CANDO

Chemically Associated Neurological Disorders

Platinum Research Project for Women with Breast Implants and their Offspring

 

Update of September 29, 2006 CANDO's Addendum to Citizen Petition regarding Platinum in implants.

Click here for Citizen Petition.

Click here for Addendum.

April 10, 2006 Click logo for their full article.

HealthCentral, April 8, 2006 Silicone Implants Linked to High Platinum Levels in Women: Study (HealthCentral removed this article entirely from their site)

Washington Post, April 7, 2006 Platinum Found in Women With Breast Implants

Update of April 7, 2006

"Total Platinum Concentration and Platinum Oxidation States in Body Fluids, Tissue, and Explants from Women Exposed to Silicone and Saline Breast Implants by IC-ICP-MS" by Lykissa and Maharaj (April, 2006) in Analytical Chemistry will be online soon. Click here for abstract. Click here for excellent summary.

Update Nov. 18, 2005 CDRH Stakeholder Meeting  

Update May 2, 2005 

Research Project #2

Platinum Testing Information

Update of April 7, 2006 Lykissa and Maharaj (2006)


Note new research published on-line April 1, 2006 by Analytical Chemistry, a peer-reviewed chemistry journal.  Although not available in the published journal until May 1st, 2006, the abstract for the study, titled "Total Platinum Concentration and Platinum Oxidation States in Body Fluids, Tissue, and Explants from Women Exposed to Silicone and Saline Breast Implants by IC-ICP-MS" may be read on-line by clicking here to link to Analytical Chemistry website.
 
A summary of the research is provided by Chemical Associated Neurological Disorders (CANDO) as follows:
 
SUMMARY
 
Women exposed to silicone breast implants have platinum levels that exceed that of the general population, and the oxidation states of the platinum indicate that the exposure may be toxic.
 
Ion chromatography-inductively coupled plasma-mass spectrometry (IC-ICP-MS) was used to determine the total platinum concentration and platinum oxidation states in samples from women exposed to silicone and saline breast implants.  Samples included:  whole blood, urine, hair, nails, sweat, brain tissue, breast milk, and explants.
 
Platinum in nine explanted silicone gel breast implants were mainly in the +2, +4, and +6 oxidation states.  Platinum in seven whole blood and six breast milk samples from women implanted with silicone breast implants occurred mainly in the +2 and +4 oxidation states.  In contrast, the fluid from the two saline breast explants did not contain detectable levels of platinum.
 
This peer-reviewed published study is the first to document the various platinum oxidation states in samples from women exposed to silicone breast implants.  Positive oxidation states indicate risk.
 
INTRODUCTION
 
A complex platinum salt, hexachloroplatinate, has been used in silicone gel-filled breast implants as a  catalyst in both the gel and envelope.  Platinum salt exposure has been associated with a range of problems, from positive skin-patch tests (indicating an allergic reaction) and contact dermatitis, to more serious problems such as asthma, immunogenicity, inhibitory effects on brain enzymes (brain damage), neurotoxicity (nerve damage), mutagenicity, carcinogenicity, and allergic anaphylactic reactions.
 
Recent studies have shown that there are significant amount of platinum in silicone breast implant gel and envelopes.  Platinum has been shown to leak out and accumulate in the scar tissue and fat tissue of women exposed to silicone breast implants.
 
Platinum in compounds that occur in oxidation states other than zero (0) may be harmful to human health.  In the compound hexachloroplatinate, the oxidation state of platinum is +4.  No previous study ever published actually analyzed a breast implant or explant for the various forms of platinum.
 
MATERIALS AND METHODS
 
The average amount of time the implants were in the women's bodies was approximately fourteen years.  The  average number of years the women were explanted before the analyses were conducted was six years.
 
The surgically explanted silicone implants in the study were all 2nd generation implants, from the 1970's through 1988, except for one more recent 3rd generation "low-bleed" silicone gel breast explant.
 
