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A Shocking Diagnosis: Breast Implants “Gave Me Cancer”

New York Times, May 14, 2017

Raylene Hollrah was 33, with a young daughter, when she learned she had breast cancer. She made a difficult decision, one she hoped would save her life: She had her breasts removed, underwent grueling chemotherapy and then had reconstructive surgery.

In 2013, six years after her first diagnosis, cancer struck again — not breast cancer, but a rare malignancy of the immune system — caused by the implants used to rebuild her chest.

“My whole world came crumbling down again,” said Ms. Hollrah, now 43, who owns an insurance agency in Hermann, Mo. “I had spent the past six years going to the oncologist every three months trying to keep cancer away, and here was something I had put in my body to try to help me feel more like a woman, and it gave me cancer. I thought, ‘I’m not going to see my kids grow up.’”

Her disease — breast implant-associated anaplastic large-cell lymphoma — is a mysterious cancer that has affected a tiny proportion of the more than 10 million women worldwide who have received implants. Nearly all the cases have been linked to implants with a textured or slightly roughened surface, rather than a smooth covering. Texturing may cause inflammation that leads to cancer. If detected early, the lymphoma is often curable.

The Food and Drug Administration first reported a link between implants and the disease in 2011, and information was added to the products’ labeling. But the added warnings are deeply embedded in a dense list of complications, and no implants have been recalled. The F.D.A. advises women only “to follow their doctor’s recommended actions for monitoring their breast implants,” a spokeswoman said in an email this month.

Until recently, many doctors had never heard of the disease, and little was known about the women who suddenly received the shocking diagnosis of cancer brought on by implants.

An F.D.A. update in March that linked nine deaths to the implants has helped raise awareness. The agency had received 359 reports of implant-associated lymphoma from around the world, although the actual tally of cases is unknown because the F.D.A.’s monitoring system relies on voluntary reports from doctors or patients. The number is expected to rise as more doctors and pathologists recognize the connection between the implants and the disease.

Women who have had the lymphoma say that the attention is long overdue, that too few women have been informed of the risk and that those with symptoms often face delays and mistakes in diagnosis, and difficulties in receiving proper care. Some have become severely ill.

Implants have become increasingly popular. From 2000 to 2016, the number of breast augmentations in the United States rose 37 percent, and reconstructions after mastectomy rose 39 percent. Annually, nearly 400,000 women in the United States get breast implants, about 300,000 for cosmetic enlargement and about 100,000 for reconstruction after cancer, according to the American Society of Plastic Surgeons. Allergan and Mentor are the major manufacturers. Worldwide, an estimated 1.4 million women got implants in 2015.

As late as 2015, only about 30 percent of plastic surgeons were routinely discussing the cancer with patients, according to Dr. Mark W. Clemens II, a plastic surgeon and an expert on the disease at the University of Texas MD Anderson Cancer Center in Houston.

“I’d like to think that since then we’ve made progress on that,” Dr. Clemens said.

Late last year, an alliance of cancer centers, the National Comprehensive Cancer Network, issued treatment guidelines. Experts agree that the essential first step is to remove the implant and the entire capsule of scar tissue around it. Otherwise, the disease is likely to recur, and the prognosis to worsen.

Not all women have been able to get the recommended treatment. Kimra Rogers, 50, a nursing assistant in Caldwell, Idaho, learned last May that she had lymphoma, from textured implants she had for more than 10 years. But instead of removing the implants and capsules immediately, her doctor prescribed six rounds of chemotherapy and 25 rounds of radiation. A year later, she still has the implants.

“Unfortunately, my doctor didn’t know the first line of defense,” Ms. Rogers said.

She learned about the importance of having the implants removed only from other women in a Facebook group for those with the disease.

Her health insurer, Blue Cross Blue Shield of Montana, covered the chemotherapy and radiation but has refused to pay for removal of the implants, and told her that her appeal rights were “exhausted.” In a statement sent to The New York Times, a spokesman said, “Cosmetic breast implants are a contract exclusion, as are any services related to complications of the cosmetic breast implants, including implant removal and reconstruction.”

Physicians dispute that reasoning, saying the surgery is needed to treat cancer. Her lawyer, Graham Newman, from Columbia, S.C., said he was planning a lawsuit against the implant makers, and had about 20 other clients with breast-implant lymphoma from Australia, Canada, England and the United States.

Ms. Rogers has been unable to work for a year. If she has to pay to have the implants removed, it will mean taking out a $12,000 loan.

“But it’s worth my life,” she said.

