Natrelle INSPIRA Breast Implants SRX-560Recalls & reported problems

Summary

The FDA's MAUDE database contains 109 adverse event reports that list this exact device (DI 10888628007574), received between May 16, 2019 and Jun 10, 2026 — classified as 108 injuries, 1 malfunction.

The most frequently reported specific device problem is “Device Appears to Trigger Rejection” (55 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 109 reports, in the reporter's own words as published by the FDA.

• InjuryJun 10, 2026Malposition of Device; Migration

  HEALTHCARE PROFESSIONAL REPORTED VIA NATIONAL BREAST IMPLANT REGISTRY (NBIR) MANUFACTURER REGISTRY SPECIFIC DATA REPORT (MRSDR) "DEVICE MIGRATION/IMPLANT MALPOSITION". THIS RECORD IS FOR THE RIGHT SIDE. DEVICE WAS EXPLANTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25460402 ↗
• InjuryApr 1, 2026Adverse Event Without Identified Device or Use Problem

  HEALTHCARE PROFESSIONAL REPORTED VIA NATIONAL BREAST IMPLANT REGISTRY (NBIR) MANUFACTURER REGISTRY SPECIFIC DATA REPORT (MRSDR) "WOUND PROBLEMS". THIS RECORD IS FOR THE RIGHT SIDE. DEVICE WAS EXPLANTED.

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

  MAUDE report 24753270 ↗
• InjuryMar 26, 2026Device Appears to Trigger Rejection

  HEALTHCARE PROFESSIONAL REPORTED "CAPSULAR CONTRACTURE BAKER GRADE III" VIA NATIONAL BREAST IMPLANT REGISTRY. THIS RECORD IS FOR THE LEFT SIDE. DEVICE WAS EXPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 24700008 ↗
• InjuryMar 26, 2026Device Appears to Trigger Rejection

  HEALTHCARE PROFESSIONAL REPORTED "CAPSULAR CONTRACTURE BAKER GRADE III" VIA NATIONAL BREAST IMPLANT REGISTRY. THIS RECORD IS FOR THE RIGHT SIDE. DEVICE WAS EXPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 24699763 ↗
• InjuryFeb 16, 2026Adverse Event Without Identified Device or Use Problem

  HEALTHCARE PROFESSIONAL REPORTED "BREAST WAS LARGER". THIS RECORD IS FOR THE RIGHT SIDE. DEVICE WAS EXPLANTED.

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

  MAUDE report 24344802 ↗
• InjuryOct 17, 2025Material Rupture; Material Rupture

  HEALTHCARE PROFESSIONAL REPORTED VIA NBIR "SUSPECTED/ACTUAL RUPTURE/DEFLATION". THIS RECORD IS FOR THE RIGHT SIDE. DEVICE HAS BEEN EXPLANTED AND REPLACED. DEVICE IS NOT AVAILABLE FOR RETURN.

  Patient problems: Failure of Implant

  MAUDE report 23323826 ↗
• InjurySep 25, 2025Material Rupture; Material Rupture

  HEALTHCARE PROFESSIONAL REPORTED "RUPTURE" CONFIRMED VIA CAT SCAN. HEALTHCARE PROFESSIONAL ADDITIONALLY REPORTED HOLE NON-SPECIFIC. HEALTHCARE PROFESSIONAL ALSO REPORTED SHORTNESS OF BREATH, CHEST PAIN, NISSEN 7 YEARS AGO, ESOPHAGEAL FOREIGN BODY SENSATION," ALL NOT RELATED TO THE DEVICE. THE DEVICE HAS BEEN EXPLANTED.

  Patient problems: Failure of Implant

  MAUDE report 23141011 ↗
• InjuryAug 27, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  HEALTHCARE PROFESSIONAL REPORTED "CAPSULAR CONTRACTURE BAKER GRADE III". PATIENT ALSO REPORTED "CAPSULAR CONTRACTURE, PAIN, FIRMNESS AND MALPOSITION" THIS RECORD IS FOR THE LEFT SIDE. DEVICE WAS EXPLANTED AND REPLACED.

  Patient problems: Capsular Contracture

  MAUDE report 22905611 ↗
• InjuryJul 9, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  HEALTHCARE PROFESSIONAL REPORTED "WAS INFECTED" AND "BULGING OUT". THIS RECORD IS FOR THE RIGHT SIDE. DEVICE WAS EXPLANTED.

  Patient problems: Unspecified Infection

  MAUDE report 22464836 ↗
• InjuryJun 12, 2025Material Rupture; Material Rupture

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

  Patient problems: Failure of Implant

  MAUDE report 22198417 ↗
• InjuryJun 3, 2025Material Rupture; No Apparent Adverse Event; Material Rupture; No Apparent Adverse Event

  HEALTHCARE PROFESSIONAL REPORTED LEFT SIDE POSSIBLE RUPTURE FROM CAR ACCIDENT. HEALTHCARE PROFESSIONAL LATER REPORTED "MALPOSITION WITH STRESSED AND COMPROMISED IMPLANT DUE TO OBVIOUS CAUSE". DEVICE HAS BEEN EXPLANTED, REPLACED, AND DISCARDED.

