TPLC - Total Product Life Cycle

• Device: prosthesis, breast, inflatable, internal, saline
• Regulation Description: Silicone inflatable breast prosthesis.
• Definition: Call for PMAs to be filed by 11/17/99 per 64 FR 45161 on 8/19/99
• Product Code: FWM
• Regulation Number: 878.3530
• Device Class: 3

Premarket Approvals (PMA)
2017	2018	2019	2020	2021	2022	2023	2024	2025	2026
14	6	5	7	9	4	6	7	6	2

MDR Year	MDR Reports	MDR Events
2017	4487	4592
2018	13223	13392
2019	15465	16034
2020	14022	14220
2021	11350	11467
2022	13641	13816
2023	10640	10726
2024	9448	9477
2025	8858	8861
2026	4794	4794

Device Problems	MDRs with this Device Problem	Events in those MDRs
Fluid/Blood Leak	42357	42399
Material Rupture	35901	36031
Adverse Event Without Identified Device or Use Problem	14282	14324
Device Appears to Trigger Rejection	7322	7367
Patient-Device Incompatibility	4105	4110
Migration	1157	1161
No Apparent Adverse Event	840	845
Deflation Problem	583	584
Appropriate Device Problem Term/Code Not Available	326	328
Insufficient Device Problem Information	313	313
Malposition of Device	294	294
Peeled/Delaminated	173	174
Unintended Deflation	159	159
Detachment of Device or Device Component	144	144
Migration or Expulsion of Device	141	141
Improper or Incorrect Procedure or Method	132	132
Connection Problem	131	131
Use of Device Problem	129	129
Device Handling Problem	119	121
Off-Label Use	118	118
Break	106	106
Microbial Contamination of Device	88	88
Device Contamination with Chemical or Other Material	86	88
Difficult to Open or Remove Packaging Material	55	55
Gel Leak	51	51
Loss of or Failure to Bond	47	47
Patient Device Interaction Problem	45	45
Material Discolored	32	33
Material Deformation	32	32
Failure to Fold	30	30
Defective Device	29	29
Material Split, Cut or Torn	29	29
Device Dislodged or Dislocated	27	27
Material Perforation	25	25
Air/Gas in Device	22	22
Defective Component	21	21
Folded	20	20
Short Fill	19	19
Material Invagination	17	17
Component Missing	14	14
Contamination /Decontamination Problem	10	10
Contamination of Device Ingredient or Reagent	9	9
Material Integrity Problem	9	9
Infusion or Flow Problem	8	8
Device Contaminated During Manufacture or Shipping	8	8
Unsealed Device Packaging	8	8
Inflation Problem	7	7
Device Damaged Prior to Use	7	7
Deformation Due to Compressive Stress	6	6
Leak/Splash	6	6

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
Failure of Implant	47304	47417
Capsular Contracture	18266	18462
No Code Available	15243	15409
Deformity/ Disfigurement	15100	15156
Pain	2606	3252
No Clinical Signs, Symptoms or Conditions	2492	2502
Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available	2038	2104
Seroma	1756	1770
Unspecified Infection	1091	1188
Breast Discomfort/Pain	1075	1092
Autoimmune Reaction	950	1025
Insufficient Information	745	757
Wrinkling	701	704
Fatigue	651	1258
Autoimmune Disorder	635	815
Complaint, Ill-Defined	612	687
Lymphoma	572	581
Breast Mass	554	574
No Known Impact Or Consequence To Patient	442	452
Swollen Lymph Nodes/Glands	431	453
Anxiety	382	719
Headache	362	698
Inflammation	351	622
Swollen Lymph Nodes	344	400
Hair Loss	333	649
Arthralgia	330	651
Depression	309	594
Local Reaction	262	265
Rash	262	504
Weight Changes	256	508
Memory Loss/Impairment	235	466
Cancer	226	260
Sleep Dysfunction	225	443
Neurological Deficit/Dysfunction	222	263
Cyst(s)	221	280
Ptosis	220	221
Injury	212	217
Hypersensitivity/Allergic reaction	210	348
Post Operative Wound Infection	202	206
Calcium Deposits/Calcification	194	204
Numbness	194	399
Paresthesia	193	199
Cognitive Changes	193	362
Anaplastic Large Cell Lymphoma	186	213
No Consequences Or Impact To Patient	176	177
Crushing Injury	169	169
Palpitations	164	336
Confusion/ Disorientation	163	325
Skin Irritation	159	198
Swelling	151	312

Recalls
Manufacturer		Recall Class	Date Posted
1	Allergan PLC	III	Dec-18-2019
2	Allergan PLC	I	Sep-11-2019
3	Ideal Implant Incorporated	II	Aug-08-2019
4	Mentor Texas, LP.	II	Dec-10-2021
5	Mentor Texas, LP.	II	May-11-2017