Natrelle INSPIRA Breast Implants SRL-290Recalls & reported problems

Summary

The FDA's MAUDE database contains 53 adverse event reports that list this exact device (DI 10888628006713), received between May 17, 2019 and Sep 10, 2026 — classified as 53 injuries.

The most frequently reported specific device problem is “Device Appears to Trigger Rejection” (25 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 53 reports, in the reporter's own words as published by the FDA.

• InjurySep 10, 2026Device Appears to Trigger Rejection; Material Rupture; Material Protrusion/Extrusion

  Patient reported "Capsular contracture" Baker Grade III. Patient later reported "intracapsular breast implant rupture", "folded over", "bubbled", "real thin in some parts", "I am so sick", "memory issues", "extreme limited mobility"," can't lift my arm above my shoulder", "migrated up kind of towards the armpit", "the sharp corner where it's folded kind of sticks out and protrudes, you can visibly see it", "it's grade IV", "pocket degradation", "not in the pocket anymore where it's supposed to be", "extreme pain", "it's like a bowling ball, it's like a rock" and "they don't know if the implant's capsule is adhesion to my lungs until they get in there". Patient also reported "extreme fatigue", "numbness and tingling in my fingers", "I am so sick", "memory issues", "extreme limited mobility"," can't lift my arm above my shoulder" and "shortness of breath" which are not device related. This record is for the left side. Device remains implanted.

  Patient problems: Capsular Contracture

  MAUDE report 50721159 ↗
• InjuryMay 30, 2025Material Rupture; Material Rupture

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

  Patient problems: Failure of Implant

  MAUDE report 22119700 ↗
• InjuryMay 12, 2025Material Rupture; Material Rupture

  HEALTHCARE PROFESSIONAL REPORTED "POSSIBLE RUPTURE". THIS RECORD IS FOR THE RIGHT SIDE. THE DEVICE HAS BEEN EXPLANTED.

  Patient problems: Failure of Implant

  MAUDE report 22002413 ↗
• InjuryMay 9, 2025Material Rupture; Material Rupture

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

  Patient problems: Failure of Implant

  MAUDE report 21997597 ↗
• InjuryFeb 11, 2025Material Rupture; Material Rupture

  HEALTHCARE PROFESSIONAL REPORTED THROUGH THE NATIONAL BREAST IMPLANT REGISTRY A LEFT SIDE SUSPECTED/ACTUAL RUPTURE, CHANGE SHAPE/SIZE/STYLE. DEVICE HAS BEEN EXPLANTED AND REPLACED WITH AN ABBVIE DEVICE.

  Patient problems: Failure of Implant

  MAUDE report 21359003 ↗
• InjuryJun 14, 2024Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

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

  Patient problems: Capsular Contracture

  MAUDE report 19538054 ↗
• InjuryNov 15, 2023Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

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

  Patient problems: Capsular Contracture

  MAUDE report 18144505 ↗
• InjuryOct 23, 2023Material Rupture; Material Rupture

  HEALTHCARE PROFESSIONAL REPORTED RIGHT SIDE RUPTURE CONFIRMED BY IMAGING. DEVICE REMAINS IMPLANTED.

  Patient problems: Failure of Implant

  MAUDE report 17990736 ↗
• InjurySep 13, 2023Material Rupture; Material Rupture

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

  Patient problems: Failure of Implant

  MAUDE report 17740252 ↗
• InjurySep 12, 2023Material Rupture; Material Rupture

  HEALTHCARE PROFESSIONAL REPORTED RIGHT SIDE RUPTURE. THE DEVICE HAS BEEN EXPLANTED.

  Patient problems: Failure of Implant

  MAUDE report 17732745 ↗
• InjuryJul 27, 2023Material Rupture; Material Rupture

  COMPANY REPRESENTATIVE REPORTED "CAN YOU LOOK INTO SEEING IF WE HAVE RECEIVED ANY OR THE PHYSICIAN¿S OFFICE HAS STARTED A WARRANTY CLAIM FOR THE FOLLOWING PATIENT:" OF AN UNKNOWN SIDE. HEALTHCARE PROFESSIONAL REPORTED RUPTURE AND CAPSULAR CONTRACTURE BAKER GRADE 1. DEVICE HAS BEEN EXPLANTED.

  Patient problems: Failure of Implant

  MAUDE report 17410705 ↗
• InjuryJun 22, 2023Device Appears to Trigger Rejection; Material Rupture; Device Appears to Trigger Rejection; Material Rupture

  HEALTHCARE PROFESSIONAL REPORTED A RIGHT SIDE RUPTURE. DEVICE REMAINS IMPLANTED.

  Patient problems: Capsular Contracture; Failure of Implant

  MAUDE report 17186949 ↗
• InjuryJun 21, 2023Device Appears to Trigger Rejection; Material Rupture; Device Appears to Trigger Rejection; Material Rupture

  HEALTHCARE PROFESSIONAL REPORTED A LEFT SIDE RUPTURE. DEVICE REMAINS IMPLANTED.

  Patient problems: Capsular Contracture; Failure of Implant

  MAUDE report 17177425 ↗
• InjuryApr 25, 2023Device Appears to Trigger Rejection; Material Rupture; Device Appears to Trigger Rejection; Material Rupture

  HEALTHCARE PROFESSIONAL REPORTED RIGHT RUPTURE, "HIGH, ELEVATION", AND CAPSULAR CONTRACTURE BAKER GRADE UNKNOWN. THE DEVICE HAS BEEN EXPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 16810339 ↗
• InjuryMar 31, 2023Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  DEVICE HAS BEEN EXPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 16659353 ↗
• InjuryMar 31, 2023Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  DEVICE HAS BEEN EXPLANTED AND REPLACED.

  Patient problems: Capsular Contracture

  MAUDE report 16659339 ↗
• InjuryJan 4, 2023Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

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

  Patient problems: Capsular Contracture

  MAUDE report 16099452 ↗
• InjuryDec 30, 2022Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

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

  Patient problems: Capsular Contracture

  MAUDE report 16077966 ↗
• InjuryDec 30, 2022Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  HEALTHCARE PROFESSIONAL REPORTED A LEFT SIDE "CAPSULAR CONTRACTURE BAKER GRADE III/IV." DEVICE HAS BEEN EXPLANTED AND REPLACED.

  Patient problems: Capsular Contracture

  MAUDE report 16077435 ↗
• InjuryOct 18, 2022Material Rupture; Material Rupture

  HEALTHCARE PROFESSIONAL REPORTED RIGHT SIDE RUPTURE. DEVICE HAS BEEN EXPLANTED AND REPLACED.

  Patient problems: Failure of Implant

  MAUDE report 15626566 ↗
• InjuryAug 26, 2022Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

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

  Patient problems: Capsular Contracture

  MAUDE report 15303070 ↗
• InjuryAug 4, 2022Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  HEALTHCARE PROFESSIONAL REPORTED RIGHT SIDE CAPSULAR CONTRACTURE, BAKER GRADE III, AND CREASING OR FOLDING OF THE IMPLANT. DEVICE EXPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 15163353 ↗
• InjuryJul 26, 2022Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

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

  Patient problems: Capsular Contracture

  MAUDE report 15102422 ↗
• InjuryJun 30, 2022Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

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

  Patient problems: Capsular Contracture

  MAUDE report 14881448 ↗
• InjuryJun 1, 2022Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  HEALTHCARE PROFESSIONAL REPORTED LEFT SIDE CAPSULAR CONTRACTURE, BAKER GRADE III, AND CREASING OR FOLDING OF THE IMPLANT. DEVICE EXPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 14567166 ↗

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-