Category Archives: Breast Cancer

Compounded Bioidentical Hormone Therapy

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

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)?

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


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

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


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.

Breast Reconstruction Options After Mastectomy


Many breast surgeons and breast cancer patients believe that breast reconstruction is an important step in recovering physically and mentally from a mastectomy.  Research shows that women who undergo flap procedures (described below) have a better quality of life after reconstruction than women undergoing reconstruction with breast implants.1

However, not all women are able to undergo those procedures.  Unfortunately, many patients are not given complete information about the different options for breast reconstruction, including the risks and benefits of each.  In fact, a 2017 study showed that only 43% of mastectomy patients received the information and counseling necessary to make an informed decision regarding their reconstruction choice.2

The Women’s Health and Cancer Rights Act of 1998 is a law that requires that private insurance companies pay for breast reconstruction if they pay for mastectomies.  This includes reconstruction on the removed breast, modification of the other breast to create a symmetric appearance, and treatment of any complications that result from a mastectomy or reconstruction.  The forms of reconstruction covered may vary by state and insurance provider, so it is important that you call your insurance provider to see which options will be covered in your particular case.3

This article does not provide medical advice, but we provide information based on scientific research and from speaking to many experts in the field.  We recommend discussing your treatment options with a physician whom you trust.  As a patient, you have the right to seek more than one medical opinion.

Which Type of Breast Reconstruction is Best?

The decision of which reconstruction option to choose, if any, is a personal one.  To make an informed choice, however, patients need to meet with breast surgeons who are skilled at the different options.  Since most breast surgeons only know how to do reconstruction with breast implants, they don’t usually provide good information to their patients about the benefits of other options.

There are several studies which look at the long-term outcomes for each of the reconstruction options, and these can help patients to make a decision.

For example, a study published in 2018 analyzed over 2000 reconstruction patients and found that patients who undergo autologous breast reconstruction (“flap” procedures) are generally more satisfied in the long-term than women who choose reconstruction with breast implants.  After two years, patients who chose to get flap procedures reported having a better quality of life than patients who got breast implants.  Some of the areas in which the flap patients reported greater satisfaction include their psychosocial, physical, and sexual well-being.4

The researchers also found differences in surgery-related complications within the first 2 years after surgery.  Flap procedures have significantly higher rates of short-term surgery-related complications that occur immediately following surgery.  In contrast, breast implants have more surgery-related complications that occur weeks or months after the surgery is completed. 5 In addition, women are likely to need multiple surgeries to replace implants over their lifetime.6

A description of the options for reconstruction is below.

Reconstruction with Breast Implants

Breast implants are the most common form of breast reconstruction after mastectomy.  7 This is probably because breast implants are the easiest form of reconstruction and most plastic surgeons are not skilled enough to perform the other types of breast reconstruction discussed below.  There are silicone gel breast implants and saline breast implants on the market, and both options have a high complication rate for reconstruction patients.  You will probably be told that breast implants are not lifetime devices, but that’s an understatement.  Studies by researchers and by implant manufacturers have shown that after three years, most reconstruction patients will have at least one serious complication.8,9

Below are some of the most common complications of breast implants.

In addition, women who have breast implants, either for mastectomy or healthy breasts, are more likely to develop a type of lymphoma (cancer of the immune system) called ALCL.17

You can read more about risks and complications related to breast implants here and more about the different types of breast implants here.  Despite the risks, some women get implants because they are not good candidates for other types of breast reconstruction.  Women who are very thin or very physically active, have poor veins, or who may become pregnant in the near future may not be good candidates for other reconstruction options.

Reconstruction with Autologous Tissue Transfer (Flap Procedures)

Autologous tissue transfer (also known as a flap or flap procedure) refers to any procedure in which the body’s own tissue is used to reconstruct breasts.  Surgeons take fat and other tissue from another part of a woman’s body and move it to create breasts.  Sometimes, implants are used along with the tissue transfer to create larger breasts.  When implants are used with flap procedures, the risk for complications is higher than for either procedure alone.  For that reason, it makes sense to choose either flap reconstruction or implants but not both.

There are various types of autologous tissue transfer as described below.

