Tag Archives: breast implant removal

Can breast implants cause cancer? WJLA investigates

“You have cancer — again.”

“What? Breast cancer?”

“No … a new one.”

So went the conversation between a stunned 40-year-old Raylene Hollrah and the plastic surgeon who performed her reconstructive surgery after she survived breast cancer seven years earlier.

Her new cancer diagnosis? Breast Implant-Associated Anaplastic Large Cell Lymphoma, or BIA-ALCL for short. Of all the potential side effects of breast implants, she did not recall her surgeon ever mentioning a small but increased risk of cancer.

“I did everything to keep cancer away,” Hollrah told 7 On Your Side. “Yet, I put a device in my body that caused cancer.”

The US Food and Drug Administration is not prepared to say that the textured breast implants Hollrah chose cause lymphoma, a cancer of the immune system.

But in 2011 and again in 2016, the FDA cautioned of a “possible association” between ALCL and implants.

“This has created a certain amount of anxiety and concern among the medical community,” said Dr. Mark Clemens of MD Anderson Cancer Center, one of the leading experts on ALCL in the world.

Clemens met Hollrah after her diagnosis, explanted her implants and asked her questions about what she was told and when. His research, and others of patients and surgeons, reveals that patients never think to ask about ALCL and only one-quarter of surgeons always discuss the risk with patients in the initial consultation.

“We would like surgeons to always discuss the small, rare, but potential risk of this serious disease,” said Clemens, who serves on the board of the American Society of Plastic Surgeons (ASPS) as the liaison to the FDA. ASPS urges its board-certified members to always talk to patients about the risks as part of the informed consent process.

When 7 On Your Side filed a Freedom of Information Request (FOIA) about ALCL cases reported to the FDA, we received more than 800 documents representing 441 cases, more than one-third unconfirmed, and at least 12 deaths. Even since the 2011 advisory from the FDA about ALCL and implants, when manufacturers responded to reported adverse events, they often listed many risks but didn’t include ALCL.

“They should. Absolutely,” said Madris Tomes, CEO of Device Events, and a former FDA analyst who managed the build of a new adverse event reporting system. Tomes looks for patterns of problems with medical devices, but spotty reporting makes pinning down exact numbers for ALCL tricky.

Whether silicone or saline, Song explained why patients choose textured implants. They have a more natural, teardrop look, thinner at the top, thicker at the bottom. Texturing is intended to keep them from rotating. Researchers are evaluating whether that texturing, or a bacteria, or genetics make a patient more vulnerable to developing lymphoma.

THE ANALYST: “We don’t know how common it is.”

7 On Your Side spoke with a leader in the field of women’s health, Diana Zuckerman, PhD, President of the National Center for Health Research. Zuckerman was our chief source for information about the risk of suicide after implants. Regarding BIA-ALCL, she wrote:

“It is not true that textured implants are the only ones associated with BIA-ALCL. This summary of a recent medical journal article clearly says that “most women with ALCL have at least one textured implant” but that doesn’t mean they all do.

Read the entire article here.

The above article was published in February 2017. In August 2014, the National Comprehensive Cancer Network (NCCN), a nonprofit alliance of leading cancer centers, provided guidelines for the diagnosis of “breast implant associated ALCL (BIA-ALCL), based on clear evidence that breast implants can cause ALCL.  In 2017, the World Health Organization (WHO) and the Food and Drug Administration (FDA) both issued statements confirming that breast implants can cause ALCL.  To read about the FDA’s 2017 report on breast implants and ALCL, click here (insert hyperlink to http://www.breastimplantinfo.org/implantalcl/)

Insurance Coverage Information for Breast Implant Removal

Did you know it might be possible to get health insurance coverage for breast implant removal?

I got breast augmentation with implants. Will my insurance cover my breast implant removal?

I got breast implants after a mastectomy. Will my insurance cover my breast implant removal?

Need financial assistance to get your implants removed?

First of all, the original reason for getting your breast implants matters to health insurance companies (as well as Medicare and Medicaid).

If your implants were put in after a mastectomy and your doctor believes that removing your implants is “medically necessary,” then your health insurance is legally obligated to cover your breast implant removal.  Click here to learn more about your rights under the Women’s Health and Cancer Rights Act of 1998 (WHCRA).

If the original reason for getting breast implants was for augmentation of healthy breasts, then some health insurance companies will cover your explant surgery if they consider the services to be “medically necessary,” but others will not.

What if my insurance company says that “complications from cosmetic surgery” are not included?

Don’t be discouraged.  Almost all health insurance policies will not cover “cosmetic surgery” or “complications from cosmetic surgery” but don’t give up so easily.  Many policies have exceptions for complications from breast implants under certain circumstances that they consider “medically necessary” or “reconstructive surgery.”

What are “medically necessary” services?

This is defined differently by different health insurance companies, and sometimes varies in different states as well.

It is important to understand that even if your doctor thinks removing your breast implants is medically necessary, the health insurance policy can refuse to pay if their policy’s definition of medically necessary is different from your doctor’s.

