Category Archives: Have Questions?

Breast Implants Have Harmed Me. How Can I Report this to the FDA?

 


Breast implants do not last a lifetime and many women report complications that they did not expect. Many women with breast implants experience implant rupture, capsular contracture, breast or body pain, joint pain and other autoimmune symptoms, mental confusion, rashes, and even cancer of the immune system (ALCL). If you have experienced any of these complications, you could help other women by reporting it to the FDA.

The FDA is responsible for protecting patients and consumers by warning them about the risks of medical products, and taking products off the market if the risks outweigh the benefits.  The main way they gather information about the risks of breast implants (and other types of implants) is when doctors, nurses, and patients report problems through the FDA’s Voluntary MedWatch Report. If the FDA sees that complications are more serious or more frequent than expected, we will urge them to require manufacturers to conduct better research or to pull the product from the market.

You can report any problems caused by your breast implants using this short online form.

You don’t need to remember exactly when the symptoms or complications started, but give an estimate of how long it was after you got your implants.  If you don’t know the exact brand or model of your implant, you should report your problems anyway, but include the brand if you can.  From 2000 to 2015, most breast implants in the US were made  by either Mentor or Allergan (also called Inamed or McGhan).

If you are in Canada, you can report medical device complications to Health Canada using this short online form.

If you have problems completing the form, ask for help at info@center4research.org

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?

 


Celebrities who removed their breast implants

Have you noticed how many celebrities are in the news announcing their decisions to remove their breast implants?  They usually talk about the importance of loving yourself the way you are and they often post Instagram pictures of “the new me.”

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 share their experiences in order to help other women.

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, frequent infections, and many other symptoms. After removing her breast implants, she instantly felt an improvement and continues to feel better. Read more about her story here.

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 now a model who had her implants removed after months of feeling sick. She has spoken out about the risks of breast implants in USA Today and People Magazine. This was well before she became known for her relationship with Donald Trump.

Stevie Nicks, the singer/songwriter and former lead singer of Fleetwood Mac, decided to have her implants removed because she believed they were causing extreme fatigue and lethargy.  After removal, Nicks told People Magazine “I’m living proof they aren’t safe. It turned out they were totally broken.”

Nicola Robinson, the Australian model and wife of prominent chef Pete Evans, decided to have her implants removed because she was so ill. Robinson told Australian TV show Sunday Night that “I knew 100 percent that they were making me sick and essentially ageing me. So it just made perfect sense to me that they had to go. There’s just so many advantages to not having two large bags attached to your chest.”

Melissa Gilbert, actress and producer, decided to have her implants removed fearing they would rupture. She told People Magazine, “What am I going to do when I’m in my 80s and I have to have a hip replacement but I also have my breast implants replaced? Because it’s inevitable, they have a life span. So I wanted them out.”

Mariel Hemingway, Kimberly Holland, and Heather Morris are among 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.

So, what usually goes wrong?

You can learn more about the risks and complications associated with breast implants here.

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, and Victoria Beckham all removed their implants for this reason.

If you’re considering getting breast implants, click here for more information.

If you’re considering removing your implants, click here for more information.

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[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.

I Have Been Diagnosed with Breast Cancer. What Are My Options so That I Can Still Have Breasts?


Q. I have been diagnosed with breast cancer. What are my options so that I can still have breasts?

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.

If you have been diagnosed with early stage breast cancer (stage I, IIa, IIb, or IIIa) , you probably can keep your breasts, and have a lumpectomy rather than a mastectomy (which removes the entire breast). Early-stage breast cancer patients who undergo a lumpectomy (which removes only the cancer and a small area around it) that is followed by radiation will live just as long as women who have a mastectomy instead. The experts recommend a lumpectomy with radiation for most women because it is less traumatic physically and emotionally, and avoids the problems from reconstructing a breast. For more information about this, see a booklet printed by the National Cancer Institute, the NIH, AHRQ, and the National Center for Health Research at http://www.stopcancerfund.org/t-breast-cancer/a-booklet-for-patients-surgery-choices-for-women-with-early-stage-breast-cancer/ .

