NATRELLE Saline-Filled Breast Implants 68LP-225Recalls & reported problems
Allergan, Inc. · NATRELLE Style 68LP-225 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 fluid-filled implant placed inside the breast. The 26 reports all mention injuries and no deaths, mostly describing deflation or leaking that led to removal, with some tightening of scar tissue around the implant. 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
- 27
- Deaths reported
- 0
- Injuries reported
- 27
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 27 adverse event reports that list this exact device (DI 10888628000551), received between Dec 1, 2017 and Sep 10, 2026 — classified as 27 injuries.
The most frequently reported specific device problem is “Fluid/Blood Leak” (25 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 Leak25
- Device Appears to Trigger Rejection4
- No Apparent Adverse Event1
Patient problems
- Failure of Implant23
- Capsular Contracture4
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 25 most recent of 27 reports, in the reporter's own words as published by the FDA.
InjurySep 10, 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 50721344 ↗InjuryAug 18, 2025Fluid/Blood Leak; No Apparent Adverse Event; Fluid/Blood Leak; No Apparent Adverse Event
PATIENT REPORTED RIGHT SIDE "NO COMPLAINT AGAINST THE DEVICE". HEALTHCARE PROFESSIONAL ADDITIONALLY REPORTED "DEFLATION". HEALTHCARE PROFESSIONAL LATER CONFIRMED "NO COMPLAINT AGAINST THE RIGHT SIDE DEVICE". DEVICE HAS BEEN EXPLANTED.
Patient problems: Failure of Implant; No Clinical Signs, Symptoms or Conditions
MAUDE report 22828897 ↗InjuryJul 25, 2025Fluid/Blood Leak; Fluid/Blood Leak
PATIENT REPORTED "DEFLATION". THIS RECORD IS FOR THE LEFT SIDE. THE DEVICE HAS BEEN EXPLANTED.
Patient problems: Failure of Implant
MAUDE report 22610541 ↗InjuryApr 25, 2025Fluid/Blood Leak; Device Appears to Trigger Rejection; Fluid/Blood Leak; Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED LEFT SIDE CAPSULAR CONTRACTURE, BAKER GRADE III. PATIENT REPORTED LEFT SIDE "RUPTURE" CONFIRMED VIA ULTRASOUND AND LOOKS LARGER THAN THE CONTRALATERAL SIDE. PATIENT REPORTED IMPLANT WAS "BOTCHED", "MIGRATED" BUT WAS UNABLE TO CONFIRM WHICH SIDE. THIS RECORD IS FOR THE LEFT SIDE. DEVICE REMAINS IMPLANTED.
Patient problems: Capsular Contracture
MAUDE report 21914610 ↗InjuryNov 21, 2023Fluid/Blood Leak; Device Appears to Trigger Rejection; Fluid/Blood Leak; Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED A RIGHT SIDE DEFLATION AND MENTIONED THE PATIENT GOT THE IMPLANTS BECAUSE OF BREAST CANCER WHICH IS NOT DEVICE RELATED. HEALTHCARE PROFESSIONAL LATER REPORTED RIGHT SIDE CAPSULAR CONTRACTURE BAKER GRADE UNKNOWN. DEVICE HAS BEEN EXPLANTED.
Patient problems: Capsular Contracture; Failure of Implant
MAUDE report 18183715 ↗InjuryOct 8, 2023Fluid/Blood Leak; Fluid/Blood Leak
HEALTHCARE PROFESSIONAL REPORTED RIGHT SIDE DEFLATION. DEVICE REMAINS IMPLANTED.
Patient problems: Failure of Implant
MAUDE report 17892780 ↗InjuryMay 4, 2023Fluid/Blood Leak; Fluid/Blood Leak
HEALTHCARE PROFESSIONAL REPORTED RIGHT SIDE DEFLATION. THE DEVICE REMAINS IMPLANTED.
Patient problems: Failure of Implant
MAUDE report 16873282 ↗InjuryMar 15, 2023Fluid/Blood Leak; Fluid/Blood Leak
HEALTHCARE PROFESSIONAL REPORTED A "LEFT SIDE DEFLATION." DEVICE HAS BEEN EXPLANTED.
Patient problems: Failure of Implant
MAUDE report 16549494 ↗InjuryMar 2, 2023Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED RIGHT SIDE CAPSULAR CONTRACTURE BAKER GRADE III. DEVICE REMAINS IMPLANTED.
Patient problems: Capsular Contracture
MAUDE report 16474128 ↗InjuryFeb 20, 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 16404522 ↗InjuryFeb 15, 2023Fluid/Blood Leak; Fluid/Blood Leak
HEALTHCARE PROFESSIONAL REPORTED UNKNOWN SIDE DEFLATION. THE DEVICE REMAINS IMPLANTED.
