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

[Guest guest]

The Truth Behind Breast Implants - Civil Justice

Facts, The Other Side of the Story, What They Don't

Want You to Know - Alice McLarty, Attorney at Law

Date: Wed, 5 Jan 2000 19:42:54 -0700

From: ilena rose ilena@...

~~~ Great article. thanks Kathi ~~~

This site was put up last April and I just found it,

wasn't sure if it had been posted

http://www.maryalice.com/cases/implants.html

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

http://www.inetconcepts.net

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