Natrelle INSPIRA Breast Implants SRX-340Recalls & reported problems

Summary

The FDA's MAUDE database contains 128 adverse event reports that list this exact device (DI 10888628007482), received between Jun 5, 2019 and Sep 14, 2026 — classified as 128 injuries.

The most frequently reported specific device problem is “Device Appears to Trigger Rejection” (84 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 128 reports, in the reporter's own words as published by the FDA.

• InjurySep 14, 2026Material Rupture

  Healthcare professional reported "Rupture." This record is for the right side. Device was explanted.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50758063 ↗
• InjurySep 12, 2026Device Appears to Trigger Rejection

  Patient problems: Capsular Contracture

  MAUDE report 50744683 ↗
• InjurySep 11, 2026Device Appears to Trigger Rejection

  Healthcare professional reported "Capsulectomy", "Baker Grade: III". Capsulectomy was performed. This record is for the right side. The device was explanted.

  Patient problems: Capsular Contracture

  MAUDE report 50744661 ↗
• InjurySep 11, 2026Device Appears to Trigger Rejection

  Patient problems: Capsular Contracture

  MAUDE report 50740044 ↗
• InjurySep 11, 2026Device Appears to Trigger Rejection

  Patient problems: Capsular Contracture

  MAUDE report 50740037 ↗
• InjurySep 10, 2026Material Rupture

  Healthcare Professional reported "Rupture" and ¿incision was open and silicone was leaking out¿. This record is for the right side. Device has been explanted.

  Patient problems: Wound Dehiscence

  MAUDE report 50716060 ↗
• InjurySep 7, 2026Device Appears to Trigger Rejection

  Patient problems: Capsular Contracture

  MAUDE report 50651566 ↗
• InjuryAug 18, 2026Device Appears to Trigger Rejection

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

  Patient problems: Capsular Contracture

  MAUDE report 50309960 ↗
• InjuryAug 11, 2026Device Appears to Trigger Rejection

  Healthcare professional reported Capsular Contracture Baker grade III. This record is for the left side. Device was explanted.

  Patient problems: Capsular Contracture

  MAUDE report 50211584 ↗
• InjuryAug 4, 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 50124597 ↗
• InjuryJul 30, 2026Device Appears to Trigger Rejection

  Patient reported "capsular contracture Baker grade III, bumps, pounding in arm, itching, burning and unilateral exchange". Later healthcare professional reported "capsular contracture Baker grade III" and "pain when lifting arm above". This record is for the left side. The device remains implanted.

  Patient problems: Capsular Contracture

  MAUDE report 50086411 ↗
• InjuryJun 29, 2026Device Appears to Trigger Rejection

  HEALTHCARE PROFESSIONAL REPORTED "POSSIBLE RUPTURE" AND LATER DID NOT REPORT THE EVENT OF RUPTURE. ADDITIONALLY, HEALTHCARE PROFESSIONAL REPORTED CAPSULAR CONTRACTURE, "BAKER GRADE IV, GRADE 3 PTOSIS, BOTTOMING OUT AND DEFORMITY". PATIENT WAS ALSO REPORTED TO BE UNDER THE RECOMMENDED AGE AT TIME OF IMPLANT. THIS RECORD IS FOR THE LEFT SIDE. DEVICE HAS BEEN EXPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 25652900 ↗
• InjuryJun 11, 2026Adverse Event Without Identified Device or Use Problem

  PATIENT REPORTED OF THE LEFT SIDE DEVICE: "CELLULITIS, INFECTION, SEPSIS, FEVER AND PAIN". THE PATIENT WAS PRESCRIBED ANTIBIOTICS AND WAS ADMITTED TO THE HOSPITAL. THE DEVICE WAS EXPLANTED.

  Patient problems: Cellulitis; Unspecified Infection

  MAUDE report 25477951 ↗
• InjuryFeb 26, 2026Device Appears to Trigger Rejection

  HEALTHCARE PROFESSIONAL REPORTED "PAIN, DISCOMFORT, FIRM, HIGHER AND CAPSULAR CONTRACTURE, BAKER GRADE IV". THIS RECORD IS FOR THE LEFT SIDE. THE DEVICE WAS EXPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 24456238 ↗
• InjurySep 19, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  PATIENT REPORTED "CAPSULAR CONTRACTURE, BAKER GRADE UNKNOWN". THIS RECORD IS FOR THE LEFT SIDE. DEVICE REMAINS IMPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 23095097 ↗
• InjurySep 17, 2025Material Rupture; No Apparent Adverse Event; Material Rupture; No Apparent Adverse Event

  HEALTHCARE PROFESSIONAL DIDN'T REPORT A COMPLAINT AGAINST THE DEVICE. LATER HEALTHCARE PROFESSIONAL REPORTED "RUPTURE". THIS RECORD IS FOR LEFT SIDE. DEVICE WAS EXPLANTED AND REPLACED.

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

  MAUDE report 23072558 ↗
• InjurySep 16, 2025Material Rupture; Material Rupture

  HEALTHCARE PROFESSIONAL REPORTED RIGHT SIDE "SUSPECTED/ACTUAL RUPTURE" VIA NBIR. PATIENT UNDERGONE CAPSULECTOMY. THE DEVICE HAS BEEN EXPLANTED AND REPLACED WITH NON-ABBVIE DEVICE.

  Patient problems: Failure of Implant

  MAUDE report 23069385 ↗
• InjurySep 11, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  PATIENT REPORTED "CAPSULAR CONTRACTURE, BAKER GRADE UNKNOWN". THIS RECORD IS FOR THE RIGHT SIDE. DEVICE REMAINS IMPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 23026391 ↗
• InjuryAug 18, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  DEVICE WAS EXPLANTED. DEVICE WAS DISCARDED.

  Patient problems: Capsular Contracture

  MAUDE report 22834560 ↗
• InjuryAug 13, 2025Device Appears to Trigger Rejection; Material Rupture; Device Appears to Trigger Rejection; Material Rupture

  HEALTHCARE PROFESSIONAL REPORTED "CAPSULAR CONTRACTURE BAKER GRADE III, INTRACAPSULAR RUPTURE, SHOOTING PAIN FROM BREAST, SHOULDER AND ARM AND FEEL LIKE CEMENT" DIAGNOSED VIA MRI. THIS RECORD IS FOR THE LEFT SIDE. DEVICE REMAINS IMPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 22794482 ↗
• InjuryJul 29, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

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

  Patient problems: Capsular Contracture

  MAUDE report 22644549 ↗
• InjuryJul 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 REMAINS IMPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 22522296 ↗
• InjuryJun 30, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  HEALTHCARE PROFESSIONAL REPORTED LEFT SIDE CAPSULAR CONTRACTURE, BAKER GRADE III. DEVICE REMAINS IMPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 22359221 ↗
• InjuryJun 30, 2025Device Appears to Trigger Rejection; Material Rupture; Device Appears to Trigger Rejection; Material Rupture

  HEALTHCARE PROFESSIONAL REPORTED A RIGHT SIDE CAPSULAR CONTRACTURE, BAKER GRADE III. HEALTHCARE PROFESSIONAL ALSO REPORTED ¿DAMAGE CAUSED BY EXPLANT¿ AS ¿HOLE ON THE BOTTOM¿. THE DEVICE HAS BEEN EXPLANTED AND REPLACED.

  Patient problems: Capsular Contracture

  MAUDE report 22358003 ↗
• InjuryMay 27, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

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

  Patient problems: Capsular Contracture

  MAUDE report 22092694 ↗

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-