Natrelle INSPIRA Breast Implants SRF-335Recalls & reported problems

Summary

The FDA's MAUDE database contains 96 adverse event reports that list this exact device (DI 10888628007291), received between May 29, 2019 and Aug 20, 2026 — classified as 96 injuries.

The most frequently reported specific device problem is “Device Appears to Trigger Rejection” (55 reports).

4 other recalls cover devices cleared under the same FDA submission (P020056); 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 25 most recent of 96 reports, in the reporter's own words as published by the FDA.

• InjuryAug 20, 2026Device Appears to Trigger Rejection

  Healthcare professional reported through Regulatory agency "capsular contracture Baker grade III". This record is for the right side. The device has been explanted.

  Patient problems: Capsular Contracture

  MAUDE report 50356635 ↗
• InjuryAug 14, 2026Device Appears to Trigger Rejection

  Healthcare professional reported Capsular Contracture Baker Grade III. This record is for the left side. The device was explanted.

  Patient problems: Capsular Contracture

  MAUDE report 50263055 ↗
• InjuryJul 1, 2026Device Appears to Trigger Rejection

  HEALTHCARE PROFESSIONAL REPORTED "CAPSULAR CONTRACTURE". LATER HEALTHCARE PROFESSIONAL REPORTED "GRADE 4". ACCOLATE AND ADM HAVE BEEN PRESCRIBED. THIS RECORD IS FOR THE LEFT SIDE. DEVICE HAS BEEN EXPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 25684654 ↗
• InjuryJun 26, 2026Device Appears to Trigger Rejection

  Patient reported "Capsular Contracture Baker Grade III". This record is for the left side. Device was explanted.

  Patient problems: Capsular Contracture

  MAUDE report 25644456 ↗
• InjuryJan 30, 2026Device Appears to Trigger Rejection

  HEALTHCARE PROFESSIONAL REPORTED CAPSULAR CONTRACTURE, BAKER GRADE IV. THIS RECORD IS FOR THE LEFT SIDE. DEVICE HAS BEEN EXPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 24225364 ↗
• InjuryJan 30, 2026Device Appears to Trigger Rejection

  HEALTHCARE PROFESSIONAL REPORTED CAPSULAR CONTRACTURE, BAKER GRADE III. THIS RECORD IS FOR THE RIGHT SIDE. DEVICE HAS BEEN EXPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 24225315 ↗
• InjurySep 19, 2025Material Rupture; Material Rupture

  HEALTHCARE PROFESSIONAL REPORTED "RUPTURE". DAIGNOSED VIA MRI. THIS RECORD IS FOR THE RIGHT SIDE. DEVICE REMAINS IMPLANTED.

  Patient problems: Failure of Implant

  MAUDE report 23100051 ↗
• InjurySep 2, 2025Material Rupture; Device Dislodged or Dislocated; Migration; Material Rupture; Device Dislodged or Dislocated; Migration

  PATIENT REPORTED LEFT SIDE "RUPTURE" WITH "BOTTOMING OUT" AND "SYMMASTIA". DEVICE HAS BEEN EXPLANTED.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 22932514 ↗
• InjuryAug 26, 2025Device Dislodged or Dislocated; Migration; Device Dislodged or Dislocated; Migration

  PATIENT REPORTED "SYMMASTIA". THIS RECORD IS FOR THE RIGHT SIDE. DEVICE HAS BEEN EXPLANTED.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 22896976 ↗
• InjuryAug 22, 2025Material Rupture; Material Rupture

  HEALTHCARE PROFESSIONAL REPORTED RIGHT SIDE "CAPSULAR CONTRACTURE BAKER GRADE II" AND "POSSIBLE RUPTURE". DEVICE REMAINS IMPLANTED.

  Patient problems: Failure of Implant

  MAUDE report 22879687 ↗
• InjuryAug 22, 2025Device Appears to Trigger Rejection; Material Rupture; Device Appears to Trigger Rejection; Material Rupture

  HEALTHCARE PROFESSIONAL REPORTED LEFT SIDE "CAPSULAR CONTRACTURE BAKER GRADE III" AND "POSSIBLE RUPTURE". DEVICE REMAINS IMPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 22879686 ↗
• InjuryAug 20, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  HEALTHCARE PROFESSIONAL REPORTED "CAPSULAR CONTRACTURE BAKER GRADE III" TREATED WITH SINGULAIR. THIS IS FOR THE RIGHT SIDE. DEVICE REMAINS IMPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 22853679 ↗
• InjuryJul 1, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  HEALTHCARE PROFESSIONAL REPORTED "CAPSULAR CONTRACTURE BAKER GRADE III". THIS RECORD IS FOR LEFT SIDE. DEVICE HAS BEN EXPLANTED AND REPLACED.

  Patient problems: Capsular Contracture

  MAUDE report 22378226 ↗
• InjuryJun 30, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  HEALTHCARE PROFESSIONAL REPORTED RIGHT SIDE "CAPSULAR CONTRACTURE BAKER GRADE III". DEVICE HAS BEEN EXPLANTED AND REPLACED.