Insurers generally cover implants after a mastectomy, but not for cosmetic enlargement, which costs $7,500 or more. Repeat operations for complications are also common, and usually cost more than the original surgery.

Diagnosis and Treatment

Most of the cancers have developed from two to 28 years after implant surgery, with a median of eight. A vast majority occurred with textured implants.

Most implants in the United States are smooth. But for some, including those with teardrop shapes that would look odd if they rotated, texturing is preferable, because tissue can grow into the rough surface and help anchor the implant.

Researchers estimate that in Europe and the United States, one in 30,000 women with textured implants will develop the disease. But in Australia the estimate is higher: one in 10,000 to one in 1,000. No one knows why there is such a discrepancy.

What’s inside the implant — silicone or saline — seems to make no difference: Case numbers have been similar for the two types. The reason for the implants — cosmetic breast enlargement or reconstruction after a mastectomy — makes no difference, either.

Symptoms of the lymphoma usually include painful swelling and fluid buildup around the implant. Sometimes there are lumps in the breast or armpit.

To make a diagnosis, doctors drain fluid from the breast and test it for a substance called CD30, which indicates lymphoma.

The disease is usually treatable and not often fatal. Removing the implant and the entire capsule of scar tissue around it often eliminates the lymphoma. But if the cancer has spread, women need chemotherapy and sometimes radiation.

“In the cases where we have seen bad outcomes, it was usually because they were not treated or there was a major delay in treatment, on the level of years,” Dr. Clemens said. Doctors at MD Anderson have treated 38 cases and have a laboratory dedicated to studying the disease.

About 85 percent of cases can be cured with surgery alone, he said. But he added that in the past, before doctors understood how well surgery worked, many women were given chemotherapy that they probably did not need.

Case reports on the F.D.A. website vary from sketchy to somewhat detailed and rarely include long-term follow-up. Some describe initial diagnoses that were apparently mistaken, including infection and other types of cancer. In some cases, symptoms lasted or recurred for years before the right diagnosis was made.

What exactly causes the disease is not known. One theory is that bacteria may cling to textured implants and form a coating called a biofilm that stirs up the immune system and causes persistent inflammation, which may eventually lead to lymphoma. The idea is medically plausible, because other types of lymphoma stem from certain chronic infections. Professional societies for plastic surgeons recommend special techniques to avoid contamination in the operating room when implants are inserted.

“It could also just be the immune system response to some component of the texturing,” Dr. Clemens said. The rough surface may be irritating or abrasive. Allergan implants seem to be associated with more cases than other types, possibly because they are more deeply textured and have more surface area for bacteria to stick to, he said. Allergan uses a “lost-salt” method that involves rolling an implant in salt to create texture and then washing the salt away. Other makers use a sponge to imprint texturing onto the implant surface.

Allergan is studying bacterial biofilms, and immune and inflammatory responses to breast implants, a spokesman said in an email. He said the company took the disease seriously and was working with professional societies to distribute educational materials about it.

Another possible cause is that some women have a genetic trait that somehow, in the presence of implants, predisposes them to lymphoma. Dr. Clemens said researchers were genetically sequencing 50 patients to look for mutations that might contribute to the disease.

Dr. Clemens was a paid consultant for Allergan from 2013 to 2015, but not for breast implants, and no longer consults for any company, he said.

A spokeswoman for Mentor said the company was monitoring reports about the lymphoma, and stood behind the safety of its implants.

[…]

Read the full article here.

Former Playmate of the Year on Removing Breast Implants: ‘I Literally Thought I Was Dying’

Kris Pickel, AZ Family: May 4, 2017

It wasn’t a decision Karen McDougal took lightly.

As a former Playboy Playmate of the Year, her career is built on beauty and fitness, but McDougal says her health deteriorated to the point she felt like she was going to die.

In January, McDougal made the decision to explant — have her breast implants removed.

McDougal says she battled health problems – issues she now believes stemmed from her implants — for more than a decade. Her health issues began eight years after she got her implants.  McDougal said she would get sick for six to eight weeks at a time, get better for a month or two and then get sick again.

It became a running joke among McDougal’s family and friends that she was the “healthiest sick person.”

For a decade, doctors failed to diagnose the cause of her sickness.  She said one doctor told her she was suffering from depression. Another told her that her implants looked great there was no need to replace them. […]

I talked to Dr. Diana Zuckerman, the president of the National Center for Health Research in Washington, D.C. She has a long history on breast implant safety.

