  MAUDE report 23295636 ↗
• InjuryAug 11, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT WHO UNDERWENT A BREAST AUGMENTATION REVISION PROCEDURE WITH A MENTOR MEMORYGEL BREAST IMPLANT 200CC GEL BREAST PROSTHESIS DEVELOPED BAKER GRADE III CAPSULAR CONTRACTURE IN HER LEFT BREAST POST IMPLANTATION. AS A RESULT, THE PATIENT UNDERWENT BILATERAL EXPLANTATION AND REPLACEMENT WITH GEL BREAST PROSTHESES ON (B)(6) 2025. DURING EXPLANT SURGERY, IT WAS OBSERVED THAT THE LEFT BREAST PROSTHESIS WAS RUPTURED.

  Patient problems: Capsular Contracture

  MAUDE report 22779307 ↗
• InjuryAug 11, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT UNDERWENT A BREAST AUGMENTATION REVISION SURGERY WITH IMPLANTATION OF A 200CC MENTOR MEMORYGEL BREAST IMPLANT PROSTHESIS. POST-OPERATIVELY, THE PATIENT DESIRED REMOVAL OF HER IMPLANTS. AS A RESULT, THE PATIENT UNDERWENT BILATERAL IMPLANT REMOVAL WITHOUT REPLACEMENTS ON (B)(6) 2025. HOWEVER, DURING THE SURGERY, BILATERALLY RUPTURED IMPLANTS WERE DISCOVERED. THERE WAS NO REPORTED PROCEDURAL DELAY OR PATIENT CONSEQUENCE DUE TO THE FINDINGS.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 22779286 ↗
• InjuryAug 11, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT UNDERWENT A BREAST AUGMENTATION REVISION SURGERY WITH IMPLANTATION OF A 200CC MENTOR MEMORYGEL BREAST IMPLANT PROSTHESIS. POST-OPERATIVELY, THE PATIENT DESIRED REMOVAL OF HER IMPLANTS. AS A RESULT, THE PATIENT UNDERWENT BILATERAL IMPLANT REMOVAL WITHOUT REPLACEMENTS ON (B)(6) 2025. HOWEVER, DURING THE SURGERY, BILATERALLY RUPTURED IMPLANTS WERE DISCOVERED. THERE WAS NO REPORTED PROCEDURAL DELAY OR PATIENT CONSEQUENCE DUE TO THE FINDINGS.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 22779283 ↗
• InjuryMay 26, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT UNDERWENT BREAST AUGMENTATION REVISION, AS PART OF A CLINICAL STUDY, WITH TWO UNKNOWN MENTOR GEL IMPLANTS. POST-OPERATIVELY, THE PATIENT HAD TO UNDERGO BILATERAL BREAST IMPLANT REMOVAL AND REPLACEMENT SURGERY, FOR UNSPECIFIED REASONS, ON (B)(6) 2025. DURING THE SURGERY, BOTH THE LEFT AND RIGHT IMPLANTS WERE IDENTIFIED TO HAVE RUPTURED. SUBSEQUENTLY, THEY WERE REPLACED WITH TWO MENTOR GEL IMPLANTS. THIS MEDWATCH FORM IS FOR THE RIGHT BREAST PROSTHESIS.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 22085233 ↗
• InjuryMay 16, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT UNDERWENT BREAST AUGMENTATION REVISION WITH A 200 CC MENTOR MEMORYGEL BREAST IMPLANT ON THE LEFT BREAST. POST-OPERATIVELY, THE PATIENT WAS DIAGNOSED, VIA MRI, WITH LEFT BREAST IMPLANT RUPTURE. AS A RESULT, THE PATIENT UNDERWENT BREAST IMPLANT REMOVAL SURGERY ON (B)(6) 2025.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 22039621 ↗
• InjuryApr 21, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT UNDERWENT A BREAST AUGMENTATION REVISION SURGERY WITH IMPLANTATION OF A 200CC MENTOR MEMORYGEL BREAST IMPLANT PROSTHESIS. POST-OPERATIVELY, THE PATIENT UNDERWENT BILATERAL REMOVAL AND REPLACEMENT WITH 350CC MENTOR SMOOTH ROUND MODERATE PLUS PROFILE SALINE BREAST IMPLANTS ON (B)(6) 2025, FOR AN UNDISCLOSED REASON. HOWEVER, DURING THE SURGERY, BILATERALLY RUPTURED BREAST IMPLANTS WERE DISCOVERED. THERE WERE NO REPORTED PROCEDURAL DELAYS OR PATIENT CONSEQUENCES DUE TO THE RUPTURES. THIS REPORT IS FOR THE LEFT BREAST PROSTHESIS.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 21873908 ↗
• InjuryFeb 5, 2025Material Rupture; Material Rupture

