NATRELLE Saline-Filled Breast Implants 168-270Recalls & reported problems
Allergan, Inc. · NATRELLE 168-270 Moderate Projection BIOCELL |textured|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
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 25
- Deaths reported
- 0
- Injuries reported
- 25
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 25 adverse event reports that list this exact device (DI 10888628000803), received between Feb 11, 2019 and Sep 30, 2026 — classified as 25 injuries.
The most frequently reported specific device problem is “Fluid/Blood Leak” (18 reports).
1 FDA recall record name this device's identifier, 1 still open.
4 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
Recalls naming this device
- Jul 24, 2019Class IOpen, Classified
The action was initiated following notification by the U.S. FDA of their recently updated, global safety information concerning the higher incidence of anaplastic large cell lymphoma (BIA-ALCL) in patients who have textured breast implants.
Z-2451-2019 · Root cause: Unknown/Undetermined by firm · Recall details · FDA record ↗
Most reported problems
Device problems
- Fluid/Blood Leak18
- Device Appears to Trigger Rejection6
- Material Rupture1
Patient problems
- Failure of Implant9
- No Clinical Signs, Symptoms or Conditions8
- Capsular Contracture6
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1
- Unspecified Infection1
Recent adverse event reports
The 25 most recent of 25 reports, in the reporter's own words as published by the FDA.
InjurySep 30, 2026Fluid/Blood Leak
Healthcare professional reported "deflation and exchange from textured to smooth." This record is for the left side. Device remains implanted.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50943415 ↗InjurySep 28, 2026Fluid/Blood Leak
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50923436 ↗InjurySep 27, 2026Fluid/Blood Leak
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50909727 ↗InjurySep 27, 2026Fluid/Blood Leak
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50909715 ↗InjurySep 25, 2026Fluid/Blood Leak
Patient reported "deflation". This record is for the right side. The device remains implanted.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50899177 ↗InjurySep 21, 2026Fluid/Blood Leak
Healthcare professional reported "rupture and infection". This record is for the left side. Device was explanted. Patient received antibiotics as treatment.
Patient problems: Unspecified Infection
MAUDE report 50842377 ↗InjurySep 17, 2026Device Appears to Trigger Rejection
Healthcare professional reported "Capsular Contracture Baker grade IV" and "exchange from textured to smooth". This record is for the right side. Device remains implanted.
Patient problems: Capsular Contracture
MAUDE report 50804695 ↗InjuryAug 28, 2026Device Appears to Trigger Rejection
Healthcare professional reported through sales representative "capsular contracture" and "textured implant need to be removed & replaced". This record is for the left side. Device remains implanted.
Patient problems: Capsular Contracture
MAUDE report 50507228 ↗InjuryAug 26, 2026Device Appears to Trigger Rejection
Healthcare professional reported through sales representative "capsular contracture" and "textured implant need to be removed & replaced". This record is for the right side. Device remains implanted.
Patient problems: Capsular Contracture
MAUDE report 50456979 ↗InjuryAug 9, 2026Device Appears to Trigger Rejection
Healthcare professional reported "exchange from textured to smooth breast implants". Healthcare professional later reported "Fear ALCL and capsular contracture Baker grade Unknown". This record is for the right side. The device has been explanted.
Patient problems: Capsular Contracture
MAUDE report 50188932 ↗InjuryJul 30, 2026Fluid/Blood Leak
Healthcare Professional reported "deflation". This record is for the left side. Device was explanted and replaced.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50087013 ↗InjuryJul 16, 2026Fluid/Blood Leak
HEALTHCARE PROFESSIONAL REPORTED OF THE RIGHT SIDE DEVICE: "DEFLATION". THE DEVICE WAS EXPLANTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25845081 ↗InjuryJun 22, 2026Fluid/Blood Leak
HEALTHCARE PROFESSIONAL REPORTED " CAPSULAR CONTRACTURE BAKER II AND EXCHANGE FROM TEXTURED TO SMOOTH". LATER PATIENT REPORTED "DEFLATED BEFORE SURGERY". THIS RECORD IS FOR THE LEFT SIDE. DEVICE WAS EXPLANTED.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 25580366 ↗InjuryMar 19, 2026Fluid/Blood Leak
HEALTHCARE PROFESSIONAL REPORTED "LEAKING". THIS RECORD IS FOR THE RIGHT SIDE. DEVICE WAS EXPLANTED AND REPLACED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24639364 ↗InjuryFeb 3, 2026Material Rupture
PATIENT REPORTED "DEFLATION". THIS RECORD IS FOR THE RIGHT SIDE. DEVICE REMAINS IMPLANTED.
