NATRELLE Saline-Filled Breast Implants 68LP-480Recalls & reported problems
Allergan, Inc. · NATRELLE Style 68LP-480 Low 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 breast implant is a smooth, round implant filled with saline. The 24 reports mostly describe the implant leaking, deflating, or rupturing, sometimes with breast discomfort or shape changes and removal or replacement. There were 24 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
- 25
- Deaths reported
- 0
- Injuries reported
- 25
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 25 adverse event reports that list this exact device (DI 10888628000643), received between Jul 19, 2018 and Jun 9, 2026 — classified as 25 injuries.
The most frequently reported specific device problem is “Fluid/Blood Leak” (24 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 Leak24
- Adverse Event Without Identified Device or Use Problem1
- Deflation Problem1
Patient problems
- Failure of Implant22
- No Clinical Signs, Symptoms or Conditions2
- Unspecified Infection1
Recent adverse event reports
The 25 most recent of 25 reports, in the reporter's own words as published by the FDA.
InjuryJun 9, 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 25451224 ↗InjuryJun 2, 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 25362234 ↗InjuryMar 28, 2025Fluid/Blood Leak; Fluid/Blood Leak
HEALTHCARE PROFESSIONAL REPORTED A LEFT SIDE "PATIENT WAS WORKING OUT AND FELT A POP IN HER LEFT BREAST. PATIENT IS NOW HAVING SOME DISCOMFORT AND ABNORMAL SHAPE OF LEFT BREAST" AND " LEFT SALINE BREAST IMPLANT RUPTURE". DEVICE HAS BEEN EXPLANTED.
Patient problems: Failure of Implant
MAUDE report 21725257 ↗InjuryJun 7, 2024Fluid/Blood Leak; Fluid/Blood Leak
PHYSICIAN LATER REPORTED "ANY CREASES" AND "HOLE ON VALVE SIDE."
Patient problems: Failure of Implant
MAUDE report 19489584 ↗InjuryJun 26, 2023Fluid/Blood Leak; Fluid/Blood Leak
HEALTHCARE PROFESSIONAL REPORTED NO COMPLAINT AGAINST LEFT DEVICE, THEN LATER LEFT DEFLATION. DEVICE REMAINS IMPLANTED.
Patient problems: Failure of Implant
MAUDE report 17205272 ↗InjuryJun 22, 2023Fluid/Blood Leak; Fluid/Blood Leak
HEALTHCARE PROFESSIONAL REPORTED LEFT SIDE DEFLATION. DEVICE HAS BEEN EXPLANTED AND REPLACED.
Patient problems: Failure of Implant
MAUDE report 17184129 ↗InjuryFeb 1, 2023Fluid/Blood Leak; Fluid/Blood Leak
HEALTHCARE PROFESSIONAL REPORTED "A RIGHT SIDE DEFLATION." THE DEVICE HAS BEEN EXPLANTED AND REPLACED.
Patient problems: Failure of Implant
MAUDE report 16280645 ↗InjuryJan 25, 2023Fluid/Blood Leak; Fluid/Blood Leak
HEALTHCARE PROFESSIONAL REPORTED LEFT SIDE DEFLATION. DEVICE REMAINS IMPLANTED.
Patient problems: Failure of Implant
MAUDE report 16241406 ↗InjuryJan 5, 2023Fluid/Blood Leak; Fluid/Blood Leak
HEALTHCARE PROFESSIONAL REPORTED RIGHT SIDE DEFLATION. DEVICE REMAINS IMPLANTED.
Patient problems: Failure of Implant
MAUDE report 16109453 ↗InjuryNov 10, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
HEALTHCARE PROFESSIONAL REPORTED RIGHT SIDE "INFECTION". DEVICE HAS BEEN EXPLANTED AND REPLACED.
Patient problems: Unspecified Infection
MAUDE report 15770865 ↗InjuryNov 8, 2022Fluid/Blood Leak; Fluid/Blood Leak
HEALTHCARE PROFESSIONAL REPORTED LEFT SIDE DEFLATION. THE DEVICE WAS EXPLANTED.
Patient problems: Failure of Implant
MAUDE report 15756559 ↗InjuryJul 20, 2022Fluid/Blood Leak; Fluid/Blood Leak
HEALTHCARE PROFESSIONAL REPORTED RIGHT SIDE DEFLATION. DEVICE HAS BEEN EXPLANTED.
Patient problems: Failure of Implant
MAUDE report 15070509 ↗InjuryJun 28, 2022Fluid/Blood Leak; Fluid/Blood Leak
COMPANY REPRESENTATIVE REPORTED A RIGHT SIDE RUPTURE AGAINST A SALINE DEVICE (DEFLATION). THE DEVICE REMAINS IMPLANTED.
Patient problems: Failure of Implant
MAUDE report 14846349 ↗InjuryMar 4, 2022Fluid/Blood Leak; Fluid/Blood Leak
HEALTHCARE PROFESSIONAL REPORTED RIGHT SIDE RUPTURE. DEVICE HAS BEEN EXPLANTED.
Patient problems: Failure of Implant
MAUDE report 13668625 ↗InjuryNov 11, 2021Fluid/Blood Leak; Fluid/Blood Leak
HEALTHCARE PROFESSIONAL REPORTED LEFT SIDE DEFLATION. DEVICE REMAINS IMPLANTED.
Patient problems: Failure of Implant
MAUDE report 12797022 ↗InjuryJun 25, 2021Fluid/Blood Leak; Fluid/Blood Leak
InjuryFeb 5, 2021Deflation Problem; Fluid/Blood Leak; Deflation Problem; Fluid/Blood Leak
InjuryFeb 3, 2021Fluid/Blood Leak; Fluid/Blood Leak
InjuryOct 11, 2020Fluid/Blood Leak; Fluid/Blood Leak
InjuryJun 18, 2020Fluid/Blood Leak; Fluid/Blood Leak
HEALTHCARE PROFESSIONAL REPORTED A RIGHT SIDE DEFLATION. DEVICE REMAINS IMPLANTED.
Patient problems: Failure of Implant
MAUDE report 10169435 ↗InjuryJul 5, 2019Fluid/Blood Leak; Fluid/Blood Leak
ADDITIONALLY, HEALTHCARE PROFESSIONAL REPORTED "ANY CREASES" AND "ANY CREASES ASSOCIATED WITH HOLE" AS NOTED ON RGA.
Patient problems: Failure of Implant
MAUDE report 8763770 ↗InjuryMay 29, 2019Fluid/Blood Leak; Fluid/Blood Leak
HEALTHCARE PROFESSIONAL REPORTED A LEFT SIDE DEFLATION. DEVICE HAS BEEN EXPLANTED.
Patient problems: Failure of Implant
MAUDE report 8650593 ↗InjuryJan 2, 2019Fluid/Blood Leak; Fluid/Blood Leak
HEALTH PROFESSIONAL REPORTED LEFT SIDE DEFLATION. DEVICE WAS EXPLANTED.
Patient problems: Failure of Implant
MAUDE report 8209059 ↗InjuryAug 27, 2018Fluid/Blood Leak; Fluid/Blood Leak
InjuryJul 19, 2018Fluid/Blood Leak; Fluid/Blood Leak
HEALTHCARE PROFESSIONAL REPORTED A LEFT SIDE DEFLATION. DEVICE REMAINS IMPLANTED.
Patient problems: Failure of Implant
MAUDE report 7705053 ↗
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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