Category Archives: Breast Cancer

Statement of Dr. Diana Zuckerman, President, National Center for Health Research, March 8, 2023

Breast Cancer, Breast Cancer, news-you-can-use, Other Cancers, Other Cancers

Today the FDA announced that 19 women were reported in medical publications who developed squamous cell carcinoma (SCC) in the capsule around breast implants. This is more than the 10 women that FDA reported in September. Several of the women died.  It is important to know that 24 cases of SCC have been reported to the FDA, but it is not known if these cases overlap with the 19 that were published or if some of the 24 cases were reported more than once. Some of the women had silicone gel implants, some had saline implants, some textured, some smooth.  Some of the women got breast implants for augmentation, others for reconstruction after mastectomy.  That means that all women with breast implants need to be aware of this risk, even though it may be rare.

Last September, the FDA also reported 12 cases of lymphomas different from anaplastic large cell lymphoma (ALCL) that were also caused by breast implants.  The agency has not updated those numbers.

Breast Implant Illness: What’s the Evidence?

Breast Cancer, , ,

Debate swirls over the risks of breast implants, and physicians and patients are justifiably confused by the conflicting information available.  Despite surgeons’ claims that implants are proven safe, tens of thousands of women with breast implants have reported that they have serious symptoms that they refer to as “breast implant illness.”  Many women with these symptoms report that they recovered when their implants are removed.  Our report finds clear scientific evidence that implants increase the chances of those symptoms and removing implants usually improves’ their health. Women considering breast implants after mastectomy or for cosmetic reasons will want to know about our report.

 

She’s the reason Arizona has a law requiring surgeons to warn patients about the dangers of breast implants

Breast Cancer, In the News, News Stories & Editorials, Uncategorized, We're In the News

Bianca Buono and Katie Wilcox, Arizona News 12 NBC: February 22, 2022

PHOENIX — Migraines. Headaches. Insomnia. Difficulty breathing. Trouble swallowing.

Robyn Towt survived three bouts with cancer. But it was breast implants that made her the sickest.

“I couldn’t figure out what was wrong with me,” Towt said.

At first, it was a mystery. She had recently survived breast cancer then had a double mastectomy with breast reconstruction. The cancer was gone, so why was she feeling so badly?

“My entire team of doctors failed me,” Towt said.

Towt said her team of doctors never mentioned that her breast implants could cause those side effects. She started doing her own research, desperate to figure out why she was feeling this way.

[….]

Undisclosed risks

Diana Zuckerman, president of the National Center for Health Research, has been outspoken about the dangers of implants for years.

“One of the things that’s been so tragic for all these years is how many women got sicker and sicker and sicker, year after year after year, going to doctors saying what’s wrong with me and the doctor saying, you know, I don’t know, do these tests and try to figure it out,” Zuckerman said.

“And then they finally discover on social media, that there are tens of thousands of women with exactly the same health problems they have, who also happen to have breast implants, and then they get their implants out, and they get better.”

Zuckerman has been pushing for acknowledgment from the FDA that breast implant illness exists, advocating for more research around what exactly causes it and pushing for transparency when it comes to the risks.

She says the FDA took a step in the right direction last year when the agency announced breast implants would be equipped with a black box warning.

The FDA boxed warning informs patients of the following:

  • Breast implants are not considered lifetime devices
  • The chance of developing complications increases over time
  • Some complications will require more surgery
  • Breast implants have been associated with the development of a cancer of the immune system called breast implant-associated anaplastic large cell lymphoma (BIA-ALCL)
  •  BIA-ALCL occurs more commonly in patients with textured breast implants than smooth implants, and deaths have occurred from BIA-ALCL
  • Breast implants have been associated with systemic symptoms

“They’re going to have what’s called a black box warning, that’s like the kind of warning you see on cigarette packages that tell you cigarettes can kill you,” Zuckerman said.

Arizona’s first-of-its-kind bill

Even still, that warning wasn’t always relayed by plastic surgeons to patients. That’s why lawmakers in Arizona decided to take matters into their own hands.

“We have to do something,” said state Sen. Michelle Ugenti-Rita.

Consultations for breast augmentations look different now in Arizona than they did a year ago.

That’s because a first-of-its-kind bill has passed in Arizona created to protect women against a badly kept secret involving breast augmentation surgery: breast implant illness.

