NATRELLE Saline-Filled Breast Implants 168-450Recalls & reported problems

Summary

The FDA's MAUDE database contains 23 adverse event reports that list this exact device (DI 10888628000865), received between Aug 15, 2017 and Aug 25, 2026 — classified as 22 injuries, 1 malfunction.

The most frequently reported specific device problem is “Fluid/Blood Leak” (20 reports).

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

4 other recalls cover devices cleared under the same FDA submission (P990074); 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-2451-2019 · Root cause: Unknown/Undetermined by firm · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 23 most recent of 23 reports, in the reporter's own words as published by the FDA.

• InjuryAug 25, 2026Fluid/Blood Leak

  Healthcare professional reported "deflation". Later healthcare professional reported "rupture", "significant calcification" and "scar capsule". This record is for the left side. Device has been explanted. Patient underwent a capsulectomy.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50434837 ↗
• InjuryJun 9, 2026Device Appears to Trigger Rejection

  Patient reported "ache and shoots sharp pain underneath it which started about a year ago", "so hard and filled" and "exchange of textured devices due to patient's concern with product". Later Healthcare Professional reported "Capsular Contracture, Baker Grade IV". Later Healthcare Professional reported "Capsular Contracture", "cut implant on on inferior edge" and "valve intact". This record is for the left side. Device has been explanted.

  Patient problems: Capsular Contracture

  MAUDE report 25440173 ↗
• InjuryApr 3, 2026Fluid/Blood Leak

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

  Patient problems: Failure of Implant

  MAUDE report 24781731 ↗
• InjuryJan 21, 2026Fluid/Blood Leak

  HEALTHCARE PROFESSIONAL REPORTED "DEFLATION" AND "EXCHANGE FROM TEXTURED TO SMOOTH BREAST IMPLANTS DUE TO THE PATIENT¿S CONCERN WITH THE PRODUCT". THIS RECORD IS FOR THE LEFT SIDE. THE DEVICE HAS BEEN EXPLANTED.

  Patient problems: Failure of Implant

  MAUDE report 24131580 ↗
• InjuryJan 5, 2026Fluid/Blood Leak

  PATIENT REPORTED "DEFLATION" AND "IMPLANT IS STARTING TO LEAK". HEALTHCARE PROFESSIONAL LATER REPORTED "RECALLED". THIS RECORD IS FOR THE LEFT SIDE. THE DEVICE REMAINS IMPLANTED. THE DEVICE WILL BE RETURNED.

  Patient problems: Failure of Implant

  MAUDE report 23960051 ↗
• InjuryDec 5, 2025Fluid/Blood Leak; Device Appears to Trigger Rejection; Fluid/Blood Leak; Device Appears to Trigger Rejection

  HEALTHCARE PROFESSIONAL REPORTED "DEFLATION". LATER HEALTHCARE PROFESSIONAL REPORTED "CAPSULE". THIS RECORD IS FOR THE RIGHT SIDE. DEVICE WAS EXPLANTED AND REPLACED.

  Patient problems: Capsular Contracture

  MAUDE report 23728241 ↗
• InjuryNov 5, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  PATIENT REPORTED "CAPSULAR CONTRACTURE BAKER GRADE UNKNOWN WITH 'BURNING FEELING', 'SAGGING' AND 'DROOPING'". PATIENT THEN REPORTED "I FOUND OUT THEY WERE RECALLED BIOCELL IMPLANTS." THIS RECORD IS FOR THE LEFT SIDE. DEVICE REMAINS IMPLANTED. DEVICE WILL BE RETURNED.

  Patient problems: Capsular Contracture

  MAUDE report 23478323 ↗
• InjuryJun 26, 2025Fluid/Blood Leak; Fluid/Blood Leak

  HEALTHCARE PROFESSIONAL REPORTED "SPONTANEOUS DEFLATION". THIS RECORD IS FOR THE RIGHT SIDE. DEVICE REMAINS IMPLANTED.

  Patient problems: Failure of Implant

  MAUDE report 22336922 ↗
• InjuryApr 29, 2025Fluid/Blood Leak; Fluid/Blood Leak

  HEALTHCARE PROFESSIONAL REPORTED LEFT SIDE EXCHANGE FROM TEXTURE TO SMOOTH IMPLANT DUE TO THE PATIENT'S CONCERNS WITH THE PRODUCT AND DEFLATION. DEVICE HAS BEEN EXPLANTED.

  Patient problems: Failure of Implant

  MAUDE report 21923670 ↗
• InjuryJul 25, 2023Fluid/Blood Leak; Fluid/Blood Leak

  PATIENT REPORTED LEFT SIDE DEFLATION. DEVICE HAS BEEN EXPLANTED.

  Patient problems: Failure of Implant

  MAUDE report 17390854 ↗
• InjuryJun 29, 2023Fluid/Blood Leak; Fluid/Blood Leak

  PREVIOUS MEDWATCH SUBMITTED STATED DEVICE WAS EXPLANTED. UPON FURTHER REVIEW, ABBVIE HAS DETERMINED THAT THE DEVICE REMAINS IMPLANTED. EXPLANT DATE PROVIDED WAS A FUTURE DATE AND COMPLETION OF SURGERY WAS NOT CONFIRMED. HEALTHCARE PROFESSIONAL LATER REPORTED THAT EXPLANT SURGERY WAS CANCELED "DUE TO PATIENT PASSING AWAY". A FOCUSED MEDICAL REVIEW WAS COMPLETED AND ABBVIE HAS DETERMINED THAT THE EVENT OF DEATH IS CATASTROPHIC AND NOT DEVICE RELATED.