“From 1983 to 1993, Dr. Zuckerman worked as a Congressional staffer in the U.S. Congress, working for the House subcommittee that has oversight jurisdiction over the U.S. Department of Health and Human Services, including the FDA,” according to her biography on BreastImplantInfo.org. “She was responsible for more than a dozen Congressional investigations and hearings on a wide range of health issues, including the first Congressional hearings on breast implants. It was Dr. Zuckerman’s congressional investigation of breast implants that first raised questions about the lack of safety data, which led to the FDA requiring safety studies of silicone gel implants in 1991. When the companies did not provide evidence that implants are safe, the FDA restricted their availability in 1992.”

Zuckerman said many studies over the years have been funded by organizations representing plastic surgeons and implant makers, all of which have a financial interest in making implants look safe.

She says the companies and organizations sometimes help shape studies with results that are not scientifically valid.

Zuckerman also said some studies might have been manipulated in a number of ways.

“I’ve spoken with some of the women in some of the studies who said as soon as they started complaining to their plastic surgeon about how sick they were feeling, suddenly they stopped hearing from the plastic surgeon about coming in to continue the study,” she said. “Suddenly, they weren’t in the study anymore. One very effective way to have studies proving that a product is safe is to just get rid of the patients in the study who aren’t feeling well — just stop talking to them and stop asking them how they are.”

Zuckerman said there are additional problems with some studies, including basing data on hospital records when most symptoms of chronic illnesses, such as fatigue and hair loss, do not require hospital stays. Also, many studies are done over short periods of time, between two and five years after the implant surgery, when illness may not start showing until several years later.

Zuckerman says if a woman decides to have her implants removed, there is a specific procedure. The implants must be removed with the scar tissue that forms around each implant, the capsule, still in place.

Read the full article here.

Kaylee Silcox: A Letter to My 20 Year-Old Self

Dear Kaylee,
You are one lucky young woman. You are the most vibrant, healthy and happy 20-year old. You have the world in the palm of your hand. You’re doing great in school, have a fun bar-tending job and a great social life. You’re a genuinely kind person, and just beautiful inside and out. If only you could see this, maybe you could learn to love yourself before it’s too late.

I know you’re struggling inside, but we all have body insecurities that we want to change. I understand that you’re most insecure about your flat chest, but I wish you could just embrace it and love yourself in your natural state. Now, let me warn you: implanting two foreign objects into your chest is going to change a whole lot more than your bra size.

I know how determined you are to achieve your idea of the “perfect body”. Even your plastic surgeon will tell you that a breast augmentation will only improve your quality of life and your self-esteem! It will make your decision to go under the knife that much easier. You will trust your plastic surgeon. Why wouldn’t you? He is a doctor, after all.  You’ll think he really has your best interest at heart. He will assure you that saline breast implants are the safest on the market.  He will silence any of your doubts. The only question he will leave in your mind is whether or not you should go bigger. He will tell you that most women wish they had, and that’s the only complaint he had ever heard from his former patients.

Your surgeon will forget to tell you one thing; you are just a guinea pig. He won’t tell you that there is a major lack of research regarding long-term effects of saline breast implants. It must have been lost in translation, as he will continue to rave about all the ways that breast implants will improve your life. He’s going to tell you that your implants will last a lifetime! Deep down, you’ll know it sounds too good to be true. That’s because it is. You will convince yourself that a one-time fee of $7,500 would be worth the money. It’s a lot of money, but he says that they will never have to be removed, and you will be one step closer to perfection. If you only knew the financial burden that awaits you.

That one-time fee of $7,500 will quickly turn to $25,000 over the next 6 years. You’ll have endless medical bills, treatments, medications, and you will ultimately need a second surgery. You will lose wages in the meantime, as you’ll be far too ill to hold down a job. Oh, and you can forget about being able to continue to bartend. Your arms and your legs will start to go numb randomly, and you’ll lose the strength in your arms and hands to even pour a drink. Besides, how are you going to be able to remember any of the customer’s orders with the memory loss and brain fog you’ll start to experience? Some days the extreme fatigue will the best of you. Just getting yourself ready and driving to work will be exhausting. Soon, you will be too sick and too tired to work at all. If your desire is to become extremely sick, broke, and depressed, then this is definitely the perfect procedure for you.

The new clothes and bathing suits you can’t wait to buy after surgery will end up going to waste. Going to the beach or on vacation will become a distant memory. The sun will be far too bright for your sensitive eyes and skin. Your joint pain will be too unbearable to lay in the sand on the beach or even on a cushioned lounge chair by the pool. The social life you once had and your motivation to get dressed up and ready to go out will become non-existent.  So there will be no need for a new wardrobe; sweat pants and t-shirts will become your new go-to outfit. Save that wardrobe money and get yourself a comfortable bed. You’re going to spend most of your time there.

