Natrelle INSPIRA Breast Implants SRF-560Recalls & reported problems

Summary

The FDA's MAUDE database contains 387 adverse event reports that list this exact device (DI 10888628007376), received between May 11, 2019 and Sep 9, 2026 — classified as 386 injuries, 1 malfunction.

The most frequently reported specific device problem is “Device Appears to Trigger Rejection” (241 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 387 reports, in the reporter's own words as published by the FDA.

• InjurySep 9, 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 50699515 ↗
• InjuryAug 7, 2026Device Appears to Trigger Rejection

  Healthcare professional reported "capsular contracture Baker grade III and infection". This record is for the left side. The device has been explanted.

  Patient problems: Capsular Contracture; Unspecified Infection

  MAUDE report 50169390 ↗
• InjuryJul 14, 2026Device Appears to Trigger Rejection

  HEALTHCARE PROFESSIONAL REPORTED "CAPSULAR CONTRACTURE, BAKER GRADE IV". PATIENT WAS PRESCRIBED SINGULAIR. THIS RECORD IS FOR THE LEFT SIDE. DEVICE WAS EXPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 25814833 ↗
• InjuryJul 7, 2026Device Appears to Trigger Rejection

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

  Patient problems: Capsular Contracture

  MAUDE report 25734302 ↗
• InjuryJun 23, 2026Device Appears to Trigger Rejection

  HEALTHCARE PROFESSIONAL REPORTED "CAPSULAR CONTRACTURE, BAKER GRADE III". PATIENT WAS PRESCRIBED SINGULAIR. THIS RECORD IS FOR THE LEFT SIDE. DEVICE REMAINS IMPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 25596878 ↗
• InjuryMay 26, 2026Device Appears to Trigger Rejection

  Healthcare professional reported "capsular contracture Baker grade IV". This record is for the right side. Device has been explanted.

  Patient problems: Capsular Contracture

  MAUDE report 25282812 ↗
• InjuryApr 24, 2026Device Appears to Trigger Rejection

  HEALTHCARE PROFESSIONAL REPORTED "EXCHANGE WITH NO COMPLAINT AGAINST THE DEVICE". LATER HEALTHCARE PROFESSIONAL REPORTED "CAPSULE HARDENING". LATER HEALTHCARE PROFESSIONAL REPORTED "CAPSULAR CONTRACTURE BAKER GRADE IV". THIS RECORD IS FOR THE RIGHT SIDE. DEVICE WAS EXPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 24988081 ↗
• InjuryApr 7, 2026Device Appears to Trigger Rejection

  PATIENT REPORTED "CAPSULAR CONTRACTURE BAKER GRADE UNKNOWN". LATER HEALTHCARE PROFESSIONAL CONFIRMED THE EVENT. THIS RECORD IS FOR THE LEFT SIDE. DEVICE WAS EXPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 24808692 ↗
• InjuryApr 1, 2026Malposition of Device; Migration

  HEALTHCARE PROFESSIONAL REPORTED "DEVICE MIGRATION/IMPLANT MALPOSITION" AND "CHANGE SHAPE/SIZE/STYLE" VIA NATIONAL BREAST IMPLANT REGISTRY (NBIR). THIS RECORD IS FOR THE RIGHT SIDE. DEVICE WAS EXPLANTED. PATIENT UNDERWENT CAPSULECTOMY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24753416 ↗
• InjuryJan 26, 2026Device Appears to Trigger Rejection

  DEVICE HAS BEEN EXPLANTED AND REPLACED.

  Patient problems: Capsular Contracture

  MAUDE report 24184130 ↗
• InjuryJan 26, 2026Device Appears to Trigger Rejection

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

  Patient problems: Capsular Contracture

  MAUDE report 24177512 ↗
• InjuryJan 21, 2026Device Appears to Trigger Rejection

  Healthcare professional reported Capsular Contracture Baker Grade IV, "pain" and "hardening". Treatment: Singulair. This record is for the left side. Device was explanted.

  Patient problems: Capsular Contracture

  MAUDE report 24138914 ↗
• InjuryJan 1, 2026Device Appears to Trigger Rejection

  PATIENT REPORTED "STARTING TO LOOK DIFFERENT". LATER, PATIENT REPORTED "CAPSULAR CONTRACTURE BAKER GRADE UNKNOWN" TREATED WITH SINGULAIR. LATER, PATIENT REPORTED "CAPSULAR CONTRACTURE BAKER GRADE IV". THIS RECORD IS FOR THE RIGHT SIDE. DEVICE REMAINS IMPLANTED. IT IS UNKNOWN IF DEVICE WILL RETURN.

