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

Rita Ruben, Forbes

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.

Sientra’s Silimed Brand “Gummy Bear” Silicone Gel Breast Implants Pose Safety Questions

gummy-bear-bubblegumMingxin Chen, MHS and Diana Zuckerman, PhD, The National Center for Health Research

In December 2012, the U.S. Food and Drug Administration (FDA) approved Sientra’s for its “Silimed silicone gel breast implants.” These implants are also called “gummy breast implants” because they are made of a thicker gel that is said to resemble candy gummy bears.

To gain approval, the company was required to submit the results of a clinical trial to prove that the implants were safe and effective. A 5-year study of these implants was published in the November 2012 issue of Plastic and Reconstructive Surgery, authored by three Sientra employees and several plastic surgeons who were paid by Sientra to conduct the research.1 The study included 1,788 participants with 3,506 breast implants.

Re-operation, Rupture, and Capsular Contracture

The three major complications measured were need for a re-operation, rupture, and capsular contracture. They can occur at any time, and become more common as the implants age. Capsular contracture refers to the formation of scar tissues around breast implants which becomes hard and potentially painful as the patients’ immune system reacts to the implant. MRIs were conducted on 571 of the 1788 participants to assess rupture that has no obvious symptoms.

The study indicated that the overall risk of rupture during the five years of the study was 2%, but that is misleading because the rupture rate was higher when “silent ruptures” measured by MRI were counted. MRI is the most accurate way to determine if an implant is ruptured, and more than 4% of first-time augmentation patients had a rupture within 5 years, which is much higher than expected. The risk of capsular contracture was 9% overall, and did not vary much for the different types of patients.

In contrast, the risk of reoperation varied considerably: 43% for first time reconstruction patients, 48% for reconstruction revision patients, compared to 17% for first time augmentation patients and 30% for augmentation revision patients. Revision patients are those whose previous implants were replaced with the Sientra implants.

Other Complications

There were many other complications affecting appearance and health. Most complications are highest for patients whose implants are for reconstruction after mastectomy; for example, 11% have asymmetry, 5% have an infection; 4% have breast pain, 4% of the implants are not in the correct position, and 3% have abnormal scarring. Complications are even higher for reconstruction patients who had earlier implants replaced by Sientra implants: 15% have breast asymmetry, 7% have implants in the wrong place, 5% have breast lumps or cysts, and 4% have breast pain.

For first-time augmentation patients, 3% have nipple sensation changes (either losing sensation or painfully sensitive) and 3% have sagging breasts. As noted earlier, reoperation, capsular contracture, and rupture are more common. Other complications, such as pain and swelling, add up, but each of these others complication is below 3%. Among revision augmentation patients, 5% have implants in the wrong position, 3% develop sagging breasts, 3% have wrinkling around the implant, and 3% have breasts that look asymmetrical.

Despite these high level of complications within only five years was high, the authors defended the implants. For example, they stated that over half of the patients who removed or replaced their implants did so for cosmetic reasons, predominantly patient request for style/size change. Regardless of the reason however, additional surgery is expensive and puts the patient at risk. And for breast cancer patients who chose mastectomy and implants so they would not have to think about cancer, these surgeries are a very unwelcome reminder.

The authors claimed Silimed is superior to the other two implant brands, Allergan and Mentor, in terms of risk of complications, as its risk of capsular contracture among first-time and revision augmentation patients within 5 years is 9% and 8%, in comparison with Allergan’s 13% and 17%, and Mentor’s 9% and 20%, both within 4 years.

Sientra, based in Santa Barbara, California, is the third largest global manufacturer of silicone implantable devices. The approval of the first gummy bear implants was welcomed by plastic surgeons, who pointed out that these implants had been manufactured and distributed outside of North America for 15 years.  However, the FDA approved the implants based on only 3 years of data, rather than the longer studies that would have been possible since the implants were on the market for 15 years.

Dollie Voyles

image1My name is Dollie Voyles and I am 48 years old. I’ve had  3 sets of breast implants over the past 21 years, starting in 1995.

I later learned that my plastic surgeon was originally an Ears, Nose, and Throat doctor . When I arrived at his office I was given a form to fill out for my basic health information. I went back to meet the doctor and he told me I would be in pain for a while and wouldn’t be able to move or lift my arms. That is all he told me about any possible risks .

