Breast implant articles . . . very interesting! - What your doctor should know!

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Page 51

Analytical and Bioanalytical Chemistry

Publisher: Springer-Verlag Heidelberg

ISSN: 1618-2642 (Paper) 1618-2650 (Online)

DOI: 10.1007/s00216-004-2714-y

Issue: Online First

Original Paper

Platinum concentration in silicone breast implant

material and capsular tissue by ICP-MS

S. V. M. Maharaj

(1)

Department of Chemistry, American University,

Washington, DC 20016, USA

Received: 5 January 2004 Revised: 28 May 2004

Accepted: 7 June 2004 Published online: 8 July 2004

Abstract Inductively coupled plasma-mass spectrometry

(ICP-MS) was used to determine the concentration of

platinum (Pt) in silicone breast implant gel (range,

0.26?48.90 g g?1 Pt; n=15), elastomer (range,

3.05?28.78 g g?1 Pt; n=7), double lumen (range,

5.79?125.27 g g?1 Pt; n=7), foam (range, 5.79?8.36 g

g?1 Pt; n=2), and capsular tissue (range, 0.003?0.272

g g?1 Pt; n=15). The results show that very high

levels of Pt are present in the encasing elastomer,

double lumen, and foam envelope materials. Silicone

breast implants can be a source of significant Pt

exposure for individuals with these implants.

Keywords Platinum - Breast implants - Silicone -

Polydimethylsiloxane - PDMS - ICP-MS

Page 52

Last update: August 27, 2004 at 7:06 AM

Platinum may leak from breast implants

http://www.startribune.com/stories/1556/4950348.html

Greg Gordon, Star Tribune Washington Bureau

Correspondent

August 27, 2004 IMPLANT0827

WASHINGTON, D.C. -- New research presented Thursday

could lend

credence to allegations that silicone gel breast

implants have leaked toxic forms of platinum into the

bodies of women and then reached their breast-fed

children.

The reactive platinum, unlike other inert platinum in

the body, can cause various forms of neurological

damage and asthma-like allergic reactions, said Ernest

Lykissa, a Houston clinical toxicologist who

co-authored the paper.

Maharaj, a chemist at American University,

detailed the findings to an American Chemical Society

meeting in Philadelphia.

Lykissa, who four years ago disclosed some of his

preliminary research to the Star Tribune, said the

paper presented Thursday reported sharply higher

levels of reactive platinum in the blood and urine of

10 women who had implants than in five control

subjects. While the sample size is small, he said in a

phone interview, the results reflect those in similar

tests he has since performed on hundreds of women.

Lykissa said that his research also has been confirmed

by a group of German scientists and that it offers an

explanation for many of the illnesses alleged by

hundreds of thousands of women who received silicone

gel implants.

Kathleen Quinn, a spokeswoman for the Food and Drug

Administration (FDA), said the agency " is not able to

comment ... at this time " on the paper. The FDA

declined last winter to lift a 12-year-old moratorium

and allow Santa Barbara, Calif.-based INAMED Corp. to

put silicone breast implants back on the U.S. market.

INAMED grew from a former subsidiary of

Maplewood-based 3M, which got out of the breast

implant business in 1984 and has paid more than $1

billion to settle suits over its products.

Dan Cohen, INAMED's vice president for global

government affairs, said he would not " dismiss [the

new study] until I've had the chance to have our

scientists review it. "

But, he said, the company has seen " no peer-reviewed,

credible data that would support Mr. Lykissa's claim. "

Cohen said the FDA's letter rejecting INAMED's

petition to fully

market its silicone breast implants included " no

discussion of the platinum issue. "

Page 53

A catalyst

INAMED and the California-based Mentor Corp. continue

to sell silicone gel implants for use in

reconstructive surgery for breast cancer victims or

for women volunteering for clinical studies.

Silicone implant makers have used platinum for decades

to produce a catalyst. The catalyst causes silicone

oil to thicken into a gel.

At issue is whether platinum left over from those

reactions is inert or reactive and whether it leaks

into women's bloodstreams if the implants rupture.

Some government scientists have expressed concern that

not all of the platinum from the manufacturing process

would be neutralized.

Lykissa said reactive platinum " is notorious for

attacking nerve

endings and interfering with the nerve impulses to the

brain. " Women he has examined, he said, suffer from

pain in their fingers and toes, have ticks in their

eyes, memory lapses and equilibrium or eyesight

imbalances.

" The children that we tested that I have seen have all

suffered from hearing and eye problems " after being

breast fed. " There were platinums detected in the

breast milk of those mothers,' " Lykissa said.

Greg Gordon is at ggordon@....

Page 54

Industry insiders said that certifications for

platinum levels & safety were falsified.

It was mentioned in depositions as well.

Anal Bioanal Chem. 2003 Feb;375(3):356-62. Epub 2003

Jan 28.

Determination of siloxanes, silicon, and platinum in

tissues of women with silicone gel-filled implants.

Flassbeck D, Pfleiderer B, Klemens P, Heumann KG,

Eltze E, Hirner AV.

Institute of Environmental Analytical Chemistry,

University of Essen, Germany.

Silicone [poly(dimethylsiloxane)] gel used in breast

implants has been known to migrate through intact

silicone elastomer shells, resulting in the clinically

observable " gel bleed " on the implant surface.

