Breast Implants - Overview Final Part III - Eeken

[Guest guest]

--- F Eeken <eeken_13@...> wrote:

>

> Overview - Part III (Final)

>

> Silicone Breast Implants

>

> (reply, comment, info. To:

>

> Eeken_04@... )

>

> Europe, The Netherlands, 17 january 2005

>

> Introduction

>

> Chemical Composition of Silicone

>

>

http://community-2.webtv.net/lany25/ChemicalsFoundin/

>

> 1991

>

> Public Relations firm manipulate Public Opinion

> (1991)

>

> Media-Plan

>

> Dow Corning

>

> The following document was obtained in discovery in

> the breast implant

> litigation. It contains a detailed proposal by

> Burson-Marsteller Public

> Relations of

>

> october 14, 1991 outlining Dow's public relations

> efforts prior to

> anticipated FDA hearings on the saftey of Breast

> Implants.

>

>

http://consumerlawpage.com/article/mediamanipulate.shtml

>

> 1992

>

> 102nd Congress Report on Breast Implant Hearings

>

> " FDA's Regulation of Silicone Breast Implants "

>

> House of Representatives - a staff report prepared

> by the humand

> resources and intergovernmental relations

> subcommitte of the committe on

> government operations -

>

> december 1992

>

> ...Findings-and conclusions....

>

> (A) FDA ignored warnings about the need to regulate

> breast implants for

> more than 12 years..

>

> ( Scientists have been concerned about the risks

> of connective

> tissue/autoimmune disorders since 1975..

>

> © Physicians, engineers. and employees of implant

> manufacturers have

> been concerned about breakage and leakage of

> silicone gel implants since

> the 1970's..

>

> (D) FDA ignored their own scientists' advice to

> reject manufacturers' PMA

> applications in 1991....

>

> Dow Corning

>

> .... McGhan.. Bioplasty.... Mentor..

>

> (E) Professional pro-implant lobbyists included

> former FDA officials and

> provided patient lobbyists with misleading

> information...

>

> (F) Manufacturers have never provided proof of

> safety to the FDA...

>

> (G) FDA officials and manufacturers prevented the

> 1991 FDA breast implant

> advisory committee from considering crucial safety

> information..

>

> (H) FDA concerns about cancer led to the removal of

> breast implants

> covered with polyurethane from the market in

> 1991....

>

> (I) The 1992 FDA advisory panel lacked crucial

> information about

> interference with mammography and other problems....

>

> (J) In 1992,

>

> Dow Corning disclosed that the company sold implants

> to Doctors before

> they were shown to be safe in animals, failed to

> disclose problems with

> the implants, and submitted fabricated information

> about quality

> control....

>

> (K) Patients have been misled about the safety of

> breast implants for at

> least the last 15 years..

>

> (L) Patients continue to be misled by the

> FDA-approved informed consent

> form....

>

> Plastic surgeon's attempts to change informed

> consent forms..., AMA's

> attempts to change informed consent forms.., FDA's

> capitulation to

> criticisms of informed consent forms...

>

> (M) FDA's public statements about breast implants

> minimized the risks....

>

> (N) FDA inspections in 1992 indicated that McGhan

> had violated good

> manufacturing practices, but FDA allowed McGhan

> sales to resume before

> problems were corrected...

>

> (0) From April 1992 to the present, FDA has failed

> to monitor the use of

> silicone breast implants, despite the promises of

> the FDA Commissioner..

>

> (P) FDA has failed to evaluate available safety

> information that lawyers

> have obtained from manufacturers..

>

> (Q) NIH has failed to support research on the safety

> of breast implants

> for cancer patients..

>

> ® Medicare and Medicaid are required to pay for

> removal of breast

> implants for medical reasons.