“I was shocked to learn that there were so many women with very very similar stories and experiences. And yet there was nothing being done from the medical community’s perspective and point of view,” Ugenti-Rita said.

[….]

To read the entire article click here.

Statement on Keytruda for Early Stage Triple Negative Breast Cancer

Breast Cancer, Breast Cancer, Testimony & Briefings, , ,

February 9, 2021

The National Center for Health Research is a nonprofit think tank that scrutinizes the safety and effectiveness of medical products.  We don’t accept funding from companies that make those products, so we have no conflicts of interest.  We welcome the opportunity to provide our views on Merck’s application for approval of Keytruda for the indication of high-risk early stage triple negative breast cancer.

Triple negative breast cancer has a lower survival rate than other breast cancers.  However, chemotherapy clearly improves 5-year survival.  Patients need additional treatment options but the bottom line for patients is that FDA should not approve an indication that is not proven to have clinically meaningful benefits, especially when the treatment has clear risks.   

The first issue to address is whether there is evidence that immune checkpoint inhibitors (ICIs) are effective for TNBC.  We agree with FDA scientists that “there is still uncertainty regarding ICIs for TNBC” based on the results from several clinical trials.

  • KEYNOTE-119 failed to meet its primary OS endpoint. 
  • KEYNOTE-355 has not met its OS endpoint. 
  • IMpassion130: clinical benefits need to be confirmed
  • IMpassion131 interim OS results favored control group

The second major issue pertains to pCR data in the study.  The results indicate only 7.5% improvement in pCRs at IA3 (the most recent interim analysis), which the FDA scientists point out may not be clinically meaningful even if statistically significant.  We agree.  The problem is that it is impossible to determine how this slight improvement would affect overall survival, and even if it does, how much neoadjuvant and adjuvant use each contribute to any benefit. 

FDA scientists were clear to the sponsor that there were concerns with their study design and that the application for approval was premature since the study was not yet completed.  The agency made it clear that that the event free survival (EFS) study results were not statistically significant, not clinically meaningful, and did not show a “stable trend.” 

FDA reviewers are clear that data on overall survival “are too immature to provide a conclusive interpretation regarding the difference in OS between treatment arms.” 

What about safety?

At IA3 (the most recent interim analysis), there were 96 deaths, which FDA points out “accounts for only 32% of the events needed for the final analysis. Therefore, the OS estimate may be unreliable, and the treatment effect size reported is subject to uncertainty.”

It is notable that the study included patient-reported outcomes (PROs), but unfortunately, KEYNOTE-522 was not designed to compare differences in PROs (symptoms, side effects, health-related quality of life), nor were these patient-reported endpoints prospectively identified and statistically tested. 

PRO assessments should have been more frequent, both for neoadjuvant and adjuvant treatments

Since many high-risk, early-stage TNBC patients will be cured with standard therapy, the key issue is whether this drug has benefits that outweigh the risks.  The benefits are unclear.  Therefore, the evidence of the drug’s “added toxicity” is worrisome.  FDA scientists concluded that “Some of these toxicities may be irreversible or require lifelong medication in patients cured of their breast cancer.

Although the sponsor counted 2 deaths due to immune-mediated adverse events, the FDA counted 4.  Either way, these deaths must be considered worrisome given the lack of clear evidence of a meaningful benefit.  And, there are many other serious adverse events in addition to the small number of deaths.   All-grade and grade ≥3 immune-mediated AEs and infusion reactions occurred more frequently in Keytruda patients compared to placebo:    43% vs. 22% for all grade AEs, and 15% vs. 2% for high grade AEs.  In fact, 10% of Keytruda patients had immune-mediated AEs and infusion reactions leading to hospitalization compared to 1% of placebo.  These included the following relatively high number of adverse events:

  • Infusion reactions (18%), 
  • Hypothyroidism (15%), 
  • Severe skin reactions (6%)
  • Hyperthyroidism (5%), adrenal insufficiency (3%), pneumonitis (2%), and thyroiditis (2%).

It is important to note that these adverse events were not resolved at the last assessment in the study for 19% of Keytruda patients.   It is also important to note that 16% of the Keytruda patients initiated thyroid hormone replacement during the study.

