Implants and Disease

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WEST LOS ANGELES, Calif., Nov. 9 /PRNewswire/ -- The Command Trust

Network, an information clearinghouse for women with breast implants, issued

the following:

Since 1991 manufacturers have noted in their product literature that

silicone gel breast implants should be replaced every ten years. But for

nearly thirty years the implants were sold with a virtual lifetime guarantee,

despite internal company documentation they leaked silicone and could

ultimately fall apart in the body over time. Furthermore, no long-term

research had been done on the safety of silicone in the body.

In the past year, researchers affiliated with the National Institutes of

Health, the National Cancer Institute, and the U.S. Food and Drug

Administration have all stated in peer-reviewed papers that there are non-

controversial health problems related to implants. They have noted high

product failure rates, serious tissue complications such as deformity, burning

rashes, muscle dysfunction and rotting breast tissue, and they have

acknowledged reports of silicone traveling throughout the body to vital

organs. These independent, government researchers have also adamantly stated

that research to date is not sufficient to say that implants are not linked to

other debilitating systemic diseases.

The first comprehensive epidemiological investigation into the rate that

atypical symptoms occur in implanted women is expected to be made public

sometime next spring. A research team headed by the National Cancer

Institute's chief environmental epidemiologist Dr. Louise Brinton is

conducting the study. The researchers are undertaking an in-depth assessment

of the health of 16,000 implanted women.

IMPLANTS AND THE FDA: A BRIEF HISTORY

* 1960's -- California and Nevada pass laws against silicone

injections, classifying them a criminal offense.

* 1962 -- Alarmed about health dangers posed by silicone, the FDA

issues strict regulations governing silicone injections.

* 1963 -- Dow Corning begins selling breast implants (liquid silicone

in thin bags) under the trade name " Silastic, " but has conducted no

long-term safety testing, and establishes no monitoring system for

the women who receive them. No FDA approval is necessary as the

agency has no authority over medical devices at that time.

* 1991 -- The FDA requests safety data from manufacturers, due to

complaints about the prostheses.

* 1992 -- An independent science panel, in a near-unanimous vote,

recommends the FDA limit the sale of silicone gel breast implants

due to lack of safety data.

* 1992 -- FDA limits the sale of silicone breast implants to use in

clinical trials of women who are receiving them after mastectomy or

to replace damaged implants.

* 1997 -- The FDA reviews the moratorium on general sale, and decides

to keep it in place due to the continued lack of adequate safety

data.

EPIDEMIOLOGY

* A blue ribbon independent science panel, appointed by the NIH,

concludes existing epidemiological research is not adequate to call

implants safe, and calls for additional study, particularly into an

" atypical " constellation of debilitating symptoms seen in many women

(Summary of the Aytpical Rheumatic Diseases and Silicone Breast

Implants Workshop, April 1997).

* A study by National Cancer Institute and FDA researchers states that

the epidemiological research conducted to date has shortcomings

rendering it insufficient to rule out systemic illnesses (Brinton

and Brown, Journal of the National Cancer Institute, Sept 1997).

* Research by a U.S. FDA scientist says more study is necessary to

definitively determine whether implants are linked to systemic

illnesses (Brown, et al, Lancet, Nov 1997).

* Lead NCI epidemiologist Dr. Louise Brinton says before a panel of

scientists that studies commonly perceived to exonerate implants are

too statistically limited to rule out disease (Transcript from

Institute of Medicine conference on the Safety of Silicone Breast

Implants, July 1998).

* In 1996, former FDA Commissioner Kessler and team of

researchers published a review of the research that determined that

existing studies still did not show implants were safe (Silverman,

Kessler, et al, ls of Internal Medicine, April 1996) .

EVIDENCE OF A NEW " ATYPICAL " DISEASE

* In recent years, the scientific debate over breast implants has

centered on reports that implanted women are suffering from symptoms

not normally grouped together. Numerous medical doctors have

reported finding debilitating symptoms -- most frequently joint

pain, Raynaud's phenomenon, incapacitating fatigue, dysphagia,

myalgias, cognitive dysfunction and other neurologic disorders -- in

a variety of constellations (, Seminars in Arthritis and

Rheumatism, Aug 1994).

* Two industry-funded research teams have found evidence linking

silicone devices to unusual symptoms. A University of Michigan team

reported that women with silicone implants have a threefold higher

risk factor for developing " undifferentiated " connective-tissue

symptoms, and a University of Calgary group found a higher rate of

peripheral neuropathy, cognitive dysfunction and myalgia in women

with implants (Schottenfeld, et al, Abstract presented at American

College of Rheumatology Meeting, Oct 1996 and Edworthy, et al,

Journal of Rheumatology, 1998).

* An UCLA team also found an increased risk of cognitive dysfunction

and peripheral neuropathy in patients with implants (Greenland and

Finkle, ls of Epidemiology, July 1998).

* A panel convened by the National Institutes of Health recommended

last year that future funding be directed toward studying and

defining this disease (Summary of the Atypical Rheumatic Diseases

and Silicone Breast Implants Workshop, April 1997).

* A National Cancer Institute study released last year concluded that

the issue of atypical disease has " not been resolved " (Brinton and

Brown, Journal of the National Cancer Institute, Sept 1997).

* The NCI's chief environmental epidemiologist, Dr. Louise Brinton,

also has stated firmly that " the possibility that there is a yet

undefined disease that's associated with silicone has not been

adequately addressed " (Transcript from Institute of Medicine

conference on the Safety of Silicone Breast Implants, July 1998).

