Category Archives: Have Questions?

I Had Breast Augmentation With Implants. Will Insurance Cover My Breast Implant Removal?

 

Insurance Coverage Information for Breast Implant Removal

The comments and statements of the National Center for Health Research are believed and intended to be accurate, and where applicable, based on scientific literature. NCHR’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 continue our work (see http://breastimplantinfo.org/donations/ )

Are “Gummy Bear” Breast Implants the Safer Implants?


“Gummy bear” implants are silicone gel implants with a thicker,more cohesive gel that has the consistency of a gummy bear candy. Initially, these implants were thought to be safer than other breast implants because the more cohesive gel made them less likely to break or leak.

However, research now shows that gummy bear implants are probably not safer than other breast implants.  For example, one 5-year study by the implant company found the rupture rate of gummy bears in first-time augmentation patients was over 4%, and the percentage of women needing additional surgeries within 5 years ranged from 17% to 48%, depending on whether the patient was getting augmentation or reconstruction after mastectomy, and whether the gummy bear implants replaced previous implants.

Like other silicone gel implants, gummy bear implants may rupture without any obvious symptoms (called silent rupture). Because most women don’t notice when a silicone gel implant ruptures, the FDA recommends that women have a breast MRI 3 years after getting breast implants. After that, a woman should have a breast MRI every other year to check for a rupture or leak.

When a medical device causes a problem in a patient, the doctor, nurse, or patient can voluntarily report it to the FDA.  It can be reported online as an “adverse event report” here.  From January 1, 2008, through June 30, 2017, 19% of all adverse event reports made to the FDA for silicone breast implants involved gummy bear implants. That is a very high percentage when you keep in mind that gummy bear implants were relatively rare in the U.S. prior to 2012.  In other words, gummy bear implants are causing problems after just a few years – perhaps even sooner than other breast implants.

NCHR’s President, Dr. Diana Zuckerman, along with colleagues Madris Tomes and Amelia Murphy, wrote a book chapter about breast implants. Read a summary of the book chapter here. Copies of the entire book chapter are available upon request at info@breastimplantinfo.org.

Why are celebrities removing their breast implants?

Amelia Murphy

Celebrities who removed their breast implants

Every now and then, a new celebrity is in the news after announcing her decision to remove her breast implants. They speak out about the importance of loving yourself the way you are, they post some Instagram pictures of “the new me,” and the public eagerly reads the related articles in tabloid magazines.

But most of these women aren’t just talking about body image; they are getting their implants removed because of their health. Breast implants can make some women so sick that removal is their best hope for feeling like themselves again.  Several celebrities are trying to spread this information to the general public.

crystal_hefner_2014Crystal Hefner, Hugh Hefner’s wife, opened up about her breast implant horror story on Facebook. She announced her implants had been slowly poisoning her and causing unexplained back pain, cognitive problems, constant neck and shoulder pain, recurring infections, and many other symptoms. Once she removed her breast implants, she instantly felt an improvement and continues to feel better. [Read more about her story in this Forbes article]

Yolanda Foster, of Real Housewives fame, removed her breast implants when she found out her silicone implants had ruptured and were leaking into her body. The silicone was making the symptoms of her Lyme disease even worse. She felt much better once she removed her implants.

Linda Blair, actress in the horror movie The Exorcist, described her experience with breast implants as a nightmare. After removing her implants, she advocated for the FDA to make sure breast implants are actually studied to be safe.

Mary McDonough, a child star in The Waltons who appeared as an adult in shows such as ER and Will and Grace, attributes her autoimmune disease (lupus) to her breast implants. She was healthy before getting implants, and it was only after her implants were removed that she immediately started to feel better. She has been one of the most outspoken celebrities on the risks of breast implants.

Karen McDougal is a former Playboy Playmate and current model who made the decision to have her implants removed after months of feeling sick. She has spoken out about the risks of breast implants in USA Today and People Magazine.

Mariel Hemingway, Sharon Osbourne, and Stevie Nicks are just a few of the other celebrities who chose to remove their breast implants because of serious health problems.

Celebrities are bringing attention to the health problems that thousands of women with implants have suffered from for decades.

First, a little history:

Women have been getting breast implants since the 1960’s, and although silicone gel implants were drastically restricted for many years during the mid-1990’s through 2005 because of safety concerns, the FDA approved them again in 2006 based on short-term studies done by breast implant manufacturers. FDA also required the manufacturers to do larger, longer-term studies after that, in order to make sure they were safe (these are called post-market studies).

