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by Pamela G. Dowd
Jackie Strange, former Deputy Postmaster General. Anne M. Adams, Lt. Colonel (Ret.). Pat Wingate,
a South Carolina housewife. Merry Grant and Nikki Kauffman, Victims of Induced Chemical Exposure. Beth West, former journalist.
What do these women have in common? Like myself and many others, each of them presented their stories of the changes
silicone breast implants have brought into their lives to the Institute of Medicine in Washington, D.C. on July 24, 1998.
Contrary to published accounts of the safety of silicone breast implants, the FDA has never approved them for human
use. The FDA has on file over 6000 pages of physician reports on the health endangerment to women since the latter part of
the 60's. Manufacturers were never required to document the safety of breast implants to the FDA. Silicone breast implants
were "grand-fathered" in without PreMarket Approval with the passage of the Medical Safety Devices Act in 1976.
The Mayo Clinic study did not examine patients and included, "as healthy", patients they had not seen since
implantation. Harvard's study was a questionnaire and included women who had received their implants only a month prior to
the "study". The NY study was also funded by breast implant manufacturers--to the tune of $1.8 million and the answers
could only have been correlated to whether or not the responder listened to gossip. Dr. Linda Cook of the Fred Hutchinson
Cancer Research Center published her Life Style study last year based on 21 responses to certain questions on random phone
calls.
Presented to the Institute of Medicine were the following findings in a survey of breast implant women.
Of the 72 respondents to the survey, 49% of the women were reconstruction patients while 51% were augmentation patients. 90%
of the respondents had silicone breast implants. 19% received salines. 68% reported between 2-4 ruptures. 48% of all ruptured
implants were from the same manufacturer. 34% of the respondents have no medical insurance to cover cost of health care related
to breast implants. 35% are drawing some form of disability. 96% have chronic fatigue syndromes. 33% have difficulty performing
simple daily tasks such as dressing while 50% have difficulty with more difficult tasks like vacuuming. While compiling the
responses to the survey, it was clear that it made no difference WHY any woman received breast implants. Both augmentation
and reconstructed patients were growing sicker with unexplained illnesses.
The published statements of Dow being
bankrupt because of breast implant litigation is a misperception of the facts. Dow has enjoyed prosperous years since 1995
and has expanded their company across the globe. The announced settlement will come from funds gained from a settlement between
Dow and their insurance carriers.
In 1992, HOUSE OF REPRESENTATIVES, FDA'S REGULATION OF SILICONE BREAST IMPLANTS,
A STAFF REPORT PREPARED by THE HUMAN RESOURCES AND INTERGOVERNMENTAL RELATIONS SUBCOMMITTEE OF THE COMMITTEE ON GOVERNMENT
OPERATIONS 061-505 0-93(59), found clear evidence that silicone breast implants do cause harm to the recipients. Their
recommendations to the FDA were as follows:
1. THE COMMITTEE SHOULD URGE FDA'S CENTER FOR DEVICES AND RADIOLOGICAL
HEALTH TO IMPROVE THEIR REGULATION OF MEDICAL DEVICES
2. THE COMMITTEE SHOULD CONSIDER LEGISLATION TO CLOSE THE
REVOLVING DOOR BETWEEN FDA AND INDUSTRY
3. THE COMMITTEE SHOULD ASSURE THAT FDA REQUEST AND EXAMINE ALL RELEVANT
DOCUMENTS THAT ARE NOT UNDER COURT PROTECTIVE ORDERS
4. THE COMMITTEE SHOULD RECOMMEND THAT THE PRESIDENT, BY EXECUTIVE
ORDER, CLARIFY FDA'S AUTHORITY TO REVIEW PROTECTED COURT DOCUMENTS RELATED TO PRODUCTS THAT IT REGULATES
5. FDA ADVISORY
COMMITTEES SHOULD REVIEW ALL RELEVANT SAFETY AND EFFICACY INFORMATION
6. THE COMMITTEE SHOULD ENSURE THAT FDA REQUIRE
IMPLANT MANUFACTURERS TO PROVIDE INFORMATION ABOUT SAFETY AND EFFECTIVENESS TO PATIENTS AS WELL PHYSICIANS
These
recommendations have largely been ignored by the FDA. Also ignored has been an April 1994 letter to Senator Herbert Kohl
of Wisconsin from Dr. Norman Anderson of John Hopkins University, which warned of the practice of sealing in the courts damaging
evidence against breast implant manufacturers, evidence which proves the dangers of silicone in the body.
Women went
to Washington DC with a mission: To tell the impact of silicone in their lives to the Institute of Medicine and to their
Congressmen/women. Christa Farley, Silicone Support International, Sarasota, FL, and Pam Dowd, Magic Valley Breast Implant
Survivors, delivered requests for a Congressional Investigation with supporting evidence to members of the Judiciary Committee
in both houses. When approached on Thursday, Senator Larry Craig of Idaho has promised to be in touch with Sen. Orrin Hatch
with his support for this measure. In all, 48 congressional offices signed for packets of information.
Kathy Keithley-Johnson,
President of Toxic Discovery Network, announced a class action lawsuit had been filed in Federal court in the District of
Columbia against the Food and Drug Administration and the American Society of Plastic and Reconstructive Surgeons. The
lawsuit says surgeons failed to inform patients and the FDA of the dangers of implants.
If the scientists of the
past had followed the current recommendations of Dr. Elizabeth Connell in her recommendations "of no further research"
to the Institute of Medicine panel, we wouldn't have x'ray machines for diagnosis because blood letting would have been "good
enough". And yes, Dr Ehrlich, we should pay attention to whom we listen. M.D. no longer means Medical Divinity.
Copyright 2000 Pamela G. Dowd
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