Natrelle INSPIRA Breast Implants SRM-375Recalls & reported problems

Summary

The FDA's MAUDE database contains 441 adverse event reports that list this exact device (DI 10888628007123), received between May 15, 2019 and Sep 29, 2026 — classified as 438 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Device Appears to Trigger Rejection” (237 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 441 reports, in the reporter's own words as published by the FDA.

• InjurySep 29, 2026Device Appears to Trigger Rejection

  Patient problems: Capsular Contracture

  MAUDE report 50939391 ↗
• InjurySep 29, 2026Device Appears to Trigger Rejection

  Healthcare professional reported "capsular contracture, baker grade III". This record is for the right side. Device remains implanted.

  Patient problems: Capsular Contracture

  MAUDE report 50930176 ↗
• InjurySep 28, 2026Device Appears to Trigger Rejection

  Patient problems: Capsular Contracture

  MAUDE report 50918094 ↗
• InjurySep 28, 2026Material Rupture

  Healthcare professional reported "unsure if ruptured but not ruled out". This record is for the left side. The device remains implanted.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50914705 ↗
• InjurySep 25, 2026Material Rupture

  Healthcare professional reported "rupture". This record is for the right side. The device remains implanted.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50899139 ↗
• InjurySep 21, 2026Device Appears to Trigger Rejection

  Healthcare professional reported "Capsular Contracture Baker Grade IV". This record is for the right side. Device remains implanted.

  Patient problems: Capsular Contracture

  MAUDE report 50843574 ↗
• InjurySep 18, 2026Material Rupture

  Healthcare professional reported "Rupture". This record is for the left side. The device was explanted.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50819723 ↗
• InjurySep 15, 2026Device Appears to Trigger Rejection

  Healthcare professional reported "no complaint against the device". Later, healthcare professional reported "Capsular Contracture" Baker grade unknown. This record is for the left side. Device was explanted.

  Patient problems: Capsular Contracture

  MAUDE report 50768849 ↗
• InjurySep 12, 2026Device Appears to Trigger Rejection

  Patient problems: Capsular Contracture

  MAUDE report 50744678 ↗
• InjurySep 11, 2026Device Appears to Trigger Rejection

  The device has been explanted.

  Patient problems: Capsular Contracture

  MAUDE report 50744551 ↗
• InjurySep 11, 2026Device Appears to Trigger Rejection

  Patient reported "capsular contracture, Baker grade unknown", "pain, "looks flat" and "feels weird". This record is for the left side. Device remains implanted.

  Patient problems: Capsular Contracture

  MAUDE report 50735068 ↗
• InjurySep 10, 2026Material Rupture

  Healthcare professional reported "rupture and leak". This record is for left side. The device remains implanted.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50718051 ↗
• InjurySep 9, 2026Material Rupture

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50701621 ↗
• InjurySep 8, 2026Material Rupture

  Healthcare Professional reported "rupture, size increase". This record is for the right side. Device has been explanted.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50665199 ↗
• InjuryAug 31, 2026Device Appears to Trigger Rejection

  Healthcare professional reported "capsular contracture Baker grade lll" and " a lot of pain". This record is for left side. The device remains implanted.

  Patient problems: Capsular Contracture

  MAUDE report 50529307 ↗
• InjuryAug 21, 2026Device Appears to Trigger Rejection; Material Rupture

  Healthcare professional reported ¿implant rupture¿. Later healthcare professional reported ¿Hole non-specific¿. Later healthcare professional reported Capsular Contracture Baker grade unknown and ¿gel bleeding without an obvious rupture¿. Later healthcare professional reported ¿silicone gel which had leaked from the shell¿. This record is for the left side. Device was explanted.

  Patient problems: Capsular Contracture

  MAUDE report 50379512 ↗
• InjuryAug 6, 2026Material Rupture

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50162330 ↗
• InjuryJul 27, 2026Device Appears to Trigger Rejection

  Healthcare professional reported "Capsular Contracture Baker Grade IV". This record is for the left side. Device remains implanted.

  Patient problems: Capsular Contracture

  MAUDE report 50039516 ↗
• InjuryJul 14, 2026Material Rupture

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25812230 ↗
• InjuryJun 18, 2026Device Appears to Trigger Rejection

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

  Patient problems: Capsular Contracture

  MAUDE report 25548970 ↗
• InjuryJun 10, 2026Device Appears to Trigger Rejection; Material Rupture

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

  Patient problems: Capsular Contracture

  MAUDE report 25458121 ↗
• InjuryJun 9, 2026Material Rupture

  HEALTHCARE PROFESSIONAL REPORTED A RUPTURE. THIS RECORD IS FOR THE RIGHT SIDE. THE DEVICE REMAINS IMPLANTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25449328 ↗
• InjuryMay 29, 2026Device Appears to Trigger Rejection

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

  Patient problems: Capsular Contracture

  MAUDE report 25331822 ↗
• InjuryMay 18, 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 25202539 ↗
• InjuryApr 23, 2026Material Rupture

  PATIENT REPORTED "LEAK" (RUPTURE). THIS RECORD IS FOR THE LEFT SIDE. DEVICE REMAINS IMPLANTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24968063 ↗

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