Patient problems: Failure of Implant
MAUDE report 24250529 ↗InjuryNov 19, 2025Fluid/Blood Leak; Fluid/Blood Leak
PATIENT REPORTED "EXCHANGE DUE TO THE PATIENT'S CONCERN WITH THE PRODUCT" AND "DEFLATION". THIS RECORD IS FOR THE LEFT SIDE. DEVICE REMAINS IMPLANTED AND IT IS UNKNOWN IF THE DEVICE WILL BE RETURNED.
Patient problems: Failure of Implant
MAUDE report 23598309 ↗InjuryJul 24, 2025Fluid/Blood Leak; Fluid/Blood Leak
HEALTHCARE PROFESSIONAL REPORTED LEFT SIDE DEFLATION AND EXCHANGE FROM TEXTURED TO SMOOTH DUE TO CONCERN WITH THE PRODUCT. DEVICE REMAINS IMPLANTED.
Patient problems: Failure of Implant
MAUDE report 22591468 ↗InjuryAug 12, 2023Fluid/Blood Leak; Fluid/Blood Leak
HEALTHCARE PROFESSIONAL REPORTED A LEFT SIDE DEFLATION. DEVICE REMAINS IMPLANTED.
Patient problems: Failure of Implant
MAUDE report 17537633 ↗InjuryJun 5, 2023Fluid/Blood Leak; Fluid/Blood Leak
HEALTHCARE PROFESSIONAL REPORTED A LEFT SIDE DEFLATION. DEVICE REMAINS IMPLANTED.
Patient problems: Failure of Implant
MAUDE report 17066541 ↗InjuryNov 29, 2022Fluid/Blood Leak; Fluid/Blood Leak
HEALTHCARE PROFESSIONAL REPORTED RIGHT SIDE DEFLATION. DEVICE HAS BEEN EXPLANTED AND REPLACED.
Patient problems: Failure of Implant
MAUDE report 15880551 ↗InjuryOct 18, 2022Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
PATIENT REPORTED, RIGHT-SIDE CAPSULAR CONTRACTURE, BAKER GRADE UNKNOWN OF "BIOCELL MACROTEXTURED BREAST IMPLANTS." THE DEVICE REMAINS IMPLANTED.
Patient problems: Capsular Contracture
MAUDE report 15627157 ↗InjuryJul 14, 2021Fluid/Blood Leak; Fluid/Blood Leak
HEALTHCARE PROFESSIONAL REPORTED A LEFT SIDE RUPTURE. DEVICE HAS BEEN EXPLANTED AND REPLACED.
Patient problems: Failure of Implant
MAUDE report 12169650 ↗InjuryMar 27, 2021Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED LEFT SIDE EXCHANGE OF BIOCELL TEXTURED. IMPLANTS DUE TO THE PATIENT'S CONCERN WITH THE PRODUCT. ADDITIONALLY HCP REPORTED CAPSULAR CONTRACTURE BAKER GRADE UNKNOWN AND "BOTTOMING OUT OF THE BREAST." DEVICE HAS BEEN EXPLANTED.
Patient problems: Capsular Contracture
MAUDE report 11580177 ↗InjuryAug 15, 2019Fluid/Blood Leak; Fluid/Blood Leak
HEALTHCARE PROFESSIONAL REPORTS LEFT SIDE DEFLATION. THE DEVICE HAS BEEN EXPLANTED.
Patient problems: Failure of Implant
MAUDE report 8897377 ↗InjuryFeb 11, 2019Fluid/Blood Leak; Fluid/Blood Leak
HEALTHCARE PROFESSIONAL REPORTED A RIGHT SIDE DEFLATION. THE DEVICE HAS BEEN EXPLANTED.
Patient problems: Failure of Implant
MAUDE report 8325724 ↗
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-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
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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 · each recall links to the FDA recall notice
- 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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