NATRELLE Saline-Filled Breast Implants 68-750Recalls & reported problems
Allergan, Inc. · NATRELLE Style 68MP-750 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 is a Natrelle saline-filled breast implant made by Allergan. Most of the 29 reports describe the implant losing its saline and deflating or rupturing, sometimes with the shell breaking down inside the breast, along with a few mentions of infection and calcification. All 29 reports describe injuries, and no deaths were reported. There are no recalls naming 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
- 29
- Deaths reported
- 0
- Injuries reported
- 29
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 29 adverse event reports that list this exact device (DI 10888628000339), received between Sep 25, 2017 and Aug 24, 2026 — classified as 29 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
- Device Appears to Trigger Rejection4
- Adverse Event Without Identified Device or Use Problem2
Patient problems
- Failure of Implant23
- Capsular Contracture3
- Bacterial Infection1
- Cellulitis1
- No Clinical Signs, Symptoms or Conditions1
- Unspecified Infection1
Recent adverse event reports
The 25 most recent of 29 reports, in the reporter's own words as published by the FDA.
InjuryAug 24, 2026Fluid/Blood Leak
Patient reported ¿deflation¿. Healthcare professional reported later "deflation". This record is for the left side. Device remains implanted.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50411751 ↗InjuryJul 27, 2026Device Appears to Trigger Rejection
Healthcare professional reported "no complaint against the device". Healthcare professional later reported "severe capsular contraction with calcifications throughout the scar capsule". Healthcare professional later reported "Particles in valve and Calcifications". This record is for the right side. The device was explanted.
Patient problems: Capsular Contracture
MAUDE report 50011681 ↗InjuryJun 2, 2026Fluid/Blood Leak
HEALTHCARE PROFESSIONAL REPORTED VIA NATIONAL BREAST IMPLANT REGISTRY (NBIR) MANUFACTURER REGISTRY SPECIFIC DATA REPORT (MRSDR) "SUSPECTED/ACTUAL RUPTURE/DEFLATION". THIS RECORD IS FOR THE LEFT SIDE. DEVICE WAS EXPLANTED.
Patient problems: Failure of Implant
MAUDE report 25364905 ↗InjuryJan 9, 2026Fluid/Blood Leak
InjurySep 19, 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 23097484 ↗InjurySep 17, 2025Fluid/Blood Leak; Fluid/Blood Leak
HEALTHCARE PROFESSIONAL REPORTED SALINE RUPTURE (DEFLATION) AND INDICATED THE DEVICE WILL BE AVAILABLE FOR RETURN. THIS RECORD IS FOR THE LEFT SIDE. THE DEVICE REMAINS IMPLANTED.
Patient problems: Failure of Implant
MAUDE report 23076798 ↗InjurySep 9, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
CONSUMER REPORTED "CELLULITIS, STAFF INFECTION". THIS RECORD IS FOR LEFT SIDE. THE DEVICE WAS EXPLANTED AND REPLACED.
Patient problems: Bacterial Infection; Cellulitis
MAUDE report 23004783 ↗InjurySep 8, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
PATIENT REPORTED "INFECTION, CALCIFICATION AND INFLAMMATION". THIS RECORD IS FOR THE LEFT SIDE. DEVICE WAS EXPLANTED.
Patient problems: Unspecified Infection
MAUDE report 22998154 ↗InjuryApr 28, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED A RIGHT SIDE CAPSULAR CONTRACTURE BAKER GRADE UNKNOWN. DEVICE HAS BEEN EXPLANTED.
Patient problems: Capsular Contracture
MAUDE report 21916420 ↗InjuryApr 24, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED A LEFT SIDE CAPSULAR CONTRACTURE BAKER GRADE UNKNOWN. DEVICE HAS BEEN EXPLANTED.
Patient problems: Capsular Contracture
MAUDE report 21902288 ↗InjuryOct 13, 2023Fluid/Blood Leak; Fluid/Blood Leak
HEALTHCARE PROFESSIONAL REPORTED RIGHT SIDE DEFLATION. DEVICE HAS BEEN EXPLANTED AND REPLACED.