In summary, we agree with FDA scientists that the deaths are “particularly concerning in this curative disease setting.”

  • “All grade and grade ≥3 immune-mediated AEs were increased in [Keytruda] patients.’
  • Some “may be severe or lifelong.” 
  • The adjuvant treatment has fewer adverse events but “has not demonstrated a significant effect on any efficacy endpoint, and may be adding risk without benefit.”

Based on our analysis, we agree with the overall conclusions made by FDA scientists: 

  1. Neoadjuvant Keytruda “confers only a small absolute improvement in pCR rate of questionable clinical meaningfulness.”
  2. Event-free survival and overall survival are “immature and unreliable.”
  3.  “The design and results of KEYNOTE-522 do not currently support a role for adjuvant [Keytruda].”
  4. “Supportive data of clinical benefit … are lacking.” 
  5. Adding Keytruda “is associated with increased toxicity … which may be severe, irreversible, and/or require life-long medication in potentially curable and otherwise healthy patients.” 

In conclusion, the FDA and the medical community do patients no favors to approve a treatment that is not proven to benefit them and at the same time is proven to cause harm for a substantial percentage of patients.  The studies should be continued to determine whether the benefit of adding Keytruda to other treatments outweigh the risks.

 

This written statement was submitted to the FDA on February 8, 2021 and an oral version with PowerPoint slides was presented at the FDA Advisory Committee meeting on February 9, 2021.

We are pleased that the FDA Advisory Committee agreed with our views and voted 10-0 on February 9 in favor of deferring an FDA regulatory decision until the study is completed.

Compounded Bioidentical Hormone Therapy

Breast Cancer, Medical Treatments with Cancer Risks, , , ,

Keris KrennHrubec, Meg Seymour, & Diana Zuckerman, PhD

To avoid the risks of conventional hormone therapy, more and more women are seeking alternatives. But how safe are compounded bioidentical hormones?

When women enter menopause, their bodies produce less estrogen and progesterone. This can cause hot flashes, night sweats, insomnia and other symptoms. Hormone therapy can supplement those hormones, but it increases the risk of breast cancer and other serious diseases. What are your options if the symptoms of menopause are difficult to cope with?

In 2002, a major research study reported that FDA-approved hormone therapy can increase a woman’s risk of heart disease, breast cancer, and stroke. (For more information, please visit: Hormone Therapy and Menopause). As a result, women started to look for alternatives to conventional hormone therapy. Custom-compounded bioidentical hormone therapy (CBHT) has been marketed as more natural and safer, but does the scientific evidence support those claims?

Natural and Safe?

Many of the hormones used in conventional hormone therapy are derived from animal products. Bioidentical hormones, on the other hand, are from plants and are more similar (although not necessarily identical) to the hormones that naturally occur in the human body. However, the term “bioidentical” is misleading and has no scientific value. Bioidenticals are created in laboratories through at least 15 chemical reactions, and they are not identical to hormones produced by human bodies.[1,2] To date, no studies have shown that bioidenticals are safer than conventional hormone therapy and experts used to assume they have similar benefits and risks for patients.[3,4]

The FDA asked the National Academies of Sciences, Engineering and Medicine to form a committee that would assess whether cBHT is an adequate substitute for the traditional therapies that are FDA-approved. In 2020, the committee issued a report that there was not sufficient data to say that cBHT is a safe and effective treatment for menopause. Although some people have reported anecdotal claims that cBHT is safe and effective, these anecdotes are not scientific data.[5] 

The Pros and Cons of Compounding

Some bioidentical hormones (such as small particles of progesterone and estradiol) have been approved by the FDA,[1] but most are not. Instead, they are prescribed as a compound with ingredients that are mixed and blended by pharmacies to “create a customized medication for an individual patient”.[6,7] Since compounding is used to make individualized medication, it is not approved by the FDA. Compounding of some medications is necessary for some patients, such as patients who are allergic to one component of an approved drug or who need a particular dosage that differs from the FDA-approved medicine. However, since it is not monitored the way an FDA-approved drug is, compounded drugs are not proven to be safe or effective.[7]

Women who are considering compounded bioidentical hormones often start by getting their individual hormone levels checked through saliva or serum tests. This may create the impression that the bioidentical drugs will be customized for each patient, but research has not shown that these hormonal tests are meaningful or can ensure a safe or effective product.[1,3]