These longer-term studies had a lot of problems, and most women did not stay in the studies long enough to provide useful scientific information.  However, studies have shown that the longer women have silicone breast implants, the more likely they are to experience problems with them.  FDA reported that the studies found that as many as 1 out of every 5 women who get silicone breast implants for cosmetic reasons need to remove their implants within 10 years.[1] This number rises to 1 out of every 2 women if they got reconstruction after a mastectomy.[1]  Were the women who dropped out of the studies the ones that were more likely to have health problems, or less likely?  You can read more about the unanswered questions from these studies here.

Breast implants were approved by the FDA even though research showed that between 15% and 20% of first-time augmentation patients will need additional surgery to fix implant problems within 3 years, whether the implants are filled with silicone gel or saline. [2][3] The chances of needing additional surgery increases as time goes on — 28% of women are on the second set of implants after 3 years, and this number doubles when the women have their implants for 6 years. The percentage is even higher than that for mastectomy patients whose implants were for reconstruction.

What usually goes wrong?

  • Rupture: All breast implants will eventually break, sometimes within a few months or years, and usually within 10 years.
  • Capsular Contracture: This is when the breasts get firm, then hard, and they can be very painful. Breast implants are a “foreign body” and the natural response for most women is that their body forms scar tissue around the implant, inside their body, to protect their body from this “foreign invader.”  This is a natural process. However, it’s called capsular contracture when the scar tissue tightens or hardens around the implants and causes abnormal firmness, hardness, or pain.
  • Pain: Besides pain caused from capsular contracture (see above), breast implants can cause back, neck, and shoulder pain because of their weight. Leaking silicone gel can also cause a painful burning sensation.
  • Anaplastic Large Cell Lymphoma (ALCL): This is a rare kind of cancer of the immune system that is more likely to occur in women with breast implants. [4] If diagnosed early, removing the implants can cure the disease.
  • Autoimmune issues:  Experts disagree on whether breast implants cause specific autoimmune diseases.  However, the fact that implants can cause cancer of the immune system (ALCL) certainly makes it more likely that implants can cause other autoimmune problems.  FDA scientists found that women with ruptured and leaking silicone gel breast implants were more likely to have fibromyalgia, a painful autoimmune disease.[5]  Many women have reported suffering from autoimmune symptoms such as joint pain, hair loss, dry eyes, or mental confusion after getting breast implants, and have also reported that these symptoms often improve or disappear after removing the implants. One study even showed the autoimmune symptoms got better for 3 out of 4 women after they removed their implants.[6]
  • Constant flu-like symptoms: Many women report feeling constantly tired or like they’re trying to get over the flu.
  • Learn more about complications from breast implants in FDA’s consumer handbook.

Besides health problems, some celebrities decide to remove their implants simply because they were annoying or embarrassing. Just to name a few, Heather Morris, Heidi Montag, Pamela Anderson, Victoria Beckham, and Jane Fonda all removed their implants for this reason.

Plastic surgeons refer to breast augmentation as a very simple surgical procedure, and as a result many people think of breast implants as an insignificant surgery with few health risks.  Hearing about celebrities who removed their breast implants sometimes makes women think twice about getting them in the first place.  It helps remind all of us to do careful research before making any decision about putting something inside your body.

ALCL Update: In March 2017, the U.S. Food and Drug Administration (FDA) updated its website to report that breast implants could cause a type of cancer of the immune system called Anaplastic Large-Cell Lymphoma (ALCL). No celebrities have reported ALCL from their implants.

Are you considering breast implants? Find out more information here.

Are you thinking about removing your breast implants? Find out more information here.

—–

[1] FDA Update on the Safety of Silicone Gel-Filled Breast Implants. Center for Devices and Radiological Health U.S. Food and Drug Administration. Page 7. June 2011

[2] Important Information for Augmentation Patients About Mentor MemoryGel™ Silicone Gel-Filled Breast Implants, Mentor. (FDA Patient Brochure) November 2006. Pages 25-27. http://www.accessdata.fda.gov/cdrh_docs/pdf3/p030053d.pdf

[3] Making An Informed Decision Saline-Filled Breast Implant Surgery, Inamed. 2004 Update. Pages 24, 32. http://www.fda.gov/downloads/medicaldevices/productsandmedicalprocedures/implantsandprosthetics/breastimplants/ucm064457.pdf

[4] Miranda et al. Breast Implant–Associated Anaplastic Large-Cell Lymphoma: Long-Term Follow-Up of 60 Patients. Journal of Clinical Oncology. Volume 32, Number 2. January 10 2014.

[5]  Brown SL, Pennello G, Berg WA, et al. Silicone Gel Breast Implant Rupture, Extracapsular Silicone, and Health Status in a Population of Women. J Rheumatology. 2001; 28:996-1003.

