MENTOR SILTEX Round SPECTRUM 3542430MRecalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00081317002079), received between Feb 24, 2018 and Sep 26, 2024 — classified as 8 injuries.

The most frequently reported specific device problem is “Material Rupture” (8 reports).

2 other recalls cover devices cleared under the same FDA submission (P990075); they may or may not involve this specific model.

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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• InjurySep 26, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT UNDERWENT A PRIMARY BREAST AUGMENTATION PROCEDURE WITH A MENTOR SILTEX ROUND SPECTRUM 225CC SALINE BREAST PROSTHESIS THAT DEFLATED POST IMPLANTATION. DEFLATION OF THE PATIENT¿S RIGHT BREAST PROSTHESIS WAS REPORTED. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 20313034 ↗
• InjuryMay 13, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT A 33-YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT PRIMARY BREAST AUGMENTATION WITH 225CC MENTOR SILTEX ROUND SPECTRUM AND EXPERIENCED BREAST IMPLANT DEFLATION ON HER RIGHT SIDE POSTOPERATIVELY; DIAGNOSED AFTER PHYSICAL EXAM. THE PATIENT HAS CONSULTED WITH THE HEALTHCARE PROFESSIONAL. AS A RESULT, THE DEVICE WAS EXPLANTED ON (B)(6) 2024.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 19297610 ↗
• InjuryAug 11, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT A 58-YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT A PRIMARY BREAST AUGMENTATION PROCEDURE WITH A MENTOR SILTEX ROUND SPECTRUM 225CC SALINE BREAST PROSTHESIS THAT DEFLATED POST IMPLANTATION. DEFLATION OF THE PATIENT¿S LEFT BREAST PROSTHESIS WAS DIAGNOSED DURING AN OFFICE VISIT. AS A RESULT, THE PATIENT UNDERWENT BILATERAL EXPLANTATION AND REPLACEMENT WITH MENTOR MEMORYGEL BREAST IMPLANT 275CC GEL BREAST PROSTHESES ON (B)(6) 2022.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 15214628 ↗
• InjuryFeb 25, 2019Material Rupture; Material Rupture

  IT WAS REPORTED THAT A FEMALE PATIENT UNDERWENT A PRIMARY BREAST RECONSTRUCTION SURGERY WITH MENTOR SILTEX ROUND SPECTRUM 225CC SALINE BREAST IMPLANTS WHICH AN UNKNOWN SIDE DEFLATED AFTER IMPLANTATION. AS A RESULT PATIENT HAD THE DEVICE REMOVED AND REPLACED WITH THE SIMILAR MENTOR DEVICE ON (B)(6) 2019.

  Patient problems: No Code Available

  MAUDE report 8368386 ↗
• InjuryJun 5, 2018Material Rupture; Material Rupture

  IT WAS REPORTED THAT A (B)(6) CAUCASIAN FEMALE PATIENT UNDERWENT PRIMARY BREAST AUGMENTATION WITH MENTOR SILTEX ROUND SPECTRUM 225CC SALINE BREAST PROSTHESIS. DEFLATION OF THE LEFT BREAST PROSTHESIS WAS DETERMINED. AS A RESULT, THE PATIENT UNDERWENT REMOVAL ON (B)(6) 2018.

  Patient problems: No Code Available

  MAUDE report 7570622 ↗
• InjuryApr 10, 2018Material Rupture; Material Rupture

  IT WAS REPORTED THAT A (B)(6) -YEAR OLD CAUCASIAN FEMALE PATIENT UNDERWENT BREAST AUGMENTATION REVISION WITH MENTOR SILTEX ROUND SPECTRUM 225CC SALINE BREAST PROSTHESES. RIGHT BREAST PROSTHESIS DEFLATION WAS DIAGNOSED BY DOCTOR'S EXAMINATION. AS A RESULT, THE PATIENT HAS BEEN SCHEDULED FOR EXPLANTATION ON (B)(6) 2018.

  Patient problems: No Code Available

  MAUDE report 7412730 ↗
• InjuryFeb 26, 2018Material Rupture; Material Rupture

  IT WAS REPORTED THAT A (B)(6) FEMALE PATIENT UNDERWENT A PRIMARY BREAST AUGMENTATION WITH MENTOR SILTEX ROUND SPECTRUM 225 CC SALINE BREAST IMPLANTS WHICH BOTH SIDE DEFLATED AFTER IMPLANTATION. PER DOCTOR'S NOTE IT ROLLED UP UPON ITSELF IN A QUADRANT. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE.

  Patient problems: No Code Available

  MAUDE report 7295862 ↗
• InjuryFeb 24, 2018Material Rupture; Material Rupture

  IT WAS REPORTED THAT A (B)(6) -YEAR-OLD FEMALE PATIENT UNDERWENT A PRIMARY BREAST AUGMENTATION WITH MENTOR SILTEX ROUND SPECTRUM 225CC SALINE BREAST IMPLANTS WHICH BOTH SIDE DEFLATED AFTER IMPLANTATION. PER DOCTOR'S NOTE IT ROLLED UP UPON ITSELF IN A QUADRANT. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE.

  Patient problems: No Code Available

  MAUDE report 7294370 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under P990075. One submission often covers many models, so check the product and lot details in each record.

• Z-0367-2022 · Sep 30, 2021 · Open, Classified
  MENTOR Saline-Filled Breast Implants are constructed from room temperature vulcanized silicone elastomer, made of polydimethylsiloxane. Surgeons inflate the silicone elastomer shel
• Z-2070-2017 · Mar 27, 2017 · Terminated
  Mentor Smooth Round SPECTRUM Post- Operatively Adjustable Saline Breast Implant, Product Code: 350-1490, UDI/GTIN: 00081317002048