You won’t have much energy at all at this point. You’ll spend what little you have left traveling from doctor to doctor, searching for an answer. You’ll almost always leave the office disappointed and in tears. You won’t even have the energy to convince your family that you’re not crazy or a hypochondriac anymore.

You will reach a place of desperation. You’ll start to hope that your doctors can find something, anything wrong. You need answers, and the years of suffering without any explanation will feel unbearable. You’ll constantly be asked what’s wrong, and you’ll barely be able to simply mutter “I’m sick”. With what? You won’t know. You will know you’re sick, but no one, including you, will know why for many years to come.

After 6 miserable years, you will learn about Breast Implant Illness (BII), and it’s all going to finally make sense. You may think back to your psychologist clearance appointment just before your surgery, which was a requirement of your trusty surgeon. You’ll wonder why he would send you to a psychologist, while supposedly having no idea that women with no mental health issues prior to implanting are still 12 times more likely to commit suicide versus women without implants. Your skepticism will continue to grow, and that high suicide rate among women with implants will come as no surprise to you by this point. Your depression and anxiety will take over your mind. You will struggle to the darkest depths, darker than you could have ever imagined possible. Some days, you will wish it could all just be over. You will have no quality of life, and some days just won’t feel worth living anymore. You will wonder how your life has completely deteriorated right before your eyes. You will feel fooled by the cosmetic surgery industry. You will wish that you could go back and just love yourself for who you are.

In your own studies, you will find that there is little to no research linking your symptoms to your implants. Adverse effects of your “safe” saline implants will be especially difficult to research as they are approved by the FDA and have been for many years. You will wonder how your own providers could promise you that your implants are not the cause of your illness. How is it even possible for doctors to come to this conclusion with such certainty? Sure, there’s no research that proves that implants make you sick, but there’s also no research that proves they don’t. These surgeons know the risks that their young, vulnerable patients are signing up for, and they will do a great disservice to many other women like you. They will operate on unsuspecting patients like yourself. They will continue to promote what will make you “beautiful”, and you will never have the opportunity to make an informed decision.

This illness is going to leave a debilitating scar on your body and your health. It will scar you emotionally as well. It will affect your ability to maintain a good relationship with your family and boyfriend. It will destroy your financial state and obliterate any career goals. In essence, it is going to ruin your life and you’re going to have to start all over, rebuilding your life piece by piece. This is why, Kaylee, I am urging you to learn to love yourself. Embrace your beauty and your perceived flaws. You are worth so much to so many people and we love you exactly as you are.

Love, Kaylee

See her story on CBS here.

Breast Implants Linked to Rare Cancer

breast implants
Diana Zuckerman, PhD, National Center for Health Research, Our Bodies Ourselves
March 28, 2017

 

Last week the media discovered that breast implants can cause cancer. Rather than causing breast cancer, experts now say that breast implants can cause a type of lymphoma (cancer of the immune system) called anaplastic large cell lymphoma (ALCL).

You’ll be excused for thinking this is news. The truth is that experts have known that breast implants cause ALCL since at least 2013, and some of the foremost plastic surgeons in the country were discussing it behind closed doors since at least 2010.

The U.S. Food and Drug Administration (FDA), which is responsible for making public information about the risks of medical devices, including breast implants, first published a report on its website about ALCL and breast implants in 2011. At that time, they said there was evidence that implants might possibly cause ALCL. The FDA’s report came months after anarticle published in Allure magazine stated that plastic surgeons and their medical societies were studying the possible link between breast implants and ALCL.

Articles subsequently published in medical journals concluded that breast implants cause ALCL. But despite the growing evidence, the FDA didn’t update its website to officially report that breast implants really can cause ALCL until last week. That’s when the media realized it was a real story.

If you think women should have been told this sooner, here’s what you need to know:

In May 2016, the World Health Organization published a report that included the term breast implant associated ALCL (BIA-ALCL). A few months later, the National Comprehensive Cancer Network (NCCN) released the first worldwide oncology standard for the disease. The guidelines (you need to sign up for a free account to see them) include a guided algorithm for surgeons and oncologists to test for and diagnose the disease. The authors conclude that any abnormal accumulation of fluid or a mass that develops near the breasts months after breast implants are  implanted must be evaluated.

They also state that even if the BIA-ALCL is confined to the scar capsule that surrounds the implant and even if that capsule is totally removed through proper explant surgery, the patient must be followed for 2 years to make sure the ALCL is eliminated.

Why didn’t plastic surgeons or the FDA make that information more widely available? I’m sure there are women and their doctors who would have benefited from that information in the last few months.

