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Results from Platinum studies -

CANDO Platinum Research Project for Women with Breast Implants and their Offspring UPDATE FROM MARLENE KEELING May 2, 2005 FDA Advisory MeetingApril 11 – 13, 2005CANDO wants to thank everyone who traveled to or sentwritten testimony to be read into the official recordduring the public comment period of the recent FDAadvisory meeting. We had approximately fourteen whohad been tested for platinum who testified.We owe a huge debt of gratitude to V.M. Maharaj,Ph.D., a professor of chemistry at AmericanUniversity, who testified regarding her published 2004research on platinum and the results from CANDOResearch Project #1. I presented raw data from CANDOResearch Project #2 which found one child born afterimplantation tested over 300 parts per billion, onewoman tested aver 200 parts per billion eleven yearsafter explantation, and nine women and one childtested over 100 parts per billion. Previously in awritten submission to the FDA and panel members, Isent a copy of the CDC’s platinum urine study in thegeneral U. S. population of over 1,000 people and notone of them had over the level of detection of <0.04parts per billion per liter of urine. Harbut, M.D., board certified in OccupationalMedicine who has limited his practice to the diagnosisand treatment of diseases caused by occupational andenvironmental toxins, provided testimony read into therecord regarding platinum. , M.D.,board certified in Internal Medicine and in Allergyand Immunology, spoke about her research regardingToxicant Induced Loss of Tolerance or TILT. This mayexplain why many breast implant patients now have alow tolerance to many chemicals in the environment.The FDA transcript on April 13, 2005 quotes SamArrepali, Ph.D. Chemist at the FDA as saying "Whilesaline-filled breast implants contain only tin, thegel-filled breast implants contain both platinum andtrace amounts of tin as both these catalysts are usedin the manufacture of gel-filled breast implants."Ionized platinum is one of the most hypersensitizingagents known to man. Oxidized platinum also is on thesuspected list as being a neurotoxicant,immunotoxicant, sense organ toxicant, and respiratorytoxicant. Some of the recognized symptoms anddiagnoses of people exposed to ionized platinuminclude the following: asthma, rhinorrhea, tinnitus,conjunctivitis, urticaria (hives), fatigue syndromessecondary to impaired oxygen exchange, neurotoxicity,sicca syndrome, and macular rashes.Ionized platinum is capable of crossing the placentalbarrier and brain barrier. The World HealthOrganization (WHO) states there is no data availableto assess the carcinogenic risk of platinum or itssalts to humans. NIH research has documented thatbreast-implanted women have a two fold increased riskof brain cancer, a three-fold increase of respiratorytract cancer, and a four fold increased rate ofsuicide. WHO also states that the acute toxic effectsof platinum are dependent on metal speciation andfurther studies are required in particular on thespeciation of platinum in the environment. Mentordrops a woman from their clinical trials if she hasher implants removed because of health concerns andelects not to be re-implanted.Independent FDAresearch found an increased incidence of fibromyalgiain breast-implanted women. It is not surprising thatresearch funded by the pro-implant lobby group findsno link to systemic disease.Dr. ph Bubinak, a board-certified oncologist,testified before a breast implant advisory board in2002 regarding his experience with the chemotherapyagent cisplatin which is mutagenic, carcinogenic,leukemogenic and teratogenic. Dr. Bubinak stated thatsome breast-implanted patients have the same systemiccomplaints and side effects as cisplatin treatedpatients including fatigue, hair loss, loss of shortterm memory, rash and other allergic reactions,respiratory system problems, and peripheral neuropathywhich is sometimes disabling. He further stated thatmigration of reactive platinum alone could explaincapsule formation and tells the world that thechemicals in breast implants are not inert.The advisory panel asked many questions regardingplatinum. Inamed’s platinum data showing no releaseof platinum from their implants was deemed irrelevantby the panel because they used inappropriate disks.Mentor did admit to platinum release from theirimplants but stated it was in the zero valence orharmless (they did not use state of the art equipmentsuch as IC-IC-PMS).CANDO’S Research Project #1 found significant levelsof platinum is released by gel-filled breast implantsand is in an ionized form. CANDO’S research alsofound significant amounts of platinum in breast-milkfrom implanted mothers and ionized platinum is beingfound in the urine of children born afterimplantation. Both Inamed and Mentor stated that theydo not plan on doing research or gathering informationon second-generation effects.CANDO has the funds to test a limited number of womenand their children born after implantation free ofcharge. We are specifically looking for womenimplanted after 1988 with Mentor third-generationsilicone gel-filled breast implants. We are uncertainif the silicone shell of saline implants contains tinor platinum as the catalyst. Therefore we will beunable to include saline implanted women in the freetesting program at this time.If you have or know of anyone who has 1988 or laterMentor gel-filled implants please contact meimmediately by e-mail keeling.m@... or by phone281/444-0662. If you know of anyone who was enrolledin the Mentor clinical trials especially the coretrials after 1992 but were either dropped or notfollowed up by a plastic surgeon, please also havethem contact CANDO.If you have children born after implantation with thefollowing symptoms or diagnoses we are interested inhearing from you: (1) year round atypical allergies(2) asthma (even atypical with no wheezing) (3)unusual rashes, hives, or atypical eczema (4) loweredtolerance to everyday chemicals (5) peripheral ordemyelinating neuropathy (6) bone pain (7) esophagealmotility (swallowing) problems or esophagitis (8)learning disabilities or other neurological disorders(9) autoimmune or connective tissue symptoms ordiagnoses (10) tinnitus or other hearing problems (11)bladder problems (especially frequency). KeelingChemically Associated Neurological DisordersP. O. Box 682633Houston, Texas 77268-2633281/444-0662281/444-5468 FAXkeeling.m@...