Natrelle INSPIRA Breast Implants SRX-445Recalls & reported problems

Summary

The FDA's MAUDE database contains 226 adverse event reports that list this exact device (DI 10888628007529), received between May 31, 2019 and Sep 30, 2026 — classified as 225 injuries, 1 malfunction.

The most frequently reported specific device problem is “Device Appears to Trigger Rejection” (159 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 226 reports, in the reporter's own words as published by the FDA.

• InjurySep 30, 2026Device Appears to Trigger Rejection

  Patient problems: Capsular Contracture

  MAUDE report 50949643 ↗
• InjurySep 28, 2026Device Appears to Trigger Rejection; Material Rupture; Migration

  Patient problems: Capsular Contracture

  MAUDE report 50923830 ↗
• InjurySep 5, 2026Device Appears to Trigger Rejection

  Healthcare professional reported a "Capsular Contracture, Baker grade III". Later on the Returned Goods Authorization (RGA) noted "Hole in bottom". This record is for the left side. The device was explanted.

  Patient problems: Capsular Contracture

  MAUDE report 50630582 ↗
• InjuryJul 28, 2026Adverse Event Without Identified Device or Use Problem

  Healthcare professional reported no complaint against the device. Later healthcare professional reported "aesthetic breast deformity", "breast asymmetry" and "cosmetic dissatisfaction". This record is for the right side. Device has been explanted.

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

  MAUDE report 50059684 ↗
• InjuryJul 27, 2026Material Rupture

  Patient reported "rupture". Later Healthcare professional repoted "rupture". This record is for the left side. The device remains implanted.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50025529 ↗
• InjuryJul 17, 2026Device Appears to Trigger Rejection

  Healthcare professional reported "exchange with no complaint against the device". Healthcare professional later reported "capsular contracture" as reason for removal. This record is for the left side. Device has been explanted.

  Patient problems: Capsular Contracture

  MAUDE report 25856208 ↗
• InjuryJul 13, 2026Device Appears to Trigger Rejection

  HEALTHCARE PROFESSIONAL REPORTED RIGHT SIDE CAPSULAR CONTRACTION, BAKER GRADE IV. THE DEVICE WAS EXPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 25807971 ↗
• InjuryJun 29, 2026Device Appears to Trigger Rejection

  HEALTHCARE PROFESSIONAL REPORTED "CAPSULAR CONTRACTURE, BAKER GRADE III". THIS RECORD IS FOR THE RIGHT SIDE. THE DEVICE REMAINS IMPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 25652546 ↗
• InjuryJun 21, 2026Device Appears to Trigger Rejection

  HEALTHCARE PROFESSIONAL REPORTED "CAPSULAR CONTRACTURE BAKER GRADE 3". THIS RECORD IS FOR THE RIGHT SIDE. DEVICE WAS EXPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 25572272 ↗
• InjuryJun 10, 2026Device Appears to Trigger Rejection; No Apparent Adverse Event

  HEALTHCARE PROFESSIONAL REPORTED "PATIENT PRESENTED WITH CAPSULAR CONTRACTURE BAKER GRADE UNKNOWN", "THE IMPLANT THAT WAS REMOVED WAS CLOUDY, AFTER SHORT TIME OF IMPLANTATION". THIS RECORD IS FOR THE RIGHT SIDE. DEVICE WAS EXPLANTED.

  Patient problems: Capsular Contracture; No Clinical Signs, Symptoms or Conditions

  MAUDE report 25459795 ↗
• InjuryApr 15, 2026Malposition of Device

  HEALTHCARE PROFESSIONAL REPORTED A "MALPOSITION". THIS RECORD IS FOR THE RIGHT SIDE. THE DEVICE WAS EXPLANTED.

  Patient problems: Failure of Implant

  MAUDE report 24888782 ↗
• InjuryApr 15, 2026Malposition of Device

  HEALTHCARE PROFESSIONAL REPORTED A "MALPOSITION". THIS RECORD IS FOR THE LEFT SIDE. THE DEVICE WAS EXPLANTED.