>

>

http://www.transgendercare.com/surgical/brst_implants_congress102.htm

>

> 1996

>

> Television Review:

>

> The Battle Over Breast Implants

>

> The New York Times, By Walter Goodman -

>

> February 27, 1996

>

> There was a time, not so long ago, when women were

> lining up for silicone

> breast implants, some in the aftermath of a

> mastectomy, others to supply

> what nature had neglected. Now tens of thousands of

> women are suing the

> manufacturers, and the implants are no longer being

> made in this country

> for rehabilitation or for decoration...

>

>

http://query.nytimes.com/gst/fullpage.html?res=9407E6DB1139F934A15751C0A96095826\

0

>

> Silicone Breast Implants: Why Has Science Been

> Ignored?

>

> 1996

>

> Prepared for the American Council on Science and

> Health by

> Fumento, a fellow with Consumer Alert in Washington,

> D.C. and a science

> correspondent for Reason magazine.

>

> http://www.fumento.com/breast.html

>

> http://www.fumento.com/breastbook.pdf

>

> Ruling out " Junk Science " -

>

> The evidence that breast implants cause serious

> illness

>

> isn't worth considering, says federal Judge.

>

> TIME, By J. Madeleine Nash JMadeleine@... ? -

> Dec. 30, 1996 [this

> Preview only]

>

> Silicone breast implants have been blamed for

> virtually every ailment

> imaginable--muscle aches, joint pain, mysterious

> rashes, even serious

> autoimmune diseases like lupus and scleroderma. So

> it is little wonder

> that implant lawsuits have clogged the nation's

> courts and forced one

> manufacturer, Dow Corning, to seek pre-emptive

> bankruptcy. Yet many

> medical and legal experts have long suspected that

> the blame laid on

> implants is based on " junk science. " Last week, in

> a bold opinion that

> surprised legal experts across the country, a

> federal district court

> judge in Portland, Oregon, endorsed that view...

>

http://www.time.com/time/archive/preview/0,10987,985772,00.html

>

> 1997

>

> Oregon judge bars experts from testifying

>

> that breast implants cause disease.

>

> Trial;

>

> 2/1/1997; Shoop, Gannon - [premium article]

>

> A federal district court ruling that expert evidence

> on the connection

> between breast implants and atypical connective

> tissue disease did not

> demonstrate a probable connection between the two

> and must be barred

> marked the first federal court exclusion of such

> evidence because it was

> found not to satisfy the requirements outlined in

> the Daubert case.

> Fredric Ellis, who has represented breast implant

> plaintiffs, states the

> ruling conflicts with other federal court decisions

> allowing causation

> evidence. Women suing breast implant manufacturers

> over illnesses

> allegedly caused by the devices..

>

>

http://www.highbeam.com/doc/1G1:19155660/Oregon+judge+bars+experts+from+testifyi\

ng+that+breast+implants+cause+disease.html

>

> Plaintiffs' Submission and Proposed Findings

>

> to the National Science Panel on Silicone Gel Breast

> Implants

>

> Women In Health -

>

> 10/06/1997

>

> http://womnhlth.home.mindspring.com/PSC/CONTENTS.HTM

>

> 1998

>

> July 5-11; A Long-Running Battle Over Breast

> Implants

>

> New York Times, By J. Morrow -

>

> July 12, 1998

>

> The Dow Corning Corporation and lawyers representing

> the tens of

> thousands of women who claimed injury from silicone

> breast implants

> agreed to a $3.2 billion settlement, bringing to a

> close one of the

> nastiest disputes in corporate history...

>

>

http://query.nytimes.com/gst/fullpage.html?res=9D07E1DD1231F931A25754C0A96E95826\

0

>

> A Breast Bone of Contention

>

> Los Angeles Daily J. -

>

> Aug. 26, 1998

>

> (op-ed on the Boxer breast implant research bill)

>

> http://members.aol.com/deliotb/djoped.html

>

> Dow Chemical: The chemical industry's secrets

>

> Houston Chronicle, By Jim -

>

> 25 october 1998

>

> ....

