Natrelle INSPIRA Breast Implants SRF-295Recalls & reported problems

Summary

The FDA's MAUDE database contains 278 adverse event reports that list this exact device (DI 10888628007277), received between May 15, 2019 and Sep 30, 2026 — classified as 278 injuries.

The most frequently reported specific device problem is “Device Appears to Trigger Rejection” (182 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 278 reports, in the reporter's own words as published by the FDA.

• InjurySep 30, 2026Material Rupture

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50954843 ↗
• InjurySep 29, 2026Device Appears to Trigger Rejection

  Healthcare Professional reported Capsular Contracture, Baker Grade III. This record is for the left side. Device remains implanted.

  Patient problems: Capsular Contracture

  MAUDE report 50932252 ↗
• InjurySep 25, 2026Device Appears to Trigger Rejection

  Patient problems: Capsular Contracture

  MAUDE report 50903026 ↗
• InjurySep 11, 2026Device Appears to Trigger Rejection

  Patient problems: Capsular Contracture

  MAUDE report 50743595 ↗
• InjurySep 8, 2026Device Appears to Trigger Rejection

  Healthcare professional reported "Capsular contracture" Baker grade unknown. This record is for the right side. Device was explanted.

  Patient problems: Capsular Contracture

  MAUDE report 50670188 ↗
• InjurySep 8, 2026Migration

  Healthcare professional reported: "bottoming out". This record is for the right-side device. The device was explanted.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50659304 ↗
• InjurySep 7, 2026Device Appears to Trigger Rejection

  Patient problems: Capsular Contracture

  MAUDE report 50652405 ↗
• InjuryAug 7, 2026Device Appears to Trigger Rejection

  Healthcare professional reported "capsular contracture Baker grade IV". This record is for the left side. The device was explanted. Patient received unknown treatment.

  Patient problems: Capsular Contracture

  MAUDE report 50176531 ↗
• InjuryJul 27, 2026Device Appears to Trigger Rejection

  Patient reported "lots of breast pain", "inflammatory issues", "capsular contracture Baker grade III/IV" and "calcification". Later healthcare professional reported "pain" and "capsular contracture Baker grade II". Later healthcare professional reported "capsular contracture Baker grade III/IV". This record is for the right side. The device was explanted.

  Patient problems: Capsular Contracture

  MAUDE report 50024660 ↗
• InjuryJun 25, 2026Device Appears to Trigger Rejection

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

  Patient problems: Capsular Contracture

  MAUDE report 25622958 ↗
• InjuryJun 25, 2026Device Appears to Trigger Rejection

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

  Patient problems: Capsular Contracture

  MAUDE report 25622949 ↗
• InjuryJun 11, 2026Adverse Event Without Identified Device or Use Problem

  HEALTHCARE PROFESSIONAL REPORTED "ONE LUMP ON BREAST", "PAIN, "JOINT PAIN", AND "INFLAMMATION". ADDITIONALLY REPORTED WERE "FATIGUE", "RINGING IN EAR, "DRY EYES", "HIGH IRON LEVELS", AND "WEIGHT GAIN" WHICH HAVE BEEN DEEMED NOT RELATED TO THE DEVICE. PATIENT THEN REPORTED "LYMPH NODE SWELLING". THIS RECORD IS FOR THE RIGHT SIDE. DEVICE REMAINS IMPLANTED.

  Patient problems: Swollen Lymph Nodes/Glands

  MAUDE report 25470593 ↗
• InjuryJun 10, 2026Adverse Event Without Identified Device or Use Problem

  HEALTHCARE PROFESSIONAL REPORTED "SWOLLEN LYMPH NODES", "THREE LUMPS ON BREAST", "PAIN, "FATIGUE", "RINGING IN EAR, "DRY EYES", "HIGH IRON LEVELS", "JOINT PAIN", "INFLAMMATION", "WEIGHT GAIN". THIS RECORD IS FOR THE LEFT SIDE. DEVICE REMAINS IMPLANTED.

  Patient problems: Swollen Lymph Nodes/Glands

  MAUDE report 25461618 ↗
• InjuryJun 4, 2026Adverse Event Without Identified Device or Use Problem

  PATIENT REPORTED "HEMATOMA", "FLUID" AND "SWELLING". THIS RECORD IS FOR THE LEFT SIDE. THE DEVICE WAS EXPLANTED.

