by Mary McDonough Here are the facts and horror stories...
Date: 9/27/2007 11:41:24 PM ( 17 y ago)
I founded In the Know as a support group for women in the entertainment industry who are struggling with these issues. It is essential that we all get "in the know."
Over the years I have worked regularly with the brave women you see in this room. These women have been courageous enough to publicly talk about their problems with breast implants, some for years, some for the first time today. Sally, Leigh, Leanza, Christy, Judy – everyone – we are all unfortunately "In the Know" about the harm breast implants can do. That is why we have gathered here today.
In October, the FDA will hold meetings about lifting restrictions on the sale of silicone gel breast implants. They are considering LESS THAN THREE years of data.
Less than three years of data? This is absurd for a device women hope will last a lifetime. All of the women here will tell you that their problems began after three years - and many of their health issues got much worse over time.
There's so much that we DON'T know about silicone gel breast implants - but we do KNOW that most problems begin YEARS after implantation. I started to have serious problems five years after my initial surgery. Researchers and clinicians agree that problems begin, on average, at seven to ten years post-implantation.
Let's look at what else we DO know
We do know that breast implants do not last a lifetime. They all fall apart in the body over time. When mine were removed, the outer lining was completely missing and the gel was held in place by my own scar tissue. According to the FDA's own research – at five years, most implants are still intact. At ten years, many are ruptured. By fifteen to twenty years, most are broken. Knowing this, the FDA is contradicting its own research by looking at only two to three years of data when it considers approval in October.
We do know that women have painful and debilitating complications in the breast area. I had so much pain I could not hold or hug my own child. Once again, according to the FDA's own consumer handbook, these problems get much worse over time.
We do know that women with breast implants require many repeat surgeries. The New England Journal of Medicine said in 1997 that one in four women need additional surgery within five years because of problems related to their breast implants.
We do know that health insurance often does not pay for these repeat surgeries or the replacement implants.
We do know that cancer survivors suffer at much higher rates from painful complications and require more repeat surgeries.
We do know that hundreds of thousands of women have been hurt by breast implants.
We do know that it's impossible to get a clean mammogram. Implants obscure about 80 percent of breast tissue.
We do know that silicone gel escapes the implant and travels all over the body.
We do NOT know the effect of silicone in the body
Today you will hear from these women. Some of them only had a few problems. Some of them got very, very sick. Their common denominator? All of them were still fairly pleased with their implants two to three years after augmentation and all had problems that developed over time.
When I contacted the FDA recently with my concerns, they sent me this statement, "We will be able to give reasonable assurance of safety and effectiveness."
What does that mean? It doesn't mean they are safe. What, exactly, is reasonable assurance? Especially when the "reasonable assurance" is coming from the very manufacturers who will make millions of dollars from selling implants. How reasonable can their assurance really be?
If the FDA is going to put their seal of approval on silicone gel implants, they need to be able to assure women that these implants will not harm them. That they will NOT fall apart in the body, that they will NOT turn as hard as rocks, that women will NOT suffer the rashes, fevers, headaches, shootings pains and completely failed health you will hear about today.
Let me make one thing clear – I am not ANTI-implant. I am PRO-safety and information. This is our last chance to get something that works. If we allow the FDA to lift restrictions on silicone, I fear we will NEVER have a good, safe implant. FDA - please study the devices long enough to assure women they are safe.
We are here to ask the FDA to do its job. Protect women
I am sharing my breast implant nightmare publicly for the first time today. Even though this is very personal and private, I must speak out.
No one ever warned me about the problems with breast implants. If the FDA approves them, women will assume they are safe. They are not. I am living proof. I was sick for years after I had my implants. Now that they've been removed I am finally starting to feel better.
It's crazy for the U.S. FDA to let these be sold after looking at less than three years of information. A lot of women are still happy with their implants after a few years. Our problems start later and get worse and worse as the years go on.
Isn't it the FDA's job to protect people from harmful food, drugs and devices? I am joining my colleagues in the entertainment industry to ask the FDA to do its job.
I was 19 years old when I got breast implants. I'd been athletic and healthy my whole life, but after having implants for a few years I started to get sick all the time. I always had sinus problems and a terrible rash on my hands.
I finally found out that the silicone implants had ruptured. My blood stream was full of silicone. I had to go through long, painful treatments to clean out my system. My breast cavity had to be scraped clean. After getting them out, a blood test confirmed that silicone had leaked into my blood.
These implants are bad news. The U.S. FDA can't get enough information to tell women they are safe after only two years. I enjoyed them for a year or two, then from ages 20 to 32, I was asking myself, 'Why do I have these? I hate these.'