>

> Into the schools - Public-school assemblies are a

> favorite venue for Dow

> Chemical, the world's biggest chlorine producer. For

> the past decade, Dow

> has sponsored a road show for middle school and high

> school students

> known first as " ChemTV, " then " ChemiPalooza " and now

> " Cranium Palladium. "

> The professional cast uses music and comedy to

> underscore the importance

> of science and, in particular, chemistry. Dow also

> distributes free

> CD-ROMs and other educational materials. None of

> these efforts, company

> spokeswoman Anne Ainsworth said, is intended to

> promote the company or

> its products. The concept, nonetheless, doesn't sit

> well with some Dow

> detractors.

>

> " Why should our children be propagandized by private

> corporations? " asked

> Montague, director of the Environmental

> Research Foundation in

> polis, Md., and editor of an Internet

> newsletter. " They're using

> subterfuge and underhanded methods to brainwash our

> children, hoping

> they'll grow up to be good chlorine chemists, or

> good consumers of

> chlorine chemistry. "

>

> In the early spring of 1996, Dow and other chemical

> companies were

> confronted with a book some called the new Silent

> Spring. Its title, Our

> Stolen Future, was equally dramatic, its premise -

> that even tiny amounts

> of some chemicals could interfere with hormones in

> humans and wildlife,

> leading to reproductive impairment and diminished

> intelligence in

> offspring - equally alarming. Two of the book's

> three authors recounted

> the industry reaction..............

>

>

http://www.bhopal.net/oldsite/presscoverage/houstonchronicle/archive/19981025-co\

ckroaches.html

>

> More on

>

> Dow Chemical -

>

>

http://www.chron.com/content/chronicle/special/vinyl/index.html

>

> Report from National Science Panel

>

> December 15, 1998

>

> The Science Panel appointed by Judge Pointer has

> found that the

> plaintiffs' claims that breast implants cause

> systemic disease are not

> supported by the available scientific evidence!

>

> http://www.fjc.gov/BREIMLIT/SCIENCE/report.htm

>

> 1999

>

> Book

>

> Breast Implant or Aspartame (Nutrasweet) Disease ?

>

> The surpresses opinion about perceived Medicolegal

> Travesty

>

> Sunshine Sentinel Press; Booklet edition, July 1,

> 1999

>

> H. J. , M.D.

>

> hjrobertsmd@... provides a plausible " missing

> link " He emphasizes the

> striking overlap of systemic complaints among breast

> implant patients and

> persons with documented reactions to products

> containing aspartame in his

> data base of over 1,200 aspartame reactors... mostly

> women. These

> products are being consumed in prodigious amounts by

> 70 percent of the

> population, especially weight - and figure -

> conscious women.

>

> Commentary:

>

> Dr. Marcia Angell, Executive Editor of the New

> England Journal of

> Medicine, emphasized: " Why has the hypothesis that

> breast implants cause

> these diseases been so readily accepted with so

> little evidence to

> support it? "

>

> http://www.sunsentpress.com/breast_asp.html

>

> Safety of Silicone Breast Implants

>

> ( 1999 )

>

> Signs and symptoms associated with silicone breast

> implants

>

> The most comprehensive review of the literature on

> implants to date, by

> the Institute of Medicine, has found no connection

> between implants and

> systemic disease of any kind.

>

> http://www.nap.edu/books/0309065321/html/

>

> Health Council of the Netherlands Reports

>

> 1999

>

> The Committee views the formation of fibrous

> capsules and capsular.

> contracture as normal reactions to the placement of

> the implant.....

>

> http://www.gr.nl/pdf.php?ID=866

>

> Government-funded Junk Science?

>

> November 18, 1999 -

>

> by Doug Bandow, a senior fellow at the Cato

> Institute

>

> http://www.cato-institute.org/people/bandow.html

>

> Silicone breast implant litigation has become a

> legal Hydra, with two

> heads replacing every one that is cut off. The

> scientific evidence is

> overwhelming: implants do not cause disease. Yet,

> the trial bar persists

> in squeezing damages from a largely bankrupt

> industry, and now threatens

> to twist scientific research to advance its case...

