NATRELLE Saline-Filled Breast Implants 68-330Recalls & reported problems
Allergan, Inc. · NATRELLE Style 68MP-330 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 breast implant has 503 reports that mostly describe the implant leaking or deflating, with some describing a rupture. Patient problems listed include hardening of the scar tissue around the implant, and a few infections. There are no deaths and 500 injuries reported, and no recalls name this device. Reports rose to 76 in the past year from 48 in the year before.
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
- 528
- Deaths reported
- 0
- Injuries reported
- 525
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 528 adverse event reports that list this exact device (DI 10888628000223), received between Aug 14, 2015 and Sep 29, 2026 — classified as 525 injuries, 3 malfunctions.
The most frequently reported specific device problem is “Fluid/Blood Leak” (440 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 Leak440
- Device Appears to Trigger Rejection57
- Patient-Device Incompatibility24
- Material Rupture12
- Adverse Event Without Identified Device or Use Problem10
- Deflation Problem4
- No Apparent Adverse Event4
- Break3
Patient problems
- Failure of Implant387
- Capsular Contracture79
- No Clinical Signs, Symptoms or Conditions48
- Unspecified Infection5
- Necrosis3
- Seroma3
- Complaint, Ill-Defined2
- Impaired Healing2
Recent adverse event reports
The 25 most recent of 528 reports, in the reporter's own words as published by the FDA.
InjurySep 29, 2026Fluid/Blood Leak
Healthcare professional reported ¿partial deflation". This record is for the right side. Device remains implanted.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50937378 ↗InjurySep 25, 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 50898066 ↗InjurySep 23, 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 50873902 ↗InjurySep 23, 2026Fluid/Blood Leak
Healthcare professional reported "deflation". This record is for the right side. The device was explanted.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50870957 ↗InjurySep 23, 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 50865907 ↗InjurySep 22, 2026Fluid/Blood Leak
Healthcare professional reported "exchange". Later, healthcare professional reported "found to have a small hole during explant, may have been caused by surgery or slow leak". This record is for the left side. Device was explanted.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50858577 ↗InjurySep 21, 2026Fluid/Blood Leak
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50848577 ↗InjurySep 19, 2026Fluid/Blood Leak
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50831736 ↗InjurySep 17, 2026Fluid/Blood Leak
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50812596 ↗InjurySep 17, 2026Fluid/Blood Leak
Healthcare professional reported a "Deflation". This record is for the left side. Device was explanted.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50798951 ↗InjuryAug 31, 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 50533638 ↗InjuryAug 30, 2026Fluid/Blood Leak
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50514707 ↗InjuryAug 30, 2026Fluid/Blood Leak
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50512918 ↗InjuryAug 28, 2026Fluid/Blood Leak; Device Appears to Trigger Rejection
Patient problems: Capsular Contracture
MAUDE report 50509662 ↗InjuryAug 27, 2026Fluid/Blood Leak
Company representative reported on behalf of the healthcare professional: "deflated implant", "a doctor put the implant in the patient", and "realized it was leaking and then took it back out before finishing the surgery". This record is for the right side device. The device was explanted.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50479590 ↗InjuryAug 25, 2026Fluid/Blood Leak
Healthcare professional reported a "deflation". Later through Returned Goods Authorization (RGA) paperwork noted "hole in valve". This record is for the left side. The device was explanted.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50434036 ↗InjuryAug 23, 2026Device Appears to Trigger Rejection
Healthcare professional reported "capsular contracture Baker grade IV". This record is for the left side. Device remains implanted.
Patient problems: Capsular Contracture
MAUDE report 50396265 ↗InjuryAug 20, 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 50349092 ↗InjuryAug 17, 2026Adverse Event Without Identified Device or Use Problem
Healthcare professional reported "breast infection". This record is for left side. The device remains implanted.
Patient problems: Unspecified Infection
MAUDE report 50279407 ↗InjuryAug 13, 2026Fluid/Blood Leak
Patient reported "Deflation". This record is for the left side. The device remains implanted.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50241318 ↗InjuryAug 12, 2026Fluid/Blood Leak
Healthcare professional reported "rupture". This record is for the right side. The device was explanted.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50225973 ↗InjuryAug 7, 2026Fluid/Blood Leak
Healthcare professional reported a left side deflation. Device has been explanted.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50179220 ↗InjuryAug 6, 2026Fluid/Blood Leak
Patient reported "erupted" "deflated completely" and "discomfort". This record is for the left side. The device remains implanted.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50166624 ↗InjuryAug 6, 2026Fluid/Blood Leak
Patient reported "may be deflating". This record is for the right side. The device remains implanted.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50159911 ↗InjuryJul 28, 2026Device Appears to Trigger Rejection
Healthcare professional reported "exchange with no complaint against the device". Later healthcare professional reported "capsular contracture". This record is for the right side. Device was explanted.
Patient problems: Capsular Contracture
MAUDE report 50060586 ↗
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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