I had smooth saline implants put under the muscle.  Initially, everything seemed fine. However, less than three years later, my right breast implant ruptured. I woke up flat . I called my plastic surgeon frantic and he said it’s ok because it’s just salty water. He had me come back for surgery 2 weeks later . I asked him why and how this happened. He  said he’s never had this happen in his practice and I believed him.

My second set of breast implants, which replaced the ruptured ones, were  textured saline implants . My plastic surgeon said he’s using this style because he thought my body didn’t take to the last kind, and by putting in textured saline it would have something to grab on to. I trusted him. He never talked about risks at this meeting either. Over the next 7 years they became  so misshapen and physically unappealing that I was so embarrassed and felt so self-conscious.

I decided I needed to change doctors and get a new opinion so I went to a more experienced doctor. This doc seemed very confident and I wasn’t going to let him do anything to my body until I get some answers. This plastic surgeon said I needed silicone gel implants instead. He said they feel more real and they don’t change shape. I was immediately conflicted because I did hear somewhere where silicone was bad for your body. He assured me that the gummy bear silicone that he’s going to use  was the best thing for me, especially with all the FDA approvals! I asked him about ruptures and he said if they did it’s just like a gummy bear, it will stay in place. He said they hold their form. I thought well, he’s the professional. Again , I wasn’t given any information about implants and definitely I wasn’t given information about silicone implants .

For over 6 years these ” safe silicone gummy bear implants – FDA approved ”  changed shape and became  painful to touch.  And they burned. I was diagnosed with severe allergies,autoimmune reactions that caused pain in my joints and legs , itchy breasts, shooting pain in my breasts, headaches, anxiety,depression, brain fog and finally fatigue. In 2012 , three years after my silicone breast implants, I suffered a stroke. I was told that the reason for my stroke was that I have low potassium and I’m anemic. These findings was startling since I was completely healthy prior to my last set of implants .

With all my pain in my breast and how crappy I was feeling I finally had an MRI and its showed that I had intracapsular rupture in my right breast. I knew something was wrong. When my explant doc opened me up my breast gushed of silicone and apparently he had to scoop silicone off my chest wall. This was nothing like a gummy bear that keeps its shape.

And it wasn’t until a few weeks ago that I learned that gummy bear implants were not FDA-approved in the U.S. in 2009!  Was I in a clinical trial that my doctor never told me about?  I certainly never gave my doctor permission to put experimental implants in my body.

Why are celebrities removing their breast implants?

Amelia Murphy

Celebrities who removed their breast implants

Every now and then, a new celebrity is in the news after announcing her decision to remove her breast implants. They speak out about the importance of loving yourself the way you are, they post some Instagram pictures of “the new me,” and the public eagerly reads the related articles in tabloid magazines.

But most of these women aren’t just talking about body image; they are getting their implants removed because of their health. Breast implants can make some women so sick that removal is their best hope for feeling like themselves again.  Several celebrities are trying to spread this information to the general public.

crystal_hefner_2014Crystal Hefner, Hugh Hefner’s wife, opened up about her breast implant horror story on Facebook. She announced her implants had been slowly poisoning her and causing unexplained back pain, cognitive problems, constant neck and shoulder pain, recurring infections, and many other symptoms. Once she removed her breast implants, she instantly felt an improvement and continues to feel better. [Read more about her story in this Forbes article]

Yolanda Foster, of Real Housewives fame, removed her breast implants when she found out her silicone implants had ruptured and were leaking into her body. The silicone was making the symptoms of her Lyme disease even worse. She felt much better once she removed her implants.

Linda Blair, actress in the horror movie The Exorcist, described her experience with breast implants as a nightmare. After removing her implants, she advocated for the FDA to make sure breast implants are actually studied to be safe.

Mary McDonough, a child star in The Waltons who appeared as an adult in shows such as ER and Will and Grace, attributes her autoimmune disease (lupus) to her breast implants. She was healthy before getting implants, and it was only after her implants were removed that she immediately started to feel better. She has been one of the most outspoken celebrities on the risks of breast implants.

