Natrelle INSPIRA Breast Implants SRL-350Recalls & reported problems

Summary

The FDA's MAUDE database contains 30 adverse event reports that list this exact device (DI 10888628006737), received between Dec 24, 2019 and Feb 9, 2026 — classified as 30 injuries.

The most frequently reported specific device problem is “Material Rupture” (17 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 30 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 9, 2026Material Rupture

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

  Patient problems: Failure of Implant

  MAUDE report 24290306 ↗
• InjuryOct 3, 2025Material Rupture; Material Rupture

  HEALTHCARE PROFESSIONAL REPORTED "RUPTURE" AND "TO DOWN SIZE¿. THIS RECORD IS FOR THE RIGHT-SIDE. DEVICE HAS BEEN EXPLANTED AND REPLACED. DEVICE HAS BEEN RETURNED.

  Patient problems: Failure of Implant

  MAUDE report 23210710 ↗
• InjuryJul 8, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  HEALTHCARE PROFESSIONAL REPORTED VIA NBIR "CAPSULAR CONTRACTURE BAKER GRADE III, DEVICE MIGRATION/IMPLANT MALPOSITION, SUSPECTED/ACTUAL RUPTURE/DEFLATION NOT CONFIRMED, CORRECTION OF ASYMMETRY, CHANGE SHAPE/SIZE/STYLE". THIS RECORD IS FOR THE LEFT SIDE. THE DEVICE HAS BEEN EXPLANTED AND REPLACED.

  Patient problems: Capsular Contracture

  MAUDE report 22441735 ↗
• InjuryJul 8, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  HEALTHCARE PROFESSIONAL REPORTED VIA NBIR "CAPSULAR CONTRACTURE BAKER GRADE III, DEVICE MIGRATION/IMPLANT MALPOSITION, SUSPECTED/ACTUAL RUPTURE/DEFLATION, CORRECTION OF ASYMMETRY, CHANGE SHAPE/SIZE/STYLE". THIS RECORD IS FOR THE RIGHT SIDE. THE DEVICE HAS BEEN EXPLANTED AND REPLACED.

  Patient problems: Capsular Contracture

  MAUDE report 22438795 ↗
• InjuryMay 29, 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 WAS EXPLANTED AND REPLACED.

  Patient problems: Capsular Contracture

  MAUDE report 22105018 ↗
• InjuryMay 28, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  HEALTHCARE PROFESSIONAL REPORTED "CAPSULAR CONTRACTURE BAKER GRADE 3". THIS RECORD IS FOR THE LEFT SIDE. DEVICE WAS EXPLANTED AND REPLACED.

  Patient problems: Capsular Contracture

  MAUDE report 22101842 ↗
• InjuryMay 21, 2025Material Invagination; Device Appears to Trigger Rejection; Material Rupture; Material Invagination; Device Appears to Trigger Rejection; Material Rupture

  LATER PATIENT REPORTED "NO RUPTURE". THE DEVICE HAS BEEN EXPLANTED.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Capsular Contracture; Ptosis

  MAUDE report 22066198 ↗
• InjuryMay 19, 2025Device Appears to Trigger Rejection; Adverse Event Without Identified Device or Use Problem; Device Appears to Trigger Rejection; Adverse Event Without Identified Device or Use Problem

  HEALTHCARE PROFESSIONAL REPORTED " NO COMPLAINT AGAINST THE DEVICE". HEALTHCARE PROFESSIONAL REPORTED "INFECTION" THIS RECORD IS FOR THE LEFT SIDE. DEVICE REMAINS IMPLANTED.

  Patient problems: Capsular Contracture; Seroma; Unspecified Infection

  MAUDE report 22042216 ↗
• InjuryApr 10, 2025Material Rupture; Material Rupture

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

  Patient problems: Failure of Implant

  MAUDE report 21819307 ↗
• InjuryMar 7, 2025Material Rupture; Material Rupture

  HEALTHCARE PROFESSIONAL REPORTED PER CUSTOMER PORTAL RIGHT SIDE "PROMINENT INFOLDING" AND "RUPTURE". DEVICE REMAINS IMPLANTED.

  Patient problems: Failure of Implant

  MAUDE report 21545415 ↗
• InjuryFeb 28, 2025Material Rupture; Material Rupture

  DEVICE HAS BEEN EXPLANTED.

