TPLC - Total Product Life Cycle

• Device: prosthesis, breast, inflatable, internal, saline
• 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)
2019	2020	2021	2022	2023	2024
5	7	9	4	6	4

MDR Year	MDR Reports	MDR Events
2019	15444	15444
2020	14022	14022
2021	11355	11355
2022	13660	13660
2023	11040	11040
2024	7131	7138

Device Problems	MDRs with this Device Problem	Events in those MDRs
Fluid/Blood Leak	26278	26278
Material Rupture	26219	26219
Adverse Event Without Identified Device or Use Problem	11776	11776
Device Appears to Trigger Rejection	5225	5225
Patient-Device Incompatibility	2937	2937
Deflation Problem	1316	1316
Migration	734	734
No Apparent Adverse Event	363	363
Insufficient Information	304	304
Appropriate Term/Code Not Available	212	212
Peeled/Delaminated	139	139
Detachment of Device or Device Component	110	110
Off-Label Use	103	103
Unintended Deflation	98	105
Improper or Incorrect Procedure or Method	91	91
Connection Problem	87	87
Device Handling Problem	84	84
Microbial Contamination of Device	80	80
Break	66	66
Use of Device Problem	58	58
Device Contamination with Chemical or Other Material	49	49
Patient Device Interaction Problem	48	48
Gel Leak	47	47
Loss of or Failure to Bond	44	44
Burst Container or Vessel	43	43
Nonstandard Device	38	38
Failure to Fold	30	30
Defective Device	29	29
Material Split, Cut or Torn	28	28
Material Deformation	26	26
Material Discolored	25	25
Material Perforation	24	24
Inflation Problem	23	23
Leak/Splash	22	22
Defective Component	21	21
Air/Gas in Device	19	19
Short Fill	19	19
Difficult to Open or Remove Packaging Material	13	13
Migration or Expulsion of Device	13	13
Contamination /Decontamination Problem	13	13
Device Dislodged or Dislocated	11	11
Malposition of Device	11	11
Material Invagination	9	9
Material Integrity Problem	7	7
Unsealed Device Packaging	6	6
Infusion or Flow Problem	6	6
Contamination of Device Ingredient or Reagent	6	6
Device Contaminated During Manufacture or Shipping	5	5
Device Damaged Prior to Use	5	5
Product Quality Problem	4	4

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
Failure of Implant	31345	31352
Capsular Contracture	12876	12876
Deformity/ Disfigurement	11178	11178
No Code Available	10437	10437
Pain	2086	2086
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	1574	1574
Seroma	1470	1470
No Clinical Signs, Symptoms or Conditions	976	976
Autoimmune Reaction	821	821
Breast Discomfort/Pain	775	775
Unspecified Infection	742	742
Insufficient Information	646	646
Wrinkling	516	516
Autoimmune Disorder	516	516
Fatigue	467	467
Lymphoma	442	442
Swollen Lymph Nodes/Glands	424	424
Breast Mass	417	417
No Known Impact Or Consequence To Patient	359	359
Swollen Lymph Nodes	298	298
Anxiety	284	284
Headache	281	281
Arthralgia	266	266
Hair Loss	251	251
Inflammation	242	242
Depression	235	235
Local Reaction	230	230
Injury	210	210
Weight Changes	189	189
Rash	188	188
Cancer	188	188
Neurological Deficit/Dysfunction	175	175
Memory Loss/Impairment	175	175
Cyst(s)	171	171
Sleep Dysfunction	168	168
Post Operative Wound Infection	167	167
Hypersensitivity/Allergic reaction	160	160
Cognitive Changes	151	151
Paresthesia	145	145
Numbness	145	145
Crushing Injury	144	144
Skin Irritation	130	130
Dyspnea	125	125
Calcium Deposits/Calcification	119	119
Granuloma	118	118
Anaplastic Large Cell Lymphoma	113	113
Palpitations	112	112
Tinnitus	111	111
Swelling	111	111
Confusion/ Disorientation	109	109

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