Natrelle INSPIRA Breast Implants SRLP-250Recalls & reported problems

Summary

The FDA's MAUDE database contains 48 adverse event reports that list this exact device (DI 10888628006874), received between May 20, 2019 and Aug 14, 2026 — classified as 48 injuries.

The most frequently reported specific device problem is “Device Appears to Trigger Rejection” (24 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 48 reports, in the reporter's own words as published by the FDA.

• InjuryAug 14, 2026Material Rupture

  Healthcare professional reported "rupture". Later, healthcare professional reported "Hole, none-specific". This record is for the left side. The device was explanted.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50255306 ↗
• InjuryAug 6, 2026Off-Label Use; Device Appears to Trigger Rejection

  Healthcare Professional reported "Capsular Contracture, Baker Grade III" and patient implanted prior to AbbVie's recommended age of 22 years old. This record is for the left side. Device remains implanted.

  Patient problems: Capsular Contracture

  MAUDE report 50168040 ↗
• InjuryApr 23, 2026Device Appears to Trigger Rejection

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

  Patient problems: Capsular Contracture

  MAUDE report 24968097 ↗
• InjurySep 19, 2025Device Appears to Trigger Rejection; Material Rupture; Device Appears to Trigger Rejection; Material Rupture

  HEALTHCARE PROFESSIONAL REPORTED "RUPTURE". LATER HEALTHCARE PROFESSIONAL REPORTED "HYPOMASTIA", "LAXITY OF UPPER ARM SKIN", "INTRACAPSULAR SILICONE IMPLANT RUPTURE", "ENCOUNTERED FREE SILICONE GEL", "LARGELY INTACT WITH VERY MINIMAL AMOUNT OF LEAKAGE" AND "THE LOWER PORTION OF THE CAPSULE WAS GETTING A LITTLE BIT THICK". LATER HEALTHCARE PROFESSIONAL REPORTED "CAPSULE WAS BEGINNING TO THICKEN SECONDARY TO THE INTRACAPSULAR RUPTURE" AND "BAKER GRADE 2". THIS RECORD IS FOR THE RIGHT SIDE. DEVICE WAS EXPLANTED AND REPLACED. DEVICE WAS RETURNED.

  Patient problems: Capsular Contracture; Failure of Implant

  MAUDE report 23097123 ↗
• InjuryJul 23, 2025Material Rupture; Material Rupture

  HEALTHCARE PROFESSIONAL REPORTED LEFT SIDE "RUPTURE" CONFIRMED VIA ULTRASOUND. DEVICE REMAINS IMPLANTED.

  Patient problems: Failure of Implant

  MAUDE report 22582711 ↗
• InjuryMay 29, 2025Material Rupture; Material Rupture

  PATIENT REPORTED "RUPTURE" CONFIRMED VIA MRI. HEALTHCARE PROFESSIONAL LATER REPORTED "RUPTURE". THIS RECORD IS FOR THE LEFT SIDE. DEVICE WAS EXPLANTED AND REPLACED WITH ANOTHER MANUFACTURER'S DEVICE.

  Patient problems: Failure of Implant

  MAUDE report 22107556 ↗
• InjuryMay 15, 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 22023666 ↗
• InjuryApr 29, 2025Device Appears to Trigger Rejection; Material Rupture; Device Appears to Trigger Rejection; Material Rupture

  HEALTHCARE PROFESSIONAL REPORTED "CAPSULAR CONTRACTURE BAKER GRADE III. LATER, HEALTHCARE PROFESSIONAL REPORTED "RUPTURE" DEVICE REMAINS IMPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 21928123 ↗
• InjuryJun 25, 2024Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  HEALTHCARE PROFESSIONAL REPORTED VIA NBIR LEFT SIDE CAPSULAR CONTRACTURE, BAKER GRADE III. DEVICE HAS BEEN EXPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 19607248 ↗
• InjuryJun 25, 2024Material Rupture; Material Rupture

  HEALTHCARE PROFESSIONAL REPORTED VIA NBIR RIGHT SIDE CAPSULAR CONTRACTURE, BAKER GRADE II, AND "RUPTURE." DEVICE HAS BEEN EXPLANTED.

  Patient problems: Failure of Implant

  MAUDE report 19607111 ↗
• InjuryOct 24, 2023Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

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

  Patient problems: Capsular Contracture

  MAUDE report 17994675 ↗
• InjuryOct 19, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  HEALTHCARE PROFESSIONAL REPORTED LEFT SIDE CELLULITIS. THE DEVICE HAS BEEN EXPLANTED.

  Patient problems: Cellulitis

  MAUDE report 17966885 ↗
• InjuryOct 4, 2023Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

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

  Patient problems: Capsular Contracture

  MAUDE report 17870894 ↗
• InjurySep 1, 2023Material Rupture; Material Rupture

  DEVICE HAS BEEN EXPLANTED AND REPLACED.

  Patient problems: Failure of Implant

  MAUDE report 17668316 ↗
• InjuryApr 21, 2023Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

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

  Patient problems: Capsular Contracture

  MAUDE report 16791804 ↗
• InjuryMar 20, 2023Material Rupture; No Apparent Adverse Event; Material Rupture; No Apparent Adverse Event

  PATIENT REPORTED LEFT SIDE RUPTURE. DEVICE REMAINS IMPLANTED.

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

  MAUDE report 16574100 ↗
• InjuryFeb 20, 2023Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  PATIENT REPORTED RIGHT SIDE CAPSULAR CONTRACTURE BAKER GRADE III. DEVICE HAS BEEN EXPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 16405937 ↗
• InjuryDec 13, 2022Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  HEALTHCARE PROFESSIONAL REPORTED "CAPSULAR CONTRACTURE, BAKER GRADE III/IV". THIS RECORD IS FOR LEFT SIDE. DEVICE HAS BEEN EXPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 15974599 ↗
• InjuryDec 2, 2022Material Rupture; Material Rupture

  HEALTHCARE PROFESSIONAL REPORTED LEFT SIDE RUPTURE. DEVICE HAS BEEN EXPLANTED.

  Patient problems: Failure of Implant

  MAUDE report 15902267 ↗
• InjuryOct 24, 2022Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

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

  Patient problems: Capsular Contracture

  MAUDE report 15658797 ↗
• InjuryOct 24, 2022Device 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 15658680 ↗
• InjuryOct 18, 2022Migration; Migration

  HEALTHCARE PROFESSIONAL REPORTED RIGHT SIDE "SILICONE LEAKING INTO PLAINTIFF'S BODY¿, "LIFE-THREATENING, RISKS THAT HAVE BEEN CAUSED BY UNREASONABLY DANGEROUS AND DEFECTIVELY DESIGN AND COMPOSITION ALLERGAN IMPLANTS, SEVERAL OF WHICH HAVE BEEN RECALLED", "TREMENDOUS PAIN AND DISCOMFORT","SUFFERED TREMENDOUS PAIN, DISCOMFORT¿, AND "DEFORMITY DIRECTLY ASSOCIATED WITH THOSE IMPLANTS¿. THE DEVICE HAS BEEN EXPLANTED.

  Patient problems: Failure of Implant

  MAUDE report 15621584 ↗
• InjuryOct 7, 2022Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  PATIENT REPORTED LEFT SIDE CAPSULAR CONTRACTURE BAKER GRADE III. DEVICE REMAINS IMPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 15564146 ↗
• InjurySep 23, 2022Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

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

  Patient problems: Capsular Contracture

  MAUDE report 15471708 ↗
• InjurySep 20, 2022Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

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

  Patient problems: Capsular Contracture

  MAUDE report 15459863 ↗

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