Natrelle Inspira Cohesive Breast Implants SCM-485Recalls & reported problems

Summary

The FDA's MAUDE database contains 58 adverse event reports that list this exact device (DI 10888628029941), received between Oct 18, 2019 and Sep 23, 2026 — classified as 58 injuries.

The most frequently reported specific device problem is “Device Appears to Trigger Rejection” (37 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 58 reports, in the reporter's own words as published by the FDA.

• InjurySep 23, 2026Device Appears to Trigger Rejection

  Healthcare professional reported no complaint against the device. Later, patient reported "encapsulated" and "pain". This record is for the left side. Device remains implanted.

  Patient problems: Capsular Contracture

  MAUDE report 50866214 ↗
• InjurySep 18, 2026Device Appears to Trigger Rejection; Material Rupture

  Patient problems: Capsular Contracture

  MAUDE report 50831578 ↗
• InjurySep 16, 2026Device Appears to Trigger Rejection; Material Rupture

  Healthcare professional reported "Capsular contracture" Baker Grade III and "Suspected/Actual Rupture/Deflation" through the National Breast Implant Registry ((b)(6)). This record is for the right side. Device was explanted.

  Patient problems: Capsular Contracture

  MAUDE report 50790701 ↗
• InjurySep 10, 2026Device Appears to Trigger Rejection

  Healthcare professional reported "Capsular contracture" Baker Grade III. This record is for the left side. Device was explanted.

  Patient problems: Capsular Contracture

  MAUDE report 50717885 ↗
• InjuryAug 27, 2026Device Appears to Trigger Rejection

  Healthcare professional reported "capsular contracture Baker grade IV". Patient was prescribed Singular and Prednisone. This record is for the right side. The device remains implanted.

  Patient problems: Capsular Contracture

  MAUDE report 50476661 ↗
• InjuryJan 6, 2026Device Appears to Trigger Rejection

  HEALTHCARE PROFESSIONAL REPORTED "IMPLANT REPLACEMENT". LATER HEALTHCARE PROFESSIONAL REPORTED "CAPSULAR CONTRACTURE BAKER GRADE LLL". THIS RECORD IS FOR RIGHT SIDE. THE DEVICE REMAINS WAS EXPLANTED AND REPLACED. DEVICE WILL NOT BE RETURNED.

  Patient problems: Capsular Contracture

  MAUDE report 23978397 ↗
• InjuryOct 28, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  HEALTHCARE PROFESSIONAL REPORTED "CAPSULAR CONTRACTURE". LATER HEALTHCARE PROFESSIONAL REPORTED "DEVELOPED A GRADE 4 CAP CON" AND "PAIN". THIS RECORD IS FOR THE LEFT SIDE. DEVICE WAS EXPLANTED AND REPLACED WITH A NON-ABBVIE DEVICE. DEVICE WAS RETURNED.

  Patient problems: Capsular Contracture

  MAUDE report 23410103 ↗
• InjurySep 23, 2025Device Appears to Trigger Rejection; Material Rupture; Device Appears to Trigger Rejection; Material Rupture

  HEALTHCARE PROFESSIONAL REPORTED "RUPTURE" CONFIRMED VIA ULTRASOUND. LATER HEALTHCARE PROFESSIONAL REPORTED "CAPSULAR CONTRACTURE BAKER GRADE UNKNOWN". LATER HEALTHCARE PROFESSIONAL REPORTED "BAKER GRADE IV". THIS RECORD IS FOR THE LEFT SIDE. DEVICE WAS EXPLANTED AND REPLACED. DEVICE WILL BE RETURNED.

  Patient problems: Capsular Contracture; Failure of Implant

  MAUDE report 23125119 ↗
• InjuryAug 14, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  HEALTHCARE PROFESSIONAL REPORTED LEFT SIDE "CAPSULAR CONTRACTURE BAKER GRADE IV". HEALTHCARE PROFESSIONAL LATER CONFIRMED "CAPSULAR CONTRACTURE, BAKER GRADE IV". DEVICE WAS EXPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 22812589 ↗
• InjuryJun 20, 2025Device Appears to Trigger Rejection; Material Rupture; Device Appears to Trigger Rejection; Material Rupture

  HEALTHCARE PROFESSIONAL REPORTED LEFT SIDE "CAPSULAR CONTRACTURE BAKER GRADE UNKNOWN OR RUPTURE". THE DEVICE REMAINS IMPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 22302299 ↗
• InjuryJun 13, 2025Material Rupture; Material Rupture

  HEALTHCARE PROFESSIONAL REPORTED LEFT SIDE "CAPSULE/RUPTURED IMPLANT". THE DEVICE HAS BEEN EXPLANTED, REPLACED, AND DISCARDED.