[6] de Boer M, Colaris M, van der Hulst RRWJ, Cohen Tervaert JW. Is explantation of silicone breast implants useful in patients with complaints? Immunologic Research. July 2016 DOI: 10.1007/s12026-016-8813-y\

What if I Need to Get My Implants Removed?

 


If you want or need to get your implants removed, it is usually best will to choose a board-certified plastic surgeon. Choosing a plastic surgeon to perform your explant surgery requires careful consideration because removal is a more complicated procedure than placing implants.

If you are having any problems with your breast implants, it is especially important to find a surgeon who can remove your implants with great skill. Your surgeon needs to be able to minimize any leakage or other potential problems resulting from the surgery. For more information on finding an experienced plastic surgeon to remove your breast implants, click here.

You may also want to know if insurance will cover the costs of removal. Insurance companies cover services that they determine to be “medically necessary” to treat a disease or illness.  

Many companies consider removal of breast implants medically necessary for patients with any of the following conditions:

You can learn more about trying to get insurance coverage for your breast implant removal here.

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

My Implants Are Making Me Sick. Can Someone Help Pay for Implant Removal?


Health Insurance (and Medicare and Medicaid)

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.

Many companies consider removal of breast implants medically necessary for patients with any of these conditions:

Unfortunately, insurance companies generally won’t cover the cost of breast implant removal for autoimmune or connective tissue diseases or other systemic complications.

Obtaining coverage for your implant removal differs depending on the type of insurance you have. Medicare and Medicaid also cover implant removal that they consider medically necessary. To learn more about trying to get insurance coverage for removal, click here.

Legal Action

Currently, there are no open class action lawsuits relating to implants. Because most women getting implants are asked to sign informed consent documents prior to their surgery, it has become very difficult for lawsuits to proceed. Recently, however, the number of individual lawsuits against breast implant makers has increased. If you believe you may have a claim against an implant manufacturer, you may want to speak to a lawyer who has experience with this type of case.

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

I’m a Teenager Considering Breast Implants. What Should I Know to Help Me Decide?


Here are a few things to consider as you are making a decision about getting breast implants:

  • Teenagers are not finished developing. Breasts can develop during the late teens and early 20s. Implants could interfere with your normal development, or the resulting size and shape could be not at all what was intended as the breasts continue to develop.
  • The body you wish you had in your teens might not the body you’re going to want in your 20s. 
  • Teenagers are often self-conscious about how they look. It’s never good enough! The odds are that you will feel a lot better about your body just a couple of years later, even without any cosmetic surgery. In fact, women who have breast implants tend to feel worse about themselves. You can read more here.
  • Some women do fine with breast implants while others have complications or health problems that can make them so sick that they call implants “the worst decision I ever made.” Before you decide, make sure you understand the risks and complications of breast implants.

Click here to read about a woman who got her implants when she was young and what she thinks about them today. Click here to read other brief stories written by women who have had breast implants.

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

After Years of Being Unhappy with My Breasts, I Am Thinking of Getting Breast Implants. I Am Healthy and Want to Stay That Way. What Are the Risks?

Q. After years of being unhappy with my breasts, I am thinking of getting breast implants. I am healthy and want to stay that way. What are the risks?

A. I’m not a doctor and we don’t provide medical advice, but I can tell you what we know based on research and from speaking with many experts and with women who have had breast implants.

Breast augmentation surgery has risks, but the risks are much greater for some women than others. According to implant makers’ patient booklets, implants are not recommended for women with any of the following:

• Active infection anywhere in your body

• Autoimmune diseases (such as arthritis, lupus and scleroderma). (If family members have these diseases, that can put you at higher risk also)

• Conditions that interfere with wound healing and blood clotting

• A weakened immune system (such as currently receiving immunosuppressive therapy)

Women who have breast cancer in their family are often concerned when they learn that implants can hide cancerous tumors. Saline and silicone breast implants show up as solid white shapes on a mammogram, hiding any tumors above or below. The latest research finds that half of the breast tissue (and half of the tumors) are obscured by breast implants, even when specially trained technicians use additional mammogram views for women with implants.

Even younger women have found that their implants interfere with an early diagnosis. Survivor star Jennifer Lyon died of breast cancer at age 37 in early 2010. According to Jennifer, in 2004 “I felt something in my right breast that didn’t feel normal. I thought it was probably scar tissue related to my breast implants. So I let it go — for a long time.” Jennifer was diagnosed with late-stage breast cancer two months after the tenth season of ‘Survivor’ wrapped in 2005.

