Natrelle INSPIRA Breast Implants SRM-600Recalls & reported problems

Summary

The FDA's MAUDE database contains 115 adverse event reports that list this exact device (DI 10888628007185), received between May 17, 2019 and Sep 17, 2026 — classified as 115 injuries.

The most frequently reported specific device problem is “Device Appears to Trigger Rejection” (59 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 115 reports, in the reporter's own words as published by the FDA.

• InjurySep 17, 2026Device Appears to Trigger Rejection; Material Rupture

  Patient reported "Nipple Discharge", "Breast feels soft when squeezed", "Capsular contracture Baker grade unknown", "So much fluid". Later healthcare professional reported "Rupture". This record is for the left side. The device remains implanted. Patient received an unknown treatment.

  Patient problems: Capsular Contracture; Seroma

  MAUDE report 50808940 ↗
• InjurySep 3, 2026Device Appears to Trigger Rejection

  Healthcare professional reported "capsular contracture baker grade III"; there are scattered areas of fibroglandular density. This record is for the right side. The device has been explanted.

  Patient problems: Capsular Contracture

  MAUDE report 50598972 ↗
• InjurySep 3, 2026Device Appears to Trigger Rejection; Material Rupture

  Healthcare professional reported "capsular contracture baker grade III". Healthcare professional later reported "Rupture"; "Hole, non-specific" were observed during surgery; also there are scattered areas of fibroglandular density. This record is for the left side. The device has been explanted.

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

  MAUDE report 50598963 ↗
• InjuryOct 28, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  HEALTHCARE PROFESSIONAL REPORTED VIA NATIONAL BREAST IMPLANT REGISTRY (NBIR) LEFT SIDE "CAPSULAR CONTRACTURE, BAKER GRADE III AND PTOSIS". THE DEVICE HAS BEEN EXPLANTED.

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

  MAUDE report 23408241 ↗
• InjuryOct 23, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

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

  Patient problems: Capsular Contracture

  MAUDE report 23373016 ↗
• InjurySep 29, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  HEALTHCARE PROFESSIONAL REPORTED "CAPSULAR CONTRACTURE BAKER GRADE IV." THIS RECORD IS FOR LEFT SIDE. THE DEVICE WAS EXPLANTED AND REPLACED.

  Patient problems: Capsular Contracture

  MAUDE report 23166266 ↗
• InjuryAug 7, 2025Material Rupture; Material Rupture

  HEALTHCARE PROFESSIONAL REPORTED VIA NBIR RIGHT SIDE "SUSPECTED/ACTUAL RUPTURE/DEFLATION, CHANGE SHAPE/SIZE/STYLE". THE DEVICE HAS BEEN EXPLANTED AND REPLACED.

  Patient problems: Failure of Implant

  MAUDE report 22742002 ↗
• InjuryAug 5, 2025Material Rupture; Material Rupture

  HEALTHCARE PROFESSIONAL REPORTED LEFT SIDE RUPTURE OBSERVED DURING SURGERY. DEVICE WAS EXPLANTED AND REPLACED.

  Patient problems: Failure of Implant

  MAUDE report 22718734 ↗
• InjuryJul 24, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  HEALTHCARE PROFESSIONAL REPORTED LEFT SIDE "CAPSULAR CONTRACTURE BAKER GRADE IV, PAINFUL, HARDENING AND BREAST DEFORMITY". DEVICE HAS BEEN EXPLANTED AND REPLACED.

  Patient problems: Capsular Contracture

  MAUDE report 22595892 ↗
• InjuryJul 24, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  HEALTHCARE PROFESSIONAL REPORTED "SEVER BAKER IV CAPSULAR CONTRACTURE, PAINFUL RIGHT BREAST DEFORMITY". THIS RECORD IS FOR THE RIGHT SIDE. DEVICE WAS EXPLANTED AND REPLACED.

  Patient problems: Capsular Contracture

  MAUDE report 22585008 ↗
• InjuryJun 30, 2025Material Rupture; Material Rupture

  HEALTHCARE PROFESSIONAL REPORTED RUPTURE. THIS RECORD IS FOR THE RIGHT SIDE. DEVICE WAS EXPLANTED.

  Patient problems: Failure of Implant

  MAUDE report 22357514 ↗
• InjuryJun 5, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  PATIENT REPORTED RIGHT SIDE IMPLANT EXCHANGE DUE TO ENCAPSULATION AND BAKER GRADE UNKNOWN AND ¿IT LOOKS TERRIBLE". DEVICE REMAINS IMPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 22151824 ↗
• InjuryMay 13, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  DEVICE WAS EXPLANTED AND REPLACED.