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

  MAUDE report 22133957 ↗
• InjuryJun 2, 2025Material Rupture; Malposition of Device; Material Rupture; Malposition of Device

  PATIENT REPRESENTATIVE REPORTED RUPTURE CONFIRMED BY ULTRASOUND. PATIENT LATER REPORTED "I¿M CAN¿T SLEEP AT NIGHT. I HAVE TO WEAR A BRA TO BED OTHERWISE IT¿S TOO UNCOMFORTABLE". THIS RECORD IS FOR THE LEFT SIDE. DEVICE REMAINS IMPLANTED.

  Patient problems: Failure of Implant

  MAUDE report 22125526 ↗
• InjuryMay 29, 2025Material Rupture; Malposition of Device; No Apparent Adverse Event; Material Rupture; Malposition of Device; No Apparent Adverse Event

  IT HAS BEEN DETERMINED THAT THE EVENT OF RUPTURE DID NOT OCCUR. THEREFORE, THIS RECORD IS NO LONGER REPORTABLE TO THE FDA AND WILL BE UNREPORTED.

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

  MAUDE report 22108805 ↗
• InjuryMay 22, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

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

  Patient problems: Capsular Contracture

  MAUDE report 22073650 ↗
• InjuryMay 2, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

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

  Patient problems: Capsular Contracture

  MAUDE report 21951198 ↗
• InjuryMay 1, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

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

  Patient problems: Capsular Contracture

  MAUDE report 21945226 ↗
• InjuryApr 24, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  HEALTHCARE PROFESSIONAL REPORTED LEFT SIDE ¿CAPSULAR CONTRACTURE BAKER GRADE UNKNOWN.¿ THE DEVICE REMAINS IMPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 21905165 ↗
• InjuryMar 13, 2024Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  HEALTHCARE PROFESSIONAL REPORTED RIGHT SIDE CAPSULAR CONTRACTURE BAKER GRADE IV. THE DEVICE HAS BEEN EXPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 18894833 ↗
• InjuryNov 28, 2023Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  HEALTHCARE PROFESSIONAL REPORTED A RIGHT SIDE "CAPSULAR CONTRACTURE BAKER GRADE III, DEVICE MIGRATION/IMPLANT MALPOSITION, AND CHANGE SHAPE/SIZE/STYLE." PATIENT UNDERGONE CAPSULECTOMY. DEVICE HAS BEEN EXPLANTED AND REPLACED.

  Patient problems: Capsular Contracture

  MAUDE report 18219888 ↗
• InjuryNov 2, 2023Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  PATIENT REPORTED RIGHT SIDE "CAPSULAR CONTRACTURE, BAKER GRADE UNKNOWN. PAIN, TIGHTNESS" AND THAT THE IMPLANT "SITS HIGHER", "PUCKERS WEIRDLY AROUND INTO THE NIPPLE AREA", "BUMPS OUT A LITTLE BIT", "MORE NARROW AND VERY HARD", "TIGHTENS THROUGHOUT THE DAY AND VERY DEFORMED". HEALTHCARE PROFESSIONAL CONFIRMED CAPSULAR CONTRACTURE BAKER GRADE IV. DEVICE REMAINS IMPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 18057974 ↗
• InjuryNov 2, 2023Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  PATIENT REPORTED LEFT SIDE CAPSULAR CONTRACTURE - BAKER GRADE UNKNOWN, "PAIN" (NON DEVICE RELATED) AND "TIGHTNESS." PATIENT REPORTED "BOTTOMED OUT", "SITS WAY LOWER THAN THE OTHER ONE", "HARD", "VERY PAINFUL", "VERY SORE" AND "SHOOTING PAIN AT THE INCISION LINE." HEALTHCARE PROFESSIONAL CONFIRMED CAPSULAR CONTRACTURE BAKER GRADE IV. DEVICE REMAINS IMPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 18057968 ↗
• InjuryOct 13, 2023Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  HEALTHCARE PROFESSIONAL REPORTED CAPSULAR CONTRACTURE, BAKER GRADE III/IV. DEVICE REMAINS IMPLANTED. THIS RELATES TO THE RIGHT SIDE.

  Patient problems: Capsular Contracture

  MAUDE report 17935024 ↗
• InjuryOct 11, 2023Material Rupture; Material Rupture

  HEALTHCARE PROFESSIONAL REPORTED RUPTURE. DEVICE HAS BEEN EXPLANTED. THIS RELATES TO THE LEFT SIDE.

  Patient problems: Failure of Implant

  MAUDE report 17914753 ↗
• InjurySep 19, 2023Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

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

  Patient problems: Capsular Contracture

  MAUDE report 17777611 ↗
• InjurySep 14, 2023Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  HEALTHCARE PROFESSIONAL REPORTED RIGHT SIDE CAPSULAR CONTRACTURE, BAKER GRADE IV. DEVICE REMAINS IMPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 17749033 ↗

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