Testimony_Anne Stansell_Marti s_Cindy Marshall_Dr.

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From: Kathynye@...Date: Sun, 1 May 2005 12:26:44 EDTSubject: POST:Testimony_Anne Stansell_Marti s_ Marshall_Dr. Kathynye@...Subj: Testimony of Anne Stansell - FDA Panel Hearings - April 2005 Date: 5/1/2005 10:03:24 AM Eastern Standard Time From: myrlj@... MS. STANSELL: I was supposed to have five minutes.CHAIRMAN CHOTI: Please go ahead. Yes.MS. STANSELL: Okay. Thank you.My name is Anne Stansell, and I have no conflicts of interest. I representa support group of about 45 women, all with experiences similar to mine.One, Ann Palmer, a cancer survivor, was in the Mentor study. When hersilicone implants

ruptured at about two years, she was dropped from thestudy. And her record at Mentor and, thus, presented to you tomorrow showsno adverse effects. Ann Palmer died of breast implant complications in2001.I was diagnosed with breast cancer when I was 39. I underwent a mastectomy,radiation therapy, and breast reconstruction with silicone implants. Fourdoctors recommended that I get silicone implants. At the time there was noresearch on silicone breast implants in cancer survivors. But none of thedoctors told me that. Not one of them told me about the risks, the factthat they can rupture and leak silicone and other chemicals into my body.Because of these chemicals in my body, I now get severe headaches when I amexposed to any common household products with phenolic disinfectant, such asLysol.After six years, I started to get sick with joint pain, muscle pain, skinproblems, dry

mouth, and dry eyes. My eyes are so dry that it has caused aretina to tear. These are all autoimmune symptoms.I was also diagnosed with an autoimmune symptoms called Grave's disease.After fighting cancer, the new illnesses caused by my implants, I then hadto fight with my insurance company to have the implants removed. You see,the law states that they must provide implants for mastectomy patients.There is no law that says insurance companies must replace them in case ofrupture or remove them in case of adverse effects.When my implants were removed, half of one of them was gone. This is notsurprising given that Inamed's own data shows that 20 percent ofreconstruction patients experience ruptured implants within just threeyears. Studies have shown that silicone can leak into the scar capsule andthe lymph nodes, even when the implants haven't yet ruptured.After I had the implants removed, I

started to slowly get better. This isalso typical. I have read a study by National Cancer Institute researcherDr. Noreen Aziz which shows that most women with implants who haverheumatological symptoms get better when their implants are removed and notreplaced. If their implants were replaced, most got worse.I am not fully recovered, unfortunately. In addition to continued fatigue,the many surgeries to put in and remove my implants had left me with suchchest tenderness that I cannot have anything more than a soft t?shirt on mychest. Now prosthetics even are out of the question.This controversy has been going on for 15 years. The whole new generationis now being seduced into believing these products are safe when they arenot.No significant improvements have been made in silicone breast implants inthe last 15 years. This is the same product with new advertising and

newhype. Just because these manufacturers have created a market for theirproducts with advertising and TV makeover shows does not mean the product issafe.If you want to help breast cancer patients, please insist on long?termsafety data before approving this product. You owe it to us older women whohave suffered for years and years and to the young women who will suffer formany years if you approve this product.==========================================================Subj: Marti s Testimony - FDA Panel Hearings - April 2005 Date: 5/1/2005 10:09:49 AM Eastern Standard Time From: myrlj@... I’m Marti s from Arizona. I have no conflicts of interest.Due to severe breast atrophy, I got silicone gel implants. I never wanted larger breasts, and I never would have gotten them had I known my health, career, and quality of life would be

destroyed. I was healthy, yet nine years later, I became very ill. Tomorrow, the industry will present only four years of safety data. If I had been in those studies, none of my problems would have shown up. Surely, we need long-term studies. After nine years, numerous symptoms presented, such as: Abnormal white blood cell count, severe fatigue, discoid rashes, muscle and joint problems, numbness of my extremities, significant hair loss, etc. These symptoms coincided with my right breast shifting lower than my left. It did not occur to me that the shift was anything but a slight change in breast tissue. Now, I believe this was when my right implant ruptured. My medical records document Discoid Lupus, Sjogren’s Syndrome, Fibromyalgia and Chronic Fatigue Syndrome -- all common conditions for many women with implants. I had to go on Social Security

Disability. The Social Security Administration determined the date of onset of my silicone-related illness was nine years post-implantation. Twenty years after implantation, a mammogram report concluded there were no ruptures. Just months later I had my implants removed only to find both were, in fact, ruptured. According to my Operative Report, quote: “On the right side there was total disruption of the implant and no visible shell was seen. On the left side, there were also several gross ruptures of the implant. It was obvious that the implants had been ruptured on both sides for quite some time.†Upon removal, my neurological problems have somewhat improved, but I still suffer with debilitating chronic fatigue, and much more. Perhaps, there is still silicone in my body. As you will hear from the company data, most women do not even realize when their implants break, and mammograms are not reliable to tell them either.

