What is BIA-ALCL?

Anaplastic Large Cell Lymphoma (ALCL) is a rare form of cancer of the immune system. Experts now agree that women with breast implants are more likely to develop ALCL¹. Since it will develop in the breast area, it is called Breast Implant Associated-ALCL (BIA-ALCL). Usually, this cancer develops in the scar tissue (capsule) that forms around a breast implant². Sometimes this cancer can be found in the lymph nodes. If it’s not treated quickly, it can be fatal.

How can breast implants cause cancer?

Scientists are trying to figure out why ALCL forms near breast implants. Many experts believe that cancer may develop in response to chronic inflammation caused by bacteria³. Most cases of BIA-ALCL have been reported in women with textured implants, which provide a better surface for bacteria to grow.

Is BIA-ALCL really rare?

The U.S. Food and Drug Administration (FDA) says that it has received 359 reports of ALCL, including 9 deaths, in women with breast implants. They say that since millions of women have breast implants, BIA-ALCL must be very rare. However, the Australian version of the FDA (called the Therapeutic Goods Administration) estimates that between 1 in 1,000 and 1 in 10,000 women with breast implants will develop ALCL⁴.

More than 300,000 women get breast implant surgery every year. If the Australian estimates are correct, about 30-300 of those women will develop ALCL every year. However, many experts believe that ALCL is underreported and therefore the chance of developing ALCL from breast implants is likely higher than the current estimates. Although awareness of BIA-ALCL is increasing, many doctors are still unaware of the risks and symptoms.

How will I know if I have BIA-ALCL?

All women with breast implants should be seeing a doctor regularly to check for any problems. If you experience redness or swelling near your implants you should see a doctor immediately. A swollen breast is usually an infection, but the fluid around your implants should be tested for ALCL as well.

Although a swollen breast is the most common symptom of BIA-ALCL, not all women with BIA-ALCL have noticeable swelling. Some women with BIA-ALCL reported feeling a lump near their implant or capsular contracture. If you find a lump, see your doctor immediately to check for breast cancer or ALCL. If you have capsular contracture, keep in mind that it could be a sign of BIA-ALCL, even though it probably isn’t.

How can I prevent BIA-ALCL?

You can’t prevent ALCL if you have breast implants. However, you can watch out for warning signs mentioned and have regular checkups with a doctor who knows about BIA-ALCL and other risks associated with breast implants.

What is the treatment for BIA-ALCL?

ALCL is treated by removing the implant and all of the surrounding scar tissue. This procedure is called a total capsulectomy, or an “en bloc” removal. This is done to make sure any cancer cells in the tissue are removed.

If any of your lymph nodes are found to have ALCL, they will also be removed.

If the cancer is found later and has spread, you may need to be treated with chemotherapy or radiation therapy.

All articles are reviewed and approved by Dr. Diana Zuckerman and other senior staff.

References

1. FDA, Center for Devices and Radiological Health. (2017). Breast Implants – Breast Implant-Associated Anaplastic Large Cell Lymphoma (BIA-ALCL). Retrieved from https://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/ImplantsandProsthetics/BreastImplants/ucm239995.htm
2.  Swerdlow, S. H., Campo, E., Pileri, S. A., Harris, N. L., Stein, H., Siebert, R., et al. (2016). The 2016 revision of the World Health Organization classification of lymphoid neoplasms. Blood, 127, 2375-2390. doi:10.1182/blood-2016-01-643569
3.  Kadin, M. E., Deva, A., Xu, H., Morgan, J., Khare, P., Macleod, R. A., Epstein, A. L., et al. (2016). Biomarkers Provide Clues to Early Events in the Pathogenesis of Breast Implant-Associated Anaplastic Large Cell Lymphoma. Aesthetic Surgery Journal, 36(7), 773-781. doi:10.1093/asj/sjw023
4. Therapeutic Goods Administration. (2017). Breast implants and anaplastic large cell lymphoma. Retrieved from https://www.tga.gov.au/alert/breast-implants-and-anaplastic-large-cell-lymphoma

