Testimony_Pam Dowd_Kathy Nye_Carolyn Wolf_Marlene Keeling

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From: Kathynye@...Date: Sun, 1 May 2005 12:16:59 EDTSubject: POST: Testimony_Pam Dowd_Kathy Nye_Carolyn Wolf_ KeelingKathynye@...Subj: Pam Dowd Testimony - FDA Panel Hearings - April 2005 From: myrlj@... My name is Pam Dowd of Boise, Idaho. I represent Implant Veterans of ToxicExposure. I have driven almost 2,500 miles in a 1984 Southwind motor homeat my own expense to be here. I felt it was that critical.On May 21st, I will reach my 30th year of being free of breast cancer. In2003, I told the panel about my experience as a breast cancer survivor andabout the failed reconstruction that included three ruptured silicone breastimplants. I told the

panel about the excruciating pain of a spontaneousrupture that literally had me pulling at my hair, about the experience ofhaving my chest scraped and cauterized following the explant, and that theMentor implants of 1988 that caused me to cough constantly and choke on myown saliva for seven years, and about the pain in the long bones that attimes has me screaming in pain.Today I come to address the issue of the denial of health care insurance forwomen who have had breast implants. On page 5 of the Mentor Corporation48?page informed consent is this warning. Inamed does not provide thisinformation online. "For patients who have undergone breast implantation,either as a cosmetic or a reconstructive procedure, health insurancepremiums may increase, coverage may be dropped, and/or future coverage maybe denied. Treatment of complications may not be covered as well. Youshould check with your insurance

company regarding these coverage issues."Ladies and gentlemen, there is no "may" about this critical health crisiswith implanted women. The denial of health insurance to women who have hadimplants is increasing across the land. Until last year, I had no personalknowledge of being denied health insurance.Last October, my late husband went on Medicare. And we lost his COBRAinsurance. For 30 years, I had been covered under group policies. BlueCross had paid for this devastation that's called breast reconstruction.Yet, in the end, I am denied health insurance based on the diagnosis ofSjogren's, Raynaud's, peripheral neuropathy, fibromyalgia, and a long listof other diagnoses I have received since getting breast implants.Insurance companies such as Blue Cross/Blue Shield, Equitable LifeInsurance, Aetna, AARP supplemental insurance, Prudential, Republic BankersLife Insurance, Times Insurance

Company are denying health care coverage towomen who have had breast implants.I found evidence on the evidentiary CDs from the MDL that this concern wasfirst reported by doctors in 1989. Insurance application forms are nowasking for implant history.If, as the manufacturers and members of the ASPRS repeatedly claim, there isno connection between implants and health problems, then why the insurancedenials? If there are no health risks, then why does Blue Cross/Blue Shieldof Texas have declined if implants are explanted as their underwritingguidelines as far back as 1996? What is the toxic secret the insurancecompanies know but aren't sharing?In 1998, I presented the results of a survey of implanted women to theInstitute of Medicine. Of the respondents, 30 percent of the women were ondisability and are drawing assistance for living needs from government andcharity offices. Many of those

who were disabled were disabled before theage of 50 and within 15 years of getting breast implants.With Inamed's latest figures of 325,000 newly augmented women per year, thishas the probability of creating another 100,000 women on disability a yearwithin the next 15 years. This has the potential of being in excess of $100million burden on the American taxpayer.On pages 40 and 41 of Mentor's 48?page informed consent are Mentor's supportof the diabolical and barbaric flat surgeries that are disabling, creatingpermanent and sometimes total disability for the recipients.The insurance companies are already saying they are not going to pay for thehealth care needs of even the reconstruction patients they have alreadycovered.Ladies and gentlemen, it will be seven and a half yearsCHAIRMAN CHOTI: Would you please sum up?MS. P. DOWD: before I am eligible for Medicare. I am 57, uninsured,

