NATRELLE Saline-Filled Breast Implants 68HP-350Recalls & reported problems
Allergan, Inc. · NATRELLE Sty 68HP-350 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 Allergan NATRELLE saline breast implant is a saline-filled device placed in the breast. Of its 275 reports, 267 are injury reports and 8 are malfunction reports, with no deaths. Most describe the implant deflating or leaking, and some describe hardening of the scar tissue around it. Some reports say the implant was removed and 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
- 288
- Deaths reported
- 0
- Injuries reported
- 280
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 288 adverse event reports that list this exact device (DI 10888628000407), received between Jul 25, 2017 and Sep 30, 2026 — classified as 280 injuries, 8 malfunctions.
The most frequently reported specific device problem is “Fluid/Blood Leak” (214 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 Leak214
- Device Appears to Trigger Rejection43
- Patient-Device Incompatibility15
- Adverse Event Without Identified Device or Use Problem7
- Material Rupture6
- No Apparent Adverse Event6
- Break5
- Deflation Problem4
Patient problems
- Failure of Implant198
- Capsular Contracture56
- No Clinical Signs, Symptoms or Conditions28
- Unspecified Infection5
- No Known Impact Or Consequence To Patient3
- Abscess2
- Inflammation2
- Swollen Lymph Nodes2
Recent adverse event reports
The 25 most recent of 288 reports, in the reporter's own words as published by the FDA.
InjurySep 30, 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 50946939 ↗InjurySep 29, 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 50934499 ↗InjurySep 28, 2026Fluid/Blood Leak
Healthcare professional reported "rupture". This record is for the left side. Device has been explanted.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50912137 ↗InjurySep 25, 2026Fluid/Blood Leak
Patient reported "rupture Deflation". This record is for the right side. The device remains implanted.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50899412 ↗InjurySep 25, 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 50896819 ↗InjurySep 24, 2026Device Appears to Trigger Rejection
Healthcare professional reported "Capsular contracture" Baker Grade IV and "Pain". This record is for the left side. Device remains implanted.
Patient problems: Capsular Contracture
MAUDE report 50889528 ↗InjurySep 16, 2026Fluid/Blood Leak
Healthcare professional reported "deflation". Later healthcare professional reported "breast was smaller" and "valve failed". This record is for the right side. The device was explanted.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50788954 ↗InjurySep 14, 2026Fluid/Blood Leak
Patient reported "not good", "deflation" and "hurt, very painful". This record is for the left side. The device remains implanted.
Patient problems: Breast Discomfort/Pain
MAUDE report 50762278 ↗InjuryAug 27, 2026Fluid/Blood Leak
Patient reported "boob went flat", "I think it had a slow leak for ten years", "had half a boob", "over an inch", "woke up in the morning and the rest of it was gone". This record is for the left side. Device remains implanted.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50476614 ↗InjuryAug 25, 2026Fluid/Blood Leak
Patient reported "deflation". This record is for left side. The device remains implanted.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50435001 ↗InjuryAug 20, 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 50357768 ↗InjuryAug 19, 2026Fluid/Blood Leak
Healthcare professional reported "Deflation". The record is for the right side. The device remains implanted.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50331137 ↗InjuryAug 11, 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 50215197 ↗InjuryAug 7, 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 50177420 ↗InjuryAug 4, 2026Fluid/Blood Leak
Patient reported "leak" and "visibly leaking". Later 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 50136395 ↗InjuryJul 31, 2026Fluid/Blood Leak
Device has been explanted and replaced.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50101558 ↗InjuryJul 31, 2026Device Appears to Trigger Rejection
Healthcare professional reported "scar tissue contracture, painful Beaker III/IV encapsulation, "hardening of the supralateral axillary region and thickening of the pectoralis mayor muscle with painful breast deformity", "double-bubble breast deformity", "decreased size" and "upper pole fullness". This record is for the right side. Device was explanted.
Patient problems: Capsular Contracture
MAUDE report 50101242 ↗InjuryJul 31, 2026Fluid/Blood Leak; Device Appears to Trigger Rejection
Healthcare professional reported "scar tissue contracture, painful Beaker IV encapsulation, possibly deflating "[side]" prothesis", "hardening of the supralateral axillary region and thickening of the pectoralis mayor muscle with painful breast deformity", "double-bubble breast deformity", "decreased size" and "upper pole fullness". This record is for the left side. Device was explanted.
Patient problems: Capsular Contracture
MAUDE report 50101240 ↗InjuryJul 16, 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 25843898 ↗InjuryJun 22, 2026Malposition of Device; Migration
HEALTHCARE PROFESSIONAL REPORTED VIA NATIONAL BREAST IMPLANT REGISTRY (NBIR) MANUFACTURER REGISTRY SPECIFIC DATA REPORT (MRSDR) "DEVICE MIGRATION/IMPLANT MALPOSITION". THIS RECORD IS FOR THE RIGHT SIDE. DEVICE WAS EXPLANTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25578654 ↗InjuryJun 5, 2026Fluid/Blood Leak
Patient reported "no complaint against the device". Healthcare Professional later reported "deflation". Healthcare professional later reported "L. Rupture" and removal of intact implant. This record is for the left side. Device was explanted.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25407161 ↗InjuryJun 2, 2026Fluid/Blood Leak
Device has been explanted and replaced.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25362732 ↗InjuryMay 21, 2026Fluid/Blood Leak
PATIENT REPORTED "DEFLATION" AND "CREASE" FOUND VIA MAMMOGRAM. THIS RECORD IS FOR THE LEFT SIDE. THE DEVICE REMAINS IMPLANTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25241828 ↗InjuryApr 8, 2026Fluid/Blood Leak
HEALTHCARE PROFESSIONAL REPORTED "SALINE RUPTURE". THIS RECORD IS FOR THE LEFT SIDE. DEVICE REMAINS IMPLANTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24821951 ↗InjuryMar 20, 2026Fluid/Blood Leak
HEALTHCARE PROFESSIONAL REPORTED "DEFLATION". THIS RECORD IS FOR THE RIGHT SIDE. THE DEVICE REMAINS IMPLANTED.
Patient problems: Failure of Implant
MAUDE report 24651742 ↗
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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