  A FEMALE PATIENT UNDERWENT PRIMARY BREAST AUGMENTATION WITH MENTOR MEMORYGEL SILICONE PROSTHESES, RECEIVING 250CC ON THE RIGHT SIDE AND 200CC ON THE LEFT SIDE. SUBSEQUENTLY, MRI EXAMINATIONS REVEALED BILATERAL SILENT RUPTURES OF THE IMPLANTS, WHICH WERE ASYMPTOMATIC AT THE TIME OF DETECTION. AS A RESULT, THE PATIENT UNDERWENT A BILATERAL REMOVAL OF THE PROSTHESES ON (B)(6) 2025. THIS REPORT SPECIFICALLY FOCUSES ON THE LEFT-SIDED IMPLANT.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 21315422 ↗
• InjuryJan 2, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT UNDERWENT PRIMARY BREAST AUGMENTATION WITH TWO 200CC MENTOR MEMORYGEL BREAST IMPLANTS. POST-OPERATIVELY, THE PATIENT NEEDED A BREAST LIFT ON AN UNSPECIFIED BREAST. AS A RESULT, THE PATIENT UNDERWENT BREAST LIFT SURGERY ON (B)(6) 2024. DURING THE SURGERY, THE IMPLANT WAS IDENTIFIED TO BE RUPTURED. SUBSEQUENTLY, THE PATIENT'S IMPLANTS WERE REPLACED BILATERALLY WITH THE FOLLOWING DEVICES: (LEFT) 200CC MENTOR MEMORYGEL BREAST IMPLANT CATALOG: 3502001BC LOT: 9993927 SN: (B)(6) AND (RIGHT) 200CC MENTOR MEMORYGEL BREAST IMPLANT CATALOG: 3502001BC LOT: 9993927 SN: (B)(6). SINCE IT WAS NOT SPECIFIED, WHICH BREAST HAD THE COMPLICATIONS, BOTH THE LEFT AND RIGHT IMPLANTS INFORMATION WAS PROVIDED.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 21058751 ↗
• InjuryNov 5, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT A 36-YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT A PRIMARY BREAST AUGMENTATION WITH A 200CC MENTOR MEMORYGEL BREAST IMPLANT AND EXPERIENCED A RUPTURE ON THE RIGHT SIDE POST-OPERATIVELY, WHICH WAS DIAGNOSED WITH AN OFFICE VISIT. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON (B)(6) 2024.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 20614414 ↗
• InjurySep 19, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT UNDERWENT A BREAST AUGMENTATION REVISION SURGERY WITH IMPLANTATION OF A 200CC MENTOR MEMORYGEL BREAST IMPLANT PROSTHESIS. POST-OPERATIVELY, THE PATIENT WAS DIAGNOSED WITH A RUPTURED RIGHT BREAST IMPLANT USING MAGNETIC RESONANCE IMAGING. AS A RESULT, THE PATIENT UNDERWENT BREAST IMPLANT REMOVAL ON (B)(6) 2024.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 20257369 ↗
• InjuryJun 19, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT UNDERWENT BREAST PROSTHESIS IMPLANTATION SURGERY WITH A 200CC MENTOR MEMORYGEL BREAST IMPLANT ON THE LEFT BREAST. POST-OPERATIVELY, THE PATIENT UNDERWENT BREAST IMPLANT REVISION FOR AN UNSPECIFIED REASON ON MAY 30, 2024. DURING THE SURGERY, THE LEFT IMPLANT WAS DISCOVERED TO BE RUPTURED. THE PATIENT'S IMPLANTS WERE REPLACED BILATERALLY WITH THE FOLLOWING: (LEFT) 350CC MENTOR MEMORYGEL XTRA BREAST IMPLANT CATALOG: SMHX350 LOT: 9902872 SN: (B)(6) AND (RIGHT) 450CC MENTOR MEMORYGEL XTRA BREAST IMPLANT CATALOG: SHPX450 LOT: 9652567 SN: (B)(6).

  Patient problems: Deformity/ Disfigurement

  MAUDE report 19569922 ↗
• InjuryMay 13, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A BREAST AUGMENTATION WITH MENTOR MEMORYGEL BREAST IMPLANTS 200CC AND EXPERIENCED HEMATOMA ON THE RIGHT SIDE POST-OPERATIVELY. AS A RESULT, THE PATIENT UNDERWENT DEVICE REMOVAL ON AN UNSPECIFIED DATE.

  Patient problems: Hematoma

  MAUDE report 19301831 ↗
• InjuryMay 13, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT UNDERWENT A BREAST AUGMENTATION WITH MENTOR MEMORYGEL BREAST IMPLANTS 200CC AND EXPERIENCED BILATERAL RUPTURE POST-OPERATIVELY. AS A RESULT, THE PATIENT UNDERWENT DEVICE REMOVAL ON AN UNSPECIFIED DATE. THIS REPORT IS FOR THE LEFT BREAST PROSTHESIS. SEE MANUFACTURER REPORT NUMBER 1645337-2024-05643 FOR CONTRALATERAL SIDE.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 19298347 ↗
• InjuryMay 13, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT UNDERWENT A BREAST AUGMENTATION WITH MENTOR MEMORYGEL BREAST IMPLANTS 200CC AND EXPERIENCED BILATERAL RUPTURE POST-OPERATIVELY. AS A RESULT, THE PATIENT UNDERWENT DEVICE REMOVAL ON AN UNSPECIFIED DATE. THIS REPORT IS FOR THE RIGHT BREAST PROSTHESIS. SEE MANUFACTURER REPORT NUMBER 1645337-2024-05642 FOR CONTRALATERAL SIDE.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 19298345 ↗
• InjuryMay 10, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT IMPLANTED WITH A 175CC (LEFT) 200CC (RIGHT) 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 19293719 ↗
• InjuryApr 23, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT UNDERWENT BREAST PROSTHESIS IMPLANTATION SURGERY WITH A 200CC MENTOR MEMORYGEL BREAST IMPLANT ON THE RIGHT BREAST. POST-OPERATIVELY, THE PATIENT SUFFERED RIGHT BREAST IMPLANT 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 19169413 ↗