Patient problems: Failure of Implant
MAUDE report 17935325 ↗InjurySep 7, 2023Fluid/Blood Leak; Fluid/Blood Leak
HEALTHCARE PROFESSIONAL REPORTED A RIGHT SIDE DEFLATION. DEVICE HAS BEEN EXPLANTED.
Patient problems: Failure of Implant
MAUDE report 17696989 ↗InjuryMay 20, 2023Fluid/Blood Leak; Fluid/Blood Leak
HEALTHCARE PROFESSIONAL REPORTED LEFT SIDE DEFLATION. DEVICE REMAINS IMPLANTED.
Patient problems: Failure of Implant
MAUDE report 16970959 ↗InjuryApr 14, 2023Fluid/Blood Leak; Fluid/Blood Leak
HEALTHCARE PROFESSIONAL REPORTED RIGHT SIDE DEFLATION. DEVICE HAS BEEN EXPLANTED.
Patient problems: Failure of Implant
MAUDE report 16745923 ↗InjuryMar 21, 2023Fluid/Blood Leak; Fluid/Blood Leak
PHYSICIAN REPORTED RIGHT SIDE DEFLATION. DEVICE HAS BEEN EXPLANTED.
Patient problems: Failure of Implant
MAUDE report 16584410 ↗InjuryMay 25, 2022Fluid/Blood Leak; Fluid/Blood Leak
PATIENT REPORTED LEFT DEFLATION. DEVICE REMAINS IMPLANTED.
Patient problems: Failure of Implant
MAUDE report 14493650 ↗InjuryFeb 18, 2022Fluid/Blood Leak; Device Appears to Trigger Rejection; Fluid/Blood Leak; Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED LEFT SIDE DEFLATION. THE DEVICE REMAINS IMPLANTED.
Patient problems: Failure of Implant
MAUDE report 13563749 ↗InjuryNov 23, 2021Fluid/Blood Leak; Fluid/Blood Leak
HEALTHCARE PROFESSIONAL RIGHT SIDE "PERFORATED". DEVICE HAS BEEN EXPLANTED.
Patient problems: Failure of Implant
MAUDE report 12862203 ↗InjuryNov 16, 2021Fluid/Blood Leak; Fluid/Blood Leak
InjuryOct 6, 2021Fluid/Blood Leak; Fluid/Blood Leak
HEALTHCARE PROFESSIONAL REPORTED, DEFLATION AGAINST RIGHT SIDE DEVICE. THE DEVICE HAS BEEN EXPLANTED AND REPLACED.
Patient problems: Failure of Implant
MAUDE report 12584363 ↗InjuryMar 9, 2021Fluid/Blood Leak; Fluid/Blood Leak
InjuryMar 2, 2021Fluid/Blood Leak; Fluid/Blood Leak
PATIENT REPORTED RIGHT SIDE "DEFLATION". DEVICE REMAINS IMPLANTED.
Patient problems: Failure of Implant
MAUDE report 11399501 ↗InjuryMar 17, 2020Fluid/Blood Leak; Fluid/Blood Leak
HEALTHCARE PROFESSIONAL REPORTED LEFT SIDE DEFLATION. DEVICE HAS BEEN EXPLANTED.
Patient problems: Failure of Implant
MAUDE report 9844685 ↗InjuryDec 11, 2019Fluid/Blood Leak; Fluid/Blood Leak
HEALTHCARE PROFESSIONAL REPORTED RIGHT SIDE DEFLATION. DEVICE HAS BEEN EXPLANTED.
Patient problems: Failure of Implant
MAUDE report 9451753 ↗InjuryDec 10, 2019Fluid/Blood Leak; Fluid/Blood Leak
HEALTHCARE PROFESSIONAL REPORTED LEFT SIDE DEFLATION. DEVICE HAS BEEN EXPLANTED.
Patient problems: Failure of Implant
MAUDE report 9446113 ↗
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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