Patient problems: Failure of Implant
MAUDE report 16382410 ↗InjuryNov 1, 2022Fluid/Blood Leak; Fluid/Blood Leak
HEALTHCARE PROFESSIONAL REPORTED LEFT SIDE "DEFLATION" AND "CAPSULECTOMY". DEVICE HAS BEEN EXPLANTED.
Patient problems: Failure of Implant
MAUDE report 15712563 ↗InjuryOct 20, 2022Fluid/Blood Leak; Fluid/Blood Leak
HEALTHCARE PROFESSIONAL REPORTED RIGHT SIDE "IMPLANT HAD A TEAR-BUT AFTER LOOKING AT IT ONCE IT WAS OUT-HE FEELS IT MAY BE A DEFECT." DEVICE HAS BEEN EXPLANTED AND REPLACED.
Patient problems: Failure of Implant
MAUDE report 15639598 ↗InjuryAug 18, 2022Fluid/Blood Leak; Fluid/Blood Leak
HEALTHCARE PROFESSIONAL REPORTED LEFT SIDE "RUPTURE" OF A SALINE DEVICE. THE DEVICE REMAINS IMPLANTED.
Patient problems: Failure of Implant
MAUDE report 15251052 ↗InjuryMay 13, 2022Fluid/Blood Leak; Fluid/Blood Leak
HEALTHCARE PROFESSIONAL REPORTED "RIGHT SIDE DEFLATION." DEVICE HAS BEEN EXPLANTED.
Patient problems: Failure of Implant
MAUDE report 14402682 ↗InjuryApr 11, 2022Fluid/Blood Leak; Fluid/Blood Leak
HEALTHCARE PROFESSIONAL REPORTED RIGHT SIDE "DEFLATION." THE DEVICE REMAINS IMPLANTED.
Patient problems: Failure of Implant
MAUDE report 14078518 ↗InjuryFeb 21, 2022Fluid/Blood Leak; Fluid/Blood Leak
PATIENT REPORTED RIGHT SIDE DEFLATION. DEVICE REMAINS IMPLANTED.
Patient problems: Failure of Implant
MAUDE report 13570817 ↗InjuryOct 20, 2021Fluid/Blood Leak; Fluid/Blood Leak
HEALTHCARE PROFESSIONAL REPORTED RIGHT SIDE DEFLATION. THE DEVICE REMAINS IMPLANTED.
Patient problems: Failure of Implant
MAUDE report 12669236 ↗InjuryFeb 5, 2021Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED LEFT SIDE CAPSULAR CONTRACTURE, BAKER GRADE III. DEVICE REMAINS IMPLANTED.
Patient problems: Capsular Contracture
MAUDE report 11284782 ↗InjuryOct 22, 2020Fluid/Blood Leak; Fluid/Blood Leak
HEALTHCARE PROFESSIONAL REPORTED LEFT SIDE DEFLATION. DEVICE REMAINS IMPLANTED.
Patient problems: Failure of Implant
MAUDE report 10717546 ↗InjuryJun 17, 2020Fluid/Blood Leak; Fluid/Blood Leak
HEALTHCARE PROFESSIONAL REPORTED A LEFT SIDE DEFLATION. DEVICE HAS BEEN EXPLANTED.
Patient problems: Failure of Implant
MAUDE report 10165116 ↗InjuryJun 4, 2020Fluid/Blood Leak; Fluid/Blood Leak
HEALTHCARE PROFESSIONAL REPORTED RIGHT SIDE DEFLATION. DEVICE REMAINS IMPLANTED.
Patient problems: Failure of Implant
MAUDE report 10119341 ↗InjuryFeb 21, 2020Fluid/Blood Leak; Fluid/Blood Leak
HEALTHCARE PROFESSIONAL REPORTED A RIGHT SIDE DEFLATION AND EXCHANGE OF TEXTURED BREAST IMPLANTS DUE TO THE PATIENT¿S CONCERN WITH THE PRODUCT. ADDITIONALLY, PATIENT REPORTED RIGHT SIDE DEFLATION. DEVICE HAS BEEN EXPLANTED.
Patient problems: Failure of Implant
MAUDE report 9739347 ↗InjuryDec 26, 2019Fluid/Blood Leak; Fluid/Blood Leak
HEALTHCARE PROFESSIONAL REPORTED DEFLATION AND "ANY CREASES". THE DEVICE WAS EXPLANTED. THIS RECORD IS FOR THE RIGHT SIDE.
Patient problems: Failure of Implant
MAUDE report 9520135 ↗InjuryDec 10, 2018Fluid/Blood Leak; Fluid/Blood Leak
HEALTHCARE PROFESSIONAL REPORTED A RIGHT SIDE DEFLATION. DEVICE REMAINS IMPLANTED.
Patient problems: Failure of Implant
MAUDE report 8146949 ↗
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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