NATRELLE Saline-Filled Breast Implants 68-510Recalls & reported problems
Allergan, Inc. · NATRELLE Style 68MP-510 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 has 271 reports, with no deaths and 268 injuries. Most describe the implant deflating or leaking, sometimes with a rupture or tear, and some describe the implant being removed. Some describe the scar tissue around the implant tightening. 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
- 297
- Deaths reported
- 0
- Injuries reported
- 294
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 297 adverse event reports that list this exact device (DI 10888628000285), received between Jul 18, 2017 and Sep 30, 2026 — classified as 294 injuries, 3 malfunctions.
The most frequently reported specific device problem is “Fluid/Blood Leak” (269 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 Leak269
- Device Appears to Trigger Rejection23
- Patient-Device Incompatibility13
- Deflation Problem7
- Break3
- Material Rupture3
- No Apparent Adverse Event3
- Improper or Incorrect Procedure or Method2
Patient problems
- Failure of Implant231
- No Clinical Signs, Symptoms or Conditions37
- Capsular Contracture34
- Seroma2
- Unspecified Infection2
- Foreign Body Reaction1
- Impaired Healing1
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 25 most recent of 297 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 right side. Device was explanted.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50950160 ↗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 50943518 ↗InjurySep 30, 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 50943195 ↗InjurySep 28, 2026Fluid/Blood Leak
Healthcare professional reported "deflated saline implant". Later healthcare professional reported "any creases associated with hole". This record is for the left side. The device was explanted.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50921708 ↗InjurySep 25, 2026Fluid/Blood Leak
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50902962 ↗InjurySep 25, 2026Fluid/Blood Leak
Healthcare professional reported "rupture". Later 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 50900157 ↗InjurySep 25, 2026Device Appears to Trigger Rejection
Healthcare professional reported a "Capsular Contracture Baker Grade III ". This record is for the right side. The device remains implanted.
Patient problems: Capsular Contracture
MAUDE report 50899144 ↗InjurySep 23, 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 50874050 ↗InjurySep 23, 2026Fluid/Blood Leak
Healthcare professional reported a "deflation". This record is for the right side. The device was explanted.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50868792 ↗InjurySep 17, 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 50801751 ↗InjurySep 16, 2026Malposition of Device
Patient reported "deflation". Healthcare professional later reported "settling and malposition" and "this implant was intact". This record is for the right side. The device was explanted.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50791963 ↗InjurySep 16, 2026Fluid/Blood Leak; Malposition of Device
Patient reported "no complaint against the device". Healthcare professional later reported "settling and malposition" and "deflated". This record is for the left side. The device was explanted.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50791666 ↗InjurySep 15, 2026Fluid/Blood Leak
Healthcare professional reported "no complaint". Later, 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 50777638 ↗InjurySep 15, 2026Fluid/Blood Leak
Healthcare professional reported "deflation". Later healthcare professional reported "deflation-valve strap failure". This record is for the right side. Device was explanted.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50768670 ↗InjurySep 10, 2026Fluid/Blood Leak
Device has been explanted.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50721847 ↗InjurySep 8, 2026Fluid/Blood Leak
The device has been explanted.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50670789 ↗InjurySep 7, 2026Fluid/Blood Leak
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50658896 ↗InjuryAug 27, 2026Fluid/Blood Leak
Healthcare professional reported "deflation". Later healthcare professional reported "valvular leak". This record is for the left side. The device was explanted.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50473244 ↗InjuryAug 26, 2026Fluid/Blood Leak
Healthcare professional reported "sudden deflation". This record is for the right side. Device remains implanted.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50453011 ↗InjuryAug 24, 2026Material Rupture
Healthcare professional reported "deflation". Healthcare professional later reported "Any creases". This record is for the left side. The device was explanted.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50408969 ↗InjuryAug 14, 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 50259191 ↗InjuryAug 13, 2026Fluid/Blood Leak; No Apparent Adverse Event
Healthcare professional reported "deflation". This record is for an unknown side. The device remains implanted.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50236524 ↗InjuryAug 10, 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 50193307 ↗InjuryAug 7, 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 50173481 ↗InjuryAug 5, 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 50150392 ↗
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-0336-06 · Dec 14, 2005 · TerminatedMcGhan Style 468-380cc Saline-Filled BIOCELL textured Breast Implants, Catalog Number:468-380
- Z-0337-06 · Dec 14, 2005 · TerminatedMcGhan Style 163-360cc Saline-Filled BIOCELL textured Breast Implants, Catalogue Number :163-360
- 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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