NATRELLE Saline-Filled Breast Implants 68-480Recalls & reported problems
Allergan, Inc. · NATRELLE Style 68MP-480 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 implant. Most of the 306 reports describe the implant leaking or deflating, and some mention ruptures or hardening of the scar tissue around it. The reports include 303 injuries and no deaths, and 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
- 322
- Deaths reported
- 0
- Injuries reported
- 319
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 322 adverse event reports that list this exact device (DI 10888628000278), received between Jul 21, 2017 and Sep 30, 2026 — classified as 319 injuries, 3 malfunctions.
The most frequently reported specific device problem is “Fluid/Blood Leak” (284 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 Leak284
- Device Appears to Trigger Rejection28
- Patient-Device Incompatibility13
- No Apparent Adverse Event5
- Adverse Event Without Identified Device or Use Problem3
- Break3
- Malposition of Device3
- Material Rupture3
Patient problems
- Failure of Implant261
- Capsular Contracture39
- No Clinical Signs, Symptoms or Conditions27
- Unspecified Infection3
- Edema1
- Erosion1
- Impaired Healing1
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 25 most recent of 322 reports, in the reporter's own words as published by the FDA.
InjurySep 30, 2026Device Appears to Trigger Rejection
Healthcare professional reported no complaint against the device. Healthcare professional reported "capsular contracture Baker grade IV and micromastia". This record is for the left side. The device has been explanted.
Patient problems: Capsular Contracture
MAUDE report 50949196 ↗InjurySep 29, 2026Malposition of Device; Migration
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50941277 ↗InjurySep 29, 2026Malposition of Device; Migration
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50941092 ↗InjurySep 28, 2026Fluid/Blood Leak
Healthcare professional reported ¿deflation¿. This record is for the right side. Device remains implanted.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50923439 ↗InjurySep 28, 2026Adverse Event Without Identified Device or Use Problem
Patient reported "Hard" and "Infection". This record is for the left side. The device was explanted.
Patient problems: Unspecified Infection
MAUDE report 50915871 ↗InjurySep 24, 2026Fluid/Blood Leak
Patient reported "deflation and pain". Healthcare Professional later reported "deflation". This record is for the left side. Device remains implanted.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50888981 ↗InjurySep 22, 2026Fluid/Blood Leak
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50862478 ↗InjurySep 22, 2026Fluid/Blood Leak
Healthcare professional reported "deflation" and "pain". This record is for the right side. Device remains implanted.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50853494 ↗InjurySep 17, 2026Fluid/Blood Leak
Patient called to report a left side "no complaint against the device". Later, healthcare professional reported "deflation". Device was explanted.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50798771 ↗InjurySep 15, 2026Fluid/Blood Leak
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50782061 ↗InjurySep 15, 2026Fluid/Blood Leak
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50781153 ↗InjuryAug 31, 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 50532849 ↗InjuryAug 28, 2026Fluid/Blood Leak
Healthcare Professional reported "ruptured" and "we ruptured her contralateral for contraction". Later healthcare Professional reported that during mammogram "Implant popped", "spontaneous rupture" and "capsule was normal but quite thin". This record is for the right side. Device has been explanted.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50493931 ↗InjuryAug 27, 2026Fluid/Blood Leak
Healthcare professional reported "Deflation". This record is for the left side. Device was explanted.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50478930 ↗InjuryAug 26, 2026Fluid/Blood Leak
Patient reported "deflation". This record is for the left side. The device was explanted.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50459286 ↗InjuryAug 11, 2026Fluid/Blood Leak
Healthcare Professional reported "deflation". This record is for the left side. The device was explanted.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50211148 ↗InjuryAug 4, 2026Fluid/Blood Leak
Healthcare professional reported "rupture". This record is for the left side. Device remains implanted.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50131908 ↗InjuryJul 31, 2026Break; Fluid/Blood Leak
Healthcare professional reported "Deflation". Later healthcare professional reported "Hole in valve, hole non specific, leaking valve". This record is for the right side. Device has been explanted.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50096464 ↗InjuryJul 27, 2026Fluid/Blood Leak
Healthcare professional reported "deflation". This record is for the right side. Device was explanted.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50046457 ↗InjuryJul 16, 2026Fluid/Blood Leak
HEALTHCARE PROFESSIONAL REPORTED DEFLATION. THIS RECORD IS FOR THE LEFT SIDE. DEVICE WAS EXPLANTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25840692 ↗InjuryJul 16, 2026Fluid/Blood Leak
HEALTHCARE PROFESSIONAL REPORTED DEFLATION. THIS RECORD IS FOR THE RIGHT SIDE. DEVICE WAS EXPLANTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25840665 ↗InjuryJun 3, 2026Fluid/Blood Leak
HEALTHCARE PROFESSIONAL REPORTED "DEFLATED". LATER HEALTHCARE PROFESSIONAL REPORTED PARTICLES IN VALVE. THIS RECORD IS FOR THE RIGHT SIDE. THE DEVICE WAS EXPLANTED.
Patient problems: Failure of Implant
MAUDE report 25386544 ↗InjuryMay 29, 2026Fluid/Blood Leak
Patient reported ¿Deflation¿ and ¿Ripples¿. Later healthcare professional reported ¿deflation¿, ¿bottoming out¿ and ¿lateral displacement¿. This record is for the right side. Device was explanted.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25334006 ↗InjuryMay 29, 2026Device Appears to Trigger Rejection
Patient reported ¿Capsular Contracture Baker grade unknown¿. Later healthcare professional reported ¿exchange with no complaint against device¿. Later healthcare professional reported ¿Capsular Contracture Baker grade III¿. This record is for the left side. Device was explanted.
Patient problems: Capsular Contracture
MAUDE report 25333950 ↗InjuryMay 20, 2026Fluid/Blood Leak
PATIENT REPORTED RIGHT SIDE DEFLATION. LATER PATIENT REPORTED SALINE "RUPTURE". DEVICE REMAINS IMPLANTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25230911 ↗
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-0337-06 · Dec 14, 2005 · TerminatedMcGhan Style 163-360cc Saline-Filled BIOCELL textured Breast Implants, Catalogue Number :163-360
- Z-0336-06 · Dec 14, 2005 · TerminatedMcGhan Style 468-380cc Saline-Filled BIOCELL textured Breast Implants, Catalog Number:468-380
- 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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