* Dow's own internal studies showed in the 1960's and 1970's that

silicone could stimulate the immune system (see last page).

PRODUCT FAILURE

* Breakages were found in 40 percent of implants after six years and

in 95 percent after twelve years in a Dow Corning-funded study by

researchers from the University of Toronto and Wellesley Hospital

published in 1996 (s, et al, Canadian Journal of Plastic

Surgery, Spring 1996).

* FDA scientist S. Lori Brown reported last fall that 95 percent of

women with double implants should expect that neither will be intact

after twenty years (Brown, et al, Lancet, Nov 1997).

* The Kessler review of literature in 1996 found that at least 70

percent ruptured within ten years (Silverman, Kessler, et al, ls

of Internal Medicine, April 1996).

* In a presentation to the Institute of Medicine this summer, Dr.

LuFeng (Case Western Reserve University) acknowledged a 60 to

70 percent failure rate within ten years, corroborated by

explantation. At the same meeting, Dr. S. Middleton (UC-San

Diego) showed that MRIs indicate a rupture rate of roughly 50

percent within ten years. (Transcript from Institute of Medicine

conference on the Safety of Silicone Breast Implants, July 1998.)

* Researchers from Mentor and McGhan -- the companies which still make

and market implants -- found three to five percent rupture rates for

implants two to four years old. This is consistent with other data

which shows significantly higher rupture rates as implants age.

Interestingly, the McGhan data also found that one-third of the

women being studied voluntarily requested that their implants be

removed within the first five years of having them. (Transcript from

Institute of Medicine conference on the Safety of Silicone Breast

Implants, July 1998.)

* Top Dow officials were warned of the rupture problem two decades

ago. A company memo from 1977 states: " As of this date, the problem

is still recurring at an inordinate rate. "

* Even when implants remain intact, silicone " bleeds through " the

lining. As far back as 1961 the company's Center for Aid to Medical

Research notified management of this problem. Later, Dow Corning

salespeople also were advised to wipe off the " oily " feel of

implants before presenting them to customers, according to internal

company documents.

LOCAL TISSUE COMPLICATIONS & CHRONIC INFLAMMATION

* A Mayo Clinic research team has reported that one of every four

women face additional surgery within the first five years after

receiving implants (, et al, New England Journal of Medicine,

March 1997).

* The Mayo Clinic study also found high numbers of breast deformities,

hematomas and bleeding, contractures, chronic pain and necrosis of

the nipple (see reference above).

* Medical research indicates that silicone can cause an extensive

cellular reaction resulting in chronic inflammation. In susceptible

individuals inflammation can lead to flu-like symptoms and an

overwhelming malaise. (Robbins Pathologic Basis of Disease, 5th Ed.

W.B. Saunder Company, 1994.)

SILICONE FOUND THROUGHOUT BODY

* A National Cancer Institute study, published in the past year,

reported that silicone leakage is " ubiquitous " and that " the range

of repercussions remains to be defined " (Brinton and Brown, Journal

of the National Cancer Institute, Sept 1997).

* Traces of silicone were found in such vital organs as the liver by

researchers at Harvard Medical School and Massachusetts General

Hospital (Pfleiderer and Garrido, et al, Magnetic Resonance

Medicine, 1995).

* In a series of tests of laboratory mice a Baylor University team

likewise found silicone collected in all vital organs examined. The

Baylor researchers wrote they were concerned about " adverse

biological effects " (Leiberman, et al, American Journal of

Pathology, March 1998).

* Dr. Brown's study described how silicone gel moved from a woman's

chest to her hand, causing pain, swelling, numbness and permanent

scarring (Brown, et al, Lancet, Nov 1997).

IMMUNOLOGICAL PROBLEMS

* There is well-documented medical evidence that, under certain

conditions, chronic inflammation can induce autoimmune-like

conditions. In addition, new studies are suggesting that silicone

may trigger malfunctions in the immune system.

* Dr. Marilyn Lightfoote, a deputy director in the Center for Devices

and Radiologic Health at the U.S. Food and Drug Administration,

reported this summer that her research shows silicone is a catalyst

in immune responses in animals (Transcript from Institute of

Medicine conference on the Safety of Silicone Breast Implants, July

1998).

* A 1997 study, published in ls of Allergy and Immunology, found

that women with implants had an overreaction to connective tissue

proteins, suggesting a potential mechanism by which silicone may

aggravate the immune system (Atkinson, et al, ls of Allergy and

Immunology, Aug 1997).

* In 1997, a Louisiana State University and Tulane University team

reported discovering a correlation between implanted women with high

counts of anti-polymer antibodies (an indicator of immune-system

problems) and women with severe, atypical autoimmune symptoms

(Garry, et al, Lancet, Feb 1997).

* Wayne State University researchers, who conducted an experiment of

silicone's effects on the immune system of mice, also said they

found evidence of immune system overstimulation (Schaefer, et al,

Arthritis and Rheumatism, June 1997).

* This new information conforms to earlier evidence from the in-house

research of Dow Corning. Of four dogs injected with silicone in a

1970 experiment, one died and the other three developed a chronic

inflammation indicative of an immune system breakdown.

* A 1985 Dow report, kept secret until the company was forced to

disclose it during legal proceedings, noted, " The preponderance of

available animal data also suggests a potential for silicone

materials to be involved in immunologically mediated disease

states. "

SOURCE Command Trust Network, Inc.

CO: Command Trust Network, Inc.

11/09/98 13:13 EST http://www.prnewswire.com