Flap Reconstruction with Muscle and Fat

In this procedure, surgeons take muscle and fat from other areas of the body and move it to the breast area.  The most common form of this procedure is the TRAM flap, which uses muscle and fat from the abdomen.  While using stomach muscle is typical, surgeons can also take muscle from the inner thigh or buttocks.  Reconstruction methods using fat and muscle create a more natural looking reconstruction than those using only fat due to their added firmness.   Also, the larger amount of tissue used during muscle and fat reconstructions enables the surgeon to create larger breasts than those with fat only.  A drawback to this type of surgery is its complexity.  Veins and arteries must be reattached to the muscle and fat, so this surgery requires an experienced vascular surgeon.  Even with a good surgeon, this surgery isn’t 100% successful.  However, if it is successful, these reconstructed breasts can last a lifetime.   But, if muscle is removed from the abdomen, the women will not have as much strength there as they did before.18

Flap Reconstruction with Fat Only

Some reconstructions are performed using only fat.  The most common form of this is the DIEP flap, which takes skin, vessels, and fat from the abdomen but spares the muscles.  Surgeons can take tissue from most areas of the body that have a large fat supply.19 Reconstruction with only fat takes more time than other procedures because the tissue has to be harvested and removed from the body before the reconstruction can take place.20 To be a good candidate for this procedure, women need more body fat to create the breast.  This means that women with low body fat or poor vascularity may not be good candidates for this surgery.  The difficulty of this form of reconstruction are similar to those of reconstructions done with muscle and fat.  However, since no muscle is used, patients should not expect to permanently lose strength in any part of their body.21

Reconstruction with the Latissimus Dorsi

This surgery, commonly known as Lat flap, uses the latissimus dorsi muscle to reconstruct breasts.  The latissimus dorsi is a muscle of the upper back that extends around the side of the body. This procedure is more likely to fail than some other flap procedures, but less likely to have surgery-related complications or need reoperations within the first two years.22

Lat flap can be performed on women who do not have enough body fat for other forms of autologous reconstruction, and is frequently used with breast implants.  Some surgeons prefer it because the only visible scar will be from the mastectomy, and because the muscle can remain attached to its original blood source, which lowers the chance of the tissue dying after transfer.  However, since the latissimus dorsi is a large and important back muscle, the procedure can lead to serious difficulties moving, lifting, or performing strenuous exercise.  Patients who choose this option can also expect to get fatigued more easily.23

It’s Your Choice

As you can see from the research above, flap procedures are a very good choice for women who want a lifetime solution that avoids the complications typical of breast implants, and the possible risk of developing lymphoma.  However, fewer doctors perform flap procedures.  They are also longer and more complicated surgeries than reconstruction using breast implants.  For this reason, it is extremely important that women choosing a flap procedure go to a surgeon who is very experienced in autologous reconstruction.

When making a reconstruction decision, it is important for each woman to weigh the risks and benefits of each procedure with a doctor that is capable of these different options, so that she can make a decision that is right for her.

We hope this information is helpful. For more information, check out http://www.breastimplantinfo.org or feel free to write to us at info@center4research.org / info@stopcancerfund.org

The comments and statements of the National Research Center for Women & Families are believed and intended to be accurate, and where applicable, based on scientific literature. NRC’s statements do not constitute medical diagnoses, medical advice, plans of treatment, or legal opinion, and we are not responsible for the use or application of this information. All medical information should be reviewed with your health care practitioner.

We hope that the information we’ve provided is helpful. In order to maintain this free service to all women and their families, we invite your tax-deductible contributions to NRC (see http://www.center4research.org/contribute/ )

Patient Satisfaction After Breast Reconstruction with Implants Compared to Flap Procedures

 

For many women, breast reconstruction can be an important step in recovering physically and mentally after a mastectomy.  However, research shows less than half of mastectomy patients received the information and counseling necessary to make an informed decision regarding their reconstruction choice.

A 2018 study by Katherine Santosa and her colleagues found that patients who undergo autologous breast reconstruction (also called “flap” procedures), are generally more satisfied in the long-term than women who choose reconstruction with breast implants.  The study included 2,013 patients, 74% of whom got breast implants and 26% of whom had autologous reconstruction. Autologous tissue transfer refers to any procedure in which the body’s own tissue is used to reconstruct breasts. Surgeons take fat and other tissue from another part of a woman’s body, usually the abdomen, and move it to create breasts.

