Natrelle Inspira SoftTouch Breast Implants SSLP-340Recalls & reported problems

Summary

The FDA's MAUDE database contains 21 adverse event reports that list this exact device (DI 10888628032750), received between Dec 27, 2019 and Jul 22, 2026 — classified as 21 injuries.

The most frequently reported specific device problem is “Device Appears to Trigger Rejection” (16 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 21 most recent of 21 reports, in the reporter's own words as published by the FDA.

• InjuryJul 22, 2026Migration

  Healthcare professional reported ¿exchange with no complaint against the device¿. Later healthcare professional reported ¿sitting a bit laterally¿, ¿Lateral Malposition¿. Capsulorraphy was performed. This record is for the left side. Device was explanted.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25903716 ↗
• InjuryJun 22, 2026Device Appears to Trigger Rejection

  HEALTHCARE PROFESSIONAL REPORTED ¿CAPSULAR CONTRACTURE BAKER GRADE III¿. THIS RECORD IS FOR THE RIGHT SIDE. DEVICE WAS EXPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 25579230 ↗
• InjuryApr 2, 2026Device Appears to Trigger Rejection; Material Rupture

  HEALTHCARE PROFESSIONAL REPORTED "RUPTURE" AND "CAPSULAR CONTRACTURE BAKER GRADE IV". THIS RECORD IS FOR LEFT SIDE. THE DEVICE REMAINS IMPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 24763123 ↗
• InjuryJul 16, 2025Material Rupture; Material Rupture

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

  Patient problems: Failure of Implant

  MAUDE report 22527119 ↗
• InjuryMay 20, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  HEALTHCARE PROVIDER REPORTED A RIGHT SIDE CAPSULAR CONTRACTURE BAKER GRADE III. HEALTHCARE PROVIDED NOTED THEY PERFORMED A CAPSULECTOMY TO TREAT THE CAPSULAR CONTRACTURE AND THE IMPLANT "LOOKED GOOD" AND DID NOT EXPLANT. THE DEVICE REMAINS IMPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 22055982 ↗
• InjuryApr 17, 2025Device 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 21853098 ↗
• InjuryJun 21, 2023Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  HEALTHCARE PROFESSIONAL CAPSULAR CONTRACTURE, BAKER GRADE III. THE DEVICE HAS BEEN EXPLANTED. THIS RELATES TO THE RIGHT SIDE.

  Patient problems: Capsular Contracture

  MAUDE report 17171643 ↗
• InjuryJun 21, 2023Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

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

  Patient problems: Capsular Contracture

  MAUDE report 17170879 ↗
• InjuryApr 12, 2023Device Appears to Trigger Rejection; Material Rupture; Device Appears to Trigger Rejection; Material Rupture

  HEALTHCARE PROFESSIONAL REPORTED RIGHT SIDE CAPSULAR CONTRACTURE BAKER GRADE III. HEALTHCARE PROFESSIONAL REPORTED RIGHT SIDE DEVICE HAS BEEN EXPLANTED. THE DEVICE WAS DISCOVERED BROKEN UPON EXPLANT.

  Patient problems: Capsular Contracture

  MAUDE report 16728095 ↗
• InjuryMar 13, 2023Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  DEVICE HAS BEEN EXPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 16530662 ↗
• InjuryNov 25, 2022Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  HEALTH CARE PROFESSIONAL REPORTED A LEFT SIDE CAPSULAR CONTRACTURE BAKER GRADE IV. DEVICE REMAINS IMPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 15866225 ↗
• InjuryOct 12, 2022Device 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 15587994 ↗
• InjuryOct 12, 2022Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

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

  Patient problems: Capsular Contracture

  MAUDE report 15587936 ↗
• InjuryFeb 23, 2022Device 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 13586575 ↗
• InjuryFeb 21, 2022Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

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

  Patient problems: Capsular Contracture

  MAUDE report 13573069 ↗
• InjuryJan 21, 2022Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

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

  Patient problems: Capsular Contracture

  MAUDE report 13314393 ↗
• InjuryJan 20, 2022Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

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

  Patient problems: Capsular Contracture

  MAUDE report 13308371 ↗
• InjuryApr 30, 2021Device Appears to Trigger Rejection; Material Rupture; Device Appears to Trigger Rejection; Material Rupture

  HEALTHCARE PROFESSIONAL REPORTED A LEFT SIDE CAPSULAR CONTRACTURE, BAKER GRADE IV, HEMATOMA AND A POSSIBLE RUPTURE. DEVICE HAS BEEN EXPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 11752817 ↗
• InjuryDec 4, 2020Patient-Device Incompatibility; Patient-Device Incompatibility

  DEVICE HAS BEEN EXPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 10949086 ↗
• InjuryAug 31, 2020Patient-Device Incompatibility; Patient-Device Incompatibility

  HEALTHCARE PROFESSIONAL REPORTED LEFT-SIDE CAPSULAR CONTRACTURE, BAKER GRADE III/IV AND "ANY CREASES." DEVICE HAS BEEN EXPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 10472454 ↗
• InjuryDec 27, 2019Patient-Device Incompatibility; Patient-Device Incompatibility

  HEALTHCARE PROFESSIONAL ADDITIONALLY REPORTED ""MALFORMATION DUE TO FOLD IN IMPLANT" AND "CREASE/FOLDING OF IMPLANT."

  Patient problems: Capsular Contracture

  MAUDE report 9526756 ↗

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