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Breast Implant Problems? Obamacare Can Help!

Farzana Akkas and Lauren Goldbeck, National Center for Health Research

If you’re having problems with your breast implants, there’s a chance you could benefit from the Affordable Care Act (ACA, or “Obamacare”). You should take advantage of the law while it’s still in place, because good quality health insurance may be less available a year from now.

Under this law, health insurance companies can’t refuse to pay for health care arising from a pre-existing condition. Those are health conditions you had before joining an insurance plan. For example, insurance companies can’t refuse to cover your medication if you were diagnosed with diabetes before buying their plan. Before the Affordable Care Act, insurance companies considered breast implants a pre-existing condition. They often refused to cover any breast implant problems or even other problems in the breast.

Now insurance companies are usually required to pay for “medically necessary” services. Medically necessary means that a service is required to improve your health or keep you healthy. Although some insurance companies say they do not cover services related to cosmetic surgery, many have exceptions when those services are medically necessary. It is important that you read the policies carefully before you choose!

Based on our experiences working with women having problems with their breast implants, here are some tips that might help you make a decision:

  • Many companies consider removal of breast implants medically necessary for these conditions:
    • Ruptured silicone gel breast implants
    • Severe capsular contracture
    • Infections that don’t go away
    • Chronic pain
    • ALCL (a rare cancer of the immune system)
  •  Aetna, UnitedHealthcare, and Cigna plans tend to have good coverage for medically necessary breast implant removal if you meet their criteria that include the conditions listed above.

What Should I Know Before Signing Up?

Go to www.healthcare.gov to look at the plans offered through your state. You can find pricing information for 2018 plans on the website. The lower your income, the less you’ll have to pay.

If you’ve recently lost your health insurance coverage, you can sign up through the online exchange now. You might also be able to sign up now if you’ve had a major life event, like getting married or having a baby.

Otherwise, you can sign up for health insurance between November 1 and December 15. Coverage would start January 1, 2018. If you live in California, Colorado, Minnesota, Washington, Massachusetts, or the District of Columbia, you have a few more days or weeks to sign up depending on your state [1,2,3,4,5,6]. If you live in these states or DC, you should check their deadlines and when your coverage would start.

If you get health insurance through your job or your spouse’s job, your enrollment dates might be different. You should check with your employer.

Before you buy a health insurance policy, you should ask to make sure it includes coverage for breast implant-related health problems that would qualify you for medically necessary removal. If they can’t answer your question or tell you it won’t be covered, reach out to us at info@center4research.org. We’ll do our best to help you find a better policy.

Want to know how much your health insurance plan will cost through the Affordable Care Act? Use this calculator to find out.

Is Medicaid an Option?

In many states, Medicaid is available for free to any individual or family under 133% of the poverty line (about $30,000/year for a family of 4). Medicaid provides coverage for surgery or services a doctor considers medically necessary. You can find out if you are eligible for Medicaid at www.healthcare.gov.

Read here for more information on getting Medicaid coverage for your breast implant removal surgery.

Unfortunately, fewer people are eligible for Medicaid in states that did not adopt the Medicaid expansion provided by Obamacare.

Is Medicare an Option?

If you’re over age 65, you are eligible for Medicare. You can also be eligible for Medicare if you’re under age 65 and receive Social Security Disability Insurance (SSDI) or have end-stage renal disease.

Read here for more information on getting Medicare coverage for your breast implant removal surgery.

If you’re on Medicaid or Medicare and have problems getting coverage for your breast implant problems, contact us at info@center4research.org.

References

  1. Covered California and the Department of Health Services. (2017). Open Enrollment Runs Through Jan. 31, 2018. Retrieved from https://www.coveredca.com/apply/. Accessed on November 1, 2017.
  2. The Colorado Division of Insurance and the Colorado Department of Regulatory Agencies. (2017). Open Enrollment Dates for 2018 Colorado Health Insurance Coverage Set: Nov. 1, 2017 to Jan. 12, 2018. Retrieved from https://www.colorado.gov/pacific/dora/news/open-enrollment-dates-2018-colorado-health-insurance-coverage-set-nov-1-2017-jan-12-2018. Accessed on November 1, 2017.
  3. (2017). Open Enrollment Period. Retrieved from https://www.mnsure.org/new-customers/enrollment-deadlines/open-enrollment/index.jsp. Accessed on November 1, 2017.
  4. Washington Health Benefit Exchange. (2017). Washington Health Benefit Exchange. Retrieved from https://www.wahbexchange.org/. Accessed on November 1, 2017.
  5. Commonwealth of Massachusetts. (2017). Health Insurance Open Enrollment and Waivers. Retrieved from http://www.mass.gov/anf/budget-taxes-and-procurement/oversight-agencies/health-policy-commission/patient-protection/health-insurance-open-enrollment-and-waivers.html. Accessed on November 1, 2017.
  6. DC Health Link. (2017). Open Enrollment & Renewal Deadlines. Retrieved from https://dchealthlink.com/open-enrollment. Accessed on November 1, 2017.