Although silicon concentrations in capsular tissues of

women with silicone prostheses have been measured with

element-specific silicon analyses, no

silicone-specific investigation of these tissues has

been performed as yet.A combination of

element-specific inductively coupled plasma

high-resolution isotope dilution mass spectrometry

(ICP-HR-IDMS) and species-specific gas chromatography

coupled mass spectrometry (GC-MS) was used to analyze

silicon, platinum, and siloxanes in prosthesis

capsule, muscle, and fat tissues of women (n=3) who

had silicone gel-filled breast implants and in breast

tissue of non-augmented women (n=3) as controls.In all

tissues of augmented women, siloxanes, in particular

octamethylcyclotetrasiloxane (D4),

decamethylcyclopentasiloxane (D5), and

dodecamethylcyclohexasiloxane (D6) were identified.

Depending on the siloxane species and type of tissue

analyzed, siloxane levels in the range of about

10-1,400 ng g(-1) were detected; total silicon was

found in all tissue samples in the range of about

8,900-85,000 ng g(-1). Higher platinum levels ranging

from 25-90 ng g(-1 )were detected in fibrin layer and

fat tissue of two patients with prostheses. No

siloxanes were detected in control breast tissue

samples.This investigation of human tissues by a

combination of element-specific and species-specific

analytical techniques clearly demonstrates for the

first time that platinum and siloxanes leak from

prostheses and accumulate in their surrounding

tissues.

PMID: 12589499 [PubMed - indexed for MEDLINE]

Page 55

Medline Abstract

Masanori Hashimoto, Akira Yokota, Eiichirou Urasaki,

Shuhji Tsujigami, and Masayuki Shimono

A case of abdominal CSF pseudocyst associated with

silicone allergy.

Childs Nerv Syst, March 4, 2004; .

Abstract

MatchMaker

Department of Neurosurgery, University of Occupational

and Environmental Health, Iseigaoka 1-1, 807-8555,

Yahata-Nishi, Kitakyushu, Japan.

Download to Citation Manager

PubMed Citation

Related Articles in PubMed

CASE REPORT. The authors present a case of a patient

with an abdominal CSF pseudocyst that resulted from an

allergic reaction to silicone. The patient underwent

repair surgery of the meningomyelocele associated with

the Chiari II malformation, and the V-P shunt was

instituted at 6 months of age. A formation of the

abdominal CSF pseudocyst and the consequent shunt

malfunction were observed 40 days after the V-P shunt.

An increase in the number of the peripheral

eosinophils and serum immunoglobulin E (IgE), and an

infiltration of eosinophils in the specimen harvested

from the pseudocyst wall suggested an allergic

reaction as the cause of the pseudocyst. A sixth

operation to revise the V-P shunt was performed using

the shunt system made of 'extracted silicone', which

was produced extracting the allergic substances.

OUTCOME. The serum IgE was normalized after surgery

and the abdominal CSF pseudocyst has not recurred for

22 months.

PMID: 14999512

Page 56

DO SILICONE IMPLANTS INCREASE THE RISK OF SYSTEMIC

LUPUS ERYTHEMATOSUS

(SLE)IN CHILDREN?

Jerry C. os, Imundo. Columbia University

College of Physicians and Surgeons, New York, NY.

10032, P. Chander. New York Medical College, Vahalla,

NY. 10595

Silicone breast implants have been reported to

increase the risk for development of autoimmune

disease in adults. We report the occurrence of

systemic lupus erythematous in two children, a 15 year

old boy in 1992, 12 years after a silicone

testicular prosthesis was implanted In the scrotum for

cosmetic reasons (unilateral cryptorchidism), and a 10

year old girl in 1981, two years after a silicone

scleral sponge was implanted in her eye (retinal

detachment). Both developed lupus nephritis requiring

treatment with prednisone and azathioprine to control

their disease. 2/50 children who have had renal

biopsies for lupus nephritis at

Babies Hospital between 1977-19933 have had silicone

implants prior to their developing SLE.

In addition, we have examined a silicone testicular

implant electively removed from an asymptomatic 7 year

old boy and demonstrated significant granular mural

small vessel staining with anti-sera to IgM. mild

staining with anti-IgG and minimal staining with

anti-IgA, C1 and C3 in the fibromuscular tissue.

These observations, although limited, suggest

development of lupus in children in association with

silicone implants at sites other than the breast.

Page 57

Microbial growth inside saline-filled breast implants

Plast Reconstr Surg. 1997 Jul;100(1):182-96.

Microbial growth inside saline-filled breast implants.

Young VL, Hertl MC, Murray PR, Jensen J, Witt H,

Schorr MW.

Division of Plastic and Reconstructive Surgery,

Washington University School of Medicine, St. Louis,

Mo., USA.

In vitro and in vivo experiments were conducted to

determine whether intraluminal saline in breast

implants can support the growth of common

wound-infecting microorganisms over a prolonged period

of time. The bacteria tested were Staphylococcus

aureus, Staphylococcus

epidermidis, Escherichia coli, Corynebacterium

jeikeium, Enterobacter cloacae, Klebsiella pneumoniae,

and Pseudomonas aeruginosa. Three fungal species also

were tested:

Aspergillus fumigatus, Paecilomyces variotii, and

Candida albicans. In the in vitro study, four

organisms survived in flasks of sterile saline for the

2 weeks in which serial cultures were performed: K.

pneumoniae, C. albicans, A. fumigatus, and P.

variotii. In the in vivo study, 61 white rabbits (122

implants) received both an experimental implant

inoculated with one of the test organisms and a

control implant containing only sterile saline. They

were sacrificed at 1-, 3-, or 6-month scheduled

endpoints. None of the control implants containing

sterile saline had positive cultures. In contrast, the

intraluminal saline was culture positive for 7 of the

10 inoculated organisms after varying lengths of time:

S. epidermidis, E. coli, E. cloacae, K. pneumoniae, P.

aeruginosa, A. fumigatus, and P. variotii. Samples of

capsular tissue also were cultured. Of the 122

capsular tissue specimens, 21 (17 percent) had

positive cultures and surrounded both inoculated and

sterile implants. In most instances, capsules that

were culture positive contained an organism different

from the one that had been inoculated in the group. In

only 3 cases was the same organism cultured from both

the periprosthetic tissue and the intraluminal saline,

and these may represent instances of the inoculated

organism migrating through the implants filler valves.