Sometimes it’s hard to know what questions to ask and who to ask. Here are some important questions to ask a board-certified plastic surgeon if you’re seriously considering breast implants:

• If your doctor shows before and after photographs of patients, ask if these were their own patients.
• Ask to see photographs of his or her patients, and including how they looked a few years later.
• Ask your doctor for written information about the risks of breast implants and read that information at least one week before surgery so you have time to ask questions and gather more information.
• Ask for the informed consent form at least one week before surgery.
• If there is a warranty on the implants, what is included? What isn’t included?
• Ask whether the doctor will remove your implants for free if you have serious problems. If so, will the surgical center services also be free? What if you want them removed, but the doctor doesn’t think it is necessary?

If you are still unsure about getting breast implants, seek advice from someone that has gone through breast implant surgery at least 5 -10 years ago. They may be able to help you make the decision that is best for you. Click here to read some personal stories from women who had breast implants.

All articles are reviewed and approved by Dr. Diana Zuckerman and other senior staff.

Farzana Akkas, 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.

Click on your state (or territory) below to see it’s official Medicare policy on breast implant removal.

If your state isn’t listed, it doesn’t have its own policy. You can look at this policy, which is usually borrowed by states that don’t have their own policy.  

Alaska

American Samoa

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South Carolina

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Virginia

Washington
Wyoming

West Virginia

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.

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.

Diana Zuckerman, PhD, and Megan Polanin, PhD, National Center for Health Research

When Angelina Jolie publicly announced her double mastectomy in 2013, she was praised for possibly saving many women’s lives. But we know more today than we did then and experts now agree that too many women are undergoing unnecessary mastectomies. Here are the facts.
A review of 10 studies found that the risk of getting breast cancer for an average woman with BRCA1 is 57%. The risk is 49% for a woman with BRCA2.[1] Keep in mind that for younger women, the lifetime risk of breast cancer is very different from the risk of getting breast cancer in the next 10 years or even 20 years. According to experts, a 40-year-old woman with the BRCA1 gene has a 14% chance of getting breast cancer before she turns 50.[2] That is not nearly as frightening, and with regular screening and all the progress in breast cancer treatments, the survival rate from breast cancer is higher than ever. Many breast cancer patients live long and healthy lives.
Most women are diagnosed with breast cancer at early stages, making it safe to undergo a lumpectomy (which removes just the cancer) rather than a mastectomy (which removes the entire breast). Yet American women are undergoing prophylactic mastectomies at a higher rate than women in other countries — many of them medically unnecessary.[3] Breast cancer experts believe that many women undergoing mastectomies do not need them and are getting them out of fear, not because of the actual risks.
In recent years, we have seen an increase in women with early-stage breast cancer choosing to get a double mastectomy. For example, a 2015 study conducted by researchers at Vanderbilt University reported that, for women diagnosed with early-stage breast cancer in one breast, the rates of double mastectomy increased from 2% to 11% from 1998 to 2011.[4] Researchers found that decisions to have a double mastectomy increased more for two groups of women: 1) Women with ductal carcinoma in situ (DCIS) where there are abnormal cells inside a milk duct in the breast that won’t spread and aren’t dangerous and 2) Women with cancer only in the breast that has not spread to the lymph nodes.
This year, researchers from Emory University and colleagues published a study focused on women diagnosed with early-state breast cancer in one breast.[5] They found that, from 2004 to 2012, the percentage of these women 45 years or older who got double mastectomies more than doubled from 4% to 10%. For women ages 20-44, the percentage tripled from 11% to 33%. Researchers found that it mattered where women lived in the United States. For example, in five Midwestern states (Nebraska, Missouri, Colorado, Iowa, and South Dakota), 42% of the women who got surgery decided to get a double mastectomy.
For many years, experts have known that women who undergo lumpectomies for a non-invasive condition called ductal carcinoma in situ (DCIS) or for early-stage breast cancer live just as long as women undergoing mastectomies. However, the latest research goes a step further: a study conducted in the Netherlands of more than 37,000 women with early-stage breast cancer found that the women undergoing lumpectomies were more likely to be alive 10 years later than women with the same diagnosis who underwent a single or double mastectomy.[7] They were also less likely to have died of breast cancer.
In 2016, Harvard cancer surgeon Dr. Mehra Golshan published a study of almost half a million women with breast cancer in one breast. She reported that those undergoing double mastectomies did not live longer than women undergoing a mastectomy in only one breast.[6]
These are just the most recent studies. For more information about the many studies that show the benefits of less radical surgery, see this article.
The bottom line is that women with DCIS or early-stage breast cancer have more effective and less radical treatment options than mastectomy. We need to stop thinking of mastectomy as the “brave” choice and understand that the risks and benefits of mastectomy are different for every woman with cancer or the risk of cancer. In breast cancer, any reasonable treatment choice is the brave choice.
The research clearly shows that mastectomies are not the best choice for most women if they want to live longer. Women should be aware of treatment choices for breast cancer and encouraged to make decisions based on their own unique situations. For each woman, it is important to weigh her own risk of cancer — in the next few years, and not just over her lifetime – and the risks of various treatments. Each woman should make the decision that is best for her, based on the facts, not on fear.