  Patient problems: Failure of Implant

  MAUDE report 21496817 ↗
• InjuryOct 13, 2023Material Rupture; No Apparent Adverse Event; Material Rupture; No Apparent Adverse Event

  HEALTHCARE PROFESSIONAL REPORTED LEFT SIDE WAS FOUND TO BE INTACT AND NOT RUPTURED UPON DEVICE EXPLANT.

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

  MAUDE report 17930881 ↗
• InjuryMay 15, 2023Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

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

  Patient problems: Capsular Contracture

  MAUDE report 16933782 ↗
• InjuryMay 10, 2023Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

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

  Patient problems: Capsular Contracture

  MAUDE report 16907549 ↗
• InjuryMar 9, 2023Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  DEVICE WAS EXPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 16513444 ↗
• InjuryFeb 17, 2023Device Appears to Trigger Rejection; Device Handling Problem; Device Appears to Trigger Rejection; Device Handling Problem

  PATIENT REPORTED LEFT CAPSULAR CONTRACTURE AND "THEY REMOVED THE IMPLANTS, REMOVED THE CAPSULE AND REPLACED WITH THE SAME IMPLANTS". THE DEVICE REMAINS IMPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 16397804 ↗
• InjuryFeb 15, 2023Device Appears to Trigger Rejection; Device Handling Problem; Device Appears to Trigger Rejection; Device Handling Problem

  PATIENT REPORTED RIGHT SIDE "CAPSULAR CONTRACTURE BAKER GRADE UNKNOWN." PATIENT ALSO REPORTED A "PREVIOUS BILATERAL CAPSULAR CONTRACTURE BAKER GRADE UNKNOWN WITH TREATMENT PROCEDURE OF REMOVING THE IMPLANTS ON (B)(6) 2022, THE PHYSICIAN REMOVED THE CAPSULE AND REPLACED WITH THE SAME IMPLANTS ON THE SAME DAY." DEVICE REMAINS IMPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 16378026 ↗
• InjuryFeb 14, 2023Device Appears to Trigger Rejection; Material Rupture; Device Appears to Trigger Rejection; Material Rupture

  HEALTHCARE PROFESSIONAL REPORTED RIGHT SIDE RUPTURE. DEVICE REMAINS IMPLANTED.

  Patient problems: Capsular Contracture; Failure of Implant

  MAUDE report 16374323 ↗
• InjuryFeb 14, 2023Device Appears to Trigger Rejection; Material Rupture; Device Appears to Trigger Rejection; Material Rupture

  HEALTHCARE PROFESSIONAL REPORTED LEFT SIDE RUPTURE. DEVICE REMAINS IMPLANTED.

  Patient problems: Capsular Contracture; Failure of Implant

  MAUDE report 16374292 ↗
• InjuryNov 28, 2022Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  HEALTHCARE PROFESSIONAL REPORTED LEFT SIDE CAPULARE CONTRACTURE BAKER GRADE III. DEVICES HAVE BEEN EXPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 15872051 ↗
• InjuryOct 18, 2022Material Rupture; Material Rupture

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

  Patient problems: Failure of Implant

  MAUDE report 15620960 ↗
• InjuryJul 27, 2022Material Rupture; Material Rupture

  HEALTHCARE PROFESSIONAL REPORTED VIA DEVICE TRACKING "RUPTURED" AGAINST DEVICE. THE DEVICE WAS NOT IMPLANTED.

  Patient problems: Failure of Implant

  MAUDE report 15117502 ↗
• InjuryFeb 16, 2022Device Appears to Trigger Rejection; Material Rupture; Device Appears to Trigger Rejection; Material Rupture

  HEALTHCARE PROFESSIONAL REPORTED "CAPSULAR CONTRACTION BAKER GRADE UNKNOWN" AGAINST LEFT DEVICE. THE DEVICE REMAINS IMPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 13544399 ↗
• InjuryJun 17, 2021Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  HEALTHCARE PROFESSIONAL REPORTED LEFT SIDE CAPSULAR CONTRACTURE, BAKER GRADE III AS WELL AS "ANY CREASES" NOTED DURING SURGERY. DEVICE HAS BEEN EXPLANTED

  Patient problems: Capsular Contracture

  MAUDE report 12017753 ↗
• InjuryNov 23, 2020Material Rupture; Material Rupture

  ADDITIONALLY, HEALTHCARE PROFESSIONAL REPORTED PAIN AND 2 SMALL SIMPLE CYSTS. DEVICE WAS EXPLANTED.

  Patient problems: Failure of Implant

  MAUDE report 10885467 ↗

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-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-