The data show that several types of bacteria

(particularly gram-negative species) and fungi can

grow and reproduce in a restricted saline environment

for extended periods of time.

PMID: 9207676 [PubMed - indexed for MEDLINE]

http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve & db=pubmed & dopt=Abstra\

\

ct & list_uids=9207676

Page 58

Saline Implants have leaky valves, shell defects

(rupture). Micro Organisms accumulate over many years.

As a result, with time, the closed space fills with a

complex mixture of bacteria, fungi, algae, and slimes

Organisms Found In Such Environments Include:

Pseudomonas Aeruginosa, Pseudomonas Putida,

Streptococci, Spivarum, CoccidioidesImmitis,

Papilloma Viri, Herpes Simplex, Aspergillus

Fumigatus, Aspergillus Boufardi, Aspergillus Niger,

Bacteroides Fragillis, Curvularia, Staphylococci,

Mycobacterium Chelonei, Mycobacterium Fortuitum,

Mycobacterium Tuberculosis, Mycobacterium Avium,

Alternaria Tenuis, Rhodotorula Glutinis, Penicillium

Notatum, Microsporum Epidermophyton, Ricophyton,

Candida Albicans, Proteus Mirabillis, Propioni

Bacterium Acne, Serratia Marcescens as well as their

metabolites and toxins

Page 59

Date: Sat Feb 12, 2005 12:34 am

Subject: Toxic Shock Syndrome and implants

Here it is, in black and white....pathogens have the

ability to traverse the elastomer shell of implants!

Case Report Toxic Shock Syndrome as a Complic­ation of

Breast

Prostheses Ann. Plast. Surg. Vol. 96, No. 7 1706 1995

Patient, Age 21-Year-Old Female 1994

History s/p bilateral augmentation mammaplasty,

Presenting Symptoms On POD 6, vomiting, weakness,

fever, ras­h

PROSTHESIS TYPE SALINE

Outcome Bilateral transmetacarpal amputations,

bilateral bel­ow-knee amputations. (She improved after

the removal of her legs and­ part of her hands) [Tell

her how safe Saline implants are] It goes on to say

In­ 1988, Nordstrom et al. mentioned a case of

Serratia marcescens infection of a t­issue expander

(saline type of implant) used for postmastectomy

breast reco­nstruction. As in our patient, bacteria

were cultured from both the periprosth­etic fluid and

the SALINE WITHIN THE IMPLANT. The exact relationship

between ba­cteria inoculation within or about an

implant and the origin of the infection r­emains a

mystery.

The ability of bacteria to traverse the membrane

elastomer a­ppears to hold the key to understanding

this pathologic process. The permeabili­ty of silicone

(saline) implants to substances or organisms occurs by

means­ of two proposed mechanisms. Either a substance

can diffuse directly though t­he membrane elastomer

(as with ether, lidocaine, iodine, steroids, and

c­ertain antibiotics) or it must leak though holes in

the membrane or fill ports.

Page 60

http://www.medicalnewstoday.com/medicalnews.php?newsid=19472

Infection in breast implants, The Lancet

01 Feb 2005

Breast augmentation is the most frequent type of

plastic surgery done in the UK and - after nose

reshaping and liposuction - it is the third most

common cosmetic procedure in the USA.

See The Lancet Infectious Diseases, February 2005,

pages 94-106

However, infection complicates 2-2•5% of breast

implantations, and is the leading cause of illness

following such surgery. The comprehensive review in

The Lancet Infectious Diseases of infection of breast

implants is particularly timely in light of the recent

call for tighter regulation of the private cosmetic

surgery industry in the UK.

Professor Brigitte Pittet (Plastic and Reconstructive

Surgery Unit, University of Geneva Hospitals, Geneva,

Switzerland) and colleagues provide a fascinating

journey through the history of breast implants and

review the myriad risk factors for breast implant

infections, before discussing clinical features such

as toxic shock syndrome and late infection occurring

months - or even years - after implantation.

Diagnostic and management strategies are proposed for

such problems.

In addition, they discuss the idea that capsular

contraction - the leading long-term complication that

follows breast implantation, involving the formation

and contraction of a collagenous sheath around the

implant, thus forming hard, spherical masses in the

breasts - may be caused by subclinical infection, and

could be prevented by antibiotics.

Brigitte Pittet comments: “Patients should be aware

that, similar to other invasive procedures involving

the implantation of foreign material, breast implants

may lead to potential complications such as infection

or capsular contracture. In good hands, however,

infection remains infrequent.”