>

> http://www.cato-institute.org/dailys/11-18-99.html

>

> 2000

>

> Trademark of The

>

> Dow Chemical Company

>

> Notice Regaring Long-Term Medical Implant

> Applications

>

> January 2000

>

> The Dow Chemical Company does not recommend any

> medical grade resin or

> film product for long-term medical implant

> applications in humans, i.e.,

> for more than 72 hours (or 30 days, for Pellethane*

> polyurethane

> elastomers)..

>

>

http://www.industrialinsulation.com/images/520_saran_tape.pdf

>

> Book

>

> Cleavage: technology, controversy,

>

> and the ironies of the man-made Breast

>

> By American medical sociologist, Nora son,

> Rutgers University Press,

>

> 2000

>

> Examines the history of breast implant technology

> from

>

> 1895 to 1990. Looks at politics and bias in medical

> practice and the role

> of bureaucracies, corporations, and governments in

> establishing policy

> and regulating implant technology..

>

>

http://www.cwhn.ca/search/pubRecord.htm?ObjectId=106358 & category=Breast%20Implan\

ts & batch_start=10 & batch_count=10

>

> 2002

>

> Breast implants and illness: a model of

> psychological illness

>

> - Department of Rheumatology, Repatriation General

> Hospital, Adelaide,

> South Australia

>

> Professor M Ahern, Department of Rheumatology,

> Repatriation General

> Hospital, Flinders University of South Australia -

>

> micharl.ahern@...

>

> - ls of the Rheumatic Diseases

>

> 2002; 61:659

>

> We read with interest the hypothesis of Dush in the

> ls of

>

> the Rheumatic Diseases (1) and provide some evidence

> to support it. Dush

> suggested that many of the symptoms of women with

> silicone breast

> implants might be attributed to somatisation,

> stress, and mass

> somatisation. We recently reviewed 179 women with

> silicone breast

> implants who were involved in product liability and

> litigation. Their

> ages ranged from 29 to 74 years (mean (SD) 46.8

> (8.1)). The indications

> for surgery were cosmetic in 146 (82%), followed by

> cancer in 17 (9%),

> fibrocystic disease in 12 (7%), and congenital

> hypoplasia in 4 (2%)

> women. The most common symptoms were burning breast

> pain in 142 (79%),

> chronic fatigue in 142 (79%), arthralgia in 134

> (75%), sleep disturbance

> in 127 (71%), cognitive dysfunction in 102 (57%),

> sicca symptoms in 100

> (56%), night sweats in 97 (54%), and myalgia in 91

> (51%). Findings on

> clinical examination were few, including chest wall

> abnormalities in 60

> (34%), tender trigger points in 31 (17%), and carpal

> tunnel syndrome in 6

> (3%) women. Sixty five (36%) women had radiological

> and/or surgical proof

> of implant leakage or rupture and 61 (34%) had signs

> of implant

> contractures. We found no evidence of increased

> occurrence of any

> connective tissue disorder such as rheumatoid

> arthritis (RA), systemic

> lupus erythematosus (SLE), or Sjögren's syndrome...

> http://ard.bmjjournals.com/cgi/content/full/61/7/659

>

> 2003

>

> Health Complications from Breast Implant Surgery

> Common

>

> Follow up procedures from private cosmetic surgery

> draw on public health

> system

>

> From the British Columbia Centre of Excellence for

> Women's Health

>

> By Aleina Tweed aleina.tweed@... - Spring-Fall

> 2003, Volume 6,

> Number 2/3

>

> http://www.cwhn.ca/network-reseau/6-23/6-23pg10.html

>

> Senators " Concerns about Silicone Gel Implants "

>

> Feinstein, Boxer, and 8 other Senators Call on FDA

> to Address their

> Concerns about Silicone Gel Breast Implants Before

> Giving its Final

> Approval for General Use

>

> December 19, 2003

>

> Washington, DC – U.S. Senators Dianne

> Feinstein (D-Calif.), Barbara

> Boxer (D-Calif.), and 8 of their Senate colleagues

> today urged the Food

> and Drug Administration (FDA) to address their

> concerns about Silicon Gel

> Breast Implants before it decides whether to lift

> the 11-year ban on

> these devices...