In 2015, plastic surgeons who had denied any link between breast implants and cancer for more than two decades published an article in a plastic surgery journal about 173 women with ALCL that was caused by their breast implants.

However, plastic surgeons across the country focused on reassuring women that BIA-ALCL is “very rare” and the FDA echoed that mantra.  But, although rare, it seems that BIA-ALCL is not “very rare.”  In Australia, which can track medical problems from any kind of implants better than the tracking of implants in the U.S., the Australian Department of Health estimates that BIA-ALCL affects as many as one in 1,000 women with breast implants.

The estimates of plastic surgeons and the FDA are much lower in the U.S., but there is no reason to think BIA-ALCL is less likely to develop in women in the U.S. than in Australia. Given the dramatic increase in BIA-ALCL diagnoses in recent years, it is clear that BIA-ALCL was under-diagnosed and under-reported for many years.

For women with ALCL, it doesn’t matter how rare it is. The sooner it is diagnosed, the more likely it can be cured easily by removing the implants and scar capsule surrounding it. At later stages, women will need chemotherapy and are less likely to survive, according to research conducted at the MD Anderson Cancer Center that was published in 2013.

The study followed women for 5 years and found that ALCL related to breast implants sometimes requires chemotherapy, and approximately 25% of the implant patients with the more serious type of ALCL died during the 5 years following their diagnosis. You can read more about the study here.

ALCL caused by breast implants can result in swelling, which is often mistaken for an infection and treated with antibiotics. Antibiotics are ineffective against ALCL and the delay in timely and appropriate treatment for ALCL is dangerous.

A published response in the same medical journal urged physicians to respond quickly and to check patients who have swelling near their implants for ALCL. This would require cytology testing rather than testing for bacteria.

This news is especially important to women who undergo mastectomies to prevent cancer or for DCIS or very early breast cancer, either of which is equally likely to be cured with a lumpectomy instead. Women trying to beat cancer by undergoing a radical surgery they don’t need are unlikely to do so if breast implants will put them at risk of developing a different type of cancer.

The news is equally frightening to cosmetic surgery patients. Many health insurance companies refuse to cover the cost of medical tests or treatment for women with breast problems related to cosmetic breast implants. We now know this can result in undetected ALCL, which can be fatal. In addition, delays in treatment for ALCL can be extremely expensive for patients and their insurance companies; the companies would be required to pay for treatment for ALCL when it is eventually diagnosed at a later stage.

Women deserve to know the facts.  And they deserved to know them years ago.

Read the full article here

FDA Agrees With WHO, Links Breast Implants To Rare Cancer. How Worried Should Women Be?

Rita Ruben, Forbes

March 22, 2017

The Food and Drug Administration has received nine reports of women dying of a rare blood cancer years after getting breast implants, according to information the agency released Tuesday.

The FDA says it now agrees with the World Health Organization that such cases are linked to the breast implants and not some unfortunate coincidence. As of Feb. 1, the FDA says, it had received a total of 359 reports of breast implant-associated anaplastic large cell lymphoma (BIA-ALCL).

The FDA reports suggest that implants with a textured surface are more likely to be associated with the cancer than smooth implants—of the 231 reports that contained information about the implant’s surface, 203 were reported to be textured implants, while 28 were reported to be smooth. The Australian Therapeutic Goods Administration (TGA) analyzed 46 confirmed cases of BIA-ALCL, including three deaths, and none of the cases occurred in women with smooth implants.

BIA-ALCL on average is diagnosed about a decade after implant surgery, according to the WHO. The first reported case of a woman with breast implants developing ALCL was published in a 1997 letter to the journal Plastic & Reconstructive Surgery. While that case was a woman with saline-filled implants, the FDA says the filling, be it saline (salt water) or silicone, doesn’t seem to make much of a difference, although no well-designed studies have yet been conducted to settle that issue.

BIA-ALCL is rare, but just how rare isn’t clear. As the FDA notes, it medical device reports can’t answer that question, because they don’t represent all cases, and the denominator—the total number of women who’ve received breast implants—isn’t known.

ALCL is more common in the breasts of women who’ve had implants than in those who don’t have implants, in whom the cancer almost never develops in the breast. A U.S. studypublished in January concluded that over their lifetime, 3.3 women out of every 100,000 with textured breast implants will develop BIA-ALCL. But the TGA estimates that the disease is more common, affecting 1 in 10,000 to 1 in 1,000 women with breast implants (that agency says it has received no reports of BIA-ALCL in women with smooth implants).

