NATRELLE Saline-Filled Breast Implants 68-600Recalls & reported problems
Allergan, Inc. · NATRELLE Style 68MP-600 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 breast implant has 118 adverse event reports, with 117 injuries and no deaths. Most describe fluid leaking from the implant or the implant deflating, and some mention capsular contracture. Reports fell from 14 in the prior 12 months to 4 in the last 12 months. 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
- 122
- Deaths reported
- 0
- Injuries reported
- 121
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 122 adverse event reports that list this exact device (DI 10888628000308), received between Jul 26, 2017 and Sep 1, 2026 — classified as 121 injuries, 1 malfunction.
The most frequently reported specific device problem is “Fluid/Blood Leak” (109 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 Leak109
- Device Appears to Trigger Rejection8
- Patient-Device Incompatibility8
- Deflation Problem2
- Material Rupture2
- Break1
Patient problems
- Failure of Implant102
- Capsular Contracture16
- No Clinical Signs, Symptoms or Conditions5
- Nipple Sensation Changes1
- Seroma1
- Unspecified Infection1
Recent adverse event reports
The 25 most recent of 122 reports, in the reporter's own words as published by the FDA.
InjurySep 1, 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 50544268 ↗InjuryAug 4, 2026Fluid/Blood Leak; Device Appears to Trigger Rejection
Healthcare professional reported "deflation". This record is for the right side. The device was explanted.
Patient problems: Capsular Contracture; No Clinical Signs, Symptoms or Conditions
MAUDE report 50126356 ↗InjuryJul 30, 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 50089749 ↗InjuryJul 13, 2026Fluid/Blood Leak
Healthcare professional reported deflation. Healthcare professional later reported no complaint against the device. Healthcare professional later reported "deflation". Later healthcare professional reported "Any creases". This record is for the left side. Device has been explanted.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25805581 ↗InjuryJun 9, 2026Fluid/Blood Leak
HEALTHCARE PROFESSIONAL REPORTED "DEFLATION". THIS RECORD IS FOR THE LEFT SIDE. THE DEVICE REMAINS IMPLANTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25451379 ↗InjuryMar 16, 2026Fluid/Blood Leak
PATIENT REPORTED "LEFT SIDE SALINE RUPTURE, LEFT SIDE PAIN, LEFT SIDE BURNING, LEFT SIDE "FELT LOOSE", AND BILATERAL NERVE DAMAGE IN NIPPLES". THIS RECORD IS FOR THE LEFT SIDE. DEVICE REMAINS IMPLANTED.
Patient problems: Nipple Sensation Changes
MAUDE report 24607527 ↗InjuryMar 6, 2026Fluid/Blood Leak
HEALTHCARE PROFESSIONAL REPORTED "LEAK". THIS RECORD IS FOR THE LEFT SIDE. THE DEVICE REMAINS IMPLANTED.
Patient problems: Failure of Implant
MAUDE report 24533010 ↗InjuryNov 13, 2025Fluid/Blood Leak; Fluid/Blood Leak
HEALTHCARE PROFESSIONAL REPORTED "DEFLATION". THIS RECORD IS FOR THE RIGHT SIDE. DEVICE WAS EXPLANTED AND REPLACED.
Patient problems: Failure of Implant
MAUDE report 23542060 ↗InjuryOct 28, 2025Fluid/Blood Leak; Fluid/Blood Leak
PATIENT REPORTED "DEFLATION" SEEN BY EXAMINATION. THIS RECORD IS FOR THE RIGHT SIDE. DEVICE REMAINS IMPLANTED.
Patient problems: Failure of Implant
MAUDE report 23403982 ↗InjuryOct 9, 2025Fluid/Blood Leak; Fluid/Blood Leak
HEALTHCARE PROFESSIONAL REPORTED "DEFLATION" PER EXAM ON 25/AUG/2025. THIS RECORD IS FOR THE LEFT SIDE. DEVICE REMAINS IMPLANTED.
Patient problems: Failure of Implant
MAUDE report 23259935 ↗InjuryAug 18, 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 22835123 ↗InjuryJul 30, 2025Fluid/Blood Leak; Fluid/Blood Leak
HEALTHCARE PROFESSIONAL REPORTED "DEFLATION SEEN VISUALLY". THIS RECORD IF FOR LEFT SIDE. DEVICE REMAINS IMPLANTED.