Contact: Professor Didier Pittet, Infection Control

Programme, University of Geneva Hospitals, 24 Rue

Micheli-du-Crest, 1211 Geneva 14, Switzerland. Tel +41

22 372 9828; fax +41 22 372 3987

http://www.thelancet.com

Page 61

234,187 Adverse Reports to FDA on Breast Implants ...

as of 30 Apr 2002

234,187 Adverse Reports to FDA on Breast Implants.

http://www.fda.gov/cdrh/osb/asr.html

You can go here:

http://www.fda.gov/medwatch/report/consumer/consumer.htm

From: Henrietta Farber <hfarb...@...>

Dear Ilena,

After all these weeks, I have finally gotten the

report from the FDA MedWatch program as to the data on

the number of adverse incidents on breast implants

reported in the year 2000 and 2001. I asked for the

most recent data.

That information is now available on the net by

clicking o

n the website Press hyperlinked. You then go to

chart #3.

So the sum total from the last report of 195,202

(including 123 deaths which were not reported here) is

now

234,187 Adverse Reports!

I added up the number for the last quarter 1999,

all 2000+the

first quarter 2001=36,089!

36,089 ADVERSE REPORTS TO THE FDA in the last two

years!

The grand total 234,187--AND THAT'S OK? (no report

of the deaths)

Please note all the questions I posed to Mr.

Press (e-mail h...@...) and got a two

sentence answer!

Love, Henrietta

From: " Press, A. " <H...@...>

" 'Henrietta Farber' " <hfarb...@...>

http://www.fda.gov/cdrh/osb/asr.html

Page 62

From: Myrl (myrlj@...)

Subject: An internal memorandum that discloses the

" Dow Strategy " for the Breast Implant Cover-Up

Date: 2004-10-18 21:50:53 PST

From anonymous sister - scanned but not corrected -

possibly from the Catch files.

This is an internal memorandum that discloses the " Dow

Strategy " for the Breast Implant Cover-Up.

June 24, 1991

It has been two weeks since we had the great session

with the BOD at which time they pointed out some of

the problems we were facing and suggested ways we

might get beyond them. This communication is intended

to simply summarize where I feel we are.

The issue of " cover-up " is going well from a long-term

perspective are moving rapidly ahead on our press

conference, and all things appear to be in place for

that with the exception of the University of Michigan

study being

finalized. I did talk to four other presidents of the

main breast implant manufacturers on Friday, and they

have given us the go-ahead on discussing the NYU

Study. I asked Tony Getty from Mentor if he was going

to participate in the University of Michigan Study,

and he said he was not sure but would respond early

this week for a final resolution. Jan Varner said

McGhan will go with us regardless.

The issue of the Breast Implant Communications Center

is almost completely put to bed at this point. It will

be very tight for our July 8 deadline in terms of

having letters out and having all the printed material

ready. The final sign-off is today, June 24. The

selection of people is completed and

the training will begin this week.

The number one issue in my mind is the establishment

of networks. I believe we have made no progress in

two weeks. Obviously, this is the largest single issue

on our platter because it affects not only the next

2-3 years profitability of DCC, but also ultimately

has a big impact on the long-term

ethics and " believability " issues. If we do not win

this one, or at least minimize the financial impact

that our people are able to achieve, you can forget

about whether we have done all these other things

correctly.

I know I am the " Lone Ranger " after all of our

sessions on this, but I still believe appointing

Burnett full time to do nothing but

" orchestrate " the NETWORKS is absolutely critical! I

still favor having somebody who has

Page 63

" moxie " and judgment skills which are excellent to be

turned loose to make the contacts to " get the ball

rolling " This is critical to the patient community.

While I have no problem with your approach, Barie, of

turning it over to Burston Marstellar, it is a very

sterile approach in the final analysis. I believe we

can make faster progress on our own, even without all

the communication documents established since the

early part of the job is primarily getting contacts

and establishing some believability as a person. It

takes a lot of time to do this, and it is going to

take someone like Burnett, as good as he is, a fair

mount of time just to get in motion.

It has become obvious to me that what is at risk here

is somewhere between $50 million and $500 million.

Right now, I think we are losing the " time race " badly

in this critical area, and I believe that the amount

of money we are going to lose is increasingly rapidly

since we are not going to be in a position to divert

the opposing forces into the directions we want soon.

The latest information that July 5 will be a day when

a legal firm in Chicago makes an announcement they

have 25 women assembled who will be suing all breast

implant manufacturers is just another example of how

good Wolfe is in knowing when our " red-letter days "

are, and anticipating and meeting

them with excellent counter strategies. I fear that if

he can pull it off, he may have a multi-city

announcement which we are not aware of at this point.

In talking to the other companies, they were not aware

of the Chicago announcement, and did not know of any

others beside the California group. I hope this is

true, because we would be ill-prepared in terms of

counter measures through the grass roots system to try

to present a counter prospective.

I have started to initiate the " surgeon contact

sessions " by getting the people at DOW together

tomorrow for an extensive development of a plan of how

we want to organize the plastic surgery community and

involve our ITSA organization, which should be

extremely effective in this. Also, I am

beginning to line up the price discussion that is

desperately needed so we present a " uniform picture "

to the outside community.

Finally, I have been in contact with Dick Hazelton,

Colin Rowland and Alain Jacquin from Europe concerning

strategies there. I believe they are in good shape at

this point, but it will be critical to get them

rolling. I understand, Barie, you have contacted

Dean, and he will be attending the press conference. I

think this is good, because at this point in time

after talking with the sales representatives in

Europe, I am convinced they do not have the same

problem yet. We obviously have a chance to get in

front there, and stay there.