-------------------------------------------------------------------------------------------Chemically Associated Neurological Disorders(CANDO) Research Project #2Click here for Platinum Testing Information Since the CANDO funded research abstract Platinum and platinum species in explanted silicone gel breast prosthetic devices using IC-ICP-MS was presented by S.V.M Maharaj, Ph.D., at the August 2004 American Chemical Society meeting, many breast implanted women have contacted either Dr. Maharaj, ExperTox, or CANDO asking about platinum testing. In response to many requests for information, I am putting this comprehensive letter together to try and respond to many of your questions.In 1994 I had my ruptured double-lumen silicone gel-filled breast implants removed because of hardened capsules, fatigue, memory loss, hair loss, depression, peripheral and demyelinating neuropathy (damage to my nerves). In networking with many breast-implanted women, I discovered they had similar symptoms and diagnoses including chronic inflammatory demyelinating neuropathy. As a result, in 1996 I along with others founded Chemically Associated Neurological Disorders (CANDO). We organized a charity golf tournament and raised funds for education and research. First let me assure you that I have worked on this issue for ten years as a volunteer (I have received no money or compensation for my time and have no financial ties to ExperTox). I met Dr. Lykissa, an expert forensic toxicologist, in 1997 when we both spoke at an FDA meeting regarding what we believed to be the harmful effects of gel-filled breast implants. While employed at Baylor College of Medicine in Houston, Dr. Lykissa and others published the following research:Detection and Characterization of Poly(dimethylsiloxane)s in Biological Tissues by GC/AED and GC/MS. Anal. Chem. 1997, 69: 1267-1271 Release of Low Molecular Weight Silicones and Platinum from Silicone Breast Implants. Anal. Chem. 1997, 69, 23: 4912-4916 Low Molecular Weight Silicones Are Widely Distributed after a Single Subcutaneous Injection in Mice. Am J Pathol. 1998, 152: 645-649 Cyclosiloxanes Produce Fatal Liver and Lung Damage in Mice. Environ Health Perspect. 1999, 107: 161-165 I filed, with the support of many other organizations, a Citizen’s Petition in 1997 requesting that the FDA revoke permission granted to manufacturers to make silicone gel-filled breast implants available to women with breast cancer (who already had a weakened immune system) and women who previously had implants (who probably already had high levels of silicone and platinum). The FDA denied this petition.In 1997 the Department of Health and Human Services asked the Institute of Medicine (IOM) to conduct a review of all research regarding the safety of silicone breast implants. In 1998, the FDA completed a study to assess the rupture rate of silicone gel-filled implants.The IOM released their report on June 22, 1999 titled " Safety of Silicone Breast Implants " with the following recommendations: " Reliable techniques for the measuring of silicone concentration in body fluids and tissues are needed to provide established, agreed-upon values and ranges of silicone concentrations in body fluids and tissues with or without exposure to silicone from an implanted medical device. Such developments could improve the study of silicones and silicone distribution in humans, could help with regulatory requirements, and might in some circumstances resolve questions by providing quantitative data on the presence or absence of silicones. Ongoing surveillance of recipients of silicone breast implants should be carried out for representative groups of women, including long-term outcomes and local complication, with attention to, or definition of the following: Implant physical and chemical characteristics, Tracking identified individual implants, Using appropriate, standardized, and validated technologies for detecting and defining outcomes, Carrying out associated toxicology studies by standards consistent with accepted toxicological standards for other devices; and Ensuring representative samples, appropriate controls and randomization in any specific studies, as required by good experimental design. The development of a national model of informed consent for women undergoing breast implantation should be encouraged, and the continuing effectiveness of such a model should be monitored. " I helped work on the Citizen’s Petition filed in 1999 by Anne Stansell, a breast cancer survivor, requesting the FDA ban the use of silicone gel-filled breast implants due to independent research documenting extremely high rupture rates (70% or more in some cases). The FDA denied this petition.From my work with the FDA and the recommendations by the IOM, I came to understand that published research of the testing of implants, the tissues and fluids of breast implanted women was perhaps the only way to convince the FDA to make regulatory changes. In 2000, CANDO funded a small study concentrating on platinum release from explants and in the blood, sweat, hair, nails, and urine of breast