If you have been diagnosed with a pre-cancerous condition such as Stage 0 breast cancer, including ductal carcinoma in situ (DCIS) or lobular carcinoma in situ (LCIS), it is very unlikely that you need a mastectomy. Women with LCIS do not have breast cancer and most will never get breast cancer. They do not need a mastectomy or even a lumpectomy, although they do need regular mammograms. Most women with DCIS can choose lumpectomy with radiation, rather than mastectomy. For more information, see http://www.stopcancerfund.org/in-the-news/free-patient-booklet-on-ductal-carcinoma-in-situ-dcis-2/

For women with breast cancer who want to have breasts, the preferred choice is usually to keep their breasts (rather than remove their breasts and create new ones). Although a lumpectomy can make the breast smaller or change the shape, it will still have the sensation of a natural breast. In contrast, a woman who has a mastectomy with reconstruction, either with implants or with tissue transferred from elsewhere in her body, will have “breast shapes” that do not have any feeling. They are numb. Reconstruction also requires at least two surgeries. Reconstructed breasts may look fuller or “younger” but when the options are explained to them, many women would prefer to have sensation in their breast (or breasts), and would prefer not to have to worry about complications and the need for additional surgery.

If a woman needs to have a mastectomy, because the DCIS has spread throughout the breast or the cancer is large, there are several choices for reconstruction: saline breast implants, silicone breast implants, and moving tissue to create a new breast, such as a TRAM flap (Transverse Rectus Abdominis Myocutaneous flap) or DIEP flap (Deep Inferior Epigastric Perforator flap).

Many plastic surgeons know how to reconstruct breasts using breast implants, but few are skilled at moving tissue (which is called autologous tissue transfer). That is one of the reasons why so many plastic surgeons recommend breast implants.

Saline or Silicone?

Some surgeons prefer silicone gel breast implants to saline, because they feel more natural. However, saline breast implants are approved by the FDA as “reasonably safe” and silicone gel implants are not. That is why women getting silicone gel breast implants must agree to be in a study. The goal is to find out how many complications or problems arise in these women in order to decide whether they are safe enough to approve. You would be part of an experiment to find out if the implants are “safe enough” for other women.

One problem with silicone breast implants is that they can break without a patient knowing it. Although less embarrassing than an instant deflation (which is likely with saline), breakage without symptoms is a bad thing, not a good thing. If silicone gel breast implants break and leak, the silicone can get into lymph nodes and travel to the lungs, liver, and brain. No research has been done on those risks, but a study by scientists at the National Cancer Institute found that women with breast implants were twice as likely to die from brain cancer or lung cancer compared to other plastic surgery patients. More research is needed, but those findings are cause for concern.

If saline implants break they are usually easy to remove. If silicone implants break, they can leak and can be extremely difficult and expensive to remove carefully. For that reason, we believe that saline are safer than silicone, even though both have very high complication rates.

Risks

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

It’s impossible to predict who will have problems with breast implants, and who won’t. It’s important to know that all implants will eventually break, sometimes within a few months or years, and usually within 10 years. Sometimes women who have a mastectomy get breast implants to replace one breast and to make the other breast look more similar to the replaced breast. However, it’s important to know that either silicone or saline breast implants interfere with mammograms. They show up white on the film, hiding tumors that are above or below.

Alternatives to Implants

An alternative to breast implants is “autologous tissue transfer,” such as the TRAM flap and DIEP flap procedures. These procedures use a woman’s own fat and tissue is used to reconstruct the breast. Many women prefer it to implants because it feels more natural and apparently lasts for a very long time (possibly forever, although the procedure has mostly been done in the last 15 years so it’s impossible to say). However, both the TRAM flap and DIEP flap procedures are more expensive than implants, require an especially skilled surgeon for a good result, and the healing process usually takes at least several months and can be painful. Women are only able to get this surgery if they have enough body fat in their abdomen area or back to form breasts. And, like a breast implant reconstruction, the breast has no feeling. For a woman who has the tissue transferred from her abdomen area (in an operation that has been compared to a “tummy tuck”), there is some loss of muscle in that area. That can be a problem for athletic women, but many other women don’t mind.

The DIEP flap is a similar type of reconstruction but does not remove any muscle. Instead, for the DIEP flap, the surgeon only removes fat and other tissue and makes a small cut in the abdominal muscle. Since no part of the abdominal muscle is removed, patients are able to maintain abdominal strength, making this surgery a better option for most women, especially those who are physically active.

Fortunately, TRAM flaps and DIEP flaps are covered by some health insurance companies. These are complicated surgeries with long recovery times and you would need to find a physician who is very experienced doing these procedures, and we highly recommend asking the doctor to put you in touch with other patients who were happy with the reconstruction.

