Bristol-Myers Squibb - Deadly Documents

[Guest guest]

Re: Bristol-Myers Squibb - Deadly Documents?

Alice McLarty

Attorney at Law

Case Facts

THE OTHER SIDE OF THE STORY

THE TRUTH BEHIND BREAST IMPLANTS

What The Breast Implant Makers Don't Want You To Know

Despite spending millions of dollars to portray

themselves as defenseless " victims, " the breast

implant makers cannot deny that the real victims here

are the thousands of women with implants who were

deliberately lied to and who are now suffering

debilitating illnesses.

The facts are: the manufacturers' own documents reveal

a calculated coverup and campaign of deceit on the

safety of silicone implants; they have refused to

comply with the law requiring them to prove that

implants are safe and effective; women were told that

this product would last a lifetime, but the rupture

rate is extraordinarily high; about 100,000 women have

manifested illnesses, with the common link being that

they all have silicone breast implants; and two recent

studies could not disprove the link between silicone

implants and diseases such as lupus and rheumatoid

arthritis.

The studies failed to ask women uniform questions and

failed to employ standard laboratory testing.

Manufacturers have known for years that leaking

silicone poses health hazards Dow Corning, the leading

manufacturer of implants, ignored doctors' complaints

about leaking implants for years.

A 1975 Dow Corning memo states that demonstration

implants were " bleeding " and instructed sales staff to

wash such implants with soap and water and towel dry

before letting doctors handle them.

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 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

silicone seen in test animals could trigger

autoimmune-type diseases in humans.

In a Bristol-Myers Squibb document from 1985, a

company employee states: " Polyurethanes have no real

history of implantation without deterioration and we

know deterioration products of polyurethanes are toxic

and in some cases carcinogenic. Whether they are

released in such low levels as to be no threat to the

human body -- time will tell. "

A 3M document from 1976 states that " It appears

virtually no documented safety and efficacy data exist

on [Don McGhan's] implant products. " McGhan's breast

implant company, McGhan Medical Corp., was purchased

by 3M. Manufacturers refuse to comply with the law

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 FDA, that their devices

are safe and effective. " Why have the manufacturers

consistently failed to comply?

Dr. Kessler wrote in the Journal of the American

Medical Association in 1993 that " the adverse effects

data on silicone gel implants submitted by the

manufacturers were so poor that the FDA could not

determine whether these devices were safe and

effective. " He 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. Breast implants

have an extremely high rupture rate, and thus are

defective Manufacturers told women that implants would

last a lifetime and that ruptures occurred less than 1

percent of the time.

But studies published in the American Journal of

Radiology in 1992 and the ls of Plastic Surgery in

1995 reveal a rupture rate of 5 to 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.

FDA Commissioner Kessler wrote in the Journal of the

American Medical Association in 1993 that: " Even with

a conservative rupture rate of 5 percent, some 75,000

of the estimated 1 to 2 million women with implants

would be at risk for potentially serious adverse

health effects. That is not a safety standard that the

FDA can accept. " Thousands of Women Suffering

illnesses constitute more than 'anecdotes' Dr. Kessler

of FDA states that studies have shown that silicone

gel is a potent stimulant to the immune system and

could generate antibodies that attack collagen, a

component of connective tissue.

In 1992, the FDA received more than 23,000 reports of

problems with implants, including complaints of

" bleeding " implants, connective tissue disorders that

could lead to arthritis-like pain and swelling in the

joints, fibrous tissue spreading around the implants,

and swelling of skin and limbs.

R. Weiner, associate professor of medicine at

the University of California at Los Angeles, asserted

in August 1994 that " [o]nce you see these women,

that's all it takes to be convinced silicone implants

can make them sick. . . . There's no one who has seen

a large number of these women who disagrees. "

Safety concerns prompted France in May 1995 to halt

the importation, manufacture, sale or use of

silicone-gel breast implants. In May, the Ministry of

Health stated that implants filled with any product

other than physiologic saline can rupture and " result

in grave danger. " France will not allow implants back

on the market " until they have been definitely shown

without risk to the user. " Two recent studies are

fatally flawed One of the most-cited papers used to

criticize the link between silicone implants and

connective-tissue diseases suffers from fundamental

flaws.

The " Mayo Clinic " study published in June 1994; (1)

failed to ask women uniform questions or employ

standard laboratory testing; (2) failed to look for

the " atypical " signs and symptoms suffered by women

with silicone poisoning; (3) admitted that the

control group (749 women with implants and 1,498

without) was insufficient and that an accurate study

would require 62,000 women with implants and 124,000

without over 10 years; (4) suggested an implant

failure rate in excess of 30 percent (of the 749 women

with implants, 257 had surgical revisions); and (5)

concluded that " No statistically valid conclusions can

be drawn from this study. "

Further, the study is at least subject to question

since it was financed in part by the Plastic Surgery

Educational Foundation, the educational arm of the

American Society of Plastic and Reconstructive

Surgeons. This group has been given hundreds of

thousands of dollars for research by implant

manufacturers.

A study published in June 1995 -- the " Harvard " study

-- suffers from similar flaws. Specifically, it (1)

failed to ask women uniform questions or use standard

laboratory testing; (2) failed to look for signs of

" atypical " connective- tissue diseases, the symptoms

of which do not fall into any clear diagnostic

category; (3) studied too few women with breast

implants (1,183 women with implants, 876 of which were

silicone gel filled); and (4) failed to account for

the fact that women with silicone implants may not

manifest illnesses during the first eight years after

implantation.

Further, as with the Mayo Clinic study, author bias is

at issue. Two authors of the Harvard study have

admitted under threat of perjury that they are paid

consultants to breast implant makers. Also, Dow

Corning has donated $5 million to Boston's Brigham and

Women's Hospital, which played a key role in this

study.

Reprinted with Permission from The Association of

Trial Lawyers of America

At 10:08 AM 3/17/01 -0800, you wrote:

PLEASE POST

Dearest Ilena: Does anybody in our group know where

there are any " deadly documents " for BMS? I would

certainly like to hear from anybody who does have any

information. (A while ago, perhaps a couple of years

or so, I think Myrl Jeffcoat put something out on

Surgitek.)

My second set of implants were Surgitek. Here in

Canada, BMS is telling lawyers that they have no

documents that pertain to any woman's case regarding

breast implants!

Love as always.........

Lea