NATRELLE Saline-Filled Breast Implants 68-300Recalls & reported problems
Allergan, Inc. · NATRELLE Style 68MP-300 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-filled breast implant is an internal breast prosthesis. Its 367 reports include 362 injuries and no deaths, and most describe the implant leaking or deflating, with some reports of saline rupture and some noting capsular contracture. 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
- 379
- Deaths reported
- 0
- Injuries reported
- 374
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 379 adverse event reports that list this exact device (DI 10888628000216), received between Jul 31, 2017 and Sep 30, 2026 — classified as 374 injuries, 5 malfunctions.
The most frequently reported specific device problem is “Fluid/Blood Leak” (311 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 Leak311
- Device Appears to Trigger Rejection54
- Patient-Device Incompatibility14
- Material Rupture8
- Adverse Event Without Identified Device or Use Problem4
- Break4
- Migration3
- No Apparent Adverse Event3
Patient problems
- Failure of Implant276
- Capsular Contracture67
- No Clinical Signs, Symptoms or Conditions28
- Unspecified Infection6
- Seroma5
- Complaint, Ill-Defined3
- Swollen Lymph Nodes2
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1
Recent adverse event reports
The 25 most recent of 379 reports, in the reporter's own words as published by the FDA.
InjurySep 30, 2026Fluid/Blood Leak
Healthcare professional reported "deflation". This record is for the left side. Device remains implanted.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50946580 ↗InjurySep 25, 2026Fluid/Blood Leak
Patient reported "implant leaking" and "not as perky and more softer". This record is for the right side. The devices remains implanted.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50896497 ↗InjurySep 25, 2026Fluid/Blood Leak
Patient reported "a little bit of rippling on top" and "leaking partially collapsed". This record is for the right side. Device remains implanted.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50895693 ↗InjurySep 21, 2026Fluid/Blood Leak
Patient reported a "deflation". This record is for the left side. The device remains implanted.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50842406 ↗InjurySep 14, 2026Fluid/Blood Leak
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50765064 ↗InjurySep 14, 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 50756825 ↗InjurySep 4, 2026Fluid/Blood Leak; Material Rupture
Healthcare professional reported "rupture". Later healthcare professional reported "deflation", "small pinhole leak", "hole in radius (edge)" and "moderate to severe ptosis". Ptosis is considered not device related. This record is for the right side. The device was explanted.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50614588 ↗InjuryAug 28, 2026Fluid/Blood Leak
Healthcare professional reported "leak". Later, healthcare professional reported Capsular Contracture "Baker grade: 2". Healthcare professional later reported "Leak/deflation". This record is for the right side. Device remains implanted.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50508874 ↗InjuryAug 21, 2026Fluid/Blood Leak
Healthcare professional reported ¿deflation¿. This record is for the left side. Device remains implanted.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50368252 ↗InjuryAug 13, 2026Fluid/Blood Leak
Healthcare professional reported a deflation. This record is for the left side. The device remains implanted.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50241672 ↗InjuryAug 6, 2026Fluid/Blood Leak
Patient reported "deflation". This record is for the right side. Device remains implanted.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50168305 ↗InjuryAug 4, 2026Fluid/Blood Leak
Healthcare professional reported "saline rupture". This record is for the right side. Device remains implanted.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50124770 ↗InjuryJul 30, 2026Fluid/Blood Leak
Healthcare professional reported ¿looks uneven¿ and ¿deflation¿. This record is for the left side. Device was explanted.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50087274 ↗InjuryJul 28, 2026Fluid/Blood Leak
Patient reported "leaking". Healthcare Professional later reported "size exchange". This record is for the right side. Device was explanted.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50057192 ↗InjuryJul 28, 2026Fluid/Blood Leak
Patient reported "leaking". Healthcare Professional later reported "size exchange". This record is for the left side. Device was explanted.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50055061 ↗InjuryJul 27, 2026Device Appears to Trigger Rejection
Patient reported "exchange with no complaint against the device". Healthcare Professional later reported "Capsular Contracture Baker grade III". This record is for the right side. Device was explanted.
Patient problems: Capsular Contracture
MAUDE report 50037824 ↗InjuryJul 15, 2026Fluid/Blood Leak; Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED "DEFLATION", "DISCOMFORT", "CAPSULAR CONTRACTURE" BAKER GRADE IV, "ANIMATION DEFORMITIES", "DISPLACEMENT" AND "CALCIFIED". THIS RECORD IS FOR THE LEFT SIDE. DEVICE WAS EXPLANTED. HEALTHCARE PROFESSIONAL ALSO REPORTED "PTOSIS" WHICH IS NOT DEVICE RELATED.
Patient problems: Capsular Contracture
MAUDE report 25834136 ↗InjuryJul 15, 2026Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED "IMPLANT DEFLATED IN OFFICE", "WATERFALL DEFORMITY, ANIMATION DEFORMITIES", "DISPLACEMENT", "CAPSULAR CONTRACTURE" BAKER GRADE IV "SYMMETRY"AND "CALCIFIED". THIS RECORD IS FOR THE RIGHT SIDE. DEVICE WAS EXPLANTED. HEALTHCARE PROFESSIONAL ALSO REPORTED "PTOSIS" WHICH IS NOT DEVICE RELATED.
Patient problems: Capsular Contracture
MAUDE report 25830070 ↗InjuryJul 8, 2026Fluid/Blood Leak
Device has been explanted and replaced.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25757123 ↗InjuryJun 17, 2026Fluid/Blood Leak
HEALTHCARE PROFESSIONAL REPORTED OF THE LEFT SIDE DEVICE: "POSSIBLE RUPTURE" AND BAKER GRADE I CAPSULAR CONTRACTURE. THE DEVICE REMAINS IMPLANTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25536036 ↗InjuryJun 10, 2026Fluid/Blood Leak
PATIENT REPORTED "DEFLATION". THIS RECORD IS FOR THE LEFT SIDE. DEVICE REMAINS IMPLANTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25460233 ↗InjuryJun 9, 2026Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED "CAPSULAR CONTRACTURE", BAKER GRADE IV. THIS RECORD IS FOR THE LEFT SIDE. THE DEVICE HAS BEEN EXPLANTED.
Patient problems: Capsular Contracture
MAUDE report 25451135 ↗InjuryJun 9, 2026Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED "CAPSULAR CONTRACTURE", BAKER GRADE IV. THIS RECORD IS FOR THE RIGHT SIDE. THE DEVICE HAS BEEN EXPLANTED.
Patient problems: Capsular Contracture
MAUDE report 25451043 ↗InjuryJun 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 25436712 ↗InjuryMay 27, 2026Fluid/Blood Leak
Healthcare professional reported a deflation. Later, a second healthcare professional reported a "slow leak". This record is for the left side. The device was explanted.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25304242 ↗
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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