Natrelle Inspira SoftTouch Breast Implants TSF-295Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 10888628034105), received between May 12, 2020 and Aug 9, 2026 — classified as 10 injuries.

The most frequently reported specific device problem is “Material Rupture” (7 reports).

1 FDA recall record name this device's identifier, 1 still open.

3 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.

Recalls naming this device

1. Jul 24, 2019Class IOpen, Classified

   The action was initiated following notification by the U.S. FDA of their recently updated, global safety information concerning the higher incidence of anaplastic large cell lymphoma (BIA-ALCL) in patients who have textured breast implants.

   Z-2453-2019 · Root cause: Unknown/Undetermined by firm · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• InjuryAug 9, 2026Adverse Event Without Identified Device or Use Problem

  Patient's representative reported left side "Palpable nodule in axillary extension." determined as Not Device Related, "Breast with predominantly heterogeneous tissue pattern, with morphostructural changes related to previous mammoplasty." "Small cysts sparse in the breast, measuring up to 0.9 cm."(Which is Not Device Related) "Accessory axillary breast, corresponding to the palpable nodule reported by the patient." "The first for prosthesis explanting, a block explant of the capsule as there was fluid leakage in the patient's body", "It was informed that the prostheses caused the patient suffering. It was informed That the addiction of the product has brought you incalculable losses and may bring even greater and irreversible." "It was reported that it is like a "time bomb" "[as reported]" that could at any moment burst. "In the case of the patient, it literally burst." "[as reported]". It was informed that the prosthesis shows clear signs of product defect" " since it presents intense pain and constant swelling,". The device remains implanted.

  Patient problems: Seroma

  MAUDE report 50189010 ↗
• InjuryJul 28, 2026Device Appears to Trigger Rejection

  Patient representative reported "replace breast prostheses due to the recall", "pain", "capsular contracture Baker Grade III". Patient's representative later reported "swelling", "circumscribed oval hypoechoic nodule at the junction of the lateral quadrants of the left breast at 3 o'clock" which is not device related. Later Patient representative reported "contracture of the prosthesis, as well as folding of the elastomer against the implant", "breast pain, which was accompanied by deformity of the prosthesis and local inflammation", "learned that there was a link between the implanted silicone and a rare type of cancer", "insecurity, panic, fibromyalgia which is not device related, and depression". This record is for the left side. Device has been explanted.

  Patient problems: Capsular Contracture; Depression

  MAUDE report 50059734 ↗
• InjuryJun 16, 2026Device Appears to Trigger Rejection; Material Rupture

  Healthcare professional reported "ruptured and encapsulated", Capsular Contracture Baker Grade IV, "periprosthetic effusion", "significant increase in volume which increases every day", "tense seroma", "destroyed", "disruption of the prosthetic capsule", "foreign body type giant cell granuloma against silicone and xanthomatous inflammation". This record is for the right side. The device was explanted.

  Patient problems: Capsular Contracture; Seroma

  MAUDE report 25522469 ↗
• InjuryJul 14, 2025Material Rupture; Material Rupture

  HEALTHCARE PROFESSIONAL REPORTED "RUPTURE". THIS IS FOR THE LEFT SIDE. DEVICE WAS EXPLANTED AND NOT REPLACED.

  Patient problems: Failure of Implant

  MAUDE report 22498413 ↗
• InjuryOct 18, 2023Material Rupture; Material Rupture

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

  Patient problems: Failure of Implant

  MAUDE report 17960422 ↗
• InjuryJun 27, 2022Material Rupture; Material Rupture

  HEALTHCARE PROFESSIONAL REPORTED AGAINST LEFT SIDE "PAIN" AND RUPTURE CONFIRMED VIA ULTRASOUND AND DURING EXPLANT SURGERY. DEVICE HAS BEEN EXPLANTED.

  Patient problems: Failure of Implant

  MAUDE report 14830897 ↗
• InjuryJan 18, 2022Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

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

  Patient problems: Capsular Contracture

  MAUDE report 13282560 ↗
• InjuryMay 18, 2021Material Rupture; Material Rupture

  PHYSICIAN REPORTED RUPTURES DIAGNOSED BY ULTRASOUND. DEVICE REMAINS IMPLANTED.

  Patient problems: Failure of Implant

  MAUDE report 11845249 ↗
• InjuryMay 18, 2021Material Rupture; Material Rupture

  PHYSICIAN REPORTED RUPTURES DIAGNOSED BY ULTRASOUND. DEVICE REMAINS IMPLANTED.

  Patient problems: Failure of Implant

  MAUDE report 11845184 ↗
• InjuryMay 12, 2020Material Rupture; Material Rupture

  PATIENT REPORTED ¿SWELLING AND LIQUID AROUND THE IMPLANT¿. PATIENT REPRESENTATIVE REPORTED THAT THE PATIENT IS "VERY CONCERNED." HEALTHCARE PROFESSIONAL REPORTED ¿PAIN, EDEMA AND YELLOWISH DISCHARGE FROM LEFT BREAST, ¿DISCONTINUITY OF SKIN IN THE BREAST¿, ¿RELAPSING SEROMA¿, POSSIBLE RUPTURE, CHRONIC AND ACUTE INFLAMMATORY PROCESS WITH GRANULOMATOUS ELEMENT ASSOCIATED TO FIBROSIS IN THE SAMPLE¿, AND THE PATIENT PERFORMED A DECOMPRESSION PUNCTURE, DRAINED THE BREAST OUT OF NECESSITY (DUE TO THE LARGE VOLUME IN THE BREAST), IN ADDITION TO THE SEROMA BEING ¿TRYING TO GET OUT OF THE SCAR¿. THE DEVICE REMAINS IMPLANTED.

  Patient problems: Fistula; Granuloma; Inflammation; Necrosis; Seroma

  MAUDE report 10049576 ↗

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-