Testimony_Cristy Warschaw_ -Miles_ Steve

[Guest guest]

Note: forwarded message attached.

Kathynye@... wrote:

From: Kathynye@...Date: Sun, 1 May 2005 12:22:00 EDTSubject: POST: Testimony_Cristy Warschaw_ -Miles_ Steve Kathynye@...Subj: Cristy Warschaw Testimony - FDA Panel Hearings - April 2005 Date: 4/30/2005 1:12:03 AM Eastern Standard Time From: myrlj@... MS. PAM DOWD: Hello. My name is Pam Dowd, and I have been asked to speakon behalf of Cristy Warschaw, founder of Women in Health, one of the largestsupport groups in southern California for silicone breast implant women.Neither she nor I have any affiliation with Inamed or Mentor. Neither of ushave received monies from either company for this testimony."I, Cristy Warschaw, have had both Inamed and

Mentor post?1990 siliconebreast implants. I am unable to attend this hearing because of my continuedhealth problems associated with these implants."My history is very simple. No health problems until November 1989, when atage 28 I underwent a mastectomy with reconstruction with silicone breastimplants."I had a family history of breast cancer and calcified fibrocystic disease.I became ill as soon as the implants were placed. I had to stop working asa medical administrator and stop my Master's degree program at UCLA."I have been on disability for most of the last 16 years. I have had sevensurgeries, all associated with the implants. As of today, at the age of 43,I have undergone total mastectomy with no further reconstruction because Iam not a candidate for TRAM flap or any other reconstructive surgery."It has been discovered that I am one of a few people allergic to silicone.If I

even ingest milk, I can have an anaphylactic reaction as silicone isused as a defoaming agent in processing. I cannot place any silicous,silicones, dimethicones, or any cones on my body because I will break out ina rash."IV needles are coated with silicone, and I have not been able to keep onein me for more than one day because of the silicone reacting and inflamingthe IV site."Having been a support group leader for 12 years and having had bothmanufacturers' implants, I have done a lot of investigation on bothcompanies. My number one concern is the FDA 483 inspections. Inamed ismanufacturing its SBIs in Costa Rica. By what means is the FDA inspectingthis manufacturing plant?"Mentor's manufacturing facilities in Texas have failed viscosity, dipping,and humidity control over and over again. Also, medical device reportinghas also proven to be a problem as well."If the FDA is taking

Inamed's chemistry and mechanical testing from onlyInamed's say, then this is a complete failure on behalf of the FDA. It isalso jeopardizing every woman receiving an SBI."Neither company has ever been able to assure shell thickness during thedipping process due to inability to control humidity. So they cannotpredict clinical outcomes, as requested by the FDA, because each lot willproduce a different result."As a health care professional who has kept clinical data for FDAexperimentation and clinical trials, I have great anxiety in allowingsilicone breast implants to be placed back on the market."Also, having been a support group leader and seeing women affected by SBIs,I know how people fall out of the studies. Women will not see a reason tofollow up in?house with a plastic surgeon at the recommended intervals."There is no way a physician can detect a silent rupture. MRIs costthousands of

dollars. The study is already set up to fail. Women move.Women with SBIs are being treated for cancer. Therefore, there is a highermortality rate for these women."No guards are set in place to retrieve post?mortem implants for study.There is a strong possibility these women can lose health insurance and willnot return for follow?up appointments."Women will have a problem and not return to the same surgeon. They mayvery well go to a surgeon who is not part of the study. What happens tothose implants?"Women do not relate their fatigue to implants and are seen by theirpersonal M.D.s for this and may not relate these to silicone breastimplants."I have had four different surgeons and to this day and am in possession offour of my five implants. The silent contained rupture was not noticed onMRI two days before I had surgery. Four years after this rupture, I had

15granulomas relieved from my chest wall by yet another surgeon."There has never been an FDA PRP report filed on me or MDR report on myrupture or fungus?infected implants. I fell through all the loops. And asa support group leader knowing about breast implants, how many of thesewomen will fall through the loops as well? Women with breast cancer are toobusy worrying about their lives to think about SBIs. They just want to bewhole again."I could go on and criticize each part of the draft guidance for industryand FDA staff saline, silicone gel, and alternative breast implants, butthat would take up more time than I have. It is my opinion that neithercompany has met the FDA guidelines to demonstrate a reasonable assurance ofthe safety and effectiveness of SBIs. Therefore, they should deny approval."After ten years of trying" ??CHAIRMAN CHOTI: If you could sum up,