anduninsurable.CHAIRMAN CHOTI: If you could please sum up for us?MS. P. DOWD: Yes.CHAIRMAN CHOTI: Your time is up.MS. P. DOWD: Putting the burden of health care of thousands of women on mychild's shoulder is a task I could not in good conscience do. Can you?Again, thank you for this opportunity.CHAIRMAN CHOTI: Thank you.===========================================================Subj: Kathleen Van Fossen-Nye Testimony - FDA Panel Hearings - April 2005 From: myrlj@... MS. VAN FOSSEN-NYE: Good morning. My name is Kathleen Van Fossen-Nye. Idrove here from Sinking Spring, Pennsylvania to speak before the panel. AndI have no conflict of interest. I spoke before the panel in October of2003.My history with silicone breast implants is almost as long as the productshave been on

the market. In 1968, when I was 22 years old, I was implantedwith the original Cronin implant following a bilateral mastectomy for aprecancerous condition.A military doctor performed my first breast implant surgery because myhusband was in the U.S. Navy. In the government lawsuit, manufacturersagreed to pay five government agencies, including the Department of Defense,the Department of Veterans Affairs, Medicaid, and Medicare, millions ofdollars to reimburse them for the costs they incurred treating women madeill by silicone breast implants. This settlement demonstrates that thefederal government is aware and has acknowledged that silicone breastimplants cause health problems and disabilities.However, how can the FDA even consider approving these PMAs when theDepartment of Health and Human Services has already made it clear thatsilicone breast implants pose a serious health risk to women,

costingmillions of dollars?In the past, I have heard the panel members ask why so many women get breastimplants and why they keep getting them, even after they fail? I have heardplastic surgeons on the panel say that the women don't mind thecomplications because they really like their implants. This was not truefor me.I started to suffer from fatigue and joint pain, and the implants were hardand painful. I went to a number of plastic surgeons, asking to have myimplants removed. I found a plastic surgeon who was willing to remove theimplants. He removed and replaced my implants with a new and improvedimplant. This started my journey through a silicone nightmare.I have experienced the gamut of problems, including outright rejection.Eventually necrosis developed, and the implant actually came out through myskin and popped out on its own. Here is the photo of what

happened.Despite my mastectomy, I developed breast cancer in '86. I have had a totalof 15 implants and expanders over the years. Why did I have 15 implants? Ihad so many because I believed my doctors when they told me they were newand improved. I wanted to believe my doctors when they told me they werenew and improved.For over 35 years, I have experienced new and improved implants. I havecome to the conclusion there is no such thing as a new and improved siliconebreast implant.-=============================================================Subj: Carolyn Wolf Testimony - FDA Panel Hearings - April 2005 From: myrlj@... MS. WOLF: Good morning. My name is Carolyn Wolf. I live in Virginia, andI came here at my own expense. I have no conflicts of interest.In 1972, after subcutaneous mastectomies, I had reconstruction

with thenewest, best construction, silicone implants, that were safe and would lastmy lifetime.There were no problems in the beginning. By the seventh year, burning,blister?like growths started on my neck and boil?like growths on myforehead. Sixteen years after, three days were spent in ICU because ofsevere burning chest pains.By the 21st year, my family had noticed a change in personality. And I hadnoticed cognitive changes. By the 25th year, though a non?smoker, I wascoughing up hard, greasy, gold?colored plugs. X?rays showed chronicobstructive pulmonary disease.A military plastic surgeon checked me every year. I never connected myproblems with the implants until my left breast capsule collapsed 28 yearsafter implantation. MRI showed both implants extensively ruptured. Shortlythereafter, a glob of silicone moved from my breast into my armpit, leavingan elongated

swelling in its path. There was excruciating pain.In April 2000, vision was lost in my left eye for 45 minutes. Paincontinued in that eye until a long, stringy glob came out of it severalweeks later. Two similar strings were exuded from my left ear in the 30thyear.Explantation performed in 2000 showed the left implant measuring only fourcentimeters. The scar capsules surrounding the implants contained chronicinflammation and foam cells containing silicone. Few women had implants aslong as I.I have been diagnosed with silicosis, rheumatoid arthritis, connectivetissue disease, Raynaud's, and silicone?induced MS?like syndrome withneuropathy of the extremities.My brain MRI shows more than 20 lesions. My silicone level is .11, morethan double what is normal. My platinum level is 20 times normal. Siliconecontinued to be exuded from my nipples until simple mastectomies to