Risks Through Compounding

In addition to not being approved by the FDA as safe or effective, compounded drugs have an additional risk of being contaminated [3] or having an inaccurate dosage.[6] Either can be dangerous. Since compounded drugs are not FDA-approved, they also lack warnings on labels about possible side effects, including serious ones.[1,8] Several of the ingredients that are commonly used in bioidentical hormones – such as testosterone – have not been approved by the FDA for use for postmenopausal women.[3]

Despite these concerns, many women have been prescribed bioidentical hormones for menopause. That’s why the FDA announced in 2018 that they will expand research on compounded bioidentical hormone therapy.[9]

How Do I Know If My Hormone Therapy Has Been Compounded?

Compounded bioidentical drugs are legal if they are in response to a doctor’s prescription.[7] It is unlawful for a pharmacy to simply give you modified drugs without consent. However, even if it is legal, that doesn’t mean it will be safe or effective. If you have any questions or concerns about your hormone therapy, you should talk to your doctor or pharmacist.[10]

You can recognize FDA-approved hormone therapy by the use of brand names such as Premarin, Vagifem and Estrace. The bioidenticals micronized progesterone (brand name Prometrium) and estradiol (brand name Vivelle) have also been approved by the FDA. If your medication has been compounded, you will see terms such as estrone, estradiol, testosterone or progesterone instead of brand names. You are probably receiving CBHT if you have been asked for a saliva or serum test to establish an individualized treatment course.[1,2]

Traditional hormone therapy can be effective for menopausal symptoms, but can increase the risk of cancer and other serious diseases. Bioidentical hormones may have the same risks. You can find more information on the FDA-approved hormone therapies here.

 

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

  1. American College of Obstetricians. (2012). Compounded bioidentical menopausal hormone therapy. Fertility and Sterility, 98(2), 308-312. (reaffirmed in 2018)
  2. Gass, M. L., Stuenkel, C. A., Utian, W. H., LaCroix, A., Liu, J. H., & Shifren, J. L. (2015). Use of compounded hormone therapy in the United States: report of the North American Menopause Society Survey. Menopause, 22(12), 1276-1285.
  3. Pinkerton, J. V., & Pickar, J. H. (2016). Update on medical and regulatory issues pertaining to compounded and FDA-approved drugs, including hormone therapy. Menopause (New York, NY), 23(2), 215.
  4. National Institute on Aging. (June 2017). Hot Flashes: What Can I Do? Retrieved from: https://www.nia.nih.gov/health/hot-flashes-what-can-i-do#risks
  5. The National Academies of Sciences, Engineering and Medicine (July 2020). Report: The Clinical Utility of Compounded Bioidentical Hormone Therapy (cBHT) A Review of Safety, Effectiveness, and Use. Retrieved from: https://www.nap.edu/resource/25791/cBHT%20Consensus%20Study%20Report%20Highlights.pdf
  6. FDA (June 2018). Report: Limited FDA Survey of Compounded Drug Products. Retrieved from: https://www.fda.gov/drugs/human-drug-compounding/report-limited-fda-survey-compounded-drug-products
  7. FDA (June 2018). Compounding and the FDA: Questions and Answers. Retrieved from: https://www.fda.gov/drugs/human-drug-compounding/compounding-and-fda-questions-and-answers.
  8. FDA (June 2018). Compounding Oversight. Retrieved from: https://www.fda.gov/drugs/human-drug-compounding/compounding-oversight
  9. FDA (September 2018). FDA announces new and expanded compounding research projects. Retrieved from: https://www.fda.gov/drugs/drug-safety-and-availability/fda-announces-new-and-expanded-compounding-research-projects
  10. FDA (February 2018). Menopause: Medicines to Help You. Retrieved from: https://www.fda.gov/consumers/free-publications-women/menopause-medicines-help-you

FDA considers black box warning for all breast implants

Breast Cancer, In the News, News Stories & Editorials, We're In the News, , ,

Mariel Carbone, WCPO Cincinnati: February 09, 2020

Although many other survivors choose implants after their mastectomies, [Lily McBreen is] adamant that she won’t. Having almost lost her life once, she’s worried the side effects of receiving breast implants could endanger it again.