  Patient problems: Capsular Contracture

  MAUDE report 23939566 ↗
• InjuryDec 31, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  PATIENT REPORTED "PAIN, LOOKS DEFORMED, FEELS HARD AND LOOKS CAVED IN¿. LATER, PATIENT REPORTED "CAPSULAR CONTRACTURE BAKER GRADE UNKNOWN" AND "IS A LOT WORSE" TREATED WITH SINGULAIR. LATER, PATIENT REPORTED "CAPSULAR CONTRACTURE BAKER GRADE IV". THIS RECORD IS FOR THE LEFT SIDE. DEVICE REMAINS IMPLANTED. IT IS UNKNOWN IF DEVICE WILL RETURN.

  Patient problems: Capsular Contracture

  MAUDE report 23938550 ↗
• InjuryOct 22, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  HEALTHCARE PROFESSIONAL REPORTED "HEMATOMA" VIA NBIR. THIS RECORD IS FOR THE LEFT SIDE. DEVICE WAS EXPLANTED AND REPLACED.

  Patient problems: Hematoma

  MAUDE report 23360971 ↗
• InjurySep 29, 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 AND REPLACED.

  Patient problems: Capsular Contracture

  MAUDE report 23168427 ↗
• InjurySep 17, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  HEALTHCARE PROFESSIONAL REPORTED "CAPSULAR CONTRACTURE, BAKER GRADE III AND PAIN" CONFIRMED VIA MAMMOGRAM. THIS RECORD IS FOR THE LEFT SIDE. DEVICE REMAINS IMPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 23073223 ↗
• InjurySep 2, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

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

  Patient problems: Capsular Contracture

  MAUDE report 22935394 ↗
• InjuryAug 22, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  PATIENT REPORTED "CAPSULAR CONTRACTURE BAKER GRADE III" AND "PAIN AND HARDNESS". HEALTHCARE PROFESSIONAL CONFIRMED CAPSULAR CONTRACTURE BAKER GRADE III. THIS RECORD IS FOR THE RIGHT SIDE. DEVICE REMAINS IMPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 22874432 ↗
• InjuryAug 6, 2025Material Rupture; Material Rupture

  HEALTHCARE PROFESSIONAL REPORTED RIGHT SIDE "RUPTURED GEL". DEVICE HAS BEEN EXPLANTED AND REPLACED.

  Patient problems: Failure of Implant

  MAUDE report 22734122 ↗
• InjuryAug 5, 2025Material Rupture; Material Rupture

  PATIENT REPORTED LEFT SIDE "NECROSIS AND INFECTION", "PAIN AND SUFFERING", AND "DEPRESSION". PATIENT LATER REPORTED LEFT SIDE RUPTURE. THE DEVICE REMAINS IMPLANTED.

  Patient problems: Necrosis; Unspecified Infection

  MAUDE report 22722664 ↗
• InjuryJul 30, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  PATIENT REPORTED "NECROSIS AND INFECTION", "PAIN AND SUFFERING, DEPRESSION" AND LATER REPORTED CAPSULAR CONTRACTURE BAKER GRADE UNKNOWN. THE DEVICE REMAINS IMPLANTED. THIS RELATES TO THE RIGHT SIDE.

  Patient problems: Capsular Contracture; Necrosis; Unspecified Infection

  MAUDE report 22664202 ↗
• InjuryJul 8, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  HEALTHCARE PROFESSIONAL REPORTED RIGHT SIDE CAPSULAR CONTRACTURE, BAKER GRADE III. THE DEVICE HAS BEEN EXPLANTED AND REPLACED.

  Patient problems: Capsular Contracture

  MAUDE report 22436704 ↗
• InjuryJun 23, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  HEALTHCARE PROFESSIONAL REPORTED "EXPLANTED ONE YEAR AGO FOR SEVERE CAP CON THAT WAS COMPRESSION SKIN AND CAUSING NECROSIS". LATER HEALTHCARE PROFESSIONAL REPORTED "BAKER GRADE- GRADE 4 - PAIN AS WELL". THIS RECORD IS FOR THE RIGHT SIDE. DEVICE WAS EXPLANTED AND REPLACED.

  Patient problems: Capsular Contracture; Necrosis

  MAUDE report 22307086 ↗
• InjuryJun 16, 2025Material Rupture; Material Rupture

  PATIENT REPORTED "INTRACAPSULAR AND EXTRACAPSULAR RUPTURES" CONFIRMED VIA MRI. THIS RECORD IS FOR THE RIGHT SIDE. DEVICE REMAINS IMPLANTED.

  Patient problems: Failure of Implant

  MAUDE report 22216178 ↗

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 108
• 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,TRL-
• 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, 110-210,