NATRELLE Saline-Filled Breast Implants 68-550Recalls & reported problems
Allergan, Inc. · NATRELLE Style 68MP-550 Moderate Projection |smooth|round|saline · Class 3 · Implant
All models of Natrelle Breast Implants (1167) · NATRELLE Saline-Filled Breast Implants (103)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This Allergan NATRELLE saline-filled breast implant is a breast prosthesis. The 228 reports mostly describe implants that leak fluid or deflate, with some reporting hardened scar tissue forming around the implant. The reports include 228 injuries and no deaths. No recalls name this device.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 235
- Deaths reported
- 0
- Injuries reported
- 235
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 235 adverse event reports that list this exact device (DI 10888628000292), received between Aug 30, 2017 and Sep 18, 2026 — classified as 235 injuries.
The most frequently reported specific device problem is “Fluid/Blood Leak” (206 reports).
5 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.
Reports received per month
Most reported problems
Device problems
- Fluid/Blood Leak206
- Device Appears to Trigger Rejection20
- Patient-Device Incompatibility13
- Material Rupture3
- Adverse Event Without Identified Device or Use Problem2
- Deflation Problem2
- Improper or Incorrect Procedure or Method2
- No Apparent Adverse Event2
Patient problems
- Failure of Implant187
- Capsular Contracture33
- No Clinical Signs, Symptoms or Conditions14
- Unspecified Infection3
- Abscess1
- Cellulitis1
- Necrosis1
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 25 most recent of 235 reports, in the reporter's own words as published by the FDA.
InjurySep 18, 2026Fluid/Blood Leak
Healthcare professional reported "deflation". This record is for the right side. The device remains implanted.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50816092 ↗InjurySep 16, 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 50790425 ↗InjuryAug 21, 2026Fluid/Blood Leak
Healthcare professional did not report any complaint against the device. Later healthcare professional reported "deflation". This record is for the right side. Device was explanted.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50382908 ↗InjuryAug 4, 2026Fluid/Blood Leak
Healthcare professional reported "deflation". This record is for the right side. The device was explanted.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50136572 ↗InjuryJul 27, 2026Fluid/Blood Leak
InjuryJul 7, 2026Fluid/Blood Leak
HEALTHCARE PROFESSIONAL REPORTED "DEFLATION, COLLAPSE, AND FLAT". THIS RECORD IS FOR THE LEFT SIDE. DEVICE WAS EXPLANTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25738481 ↗InjuryJul 1, 2026Fluid/Blood Leak
PATIENT REPORTED "DEFLATION" AND "TRAUMA PRIOR TO THE DEFLATION". THIS RECORD IS FOR THE LEFT SIDE. THE DEVICE WAS EXPLANTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25681555 ↗InjuryJun 12, 2026Fluid/Blood Leak
PATIENT REPORTED ¿RIGHT SIDE RIPPLING AND DEFLATION¿. HEALTHCARE PROFESSIONAL LATER REPORTED "DEFLATION". DEVICE HAS BEEN EXPLANTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25487798 ↗InjuryJun 4, 2026Fluid/Blood Leak
PATIENT REPORTED ¿DEFLATION¿. LATER HEALTHCARE PROFESSIONAL REPORTED "DEFLATION". THIS RECORD IS FOR THE RIGHT SIDE. DEVICE REMAINS IMPLANTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25402551 ↗InjuryApr 20, 2026Fluid/Blood Leak
PATIENT REPORTED "DEFLATION". THIS RECORD IS FOR THE LEFT SIDE. DEVICE REMAINS IMPLANTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24933012 ↗InjuryApr 20, 2026Fluid/Blood Leak
PATIENT REPORTED "DEFLATION". THIS RECORD IS FOR THE RIGHT SIDE. DEVICE REMAINS IMPLANTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24932993 ↗InjuryApr 3, 2026Fluid/Blood Leak
HEALTHCARE PROFESSIONAL REPORTED ¿SALINE RUPTURE¿. THIS RECORD IS FOR THE RIGHT SIDE. DEVICE REMAINS IMPLANTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24777381 ↗InjuryFeb 10, 2026Fluid/Blood Leak
HEALTHCARE PROFESSIONAL REPORTED "DEFLATION". THIS RECORD IS FOR THE RIGHT SIDE. THE DEVICE WAS EXPLANTED.
Patient problems: Failure of Implant
MAUDE report 24307996 ↗InjuryJan 9, 2026Fluid/Blood Leak
HEALTHCARE PROFESSIONAL REPORTED ¿RUPTURED/DEFLATION¿. THIS RECORD IS FOR THE LEFT SIDE. DEVICE WAS EXPLANTED.
Patient problems: Failure of Implant
MAUDE report 24030661 ↗InjuryJan 8, 2026Fluid/Blood Leak
HEALTHCARE PROFESSIONAL REPORTED "RUPTURE FOR A SALINE DEVICE". THIS RECORD IS FOR THE RIGHT SIDE. DEVICE WAS EXPLANTED.
Patient problems: Failure of Implant
MAUDE report 24014949 ↗InjuryDec 10, 2025Fluid/Blood Leak; Fluid/Blood Leak
HEALTHCARE PROFESSIONAL REPORTED "DEFLATION". THIS RECORD IS FOR THE RIGHT SIDE. THE DEVICE WAS EXPLANTED AND IT WILL BE RETURNED.