[…]

“I wanted to avoid the rheumatological symptoms that have been out in the news for so many decades,” she said. “There has been so many accounts of women complaining of problems with them.”

Those symptoms, which women are calling “breast implant illness,” are among the many reasons the United States Food and Drug Administration could soon take extreme measures when it comes to educating the public about implants.

[…]

Currently, the black box warning exists only as a draft while the FDA continues to consider its implementation.

The draft warning outlines three main concerns.

First, “breast implants are not considered life time devices” and women may require more surgery if complications occur.

It also states that implants have been associated with BIA-ALCL.

[…]

Finally, it describes how some patients have reported a variety of symptoms, including “joint paint, muscle aches, confusion, chronic fatigue, autoimmune disease and others.”

The FDA is also proposing a patient decision checklist, which would include situations in which the device should not be used, considerations for a successful breast implant candidate, risks of surgery, the importance of using an appropriate physician, the risk of BIA-ALCL and other symptoms and discussion of other options.

Still, some have said these proposals don’t go far enough, including Diana Zuckerman who is President of the National Center for Health Research. The center initiated the Breast Implant Working Group, which is made up of six experts including patient advocates and plastic surgeons.

“The FDA’s draft Black Box warning is too vaguely worded on BIA-ALCL and breast implant illness, and includes jargon that will not be understood by all patients,” the working group said in a statement. “The FDA draft Black Box states that ‘breast implants have been associated with the development of a cancer of the immune system called breast implant-associated anaplastic large cell lymphoma (BIA-ALCL).’ Association implies correlation rather than causation. In fact, the evidence is clear that breast implants can cause BIA-ALCL.”

Read the original story here.

Should You Get a Sentinel Lymph Node Biopsy (SLNB) for Stage Zero Breast Cancer (DCIS)?

Breast Cancer

Nina Zeldes, National Center for Health Research

Thanks to widespread use of screening mammography, there has been a dramatic increase in women diagnosed with ductal carcinoma in situ (DCIS), the most frequently diagnosed type of Stage Zero breast cancer. It accounts for 20-25% of new breast cancer cases diagnosed each year. DCIS is referred to as “stage zero breast cancer” or a “pre-cancer” because it is not invasive. It is almost always diagnosed on a mammogram, where it looks like white specks. DCIS rarely forms a lump, which is why it isn’t diagnosed by a breast exam. In DCIS, some of the cells lining the ducts (the parts of the breast that secrete milk) have developed abnormally, but since it is not invasive, it does not spread unless the DCIS changes into stage 1 breast cancer.

DCIS is not painful or dangerous and most women with DCIS will never develop invasive cancer whether they are treated or not. But DCIS can change into stage 1 breast cancer, and it is impossible to predict which women with DCIS will develop cancer and which ones won’t. That’s why treatment is recommended. Fortunately, only 3% of women treated for DCIS die of breast cancer within 20 years.

What are Your DCIS Treatment Options?

DCIS usually grows slowly. A patient can spend a few weeks after her diagnosis to talk with her doctors, learn the facts about her treatment choices, and think about what is important to her before she chooses which kind of treatment to have.

Treatment choices for DCIS are similar to those for invasive breast cancer. Most patients can choose fewer treatments with fewer side effects, but surgery to remove the DCIS is almost always recommended.

Most DCIS patients can choose a lumpectomy (which removes the DCIS but does not remove the entire breast). Radiation therapy and/or hormonal therapy are often recommended to reduce the chances of recurrence, although neither increases the already very good chances of survival.

Sentinel Lymph Node Biopsies for DCIS – Beneficial or Overtreatment?

Some DCIS patients that choose lumpectomy are encouraged to undergo a sentinel lymph node biopsy, which removes a few lymph nodes from under the arm to check if cancer has spread there. However, since DCIS does not spread, experts generally do not recommend this procedure for patients diagnosed with DCIS.

Despite this, approximately one in four women diagnosed with DCIS currently undergo sentinel lymph node biopsies. Is this a good way to “be cautious” to prevent breast cancer in the future, or is it overtreatment?

To find out if there are any long-term benefits for women, Dr. Shiyi Wang and his colleagues at Yale University published a study in 2019[1] that looked at 5,957 women who were diagnosed with DCIS and had undergone a lumpectomy, and compared the women who had also undergone sentinel lymph node biopsies with those who had not.

