NATRELLE Saline-Filled Breast Implants 168-240Recalls & reported problems

Summary

The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 10888628000797), received between Jan 8, 2015 and Aug 10, 2026 — classified as 16 injuries.

The most frequently reported specific device problem is “Fluid/Blood Leak” (10 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 16 most recent of 16 reports, in the reporter's own words as published by the FDA.

• InjuryAug 10, 2026Fluid/Blood Leak

  Healthcare professional reported "deflation". This record is for the left side. Device remains implanted.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50196462 ↗
• InjuryJul 27, 2026Fluid/Blood Leak

  Patient reported "deflation, infection, pain, burning, hot, hard, swollen" and "rippling, very sick, fever and implant exchange". This record is for the left side. The device remains implanted.

  Patient problems: Unspecified Infection

  MAUDE report 50045705 ↗
• InjuryJun 20, 2026Device Appears to Trigger Rejection

  HEALTHCARE PROFESSIONAL REPORTED "EXCHANGE FROM TEXTURED TO SMOOTH DUE TO THE PATIENT¿S CONCERN OF THE IMPLANT". LATER HEALTHCARE PROFESSIONAL REPORTED "CAPSULAR CONTRACTURE BAKER GRADE UNKNOWN, CONTRALATERAL SIDE WORSE THAN THIS SIDE". THIS RECORD IS FOR THE RIGHT SIDE. CAPSULOTOMIE AND CAPSULORRHAPHY WAS PERFORMED AS TREATMENT FOR SYMPTOMS. THIS RECORD IS FOR THE RIGHT SIDE. DEVICE WAS EXPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 25569980 ↗
• InjuryMay 18, 2026Fluid/Blood Leak

  HEALTHCARE PROFESSIONAL REPORTED "IMPLANT REMOVAL FROM TEXTURED TO SMOOTH DUE TO PRODUCT CONCERN." LATER HEALTHCARE PROFESSIONAL REPORTED "DEFLATION". THIS RECORD IS FOR THE LEFT SIDE. DEVICE REMAINS IMPLANTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25202313 ↗
• InjuryDec 22, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

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

  Patient problems: Capsular Contracture

  MAUDE report 23873102 ↗
• InjuryDec 22, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

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

  Patient problems: Capsular Contracture

  MAUDE report 23872999 ↗
• InjuryNov 25, 2025Fluid/Blood Leak; Fluid/Blood Leak

  PATIENT REPORTED "RUPTURE AND IT'S SAGGY". LATER HEALTHCARE PROFESSIONAL REPORTED "DEFLATION". THIS RECORD IS FOR THE LEFT SIDE. DEVICE REMAINS IMPLANTED AND WILL BE RETURNED.

  Patient problems: Failure of Implant

  MAUDE report 23642267 ↗
• InjuryNov 7, 2025Fluid/Blood Leak; Fluid/Blood Leak

  LATER PATIENT REPORTED "EXCHANGE FROM TEXTURED TO SMOOTH DUE TO THE PATIENTS CONCERNS WITH THE PRODUCT". LATER HEALTHCARE PROFESSIONAL REPORTED " DEFLATION" AND " REMOVAL FROM TEXTURED TO SMOOTH DUE TO THE CONCERNS OF THE PRODUCT". DEVICE WAS EXPLANTED AND REPLACED.

  Patient problems: Failure of Implant

  MAUDE report 23502968 ↗
• InjuryNov 7, 2025Fluid/Blood Leak; Device Appears to Trigger Rejection; Fluid/Blood Leak; Device Appears to Trigger Rejection

  HEALTHCARE PROFESSIONAL REPORTED "TEXTURED MAMMARY IMPLANTS", "CAPSULAR CONTRACTURES...BAKER GRADE III", "POSSIBLE LEAKING" AND "BREAST IMPLANT ILLNESS" NOT DEVICE RELATED. THIS RECORD IS FOR THE LEFT SIDE. THE DEVICE WAS EXPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 23498820 ↗
• InjuryNov 6, 2025Fluid/Blood Leak; Device Appears to Trigger Rejection; Fluid/Blood Leak; Device Appears to Trigger Rejection