All breast implants, silicone or saline, have high complication rates. Research conducted by implant manufacturers and analyzed by the FDA finds that most women have at least one serious complication within the first 3 years. Two of the most common are capsular contracture (which causes breast hardness and pain) and the need for additional surgery.

Most women like the way the implants look and feel for the first few years, but after that many find their implants look less natural or start to feel too firm or hard, and can be very painful. If an implant breaks or causes pain, surgery is necessary – but we hear from many women who can’t afford to pay to have their implants surgically removed. Unfortunately, surgery to fix implant problems can cost more than the augmentation itself. That is why we urge women not to have augmentation surgery unless they have at least an extra $5,000 in savings that they can put away and not spend until they need additional surgery.

The biggest controversy about breast implants is whether they can cause diseases or symptoms that are not in the breast area. We have talked to many implant patients who describe “flu-like” symptoms, or their joints hurt, or their hair started falling out. That’s what happened to Kacey Long, who was featured in Parade Magazine and on MTV’s I Want a Famous Face. Kacey was 19 when she got implants and 21 when she had them removed. She got arthritis and could barely get out of bed, but didn’t think it was related to her implants. However, when her implants were removed she immediately started to feel better.

You can get more information about what to expect if you get implants by checking out our website at http://www.breastimplantinfo.org/before-you-get-implants/.

You can also read some more personal stories of women who have had implants, including Kacey’s story, on our website at http://www.breastimplantinfo.org/personal-stories/ and you can look at some photos of common implant problems at http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/ImplantsandProsthetics/BreastImplants/ucm064106.htm.

When studies include women who have implants for just a few months or years, the women seem quite healthy. However, one study by NIH scientists found that women with breast implants for at least 12 years were twice as likely to die of brain cancer, lung cancer, or suicide, compared to other plastic surgery patients. A Canadian study found that women with breast implants were more likely to be hospitalized in the years following their augmentation surgery, than women who did not have breast augmentation.

Of course, many things in life have risks, and only you can decide what risks you are willing to take. Some women are happy with their implants, but we know many who wish they had never made that choice.

We hope this information has been helpful.

The comments and statements of the National Center for Health Research are believed and intended to be accurate, and where applicable, based on scientific literature. NCHR’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 continue our work (see http://breastimplantinfo.org/donations/)

My Silicone Gel Breast Implant May Be Leaking. How Do I Find Out if It Is Leaking, and What Should I Do if It Is?


If your silicone gel implant ruptures, you might – or might not – notice a change in the size or shape of your breast. Or you might feel pain or tenderness, swelling, numbness, burning, or tingling. However, you might not have any symptoms, and might not realize that your implant is broken and possibly leaking. This can be harmful to your health, and the longer the implant is leaking in your body, the more harm it can cause.

The best way to know whether your silicone breast implant has ruptured or is leaking is to have an MRI with a breast coil. Unfortunately, MRIs are expensive and MRIs to check for implant rupture may not be covered by insurance.

Because most women don’t realize that a silicone gel implant has ruptured, the FDA recommends having a breast MRI three years after getting breast implants. After that, a breast MRI should be done every other year to check for a rupture.  That way any leaks can be caught early, helping to protect your health.

A mammogram is not usually an accurate way to diagnose a ruptured silicone-gel breast implant. In addition, the pressure from mammography could cause the implant to break and could cause a broken implant to leak.

If even one of your silicone gel implants is ruptured, it should be removed as soon as possible. The longer the silicone is leaking into your body, the more time it has to migrate to your other organs, such as your lungs or liver, or even your brain. When that happens, the silicone can be impossible to remove.

To read more about breast implant ruptures or leakage, click here. To read more about removing ruptured breast implants, click here.

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

My Saline Breast Implant Deflated. What Should I Do?

Q. My saline breast implant deflated. What should I do?

A. We’re not doctors and we don’t provide medical advice, but I can tell you what we know based on research and from speaking with many experts and with women who have had breast implants.

Once a saline breast implant has deflated, it can not be refilled. If your implants have not caused any health problems before they deflate, ruptured saline implants are relatively safe if there is no mold, bacteria, or fungus. If any of these are present, you will probably notice symptoms of infection or allergic-type symptoms.

If your implants are more than a few years old, it makes sense to remove both implants at the same time, even if only one of them has ruptured. The cost of implant removal, with or without replacement, is very similar whether it involves one implant or two. As implants get older it becomes more and more likely that they will rupture. Rather than have two surgeries, it makes sense to remove (and if you want to replace) both implants together.