As far as Australia is concerned, I am out of data at

this point, but will get caught up. The place we have

the biggest " hole " still missing and two weeks behind

from the time we got the word from McKannan, is

in this whole arena of getting a patient grass roots

movement going. I will keep working diligently and as

much as needed to help us get to " the other side, " but

I am very worried

Page 64

From: Myrl (myrlj@...)

Subject: 1992/MFGs paid Millions/Secret Agreements -

from the evidentiary files of breast implant

litigation

Date: 2004-05-21 06:56:08 PST

Thanks to Pam Dowd for sending the following from the

evidentiary

files of breast implant litigation. . .Myrl

PUBLICATION Montreal Gazette

PUBLICATION DATE Sat 15 Feb 92

EDITION FINAL

BYLINE PATRICIA ANSTETT

SECTION NEWS

CompuServe Mail

PAGE Al2

Breast-implant firms paid millions to settle suits;

Lawyers say

settlements are secret because of court gag orders

over decade

DETROIT - Dow Corning and other breast-implant

manufacturers have paid millions of dollars in

out-of-court breast-implant settlements over the last

decade, buying silence about implant problems through

strict secrecy agreements that keep vital health

information from the public, lawyers say.

" Had this stuff been made public, there would have

been hundreds of women today that would have never had

those implants, " said Kotoske, a Palo Alto,

Calif. lawyer. He has settled about 100 breast implant

lawsuits since 1980, nearly all covered by secrecy

agreements.

Next week, some expert witnesses bound for years by

these legal

agreements will give testimony to a U.S. Food and Drug

Administration panel. They say they no longer have to

keep quiet since Dow Corning of Midland, Mich.,

released many top-secret documents Monday.

Kotoske has won two lawsuits that breast implant

manufacturers filed, alleging he broke secrecy

agreements. He was one of more than a dozen lawyers

interviewed nationwide who have settled out of court

with manufacturers of saline-filled and silicone-gel

implants. Michigan lawyers and expert witnesses told

of being involved in more than 50 such cases. Hundreds

of other lawsuits are pending, including more than a

dozen filed in Detroit or consolidated in Chicago

yesterday.

" One of the reasons this information has taken so long

to get to the public is because of Dow Corning's use

of protective orders, " said lawyer Feldstein,

who settled a case with Dow Corning.

McKeenon, Dow Corning's new chief executive

officer, disputed estimates of hundreds of

settlements.

~Ms

Page 65

From: Myrl (myrlj@...)

Subject: What Dow Knew and When They Knew It:

Date: 2004-10-16 20:57:44 PST

What Dow Knew and When

WHAT Dow Chemical Knew and When They Knew It:

From: Court Documents, Internal Corporate Memos

1950: Silicones later used in breast implants by Dow

Corning were

bioreactive, immunogenic, toxic, and inflammatory in

the human body.

1954: Dr. Spencer of Dow Chemical reported that

chemical compounds of silicone gel are highly toxic.

1955: Dr. Rowe of Dow Chemical reports that materials

of implant

shells cause diffuse cellular infiltrates and

fibrocystic changes in the lungs and organs of

animals.

1956: Dow Chemical study of the biological effects of

Octamethylcyclotetrasiloxane (D4), the building block

of silicone gel used in implants, found if

administered orally or by intramuscular injection, led

to traces of siloxans throughout the bodies of

laboratory animals that caused a slight initial weight

loss and moderate liver pathology.

1956: Dow Chemical study of D4 found that it had a

biological effect on the eye and that contact would

cause painful irritation of the conjuntival membranes.

Nine Dow Chemical reports indicated in test results

that D4 caused irritation to the eyes and skin. One

report indicated that the silicone fluid caused

hyperemia, edema, and geneal skin rawness in all

cases.

1956: Dow Chemical funded a research project with the

University of Miami in which results found that a

silicone compound (Z04141) caused deposits of silicone

in the livers of laboratory rats, a fact not mentioned

in the final report.

1957: Dow Corning report sent to Dow Chemical reports

that: Dow

Corning Fluid 200 was absorbed through the skin and

found in the

adrenal and kidneys of laboratory rabbits.

1961: Dow Chemical tested Dow Corning Fluid 200 when

it was heat

treated. The fluid caused death in all but one

laboratory rat in the test. Irritation of the

respiratory tract was given as the cause of death.

The Dow Chemical Company, parent company of the

leading manufacturer of silicone breast implants, Dow

Corning, researched the health effects of exposure to

commercial silicones as early as the 1940's. (See

below: a partial quote of Dow Chemical Co.'s own

report in the Journal of Industrial Hygiene and

Toxicology by Drs. Spencer and Rowe of Dow Chemical,

published in 1948. Dow Chemical and Dow Corning also

conducted secret research in the 1960s that revealed

that certain silicone compounds possessed sufficient

biological activity to have potential uses as

pharmaceuticals. Specifically, the research showed

that silicones could affect the central nervous

system. The companies pursued the

development of silicone-based drugs for central

nervous system

disorders. Out of this research, the companies'

scientists also learned that silicone compounds could

affect the immune system.

Page 66

Heyer-Schulte, a subsidiary of American Hospital

Supply Corp., Dow Corning, Bristol Meyers, 3-M, the

Veterans Hospital (which did testing for them), the

FDA (who was warned many times but allowed these

manufacturers to set their own guidelines ignored

complaints and warnings from around the world about

leaking implants for 30 years. A 1975 Dow Corning memo

(and other implant manufacturers internal memos) state

that demonstration implants were bleeding and

instructed sales staff to wash the implants with soap

and water and towel dry them

before letting doctors handle them. The Plastic

Surgeons Society was well aware of the bleeding and

failure rate and wrote warning letters to these

companies.

