NATRELLE Silicone-Filled Breast Implants 115-253Recalls & reported problems

Summary

The FDA's MAUDE database contains 76 adverse event reports that list this exact device (DI 10888628002357), received between May 21, 2019 and Sep 22, 2026 — classified as 76 injuries.

The most frequently reported specific device problem is “Material Rupture” (64 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-2454-2019 · Root cause: Unknown/Undetermined by firm · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 76 reports, in the reporter's own words as published by the FDA.

• InjurySep 22, 2026Material Rupture; Improper or Incorrect Procedure or Method

  Healthcare professional, through distributor, reported "implant rupture". The inner silicone gel came into contact with the patient. This record is for the left side. Device was explanted. Capsulotomy treatment was performed.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50859660 ↗
• InjurySep 14, 2026Material Rupture

  Healthcare professional reported "rupture" and "exchange from textured to smooth implants". This record is for the right side. The device remains implanted.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50755659 ↗
• InjuryJul 10, 2026Material Rupture

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25787534 ↗
• InjuryFeb 10, 2026Device Appears to Trigger Rejection; Material Rupture

  HEALTHCARE PROFESSIONAL LATER REPORTED CAPSULAR CONTRACTURE BAKER GRADE IV.

  Patient problems: Capsular Contracture

  MAUDE report 24305986 ↗
• InjuryFeb 10, 2026Device Appears to Trigger Rejection; No Apparent Adverse Event

  PATIENT REPORTED "CAPSULAR CONTRACTURE BAKER GRADE UNKNOWN". LATER HEALTHCARE PROFESSIONAL REPORTED "EXCHANGE WITH NO COMPLAINT AGAINST THE DEVICE". THIS RECORD IS FOR THE RIGHT SIDE. DEVICE REMAINS IMPLANTED.

  Patient problems: Capsular Contracture; No Clinical Signs, Symptoms or Conditions

  MAUDE report 24304021 ↗
• InjuryFeb 6, 2026Material Rupture

  DEVICE HAS BEEN EXPLANTED AND REPLACED.

  Patient problems: Failure of Implant

  MAUDE report 24283658 ↗
• InjuryFeb 5, 2026Material Rupture

  HEALTHCARE PROFESSIONAL REPORTED THOUGH DISTRIBUTOR "RUPTURE". THIS RECORD IS FOR THE RIGHT SIDE. THE DEVICE WAS EXPLANTED.

  Patient problems: Failure of Implant

  MAUDE report 24270185 ↗
• InjuryFeb 5, 2026Material 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 24268703 ↗
• InjuryJan 20, 2026Material Rupture

  PATIENT REPORTED "POSSIBLY FOLDED, POSSIBLE RUPTURE AND EXCHANGE FROM TEXTURED TO SMOOTH DEVICES DUE TO THE PATIENT'S CONCERN WITH THE PRODUCT". THIS RECORD IS FOR THE LEFT SIDE. THE DEVICE REMAINS IMPLANTED.

  Patient problems: Failure of Implant

  MAUDE report 24124100 ↗
• InjuryJan 15, 2026Material Rupture

  HEALTHCARE PROFESSIONAL THROUGH SALES REPRESENTATIVE REPORTED "RUPTURE". THIS RECORD IS FOR THE RIGHT SIDE. DEVICE WAS EXPLANTED.

  Patient problems: Failure of Implant

  MAUDE report 24086564 ↗
• InjuryJan 14, 2026Material Rupture

  HEALTHCARE PROFESSIONAL THROUGH SALES REPRESENTATIVE REPORTED "RUPTURE". THIS RECORD IS FOR THE LEFT SIDE. DEVICE WAS EXPLANTED AND REPLACED WITH ANOTHER MANUFACTURER'S DEVICE.

  Patient problems: Failure of Implant

  MAUDE report 24076082 ↗
• InjuryJan 9, 2026Material Rupture

  AFFECTED SIDE IS RIGHT.

  Patient problems: Failure of Implant

  MAUDE report 24027477 ↗
• InjuryJan 9, 2026Material Rupture

  AFFECTED SIDE IS LEFT.

  Patient problems: Failure of Implant

  MAUDE report 24027328 ↗
• InjuryDec 24, 2025Material Rupture; Material Rupture

  HEALTHCARE PROFESSIONAL REPORTED "START A BIOCELL WARRANTY" AND "RUPTURE". LATER HEALTHCARE PROFESSIONAL REPORTED "HOLE, NON-SPECIFIC" WHICH IS RELATED TO THE RUPTURE. THIS RECORD IS FOR RIGHT SIDE. THE DEVICE WAS EXPLANTED. DEVICE WILL BE RETURNED.

  Patient problems: Failure of Implant

  MAUDE report 23888212 ↗
• InjuryDec 24, 2025Material Rupture; Material Rupture

  PATIENT REPORTED "START A BIOCELL WARRANTY" AND "RUPTURE". LATER HEALTHCARE PROFESSIONAL REPORTED "HOLE, NON-SPECIFIC" WHICH IS RELATED TO THE RUPTURE. THIS RECORD IS FOR LEFT SIDE. THE DEVICE WAS EXPLANTED. DEVICE WILL BE RETURNED.