MRI’s have been proven to be more reliable, but how will women afford them?How would women get an MRI immediately upon a rupture?How will women afford and receive the urgent removal surgery?This is why so many women have been exposed to leaking silicone.What possible reason can these companies have for never providing you with long-term safety data - especially when women like me have expressed our concerns over and over again? I question whether silicone gel implants can ever be proven safe, and ask you – If it is against the law to inject silicone gel into women’s breasts, what on earth makes it okay to put it in a breakable baggie? Since we know implants break down and rupture; wouldn’t it have to be proven safe for gel to be inserted directly in breast tissue? That’s what a rupture is. If you approve these implants, you will not be protecting women, because they will believe they are safe, when clearly this has not been proven. Please just say

NO.==========================================================Subj: Marshall Testimony - FDA Panel Hearings - April 2005 myrlj@... MS. MARSHALL: Good morning. Good afternoon. Hello. My name is Marshall. Here's my story, which is, sadly, just one of literally hundredsof thousands of similar stories.Silicone gel implants have destroyed my precious, priceless health,drastically changing forever the quality of my life. Women like me areproof of the truth.I still remember the words that board?certified plastic surgeon spoke to me,"These implants are safe to last a

lifetime." What a wonderful 21stbirthday gift, "You'll forever love how you'll look and feel." If only hiswords were true.I first experienced flu?like symptoms, hair loss, bone pain, fatigue, whichresulted in countless doctor appointments. I had three mammograms,beginning in 1997, then in 2000, last in 2003.The last mammogram indicated that my silicone gel breast implants wereleaking and ruptured. I had to get explanted quickly and was in May 2004.By this time, it was too late. The damage was already done. My siliconegel breast implants had leaked and ruptured, leaving me with currentlyirreversible damage, silicone poisoning, and silicone?associated disease.Here are just some of the numerous symptoms, conditions, and diseases:swollen lymph nodes; hair loss; chronic bone muscle; skin tissue and organpain; connective tissue disease; arthritis; scalp, face, body rashes;

visionproblems; blood in stools; blood leakage from breasts; chronic weakness,fatigue; Raynaud's syndrome; irreversible brain damage, demyelinatingdisease; MS?like.I used to have a business in home health care. Now I am the patient. Iexperience scary, unpredictable episodes and attacks during these times inwhich I have slurred speech, severe termor, difficulty walking or fall down,and even episodes of paralysis.I must depend on others for my daily needs because of my difficultyperforming. I have difficulty performing even the simplest of tasks: usingthe bathroom, showering, dressing, and feeding myself. One of my doctorsnow thinks I have lupus.If I had been informed of the truth that silicone gel implants were neverproven safe, that they leak, rupture, and bleed toxic substances into theimmune system, contain close to 40 known toxic chemicals, mind you, notmeant for human

consumption, never ever would I have consented or allowedthem to be put into my body.I'm only 37, a single mom of 3 beautiful girls. I just want to be here for, a, and le. My children who need their mommy fear fortheir mommy, who fears for every young girl and woman everywhere.FDA, please support public health safety and not the industry poisoning thepublic. Thank you.============================================================Subj: Testimony - FDA Panel Hearings - April 2005 Date: 5/1/2005 10:22:54 AM Eastern Standard Time myrlj@... DR. MILLER: My name is Dr. . I have no financial interests in this hearing, and I'm here at my own expense. I'm actually a professor at UT Health Science Center in San . I'm an allergist/immunologist. And my research is focused on people who report

chronic disabling symptoms following some environmental exposure, the symptoms you have heard about today. I have served as a consultant to the Department of Veterans Affairs on Gulf War veterans, the EPA on sick buildings, the National Institute of Dental and Craniofacial Research on temporomandibular joint implants, where, by the way, you see similar kinds of complaints. What unites ill Gulf War veterans, sick building occupants, and patient with implants who are having problems is the fact that following a well-defined exposure event, a subset, not every one, a subset of them, go on to lose their prior natural tolerance for a wide variety of substances that are structurally unrelated. Thereafter, common foods, medications, alcoholic beverages, caffeine, chemical inhalants, like diesel exhaust, and fragrances you have heard about

today, exposures that never bothered people before suddenly trigger symptoms in them. And these can be disabling. This two-step disease process -- you can go to the next slide -- has come to be known as toxicant-induced loss of tolerance, or TILT. It does not appear to matter whether the exposure that initiated this, which is at the bottom of the right-hand slide, was endogenous or exogenous. The body's response is remarkably similar. Next slide. We have reported on 87 individuals with surgical implants, three?quarters of them with breast implants. Sixty-nine percent reported rupture. Seventy-eight percent had one or more implants removed. Of those who had undergone explanation, less than ten percent reported their health status as greatly improved. Next slide. Using a validated

questionnaire, we found that the symptom severity scores of implant recipients rivaled those of the environmental exposed groups we were studying. And there were four of those. Next. Compared to controls, implant recipients reported much more severe adverse responses to everyday chemical exposures as well as having problems with various foods, medications, alcoholic beverages, and caffeine. We are a couple of slides behind. Go ahead. Next slide and then the next one. Thank you. And then the next one. Toxicant-induced loss of tolerance is a new paradigm for environmentally induced disease that differs from classical toxicity and allergy. Affected individuals may be completely unaware of the intolerances resulting from this because of a phenomenon we call masking. If a person is reacting to

many different things and having symptoms as a result of those, then the symptoms may overlap in time. And, consequently, they feel sick all of the time, often reporting chronic fatigue or flu-like illness that won't go away. Recent Canadian studies show that genetic polymorphisms may determine who is more vulnerable to developing this illness. And in September ?? next slide ?? I will be chairing a meeting on the toxicant?induced loss of tolerance sponsored by two NIH institutes where we'll be discussing various aspects, clinical models, animal models, and so on, in order to understand this problem better in providing you with a questionnaire that I showed a moment ago to help physicians and researchers better understand this problem. And I will be happy to provide you with any references. Thank you.