The researchers surveyed women on their quality of life 90 days before their mastectomy, and at 1, 2, 3, and 4 years after reconstruction. The survey included questions on four topics: Patients’ satisfaction with their breasts, emotional and social well-being, sexual well-being, and physical well-being. In the satisfaction with breasts category, women were asked questions about their breasts appearance, their satisfaction with breasts and how bras fit, and how the breasts feel to the touch. To understand women’s emotional and social well-being, researchers asked questions about body image and a woman’s confidence in social settings. Women were also asked about their sexual well-being, including questions about feelings of sexual attractiveness, sexual confidence, and comfort level during sex. Lastly, researchers asked women about their physical well-being, including information about pain, tightness, and any physical difficulty with performing daily activities.

Patients who chose autologous reconstruction reported higher satisfaction with their breasts than those who got breast implants. The women who had autologous reconstruction also reported greater emotional and social well-being and sexual well-being compared to before reconstruction. In contrast, patients who got breast implants reported worsened sexual well-being compared to before reconstruction.

The information from this study can provide useful information to patients and their doctors about patients’ likely quality of life following breast reconstruction with autologous or “flap” procedures compared to breast implants.

You can read a summary of the original article here.

Reference:

  1. Santosa, Katherine B et al. Long-term Patient-Reported Outcomes in Postmastectomy Breast Reconstruction. JAMA Surgery. 2018; 153(10): 891 – 899.

Summary of Published Study by MD Anderson Physicians on the Increase in Rare Diseases Among Women with Breast Implants

National Center for Health Research: September 17, 2018.


A study published in September 2018 in the medical journal Annals of Surgery, entitled US FDA Breast Implant Postapproval Studies: Long-term Outcomes in 99,993 Patients, concluded that “silicone implants are associated with an increased risk of certain rare harms” and that further study is needed “to inform patient and surgeon decision-making.” Also, the study was published on social networks and became more visible with many subscribers and comments which were provided by The Marketing Heaven. The study is important because it is largest study to date, but it has limitations because it is based on data from flawed studies conducted by two implant companies, Mentor and Allergan.

The data collected from the two studies were supposed to be very similar, but because of how poorly the studies were conducted, they are not comparable.  Mentor’s data are focused on patients’ self-reporting on questionnaires, primarily on data of only 20% of the patients collected 7 years after the study was started. Allergan’s data are based on physicians’ diagnoses during the first two years after the patients had implant surgery.  Since patients’ self-reports at 7 years would be expected to include more complications than physicians’ diagnoses after 2 years, it is impossible to make meaningful comparisons between the two manufacturers. Nevertheless, it is important to note that the MD Anderson researchers found that the risks of certain autoimmune diseases increased by 800% (Sjogren syndrome), 700% (scleroderma), and 600% (arthritis) for the women with Mentor silicone gel breast implants compared to the general population of women of the same age and demographics.  Stillbirths increased by 450% in the women who became pregnant.  Other autoimmune and rare diseases were also significantly higher among women with Mentor silicone gel implants.  These diagnoses were also statistically significantly higher (although not as dramatically increased) for women with Allergan implants compared to the general population of women of similar demographics. Given the large percentage of women who were not in the study for more than 1 year, it is not possible to know how representative these findings are. However, these results certainly deserve careful attention.

It is also important to note that the women with saline breast implants who were in the Mentor and Allergan studies were not analyzed in the MD Anderson study.

FDA Response

In response to this important study, Dr. Binita Ashar of the FDA published an editorial in the same issue of the same medical journal, claiming that the MD Anderson study “failed to account for methodologic differences between studies, inconsistencies in the data, differential loss to follow-up, confound and other potential sources of bias.”  That is true.  However, Dr. Ashar did not mention that the FDA should take responsibility for all the shortcomings of the data that MD Anderson analyzed.  She did not mention that the flawed data were based on studies that were required by the FDA as a condition of approval for the breast implants made by Allergan and Mentor.  The data were flawed because women soon disappeared from the study, and the FDA did not require the companies to finish the studies, as they should have,