  Patient problems: Failure of Implant

  MAUDE report 23888065 ↗
• InjuryNov 14, 2025Material Rupture; Material Rupture

  DEVICE WAS EXPLANTED. DEVICE WILL BE RETURNED.

  Patient problems: Failure of Implant

  MAUDE report 23555498 ↗
• InjuryAug 26, 2025Material Rupture; Material Rupture

  HEALTHCARE PROFESSIONAL REPORTED LEFT SIDE "INTRACAPSULAR RUPTURE". DEVICE HAS BEEN EXPLANTED AND REPLACED WITH ANOTHER MANUFACTURER'S DEVICE.

  Patient problems: Failure of Implant

  MAUDE report 22897238 ↗
• InjuryAug 21, 2025Device Appears to Trigger Rejection; Material Rupture; Device Appears to Trigger Rejection; Material Rupture

  HEALTHCARE PROFESSIONAL REPORTED "INTRACAPSULAR RUPTURE", ¿BENIGN CALCIFICATIONS¿, ¿ASYMMETRICAL BREAST CONTOURS¿, AND ¿POSSIBLE CAPSULAR CONTRACTURE GRADE UNKNOWN¿ DIAGNOSED VIA MRI. THIS RECORD IS FOR THE RIGHT-SIDE. DEVICE HAS BEEN EXPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 22862224 ↗
• InjuryJul 31, 2025Device Appears to Trigger Rejection; Malposition of Device; Device Appears to Trigger Rejection; Malposition of Device

  PATIENT REPORTED LEFT SIDE "BREAST HAS FLIPPED OVER, DEVELOPED A SEROMA, HAD AN INFECTION, PAINFUL, TENDER TO TOUCH, THE APPEARANCE AND FEEL OF IT IS DIFFERENT, THERE'S LUMPS ALL AROUND, A LOT OF INFLAMMATORY AND DISCOMFORT. I ALSO BELIEVE THAT I COULD BE SUFFERING FROM BREAST IMPLANT ILLNESS. SYSTEMICALLY I FEEL FATIGUE, JOINT PAIN MUSCLE PAIN, BRAIN FOG AND COGNITIVE ISSUES WITH HAIR LOSS. MAYBE I HAVE SOME SCAR TISSUE FORMATION OR POSSIBLY A CAPSULAR CONTRACTURE "BAKER UNKNOWN". I HAVE INCREASED, EXTREME FIBROGLANDULAR TISSUE AND PREVIOUS TO THAT, I HAVE GIANT CELLS. IT HAS BEEN PAINFUL, A HARDSHIP AND STRESSFUL, CAUSED ALOT OF SUFFERING". THE DEVICE REMAINS IMPLANTED.

  Patient problems: Cancer; Capsular Contracture; Fatigue; Fluid Discharge; Pain; Seroma; Unspecified Infection; Vomiting

  MAUDE report 22682869 ↗
• InjuryJul 16, 2025Material Rupture; Material Rupture

  PHYSICIAN REPORTED LEFT SIDE RUPTURE AND FLUID COLLECTION. PHYSICIAN LATER REPORTED "HIGH BLOOD PRESSURE AND HEART FAILURE", WHICH IS NOT DEVICE RELATED. DEVICE HAS BEEN EXPLANTED.

  Patient problems: Failure of Implant; Seroma

  MAUDE report 22521761 ↗
• InjuryJul 16, 2025Material Rupture; Material Rupture

  PATIENT WAS THE INITIAL REPORTER WHO PROVIDED A PHYSICIAN DIAGNOSIS OF RUPTURE. HEALTHCARE PROFESSIONAL REPORTED AFTER SURGERY, THE DEVICE WAS DISCARDED ACCORDING TO HOSPITAL REGULATIONS.

  Patient problems: Failure of Implant; Seroma

  MAUDE report 22520181 ↗
• InjuryJul 9, 2025Material Rupture; Material Rupture

  HEALTHCARE PROFESSIONAL REPORTED LEFT SIDE "EXCHANGE FROM A TEXTURED TO SMOOTH BREAST IMPLANT DUE TO THE PATIENT¿S CONCERN WITH THE PRODUCT". HEALTHCARE PROFESSIONAL LATER REPORTED "RUPTURE". THE DEVICE HAS BEEN EXPLANTED AND DISCARDED.

  Patient problems: Failure of Implant

  MAUDE report 22462322 ↗
• InjuryJul 1, 2025Material Rupture; Material Rupture

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

  Patient problems: Failure of Implant

  MAUDE report 22376602 ↗
• InjuryJan 29, 2025Material Rupture; Material Rupture

  PATIENT REPORTED RUPTURE. DEVICE REMAINS IMPLANTED. THIS RELATES TO THE LEFT SIDE.

  Patient problems: Failure of Implant

  MAUDE report 21263062 ↗
• InjuryNov 13, 2024Material Rupture; Material Rupture

  HEALTHCARE PROFESSIONAL REPORTED, VIA CUSTOMER PORTAL LEFT SIDE RUPTURE. DOUBLE CAPSULE, SEROMA, "SCATTERED PAPILLARY GROWTH", "BREAST ENLARGEMENT/PAIN" AND "TEXTURED". DEVICE HAS BEEN EXPLANTED.

  Patient problems: Seroma

  MAUDE report 20678819 ↗

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