Questionnaires were completed to provide information regarding whether the women had been treated with platinum-based chemotherapy drugs; had worked in occupational settings where exposure to platinum may have occurred; or had dental amalgams that contained platinum.
 
RESULTS AND DISCUSSION
 
The average platinum concentration in samples from women exposed to silicone breast implants was found to be the following when compared to samples from individuals with no known platinum exposure:
  Hair samples                 14 times higher
  Nail samples                  3 times higher
  Breast Milk                   100 times higher
  Urine                          60 - 1700 times higher
 
Our results indicate that platinum migrates from silicone implants via the lymphatic and blood systems into the urine, sweat, and breast milk, with deposits and accumulation in hair and nails.  Platinum, including ionized forms of platinum, may persist years after the silicone gel breast implants have been removed.  Like lead, platinum may accumulate in bone tissue.
 
The women did not have other platinum exposures that could explain the results.
 
All silicone envelopes used in silicone, saline, and in testicular implants catalyzed with ionized platinum would be expected to degrade and depolymerize as they age. 
 
CONCLUSION
 
Silicone gel breast implants are the most likely source of the elevated total platinum levels, and the reactive forms of platinum in women exposed to these devices.
 
Chemically Associated Neurological Disorders (CANDO)
P.O. Box 682633
Houston, Texas 77268-2633
281/444-0662
Sent: Friday, November 18, 2005 8:55 AM
Subject: 11-17-05 CDRH Stakeholder Meeting

The attached statement was made yesterday before the Center for Devices & Radiologic Health (CDRH) meeting at the FDA during their Third Annual stakeholders meeting.  It was presented under the Premarket Review Performance Goals section which has to do with how many days it takes the FDA to respond to Premarket Approval Applications (PMA) from manufacturers under MDUFMA.  Dr. Daniel Schultz, Director, CDRH told me later that he listened very carefully to what I had to say and told me that I was relying too heavily on what "the newspapers" were printing (of course when the conditions for approval are secret this is all we have to go on).  Dr. Schultz assured me that the FDA was very concerned about "long-term data".  Diana Zuckerman, Ph.D. and Lindsey Wade with the National Research Center for Women & Families spoke at this meeting along with Claudia Miller, M.D.  Dr. Miller is a professor of environmental and occupational medicine and a board certified internist, allergist and immunologist at the University of Texas Health Science Center at San Antonio, Texas.  Research published in 1999 by Dr. Miller includes "A controlled comparison of symptoms and chemical intolerances report by Gulf War veterans, implant recipients and persons with multiple chemical sensitivity".
 
Marlene Keeling

Chemically Associated Neurological Disorders

(return to top)


CDRH Stakeholder Meeting

November 17, 2005

My name is Marlene Keeling. I am president and a founding director of Chemically Associated Neurological Disorders or CANDO. I want to thank the FDA for the opportunity to speak before this stakeholders meeting. I am here representing consumers of medical devices. In particular I will address the approvable letter with conditions recently sent by the FDA to the manufacturers of breast implants. My concern is not with the time it took the FDA to respond to the manufactures PMA application but the science behind the decision to approve this class III device.

 

My concern is with the proprietary or “secret” conditions as set forth by the FDA for ultimate approval. The Washington Post quotes a cover letter recently sent by Mentor to plastic surgeons stating “In anticipation of a final gel breast approval, the FDA is requiring that study doctors send a letter to their study patients to remind them of the importance of their commitment to continue their 1-, 3-, and 5-year follow-up visits.” Does this mean that the FDA is only going to require the manufacturers to follow breast implanted patients for five years? In networking with thousands of breast implanted patients, we know that often it takes seven years or more after implantation for symptoms of systemic disease to appear.

 

The most common local complication of implants is encapsulation. It is well recognized that this is an inflammatory response and the bodies attempt to wall off this foreign material. Recently there has been much written about inflammation and its role in systemic disease. Common sense tells me that after a number of years and when these implants start to degrade, it overwhelms the immune system and detoxification ability of the human body.