Patient problems: Failure of Implant
MAUDE report 23767797 ↗InjuryDec 9, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED "CAPSULAR CONTRACTURE BAKER GRADE III". THIS RECORD IS FOR THE LEFT SIDE. DEVICE REMAINS IMPLANTED AND IT WILL BE RETURNED.
Patient problems: Capsular Contracture
MAUDE report 23761085 ↗InjuryDec 8, 2025Fluid/Blood Leak; Fluid/Blood Leak
PATIENT REPORTED REPORTED ¿EXCHANGE WITH NO COMPLAINT AGAINST THE DEVICE¿ AND LATER HEALTHCARE PROFESSIONAL REPORTED ¿DEFLATION¿. THIS RECORD IS FOR THE LEFT-SIDE. DEVICE HAS BEEN EXPLANTED AND REPLACED.
Patient problems: Failure of Implant
MAUDE report 23743966 ↗InjuryNov 6, 2025Fluid/Blood Leak; Fluid/Blood Leak
PATIENT REPORTED "DEFLATION" THIS RECORD IS FOR LEFT SIDE. THE DEVICE REMAINS IMPLANTED.
Patient problems: Failure of Implant
MAUDE report 23486757 ↗InjuryOct 27, 2025Fluid/Blood Leak; Fluid/Blood Leak
HEALTHCARE PROFESSIONAL REPORTED "DEFLATION". THIS RECORD IS FOR THE RIGHT SIDE. THE DEVICE HAS BEEN EXPLANTED.
Patient problems: Failure of Implant
MAUDE report 23391927 ↗InjuryOct 23, 2025Fluid/Blood Leak; Fluid/Blood Leak
PATIENT REPORTED "RUPTURE". THIS RECORD IS FOR THE RIGHT SIDE. DEVICE REMAINS IMPLANTED.
Patient problems: Failure of Implant
MAUDE report 23369997 ↗InjurySep 29, 2025Fluid/Blood Leak; Fluid/Blood Leak
PATIENT REPORTED "DEFLATION, PAIN, STAPH INFECTIONS, CONCERNS WITH THE RECALLED PRODUCT, BREAST IMPLANT ILLNESS IMPLANT EXCHANGE". THIS RECORD IS FOR THE LEFT -SIDE. DEVICE REMAINS IMPLANTED.
Patient problems: Unspecified Infection
MAUDE report 23176418 ↗InjurySep 3, 2025Fluid/Blood Leak; Fluid/Blood Leak
InjuryAug 12, 2025Fluid/Blood Leak; Fluid/Blood Leak
HEALTHCARE PROFESSIONAL REPORTED DEVICE IS "LEAKING, IT´S A DEFLATION". THIS RECORD IS FOR THE LEFT SIDE. DEVICE REMAINS IMPLANTED.
Patient problems: Failure of Implant
MAUDE report 22787544 ↗InjuryAug 4, 2025Fluid/Blood Leak; Fluid/Blood Leak
HEALTHCARE PROFESSIONAL REPORTED DEFLATION. THIS RECORD IS FOR THE LEFT SIDE. DEVICE REMAINS IMPLANTED.
Patient problems: Failure of Implant
MAUDE report 22710372 ↗
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 · TerminatedNatrelle 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-2451-2019 · Jul 24, 2019 · Open, ClassifiedNatrelle, Saline-Filled Breast Implant Biocell Full Height with Fill Tube, Sterile, for the following style numbers: Style 163:163-360CC, 163-440CC, 163-530CC, 163-655CC, 163-7
- Z-0336-06 · Dec 14, 2005 · TerminatedMcGhan Style 468-380cc Saline-Filled BIOCELL textured Breast Implants, Catalog Number:468-380
- Z-0337-06 · Dec 14, 2005 · TerminatedMcGhan Style 163-360cc Saline-Filled BIOCELL textured Breast Implants, Catalogue Number :163-360
- Z-0851-05 · May 5, 2005 · TerminatedStyle 363 Saline-Filled BIOCELL textured Breast Implants
Other Prosthesis, Breast, Inflatable, Internal, Saline devices
- MENTOR Smooth Round Moderate Profile 3501650Mentor Texas L.P. · Prosthesis, breast, inflatable, internal, saline2,187 reports
- MENTOR Smooth Round Moderate Profile 3501660Mentor Texas L.P. · Prosthesis, breast, inflatable, internal, saline1,972 reports
- MENTOR Smooth Round Moderate Profile 3501670Mentor Texas L.P. · Prosthesis, breast, inflatable, internal, saline1,899 reports
- MENTOR Smooth Round Moderate Profile 3501645Mentor Texas L.P. · Prosthesis, breast, inflatable, internal, saline1,655 reports
- MENTOR Smooth Round Moderate Profile 3501655Mentor Texas L.P. · Prosthesis, breast, inflatable, internal, saline1,534 reports
- MENTOR Smooth Round Moderate Profile 3501640Mentor Texas L.P. · Prosthesis, breast, inflatable, internal, saline1,294 reports
- MENTOR Smooth Round Moderate Profile 3501680Mentor Texas L.P. · Prosthesis, breast, inflatable, internal, saline1,095 reports
- MENTOR Smooth Round Moderate Profile 3501635Mentor Texas L.P. · Prosthesis, breast, inflatable, internal, saline864 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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