Quick Links: Skip to main page content
Skip to Search
Skip to Topics Menu
Skip to Common Links
U.S. Food & Drug Administration
Follow FDA
En Español
Search FDA
Home
Food
Drugs
Medical Devices
Radiation-Emitting Products
Vaccines, Blood & Biologics
Animal & Veterinary
Cosmetics
Tobacco Products
TPLC - Total Product Life Cycle
FDA Home
Medical Devices
Databases
-
510(k)
|
DeNovo
|
Registration & Listing
|
Adverse Events
|
Recalls
|
PMA
|
HDE
|
Classification
|
Standards
CFR Title 21
|
Radiation-Emitting Products
|
X-Ray Assembler
|
Medsun Reports
|
CLIA
|
TPLC
New Search
show TPLC since
2006
2007
2008
2009
2010
2011
2012
2013
2014
2015
2016
2017
2018
2019
2020
2021
Back to Search Results
Device
prosthesis, breast, noninflatable, internal, silicone gel-filled
Regulation Description
Silicone gel-filled breast prosthesis.
Definition
Call for pmas to be filed by 7/9/91 per 56 fr 14627 on 4/10/91
Product Code
FTR
Regulation Number
878.3540
Device Class
3
Premarket Approvals (PMA)
2016
2017
2018
2019
2020
2021
20
33
11
14
10
1
MDR Year
MDR Reports
MDR Events
2016
289
289
2017
927
927
2018
2635
2635
2019
21365
21365
2020
24231
24231
2021
6228
6228
Device Problems
MDRs with this Device Problem
Events in those MDRs
Material Rupture
24754
24754
Adverse Event Without Identified Device or Use Problem
15829
15829
Patient-Device Incompatibility
14086
14086
Device Appears to Trigger Rejection
2277
2277
Migration
1062
1062
Gel Leak
333
333
Insufficient Information
265
265
No Apparent Adverse Event
228
228
Appropriate Term/Code Not Available
199
199
Off-Label Use
170
170
Fluid Leak
148
148
Migration or Expulsion of Device
118
118
Break
103
103
Material Deformation
85
85
Material Discolored
71
71
Improper or Incorrect Procedure or Method
68
68
Leak/Splash
59
59
Device Contamination with Chemical or Other Material
54
54
Nonstandard Device
50
50
Malposition of Device
44
44
Device Dislodged or Dislocated
26
26
Short Fill
24
24
Defective Device
22
22
Delivered as Unsterile Product
21
21
Material Protrusion/Extrusion
14
14
Device Handling Problem
14
14
Device Operates Differently Than Expected
11
11
Inadequacy of Device Shape and/or Size
11
11
Product Quality Problem
11
11
Device Markings/Labelling Problem
11
11
Material Integrity Problem
11
11
Defective Component
10
10
Loss of or Failure to Bond
9
9
Use of Device Problem
9
9
Deflation Problem
8
8
Structural Problem
8
8
Biofilm coating in Device
8
8
Contamination /Decontamination Problem
7
7
Manufacturing, Packaging or Shipping Problem
7
7
Device Contaminated During Manufacture or Shipping
6
6
Contamination
6
6
Peeled/Delaminated
6
6
Shipping Damage or Problem
6
6
Microbial Contamination of Device
5
5
Unsealed Device Packaging
5
5
Burst Container or Vessel
5
5
Positioning Problem
5
5
Unintended Movement
4
4
Contamination of Device Ingredient or Reagent
4
4
Material Invagination
4
4
Therapeutic or Diagnostic Output Failure
4
4
Material Split, Cut or Torn
4
4
Noise, Audible
3
3
Patient Device Interaction Problem
3
3
Folded
3
3
Unintended Ejection
3
3
Degraded
3
3
Material Separation
3
3
Device Issue
3
3
Tear, Rip or Hole in Device Packaging
3
3
Air/Gas in Device
3
3
Scratched Material
2
2
Fungus in Device Environment
2
2
Dent in Material
2
2
Device Ingredient or Reagent Problem
2
2
Connection Problem
2
2
Metal Shedding Debris
2
2
Component Missing
2
2
Material Too Rigid or Stiff
2
2
Material Puncture/Hole
2
2
