Re: saline shell components

[Guest guest]

Here's a start on the shell...I'll keep looking for specifically

saline:

http://implants.clic.net/tony/Report/02.htm

McGhan Implants Ingredients from FDA ~ Chief of PS Devices

Date: Sunday, December 05, 1999 10:20 AM

Subject: McGhan Implants

Ms. Pyron:

Your e-mail dated November 25 regarding McGhan Medical breast

implants was forwarded to me. You had two inquiries: when your

implants were manufactured and what are the material constituents.

For the former, FDA does not have information on the date of

manufacture of implants based on lot numbers. For this you can

contact McGhan Medical in Santa Barbara, CA, 1-800-624-4261.

Regarding the materials, this style of implant has a silicone rubber

shell and is filled with silicone gel. The silicone rubber contains

the following substances:

1. small amounts (parts per million) of various smaller silicones.

2. small amounts (50 - 100 parts per million) of metals like tin and

platinum and very trace amounts of other metals.

3. trace amounts of volatile materials like xylene and other organic

compounds.

4. considerable amounts (approximately 20 parts per hundred) of

finely powdered silica that is tightly bound to silicone rubber

pouch.

The filler material contains silicone oil and silicone gel in

addition to the four materials (chemicals) listed above.

I hope this answers your questions.

Sincerely,

Chief, Plastic and Reconstructive Surgery Devices

--- In , " graceinlve " <graceinlve@...>

wrote:

>

> Does anyone know where i can find the typical make-up of

> chemical ingredients found in saline implant shells? I

> remember reading an email about it that was in " 48 reasons not

> to get a boob job " , but is not on his website. Any ideas?

>

> God Bless,

> Liz

>

[Guest guest]

This is not a list per se, but is a list of requirements to the FDA

for analysis of implants. Notice the mention of the heavy metals

used to cure the silicone into an elastomer shell. (Section 4.5)

http://www.fda.gov/cdrh/ode/guidance/1354.html

4. Chemistry Data

4.1 General Information

You should provide the following general information regarding the

chemicals/materials used in the manufacture of your breast implant:

the common names and trade names of each chemical/material

(including additives, plasticizers, and antioxidants)

the specific role of each chemical/material in the manufacturing

process and/or in the final device

the location of the material within the device (e.g., shell, filler,

valve, adhesive)

the chemical name, the mean molecular weight, and a measure of the

polydispersity for each polymeric component

material safety data sheets for each chemical

MAF numbers for each material, including specific volume and page

number references.

You should provide confirmation that the silica used in the

elastomer shell dispersion is in the amorphous form, rather than

crystalline form.

Sections 4.2 through 4.5 describe chemical analyses of the elastomer

shell, including the patch and valve. Sections 4.6 through 4.9

describe chemical analyses of the filler material. Changes in design

features, such as texturing, variations of device components, such

as patches or valves, or changes in sterilization may necessitate

additional analyses.

4.2 Extent of Crosslinking

The manufacture of the shell involves curing of polymeric components

of silicones by chemical crosslinking. You should provide the extent

of crosslinking from at least three different lots to confirm the

uniformity of the degree of crosslinking across lots. Suggested

methods to determine the degree of crosslinking include:

measurement of Young's modulus at low strain (this is approximately

proportional to crosslink density)

measurement of equilibrium swelling of the polymeric component by a

good solvent

determination of the amount of unreacted crosslinker from the total

extractables

any other acceptable scientific method.

You should also perform a Fourier Transform Infrared Spectroscopy

(FTIR) analysis on the cured polymer to confirm the presence of

silicone functional groups.