For many years, I loved my silicone breast implants. They never got hard on me and they looked great. But I started to have health problems four years after I'd been augmented. At first, I didn't connect my problems to my implants. But I kept having strange illnesses that wouldn't go away and that got worse over the 10 years that I kept my implants in.
I had itchy, red rashes in various areas on my body. And when I went to the dermatologist, they told me they didn't know exactly what they were. They thought the rashes might be a sort of eczema, but the cortisone creams prescribed to me would not make them go away.
My knees, ankles and hips started to ache. I would get really nauseas and have to lay down at least once a week. It felt like I was coming down with the flu - especially if I over exerted myself physically. I remember one time I went for a run and collapsed beside a lake. A stranger had to drive me home. This was very unusual for me because I had always been very active and had competed in triathalons and 10Ks for 10 years previous to this.
I also became very sensitive to chemicals. I couldn't use hair spray, perfume, fabric softener, or heavy detergents. I couldn't even walk down the laundry detergent aisle in the grocery store because I would start itching all over and my eyes would water like crazy. Towards the end of the time I had my implants in, I had a terrible cough that wouldn't go away, which continued for two years until I had them removed.
Finally, in 1993 I had an MRI. The technician said he felt something was terribly wrong. My left implant was definitely ruptured and the right one looked as though it might be also. I had the implants removed two weeks later. When they took them out, both of the outer shells had completely dissolved. They also found a golf ball-sized cyst filled with silicone behind the left implant, which technicians were unable to detect with an ultrasound and a mammogram before my MRI.
I didn't even realize how sick they had made me. Because it happened gradually over a period of ten years, I felt that a lot of my symptoms were from old age and motherhood. After the implants were removed my rashes, allergies and joint aches all began to improve. I have no doubt my health problems were a direct result of those ruptured implants. I also have no doubt that the improvement in my health was a direct result of those implants being removed from my body.
The U.S. FDA simply MUST consider more than two years of data before they approve silicone implants back on the market. Women need to be more informed and know what they are getting themselves into. I feel that it is an insult to women, a huge slap in the face, not to study these devices long enough to ensure their safety.
I first got silicone gel breast implants in 1986. Three years later, I began to have health problems which got progressively worse the longer I had the implants. Before I had them removed, I was in crippling pain, particularly in my arms, chest, back and neck. I had shooting pains down my legs. I had constant infections and inflammations. I was always sick with viruses. Over the years I was diagnosed with Epstein-Barr, rheumatoid arthritis, borderline MS and borderline Hepatitis. I went from being a Yoga master and aerobics instructor to a very ill woman – at a very young age.
I had the silicone implants taken out and replaced with saline in 1995. After several unsuccessful saline surgeries, I had the saline implants removed in 1998. When the silicone implants were removed, there was silicone all over my body - in my blood, joints and organs. I literally saw test tubes of my blood that looked like it had glue in it. The silicone was causing me terrible joint pain and preventing my organs from working correctly. My pancreas, gall bladder and kidneys were not functioning properly.
Since being explanted in 1998, the inflammation has miraculously improved. But I still have silicone in my system. I undergo constant treatments to detoxify myself and boost my immune system.
The FDA should NOT remove restrictions from the sale of silicone gel breast implants, especially after reviewing less than three years of data. I didn't get sick until 1989 – three years after having implants – and continued to get sicker every year after that. The FDA should protect American women. No one should have to live through the nightmare I've been through and continue to endure.
When I got breast implants in 1983, I was never warned of any possible side effects. A lot of women were getting them and I assumed they were safe.
It was nearly eleven years before I began to notice problems related to the implants. I was concerned about scar tissue which had thickened and become much harder. It even hurt to wear clothes that were tight across the scar tissue. I was also planning to start a family and I was concerned about being able to safely breast feed, without pain or danger to the baby's health.
Many women got a lot sicker than I did. But I wish I'd been told more about the potential health dangers and pain before I got them.
The FDA needs to look at more than three years of data - my problems didn't start for over a decade. Failing to properly evaluate product safety will allow companies to continue to place this unhealthy product in women's bodies, rather than working to create a better, safer implant.
The first time I remember being dissatisfied with how I looked was when I was in 9th grade, and I saw Isabelle, a beautiful frail senior, weigh herself regularly in the dorm bathroom at my New England boarding school. I felt like an ungainly cow next to pale, blonde, petite Isabelle, and I began to wonder if I was too big. Hearing about other girls talk about their dissatisfaction with their bodies made me unhappy with mine. My body was changing, and it wasn’t turning into the small-waisted, curvaceous figure that Betty and Veronica had in the Archie comics I devoured as a kid. Instead, I was tall with big shoulders, strong legs, and no waist. I also had the babyfat typical of teenagers. Thus, at 14 years old, began decades of war with my physical body.