Karen McDougal is a former Playboy Playmate and current model who made the decision to have her implants removed after months of feeling sick. She has spoken out about the risks of breast implants in USA Today and People Magazine.

Mariel Hemingway, Sharon Osbourne, and Stevie Nicks are just a few of the other celebrities who chose to remove their breast implants because of serious health problems.

Celebrities are bringing attention to the health problems that thousands of women with implants have suffered from for decades.

First, a little history:

Women have been getting breast implants since the 1960’s, and although silicone gel implants were drastically restricted for many years during the mid-1990’s through 2005 because of safety concerns, the FDA approved them again in 2006 based on short-term studies done by breast implant manufacturers. FDA also required the manufacturers to do larger, longer-term studies after that, in order to make sure they were safe (these are called post-market studies).

These longer-term studies had a lot of problems, and most women did not stay in the studies long enough to provide useful scientific information.  However, studies have shown that the longer women have silicone breast implants, the more likely they are to experience problems with them.  FDA reported that the studies found that as many as 1 out of every 5 women who get silicone breast implants for cosmetic reasons need to remove their implants within 10 years.[1] This number rises to 1 out of every 2 women if they got reconstruction after a mastectomy.[1]  Were the women who dropped out of the studies the ones that were more likely to have health problems, or less likely?  You can read more about the unanswered questions from these studies here.

Breast implants were approved by the FDA even though research showed that between 15% and 20% of first-time augmentation patients will need additional surgery to fix implant problems within 3 years, whether the implants are filled with silicone gel or saline. [2][3] The chances of needing additional surgery increases as time goes on — 28% of women are on the second set of implants after 3 years, and this number doubles when the women have their implants for 6 years. The percentage is even higher than that for mastectomy patients whose implants were for reconstruction.

Are Your Breast Implants Making You Sick- (2)What usually goes wrong?

  • Rupture: All breast implants will eventually break, sometimes within a few months or years, and usually within 10 years.
  • Capsular Contracture: This is when the breasts get firm, then hard, and they can be very painful. Breast implants are a “foreign body” and the natural response for most women is that their body forms scar tissue around the implant, inside their body, to protect their body from this “foreign invader.”  This is a natural process. However, it’s called capsular contracture when the scar tissue tightens or hardens around the implants and causes abnormal firmness, hardness, or pain.
  • Pain: Besides pain caused from capsular contracture (see above), breast implants can cause back, neck, and shoulder pain because of their weight. Leaking silicone gel can also cause a painful burning sensation.
  • Anaplastic Large Cell Lymphoma (ALCL): This is a rare kind of cancer of the immune system that is more likely to occur in women with breast implants. [4] If diagnosed early, removing the implants can cure the disease.
  • Autoimmune issues:  Experts disagree on whether breast implants cause specific autoimmune diseases.  However, the fact that implants can cause cancer of the immune system (ALCL) certainly makes it more likely that implants can cause other autoimmune problems.  FDA scientists found that women with ruptured and leaking silicone gel breast implants were more likely to have fibromyalgia, a painful autoimmune disease.[5]  Many women have reported suffering from autoimmune symptoms such as joint pain, hair loss, dry eyes, or mental confusion after getting breast implants, and have also reported that these symptoms often improve or disappear after removing the implants. One study even showed the autoimmune symptoms got better for 3 out of 4 women after they removed their implants.[6]
  • Constant flu-like symptoms: Many women report feeling constantly tired or like they’re trying to get over the flu.
  • Learn more about complications from breast implants in FDA’s consumer handbook.

Besides health problems, some celebrities decide to remove their implants simply because they were annoying or embarrassing. Just to name a few, Heather Morris, Heidi Montag, Pamela Anderson, Victoria Beckham, and Jane Fonda all removed their implants for this reason.

Plastic surgeons refer to breast augmentation as a very simple surgical procedure, and as a result many people think of breast implants as an insignificant surgery with few health risks.  Hearing about celebrities who removed their breast implants sometimes makes women think twice about getting them in the first place.  It helps remind all of us to do careful research before making any decision about putting something inside your body.

Are you considering breast implants? Find out more information here.

Are you thinking about removing your breast implants? Find out more information here.