All articles are reviewed and approved by Dr. Diana Zuckerman and other senior staff.
1. Chen, S., & Parmigiani, G. (2007). Meta-analysis of BRCA1 and BRCA2 penetrance. Journal of Clinical Oncology, 25(11), 1329-1333.
2. Chen, S., Iversen, E. S., Friebel, T., Finkelstein, D., Weber, B. L., Eisen, A., … & Corio, C. (2006). Characterization of BRCA1 and BRCA2 mutations in a large United States sample. Journal of Clinical Oncology, 24(6), 863-871.
3. Metcalfe, K. A., Birenbaum?Carmeli, D., Lubinski, J., Gronwald, J., Lynch, H., Moller, P., … & Kim?Sing, C. (2008). International variation in rates of uptake of preventive options in BRCA1 and BRCA2 mutation carriers. International journal of cancer, 122(9), 2017-2022.
4. Kummerow, K. L., Du, L., Penson, D. F., Shyr, Y., & Hooks, M. A. (2015). Nationwide trends in mastectomy for early-stage breast cancer. JAMA surgery, 150(1), 9-16.
5. Nash, R., Goodman, M., Lin, C. C., Freedman, R. A., Dominici, L. S., Ward, K., & Jemal, A. (2017). State variation in the receipt of a contralateral prophylactic mastectomy among women who received a diagnosis of invasive unilateral early-stage breast cancer in the United States, 2004-2012. JAMA surgery.
6. Wong, S. M., Freedman, R. A., Sagara, Y., Aydogan, F., Barry, W. T., & Golshan, M. (2017). Growing use of contralateral prophylactic mastectomy despite no improvement in long-term survival for invasive breast cancer. Annals of surgery, 265(3), 581-589.
7. van Maaren, M. C., de Munck, L., de Bock, G. H., Jobsen, J. J., van Dalen, T., Linn, S. C., … & Siesling, S. (2016). 10 year survival after breast-conserving surgery plus radiotherapy compared with mastectomy in early breast cancer in the Netherlands: a population-based study. The Lancet Oncology, 17(8), 1158-1170.
8. Hwang, E. S., Lichtensztajn, D. Y., Gomez, S. L., Fowble, B., & Clarke, C. A. (2013). Survival after lumpectomy and mastectomy for early stage invasive breast cancer. Cancer, 119(7), 1402-1411.
9. Kurian, A. W., Lichtensztajn, D. Y., Keegan, T. H., Nelson, D. O., Clarke, C. A., & Gomez, S. L. (2014). Use of and mortality after bilateral mastectomy compared with other surgical treatments for breast cancer in California, 1998-2011. JAMA, 312(9), 902-914.