MENTOR MemoryGel Xtra Breast Implant THPX620Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00081317025771), received between Aug 14, 2019 and Jan 30, 2026 — classified as 9 injuries.

The most frequently reported specific device problem is “Material Rupture” (4 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• InjuryJan 30, 2026Material Rupture

  IT WAS REPORTED THAT A PATIENT WITH MENTOR MEMORYGEL XTRA BREAST IMPLANTS EXPERIENCED RUPTURE ON THE LEFT SIDE POST-OPERATIVELY, WHICH WAS CONFIRMED DURING A PHYSICAL EXAM. AS A RESULT, THE PATIENT UNDERWENT DEVICE REMOVAL AND REPLACEMENT.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 24225593 ↗
• InjuryJan 23, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A PRIMARY BREAST AUGMENTATION SURGERY WITH IMPLANTATION OF A 620CC MENTOR MEMORYGEL XTRA BREAST IMPLANT PROSTHESIS. POST-OPERATIVELY, THE PATIENT UNDERWENT A REVISION SURGERY ON (B)(6) 2025, AS SHE COMPLAINED OF SMALL BREASTS AND BILATERAL BREAST PTOSIS. DURING THE SURGERY, A RUPTURED RIGHT IMPLANT WAS DISCOVERED WHICH RESULTED IN BILATERAL EXCHANGE WITH SIENTRA (NON-MENTOR) IMPLANTS. THERE WAS A 45-MINUTE DELAY, BUT NO PATIENT HARMS OR CONSEQUENCES WERE REPORTED AS A RESULT. THIS REPORT IS FOR THE LEFT BREAST PROSTHESIS.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 24167421 ↗
• InjuryNov 24, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT UNDERWENT A PRIMARY BREAST AUGMENTATION SURGERY WITH IMPLANTATION OF A 620CC MENTOR MEMORYGEL XTRA BREAST IMPLANT PROSTHESIS. POST-OPERATIVELY, THE PATIENT UNDERWENT A REVISION SURGERY ON (B)(6) 2025, FOR AN UNDISCLOSED REASON. HOWEVER, DURING THE SURGERY A RUPTURED RIGHT IMPLANT WAS DISCOVERED WHICH RESULTED IN BILATERAL EXCHANGE WITH SIENTRA (NON-MENTOR) IMPLANTS. THERE WAS A 45-MINUTE DELAY, BUT NO PATIENT HARMS OR CONSEQUENCES WERE REPORTED AS A RESULT.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 23634305 ↗
• InjuryFeb 21, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT A FEMALE PATIENT UNDERWENT BREAST AUGMENTATION PROCEDURE WITH 620CC MENTOR MEMORYGEL XTRA BREAST IMPLANT AND EXPERIENCED BREAST IMPLANT RUPTURE ON HER RIGHT SIDE POSTOPERATIVELY. AS A RESULT, THE PATIENT UNDERWENT RIGHT SIDE REPLACEMENT SURGERY WITH CATALOG NUMBER THPX620; SERIAL NUMBER (B)(6), ON (B)(6) 2025.

  Patient problems: Breast Discomfort/Pain; Deformity/ Disfigurement

  MAUDE report 21432440 ↗
• InjuryMar 19, 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 REVISION SURGERY WITH IMPLANTATION OF A 620CC MENTOR MEMORYGEL XTRA BREAST IMPLANT PROSTHESIS. POST-OPERATIVELY, THE PATIENT EXPERIENCED RIGHT BREAST PAIN AND FIRMNESS. SUBSEQUENTLY, SHE WAS DIAGNOSED WITH BAKER GRADE IV CAPSULAR CONTRACTURE OF THE RIGHT BREAST BY A MEDICAL PROFESSIONAL USING THE PATIENT'S SYMPTOMS. AS A RESULT, THE PATIENT UNDERWENT BREAST IMPLANT REMOVAL ON (B)(6) 2024.

  Patient problems: Capsular Contracture

  MAUDE report 18933750 ↗
• InjuryJul 11, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT A FEMALE PATIENT WHO HAD A 620CC MENTOR MEMORYGEL XTRA BREAST IMPLANT EXPERIENCED RUPTURE OF AN UNKNOWN SIDE POST PROCEDURE. THE RUPTURE WAS NOTED SHORTLY AFTER A CAR ACCIDENT. BREAST PAIN WAS ALSO PRESENT. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE. BECAUSE THE SIDE OF THE RUPTURE COULD NOT BE DETERMINED, IT COULD NOT BE DETERMINED WHICH OF THE TWO LOT AND SERIAL NUMBERS PROVIDED BELONGS TO THE RUPTURED IMPLANT. SECTION D HAS BEEN UPDATED TO REFLECT THAT.

  Patient problems: Breast Discomfort/Pain; Crushing Injury

  MAUDE report 14983156 ↗
• InjuryJun 30, 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 HISPANIC FEMALE PATIENT WHO UNDERWENT A BREAST AUGMENTATION REVISION PROCEDURE WITH MENTOR MEMORYGEL XTRA BREAST IMPLANT 620CC GEL BREAST PROSTHESES HAD PURULENT FLUID DISCHARGING FROM BOTH OF HER BREASTS. MORE FLUID WAS DISCHARGED FROM THE LEFT BREAST THAN THE RIGHT BREAST. THE PATIENT WAS TREATED WITH ANTIBIOTICS AND DRAINS WERE INSERTED TO DRAIN THE FLUID. AS A RESULT, THE PATIENT UNDERWENT BILATERAL EXPLANTATION ON (B)(6) 2020. THIS MEDWATCH REPORT IS FOR THE PATIENT¿S LEFT BREAST PROSTHESIS.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 10214470 ↗
• InjuryJun 30, 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 HISPANIC FEMALE PATIENT WHO UNDERWENT A BREAST AUGMENTATION REVISION PROCEDURE WITH MENTOR MEMORYGEL XTRA BREAST IMPLANT 620CC GEL BREAST PROSTHESES HAD PURULENT FLUID DISCHARGING FROM BOTH OF HER BREASTS. MORE FLUID WAS DISCHARGED FROM THE LEFT BREAST THAN THE RIGHT BREAST. THE PATIENT WAS TREATED WITH ANTIBIOTICS AND DRAINS WERE INSERTED TO DRAIN THE FLUID. AS A RESULT, THE PATIENT UNDERWENT BILATERAL EXPLANTATION ON (B)(6) 2020. THIS MEDWATCH REPORT IS FOR THE PATIENT¿S RIGHT BREAST PROSTHESIS.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 10214463 ↗
• InjuryAug 14, 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 FEMALE PATIENT UNDERWENT PRIMARY BREAST AUGMENTATION WITH A 620CC MENTOR MEMORYGEL XTRA BREAST IMPLANT AND WAS PRESENTED WITH LEFT SIDE CAPSULAR CONTRACTURE; BAKER GRADE III NOTICED BY PATIENT ON (B)(6) 2019 AT A CONSULTATION WITH DOCTOR. AS A RESULT, THE DEVICE WAS EXPLANTED ON (B)(6) 2019.

  Patient problems: Capsular Contracture; No Code Available

  MAUDE report 8893510 ↗