  Patient problems: Failure of Implant

  MAUDE report 22206845 ↗
• InjuryMay 21, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  HEALTHCARE PROFESSIONAL REPORTED LEFT SIDE "CAPSULAR CONTRACTURE BAKER GRADE UNKNOWN". HEALTHCARE PROFESSIONAL LATER REPORTED "CAPSULAR CONTRACTURE BAKER GRADE III". PATIENT UNDERGONE CAPSULECTOMY. DEVICE HAS BEEN EXPLANTED, REPLACED WITH NON-ABBVIE DEVICE, AND DISCARDED.

  Patient problems: Capsular Contracture

  MAUDE report 22065328 ↗
• InjuryMay 6, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  HEALTHCARE PROFESSIONAL REPORTED "WOUND NOT HEALING". THIS RECORD IS FOR THE RIGHT SIDE. DEVICE WAS EXPLANTED.

  Patient problems: Impaired Healing

  MAUDE report 21969404 ↗
• InjuryMay 6, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  HEALTHCARE PROFESSIONAL REPORTED "WOUND NOT HEALING". THIS RECORD IS FOR THE LEFT SIDE. DEVICE WAS EXPLANTED.

  Patient problems: Impaired Healing

  MAUDE report 21968367 ↗
• InjuryOct 10, 2024Device 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 20421915 ↗
• InjuryMar 1, 2024Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  HEALTHCARE PROFESSIONAL REPORTED A RIGHT- SIDE IMPLANT EXCHANGE WITH NO COMPLAINT AGAINST THE DEVICE. HEALTHCARE PROFESSIONAL LATER REPORTED CAPSULAR CONTRACTURE, BAKER GRADE IV. DEVICE REMAINS IMPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 18816333 ↗
• InjuryNov 20, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  HEALTHCARE PROFESSIONAL REPORTED LEFT SIDE "DEHISCENCE". THE DEVICE HAS BEEN EXPLANTED.

  Patient problems: Wound Dehiscence

  MAUDE report 18173540 ↗
• InjuryNov 13, 2023Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

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

  Patient problems: Capsular Contracture

  MAUDE report 18120252 ↗
• InjuryNov 13, 2023Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  HEALTHCARE PROFESSIONAL REPORTED RIGHT SIDE ¿CAPSULE". HEALTHCARE PROFESSIONAL LATER REPORTED RIGHT CAPSULAR CONTRACTURE, BAKER GRADE IV AND "ANY CREASES" VIA RGA. DEVICE HAS BEEN EXPLANTED AND REPLACED.

  Patient problems: Capsular Contracture

  MAUDE report 18120108 ↗
• InjuryNov 1, 2023Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

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

  Patient problems: Capsular Contracture

  MAUDE report 18052006 ↗
• InjuryOct 24, 2023Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  PATIENT REPORTED RIGHT SIDE CAPSULAR CONTRACTURE, BAKER GRADE UNKNOWN WITH "CAUSING PAIN, CAN'T TURN MY NECK, CAN SEE THE IMPLANT TOWARDS THE TOP AND I SEE RIPPLING AND MY NIPPLE IS ITCHY". DEVICE REMAINS IMPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 17995159 ↗
• InjurySep 26, 2023Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

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

  Patient problems: Capsular Contracture

  MAUDE report 17818210 ↗
• InjuryJan 25, 2023Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  DEVICE HAS BEEN EXPLANTED AND REPLACED.

  Patient problems: Capsular Contracture

  MAUDE report 16241811 ↗
• InjuryJan 25, 2023Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  THE DEVICE HAS BEEN EXPLANTED AND REPLACED.

  Patient problems: Capsular Contracture

  MAUDE report 16241644 ↗
• InjuryJan 19, 2023Device 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 16212010 ↗

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-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-