 

I would like to briefly review the record of the FDA and breast implant manufacturers:

  • Seventeen years ago the FDA classified all breast implants into the class III category because of reports of adverse events in the medical literature.
  • Fourteen years ago PMA’s submitted by manufacturers did not contain sufficient data to warrant a review by FDA
  • Thirteen years ago FDA decides to allow silicone gel-filled implants on the market only under controlled clinical studies.
  • Nine years ago FDA sent a letter to manufacturers detailing information needed for core studies (stage 3 studies)
  • This year FDA sent manufacturers an approval letter with conditions after reviewing only one, two, and three years of data.

 

My understanding is that the current third generation implants being considered for approval have been manufactured since 1988. The question then becomes why do the manufacturers not have thirteen years of data or even nine years of data? I believe I know why after networking with thousands of breast implanted patients. The incidence of complications becomes too high of this non life-saving device and the women are not being followed in many cases as required by the FDA especially after they develop local complications or systemic disease.

 

In 1997 when I filed my first citizen petition regarding breast implants, the manufacturers were being allowed to quote a 1% rupture or failure rate and many women were being told that their implants would last a lifetime. This was the information that women were using to make a decision as to how much risk they were willing to take. After independent MRI research by the FDA it was determined that the rupture rate was 77% with silicone seen outside of the scar capsule 21% of the time. Manufacturers then changed the wording in the product insert to simply say “implants may not last a lifetime”.

 

As stated by the Washington Post, some of the major reservations voiced by the FDA scientists and 2005 advisory panel experts involved the relatively limited amount of long-term information about the implants’ effects on women’s bodies. Paul Wooley, director of research for orthopedic surgery at Wayne State University recently stated “It’s been suspected for at least a decade that heavy metals used in manufacturing of implants might cause problems for women who receive these implants.”

 

Independent research by the FDA published after the IOM review in 1999 found an increased incidence of fibromyalgia in breast implanted women. Independent research by the NIH also published after the IOM review, found an increased incidence of some cancers in breast implanted women including brain and respiratory cancers as well as others. I find it curious that when the manufacturers pay for studies they do not find an increased incidence of systemic disease for the most part.

 

Former Mentor employees reported to the New York Times that data was falsified regarding breast implants. One employee who was a former product evaluation manager from 1996 to 1998 said Mentor never met basic quality standards for implant manufacturing while he was there. One employee who supervised Mentor’s complaint department said she received about 6,000 complaints of ruptured implants in each of her three years at the company. However, in a recent filing with the FDA Mentor stated that it received a total of 8,060 rupture complaints from 1985 to 2003 or approximately 400 a year. How can the FDA rely on any data submitted by Mentor under these circumstances?

 

Inamed stated at the 2005 FDA advisory panel hearings that their gel implants did not leak platinum. Mentor stated that their implants did leak platinum but that it was in a zero valence. CANDO submitted data to the FDA after the advisory meeting on a woman with 1997 Mentor third-generation gel implants and her four year old son born after implantation. Both were found to have significant amounts of ionized platinum in their urine with a valence up to +4.

 

Ionized platinum is on the suspected list as being a neurotoxicant, immunotoxicant, respitory toxicant, and a sense organ toxicant. Dow notified the EPA in 1996 of substantial risk to their platinum catalyst used in the manufacturing of breast implants.

Any detectable level of ionized platinum is a health hazard, the more the worse it is. Several families with children born after implantation testified at and sent documentation to the FDA of significant platinum urine levels up to 382 ug/L (parts per billion per liter of urine). In an ongoing research project CANDO has now tested the urine of twenty children born to breast implanted mothers. Why is this research being ignored by the FDA?

