NATRELLE Saline-Filled Breast Implants 68-270Recalls & reported problems
Allergan, Inc. · NATRELLE Style 68MP-270 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 Natrelle saline breast implant from Allergan has 225 adverse event reports, including 221 injuries and 4 malfunctions, and no deaths. Most reports describe the saline implant leaking or deflating, with some patients noticing lumps, and others describe tightening of the scar tissue around the implant. Some reports say the implant was removed or replaced. 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
- 239
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 243 adverse event reports that list this exact device (DI 10888628000209), received between Jul 25, 2017 and Sep 30, 2026 — classified as 239 injuries, 4 malfunctions.
The most frequently reported specific device problem is “Fluid/Blood Leak” (206 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 Leak206
- Device Appears to Trigger Rejection20
- Patient-Device Incompatibility13
- Material Rupture5
- Peeled/Delaminated4
- Deflation Problem3
- Device Contamination with Chemical or Other Material2
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- Failure of Implant179
- Capsular Contracture32
- No Clinical Signs, Symptoms or Conditions29
- Unspecified Infection2
- Abscess1
- Bacterial Infection1
- Foreign Body Reaction1
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 25 most recent of 243 reports, in the reporter's own words as published by the FDA.
InjurySep 30, 2026Fluid/Blood Leak
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50952872 ↗InjurySep 23, 2026Fluid/Blood Leak
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50862930 ↗InjurySep 16, 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 50793365 ↗InjurySep 3, 2026Fluid/Blood Leak
Patient reported "rupture" of a saline device. This record is for the left side. Device remains implanted.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50589055 ↗InjuryAug 25, 2026Fluid/Blood Leak; Off-Label Use
Healthcare professional reported "deflation". The device was implanted after expiry date. This record is for the left side. The device remains implanted.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50436106 ↗InjuryAug 24, 2026Fluid/Blood Leak
Patient reported "lumps", "deflation" . This record is for the left side. Device remains implanted.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50410494 ↗InjuryAug 24, 2026Fluid/Blood Leak
Patient reported "lumps", "deflation" . This record is for the right side. Device remains implanted.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50410382 ↗InjuryAug 23, 2026Fluid/Blood Leak
Device has been explanted and replaced.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50395837 ↗InjuryAug 21, 2026Fluid/Blood Leak
Healthcare professional reported "deflation". This record is for the left side. The device remains implanted.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50379039 ↗InjuryAug 21, 2026Fluid/Blood Leak
Device has been explanted and replaced.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50371867 ↗InjuryAug 20, 2026Fluid/Blood Leak
Healthcare professional reported: "rupture". This record is for the left-side device. The device remains implanted.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50359836 ↗InjuryAug 20, 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 50355725 ↗InjuryAug 12, 2026Fluid/Blood Leak
Healthcare professional reported "Deflation" against the right side. The device was explanted.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50222710 ↗InjuryAug 11, 2026Fluid/Blood Leak
Later healthcare professional reported "hole in valve".
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50201470 ↗InjuryAug 6, 2026Fluid/Blood Leak
Healthcare professional reported "rupture" of a saline device. This record is for the left side. Device was explanted.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50159762 ↗InjuryAug 3, 2026Fluid/Blood Leak
Healthcare professional reported "Deflation". Later healthcare professional reported "leak". This record is for the right side. The device was explanted.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50122463 ↗InjuryJul 27, 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 50038161 ↗InjuryJul 27, 2026Fluid/Blood Leak
Healthcare professional reported "deflation". Later another healthcare professional reported "rupture". This record is for the left side. Device remains implanted.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50014790 ↗InjuryJul 20, 2026Fluid/Blood Leak
HEALTHCARE PROFESSIONAL REPORTED "BREAST IMPLANT RUPTURE". THIS RECORD IS FOR THE RIGHT SIDE. DEVICE REMAINS IMPLANTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25882642 ↗InjuryJul 20, 2026Fluid/Blood Leak
Healthcare professional reported of the right side device: "has a leak". Device has been explanted and replaced.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25873060 ↗InjuryJul 17, 2026Fluid/Blood Leak
HEALTHCARE PROFESSIONAL REPORTED "DEFLATION IMPLANT". THIS RECORD IS FOR THE LEFT SIDE. THE DEVICE HAS BEEN EXPLANTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25864305 ↗InjuryJul 8, 2026Fluid/Blood Leak; Device Appears to Trigger Rejection
Healthcare professional additionally reported "hole on patch side." The device has been explanted.
Patient problems: Capsular Contracture
MAUDE report 25748683 ↗InjuryJun 24, 2026Fluid/Blood Leak
Healthcare professional reported "deflation". This record is for the left side. The device was explanted.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25611576 ↗InjuryJun 24, 2026Fluid/Blood Leak
HEALTHCARE PROFESSIONAL REPORTED "DEFLATED SALINE IMPLANT". THIS RECORD IS FOR THE RIGHT SIDE. DEVICE REMAINS IMPLANTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25610385 ↗InjuryJun 24, 2026Fluid/Blood Leak
HEALTHCARE PROFESSIONAL REPORTED "DEFLATION". THIS RECORD IS FOR THE LEFT SIDE. THE DEVICE REMAINS IMPLANTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25609442 ↗
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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