SOURCE Command Trust Network, Inc.


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.



* 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 David 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, Annals of Internal Medicine, April 1996) .


* 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 (Solomon, 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, Annals 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).



* 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 (Peters, 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, Annals of Internal Medicine, April 1996).

* In a presentation to the Institute of Medicine this summer, Dr. LuJean Feng (Case Western Reserve University) acknowledged a 60 to 70 percent failure rate within ten years, corroborated by  explantation. At the same meeting, Dr. Michael 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.



* A Mayo Clinic research team has reported that one of every four women face additional surgery within the first five years after receiving implants (Gabriel, 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.)



* 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).



* 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 Annals 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, Annals 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."

CO: Command Trust Network, Inc.