Are “Gummy Bear” Breast Implants the Safer Implants?

Diana Zuckerman, PhD, Madris Tomes, and Amelia Murphy, National Center for Health Research and Device Events

Based on the summary of book chapter in Breast Implants, Rene Simon (ed.), Nova Science Publishers, 2017.

Our new book chapter on breast implants explains that the 55-year history of breast implants reflects repeated efforts to improve their safety and effectiveness by reducing the cosmetic problems and health complications that develop during the years while they are in the human body. The most recent effort is the type of highly cohesive breast implants known as “gummy bear implants” because of the thick gel that is described as similar to gummy bear candies. The goal of the more cohesive gel is to make implants last longer and be less likely to leak. First approved in the United States in 2012, adverse event reports indicate that this newest generation of implants causes complications similar to older generations of silicone gel breast implants.

The first breast implants, made in the 1960’s, were for cosmetic enhancement. When women’s augmented breasts became hard over time, implant manufacturers responded by making the silicone gel thinner. One manufacturer, Surgitek, added polyurethane foam to the outside to make the breasts feel softer. Those design changes caused other problems, however: the thinner gel had a tendency to “bleed” through the silicone elastomer shell, which contributed to the most common complication, capsular contracture. Breast implants made with thinner gel also ruptured and leaked more easily, and the gel broke down into silicone oil which could migrate to other organs or cause silicone granulomas inside their bodies. The polyurethane foam caused other problems: implant removal was very difficult and women lost their breast tissue during explant surgery, and the foam was found to break down to a known carcinogen.

The Food and Drug Administration (FDA) did not require breast implant manufacturers to submit data to prove the implants were safe and effective until 1992. By that time, the manufacturers had developed implants with a thicker shell and a more cohesive silicone gel. However, the studies revealed that, like the earlier implants, the more cohesive implants did not “last a lifetime” as had been claimed. As a result, manufacturers continued to modify the silicone gel to make it less likely to rupture and leak.

Despite claims that gummy bear implants are safer than other breast implants, a 5-year study found that the rupture rate was more than 4% for first-time augmentation patients.  The percentage of women needing additional surgery within 5 years ranged from 17% to 48%, depending on whether the patients were augmentation patients or reconstruction patients, and whether the gummy bear implants replaced previous implants. Our analysis found that from January 1, 2008 through June 30, 2017, 1298 adverse event reports for silicone gel breast implants were made to the FDA, 252 (19%) of which were for gummy bear implants. This is very high when you keep in mind that gummy bear implants were relatively rare in the U.S. prior to FDA approval in 2012. This chapter puts these statistics in the context of what is known about the safety of silicone breast implants and how that has changed over time.

Copies of the entire book chapter are available upon request at info@center4research.org

Will Medicaid Pay To Remove My Breast Implants?

Medicaid is a program that pays for medical costs for people with low incomes or limited resources. It is paid for by both federal and state governments.

Each state decides exactly what services will be paid for and how much they cost. In order for implant removal or any other service to be covered, your doctor must tell Medicaid that the service is medically necessary.

Because each state has different policies, you’ll have to do some research to find out whether your implant removal surgery will be paid for in the state where you live.

Even though each state runs its own Medicaid program, there are still guidelines they have to follow. All Medicaid patients across the country are entitled to certain medical services, including prevention services and screenings.

Where to Start

  1. You should make an appointment with your primary care doctor. Under Medicaid, that doctor is your “primary care coordinator.” Your doctor will have to approve the procedure and ask Medicaid if they will cover the costs.
  2. If your primary care doctor is part of an HMO (Health Maintenance Organization), he or she will refer you to a surgeon within the HMO. You may be required to use an HMO surgeon in order for Medicaid to cover the cost. If your HMO doesn’t have a surgeon who can do the surgery, you might be referred to a surgeon outside the network.
  3. If your primary care doctor is not part of an HMO, she/he may be able to tell you which surgeons in your area will accept Medicaid patients.

If you have Medicaid and Medicare

Dual Eligible Beneficiaries

People who are enrolled in both Medicare and Medicaid are called “Dual Eligible Beneficiaries.” They are enrolled in Medicare Part A and/or Part B and receive full Medicaid benefits and assistance with Medicare premiums.