 

History will reflect that it was under your administration, these devices that rupture at an alarming rate and spill chemicals and heavy metals into a woman’s body were approved due to the combined lobby effort of the chemical companies, the manufacturers, and the plastic surgeons. These are the beneficiaries who have the money to do clinical trials. It would be negligent should the FDA allow these manufacturers to follow these women for only five years. It would be negligent for the FDA not to require the manufacturers to follow-up on any children born to breast implanted women enrolled in a clinical study or not to require platinum urine testing.

 

Because the chemicals and heavy metals used in the manufacturering of medical devices are considered proprietary information or “secret”, consumers must rely on the FDA to protect them and advise them of potential risks. If approval is given, will consumers be advised that their implants may leak heavy metals and these heavy metals if ionized may cross the placental barrier and brain barrier? I would consider it grossly negligent of the FDA not to require the manufacturers to inform consumers of this important information when making an informed decision on how much risk they were willing to take when implanted with these devices for many years and during their child-bearing years.

 

Thank you,

Marlene Keeling

Chemically Associated Neurological Disorders

P.O. Box 682633

Houston, Tx. 77268-2633

281/444-0662

281/444-5468 FAX

keeling.m@worldnet.att.net

Update Nov. 18, 2005 CDRH Stakeholder Meeting  

Update May 2, 2005 

Research Project #2

Platinum Testing Information

Return to Top

 


UPDATE FROM MARLENE KEELING

May 2, 2005

FDA Advisory Meeting
April 11 – 13, 2005

CANDO wants to thank everyone who traveled to or sent
written testimony to be read into the official record
during the public comment period of the recent FDA
advisory meeting.
We had approximately fourteen who
had been tested for platinum who testified.


We owe a huge debt of gratitude to Susan V.M. Maharaj,
Ph.D., a professor of chemistry at American
University, who testified regarding her published 2004
research on platinum and the results from CANDO
Research Project #1. I presented raw data from CANDO
Research Project #2 which found
one child born after
implantation tested over 300 parts per billion
, one
woman tested aver 200 parts per billion eleven years
after explantation, and nine women and one child
tested over 100 parts per billion.
Previously in a
written submission to the FDA and panel members, I
sent a copy of the CDC’s platinum urine study
in the
general U. S. population of over 1,000 people and not
one of them had over the level of detection of <0.04
parts per billion per liter of urine.


Michael Harbut, M.D., board certified in Occupational
Medicine who has limited his practice to the diagnosis
and treatment of diseases caused by occupational and
environmental toxins, provided testimony read into the
record regarding platinum. Claudia Miller, M.D.,
board certified in Internal Medicine and in Allergy
and Immunology, spoke about her research regarding
Toxicant Induced Loss of Tolerance or TILT. This may
explain why many breast implant patients now have a
low tolerance to many chemicals in the environment.

The FDA transcript on April 13, 2005 quotes Sam
Arrepali, Ph.D. Chemist at the FDA as saying
"While
saline-filled breast implants contain only tin, the
gel-filled breast implants contain both platinum and
trace amounts of tin as both these catalysts are used
in the manufacture of gel-filled breast implants."


Ionized platinum is one of the most hypersensitizing
agents known to man. Oxidized platinum also is on the
suspected list as being a neurotoxicant,
immunotoxicant, sense organ toxicant, and respiratory
toxicant. Some of the recognized symptoms and
diagnoses of people exposed to ionized platinum
include the following: asthma, rhinorrhea, tinnitus,
conjunctivitis, urticaria (hives), fatigue syndromes
secondary to impaired oxygen exchange, neurotoxicity,
sicca syndrome, and macular rashes.


Ionized platinum is capable of crossing the placental
barrier and brain barrier. The World Health
Organization (WHO) states there is no data available
to assess the carcinogenic risk of platinum or its
salts to humans.
NIH research has documented that
breast-implanted women have a two fold increased risk
of brain cancer, a three-fold increase of respiratory
tract cancer, and a four fold increased rate of
suicide.
WHO also states that the acute toxic effects
of platinum are dependent on metal speciation and
further studies are required in particular on the
speciation of platinum in the environment.
Mentor
drops a woman from their clinical trials if she has
her implants removed because of health concerns and
elects not to be re-implanted.