  HEALTHCARE PROFESSIONAL REPORTED "TEXTURED MAMMARY IMPLANTS", "CAPSULAR CONTRACTURES...BAKER GRADE III", "POSSIBLE LEAKING" AND "BREAST IMPLANT ILLNESS". THIS RECORD IS FOR THE RIGHT SIDE. THE DEVICE WAS EXPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 23486834 ↗
• InjuryJan 12, 2023Fluid/Blood Leak; Fluid/Blood Leak

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

  Patient problems: Failure of Implant

  MAUDE report 16148545 ↗
• InjuryJan 11, 2023Fluid/Blood Leak; Fluid/Blood Leak

  HEALTHCARE PROFESSIONAL REPORTED A LEFT SIDE DEFLATION. THE DEVICE HAS BEEN EXPLANTED AND REPLACED.

  Patient problems: Failure of Implant

  MAUDE report 16137891 ↗
• InjuryJun 24, 2022Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  HEALTHCARE PROFESSIONAL REPORTED UNKNOWN SIDE "FIBROUS CAPSULE +++ AND A LOT OF PLEATING [¿]NOTICED THAT THERE WERE TEXTURED IMPLANTS AND THE PRESENCE OF FLUID BETWEEN THE IMPLANTS". DEVICE HAS BEEN EXPLANTED. ¿PATHOLOGICAL MARKERS CONFIRMING ALCL HAVE NOT BEEN RECEIVED.¿

  Patient problems: Capsular Contracture; Lymphoma; Seroma

  MAUDE report 14799440 ↗
• InjuryJun 23, 2022Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  HEALTHCARE PROFESSIONAL REPORTED "INITIALLY IT WAS OPERATED FOR A FIBROUS CAPSULE, AND A LOT OF PLEATING. [HEALTHCARE PROFESSIONAL] NOTICED THAT THERE WERE TEXTURED IMPLANTS AND THE PRESENCE OF FLUID BETWEEN THE IMPLANTS AND THE CAPSULE THEY DECIDED TO REMOVE THEM AND SEND THE LIQUID IN PATHO FOR A CD30;" PATHOLOGY HAS NOT BEEN RECEIVED. THE SIDE OF THIS COMPLAINT IS UNKNOWN. THE DEVICE HAS BEEN EXPLANTED.

  Patient problems: Capsular Contracture; Seroma

  MAUDE report 14793048 ↗
• InjuryNov 9, 2020Fluid/Blood Leak; Fluid/Blood Leak

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

  Patient problems: Failure of Implant

  MAUDE report 10809550 ↗
• InjuryJan 8, 2015Patient-Device Incompatibility; Appropriate Device Problem Term/Code Not Available

  HEALTHCARE PROFESSIONAL REPORTED A LEFT SIDE SALINE IMPLANT INFLATION, STATING "THERE WAS A HOLE IN IT, " AND "INSTEAD OF LEAKING FLUID OUT, IT SUCKED IN". THE REPORTER INDICATED THERE WAS "VALVE FAILURE ON THE LEFT SIDE," AND THE DEVICE "MAYBE STARTED AT 200 SOMETHING ML, SO IT DOUBLED IN SIZE" (TO 450 ML). THE TYPE OF SALINE USED IS UNK.

  Patient problems: Capsular Contracture; No Information

  MAUDE report 4407111 ↗

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-0337-06 · Dec 14, 2005 · Terminated
  McGhan Style 163-360cc Saline-Filled BIOCELL textured Breast Implants, Catalogue Number :163-360
• Z-0336-06 · Dec 14, 2005 · Terminated
  McGhan Style 468-380cc Saline-Filled BIOCELL textured Breast Implants, Catalog Number:468-380
• Z-0851-05 · May 5, 2005 · Terminated
  Style 363 Saline-Filled BIOCELL textured Breast Implants