They found that over the next 5.75 years, the biopsy did not:

  • decrease DCIS patients’ chances of undergoing mastectomy (removal of the breast)
  • decrease DCIS patients’ chances of developing invasive breast cancer
  • reduce the likelihood of a DCIS patient dying from breast cancer

At the same time, the study found that having the biopsy increased the risk for several serious side effects, such as pain, wound infection, and lymphedema. Lymphedema is a painful, chronic condition that can restrict a woman’s arm movements.

The researchers therefore concluded that there are no long-term benefits for undergoing sentinel lymph node biopsies for DCIS patients, and that the risks of complications should convince most DCIS patients and their physicians not to undergo the procedure.

The study was limited to older women (67-94) and did not control for risk factors such as obesity or using hormonal therapy such as Tamoxifen or aromatase inhibitors. For that reason, the results might not be relevant to younger women or women with a high-risk type of DCIS, which can be diagnosed prior to surgery. The possible impact of hormonal therapy or weight is unknown. However, the study has important implications for tens of thousands of women with the most common type of stage zero breast cancer (DCIS).

Bottom Line: Most women who receive a lumpectomy for DCIS (stage zero breast cancer) are being overtreated if they undergo a sentinel lymph node biopsy. The most recent research shows that this procedure has no long-term benefits for most DCIS patients and can cause long-lasting pain and other problems.

Read more information about this study here. You can access the study by clicking on the following link: Long-Term Outcomes of Sentinel Lymph Node Biopsy for Ductal Carcinoma in Situ.

For more information about surgery options for DCIS, see our free DCIS patient booklet. Find out if women with pre-cancers are getting mastectomies they don’t need here. You can also find some more general information about DCIS here. If you want to find out more about radiation therapy for DCIS click here. For more information about hormone therapy, such as Tamoxifen, for DCIS, click here.

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

  1. Hung, Peiyin, et al. “Long-Term Outcomes of Sentinel Lymph Node Biopsy for Ductal Carcinoma in Situ.” JNCI Cancer Spectrum 3.4 (2019): pkz052.

Dr. Diana Zuckerman’s Statement on FDA’s Draft Guidance on Labeling for Breast Implants

Breast Cancer, Breast Cancer, Policy, Press Releases, Testimony & Briefings

Statement of Dr. Diana Zuckerman, President, National Center for Health Research on October 23 Regarding FDA Labeling Recommendations to Improve Patient Communication Draft Guidance

We thank the FDA for proposing a black box warning and a patient Informed Consent check list that provides specific, understandable information about the risks of breast implants.  The FDA’s draft includes the types of information that we have proposed to the FDA in recent months in our work with patient advocates and plastic surgeons.  The devil is in the details, so we look forward to working with the FDA to finalize these materials so that patients can make better informed decisions in the future than most women considering breast implants have been able to make. We will  keep working closely with the FDA, patients, and plastic surgeons to make that goal a reality.

For more information see FDA’s Draft Guidance here.

Insurance Coverage Information for Breast Implant Removal

Breast Cancer, Breast Cancer, Treatment & Management

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 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.”

What are “Medically Necessary” Services?

Insurance companies cover services that they determine to be “medically necessary” to treat a disease or illness. Although you or your doctor may believe a service is medically necessary, insurance companies don’t always agree.

Most insurance companies will not cover any cosmetic procedures and some will not cover complications from previous cosmetic procedures.  However, many companies consider removal of breast implants medically necessary for patients with any of these conditions:

Unfortunately, insurance companies usually won’t cover the cost of breast implant removal for autoimmune or connective tissue diseases or other systemic complications. If you have any of the conditions listed in the bullets above, you should focus on those in your insurance claim because insurance companies are more likely to cover these symptoms.

How do I know whether my insurance company will cover the cost of removal?

To find out if your insurance company is likely to cover removal, you will need to look at your specific policy language. You can usually find this language in a document called “Evidence of Coverage” (EOC), this is also sometimes called a “Benefits Booklet.” It is a document (typically about 100 pages) that describes in detail the healthcare benefits covered by your health plan, including procedures that your insurance company will and will not cover.