The most generous health insurance policies regarding breast implant removal are usually based on one of the following conditions:

  1. Silicone gel implants that are proven to be ruptured.
  2. Silicone or saline implants that are causing Baker III or Baker IV capsular contracture.
  3. Breast implants that are causing necrosis (death of skin or tissue).
  4. Breast implants that need to be removed because of infection or ALCL (a rare cancer that can develop around breast implants).

Rupture: If your implants are ruptured, you will need proof. MRIs are  the best measurement of implant ruptures, but ultrasounds or mammograms may be accepted too. However, the pressure from mammography can cause old breast implants to break or leak and are not very accurate for detecting rupture, so it is much better to avoid mammography if you can.

Capsular Contracture: Breast implants are a “foreign body” and the natural response for most women is that the body forms scar tissue around the implant, inside your body, to protect your body from this “foreign invader.” This is a natural process. However, it is called capsular contracture when the scar tissue tightens or hardens around the implants. Capsular contracture can happen with either saline or silicone breast implants. It can feel slightly uncomfortable or cause debilitating pain. The mild version of capsular contracture is called “Baker I” or Baker II” (named after a Dr. Baker who devised the categories) and the most severe is called “Baker III or Baker IV.” Baker III or Baker IV breasts are hard and/or painful.  Insurance companies usually only consider Baker III and/or Baker IV level capsular contracture to be a medically necessary reason for removal.

Pain: Pain caused by capsular contracture is often considered justification for insurance coverage of removal.  In addition, if your implants are causing extensive pain because of nerve damage or the weight of the implants, it is sometimes possible to get your insurance company to pay for removal.

Improved health after removal: If you can prove that your symptoms have drastically improved after your breast implants were removed, you may be able to make a case that it was medically necessary to remove them in the first place. If you are no longer in pain, or are now able to return to work after being unable to work as a result of complications from your breast implants, you could make a strong case for why the implant removal was needed.  However, it is always riskier to pay for implant removal and then hope the surgery will be reimbursed.

What is generally NOT considered “medically necessary”?

Unfortunately, most insurance companies do not consider any autoimmune diseases/symptoms or anxiety related to your implants to be proof that it is medically necessary to remove your breast implants.  However, many women who have those symptoms also have other problems, such as leaking silicone implants or capsular contracture.  So, focus on the symptoms that the insurance company cares about, not the ones that they don’t cover.

What does “reconstructive surgery” mean?

Some insurance companies will consider your breast implant removal “reconstructive surgery” as opposed to “cosmetic surgery” and therefore medically necessary when the purpose of your surgery is to treat a medical condition. This usually means that you have Baker grade III or IV capsular contracture, and/or limited movement affecting your ability to do simple tasks such as reaching above your head or combing your hair. Your breast implant removal may also be considered reconstructive if you have lumps of silicone in the breast area that interfere with the diagnosis of breast cancer.

How do I know when/if my insurance plan considers breast implant removal “medically necessary”?

To find out what your insurance plan covers, you can read through a copy of your actual policy. There are often 3 versions of your health insurance policy:

  1. A short summary, also called a Summary of Benefits and Coverage. This will not have the information you need.
  2. A description of the plan. This will have more information than the summary, will probably specify that cosmetic surgery is not covered, and may even mention breast implants specifically.  However, it usually will not have the specific information you need to know if your policy will cover implant removal.
  3. The specific policies regarding breast implants or cosmetic surgery complications are in the “contract” that you sign when you buy health insurance coverage. This contract has all the very specific policies that you need to know about.  As a customer who bought that policy, you are entitled to receive a copy online or in the mail, so you can call to ask for it.  If your current insurance policy does not cover implant removal, you should shop around to look for one that does.  However, that can be difficult to find out.

Persistence can make a difference! For example, Medicare denied Karen’s initial claim for breast implant removal because they concluded that explanting her ruptured silicone gel implants was not medically necessary. In her appeal, she sent copies of several insurance policies from other companies, stating that they cover surgical removal of silicone gel breast implants when they are ruptured. Medicare finally granted her coverage for her explant surgery. Karen is already feeling better than she had in months/years.

We would be happy to help you with this. To start that process, you can fill out our very short survey here: https://www.surveymonkey.com/s/KHCWGM8

What do I need from my doctor?

When the time comes to ask the insurance company for coverage, it helps if your doctor sends a letter to your insurance company detailing why removal of your breast implants is medically necessary. He/she should focus on the complications that you have that are more likely to be covered by your insurance (such as implant rupture or Baker III or IV capsular contracture).  It is usually better to not talk about your other symptoms (such as autoimmune symptoms), because it will detract from what the insurance company needs to hear.

What if I have Medicare?

Your doctor should be able to call Medicare’s provider line to check if your breast implant removal surgery will be covered.

Q: My implants are silicone, they were implanted before 2007, and my insurance has denied coverage to remove my implants (or I have no insurance or Medicaid).  I do not have Medicare.  Can you help me?

If this is the case, you may be eligible for a financial assistance program to help you afford your breast implant removal. Please visit www.explantassistance.com and download the Notice of Interest form. If you have any questions, you can contact the Program Administrator, Jeff Condra, at jcondra@oplc.org or 205-252-6784.

What do I need to know about breast implant removal surgery?

See our article here.

How we can help you file a claim-appeal for breast implant removal -final