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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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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 CodeFTR
Regulation Number 878.3540
Device Class 3

Premarket Approvals (PMA)
2007 2008 2009 2010 2011 2012 2013 2014 2015 2016 2017
5 7 4 2 2 7 12 19 28 20 29

Device Problems
Material rupture 397
Not Applicable 305
Patient-device incompatibility 166
Implant, removal of 57
Electro-magnetic interference (EMI) 37
No Known Device Problem 35
Rupture, cause unknown 34
Migration of device or device component 26
No code available 21
Fluid leak 18
No Information 15
Gel leak 14
Folded 8
Delivered as unsterile product 6
Break 6
Item contaminated during manufacturing or shipping 6
Elective replacement 5
Device expiration issue 5
Malposition of device 5
Device Issue 4
Explanted 4
Elective removal 3
Deflation, cause unknown 3
Foreign material present in device 3
Material deformation 2
Degraded 2
Contamination during use 2
Leak 2
Device, or device fragments remain in patient 2
Replace 1
Decreased pump speed 1
Rupture due to trauma 1
Shipping damage or problem 1
Use of Device Issue 1
Rupture due to capsulotomy 1
Extrusion 1
Fracture 1
Augmentation, loss of 1
Calcified 1
Clumping in device or device ingredient 1
Component(s), broken 1
Incorrect device or component shipped 1
Total Device Problems 1206

Recalls
  2007 2008 2009 2010 2011 2012 2013 2014 2015 2016 2017
Class I 0 0 0 0 0 0 0 0 0 0 0
Class II 0 0 0 0 0 0 0 0 0 1 0
Class III 0 0 0 0 0 0 0 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 Mentor Texas, LP. II Aug-03-2016

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