  Patient problems: Failure of Implant

  MAUDE report 24888704 ↗
• InjuryMar 5, 2026Device Appears to Trigger Rejection

  HEALTHCARE PROFESSIONAL REPORTED "CAPSULAR CONTRACTURE BAKER GRADE III". THIS RECORD IS FOR THE RIGHT SIDE. DEVICE WAS EXPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 24518410 ↗
• InjuryMar 2, 2026Device Appears to Trigger Rejection

  HEALTHCARE PROFESSIONAL INITIALLY REPORTED A "GRADE III CAPSULAR CONTRACTURE" AND INDICATED THAT A PREVIOUS CLAIM FOR RUPTURE HAD BEEN FILED. ON FOLLOW UP, HEALTHCARE PROFESSIONAL CONFIRMED CAPSULAR CONTRACTURE ONLY. THIS RECORD IS FOR THE LEFT SIDE. THE DEVICE REMAINS IMPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 24489494 ↗
• InjuryFeb 5, 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 24273432 ↗
• InjuryJan 22, 2026Material Rupture

  PATIENT REPORTED "RUPTURE". THIS RECORD IS FOR THE LEFT SIDE. DEVICE WAS EXPLANTED.

  Patient problems: Failure of Implant

  MAUDE report 24143932 ↗
• InjuryDec 22, 2025Material Rupture; Material Rupture

  HEALTHCARE PROFESSIONAL REPORTED "RUPTURE" AND "PATIENT WAS UNDERAGE WHEN RECEIVED DEVICE". THIS RECORD IS FOR THE LEFT SIDE. THE DEVICE WAS EXPLANTED AND REPLACED. THE DEVICE WILL BE RETURNED.

  Patient problems: Failure of Implant

  MAUDE report 23864932 ↗
• InjuryAug 21, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  DEVICE HAS BEEN EXPLANTED AND REPLACED.

  Patient problems: Capsular Contracture

  MAUDE report 22867998 ↗
• InjuryAug 15, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

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

  Patient problems: Capsular Contracture

  MAUDE report 22821600 ↗
• InjuryAug 7, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  PATIENT REPORTED LEFT SIDE CAPSULAR CONTRACTURE BAKER GRADE III/IV. HEALTHCARE PROFESSIONAL LATER CONFIRMED CAPSULAR CONTRACTURE BAKER GRADE III/IV. DEVICE HAS BEEN EXPLANTED AND REPLACED.

  Patient problems: Capsular Contracture

  MAUDE report 22739823 ↗
• InjuryAug 1, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  PATIENT REPORTED "CAPSULAR CONTRACTURE, BAKER GRADE III TO IV". HEALTHCARE PROFESSIONAL LATER CONFIRMED "CAPSULAR CONTRACTURE BAKER GRADE III". THIS RECORD IS FOR THE RIGHT SIDE. DEVICE WAS EXPLANTED AND REPLACED.

  Patient problems: Capsular Contracture

  MAUDE report 22684914 ↗
• InjuryJul 8, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  HEALTHCARE PROFESSIONAL REPORTED "CAPSULAR CONTRACTURE BAKER GRADE III¿. THIS RECORD IS FOR THE RIGHT SIDE. DEVICE WAS EXPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 22440256 ↗
• InjuryJun 27, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

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

  Patient problems: Capsular Contracture

  MAUDE report 22345270 ↗
• InjuryJun 25, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  THE DEVICE HAS BEEN EXPLANTED AND REPLACED.

  Patient problems: Capsular Contracture

  MAUDE report 22326373 ↗
• InjuryJun 3, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  HEALTHCARE PROFESSIONAL REPORTED LEFT SIDE CAPSULAR CONTRACTURE BAKER GRADE III. THE DEVICE HAS BEEN EXPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 22134098 ↗

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-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
• 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-