“There is no reason to think it is less likely to develop in women in the U.S., and given the dramatic increase in diagnoses in recent years, it is clear that it was under-diagnosed and under-reported for many years,” Diana Zuckerman, a health advocate who has long questioned the safety of breast implants, told me.  Zuckerman serves as president of both the National Center for Health Research and the Cancer Prevention and Treatment Fund, nonprofits based in Washington, D.C.

Read the full article here.

Karen McDougal

karen mcdougalI had my implants put in March 1996 and removed almost 21 years later on January 31, 2017.   I was a Playmate of the year and a successful model, so the decision to have my implants removed was not an easy one.
I had smooth saline on top of the muscle.  I thought I had 350 cc but they were much larger – so large that my explanting surgeon, Dr. Rankin, said they were crammed up under my arms.  I drafted this only 3 weeks after my explant surgery, but I already felt better — my vision wasn’t blurred, my severe knee pain was gone, migraines were gone, dizziness gone.  It’s now 7 weeks after my explant surgery and I’m feeling even better — better than I have in over a year!

I got the implants put in because I wanted a larger bust.   I thought it would make me feel more like a woman, and I guess it did in a superficial way! I did love having them, to be honest.  If I knew then what I know now, though, I would have NEVER gotten implanted!

By the time I decided to have the implants removed, I felt like I was slowly dying.  All I could do was lay in bed, cry and pray to God, asking him to please “don’t take me yet..give me one more day”!
Here’s my story.

Around January 2016 I started getting ‘sick,’ but as I look back, many symptoms began around 7-8 years after getting the implants.  For example, my hormones were disrupted, I had fatigue and thyroid issues, I developed allergies to everything, my eyes were consistently red/sick looking.  In fact, I got sick so much that it became a joke to those around me, “You are the sickest healthy person I know”! I would get sick every few months, and the worst part was, each sickness lasted 6-8 weeks at a time, and I’d have to spend my days in bed when that happened.  I couldn’t understand how someone so healthy and fit could get so sick all the time! Then the headaches became more frequent.

Fast forward to around July 2016: I was getting worse.  My vision was blurred and I was dizzy most of the time –blacking out or almost passing out many times a day, hard to breathe, having trouble swallowing or a choking feeling, chronic fatigue, memory issues, heart palpitations.  Even on my ‘good days’ I was at 50% — but I really looked forward to those days.  I’d have between 3-5 good days and I would try to do as much as I could because I knew the bad days were coming again.  I would get my errands done, work done, play with my animals a lot as I couldn’t do much when ‘down’, I’d work out (even though I had no strength to work out, because I figured a  light workout was better than nothing, especially mentally).  On good days I’d also have nail and hair appointments, take my selfies for my social media, etc.

I was seriously worried about my health and my life! I went to the doctor, neurologist, hormone doctor – but they all said “There’s nothing wrong, you are healthy, maybe you are depressed.”  I mentioned breast implant Illness to them and none really believed in it.  So I stopped wasting money for NO answers.

I prayed and prayed and GOD led me to do what was necessary to regain my health.  It was October 2016.  I had to stop driving because I would have such severe panic attacks, and my vision was blurry consistently now.  The dizziness/blacking out was most of the day, the headaches became severe migraines that were so bad that prescription migraine meds wouldn’t even touch them.  My hearing sensitivity was so bad that  couldn’t handle any noise –not the TV, radio, or even people talking.  Hearing my own voice hurt me!  I also had light sensitivity, which made it hard to even look outside — and when I did, I felt dizzier.

I had NO life!! People just didn’t understand.  I had friends say “you’re always sick” or thinking I was just lazy or just ignoring them.  Nobody had heard of breast implants causing illness, but in their defense, I have to admit I had rolled my eyes when my friend brought it up to me a year before when he told me his wife went through it.  At the time, I had thought “I’ve had mine for years, and I’m fine”.

So I stopped talking about it to anyone.  It became my ‘silent’ misery, my nightmare. Lying in bed for 4 months (with fewer “good days” now), I was just praying to live and get healthy again! It was at that point, after a year of researching breast implant illness and doctors who are experts in explanting, that I knew that I desperately needed these toxic bags out of me immediately. I truly think I would have not made it another few months had I kept them.  Or if I had, it would have been pure hell.
Ironically, I had a fitness cover shoot (Muscle and Fitness Hers) in early January 2017.  I was sick (again) with a nasty flu for 6 weeks, and on top of my other symptoms, trying to do a photo shoot – I was an emotional and physical mess. But, I’m a ‘warrior’ as so many of the women are who have been ill because of their breast implants, so I got it done.  The crew that day was amazing — they helped me through the day.  I appreciated their compassion.  That cover came out February 21, 2017, and I dedicate it to all the beautiful women who have suffered from breast implant illness.  Stay the brave warriors you are !

