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Artikelen FDA:

Confidential, Trade secret. Report 246 Gelbleed study 

Core study of the safety and effectiviness of Mentor gel-filles mammary protheses  

Premarket approval application Mentor Low - Bleed mammary protheses 2002 

Adjunct Study Protocol 

Saliine filled breast implants 

40 rapporten   Siltex 

10 rapporten over Siltex 

6 rapporten over Siltex

 

Schadeclaims (bij scheuren e.d)



Samenstelling Mentor implantaten

Volatile Results

Compound Shell

to Gel (ppm)

Not Exposed to Gel (ppm)

 

Shell Exposed

to gel (ppm)

 

Gel Filler  (ppm)

 

Whole Device

(ppm)

D3

ND

0.19

0.18

0.18

D4

<0.06

0.23

0.49

0.46

D5

0.28

0.79

1.60

1.47

Methoxytrimethylsilane

3.13

3.34

ND

0.43

Dimethoxydimethylsilane

ND

0.20

ND

0.03

Methoxytriethoxysilane

0.04

ND

ND

ND

Tetramethyldiethyldisiloxane

ND

ND

0.05

0.04

Acetone

1.02

1.38

ND

0.18

Isopropanol

<1.06

2.03

ND

0.26

2-Pentanone

0.05

ND

Nd

ND

Methyl Butanoate

0.04

ND

0.09

0.01

Ethylbenzene

<0.01

ND

BD

ND

m- & p-xylene

0.06

ND

<0.09

0.08

4-Methyl-3-penten-2-one

0.07

0.08

ND

0.01

o-xylene

<0.02

ND

ND

ND

Alpha- Pinene

<0.02

ND

ND

ND

Cyclohexanone

<0.56

ND

ND

ND

1-Ethyl-2-methylbenzene

0.02

0.06

ND

0.01

Decane

0.09

ND

ND

ND

Benzaldehyde

0.04

0.08

ND

0.01

1,3,5-Trimethylbenzene

0.04

0.04

ND

0.01

Limonene

0.02

0.05

ND

0.01

Undecane

1.39

<0.45

<0.34

0.35

Acetophenone

0.03

0.06

ND

0.01

Dodecane

3.00

<0.55

ND

0.07

 

 

 

 

 

Total Volatiles

<<11.07

<10.16

<2.84

3.67