MENTOR MemoryGel Breast Implant 3545295Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00081317007104), received between Apr 16, 2020 and Feb 25, 2025 — classified as 5 injuries, 1 malfunction.

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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 25, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT A 295CC MENTOR MEMORYGEL BREAST IMPLANT RUPTURED INTRAOPERATIVELY. THERE WERE NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21463152 ↗
• InjuryApr 23, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT A FEMALE PATIENT WHO UNDERWENT BREAST AUGMENTATION SURGERY WITH TWO 295CC MENTOR MEMORYGEL BREAST IMPLANTS EXPERIENCED BILATERAL RUPTURE POST PROCEDURE. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE. THIS MEDWATCH FORM IS FOR BREAST PROSTHESIS B.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 14191121 ↗
• InjuryApr 23, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT A FEMALE PATIENT WHO UNDERWENT BREAST AUGMENTATION SURGERY WITH TWO 295CC MENTOR MEMORYGEL BREAST IMPLANTS EXPERIENCED BILATERAL RUPTURE POST PROCEDURE. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE. THIS MEDWATCH FORM IS FOR BREAST PROSTHESIS A.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 14191120 ↗
• InjurySep 24, 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 RECONSTRUCTION WITH A 295CC MENTOR MEMORYGEL BREAST IMPLANT EXPERIENCED SEVERAL UNEXPLAINED SYSTEMIC SYMPTOMS POST PROCEDURE. TINGLING, NUMBNESS TO THE FINGERTIPS, HAIR LOSS, WEIGHT LOSS, NAUSEA, SWEATINESS UNSPECIFIED PRESSURE, AND AN UNSPECIFIED FEELING OF ILLNESS WERE ALL NOTED. ADDITIONALLY, LEFT SIDED PAIN AND WRINKLING WERE NOTED. THERE IS NO PROSTHESIS ON THE RIGHT SIDE. NO DEVICE ISSUE SUCH AS RUPTURE WAS REPORTED. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE.

  Patient problems: No Code Available; Pain; Wrinkling

  MAUDE report 10582773 ↗
• InjuryApr 16, 2020Material Rupture; Material Rupture

  IT WAS REPORTED FROM THE US THAT A 56-YEAR-OLD FEMALE PATIENT OF AN UNKNOWN ETHNICITY WHO UNDERWENT BREAST AUGMENTATION REVISION IMPLANT SURGERY WITH MENTOR MEDICAL DEVICES (SILTEX UHP 295CC, DATE OF IMPLANT (B)(6) 2013 HAS EXPERIENCED RIGHT BREAST IMPLANT RUPTURE, CAPSULAR CONTRACTURE, AND GRANULOMA. AN ULTRASOUND THAT WAS PERFORMED DISPLAYED 9 SEPARATE SILICONE GRANULOMAS OF THE RIGHT BREAST EXTENDING FROM THE AXILLARY TAIL DOWN ALONG THE LATERAL CHEST WALL WITH THE LOWEST AND LARGEST AT 1 AND 8 O¿CLOCK CORRESPONDING TO THE MASS FELT BY THE PATIENT. AS A RESULT, THE PATIENT UNDERWENT EXPLANATION OF THE DEVICES ON (B)(6) 2020. THE LEFT BREAST IMPLANT WAS REMOVED PROPHYLACTICALLY BECAUSE THE DOCTOR HAD A SUSPICION THAT THE PATIENT HAD BIA-ALCL. AS PER THE OPERATIVE REPORT, THE DOCTOR REPORTS THAT THE RIGHT-SIDE CAPSULE WAS THICKENED AND ABNORMAL LOOKING. HE STATED THAT HE FEARED THAT THE PATIENT MIGHT HAVE BIA-ALCL AND THEREFORE DID A BILATERAL TOTAL CAPSULECTOMY. BOTH CAPSULES WERE SENT TO THE LAB AND RESULTS SHOWED INFLAMED TISSUE WITH NO MALIGNANCY.

  Patient problems: Breast Mass; Capsular Contracture; Granuloma; No Code Available

  MAUDE report 9970051 ↗
• InjuryApr 16, 2020Adverse Event Without Identified Device or Use Problem; Appropriate Device Problem Term/Code Not Available; Adverse Event Without Identified Device or Use Problem; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED FROM THE US THAT A 56-YEAR-OLD FEMALE PATIENT OF AN UNKNOWN ETHNICITY WHO UNDERWENT BREAST AUGMENTATION REVISION IMPLANT SURGERY WITH MENTOR MEDICAL DEVICES (SILTEX UHP 295CC, DATE OF IMPLANT (B)(6) 2013 HAS EXPERIENCED RIGHT BREAST IMPLANT RUPTURE, CAPSULAR CONTRACTURE, AND GRANULOMA. AN ULTRASOUND THAT WAS PERFORMED DISPLAYED 9 SEPARATE SILICONE GRANULOMAS OF THE RIGHT BREAST EXTENDING FROM THE AXILLARY TAIL DOWN ALONG THE LATERAL CHEST WALL WITH THE LOWEST AND LARGEST AT 1 AND 8 O¿CLOCK CORRESPONDING TO THE MASS FELT BY THE PATIENT. AS A RESULT, THE PATIENT UNDERWENT EXPLANATION OF THE DEVICES ON (B)(6) 2020. THE LEFT BREAST IMPLANT WAS REMOVED PROPHYLACTICALLY BECAUSE THE DOCTOR HAD A SUSPICION THAT THE PATIENT HAD BIA-ALCL. AS PER THE OPERATIVE REPORT, THE DOCTOR REPORTS THAT THE RIGHT-SIDE CAPSULE WAS THICKENED AND ABNORMAL LOOKING. HE STATED THAT HE FEARED THAT THE PATIENT MIGHT HAVE BIA-ALCL AND THEREFORE DID A BILATERAL TOTAL CAPSULECTOMY. BOTH CAPSULES WERE SENT TO THE LAB AND RESULTS SHOWED INFLAMED TISSUE WITH NO MALIGNANCY.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Code Available

  MAUDE report 9970047 ↗