For my explant surgery, I choose Dr. David Rankin, who practices in Jupiter, Florida.  He knows the importance of removing the entire capsule (as a lot of times it grows into our breast tissue, ribs, etc and has to be scrapped off) –not fun, trust me.  And for me, the cosmetic results were still important, and I felt he was the best choice for me as a healer and an artist.

You can read other stories about me in USA Today and People Magazine. But the most important thing for you to know is that, like many other women, I got sicker and sicker for years before I finally realized that there was one solution: getting my implants removed by a plastic surgeon who was an explant expert.  I am making my story public because I hope that other women can be helped.

Right to Try Laws allow Big Pharma to Exploit False Hope

If you or a loved one were dying of a terminal illness and your doctor told you there were no proven treatments, would you take the risk of trying an experimental, unproven drug?

Many patients would say yes. But as with most medical decisions, the more you know, the more you realize the answer is not so simple.

As has been clearly shown, Congress is not very good at making complicated and nuanced decisions about medical care.

That’s reason enough to question the new federal Right to Try Act dozens of senators and representatives are pushing this spring.

The most important thing to know is that all terminally ill patients already have a right to try experimental drugs in this country.

The proposed new law, however, is much more dangerous to all patients, and not just those facing fatal illness. Here’s why:

The current national expanded access program enables doctors to request experimental drugs for their patients. If the company that makes the treatment agrees, the patient will get the treatment for free or at cost; companies are not allowed to sell experimental drugs for a profit.

Many patients get access to experimental drugs through this existing program, and improvements are underway to further streamline the process.

In contrast, under the proposed new law, a drug company could charge desperate patients as much as they want to get access to an experimental drug.

Since insurance companies do not pay for experimental treatments, many patients would wind up with the right, but not the money, to try such regimens. Out of desperation, some would surely go into debilitating debt to try a drug that might harm rather than help them.

The current national program makes sure patients understand the risks of taking an experimental treatment and requires that the drug has been studied enough to know that the patient might possibly benefit from it.

Under the proposed new law, drugs that were only studied at a low dose on a small number of healthy volunteers could be sold to patients, and unethical doctors could receive kickbacks for persuading patients to try treatments that will not help them.

It’s easy to understand why every patient wants to have hope of a cure, and that’s the power of right-to-try laws.

So far, hype and false hope have convinced 33 states to pass right-to-try laws that provide no real advantage over the current national program. But rather than learning from the mistakes at the state level, patient activists and others are pushing Congress to pass a much more dangerous federal law.

In addition to encouraging the sale of unproven treatments at sky-high prices to desperate patients, the 2017 federal Right to Try Act would do the following:

  • Allow the sale of almost all experimental drugs, even those never tested on patients before.
  • Prevent patients and family members from suing the company if the treatment harms or even kills them.
  • Prohibit doctors and scientists from evaluating the benefit or harm of the experimental drugs.

Desperate patients are lobbying for the bill, but do they realize what they are lobbying for?

Instead of getting access to free experimental drugs that have some evidence of benefit and are being tested to help all patients, this law would allow naive and desperate patients to be exploited by greedy companies and unethical doctors.

The right-to-try movement opposes the FDA for what’s described as “interfering” with the doctor-patient relationship. They do not understand that unbiased scientific evidence is needed to help physicians and patients make informed decisions – whether to save a life or make a patient’s last months as enjoyable as possible.

Patients already have a right to try through the FDA’s humanitarian expanded access program, which gives them hope while protecting them from greedy exploitation. The proposed federal Right to Try Act would not.

Read original article here.

Trump’s FDA Nominee Spurs Concerns About Drug Approvals, Off-Label Promotion

Bronwyn Mixter, Bloomberg BNA: March 14, 2017

President Donald Trump’s pick to head the FDA is spurring concerns about drug approvals and off-label promotion.

Trump March 10 nominated Scott Gottlieb to be the commissioner of the Food and Drug Administration. The nomination was widely praised by drug and device industry groups, but a consumer group and other stakeholders told Bloomberg BNA they are concerned that Gottlieb, who is a resident fellow at the American Enterprise Institute and previously worked at the agency as a deputy commissioner, has advocated for quicker drug approvals with less evidence and wants to loosen restrictions on off-label promotion of drugs and medical devices. Critics of the nomination also are concerned that Gottlieb is too closely tied to industry. […]

Gottlieb “is someone who is entangled in an incredible, unprecedented web of ties to industry spanning his professional career,” Public Citizen’s Carome told Bloomberg BNA.