A 1977 memo relates how a Dow Corning employee told

plastic surgeons with crossed fingers that Dow Corning

too had an active

contracture/gel migration study underway. This

apparently satisfied them for the moment, but one of

these days they will be asking us for the results of

our studies. In fact, Dow Corning was not studying

contracture, a complication that occurs when the scar

around the implant contracts.

In 1983, Dow Corning's head of biomaterial safety

wrote top

company management: However, I want to emphasize that

to my knowledge, we have no valid long-term implant

data to substantiate the safety of gels for long-term

implant use. This statement was made twenty-one (21)

years AFTER Dow Corning first put silicone implants on

the market and assured women that implants were safe.

In a 1987 study, the Medtox Project Report, Dow

Corning acknowledged that the chronic reactions to

silicones seen in test animals could trigger

autoimmune-type diseases in humans.

In a Bristol-Meyers Squibb document from 1985, a

company employee

states: Polurethanes have no real history of

implantation without

deterioration and we know deterioration products of

polyurethanes are toxic and in come cases

carcinogenic. Whether they are released in such low

levels as to be no threat to the human only time will

tell.

A 1976 3-M (Minnesota Mining and Manufacturing)

document states that: It appears virtually no

documented safety and efficacy data exists on (Don

McGhan's) implant products. McGhan's breast implant

company, McGhan Medical Corp., was purchased by 3-M.

The McGhan Corp., Don McGhan, spun off from

Heyer-Schulte. Heyer-Schulte Corp., spun off from Dow

Corning. (See inspection photos of Corning Glass Works

and Dow Chemical owners (Amory Houghton and CEO,

Armistead and Dow Chemical at Dow Corning

Plant.) Dr. Kessler, Commissioner of the Food

and Drug Administration, reiterated in testimony

before Congress in August, 1995, that the law requires

manufacturers to prove affirmatively, with valid

scientific data evaluated by the FDA, that their

devices are safe and effective. The manufacturers have

consistently failed to comply. Now they are bullying

Dr. Kessler as they have all the previous FDA

Commissioners.

Dr. Kessler wrote in the Journal of the American

Medical

Association in 1993 that: the adverse effects data on

silicone get implants submitted by the manufacturers

were so poor that the FDA could not determine where

these devices were safe and effective. He

Page 67

added that the manufacturers' documents suggested that

there were inadequate quality control procedures to

prevent safety problems and that problems had been

evident for years.

Saline breast implants were never approved. There have

been seven

saline breast implant deaths. Three employees of

Heyer-Schulte breast implant manufacturing company

died of human adjuvant disease and cancer in handling

silicone. Manufacturers told women that implants would

last a lifetime and that ruptures occurred less than 1

percent of the time. Studies published in the American

Journal of Radiology in 1992 and the ls of Plastic

Surgery in 1995 reveal a rupture rate of 51 percent.

A third study, published in Plastic and Reconstructive

Surgery in

1993, ties rupture to the age of the implant. Of

implants aged one to nine years, 35.7 percent had

ruptured. Of those aged 10 to 17 years, 95.7 percent

had ruptured. The FDA's own implant rupture rate on

microfiche illustrates this rupture rate.

The Food and Drug Commissioner, Dr. Kessler

wrote in the Journal of the American Medical

Association in 1993 that: Even with a conservative

rupture rate, some 75,000 of the 1 to 2 million women

(actually the number turned out to be only around

600,000,) would be at risk for potentially serious

adverse health effects. That is NOT a safety standard

that the FDA can accept.

Page 68

Dow Corning Knew. . .

1968 Silicone Compounds Kill Roaches.

Dow Corning has always insisted that the silicone gel

in its breast implants was biologically inert, meaning

that it cannot harm the body. Unfortunately, their

own internal documents reveal that for almost thirty

years, they've been lying.

Soon after Dow Corning began marketing the implants,

they tested the silicone gel for use as an

insecticide. They had discovered that the silicone

killed roaches. They also explored using silicone

compounds to control fleas, lice, and weevils.

And Dow hid other vital information. Dow filed a

study claiming that four dogs used in a 1970

experiment showed no adverse effects six months after

being implanted with silicone. But Dow never reported

that two years after implantation, one dog was dead

and the other three developed a chronic inflammation

indicative of immune system problems, and similar to

an affliction now seen in women with implants. If

only Dow had told the truth then.

In another experiement, male rabbits were swabbed with

silicone. Reports show the rabbits developed a " trend

toward testicular atrophy. " Biologically inert?

At one time, Dow actually considered selling a

silicone compound as a potent stimulator of the the

human immune system. And a 1985 secred Dow report

says: " The preponderance of available animal data also

suggests a potential for silicone materials to be

involved in immunologically mediated disease states. "

Today, as more and more women are suffering

immune-related disease, Dow Corning has created a

smokescreen of flawed science. Meanwhile, a growing

and largely ignored body of scientific literature

bears out what Dow Corning's own research revealed

thirty years ago--silicone implants rupture, silicone

implants leak, silicone migrates throughout the body.

Indeed, these implants contain a biologically active

material that can affect the human immune system.

Dow Corning has always insisted that the silicone gel

in its breast implants was biologically inert, meaning

that it cannot harm the body. Unfortunately, their

own internal documents reveal that for almost thirty

years, they've been lying.