4.3 Extractables

An analysis of the extractable or releasable chemicals is necessary

to identify potentially toxic chemicals and estimate the upper

limits of the chemicals that could be released to the patient. The

following is one suggested method to obtain extractable data. You

should perform the extraction of the shell for chemical analyses

with at least one polar solvent (i.e., ethanol or a mixture of

ethanol-water) and two non-polar solvents (i.e., dichloromethane and

hexane) at 37°C. To determine the duration of the exhaustive

extractions, you should conduct a series of successive extractions

by exposing the sample to the solvent for a period of time,

analyzing the solvent for extractables, replacing with fresh

solvent, exposing the sample again for a period of time, analyzing,

and repeating the process. When the level of the analyte for the

extraction is one-tenth (0.1) the level in the previous extraction,

the extraction is deemed complete so that a 10% correction to the

total extractable material can be applied. In cases where this

condition may not occur because of extremely slow migration of the

higher molecular weight material, apply the test to the contents of

the extract with molecular weights of <=1500 Daltons because these

are the compounds of greatest interest. Add all separate analyte

levels to calculate the cumulative value and, via the sample/solvent

ratio, the sample and device levels. You should use the total

extraction from the polar solvent and the extraction from one of the

non-polar solvents that yields the higher amounts of extractables

for both quantitative and qualitative analyses. For extracts that

may contain oligomeric or polymeric species, you should provide the

molecular weight distribution, along with the number and weight

average molecular weights and the polydispersity. You should perform

an FTIR analysis on the extractable residuals.

You should provide the following data from the extractables:

identification and quantification of all compounds below a molecular

weight of <=1500 Daltons after exhaustive extraction of the final

sterilized shell. These include, but are not limited to:

- residual monomers, cyclic and linear oligo-siloxanes

- known toxic residues such as polychlorinated biphenyls (PCBs) if

peroxide curing process is involved

- aromatic amines if polyurethanes are used

the percent recovery, especially for the polydimethylsiloxanes (up

to D20)

evidence that shows that exhaustive extraction has been achieved

with one of the solvents

identification of all experimental methodology1 and provide raw data

(including instrument reports) with all chromatograms, spectrograms,

etc. You should also provide the practical quantitative limit when

the analyte of interest is not detected2.

---------------------------------------------------------------------

-----------

1For example: Gel Permeable Chromatography (GPC), Gas Liquid

Chromatography (GLC), Mass Spectometry (MS), Atomic Emission

Detector (AED), and FTIR.

2, L. Compilation of EPA's Sampling and Analysis Methods.

publishers, 1992.

4.4 Volatiles

You should analyze the elastomer shell for volatile components suing

a headspace detector.

4.5 Heavy Metals

You should provide qualitative and quantitative analyses for heavy

metals on the final finished shell. The heavy metal analyses should

include, but not be limited to, analyses of the following metals:

platinum (Pt); tin (Sn); zinc (Zn); chromium (Cr); arsenic (As);

lead (Pb); antimony (Sb); nickel (Ni); and copper (Cu). In addition,

for the metal used as the catalyst in the curing reaction, you

should provide the valence state and the amount of residue of the

catalyst.

In lieu of providing a complete heavy metal analysis on the finished

shell, you may provide the purity of the catalyst (with trace

elements) used in the raw shell material, along with an analysis of

the finished shell for just the catalyst metal used.

4.6 Saline Filler

Normal physiological sterile saline has a long history of use in

breast implants and is standardized by the USP. As stated above, the

sterile saline used with your implant should conform to USP

standards of Normal Physiological Saline (injection grade) which has

a concentration of 0.15M and a pH of 7.2-7.4. If your breast implant

is used with any other saline, provide a complete chemical analysis

of that saline.

--- In , " graceinlve " <graceinlve@...>

wrote:

>

> Does anyone know where i can find the typical make-up of

> chemical ingredients found in saline implant shells? I

> remember reading an email about it that was in " 48 reasons not

> to get a boob job " , but is not on his website. Any ideas?

>

> God Bless,

> Liz

>

[Guest guest]

Found it!

http://www.orgsites.com/fl/adjuvantdisease/_pgg3.php3

The chemical composition of a saline-filled breast implant consists

of the following:

Filler-The filler of a saline-filled breast implant is sterile

saline.

Shell-The shell of a saline-filled breast implant has the following

composition:

1. 80% high molecular weight silicones

2. 20% finely powdered silica

3. catalyst: small amounts (50-100 parts per million) of a tin or

platinum

4. impurities:

-small amounts of (1-500 parts per million) of various smaller

silicones

-trace amounts of (<5 parts per million) of volatile (readily

evaporating) materials like xylene and other organic compounds

(impurities)

-trace amounts (<5 parts per million) of metals (impurities).

The shell of a saline-filled breast implant and the shell of a

silicone gel-filled breast implant have the same general chemical

composition.

--- In , " graceinlve " <graceinlve@...>

wrote:

>

> Does anyone know where i can find the typical make-up of

> chemical ingredients found in saline implant shells? I

> remember reading an email about it that was in " 48 reasons not

> to get a boob job " , but is not on his website. Any ideas?

>

> God Bless,

> Liz

>