removepainful calcified tissue was performed six months ago.National Cancer Institute has conducted the only study of women implantedfor more than eight years. That found women are much more likely to die ofbrain and lung cancers and suicide. If implants are so safe, make sure thatmanufacturers prove that it is safe.The studies you will hear about tomorrow do not prove that. The womenstudied were not implanted for more than ten years. You have no controlover the advice given or not given by plastic surgeons. What happened to mewill eventually happen to thousands of women with silicone implants. Andplease do not inflict this on another generation.----------------------------------------------------------------------------------------------------------------------Subj: Keeling Testimony - FDA Panel Hearings - April 2005 From: myrlj@...

MS. KEELING: My name is Keeling. I am President and foundingDirector of Chemically Associated Neurological Disorders, or CANDO. I havepaid my own way here because of my concern over toxic and hypersensitizingchemicals that I am convinced are leaking or bleeding from implants into notonly the bodies of women but, even more worrisome, their children born afterimplantation.I was implanted with McGhan double lumen breast implants in 1978. I had myruptured implants removed in 1994, after I became convinced that my implantswere causing my swollen lymph nodes, hair loss, memory loss, overwhelmingfatigue, peripheral and demyelinating neuropathy. I was perfectly healthybefore I got implants, got sick, had my implants and scar capsule removed inblock and not replaced, got better.When tested for platinum six years after explantation, my urine was found tocontain 36 parts per billion

per liter of urine. Platinum was found to leakfrom my implants. And platinum was also found in my hair, nails, sweat, andblood.The ionization or speciation of my platinum was +2 and +4. Dr. phBubinak, a board?certified hematologist and medical oncologist, testifiedbefore a breast implant advisory board in 2002 regarding his experience withthe chemotherapy agent cisplatin.Dr. Bubinak reported that he was astounded to learn that the catalyst usedto manufacture the silicone for breast implants was platinum chloride, ahighly reactive molecule and precursor to the chemotherapy agent cisplatin.He stated that some breast?implanted patients have the same systemiccomplaints and side effects as cisplatin?treated patients, includingfatigue; hair loss; loss of short?term memory; rash; and other allergicreactions; respiratory system problems; and peripheral neuropathy, which issometimes disabling.Dr.

Bubinak stated that the migration of reactive platinum alone couldexplain capsule formation and tells the world that the chemicals in breastimplants are not inert.Can you go to C? Dr. Maharaj has presented data from CANDO's researchproject number 1 here today. Based on this research, it was determined thaturine was the least invasive, best method to test for platinum levels in thebody.CANDO's research project number 2 has now tested the urine of over 50breast?implanted women and their children born prior to and afterimplantation. I have copies of this raw data, which I can give to the paneltoday.Previously in a written submission, I gave the panel a copy of the CDC'splatinum 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 perbillion.To quickly recap, the results of the raw data presented today, one

childborn after implantation tested over 300 parts per billion. One woman testedover 200 parts per billion 11 years after explantation. And nine women andone child tested over 100 parts per billion.The panel was also given a copy of Dow?Corning's 1996 letter notifying theEPA of substantial risk to their platinum catalyst used in breast implants.Ionized platinum is on the list as being a suspected neurotoxicant andimmunotoxicant.Mentor's most recent FDA-approved product insert makes the followingstatement, "Toxicity studies are currently in progress by various researchfacilities, universities, government agencies, the medical community, andthe medical device industry. Some of these studies are conducted in animalmodels to determine potential immunotoxicity and autoimmune issues relatedto silicone materials. There is the potential that in the animal modelsbeing studied, immunotoxicity may

result."I submit it is not safe enough for the FDA to simply say it is not known ifa small amount of silicone may pass from the silicone shell of an implantinto breast milk. If this occurs, it is not known what effect it may haveon the nursing infant. We must protect our future generation, who cannotmake a choice.Thank you.