  Patient problems: Capsular Contracture

  MAUDE report 22367132 ↗
• InjuryJun 30, 2025Device Appears to Trigger Rejection; Material Rupture; Device Appears to Trigger Rejection; Material Rupture

  HEALTHCARE PROFESSIONAL REPORTED RIGHT SIDE CAPSULAR CONTRACTURE BAKER GRADE III, RUPTURE, FIRMNESS AND PAIN. DEVICE HAS BEEN EXPLANTED AND REPLACED WITH NON-ABBVIE DEVICE.

  Patient problems: Capsular Contracture

  MAUDE report 22359460 ↗
• InjuryJun 26, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  HEALTHCARE PROFESSIONAL REPORTED RIGHT SIDE "CAPSULAR CONTRACTURE BAKER GRADE IV". DEVICE REMAINS IMPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 22340450 ↗
• InjuryJun 15, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  HEALTHCARE PROFESSIONAL REPORTED RIGHT SIDE CAPSULAR CONTRACTURE, BAKER GRADE UNKNOWN. THE DEVICE HAS BEEN EXPLANTED AND REPLACED.

  Patient problems: Capsular Contracture

  MAUDE report 22208652 ↗
• InjuryApr 24, 2025Device Appears to Trigger Rejection; Material Rupture; Migration; Device Appears to Trigger Rejection; Material Rupture; Migration

  HEALTHCARE PROFESSIONAL REPORTED LEFT SIDE RUPTURE AND "LOPSIDED, SOMETHING NOT RIGHT AND WAY UP, RISE.". HEALTHCARE PROFESSIONAL LATER REPORTED UPON REMOVAL LEFT SIDE IMPLANT WAS NOT RUPTURE, THE DEVICE MIGRATED. DEVICE HAS BEEN EXPLANTED.

  Patient problems: Capsular Contracture; Failure of Implant

  MAUDE report 21904566 ↗
• InjuryMar 17, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  HEALTHCARE PROFESSIONAL REPORTED "INFECTION". LATER, HEALTHCARE PROFESSIONAL REPORTED CAPSULAR CONTRACTURE, BAKER GRADE II, HEMATOMA, AND "INCISION OPENED". DEVICE HAS BEEN EXPLANTED. THIS RELATES TO THE RIGHT SIDE.

  Patient problems: Unspecified Infection; Wound Dehiscence

  MAUDE report 21619338 ↗
• InjuryNov 13, 2023Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  HEALTHCARE PROFESSIONAL REPORTED LEFT SIDE CAPSULAR CONTRACTURE, BAKER GRADE III. DEVICE WAS EXPLANTED AND REPLACED.

  Patient problems: Capsular Contracture

  MAUDE report 18120793 ↗
• InjuryJul 11, 2023Material Rupture; Material Rupture

  HEALTHCARE PROFESSIONAL REPORTED RIGHT SIDE RUPTURE. THE DEVICE HAS BEEN EXPLANTED AND REPLACED.

  Patient problems: Failure of Implant

  MAUDE report 17301998 ↗
• InjuryJul 6, 2023Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  SALES REPRESENTATIVE REPORTED LEFT SIDE CAPSULAR CONTRACTURE BAKER GRADE III. DEVICE HAS BEEN EXPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 17266195 ↗
• InjuryJun 13, 2023Material Rupture; Material Rupture

  DEVICE HAS BEEN EXPLANTED.

  Patient problems: Failure of Implant

  MAUDE report 17122111 ↗
• InjuryJun 9, 2023Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  HEALTHCARE PROFESSIONAL REPORTED A RIGHT SIDE CAPSULAR CONTRACTURE, BAKER GRADE IV. DEVICE HAS BEEN EXPLANTED AND REPLACED.

  Patient problems: Capsular Contracture

  MAUDE report 17098996 ↗
• InjuryMay 25, 2023Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  DEVICE HAS BEEN EXPLANTED AND REPLACED.

  Patient problems: Capsular Contracture

  MAUDE report 17001892 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under P020056. One submission often covers many models, so check the product and lot details in each record.

• Z-0700-2020 · Nov 6, 2019 · Terminated
  Natrelle Silicone Filled Breast Implants for the following Styles and Sizes: Style 10, Style 15, Style 20, Style 40, Style 45 Style 10/UDI: NATRELLE Style 10-180 Gel Round Mod
• Z-0701-2020 · Nov 6, 2019 · Terminated
  Natrelle Inspira Sillicone-Filled Breast Implants for the following Styles and Sizes: 7607 SSM, 7608 SSF, 7609 SSX, 7513 SRL, 7514 SRLP, 7515 SRM, 7516 SRF, 7517 SRX, 7626 SCL, 762
• Z-2454-2019 · Jul 24, 2019 · Open, Classified
  Natrelle and McGhan Silicone-Filled Breast Implant BioCell Round Moderate Profile, Sterile, for the following style numbers: Style 110:110-090, 110-120, 110-150, 110-180, 110-
• Z-2453-2019 · Jul 24, 2019 · Open, Classified
  Natrelle Inspira, Silicone-Filled Breast Implants, Sterile, for the following style numbers: Style TRL: TRL-110TRL-125,TRL-140,TRL-170,TRL-200,TRL-230,TRL-260,TRL-290,TRL-320,TR