NATRELLE Saline-Filled Breast Implants 68HP-465Recalls & reported problems
Allergan, Inc. · NATRELLE Sty 68HP-465 High 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 Natrelle saline breast implant from Allergan has 225 adverse event reports, including 223 injuries and 2 malfunctions, and no deaths. Most reports describe the saline implant leaking or deflating, and many describe tightening of the scar tissue around the implant. Some reports say the implant was removed. 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
- 243
- Deaths reported
- 0
- Injuries reported
- 241
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 243 adverse event reports that list this exact device (DI 10888628000438), received between Sep 4, 2017 and Sep 25, 2026 — classified as 241 injuries, 2 malfunctions.
The most frequently reported specific device problem is “Fluid/Blood Leak” (198 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 Leak198
- Device Appears to Trigger Rejection31
- Patient-Device Incompatibility13
- Material Rupture4
- Adverse Event Without Identified Device or Use Problem2
- No Apparent Adverse Event2
- Break1
- Delivered as Unsterile Product1
Patient problems
- Failure of Implant174
- Capsular Contracture44
- No Clinical Signs, Symptoms or Conditions25
- Granuloma2
- Seroma2
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1
- Erosion1
- Hematoma1
Recent adverse event reports
The 25 most recent of 243 reports, in the reporter's own words as published by the FDA.
InjurySep 25, 2026Fluid/Blood Leak
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 50906253 ↗InjurySep 21, 2026Fluid/Blood Leak
Healthcare professional reported "deflation". This record is for the left side. Device has been explanted.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50846502 ↗InjurySep 16, 2026Fluid/Blood Leak; Device Appears to Trigger Rejection
Healthcare professional reported "Deflation". Later reported "Pain" and "Scar tissue contracture, baker grade IV" and "yellow proteinaceous fluid which is associated with a chronic rupture". This record is for the left side. Device was explanted. A capsulectomy was performed.
Patient problems: Capsular Contracture
MAUDE report 50788247 ↗InjurySep 15, 2026Fluid/Blood Leak
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50781742 ↗InjurySep 15, 2026Fluid/Blood Leak
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50780545 ↗InjurySep 1, 2026Fluid/Blood Leak
Healthcare professional reported "deflation". This record is for the left side. Device was explanted.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50547330 ↗InjuryAug 23, 2026Fluid/Blood Leak
Healthcare Professional reported "Rupture/Deflation". This record is for the right side. Device has been explanted.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50395952 ↗InjuryAug 19, 2026Fluid/Blood Leak
Healthcare professional reported "deflation". This record is for the right side. The device remains implanted.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50332424 ↗InjuryAug 19, 2026Fluid/Blood Leak
Patient reported "deflation". This record is for the left side. Device has been explanted and replaced.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50329258 ↗InjuryAug 17, 2026Fluid/Blood Leak; Device Appears to Trigger Rejection
Healthcare professional reported a "severe Baker Grade IV capsular contracture, painful breast deformity with deflating saline prosthesis. Increasing hardening, severe encapsulation", "malposition of implants and disfigurement". Later reported "Grade 3 Ptosis"-Not device related- and "Calcified Granulomas". This record is for the left side. The device was explanted.
Patient problems: Capsular Contracture; Granuloma
MAUDE report 50278599 ↗InjuryAug 5, 2026Fluid/Blood Leak
Healthcare professional reported "Saline rupture" and "hole on valve side". This record is for the left side. The device has been explanted.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50143603 ↗InjuryAug 4, 2026Fluid/Blood Leak
Healthcare professional reported "Deflation" against the left side. The device was explanted.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50131601 ↗InjuryJul 30, 2026Fluid/Blood Leak
Patient reported of the right side device: "deflation". Later, healthcare professional reported "deflation". Later healthcare professional reported "breast ptosis" not device related. The device was explanted.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50084675 ↗InjuryJul 28, 2026Fluid/Blood Leak
Patient reported "rupture" with "deformation in my breasts", "nipples are different" and "have decreased". This record is for the left side. The device remains implanted.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50055397 ↗InjuryJul 27, 2026Device Appears to Trigger Rejection
Patient reported "breast pain and Capsular Contracture Baker grade Unknown". This record is for the left side. Device remains implanted.
Patient problems: Capsular Contracture
MAUDE report 50028116 ↗InjuryJul 16, 2026Fluid/Blood Leak
HEALTHCARE PROFESSIONAL REPORTED "DEFLATION" AGAINST THE LEFT SIDE DEVICE. THE DEVICE WAS EXPLANTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25846332 ↗InjuryJul 14, 2026Fluid/Blood Leak
Device has been explanted and replaced.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25816019 ↗InjuryJul 8, 2026Fluid/Blood Leak
Healthcare professional reported ¿deflation¿. This record is for the right side. Device was explanted.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25753316 ↗InjuryJul 8, 2026Fluid/Blood Leak
Healthcare professional reported a deflation. This record is for the left side. The device was explanted.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25748449 ↗InjuryJun 29, 2026Fluid/Blood Leak
HEALTHCARE PROFESSIONAL REPORTED "DEFLATION". THIS RECORD IS FOR THE RIGHT SIDE. DEVICE WAS EXPLANTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25662065 ↗InjuryMay 21, 2026Fluid/Blood Leak; Off-Label Use
HEALTHCARE PROFESSIONAL REPORTED "DEFLATION" AND DEVICE IMPLANTED AFTER EXPIRATION DATE. THIS RECORD IS FOR THE RIGHT SIDE. DEVICE REMAINS IMPLANTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25244346 ↗InjuryMay 14, 2026Fluid/Blood Leak; No Apparent Adverse Event
HEALTHCARE PROFESSIONAL REPORTED "EXCHANGE WITH NO COMPLAINT AGAINST THE DEVICE". LATER HEALTHCARE PROFESSIONAL REPORTED "RUPTURE/DEFLATION". THIS RECORD IS FOR THE RIGHT SIDE. DEVICE WAS EXPLANTED.
Patient problems: Failure of Implant; No Clinical Signs, Symptoms or Conditions
MAUDE report 25176972 ↗InjuryMay 14, 2026Fluid/Blood Leak
HEALTHCARE PROFESSIONAL REPORTED "DEFLATION". THIS RECORD IS FOR THE LEFT SIDE. DEVICE WAS EXPLANTED.
Patient problems: Failure of Implant
MAUDE report 25176970 ↗InjuryMay 7, 2026Fluid/Blood Leak
Healthcare professional reported "Rupture for a saline device". This record is for the left side. Device was explanted.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25117353 ↗InjuryApr 28, 2026Fluid/Blood Leak
HEALTHCARE PROFESSIONAL REPORTED "DEFLATION". THIS RECORD IS FOR THE LEFT SIDE. DEVICE WAS EXPLANTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25018803 ↗
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
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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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