Soon after Dow Corning began marketing the implants,

they began testing the silicone gel inside for use as

an insecticide. They had discovered that the silicone

killed roaches. They also explored using silicone

compounds to control fleas, lice, and weevils.

Page 69

And Dow hid other vital information. Dow published a

study claiming that four dogs used in a 1970

experiment showed no adverse effects six months after

being implanted with silicone.. But Dow never

reported that two years after implantation, one dog

was dead and the other three developed a chronic

inflammation indicative of immune system problems, and

similar to an affliction now seen in women with

implants. If only Dow had told the truth then.

In another experiment, male rabbits were swabbed with

silicone. Reports show the rabbits developed a " trend

toward testicular atrophy. " . . .Biologically inert?

__________________

Dow studies I-IV: Effects of Silicone on: mealy bugs,

cockroaches, mites and aphids (DCC-0160011144-47).

" cockroaches went into the silicone fluid...never got

more than a few inches from the dish before dying. "

Dow study IV (1968): Effects of Silicone Oils on

Cochroaches (DCC-016001147).

" Insecticidal activity against several insect species

has been demonstrated... " " Organosilicon Insect

Toxicants, " LVier, Dow Corning Corpation Research

Department, January 16, 1987.

" After 2 years, the normal health of the dogs was

confirmed by close examination. " " Toxicologic studies,

quality control, and efficacy of the Silastic mammary

prosthesis. " on and Braley, Medical Products

Business, Dow Corning Corporation. Association for

the Advancement of Medical Instrumentation,

March-April 1973; 7(2); 100-103.

" One dog, No. 5904F, died during the 48th week of

study. " Another dog, " showed a 3 to 4+ acute and

chronic inflammatory cell reaction " and " ...slight

connective tissue reaction about the implant with

inflammatory reactions. " Two-year Studies with

Miniature Silastic Mammary Implants. (TX 202A and TX

202B) in Dogs, " submitted to Dow Corning Corporaton,

April 20, 1970.

" All animals except controls showed a trend toward

testicular atrophy. " Dow Corning memo from K.J. Olson

to E.E. Frisch, June 10, 1969

Page 70 -71-72-73

CHRONOLOGY OF FDA ACTIVITIES RELATED TO BREAST

IMPLANTS

May 28, 1976: The Medical Device Amendments were

enacted, giving FDA authority to regulate medical

devices such as breast implants, which were already on

the market.

July 23, 1976: The FDA General and Plastic Surgery

Devices Panel (referred to as the Panel) recommended

that breast implants be placed in class II,18

requiring general controls and performance standards.

January 19, 1982: Because of some reports of adverse

events in the medical literature, FDA announced a

proposal to place breast implants in class III. Class

III devices have stringent controls for safety and

effectiveness.

June 24, 1988: FDA classified all breast implants into

class III. After prescribed waiting period of 30

months, FDA could require the submission of premarket

approval applications (PMAs) in which manufacturers

present data showing the safety and effectiveness of

these devices.

January - March 1989: An unpublished study showed that

polyurethane foam, which was used as a coating on

certain types of silicone gel-filled breast implants,

would degrade and release 2-toluene diamine (TDA), a

chemical known to cause cancer in animals, under

conditions of high temperature and alkalinity. FDA

requested specific information from the manufacturer

about the chemical composition and safety testing of

polyurethane foam. Shortly afterwards, the

manufacturer of polyurethane-coated breast implants

removed them from the market

May 17, 1990: FDA issued a proposed 515( regulation

(call for safety and effectiveness data) in the

Federal Register on silicone gel-filled implants.

April 10, 1991: FDA published a final 515(

regulation in the Federal Register that required

manufacturers of silicone gel-filled implants to

submit PMAs with data showing the safety and

effectiveness of the implants by July 9, 1991.

June 1991: FDA required the manufacturer of

polyurethane-coated implants to conduct research on

the material. In taking this action FDA made the first

use of new postmarket surveillance authority under the

Safe Medical Devices Act of 1990.

July 31, 1991: The Panel reviewed FDA's risk

assessment of polyurethane foam coating. The Panel

found that the risk of cancer, if any, appears minimal

and would very likely be outweighed by the surgical

risk involved in removing a polyurethane-coated

implant.

August 22, 1991: FDA determined that PMAs submitted by

three manufacturers of silicone gel-filled implants

did not contain sufficient data to warrant a full

review. v September 26, 1991: FDA issued a Notice in

the Federal Register requiring dissemination of

information to patients on the risks associated with

breast implants.

November 12-14, 1991: FDA convened the Panel to

consider whether the PMA data received from the

manufacturers was sufficient to establish that the

silicone gel-filled implants are safe and effective.

Despite the lack of data, the Panel voted unanimously

to advise FDA that the implants filled a public health

need and should continue to be available while the

manufacturers collected additional data.

January 6, 1992: FDA called for a moratorium on the

use of silicone gel-filled implants until new safety

information could be thoroughly reviewed by the Panel.

February 18, 1992: The Panel met again to review new

information on silicone gel-filled implants. This

included case reports of autoimmune diseases;

information not included in the manufacturers'original

submissions to FDA; and evidence that some early

models may have leaked excessively.

March 19, 1992: Dow Corning withdrew from the silicone

implant market, but continued to supply gel to one

implant manufacturer.

April 16, 1992: FDA lifted the moratorium on breast

implants and announced its decision to allow silicone

gel-filled implants on the market only under

controlled clinical studies for reconstruction after

mastectomy, correction of congenital deformities, or

replacement for ruptured silicone gel-filled implants

for augmentation. FDA denied applications for using

silicone breast implants for augmentation but planned

that the manufacturers would later conduct clinical

trials that would include a limited number of

augmentation patients (the stage 3 or core studies).