implanted women and their children born after implantation (children born prior to implantation and women without implants were used as controls). Breast-milk from nursing breast- implanted mothers was also tested. My explant was tested in this initial research and found to release significant amounts of ionized platinum in the 2+ and 4+ ionization state. On September 11, 2000 the initial results of my explant testing along with the other explants tested in this small CANDO research project was presented to the FDA. On November 7, 2000 I filed, along with the support of many other organizations, a Citizen’s Petition requesting that the FDA revoke the implantation of silicone gel-filled breast implants for any reason in light of new research documenting the release of platinum in a reactive valence from intact implants. The FDA denied this petition.Note that on December 27, 1996 Dow Corning sent a notification of substantial risk to the Office of Pollution Prevention and Toxics at the Environmental Protection Agency regarding their 3-8015 Intermediate (Platinum #2). Dow Mammary Implant Material Formulation documents that 3-8015 INT (PLATNM2) Chloroplatinic Acid was used as a catalyst in the making of silicone gel-filled breast implants.The FDA issued new guidance for breast implant manufacturers on August 13, 2001 that required for the first time that they provide qualitative and quantitative analysis for heavy metals and residues of catalysts including the valence status of any heavy metal.Platinum was found in my hair, blood, nails, sweat, and my urine contained 36.0 ug/L (parts per billion per liter of urine). Two studies done by the CDC in 1999 show that for the sample of the general U.S. population (2465 people) ages 6 and over no platinum (ionized or elemental) was found in their urine. These initial research findings along with the other participants (no names were revealed only patient numbers) were given to the FDA in a teleconference on 11/26/01. German research Determination of Siloxanes, Silicon, and Platinum in Tissues of Women with Silicone Gel-filled Implants was published in 2003 documenting for the first time platinum in the tissues of breast implanted women.After the FDA panel hearing in 2003 I filed, along with the support of others, a Citizen’s Petition asking that the FDA delay the approval of gel-filled breast implants until additional valid long-term scientific data was collected. The FDA denied my petition.S.V.M. Maharaj, Ph.D. published research in 2004 titled Platinum concentration in silicone breast implant material and capsular tissue by ICP-MS documenting significant amounts of platinum in the capsular tissue and breast implants of fifteen women. Dr. Maharaj agreed to collaborate free of charge with ExperTox to help get the CANDO Research Project #1 published. Please forgive the length of this letter documenting the history of CANDO but I felt it was necessary because I have recently become aware that I was being accused of a for-profit motive and being part of groups that are interconnected on a non-scientific basis. While I do admit that I do not have a scientific or medical background, I do have common sense. I have used my small settlement from the manufacturer of my defective implants to try and learn the truth about the health risks of chemicals implanted in the body. Women need accurate information on the risks to make an informed decision or give informed consent.ExperTox must charge a fee to test for toxic chemicals. Other wise they would go bankrupt and we would have one less independent lab (not owned by the chemical companies). From the initial CANDO research project it was determined that the urine was the least invasive best method to test for platinum in the body (confirmed by the CDC study done of the general U.S.). To make it as simple as possible and at the lowest cost, we have made the protocol to include collection in your own home with instructions to ship it overnight to ExperTox. CANDO is out of funds. However, I am expanding the research to be called CANDO Research Project #2 by inviting all interested breast implanted women and their children to participate. ExperTox has agreed to do this platinum urine testing for the reduced fee of $150 per person for anyone willing to fill out a questionnaire. The questionnaire is necessary to try and rule out any other significant sources of platinum you might have been exposed to in your environment. Our purpose in expanding the research is to try and determine why we find platinum in the urine of some breast implanted women and not others. Does length of implantation make a difference? Does type of implant and manufacturer make a difference? We need your results even if they are non-detect to try and answer these questions. Does length of time after explantation before testing is done make a difference? We hope to force the FDA to do some independent testing or require the manufacturers of implants to test explants in a retrieval study. As many of you told the IOM, we are the " evidence " . Test our fluids and tissues. This was not done in the Mayo study, the Harvard study, or the NIH study – only medical records were reviewed or questionnaires filled out.I am helping to collect the questionnaires and data to get this important research published. If you have already had your urine tested, please let me know so that we can include your results. If you don’t know what your levels of platinum might be and would like to participate in this project, please contact me and I will either e-mail or send by mail the protocol and questionnaire. Together we can make a difference.Sincerely, Keeling, PresidentChemically Associated Neurological DisordersP.O. Box 682633Houston, Texas 77268-2633281-444-0662keeling.m@...