>

>

http://feinstein.senate.gov/03Releases/r-silicone.htm

>

> 2004

>

> NDP Introduces Bill for Breast Implant Registry

>

> " Women's health is at risk and Canada has no way of

> accurately assessing

> the risk of implants or coordinating a response,

> when problems arise. " -

> Judy Wasylycia-Leis

>

> March 26, 2004

>

> OTTAWA - New Democrat MP Judy Wasylycia-Leis

>

> wasylj@... today introduced a Private

> Member's Bill to establish a

> national breast implant registry to monitor implant

> procedures and

> further scientific research. " This bill is designed

> to fill an important

> void in women's health protection, " said

> Wasylycia-Leis. " Breast implants

> have been shown to pose a serious health risk, yet

> we currently have no

> way of either accurately assessing that risk or

> coordinating a response,

> should problems arise. " ...

>

http://www.cwhn.ca/resources/breast_health/registry.html

>

> Dow Corning: Payments in Canadian breast-implant

> lawsuits

>

> By JOE FRIESEN -

>

> June 12, 2004

>

> Joyce Attis got one breast implant in 1972, and she

> says she's been

> paying for it ever since.

>

> Now, after an 11-year legal battle, she may finally

> get part of the

> $24.2-million Ontario class-action settlement agreed

> to with Dow Corning

> Corp. in 1998, but held up by bankruptcy proceedings

> for the past six

> years..

>

>

http://www.theglobeandmail.com/servlet/ArticleNews/TPStory/LAC/20040612/IMPLANT1\

2/TPNational/TopStories

>

> Claimants' Advisory Committe E-Newsletter

>

> Volume 1, No. 3,

>

> July 27, 2004

>

> Welcome to the third e-newsletter from the

> Claimants' Advisory Committee

> (CAC) in the Dow Corning bankruptcy Settlement

> Plan...

>

> http://www.tortcomm.org/newsletter_040727.shtml

>

> 2005

>

> The ugly side of beauty

>

> July 2, 2005 -

>

> The Guardian

>

> Breast implants for 18-year-olds? Hymen

> reconstructions? Rape-themed

> fashion collections? Don't tell Sheila s

> these are signs of female

> liberation. The radical feminist talks to

> Bindel

>

>

http://books.guardian.co.uk/departments/politicsphilosophyandsociety/story/0,600\

0,1519268,00.html

>

> Silicone " pumping " Parties Beware !

>

> As of

>

> July 2005, there was one recent death in San Diego

> County due to someone

> being injected at a " Silicone Pump Party " . As I

> watched the news, I was

> horrified to hear a plastic surgeon state during

> this news broadcast that

> silicone in smaller doses is NOT toxic! Do NOT be

> deceived. Consider his

> motivation, it is called 'greed'. Even saline

> implants are encased in

> silicone pouches. Within 72 hours, every major

> organ, including your

> brain, has been breached with deadly silicone. I

> have been hearing about

> these parties, and receiving emails about the

> horrific results since 2001

> - that is 4 years! These parties promise instant

> 'beauty'.....