April 16, 1992: FDA authorized limited distribution of

reconstructive silicone gel-filled implants on an

urgent need basis along with a very detailed informed

consent form.

July 24, 1992: FDA approved Mentor Corporations stage

2 or adjunct study protocol for silicone gel-filled

implants for reconstruction only.

December 1992: Dow Corning announced that it will no

longer make five implant grades of silicone for sale

after March 31, 1993, but that it will continue to

manufacture 45 other medical grades of silicone

materials.

January 8, 1993: FDA published a 515( proposal in

the Federal Register calling for safety and

effectiveness data for saline-filled implants. The

proposal provided for a 60-day comment period.

June 2, 1994: FDA sponsored a Part 15 Hearing on

saline breast implants to hear testimony from all

interested parties concerning the timing of the

agency's review of the safety and effectiveness of

saline-filled breast implants. FDA promised to make a

decision by the end of the year.

July 15, 1994: FDA granted conditional approval of a

pilot study of 50 patients for a breast implant filled

with a purified form of soybean oil.

October 21, 1994: FDA sponsored a workshop entitled,

Alternatives to Silicone Breast Implants. The workshop

provided a forum for FDA to present draft guidance

concerning testing requirements for alternative breast

implants.

December 23, 1994: FDA issued a Talk Paper describing

the types of studies required to demonstrate the

safety and effectiveness of saline breast implants,

and when the studies are expected to be completed.

Pre-clinical data were submitted throughout 1995, and

final clinical data are expected by early 1999.

April 20, 1995: FDA updated the Patient Information

Sheet on saline breast implants that manufacturers

give to physicians who, in turn, provide them to

patients considering implant surgery. The Information

Sheet lists known and unknown risks.

January 11, 1996: FDA sends a letter to current and

potential manufacturers of silicone gel-filled breast

implants detailing the type of information needed for

core studies (stage 3 studies) of both augmentation

and reconstruction patients with the silicone

gel-filled implants.

September 4, 1996: FDA cleared Poly Implants

Prostheses (PIP) for marketing of saline breast

implants through the 510(k) process.

September 19, 1996: FDA received a Citizen's Petition

from the Y-Me National Breast Cancer Organization and

other related organizations requesting that the FDA

ease restrictions on the availability of silicone

gel-filled breast implants for women who choose

reconstruction after a mastectomy and who have other

special medical needs.

February 11, 1997: FDA received a Citizen's Petition

from implant recipients (who reported significant

problems with their silicone implants) requesting that

the FDA revoke the manufacturers' permission to make

silicone gel-filled breast implants available to women

with breast cancer and women who previously had

implants.

May 20, 1997: FDA cleared Hutchinson International for

marketing of saline breast implants through the 510(k)

process. FDA is currently working with saline breast

implant manufacturers to submit staged submissions of

preclinical and clinical data in anticipation of the

call for PMAs in late 1998.

October 15, 1997: FDA sent letters in response to the

two Citizen's Petitions dated 9/19/96 and 2/11/97. The

FDA responded to both petitioners that we do not, at

this time, have sufficient information to change the

current regulatory policy on silicone gel implants.

FDA noted the petitioners' numerous concerns, and

stated that the combination of available literature,

updated PMA applications and additional ongoing

studies should permit FDA to make a thorough

evaluation of the safety and effectiveness of silicone

gel-filled breast implants.

The FDA is conducting a study to assess the rupture

rate of silicone gel-filled breast implants. This

study will include more than 1200 women, and medical

records will be sought if their breast implants have

been explanted. A sub-group of women who still have

their implants will receive MRI to determine if the

implants are intact. This study began in early 1998.

The Department of Health and Human Services (DHHS)

asked the Institute of Medicine (IOM) to conduct an

independent, unbiased review of all past and ongoing

scientific research regarding the safety of silicone

breast implants A committee of experts in relevant

scientific and clinical areas will evaluate past and

ongoing studies of the relationship, if any, between

implants and systemic disease; assess the biologic and

immunologic effects of silicone and other chemical

components of breast implant; and assess the impact of

breast implants, if any, on the offspring of women

with implants or the accuracy of mammograms. For more

information, visit the IOM website at

http://www2.nas.edu/hpdp/22f6.html

March 30, 1998: FDA approved McGhan Medicals Stage 2

or Adjunct study protocol for silicone gel-filled

breast implants for reconstruction only.

May 6, 1998, Mentor Corporation and its subsidiary,

Mentor Texas, signed a consent decree of permanent

injunction, promising that the company would

manufacture its breast implants in compliance with the

Quality System Regulation.

June 5, 1998, FDA approved McGhan medical's IDE study

for silicone gel-filled breast implants for

augmentation, reconstruction, and revision for a

limited number of patients at a limited number of

sites.

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*FDA has three regulatory categories for medical

devices. Class I and class II are for devices whose

safety and effectiveness are well-established. Class I

devices are simple devices whose risks can be

controlled by the manufacturing process; class II

devices require additional measures, called special

controls, to control risks. Special controls may

include performance standards, postmarket surveillance

studies, user education or other measures. If there is

a lack of information about what makes a device safe

and effective, it is put into class III and the

highest level of premarket review is required. Class

III devices include innovative, medical breakthrough

and new technology devices, as well as devices with

poorly established or questionable safety and

effectiveness.