Spring newsletter submission
Date: Thu, 30 Mar 2000 06:02:51 -0800
From: "Richard and Adella Matthew"
adellaem@shaw.caTo: "Royce Dueck"
rdueck@cw.bc.caCC: "Tony and Micheline Lambert"
delphine1939@videotron.ca
I.A.S. IMPLANT AWARENESS SOCIETY
102 - 6086 Boundary Drive West
Surrey, B.C., Canada V3X 2B3
Telephone: (604) 572-8486
Website:
http://www.info-implants.com/BC/index.htmle-mail:
adellaem@shaw.ca
Dear Silicone Sisters,
There has been much discussion on the FDA's special hearing regarding the PMA (pre-market approval) on saline breast implants, March 1-3, 2000. Since 1988, the manufacturers knew this day was coming and David Kreuse of the FDA finally called the day in August 1999. HELLO, this is 10 years later. However, in November the FDA was hearing from some manufacturers.
The panel, from the information supplied, favoured Mentor and McGhan. The final decision has yet to be made and more reviews will take place in April. David Krause of the FDA says of all breast implants, "only the most high risk or least understood devices were placed into class III." Interesting that, "Washington, March 23, 2000, USA Today reported, citing a memo from FDA's Office of Criminal Investigation, Mentor Corp., maker of saline breast implants, is the subject of a U.S. Food and Drug Administration criminal probe into allegations of research irregularities in implant studies."
Dr.. Diana Zuckerman, the scientist who initiated the congressional investigation of silicone breast implants for THE FDA's REGULATION OF SILICONE BREAST IMPLANTS, in December 1992, clearly states: "Here is our new summary of the 'same old research'; included in the Institute Of Medicine report, etc. I think you might find it of interest, and feel free to share it with reporters and others. It describes the limitations of the epidemiological research that has been done, and explains why those studies
Don't prove that implants are SAFE. It also focuses on the lack of information about the safety of implants for breast cancer patients." Check out this valuable website:
It is updated regularly.
The IOM report failed, and some segments based on "17 flawed studies, will be questioned by any unbiased researcher." The following research bears Zuckerman out.
International Journal of Occupational Medicine and Toxicology, Volume 4, Number 1, January - March 1995, page 11 (there are 28 MDs, editors, and associate editors):
1. Mayo Clinic study by Gabriel et al. (1994): This study is severely flawed, and one wonders how it came to be published. Not even one patient was examined. The study did not evaluate even one sick patient, and examined only connective tissue disease in nonsymptomatic patients. This is like trying to answer "What causes diarrhea? " in a group of patients who do not have diarrhea. Furthermore, this study did not address a multisystem disease (which afflicts 80% of the patients), but limited the record review to only 20% of the silicone-symptomatic patients.
2. Recent "Harvard" study: In this study, not one patient was examined; only charts were reviewed. No charts were examined for lung disease, nervous system disease, or abnormalities of T- and B-cells. Unfortunately, the medical doctors who examined the charts did not understand that this is a multisystem disease, and did not understand that to establish causation they need probability, meaning, more likely than not, a 51% probability, not a 95% probability.
For the doctor who sees patients with a certain pattern of exposure and disease presentation, all that is needed is medical probability. To claim that "we need large-scale studies" is to let bodies fall and patients die in the name of statistics, not in the name of medicine."
Also, on page 206:
Hill (1965) has argued that consistent clinical observations, temporal relationship with exacerbation after placement and remission after removal, and dose-response curve coupled with experimental plausibility, are sufficient to establish causation. All of Hill's criteria have been satisfied in the above-cited studies.
In addition, on page 160:
Silicone is biologically and chemically active. It has been demonstrated that both silicone and silica (up to 30% of the elastomer shell and the gel of a breast implant) are cytotoxic (Kessel et al., 1963; Allison et al., 1966; Kossovsky et al., 1987) and immunostimulatory agents (Pernis and Paronetto, 1962; Heggers et al., 1983; Mancino et al., 1984; Kossovsky et al., 1987). They are efficiently taken up by macrophages from the implant surface and react with the membranes surrounding the secondary lysosomes, causing death of the macrophage and general damage to the adjacent tissue (Kossovsky et al., 1987).
The Implant Awareness Society is looking for some volunteers. If you would like to be part of a great team that is now having some world acclaim, or if you have questions about the above information, please give me a call. Our phone and e-mail is in our heading. I invite all enquiries.
Sincerely,
Adella Matthew
President