MENTOR SILTEX Round SPECTRUM 3542420MRecalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00081317002062), received between Jan 11, 2019 and Mar 27, 2024 — classified as 8 injuries.

The most frequently reported specific device problem is “Material Rupture” (7 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.

• InjuryMar 27, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT A FEMALE PATIENT WHO UNDERWENT AN UNKNOWN BREAST SURGERY WITH A MENTOR SILTEX ROUND SPECTRUM, 175CC SALINE BREAST IMPLANT EXPERIENCED RIGHT-SIDED DEFLATION POSTOPERATIVE. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 18988921 ↗
• InjuryMay 20, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT A (B)(6) CAUCASIAN FEMALE WHO UNDERWENT A BREAST AUGMENTATION PRIMARY WITH AN UNKNOWN MENTOR SALINE BREAST IMPLANT EXPERIENCED LEFT SIDED DEFLATION POSTOPERATIVELY. THE ISSUE WAS DIAGNOSED THROUGH PHYSICAL EXAMINATION AND CONFIRMED BY THE CAT SCAN EXAMINATIONS. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 14463127 ↗
• InjuryMay 13, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A (B)(6) CAUCASIAN FEMALE PATIENT UNDERWENT PRIMARY BREAST RECONSTRUCTION SURGERY WITH 175CC MENTOR SILTEX ROUND SPECTRUM AND EXPERIENCED RIGHT SIDE PAIN, DEFORMITY, WRINKLING, AND LOSS OF VOLUME. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE.

  Patient problems: Breast Discomfort/Pain; Deformity/ Disfigurement; Wrinkling

  MAUDE report 14397578 ↗
• InjuryNov 4, 2021Material Rupture; Material Rupture

  IT WAS REPORTED THAT A (B)(6) YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT A BREAST AUGMENTATION PRIMARY WITH A MENTOR SILTEX ROUND SPECTRUM 175CC BREAST IMPLANT AND EXPERIENCED DEFLATION ON THE RIGHT SIDE POST-OPERATIVELY, WHICH WAS CONFIRMED VIA MAMMOGRAM. AS A RESULT, THE PATIENT IS SCHEDULED FOR REMOVAL ON (B)(6) 2021.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 12751967 ↗
• InjuryOct 22, 2021Material Rupture; Material Rupture

  IT WAS REPORTED THAT A FEMALE WHO UNDERWENT AN UNKNOWN BREAST AUGMENTATION RECONSTRUCTION WITH A MENTOR SILTEX ROUND SPECTRUM, 175CC BREAST IMPLANT EXPERIENCED UNKNOWN-SIDED DEFLATION POST PROCEDURE. AS A RESULT PATIENT UNDERWENT AN EXPLANT ON (B)(6)2 021.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 12682163 ↗
• InjuryMar 7, 2019Material Rupture; Material Rupture

  IT WAS REPORTED THAT A (B)(6) FEMALE PATIENT WHO UNDERWENT PRIMARY BREAST AUGMENTATION WITH A 175CC MENTOR SILTEX ROUND SPECTRUM SALINE BREAST PROSTHESIS, EXPERIENCED LEFT SIDE DEFLATION POST-OPERATIVELY. 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 8400300 ↗
• InjuryJan 11, 2019Material Rupture; Material Rupture

  IT WAS REPORTED THAT A (B)(6) YEAR OLD FEMALE PATIENT UNDERWENT A BREAST AUGMENTATION REVISION WITH A SALINE MENTOR SILTEX ROUND SPECTRUM 175CC AND EXPERIENCED BILATERAL DEFLATION ON BREAST IMPLANTS. AS A RESULT, THE PATIENT UNDERWENT BILATERAL REMOVAL AND REPLACEMENT WITH MENTOR SMOOTH ROUND MODERATE PROFILE SALINE IMPLANTS, CATALOG # 3501685, 525CC, S/N (B)(4) AND CATALOG # 3501670, 425CC, S/N (B)(4) ON 12/5/2018. THIS IS FOR THE RIGHT SIDE IMPLANT, SEE MANUFACTURER REPORT NUMBER 1645337-2019-07878 FOR CONTRALATERAL PROSTHESIS.

  Patient problems: No Code Available

  MAUDE report 8240499 ↗
• InjuryJan 11, 2019Material Rupture; Material Rupture

  IT WAS REPORTED THAT A (B)(6) YEAR OLD FEMALE PATIENT UNDERWENT A BREAST AUGMENTATION REVISION WITH A SALINE MENTOR SILTEX ROUND SPECTRUM 175 CC AND EXPERIENCED BILATERAL DEFLATION ON BREAST IMPLANTS. AS A RESULT, THE PATIENT UNDERWENT BILATERAL REMOVAL AND REPLACEMENT WITH MENTOR SMOOTH ROUND MODERATE PROFILE SALINE IMPLANTS, CATALOG # 3501685, 525 CC, S/N (B)(4) (L) AND CATALOG # 3501670, 425 CC, S/N (B)(4) (R) ON (B)(6) 2018. THIS IS FOR THE LEFT SIDE IMPLANT, SEE MANUFACTURER REPORT NUMBER 1645337-2019-07876 FOR CONTRALATERAL PROSTHESIS.

  Patient problems: No Code Available

  MAUDE report 8240493 ↗

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