  Patient problems: Capsular Contracture

  MAUDE report 22012573 ↗
• InjuryApr 24, 2025Material Rupture; No Apparent Adverse Event; Material Rupture; No Apparent Adverse Event

  SALES REP. REPORTED "RUPTURE". THIS RECORD IS FOR THE RIGHT SIDE. DEVICE REMAINS IMPLANTED.

  Patient problems: Failure of Implant; No Clinical Signs, Symptoms or Conditions

  MAUDE report 21900450 ↗
• InjuryApr 23, 2025Material Rupture; Material Rupture

  HEALTHCARE PROFESSIONAL REPORTED "RUPTURE". THIS RECORD IS FOR THE LEFT SIDE. DEVICE REMAINS IMPLANTED.

  Patient problems: Failure of Implant

  MAUDE report 21896690 ↗
• InjuryApr 21, 2025Material Rupture; Material Rupture

  HEALTHCARE PROFESSIONAL REPORTED "RUPTURE". HEALTHCARE PROFESSIONAL LATER REPORTED LEFT SIDE RUPTURE AND "HOLE NON-SPECIFIC." HEALTHCARE PROFESSIONAL LATER REPORTED "RUPTURED IMPLANT AFTER CAR ACCIDENT". DEVICE HAS BEEN EXPLANTED.

  Patient problems: Failure of Implant

  MAUDE report 21874082 ↗
• InjuryNov 8, 2023Material Rupture; No Apparent Adverse Event; Material Rupture; No Apparent Adverse Event

  PREVIOUS MEDWATCH SUBMISSION NOTED RUPTURE. HEALTHCARE PROFESSIONAL REPORTED THAT DEVICE WAS FOUND INTACT UPON EXPLANT. DEVICE HAS BEEN EXPLANTED AND DISCARDED.

  Patient problems: Failure of Implant; No Clinical Signs, Symptoms or Conditions

  MAUDE report 18093561 ↗
• InjuryOct 25, 2023Device Appears to Trigger Rejection; Patient-Device Incompatibility; Device Appears to Trigger Rejection; Patient-Device Incompatibility

  HEALTHCARE PROFESSIONAL REPORTED RIGHT SIDE CAPSULAR CONTRACTURE BAKER GRADE UNKNOWN AND "POSED BREAST IMPLANT, BREAST HYPOPLASIA." DEVICE HAS BEEN EXPLANTED.

  Patient problems: Capsular Contracture; Foreign Body Reaction

  MAUDE report 18007954 ↗
• InjuryOct 25, 2023Device Appears to Trigger Rejection; Patient-Device Incompatibility; Device Appears to Trigger Rejection; Patient-Device Incompatibility

  HEALTHCARE PROFESSIONAL REPORTED LEFT SIDE CAPSULAR CONTRACTURE BAKER GRADE UNKNOWN AND "POSED BREAST IMPLANT, BREAST HYPOPLASIA." DEVICE HAS BEEN EXPLANTED.

  Patient problems: Capsular Contracture; Foreign Body Reaction

  MAUDE report 18007901 ↗
• InjuryOct 24, 2023Material Rupture; Material Rupture

  HEALTHCARE PROFESSIONAL REPORTED, RIGHT SIDE "RUPTURE LEAKING" AND "SWELLING". THE DEVICE HAS BEEN EXPLANTED.

  Patient problems: Failure of Implant

  MAUDE report 17999898 ↗
• InjuryOct 20, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  COMPANY REPRESENTATIVE REPORTED INFECTION AND CANCER PATIENT HISTORY. THIS RECORD IS FOR THE RIGHT SIDE. DEVICE HAS BEEN EXPLANTED.

  Patient problems: Unspecified Infection

  MAUDE report 17974241 ↗
• InjuryJul 31, 2023Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  DEVICE HAS BEEN EXPLANTED AND REPLACED..

  Patient problems: Capsular Contracture

  MAUDE report 17425025 ↗
• InjuryJul 11, 2023Material Rupture; Material Rupture

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

  Patient problems: Failure of Implant

  MAUDE report 17302060 ↗
• InjuryJul 7, 2023Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  PATIENT REPORTED LEFT SIDE "CAPSULAR CONTRACTURE BAKER GRADE IV, HURTING". DEVICE REMAINS IMPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 17279269 ↗
• InjuryJun 15, 2023Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  DEVICE HAS BEEN EXPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 17140719 ↗

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-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-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-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