please?MS. PAM DOWD: Yes. I've just got this one sentence."After ten years of trying, yet just not making it, SBIs should be removedfrom the market altogether."=============================================================Subj: (Becky) -Miles - FDA Panel Hearings - April 2005 From: myrlj@... MS. SMITH-MILES: Good morning. My name is -Miles, or Becky.I am from northern Michigan. I am a registered nurse. My husband is aradiologist. I have no conflicts of interest.I had silicone implants put in over 15 years ago. Within two years, Ideveloped capsular contracture and experienced intense pain. My plan to bemore beautiful was ironic in that I was uglier by the day. I had largerbreasts, but they were hard, painful, and ugly. I was ashamed for even myhusband to see

them.Within seven years of getting the implants, I was diagnosed with an atypicalneurological disease. Eight years after being implanted, I had my implantsand scar capsules removed. They had ruptured. And the plastic surgeonattempted to retrieve all of the leaked silicone, but he was unsuccessful.If I had been included in the three-year and four-year studies at that time,only capsular contracture and pain would have been picked up, not therupture and not the systemic problems.I have gone from being a very athletic and active person to being physicallyinactive and at times bedridden. I worked daily prior to getting implants.Now I'm on disability. And sometimes I'm even unable to perform my dailyhousehold tasks, simple tasks.I have severe overwhelming fatigue, joint and muscle aches, pain, dry,scratchy eyes, skin rashes, numbness in my calves and toes, hair loss, nightsweats, and

daily headaches. I am easily confused and have a constant fogin my head.My skin develops rashes and reacts to previously normal substances. I haveblister-like eruptions in my fingers that are intensely painful. And alongwith the pain comes burning and itching and total intolerance to anypressure. I can't use that finger. I scratched it and scratched it untilthe top came off. And then I felt with my tongue a tiny sliver of crystal.When I got that crystal out, it healed immediately.I fear that I have silicone crystals running throughout my body, and Iwonder what kind of damage it has done to my internal organs. I hadsilicone leakage in my chest, axillary lymph nodes down my arms.My last surgery a year ago removed silicone after an ultrasound located itin my chest and breasts. I had a lemon-sized portion of my right breasttissue removed as a result of the leaking silicone

from the rupture over tenyears ago. The surgery has made that right breast noticeably smaller, butit's worth it.My life since getting implants has changed completely. My social and familylives have suffered. I can no longer be a normal wife, mother, orgrandmother. Even so, I'm lucky because my husband is a physician, and weare not financially devastated by my disability.I beg you, as you make this very important decision, think not only of myexperience but also of the lives of other women, your friends, yourrelatives, who may end up like me. Silicone breasts are not worth the knownrisks, let alone the unknown long-term risks.Thank you. Any questions?============================================================Subj: Steve Testimony - FDA Panel Hearings - April 2005 Date: 5/1/2005 9:58:18 AM Eastern Standard Time From: myrlj@... myrlj@... Sent from the Internet (Details) MR. MILLER: My name is Steve . I have no conflict of interest. Mywife is here today. And she will be sharing her story about how siliconeimplants she received for correction of a congenital defect have harmed her.I am reading this testimony on behalf of another man whose wife has alsosuffered greatly due to silicone implants. I am here to read the testimonyof T. Wade Clegg of Panama City, Florida who could not be here with ustoday. He has no conflict of interest."My family life has been severely affected by my wife's disastrousexperience with silicone gel breast implants. That is why I wish to sharemy thoughts with the Advisory Panel."I believe that silicone gel is one of the most insidious and invasiveproducts ever

allowed in the public marketplace. Silicone can migrate todistant places within the body, such as the liver, thyroid, under the arms,into the arms, and across the chest. Such was my wife's experience."For years, her neck would swell and diminish, blocking her breathing. Herthyroid was removed, and the pathology report said it was Sjogren's disease.She is now on permanent medication and must wear a 24-hour opium patch."Sjogren's disease, by the way, can take years to diagnose. Only long-termstudies will be able to show whether implants cause this disease."My wife was not informed about the dangers of silicone breast implants.She is serving a life sentence of pain. Normal for my wife has become aloss of physicality, loss of sleep, and diminished health, which has led tomassive medical bills, bankruptcy, the loss of our farm, and a downwardspiral resulted from silicone gel breast

implants."Most women do not know that silicone gel can calcify and mix into breasttissue. The pain can be extreme, as in my wife's case. Once this takesplace, the surgeon has to literally scrape the silicone off the chest cavityuntil there is nothing left. This was my wife's experience."My wife no longer has breasts. For women of childbearing age, this isparticularly devastating and can mean the inability to breast?feed."The FDA had questions about the safety of implants last year and didn'tapprove the application for implants back then. The real question is, havethe manufacturers really answered all of these questions in the space of oneyear? Since only four years worth of data is being presented, I doubt it."Please ask yourself, if the same question exists, then why are we here? Iplead with this FDA Advisory Committee to continue to restrict silicone gelimplants while

research continues. Do not improve implants which have notbeen proven safe for long-term use. This is not about aesthetics. It'sabout women's health."Thank you."