Patient problems: Failure of Implant
MAUDE report 22666738 ↗InjuryJul 7, 2025Fluid/Blood Leak; Fluid/Blood Leak
HEALTHCARE PROFESSIONAL REPORTED "RIGHT DEFLATION." THE DEVICE HAS BEEN EXPLANTED AND NOT REPLACED.
Patient problems: Failure of Implant
MAUDE report 22414231 ↗InjuryJul 1, 2025Fluid/Blood Leak; Fluid/Blood Leak
HEALTHCARE PROFESSIONAL REPORTED RIGHT SIDE DEFLATION. THE DEVICE HAS BEN EXPLANTED AND REPLACED.
Patient problems: Failure of Implant
MAUDE report 22371001 ↗InjuryJun 2, 2025Fluid/Blood Leak; Fluid/Blood Leak
InjuryMay 27, 2025Fluid/Blood Leak; Fluid/Blood Leak
HEALTHCARE PROFESSIONAL REPORTED "DEFLATION". THIS RECORD IS FOR THE RIGHT SIDE. DEVICE EXPLANTED.
Patient problems: Failure of Implant
MAUDE report 22088604 ↗InjuryMay 27, 2025Fluid/Blood Leak; Fluid/Blood Leak
HEALTHCARE PROFESSIONAL REPORTED RIGHT SIDE DEFLATION. DEVICE HAS BEEN EXPLANTED AND REPLACED.
Patient problems: Failure of Implant
MAUDE report 22087987 ↗InjuryMay 23, 2025Fluid/Blood Leak; Fluid/Blood Leak
HEALTHCARE PROFESSIONAL REPORTED LEFT SIDE DEFLATION. IT WAS ADDITIONALLY REPORTED "HOLE ON BOTTOM". THE DEVICE HAS BEEN EXPLANTED.
Patient problems: Failure of Implant
MAUDE report 22081626 ↗InjuryApr 28, 2025Fluid/Blood Leak; Fluid/Blood Leak
HEALTHCARE PROFESSIONAL REPORTED RIGHT SIDE DEFLATION. THE DEVICE HAS BEEN EXPLANTED.
Patient problems: Failure of Implant
MAUDE report 21920070 ↗MalfunctionApr 24, 2025Break; Break
HEALTHCARE PROFESSIONAL REPORTED A SMALL HOLE/LEAK UPON SALINE FILLING IN VIVO. DEVICE NOT IMPLANTED.
Patient problems: Failure of Implant
MAUDE report 21902052 ↗InjuryApr 23, 2025Fluid/Blood Leak; Fluid/Blood Leak
HEALTHCARE PROFESSIONAL REPORTED RIGHT SIDE DEFLATION. DEVICE REMAINS IMPLANTED.
Patient problems: Failure of Implant
MAUDE report 21890812 ↗InjuryMar 11, 2025Fluid/Blood Leak; Fluid/Blood Leak
HEALTHCARE PROFESSIONAL REPORTED A LEFT SIDE DEFLATION. THE DEVICE REMAINS IMPLANTED.
Patient problems: Failure of Implant
MAUDE report 21572943 ↗InjuryMar 21, 2024Fluid/Blood Leak; Fluid/Blood Leak
PATIENT REPORTED NO COMPLAINT AGAINST THE DEVICE. PATIENT LATER REPORTED "WHOLE THING EXPLODED"(DEFLATION).THIS RECORD IS FOR THE RIGHT SIDE.THE DEVICE REMAINS IMPLANTED.
Patient problems: Failure of Implant
MAUDE report 18949990 ↗InjuryDec 5, 2023Fluid/Blood Leak; Fluid/Blood Leak
InjuryDec 1, 2023Fluid/Blood Leak; Fluid/Blood Leak
HEALTHCARE PROFESSIONAL REPORTED A RIGHT SIDE DEFLATION. DEVICE REMAINS IMPLANTED.
Patient problems: Failure of Implant
MAUDE report 18248721 ↗
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
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- 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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