I am 40 now, and it has been over 12 years since I was bulimic – overcoming bulimia was one of the biggest accomplishments of my life. Therapy got me ready to change, and I was in the 12 Step Program Overeaters Anonymous when I finally stopped throwing up for good at 28 years old. For years afterwards, I couldn’t discuss it without becoming teary with gratitude that I had managed to free myself of that terrible burden. I often wonder how those years might have been different if I hadn’t had to deal with my food obsession day after day, everyday — but, then again, maybe I wouldn’t be blessed with this self-awareness or empathy for others if my teens and twenties had gone swimmingly. And does anyone have an easy time of it as a young adult anyway? I struggled with food, but for others it is drugs, sex, alcohol, self-confidence, assertiveness and on and on. I suspect that if our challenges don’t come then, they come later. Now, at 40, I feel blessed to not feel the pull to binge and purge. Life seems so much easier without that secret, that torture. Not that I am now unconcerned with weight and food – to pretend that would be a lie. I have a nutritionist that I consult regularly, daily exercise is a very high priority to me, and I crave sweets more than the average person. I am still diligent about maintaining my weight, and I hate it when I gain 5 pounds, but I don’t turn to food as automatically when I am sad or bored or frustrated. There is no longer that literal emptiness inside that I tried to stuff full with food, and I no longer founder myself on late night icecream-and-anything-else-my-mom-never-let-me-have-as-a-kid binges, purging for relief. In these 12 abstinent years, I can count on one hand the times I wanted to binge and throw up, and each time I recognized the pull and called my sister to talk it through. What a change from the woman who might throw up 3 times in a day. What is different? I was so afraid of being disliked that I wasn’t honest with people about what I wanted. I could not say “no” – no I don’t want to be your friend, no I don’t want to do that extra work, no I don’t want to drive all the way to that restaurant. For comfort and for respite from being that good girl I turned to food and broke all the rules there. Now I have firm boundaries, and I lead the life that I choose. I am more willing to really feel anger, sadness and hurt, and when I am really feeling there is no room for food. It is in that limbo of not knowing what I am feeling that my wild craving to eat comes up, to distract me from knowing.
Ironically, I look better now and my weight is more stable than when I was throwing up, which proves that my bulimia wasn’t really about weight at all. But seeking a concrete number on the scale seemed simpler than dealing with the complications of growing up into a powerful, emotion-filled woman. But it wasn’t. My life is actually simpler now, even with all those messy emotions and the risks that come with sticking up for myself. And when I hear women talk about their dissatisfaction with their own bodies, I can relate, but I don’t hate myself also. I am grateful for my body — it ain’t perfect, but it works.
I had silicone gel breast implants for over ten years before I began having problems with them. Then I started to notice that my breasts were getting hard, painful and, a little later, I had problems raising my right arm.
I had the implants replaced. It took the doctor over three hours just to scrape the calcification and scar tissue out of my chest. My left breast would not heal from surgery. I then received a third implant in my left breast. Within one month, I had severe pain that wrapped around my breast and ran down my back. The pain was so intense that, if it happened while I was driving, I would have to pull the car off the road. It literally hurt to breathe. Soon it became difficult for me to lift my left arm.
I finally decided to have the implants permanently removed. After this surgery, I began to lose mobility in both of my arms and was in constant pain whether I was moved or was still. I couldn't raise them more than a foot from my sides. It took almost a year to regain full use. In some of those months, I needed full time care to eat, dress myself or drive.
I spent a minimum of $70,000 (probably more) in care and treatment, and all of my time getting better. None of the repeat surgeries or treatments was covered by insurance. I was often unsure whether I would succeed and recover, as there was no information readily available to explain, diagnose or treat my condition. Today, I can gratefully say that I have come to full restored health. To me it is a miracle given the odds and the lack of information.
There is no question that I answer and account for my own choices. In the soul searching I have done, I am clear that all women can and will benefit from MUCH MORE information regarding the ramifications over time of the presence of silicone in the human body. Thousands of women have already been harmed by implants and millions more could be harmed if restrictions are lifted now, and more years of extended study are not implemented.
I'm joining my colleagues in the entertainment community to call on the FDA and our elected officials to protect women with much more thorough and long term study regarding silicone implants. We have the right, and need, to be as fully informed as possible about medical devices and procedures. We can then make clearer choices for our health, rather than succumb to the aesthetic pressure of our culture, at such great risk.
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