—–

[1] FDA Update on the Safety of Silicone Gel-Filled Breast Implants. Center for Devices and Radiological Health U.S. Food and Drug Administration. Page 7. June 2011

[2] Important Information for Augmentation Patients About Mentor MemoryGel™ Silicone Gel-Filled Breast Implants, Mentor. (FDA Patient Brochure) November 2006. Pages 25-27. http://www.accessdata.fda.gov/cdrh_docs/pdf3/p030053d.pdf

[3] Making An Informed Decision Saline-Filled Breast Implant Surgery, Inamed. 2004 Update. Pages 24, 32. http://www.fda.gov/downloads/medicaldevices/productsandmedicalprocedures/implantsandprosthetics/breastimplants/ucm064457.pdf

[4] Miranda et al. Breast Implant–Associated Anaplastic Large-Cell Lymphoma: Long-Term Follow-Up of 60 Patients. Journal of Clinical Oncology. Volume 32, Number 2. January 10 2014.

[5]  Brown SL, Pennello G, Berg WA, et al. Silicone Gel Breast Implant Rupture, Extracapsular Silicone, and Health Status in a Population of Women. J Rheumatology. 2001; 28:996-1003.

[6] de Boer M, Colaris M, van der Hulst RRWJ, Cohen Tervaert JW. Is explantation of silicone breast implants useful in patients with complaints? Immunologic Research. July 2016 DOI: 10.1007/s12026-016-8813-y\

Furor Over Drug Prices Puts Patient Advocacy Groups in Bind

By Katie Thomas, New York Times

September 27, 2016

Public anger over the cost of medical products has burned hot for a year, coursing through social media, popping up on the presidential campaign, and erupting in a series of congressional hearings, including one last week over the rising price of the allergy treatment EpiPen.

But one set of voices has been oddly muted — the nation’s biggest patient advocacy groups. The groups wield multimillion-dollar budgets and influence on Capitol Hill, but they have been largely absent in the public debate over pricing.

To those who have closely followed the drug world, the reason is simple: Many of the groups receive millions of dollars a year in donations from companies behind the drugs used by their members. When they prod drug companies, it is generally for better — not less expensive — treatments.

But critics say that by avoiding the debate over cost, they are failing in their patient-advocacy duties..

“It is a conflict of interest, because the interests of the pharmaceutical industry, from whom they are getting support, may be different from the interests of the patients,” said Dr. Michael Carome, the director of the Health Research Group at Public Citizen, a consumer advocacy group.

Over the last year, pharmaceutical companies have increased prices on medications as varied as breakthrough hepatitis C drugs and little-known generics that have been around for decades. The higher prices have hit American pocketbooks harder than usual, as insurers have increasingly shifted costs to patients.

And for patient groups, loudly addressing the issue can be perilous, as Cyndi Zagieboylo, the chief executive of the National Multiple Sclerosis Society, recently discovered.

She said members of her group, one of the most influential patient charities, had identified cost as a priority. The average annual cost for multiple sclerosis medications is $78,000 today, nearly 400 percent higher than the $16,000 average in 2004, the group says.

But as soon as Ms. Zagieboylo started discussing a plan — a modest proposal that involved bringing together drug makers, insurers and others to find solutions — she said she encountered resistance. Other patient groups would not join her, and she said she was told by members of Congress, as well as some of the pharmaceutical companies that donate to her group, to tread carefully.

“We were warned, you know, in a number of ways, just sort of to be careful about this,” Ms. Zagieboylo said. “A couple of pharmaceutical companies mentioned, ‘Boy, we support you, why are you doing this to us?’”

The group went ahead with the new campaign anyway, announcing it last week at an event attended by the National Health Council, an umbrella group for patient advocacy groups.

But Ms. Zagieboylo said the pushback gave her pause. She said she and the group’s board members decided they had to be ready to lose donors over the issue, including drug companies. The pharmaceutical industry donated about $10 million to the group in 2015, according to its website, accounting for about 4 percent of its annual budget.

“They are taking a lot of heat,” she said of the companies, who she said were not solely to blame for higher drug prices. “And they don’t want us to pile onto that, because they know we have influence.”