Material Disintegration
2
2
Explanted
2
2
Hole In Material
2
2
Melted
2
2
Deformation Due to Compressive Stress
2
2
Material Twisted/Bent
2
2
Measurement System Incompatibility
1
1
Optical Discoloration
1
1
Packaging Problem
1
1
Expulsion
1
1
Gas Leak
1
1
Inadequate Instructions for Non-Healthcare Professional
1
1
Detachment of Device or Device Component
1
1
Application Security Problem
1
1
Split
1
1
Unintended Deflation
1
1
Material Opacification
1
1
Device Expiration Issue
1
1
Crack
1
1
Air Leak
1
1
Difficult to Remove
1
1
Incorrect, Inadequate or Imprecise Resultor Readings
1
1
Out-Of-Box Failure
1
1
Incomplete or Missing Packaging
1
1
Material Perforation
1
1
Device Misassembled During Manufacturing /Shipping
1
1
Extrusion
1
1
Compatibility Problem
1
1
Incorrect Device Or Component Shipped
1
1
Device Displays Incorrect Message
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
Capsular Contracture
25324
25324
No Code Available
13547
13548
Failure of Implant
13204
13204
Seroma
3499
3499
Pain
3118
3119
Unspecified Infection
1292
1292
Fatigue
1018
1019
Deformity/ Disfigurement
989
989
Autoimmune Reaction
931
931
Swollen Lymph Nodes
907
907
Inflammation
537
537
Anxiety
530
530
Breast Mass
529
529
Lymphoma
528
528
Headache
522
523
Granuloma
509
509
Hair Loss
502
503
Arthralgia
492
492
Anaplastic Large Cell Lymphoma
492
492
Wrinkling
404
404
Depression
389
389
Weight Changes
373
373
Memory Loss/Impairment
370
371
Rash
361
362
Autoimmune Disorder
324
325
Injury
319
319
Swelling
312
312
Sleep Dysfunction
295
295
Neurological Deficit/Dysfunction
292
292
Hematoma
286
286
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
280
280
Palpitations
270
271
Wound Dehiscence
262
262
Local Reaction
261
261
Skin Irritation
246
246
Hypersensitivity/Allergic reaction
245
245
Numbness
241
241
No Known Impact Or Consequence To Patient
237
237
Confusion/ Disorientation
233
233
Cognitive Changes
229
229
Thyroid Problems
221
221
Dyspnea
220
220
Cyst(s)
216
216
Complaint, Ill-Defined
212
212
No Consequences Or Impact To Patient
209
209
Chest Pain
192
192
Impaired Healing
190
190
No Patient Involvement
188
188
Blurred Vision
182
182
Tingling
177
177
Sweating
177
178
Necrosis
173
173
Tinnitus
164
164
Cancer
162
162
Dry Eye(s)
160
160
Burning Sensation
159
159
Vertigo
154
154
Dizziness
146
146
Itching Sensation
135
136
Nausea
124
124
Swollen Lymph Nodes/Glands
121
121
Emotional Changes
114
115
Myalgia
114
114
Weakness
108
108
Foreign Body Sensation in Eye
101
101
Visual Impairment
99
99
Increased Sensitivity
99
99
Toxicity
97
97
Edema
97
97
Insufficient Information
96
96
No Clinical Signs, Symptoms or Conditions
93
93
Fungal Infection
87
87
Rheumatoid Arthritis
84
84
Neck Pain
83
83
Muscle Weakness
80
80
Discomfort
78
78
Malaise
77
77
Scarring
76
76
Fever
76
76
Cellulitis
74
74
Test Result
74
74
Patient Problem/Medical Problem
69
69
Death
69
69
Calcium Deposits/Calcification
68
68
Arthritis
64
64
Lupus
62
62
Raynauds Phenomenon
61
61
Abdominal Distention
60
60
High Blood Pressure/ Hypertension
59
59
Bacterial Infection
59
59
Dehydration
56
56
Pocket Erosion
56
56
Visual Disturbances
56
56
Bruise/Contusion
55
55
Fluid Discharge
54
54
Paresthesia
54
54
Abscess
53
53
Crushing Injury
53
53
Muscle Spasm(s)
51
51
Abdominal Pain
50
50
Recalls
Manufacturer
Recall Class
Date Posted
1
Allergan PLC
III
Dec-18-2019
2
Allergan PLC
I
Sep-11-2019
3
Mentor Texas, LP.
II
Aug-03-2016
-
-