You can access an electronic copy of your EOC through your online account on your insurance company’s website. You can also call the member services number on the back of your insurance card and ask an insurance representative for a copy of this document.

What Do I Look For?

Once you have your policy, look for language about breast implant removal.  If you don’t see any language about breast implant removal, search for language on complications from cosmetic surgery. If you cannot find any specific language about breast implant removal, you should also look to see what your insurance company’s definition of “medically necessary” is. It is also important to check whether your insurance plan requires pre-authorization for any surgeries.

If you’re using an electronic copy, you don’t need to read the entire document. You can easily find terms using the “Control+F” keys on your keyboard. That will provide a “search box” that will search for any words you enter. Just enter the word “breast” or “cosmetic” or “medically” in the search box. If you are unable to find what you need in the lengthy document, call your member services line and ask for assistance to locate the correct pages.

File for Pre-Authorization

Most insurance companies will require that you get pre-authorization (also called prior approval or pre-certification) before the surgery. This means your insurance company reviews your relevant information and determines whether surgery is medically necessary. Then, the insurance company will let you know if it is likely to cover your surgery. However, that pre-authorization isn’t a promise that your surgery will be covered.

The easiest way to get pre-authorization is to have your plastic surgeon sign and submit a letter that lists your symptoms and explains why removal is medically necessary based on your insurance policy language. (Usually one or more of health problems listed on the bullets earlier in this article). Your surgeon should also enclose any medical documentation that provides proof of your symptoms.

It is best if your plastic surgeon signs this letter to send with your insurance claim. However, if your surgeon is unwilling to sign the letter, another doctor involved with your care, such as your primary care provider, can sign. You can find templates for these letters here. If your doctor agrees to sign the letter, but won’t submit it to your insurance company, you will need to submit the letter before your surgery to ensure you receive pre-authorization.

NOTE: If you don’t get pre-authorization when it was required, the insurance company isn’t required to cover the surgery, even if it considers the procedure to be medically necessary.

After Your Surgery: Filing a Reimbursement Claim

If your surgeon is in your insurance company network, he/she should file a claim on your behalf. If not, you will have to pay upfront for the surgery and file the reimbursement claim with your insurance company. Even if you see a surgeon who doesn’t take insurance, you should still file a pre-authorization claim with your insurance company. If you didn’t seek pre-authorization before your surgery, you can still file a reimbursement claim.

In your reimbursement claim, you will need to submit your pre- and post-operative reports, along with a letter from the surgeon stating that the procedure was medically necessary.

You can learn more about getting private insurance to cover your explant surgery, including how to appeal a denial, here on our breast implant information website. 

What if I have Medicare?

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)
  • Breast Implant-Associated Anaplastic Large Cell Lymphoma (BIA-ALCL), a cancer of the immune system)

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.

You can learn more about getting Medicare to cover your explant surgery here on our breast implant information website. 

You can learn more about getting Medicaid to cover your explant surgery here on our breast implant information website. 

What do I Need to Know about Breast Implant Removal Surgery?

See our article here.

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

NCHR Statement on FDA’s Request for Recall of Allergan Breast Implants and Expanders

Breast Cancer, Breast Cancer, Policy

Statement of Dr. Diana Zuckerman, President, National Center for Health Research on July 24 Announced Recall of Allergan Biocell Breast Implants and Expanders

h Research on July 24 Announced Recall of Allergan Biocell Breast Implants and Expanders

“The FDA announced today that at its request, Allergan is implementing a worldwide recall of their Biocell textured breast implants and expanders.  This recall is an important step toward reducing the risk of a type of cancer of the immune system called Anaplastic Large Cell Lymphoma (ALCL) caused by breast implants.  Many other countries had already banned this type of Allergan textured breast implant, but the FDA had previously stated that such a ban was premature.  However, it was inevitable that either the company would voluntarily decide to withdraw them from the market to protect from lawsuits, or the FDA would persuade Allergan to do so.  It is a little surprising that the FDA is taking credit for the recall, since most recalls of medical devices are described by the companies as voluntary.

“When women decide to get breast implants for reconstruction after mastectomy or for breast augmentation, they should not be putting their lives at risk for lymphoma.  This recall will reduce that risk but it won’t eliminate it.”

For more information, see the FDA’s Press Release here.