MENTOR SILTEX Round SPECTRUM 3542480MRecalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00081317002123), received between Dec 3, 2018 and Dec 2, 2022 — 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.

• InjuryDec 2, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT A 67-YEAR-OLD FEMALE PATIENT UNDERWENT A BREAST AUGMENTATION REVISION WITH TWO UNSPECIFIED SALINE BREAST PROSTHESES AND EXPERIENCED GENERALIZED ILLNESS SYMPTOMS INCLUDING ALLERGIES, BREAST IMPLANT ILLNESS, ANXIETY, PAIN, HEADACHES, FEELS IRRITABLE, JUST FEELS DIFFERENT, DEPRESSION, AND STATING SHE DOES NOT FEEL LIKE HERSELF ANYMORE POST-OPERATIVELY. IT WAS ALSO REPORTED THAT THE PATIENT HAD BILATERAL DEFLATION. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE. IT WAS UNKNOWN IF THE REPORTED DEVICE WAS A MENTOR DEVICE AND AS SUCH THE COMPLAINT IS BEING REPORTED CONSERVATIVELY. IF MORE INFORMATION BECOMES AVAILABLE, MENTOR WILL SUBMIT A SUPPLEMENTAL REPORT ACCORDINGLY. THIS REPORT IS FOR THE LEFT SIDE DEVICE.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 15910543 ↗
• InjuryDec 2, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT A 67-YEAR-OLD FEMALE PATIENT UNDERWENT A BREAST AUGMENTATION REVISION WITH TWO UNSPECIFIED SALINE BREAST PROSTHESES AND EXPERIENCED GENERALIZED ILLNESS SYMPTOMS INCLUDING ALLERGIES, BREAST IMPLANT ILLNESS, ANXIETY, PAIN, HEADACHES, FEELS IRRITABLE, JUST FEELS DIFFERENT, DEPRESSION, AND STATING SHE DOES NOT FEEL LIKE HERSELF ANYMORE POST-OPERATIVELY. IT WAS ALSO REPORTED THAT THE PATIENT HAD BILATERAL DEFLATION. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE. IT WAS UNKNOWN IF THE REPORTED DEVICE WAS A MENTOR DEVICE AND AS SUCH THE COMPLAINT IS BEING REPORTED CONSERVATIVELY. IF MORE INFORMATION BECOMES AVAILABLE, MENTOR WILL SUBMIT A SUPPLEMENTAL REPORT ACCORDINGLY. THIS REPORT IS FOR THE RIGHT SIDE DEVICE.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 15909572 ↗
• InjuryOct 11, 2021Material Rupture; Material Rupture

  IT WAS REPORTED THAT A (B)(6) YEAR OLD CAUCASIAN FEMALE PATIENT, WHO'S UNDERGONE BREAST AUGMENTATION REVISION WITH TWO 475CC MENTOR SILTEX ROUND SPECTRUM SALINE BREAST PROSTHESES, SUFFERED SPONTANEOUS RIGHT BREAST IMPLANT DEFLATION, POST-PROCEDURE. THE DEFLATION WAS DIAGNOSED VIA PHYSICAL EXAMINATION. AS A RESULT, THE PATIENT UNDERWENT IMPLANT EXPLANTATION SURGERY ON (B)(6) 2021.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 12611730 ↗
• InjuryJun 14, 2021Material Rupture; Material Rupture

  IT WAS REPORTED THAT A (B)(6)-YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT A BREAST AUGMENTATION PRIMARY WITH A SALINE MENTOR SILTEX ROUND SPECTRUM 475 CC BREAST IMPLANT AND EXPERIENCED DEFLATION ON THE LEFT SIDE POST-OPERATIVELY. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 11992525 ↗
• InjuryMar 27, 2021Material Rupture; Defective Device; Material Rupture; Defective Device

  IT WAS REPORTED THAT A FEMALE PATIENT UNDERWENT A BREAST SURGERY WITH A 475CC MENTOR SILTEX ROUND SPECTRUM PROSTHESIS (LEFT) AND EXPERIENCED AN UNSPECIFIED ISSUE POSTOPERATIVELY. AS A RESULT, THE PATIENT UNDERWENT REMOVAL AND REPLACEMENT WITH AN UNSPECIFIED BREAST IMPLANT ON (B)(6) 2021. AT THIS TIME OF REPORT, IT IS UNKNOWN WHAT KIND OF ISSUE THAT THE PATIENT EXPERIENCED AND RESULTED IN THE REVISION SURGERY. FOLLOW-UP IS STILL IN PROGRESS. IF ADDITIONAL INFORMATION IS RECEIVED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

  Patient problems: Insufficient Information

  MAUDE report 11579214 ↗
• InjuryDec 19, 2019Material Rupture; Material Rupture

  IT WAS REPORTED THAT A (B)(6) CAUCASIAN FEMALE PATIENT UNDERWENT A BREAST AUGMENTATION PRIMARY WITH A SALINE MENTOR SILTEX ROUND SPECTRUM 475CC AND EXPERIENCED DEFLATION ON THE LEFT BREAST IMPLANT. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE. THE PATIENT IS PLANNING ON REMOVING AND REPLACING WITH SALINE BREAST IMPLANT SOMETIME IN THE FUTURE.

  Patient problems: No Code Available

  MAUDE report 9498831 ↗
• InjuryAug 2, 2019Material Rupture; Migration; Material Rupture; Migration

  IT WAS REPORTED THAT A (B)(6) YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT A BREAST RECONSTRUCTION REVISION WITH MENTOR SILTEX ROUND SPECTRUM 475CC (LEFT) AND MENTOR SILTEX CONTOUR PROFILE SPECTRUM 450CC (RIGHT) AND EXPERIENCED A BILATERAL CHEST INJURY, A DEFLATION AND DEVICE MIGRATION ON THE LEFT SIDE, AND CAPSULAR CONTRACTURE BAKER GRADE 4 ON THE RIGHT SIDE POST-OPERATIVELY. ALL WERE CONFIRMED BY A PHYSICIAN VIA 3D MAMMOGRAM AND AN ULTRASOUND. AS A RESULT, THE PATIENT UNDERWENT REMOVAL AND REPLACEMENT WITH MENTOR MEMORYGEL BREAST IMPLANT 425CC, CATALOG # 3504254BC, SERIAL # (B)(4) (LEFT) AND (B)(4) (RIGHT) ON (B)(6) 2019. THIS REPORT IS FOR THE LEFT SIDE DEVICE.

  Patient problems: Injury; No Code Available

  MAUDE report 8857735 ↗
• InjuryDec 3, 2018Material Rupture; Material Rupture

  IT WAS REPORTED THAT A (B)(6) CAUCASIAN MALE PATIENT UNDERWENT A BREAST AUGMENTATION WITH A SALINE MENTOR SILTEX ROUND SPECTRUM 475CC BREAST IMPLANT AND EXPERIENCED DEFLATION ON THE LEFT SIDE. DEFLATION WAS CONFIRMED BY PHYSICIAN DURING EXAM. AS A RESULT, THE PATIENT UNDERWENT REMOVAL ON (B)(6) 2018.

  Patient problems: No Code Available

  MAUDE report 8125747 ↗

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