  Patient problems: Failure of Implant

  MAUDE report 17224822 ↗
• InjuryApr 20, 2023Fluid/Blood Leak; Fluid/Blood Leak

  HEALTHCARE PROFESSIONAL REPORTED DEFLATION. THE DEVICE REMAINS IMPLANTED. THIS RELATES TO THE LEFT SIDE.

  Patient problems: Failure of Implant

  MAUDE report 16777577 ↗
• InjuryApr 4, 2023Fluid/Blood Leak; Fluid/Blood Leak

  HEALTHCARE PROFESSIONAL REPORTED LEFT SIDE DEFLATION. DEVICE REMAINS IMPLANTED.

  Patient problems: Failure of Implant

  MAUDE report 16677860 ↗
• InjuryOct 1, 2021Fluid/Blood Leak; Fluid/Blood Leak

  HEALTHCARE PROFESSIONAL REPORTED LEFT SIDE DEFLATION. DEVICE HAS BEEN EXPLANTED.

  Patient problems: Failure of Implant

  MAUDE report 12561846 ↗
• InjurySep 9, 2021Fluid/Blood Leak; Fluid/Blood Leak

  HEALTHCARE PROFESSIONAL REPORTED LEFT SIDE DEFLATION. DEVICE WAS EXPLANTED.

  Patient problems: Failure of Implant

  MAUDE report 12446527 ↗
• InjuryJul 20, 2021Fluid/Blood Leak; Fluid/Blood Leak

  DEVICE HAS BEEN EXPLANTED.

  Patient problems: Failure of Implant

  MAUDE report 12197079 ↗
• InjuryApr 8, 2021Fluid/Blood Leak; Fluid/Blood Leak

  HEALTHCARE PROFESSIONAL ADDITIONALLY REPORTED RIGHT SIDE "TEXTURED IMPLANTS. DEVICE HAS BEE EXPLANTED.

  Patient problems: Failure of Implant

  MAUDE report 11634147 ↗
• InjuryDec 13, 2019Fluid/Blood Leak; Fluid/Blood Leak

  HEALTHCARE PROFESSIONAL REPORTED A RIGHT SIDE DEFLATION. DEVICE HAS BEEN EXPECTED.

  Patient problems: Failure of Implant

  MAUDE report 9467332 ↗
• InjuryJun 11, 2018Fluid/Blood Leak; Fluid/Blood Leak

  HEALTHCARE PROFESSIONAL REPORTED A LEFT SIDE DEFLATION. DEVICE WAS EXPLANTED.

  Patient problems: Failure of Implant

  MAUDE report 7589401 ↗
• MalfunctionMay 8, 2018Break; Break

  HEALTHCARE PROFESSIONAL REPORTED "FLUID COMING OUT" OF DEVICE UPON INSERTION AND THE DEVICE "WAS FOUND WITH A TEAR IN IT." THE DEVICE MADE CONTACT WITH THE PATIENT. SURGERY WAS COMPLETED WITH A BACK-UP DEVICE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7495264 ↗
• InjuryApr 17, 2018Fluid/Blood Leak; Fluid/Blood Leak

  PATIENT REPORTED POSSIBLE RIGHT SIDE DEFLATION. THE DEVICE REMAINS IMPLANTED.

  Patient problems: Failure of Implant

  MAUDE report 7437068 ↗
• InjuryOct 27, 2017Fluid/Blood Leak; Fluid/Blood Leak

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

  Patient problems: Failure of Implant

  MAUDE report 6983429 ↗
• InjuryAug 15, 2017Fluid/Blood Leak; Fluid/Blood Leak

  PHYSICIAN REPORTED RIGHT SIDE DEFLATION AND THAT THE SIDE IS "GROSSLY DEFORMED." DEVICE HAS BEEN EXPLANTED.

  Patient problems: Failure of Implant; No Code Available

  MAUDE report 6795831 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under P990074. One submission often covers many models, so check the product and lot details in each record.

• Z-0699-2020 · Nov 6, 2019 · Terminated
  Natrelle Saline-Filled Breast Implant, for the following Styles and sizes, Style LP, Style 68 HP, Style 68 MP, Style LP/UDI: NATRELLE Style 68LP-125 Saline Round Low 108886280
• Z-0336-06 · Dec 14, 2005 · Terminated
  McGhan Style 468-380cc Saline-Filled BIOCELL textured Breast Implants, Catalog Number:468-380
• Z-0337-06 · Dec 14, 2005 · Terminated
  McGhan Style 163-360cc Saline-Filled BIOCELL textured Breast Implants, Catalogue Number :163-360
• Z-0851-05 · May 5, 2005 · Terminated
  Style 363 Saline-Filled BIOCELL textured Breast Implants