Many plastic surgeons are reluctant to remove an implant without replacing it because they are concerned that the patient will be very unhappy with their appearance after the implant is removed. The breast tissue stretches from the implant, and if the surgeon is not skilled in explantation without replacement, the breast is unlikely to be as attractive as it was before the implant surgery. However, after implants are removed by an experienced explant surgeon, many women are very pleased with the way their breasts look and feel. You can read some of their stories on the www.explantation.com website.

Whether or not you decide to replace your implants, you need a plastic surgeon that you are confident will do a great job. Removal can be much more complicated and expensive than the original surgery. Some plastic surgeons are very experienced at removal and are especially skilled at getting the best possible cosmetic result. The surgeon you choose should be board certified and should be willing to show you pictures of many patients’ post-explantation results, or better still, offer to have former patients talk to you. Find out if they were happy with their doctor and with their results.

The comments and statements of the National Center for Health Research are believed and intended to be accurate, and where applicable, based on scientific literature. NCHR’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 continue our work (see http://breastimplantinfo.org/donations/)

I Am Wondering if Some of My Health Problems Are Caused by My Breast Implants

Q. I am wondering if some of my health problems are caused by my breast implants.

A. We’re not doctors and we don’t provide medical advice, but I can tell you what we know based on research and from speaking with many experts and with women who have had breast implants.

In testimony before the FDA, women with implants have described symptoms such as joint pain, chronic fatigue, mental confusion, hair loss, and flu-like symptoms. These are considered to be auto-immune symptoms, and according to the FDA, some of these symptoms are more common for women two years after getting silicone gel breast implants than they are before the women got breast implants. Those findings are based on the FDA’s analysis of women with silicone gel breast implants, and were made public on April 12-13, 2005 at a public meeting of the FDA advisory panel on breast implants.

All breast implants, even saline implants, are enveloped in an outer shell made of silicone. The envelope also contains other chemicals and some heavy metals, such as microscopic amounts of platinum or tin, which vary during the manufacturing process. Unfortunately, some women have a negative reaction to those substances. Although silicone is considered “biocompatible” and most people don’t have an allergic or autoimmune response, some people do. (Just as some people have an allergic response to peanuts or bee stings).

Any woman could potentially have a bad reaction to silicone or other substances in breast implants. However, the risks are higher for some women than others. Implant makers warn women with certain medical histories in their family or who have specific medical conditions that breast implants could be especially risky for them. Women who have family members with autoimmune diseases such as arthritis, MS, or lupus are one of the examples. Here is their exact language, located on the FDA website: http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/ImplantsandProsthetics/BreastImplants/ucm063743.htm.

In a study of women who had breast implants for at least 7 years, FDA scientists found that women with leaking silicone gel breast implants were more likely to have fibromyalgia and other painful diseases than women with implants that were not leaking. Symptoms of fibromyalgia include pain and chronic fatigue. The FDA study was the first and most well-designed study evaluating the health effects of leaking silicone breast implants. Unfortunately, not all plastic surgeons are aware of the study, which is described in more detail on our website http://www.breastimplantinfo.org/what-you-need-to-know/ and the FDA website http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/MedicalDevices/MedicalDevicesAdvisoryCommittee/GeneralandPlasticSurgeryDevicesPanel/UCM269672.pdf.

The good news is that research shows that many women with breast implants and rheumatologic pain and symptoms find that their health improves dramatically after their implants are removed and not replaced. Dr. Frank Vasey from the University of South Florida and Dr. Noreen Aziz, a scientist at National Cancer Institute, found that most women with pain, fatigue, and other rheumatology symptoms felt better after their silicone implants were removed and not replaced. Many symptoms lessened or disappeared over the next few months. In contrast, most women who did not have their implants removed became even more ill. Those who had their implants removed and replaced with saline usually did not get better either.

You might have read about Kacey Long, who was featured in Parade Magazine, People, and on MTV’s I Want a Famous Face. Kacey was 19 when she got saline breast implants and 21 when she had them removed. She got sick very quickly, but didn’t realize her health problems were related to her implants. She started spending all her time in bed, and was in too much pain to even comb her hair. However, when her implants were removed she immediately started to feel better.

For examples of women who had similar symptoms and felt better after their implants were removed, see the personal stories on our website at http://www.breastimplantinfo.org/personal-stories/.

If the symptoms the other women describe sound like you, you may want to consider having your implants removed. If you have silicone gel breast implants that are broken, it is important to have them removed as soon as possible. For more information about that, read the other FAQs.

The comments and statements of the National Center for Health Research are believed and intended to be accurate, and where applicable, based on scientific literature. NCHR’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 continue our work (see http://breastimplantinfo.org/donations/)