  Patient problems: Hematoma

  MAUDE report 25389857 ↗
• InjuryMay 26, 2026Device Appears to Trigger Rejection; Material Rupture

  Patient reported "rupture". Later healthcare professional reported "Capsular Contracture Baker Grade III". Patient has undergone capsulectomy. This record is for the left side. Device has been explanted.

  Patient problems: Capsular Contracture

  MAUDE report 25278867 ↗
• InjuryApr 7, 2026Device Appears to Trigger Rejection

  HEALTHCARE PROFESSIONAL REPORTED VIA NATIONAL BREAST IMPLANT REGISTRY (NBIR) "CAPSULAR CONTRACTURE BAKER GRADE IV, CORRECTION OF ASYMMETRY, CHANGE SHAPE/SIZE/STYLE". THIS RECORD IS FOR THE LEFT SIDE. DEVICE WAS EXPLANTED AND REPLACED WITH A NON-ABBVIE DEVICE.

  Patient problems: Capsular Contracture

  MAUDE report 24801321 ↗
• InjuryFeb 6, 2026Device Appears to Trigger Rejection

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

  Patient problems: Capsular Contracture

  MAUDE report 24280437 ↗
• InjuryDec 11, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  HEALTHCARE PROFESSIONAL REPORTED "EXCHANGE WITH NO COMPLAINT AGAINST THE DEVICE". LATER, HEALTHCARE PROFESSIONAL REPORTED CAPSULAR "CONTRACTURE" BAKER GRADE UNKNOWN. THIS RECORD IS FOR THE LEFT SIDE. DEVICE WAS EXPLANTED AND REPLACED.

  Patient problems: Capsular Contracture

  MAUDE report 23777476 ↗
• InjuryDec 5, 2025Device Appears to Trigger Rejection; Material Rupture; Device Appears to Trigger Rejection; Material Rupture

  HEALTHCARE PROFESSIONAL REPORTED "RUPTURE". THIS RECORD IS FOR THE LEFT SIDE. LATER, HEALTHCARE PROFESSIONAL REPORTED "CAPSULAR CONTRACTURE BAKER GRADE IV". THE PATIENT UNDERWENT CAPSULOTOMY AND FAT GRAFTING AS TREATMENT. DEVICE WAS EXPLANTED AND REPLACED.

  Patient problems: Capsular Contracture

  MAUDE report 23729052 ↗
• InjuryNov 18, 2025Device Appears to Trigger Rejection; Material Rupture; Migration; Device Appears to Trigger Rejection; Material Rupture; Migration

  HEALTHCARE PROFESSIONAL REPORTED ¿CAPSULAR CONTRACTURE BAKER GRADE II¿, ¿DEVICE MIGRATION/IMPLANT MALPOSITION¿ AND ¿SUSPECTED/ACTUAL RUPTURE/DEFLATION¿ THROUGH THE NATIONAL BREAST IMPLANT REGISTRY (NBIR). THIS RECORD IS FOR THE RIGHT SIDE. DEVICE WAS EXPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 23585626 ↗
• InjuryNov 17, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  HEALTHCARE PROFESSIONAL REPORTED ¿CAPSULAR CONTRACTURE BAKER GRADE II¿ THROUGH THE NATIONAL BREAST IMPLANT REGISTRY (NBIR). THIS RECORD IS FOR THE LEFT SIDE. DEVICE WAS EXPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 23573732 ↗
• InjurySep 18, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  HEALTHCARE PROFESSIONAL REPORTED "CAPSULAR CONTRACTURE BAKER GRADE IV WITH PAIN". THIS RECORD IS FOR RIGHT SIDE. THE DEVICE REMAINS IMPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 23080973 ↗
• InjurySep 16, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  HEALTHCARE PROFESSIONAL REPORTED CAPSULAR CONTRACTURE, BAKER GRADE IV AND PAIN. THIS RECORD IS FOR LEFT SIDE. THE DEVICE REMAINS IMPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 23066072 ↗
• InjurySep 16, 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 HAS BEEN EXPLANTED.

  Patient problems: Capsular Contracture; Seroma

  MAUDE report 23065191 ↗
• InjurySep 2, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  DEVICE HAS BEEN EXPLANTED AND REPLACED.

  Patient problems: Capsular Contracture

  MAUDE report 22948717 ↗

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-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-