Part of Some Government Reports & News Articles

[Guest guest]

BPA is found in breast implants . . . It's been known to be a hormone disruptor for many years - yet nothing has been done about it YET!

You should find this interesting . . . Rogene

Part of Some Government Reports & News Articles-----------------------------------------------------Chemical Law Has Global Impact: Europe this month rolled out new restrictions on makers of chemicals linked to cancer and other health problems … June 12, 2008 -------------------------------------------------------------ABC NEWS June 11, 2008 ~ EXCERPT:Supreme Court Gives Med Device Industry a Free Ride Because FDA Claims Device is "Safe"

Sen. Arlen Specter, R-Pa., put the blame on the FDA which approved the faulty device. "The FDA has become a joke,"--------------------------------------------------------------------------------------------Senators Propose Ban on Chemical in Plastics … April 30, 2008 Schumer said he wants the CDC to weigh in because of conflicting scientific studies on BPA. A growing body of new studies has linked the chemical to prostate and breast cancers, diabetes, behavioral disorders such as hyperactivity, and reproductive problems in laboratory animals. Dingell is concerned. More than 100 studies performed by government scientists and university laboratories have found health concerns

associated with BPA; the industry-funded studies say it is safe.-------------------------------------------------------------Report cites chemical's risk : Milwaukee Journal Sentinel April 15, 2008 "It appears that NTP has really listened to the concerns of scientists in this field," said Henry Waxman (D-Calif.), chairman of the House Committee on Oversight and Government Reform. "This is an important public health issue, and we can't afford to get it wrong." Reps. D. Dingell (D-Mich.), chairman of the Committee on Energy and Commerce, and Bart Stupak (D-Mich.), chairman of the Energy and Commerce Committee's Oversight and Investigations Subcommittee, have been investigating the use of bisphenol A in the lining of infant-formula cans. They called on the Food and Drug Administration to reconsider its earlier determination that bisphenol A is safe. In its determination,

the FDA considered only two studies, both funded by chemical manufacturers, the congressional inquiry found.

WARNING: The chemical bisphenol A: Milwaukee Journal Sentinel Dec. 2, 2007-------------------------------------------------------------------------------------------CRS reports were produced by the Congressional Research Service : January 11, 2001 Attention has focused on certain chemicals that are ubiquitous at low levels in the air, surface water, and food, and at higher levels in many consumer products, including medical devices and baby

toys.--------------------------------------------------------------------------------------------OSEL: Toxicity of compounds released from medical device materials. January 27, 2005Biological Effects of Chemicals and Medical Device MaterialsOSEL is conducting a wide range of projects designed to examine the biological effects of chemicals released, intentionally or unintentionally, from medical device materials or the tissue-device interactions themselves. The general goals of these studies are to evaluate

the safety of these chemicals and materials and to develop or refine test methods that improve preclinical testing of device materials. Studies in this area fall into several subcategories:Immunological/ Inflammatory/ Proliferative effects. OSEL is conducting research to examine the immunological, inflammatory, and proliferative effects of materials and chemicals released from materials, including examination of the stimulation of chronic inflammation by particles using both in vitro and in vivo models, and the induction of allergic responses by material constituents, such as natural rubber latex proteins and metals. In addition, OSEL is conducting research on the ability of compounds incorporated into a device (e. g., drug-eluting coronary stents) that are

intentionally released in order to mitigate inflammatory or cell proliferative responses induced by the device.Toxicity of compounds released from medical device materials. OSEL is involved in investigation of the adverse effects of compounds (e. g., metals, DEHP, ethylene oxide, bisphenol A, endocrine disruptors) released from medical device materials using small and large animal models, the development of toxicity tests specific for medical device materials (e. g., polymers that cure in situ), and the development of biomarkers to detect early cell and tissue damage caused by compounds released from devices.

Biological effects of nanotechnology products and tissue engineered medical products (TEMPs). The development of TEMPs and nanoparticles in health care delivery is at the cutting edge of medical device technology. OSEL is developing test methods to examine the potential tissue interactions of these materials and medical devices, such as TEMPs scaffold materials and nanoparticles, in patients receiving the device and on the cells and tissues that are components of the device---------------------------------------------------------------------------------------------

US FDA Research Project Level Inventory by Agency Involvement 1995/1996

Some components of materials; used in medical devices have been shown to have estrogenic properties.We are determining the inflamatory and immunological responses to particles of materials used in medical implants.There is concern over the potential exposure in the general population- especially during fetal or early postnatal development- to estrogenic like compounds -bisphenol A, nonyl phenol, phthalates- present in polymeric medical devices. In the body, these chemicals can emulate estrogen and trigger unwanted biological effects. Development of a physiologically-based pharmacokinetic model (PBPK) would allow a more quantitative assessment of the potential risks associated with low dose exposure of endocrine disruptors leached from medical devices.

We are developing an assay for estrogenic responses that measures the interaction of the ligand with the estrogen receptor via release from the receptor complex of heat shock proteins. This assay, once developed may then be applied to testing materia1s found in medical devices for estrogenicity.

Some components of materials; used in medical devices have been shown to have estrogenic properties. However, no systematic survey of these materials for estrogenic activity has been undertaken. We are beginning to survey the classes of rnaterials found in medical devices f or estrogenic activity using a cell culture screen, confirmed when necessary by the mouse uterotrophic assay, when deemed suitable to the Center's needs, by a molecular gene activation assay.-----------------------------------------------------------------------------------------------------California More than 130 studies suggest that BPA exposure Bisphenol-A OverviewOriginally produced for use as a synthetic hormone in 1936, today bisphenol-A (BPA) is manufactured in excess of six billion pounds per

year. -----------------------------------------------------------------------------------------------------2004-8 PatentStorm LLC.In part as a response to the recent concern over the effects of endocrine disruptors, the United States government and foreign governments have become active in the testing and regulation of endocrine disruptors. In the United States , the Food Quality Protection Act of 1996 requires that the United States Environmental Protection Agency to develop an endocrine disruptor screening program. The Safe Drinking Water Act of 1996 authorizes the United States Environmental Protection Agency to screen endocrine disruptors found in drinking water. Outside the United States , a number of countries

have adopted regulations of endocrine disruptors. For example, the European Union banned the use of phthalates and PVC, known endocrine disruptors, in toys for children under three years of age.------------------------------------------------------------------------------------------------------- Australian Chemical Trauma Alliance : Multiple Chemical Sensitivity (MCS).-------------------------------------------------------------------------------------------------------Medical Device Tracking; Guidance for Industry and FDA Staff ... Document Issued on: May 23, 2008------------------------------------------------------------------------------------------------------IMMUNOTOXICOLOGY/TOXICOLOGY ... Endocrine Disruption bisphenol A NOTE: this is not found on the FDA site in the area of

breast implants-------------------------------------------------------------------------------------------------------

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