>

> http://www.jussta.com/silicone_parties_beware.htm

>

> Man Injected At 'Silicone Party' Dies -

>

> July 10, 2005

>

> http://www.nbcsandiego.com/news/4705943/detail.html

>

> Transgender Victims Near Death After Silicone Party

> -

>

> June 22, 2005

>

> http://www.nbcsandiego.com/news/4640939/detail.html

>

> Two sentenced in silicone death

>

> - July 30, 2003

>

>

http://www.tsroadmap.com/physical/silicone/silicone-death.html

>

> Women Senators Urge FDA to Consider Women's Health

> Safety in Decision on

> Silicone Breast Implants

>

> July 28, 2005

>

> Washington, DC – U.S. Senators Dianne

> Feinstein (D-Calif.)

>

> webmail@... ,

> senator@... and

> Olympia Snowe (R-Maine) olympia@...

>

> along with seven other women Senators today urged

> the FDA to carefully

> consider the safety of American women and the

> recommendations of FDA's

> own scientists prior to making a final decision on

> approval of silicone

> gel breast implants. They wrote to express concerns

> about the recent

> split decision by the General and Plastic Surgery

> Devices Panel of the

> Food and Drug Administration (FDA) on the

> applications of silicone gel

> implant manufacturers Inamed and Mentor

> Corporations.

>

>

http://feinstein.senate.gov/05releases/r-fda-silcone.htm

>

> FDA Protests Firm's Letters About Implants

>

> Washington Post,By Marc Kaufman -

>

> November 2, 2005

>

> The Food and Drug Administration has objected to a

> letter sent last week

> by a manufacturer of silicone-gel breast implants

> advising doctors that

> approval of its controversial product was imminent,

> causing Mentor Corp.

> to send out a second letter two days later

> retracting the first.

>

>

http://www.washingtonpost.com/wp-dyn/content/article/2005/11/01/AR2005110101669.\

html

>

> Senators " Investigate Whisteblower Claims Breast

> Implants "

>

> Senators Feinstein, Snowe Urge FDA to Investigate

> Whisteblower Claims of

> Safety Risks in Mentor Corp. Silicone Breast

> Implants

>

> senator@...

>

> , olympia@...

>

> December 7, 2005

>

> Washington, DC – U.S. Senators Dianne

> Feinstein (D-Calif.) and

> Olympia Snowe (R-Maine) are urging the Federal Drug

> Administration (FDA)

> to rigorously investigate safety concerns raised by

> a whistleblower about

> Mentor's silicone breast implants.

>

>

http://feinstein.senate.gov/05releases/r-silicone-implants.htm

>

> Silicone solutions

>

> Kirsty

>

> 23/12/2005

>

> - Silicones are fuelling innovations in topical drug

> excipients, due to

> their unique set of physicochemical properties that

> improve active

> pharmaceutical ingredient (API) delivery and ease of

> product

> application...

>

http://www.in-pharmatechnologist.com/news/ng.asp?n=64767-dow-corning-galderma-si\

licone

>

> 2006

>

> Silicone breast implant safety unclear: study

>

> January 13, 2006

>

> - By Sheryl Ubelacker, The Canadian Press

>

> TORONTO -- Health Canada should set up and

> administer a registry of women

> with breast implants and seek more information about

> the long-term safety

> of the silicone-gel form of the devices, an expert

> scientific panel says

> in its long-awaited report.

>

>

http://lfpress.ca/newsstand/News/National/2006/01/13/1391696-sun.html

>

> Lingering concern over silicone

>

> Breast implant registry needed to track safety, says

> health panel

>

> By Sheryl Ubelacker, The Canadian Press

>

> TORONTO-

>

> Jan 13, 2006 - Health Canada should set up and

> administer a registry of

> women with breast implants and seek more information

> about the long-term

> safety of the silicone-gel form of the devices, says

> an expert scientific

> panel. Their report, made public yesterday on Health

> Canada's website,

> will be used in part to decide if sales of the

> controversial devices

> should be resumed

>

>

http://www.hamiltonspectator.com/NASApp/cs/ContentServer?pagename=hamilton/Layou\

t/Article_Type1 & c=Article & cid=1137107411681 & call_pageid=1020420665036 & col=111210\

1662670

>

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