That influence is what makes patient groups so attractive to the drug industry. Some of the largest groups can call on millions of dedicated and highly motivated members and help drug companies by signing up participants for clinical trials, running financial assistance programs and even lobbying government officials for drug approvals or favorable legislation.

“It’s much more compelling when a parent reaches out to their congressman and says, ‘Please contact the F.D.A., because my child is dying,’” said Diana Zuckerman, the president of the National Center for Health Research, a nonprofit that does not accept money from industry.

But she said patient groups were less likely to take positions that might undermine a drug company’s business. “I’ve found almost none that are focused on the public health issues of affordable health care, affordable insurance, a sustainable system,” she said.

Some patient groups have directly challenged the industry. The American Diabetes Association, for example, this year called on drug companies to be more open about their prices and to allow the federal government to negotiate over Medicare drug pricing. The association said it received $26.7 million from the pharmaceutical industry in 2015, accounting for 14.5 percent of its budget.

But those actions have been the exceptions. And when patient groups have discussed pricing, their ire is largely focused on insurance companies, expressing arguments similar to those used by the pharmaceutical industry.

The Leukemia & Lymphoma Society, for instance, one of the largestcharities in the United States, has frequently criticized insurers for exposing patients to high out-of-pocket costs for patients, commissioning two studiesthat looked at the impact of these high costs. But it has not been as outspoken about the decision by drug companies to set those prices. Some blood cancer drugs that the society’s members need cost tens of thousands of dollars.

The group, which has an annual budget of about $300 million, spends millions of dollars a year funding research at universities and pharmaceutical companies that it hopes will lead to new treatments for blood cancers. According to its annual report, of the group’s 16 largest donors, eight were pharmaceutical companies. All eight donated more than $1 million to the society in 2015.

The group has been soliciting corporate sponsorships as well. On its website promoting sponsorships, aimed at drug and other companies, the society pointed to its “powerful footprint” of millions of constituents, and described itself as “an outstanding cause to build good will, positive public relations and marketing benefits that align with your brand and reputation.”

Last week, the society removed its corporate sponsorship page from its website, after The New York Times asked a spokeswoman about the language on the web page. She said the page was removed because the information was out of date.

Andrea Greif, a spokeswoman for the leukemia society, said the group considered access to drugs a key issue, and that it was meeting later this year with patients, insurers and manufacturers to address the problem.

She also said the group was “in the process of taking a fresh look at our position to ensure that we are living up to our role as the voice for all blood cancer patients.”

Part of the problem for the patient groups, many people said, is that there are no easy answers. Drug pricing is notoriously opaque and complex, involving a series of companies — such as pharmacy benefit managers like Express Scripts, drug distributors like Cardinal Health, or pharmacies like CVS or Walgreens — that can also profit from higher prices.

“We’re in an environment where all the stakeholders are blaming each other, and undermining each other, because of escalating costs,” said Marc Boutin, chief executive of the National Health Council, the organization that represents patient groups. Pharmaceutical companies accounted for 62 percent of the council’s $3.5 million budget in 2015, a spokeswoman said, and representatives from drug companies and an insurer sit on its board.

Representatives for the drug industry say the spotlight on pricing has obscured the headway companies have made in treating serious conditions.

“We are on the cusp of a new era of medicine,” said Robert Zirkelbach, a spokesman for the Pharmaceutical Research and Manufacturers of America, an industry lobbying group.

Yet patient groups may be increasingly pulled into the pricing debate whether they like it or not. Dr. James R. Baker Jr. and his group, Food Allergy Research & Education, got an uncomfortably close look at the shifting landscape several weeks ago, when they were criticized for taking money from Mylan, the company that makes the EpiPen.

This month, the group announced it would stop taking money from Mylan until there was meaningful competition in the market. Dr. Baker said about 6 percent of the group’s budget came from the pharmaceutical industry, but did not say how much came from Mylan, citing a confidentiality agreement with the company.

Part of the reason patient groups have not taken up the drug pricing issue, Dr. Baker said, is because for years, many of their members had insurance with low co-payments and deductibles, shielding them from the total cost of drugs.

“It was more of an issue of whether or not they could get the drug, and whether it was on the formulary, than what they were paying for it,” he said. “I think that is changing.”