Carome said Gottlieb has been both a venture capitalist and sat on the boards of several drug companies. Gottlieb also “accepted large amounts of money for the period 2012 to 2015, at least $400,000, in speaking fees and consulting fees from several companies and we think it’s just impossible for him to really fully disengage from those ties to industry,” Carome said.

“Like many of President Trump’s other nominees, Scott Gottlieb has extensive financial ties to the industries he’d be in charge of regulating and has shown more interest in reducing regulations rather than enforcing them,” Diana Zuckerman, president of the National Center for Health Research, told Bloomberg BNA in an email.

Zuckerman said “when FDA focuses too heavily on easing the burdens on industry, that shifts the burden to patients, consumers, and physicians” and “none of us can make informed decisions about medical treatments, diagnostics, or prevention strategies when the FDA doesn’t require clear scientific evidence and isn’t transparent about its decisions.”

“If he becomes Commissioner, I hope Dr. Gottlieb will enforce the law and focus on fulfilling the FDA’s essential public health mission,” Zuckerman said. “I expect that industry will strongly support Dr. Gottlieb’s nomination but divesting could potentially be complicated and therefore could delay his confirmation.” […]

Read the full article here.

What If Ryan Gets His Wish and Trumpcare Becomes Law

Shannon Firth, Washington Correspondent, MedPage Today: March 14, 2017

WASHINGTON — The Republican’s repeal and replace bill, American Health Care Act, cleared two congressional committees and the Congressional Budget Office released its scoring report, Speaker of the House Paul Ryan (R-Wisc) says passing the GOP plan is a make or break issue Congress.

So it is time to ask the pundits: what will happen if this bill becomes law?

MedPage Today asked policy experts on both sides of the great healthcare divide to answer that question and this is what they told us.

From the Pro Repeal and Replace Camp:

Douglas Holtz-Eakin, PhD, president of the American Action Forum touted the bill because it allows people to make their own choice. He predicts that eliminating the individual mandate will mean 5 million fewer uninsured in 2018.

“The bill basically says we respect your decision to not purchase insurance. There’s a public policy decision about how much we respect people’s decisions and clearly we know where the bill comes down on that,” he said. […]

And Now the Loyal Opposition:

Under the Affordable Care Act, the reason everyone pays for all of the various benefits was because doing so lowered costs, explained, Diana Zuckerman, PhD of the National Center for Health Research.

In the same way that car insurance lowers the cost of having an accident when everyone buys it, under this philosophy healthcare also protects everyone who buys it, Zuckerman said.

“Under [the AHCA] it’s a different view. It’s not that view of ‘We’re all in this together,’ and if we all share the cost, we’ll all get good insurance. Instead the view of this plan is every person for themselves. Everybody should get what seems best for them, even though that could result in 24 million not getting any insurance.” […]

Read the full article here.

Statement of Dr. Diana Zuckerman, President, National Center for Health Research, Regarding the American Health Care Act

Diana Zuckerman, PhD, National Center for Health Research
March 9, 2017

The goal of the American Health Care Act is to replace the Affordable Care Act (ACA) with something better, but instead it represents a giant step backward for health care for all Americans. This proposed plan will cover far fewer Americans than the Affordable Care Act (ACA), and insurance will pay for less and cost more. The proposed tax credits and Health Savings Accounts (HSAs) will not begin to provide adequate health insurance for Americans covered under the ACA, particularly low-income patients.

A substantial number of people who had health insurance for the first time under ACA will lose it. The proposed 30% surcharge for those who let their insurance lapse is an insufficient incentive for healthy people to purchase insurance. Since the surcharge is the same for patients whose insurance lapses for 2 months or 20 years, it actually discourages healthy patients from buying health insurance until they have substantial medical expenses. The lack of healthy patients in the insurance pool means higher premiums and deductibles for all of us. And, as more uninsured patients end up in hospitals needing expensive medical care for cancer, heart disease, or other serious illnesses, that uncompensated care means higher hospital costs for all of us.

The very obvious shortcomings of the proposed TrumpCare bill are the reasons why hospital organizations, the American Medical Association (AMA), AARP, and many insurers are all against this legislation. It would disrupt the marketplace, create confusion and uncertainty, and reduce or strip health care coverage from millions of Americans.

Meanwhile, the bill would provide tax breaks for the wealthy at the expense of those losing health coverage. The legislation also would serve to severely reduce Medicaid benefits over time, by eventually turning the Medicaid coverage now provided into block grants to states, many of which might spend the funds on issues other than health care.