Independent FDA
research found an increased incidence of fibromyalgia
in breast-implanted women. It is not surprising that
research funded by the pro-implant lobby group finds
no link to systemic disease.


Dr. Joseph Bubinak, a board-certified oncologist,
testified before a breast implant advisory board in
2002 regarding his experience with the chemotherapy
agent cisplatin which is mutagenic, carcinogenic,
leukemogenic and teratogenic. Dr. Bubinak stated that
some breast-implanted patients have the same systemic
complaints and side effects as cisplatin treated
patients including fatigue, hair loss, loss of short
term memory, rash and other allergic reactions,
respiratory system problems, and peripheral neuropathy
which is sometimes disabling. He further stated that
migration of reactive platinum alone could explain
capsule formation and tells the world that the
chemicals in breast implants are not inert.

The advisory panel asked many questions regarding
platinum. Inamed’s platinum data showing no release
of platinum from their implants was deemed irrelevant
by the panel because they used inappropriate disks.
Mentor did admit to platinum release from their
implants but stated it was in the zero valence or
harmless (they did not use state of the art equipment
such as IC-IC-PMS).

CANDO’S Research Project #1 found significant levels
of platinum is released by gel-filled breast implants
and is in an ionized form. CANDO’S research also
found significant amounts of platinum in breast-milk
from implanted mothers and ionized platinum is being
found in the urine of children born after
implantation. Both Inamed and Mentor stated that they
do not plan on doing research or gathering information
on second-generation effects.

CANDO has the funds to test a limited number of women
and their children born after implantation free of
charge. We are specifically looking for women
implanted after 1988 with Mentor third-generation
silicone gel-filled breast implants. We are uncertain
if the silicone shell of saline implants contains tin
or platinum as the catalyst. Therefore we will be
unable to include saline implanted women in the free
testing program at this time.

If you have or know of anyone who has 1988 or later
Mentor gel-filled implants please contact me
immediately by e-mail
keeling.m@att.net or by phone
281/444-0662. If you know of anyone who was enrolled
in the Mentor clinical trials especially the core
trials after 1992 but were either dropped or not
followed up by a plastic surgeon, please also have
them contact CANDO.

If you have children born after implantation with the
following symptoms or diagnoses we are interested in
hearing from you: (1) year round atypical allergies
(2) asthma (even atypical with no wheezing) (3)
unusual rashes, hives, or atypical eczema (4) lowered
tolerance to everyday chemicals (5) peripheral or
demyelinating neuropathy (6) bone pain (7) esophageal
motility (swallowing) problems or esophagitis (8)
learning disabilities or other neurological disorders
(9) autoimmune or connective tissue symptoms or
diagnoses (10) tinnitus or other hearing problems (11)
bladder problems (especially frequency).

Marlene Keeling
Chemically Associated Neurological Disorders
P. O. Box 682633
Houston, Texas 77268-2633
281/444-0662
281/444-5468 FAX

keeling.m@att.net

 

 

Chemically Associated Neurological Disorders

(CANDO)

Research Project #2

Click 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:

  1. 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.

 

  1. 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.

 

  1. 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,

 

 

 

Marlene Keeling, President

Chemically Associated Neurological Disorders

P.O. Box 682633

Houston, Texas 77268-2633

281-444-0662

keeling.m@att.net

 

 

Click here for Platinum Testing Information

Update of April 3, 2006

"Total Platinum Concentration and Platinum Oxidation States in Body Fluids, Tissue, and Explants from Women Exposed to Silicone and Saline Breast Implants by IC-ICP-MS" by Lykissa and Maharaj (April, 2006) in Analytical Chemistry (click here to open pdf file)

Update Nov. 18, 2005 CDRH Stakeholder Meeting  

Update May 2, 2005 

Research Project #2

Platinum Testing Information

Return to Top

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