As a result of the FDA’s failure to enforce the study requirements, the large Allergan and Mentor studies used as the basis of the MD Anderson analyses were very flawed short-term studies rather than the 10-year studies that FDA had proudly said they were requiring.  Whereas the companies blamed the study shortcomings on the enormous number of women who “dropped out” of the study shortly after enrolling (including 80% of the women with Mentor implants after only 1 year), we have interviewed women who were enrolled in those studies who told us that they did not drop out of the studies – rather they were “dropped” from the study by the researchers without their consent.  They never heard from the researchers and hence had no opportunity to tell the researchers how sick they had become after getting breast implants.   Instead, several of those women went to the FDA this month to explain to FDA scientists what happened.  They told Dr. Ashar and other FDA officials that they were dropped from the studies.  They told Dr. Ashar and other FDA officials that they had suffered from autoimmune and connective tissue symptoms such as the ones reported in the MD Anderson study.  They told Dr. Ashar and the other FDA officials that despite being sick for years, they were unaware that breast implants could be the cause because neither the FDA nor their plastic surgeons had warned them of the risks.  When they finally found each other on social media (on Facebook pages joined by more than 50,000 women harmed by breast implants), they realized that removing their implants might help.  Much to their surprise, they experienced almost miraculous recoveries after their implants were removed by experienced explant surgeons.   The women told Dr. Ashar and other FDA officials that their symptoms disappeared entirely or improved by 85%.

The FDA editorial was written before Dr. Ashar met with the former implant patients this month, but she had previously met with several of the same women who had reported these same problems and recoveries after explant surgery.  So it is very discouraging that FDA staff have been and continue to be so close-minded about the risk of breast implants despite the MD Anderson analyses.

What Have we Learned from the MD Anderson Study?

We agree with the FDA and the MD Anderson researchers that these results can’t be considered conclusive, but the FDA needs to look at the data more carefully and require better studies so that they can reconsider their repeated claim that breast implants are only proven to cause local complications, such as leaking and painful implants.  Although the FDA admits that breast implants can cause a cancer of the immune system known as ALCL, they continue to quote industry-funded studies claiming that implants do not cause other systemic illnesses.  It should be obvious to open-minded scientists that if breast implants can cause cancer of the immune system, they can probably cause other serious immune system diseases and symptoms.  Moreover, the results of the MD Anderson study supports those concerns about autoimmune symptoms and diseases.

What should be the key information of importance to women considering breast implants or women who have them in their bodies? Clearly, these studies indicate that patients should report any new symptoms that develop after getting their implants, whether involving their breasts or other parts of their body.  Breast implant patients should know that the FDA recommends MRI imaging of silicone breast implants 3 years after the augmentation or reconstructive surgery and every 2 years thereafter.

  

Statement of Dr. Diana Zuckerman, President of the National Center for Health Research Regarding the New Study of 100,000 Women with Breast Implants

Dr. Diana Zuckerman, President of the NCHR: September 17, 2018.


In the largest study ever conducted of long-term health risks for patients with breast implants, researchers at The University of Texas MD Anderson Cancer Center have reported that women with silicone implants are more likely to be diagnosed with several rare diseases, autoimmune disorders, and other conditions.  These results are consistent with numerous previously published studies, but contradict the conclusions of studies funded by implant manufacturers or plastic surgery medical societies.

The study, published in the medical journal Annals of Surgery, is by researchers in MD Anderson’s Department of Plastic Surgery and is based on analyses of almost 100,000 patients with either saline or silicone implants. The information was derived from the FDA’s database dating back to 2005.  When the FDA approved silicone gel breast implants made by two manufacturers in 2006, the agency required that each of the manufacturers study at least 40,000 women for 10 years.  Those studies were started but never completed, making it impossible to determine the long-term risks of breast implants.  In the absence of such crucial studies, patients report that they were not warned about the risks when they decided to get breast implants.

We thank Mark W. Clemens, M.D., associate professor, Plastic Surgery, the senior investigator of this very important study.  The findings are consistent with what thousands of women with breast implants have reported in Facebook groups and other social media, and directly challenge the FDA’s claims that breast implants do not cause such diseases.  We urge the FDA to be more patient-centered and finally require independent studies be conducted of women before and after their breast implants are removed.  Many women have reported that their debilitating autoimmune symptoms decreased or disappeared after their breast implants were removed, but scientific data is needed to establish the rate of recovery.