Marlene Keeling attached statement was made yesterday before the CDRH Stakeholder Meeting November 17, 2005

[Guest guest]

> Subject: Keeling attached statement was

> made yesterday before the CDRH Stakeholder Meeting

> November 17, 2005

> Date: Fri, 18 Nov 2005 14:15:14 -0800

>

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> 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. 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 " .

> Zuckerman, Ph.D. and Lindsey Wade with the

> National Research Center

> for Women & Families spoke at this meeting along

> with , M.D.

> Dr. 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 , Texas.

> Research published in

> 1999 by Dr. includes " A controlled comparison

> of symptoms and

> chemical intolerances report by Gulf War veterans,

> implant recipients and

> persons with multiple chemical sensitivity " .

>

>

>

> Keeling

>

> Chemically Associated Neurological Disorders

>

>

>

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>

>

> CDRH Stakeholder Meeting

>

> November 17, 2005

>

>

>

> My name is 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. 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,

>

>

>

> Keeling

>

> Chemically Associated Neurological Disorders

>

> P.O. Box 682633

>

> Houston, Tx. 77268-2633

>

> 281/444-0662

>

> 281/444-5468 FAX

>

> keeling.m@...

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