If you are dual eligible, Medicare will pay for your medical services first. Medicaid may cover the cost of care that Medicare won’t. You should speak with your primary care doctor about the specifics.

Will Medicare Pay to Remove My Breast Implants?

Medicare usually covers breast implant (saline or silicone) removal for any of these conditions:

  • Painful capsular contracture with disfigurement
  • Implant rupture
  • Infection
  • Implant extrusion (coming through the skin)
  • Interference with the diagnosis of breast cancer
  • Siliconoma or granuloma (silicone-filled lumps under the skin)

Medicare coverage can differ depending on the state where you live. You can check the specific Medicare policies on breast implants removal in your state here.

Whether or not Medicare will pay for your breast implant removal depends on many factors. Below are some questions that will help you figure this out.

Original Medicare Plan

Original Medicare means you’re enrolled in Medicare Parts A & B and don’t have a Medicare Advantage plan.

1) Is your surgeon a Medicare Participating Provider “who takes assignment?” If you aren’t sure, ask the surgeon’s office whether they “take assignment.”

  • A surgeon who “takes assignment” has agreed to accept the Medicare fee as full payment for the surgery. The surgeon must submit the claim for your surgery directly to Medicare. Your surgeon CANNOT charge you, except for the deductible and/or copay amounts that Medicare doesn’t cover. Your surgeon should call the Medicare provider line to see if your surgery will be covered.
  • Even if your surgeon doesn’t think Medicare will cover the surgery, you still should ask the surgeon’s office to call the Medicare provider line to check. Many surgeons don’t know that Medicare will cover breast implant removal, so it’s important to have them check.
  • A Medicare Participating Provider who takes assignment IS REQUIRED to submit your Medicare claim within a year of your surgery. If they don’t, Medicare won’t pay and the doctor might try to get the patient to pay. That isn’t fair, so don’t let that happen to you.
  • You can check for Medicare participating providers here.

2) Is the surgeon you are thinking of using a Medicare Participating Provider “who does NOT take assignment?”

  • A surgeon who “doesn’t take assignment” can charge you up to 115% of the Medicare-approved fee. You might be asked for full payment upfront (at the time the surgery is done).
  • A surgeon who does not usually “take assignment,” can do so on a case-by-case basis, so you should check to see if the surgeon is willing to “take assignment” from Medicare in your case.
  • A surgeon who doesn’t take assignment may not be able to submit your claim to Medicare. You should ask the surgeon’s office who will be responsible for filing your claim. If the surgeon agrees to file, you should check to make sure it is filed soon. IMPORTANT: If it is not filed within one year of your surgery, Medicare will NOT pay the claim and you may be liable for the entire amount.
  • If your surgeon won’t submit your claim to Medicare, you can fill out this form for reimbursement with Medicare.

3) Has the surgeon you plan to use “Opted Out” of Medicare?

  • Surgeons who have “opted out” of Medicare don’t take assignment, submit Medicare claims, or limit fees to the Medicare-approved fee amounts.
  • Surgeons who have “opted out” of Medicare are REQUIRED to notify the patient with a written contract. This contract confirms that a patient understands she is directly responsible for paying the surgeon whatever he or she charges and that she CANNOT seek reimbursement from Medicare.

4) Do you have a supplemental insurance plan in addition to your Medicare coverage?

  • A supplemental plan might cover the deductible and/or copay amounts.
  • Medicare is your primary insurance and will reimburse the surgeon. You will need to get approval from Medicare BEFORE going to your supplemental plan.

Medicare Advantage Plan

1) Are you enrolled in a Medicare Part C Advantage Plan?

2) Is your surgeon part of your Plan network? If you are unsure, ask your Plan.

Because Medicare Part C Advantage Plans deal with Medicare directly, you won’t have to submit a claim to Medicare.

If your surgeon is NOT in your Plan network of providers, you may have to submit a claim directly to your Plan, Your Plan may limit what they will pay for your surgery. IMPORTANT: To avoid unplanned expenses, check with your Plan BEFORE you schedule surgery with a surgeon who is outside your Plan network.

3) Does your Plan require that you get pre-approval for your surgery and, if so, have you received pre-approval?

Most plans require that you get permission from your Plan before the surgery. If you don’t get pre-approval, the Plan might not cover your surgery.

Are you on Medicare and Medicaid?

People who are enrolled in both Medicare and Medicaid are called “Dual Eligible Beneficiaries.” They are enrolled in Medicare Part A and/or Part B and receive full Medicaid benefits and assistance with Medicare premiums.

If you’re dual eligible, your medical services generally are usually paid at the Medicare-approved amount. Because it depends on your unique situation, you should speak to your primary care doctor about the specifics.

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.