Latissimus Dorsi Flap Surgery

Reconstruction using the latissimus dorsi muscle usually combines a breast implant with autologous tissue from your own body.  In a way, this is the worst of all worlds: the risks, complications, and cost of autologous tissue surgery with the risks and replacement costs of breast implants.  Some surgeons offer it because they do not have the skills to do a DIEP.  If you want a natural, long-lasting reconstruction, we suggest you keep looking to find a surgeon who is experienced with DIEP.

In a latissimus dorsi flap procedure, an oval flap of skin, fat, muscle, and blood vessels from your upper back is used to reconstruct the breast. Keep in mind that the fat in that area feels stiffer than breast fat skin on your back usually has a slightly different color and texture than breast skin.  The surgery can cause a partial loss of strength or function that makes it hard to lift things and twist, and can affect your ability to swim, golf, or play tennis.

For more information about the risks, see here:  Latissimus Dorsi Flap Surgery Risks

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/)

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?

Breast implant surgery comes with a high complication rate. Complications can happen immediately after the surgery or years after. The major health risks of breast augmentation surgery are:

Capsular Contracture – The most common complication of breast implants is capsular contracture. Capsular contracture occurs when the scar tissue tightens around the breast implant. This can cause the breast to feel hard and very painful.

Breast Pain, Redness, or Swelling – As with any surgery, augmentation patients should expect to feel pain immediately after surgery. However, pain that lasts for months or longer can have many different causes and requires treatment. It can be a sign of an infection, especially if the pain is accompanied by redness, swelling, and tenderness. Or it can be a sign of nerve damage, which can be temporary or permanent. The weight of breast implants can strain the muscles in your neck, back, and chest and can cause chronic back pain and shoulder pain, and can even cause permanent damage.

Rupture – If a breast implant tears or develops a hole, it is called a rupture. Some ruptures happen during the first few months, but the older an .implant is, the more likely it is to rupture. It’s not always obvious when an implant has ruptured. Here’s what you need to know. Link?

Autoimmune Symptoms – Breast implant companies were required to complete safety studies before they could sell their implants in the United States. Although the Food and Drug Administration (FDA) approved breast implants, they admitted that “studies would need to be larger and longer” to find out if implants could cause the kinds of autoimmune symptoms many women report, such as joint pain, memory loss, hair loss, and dry eyes.

Interference with Breast Cancer Detection – Breast implants make it more difficult to detect breast cancer when they hide cancer tumors. If you are considering getting breast implants or already have breast implants, it is important to know how they can make mammography and breast exams less accurate.

Infection – Infections can happen after breast augmentation surgery if bacteria get into the incision site. Or bacteria can thrive around and implant. These infections can be serious. The Food and Drug Administration (FDA) warns that toxic shock syndrome, a life-threatening complication from bacterial infections, has been reported following breast augmentation surgery.

Pregnancy and Breastfeeding Concerns – Pregnancy can cause drastic changes in breast size and shape, so having implants may affect the shape of breasts after the baby is born. In addition, women with breast implants may find it difficult to produce enough milk due to pressure on the milk ducts from implants or damage to mammary glands or ducts during the implant surgery.

Breast Implant Associated-Anaplastic Large Cell Lymphoma (BIA-ALCL) – Cancer experts agree that women with breast implants are more likely to develop ALCL, a rare cancer of the immune system that develops in the scar tissue (capsule) that forms around a breast implant.

Extrusion – Extrusion, or when a breast implant comes through the skin and becomes exposed, is an uncommon, but dangerous, complication of breast implant surgery.

For more information about risks and complications, click here. In addition to the health risks, there also are financial costs. For more information about the costs of breast implants, click here.

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

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?

A saline breast implant deflates when it ruptures. When this happens, your breast will change in size and shape. If your breast implant ruptures, you should have it removed to prevent infection, leakage, pain, and other problems.

Because breast implant removal includes costs (such as anesthesia) that are similar whether you have one implant removed or two, it is usually best to remove them both at the same time, whether or not you want them to be replaced. For example, if your implants were put in at the same time and one is ruptured, it is likely that the other will rupture soon. One surgery is much less expensive than two.

You will also need to decide whether to have your implants replaced. If you have had problems with one or both of your breast implants, it is likely that those problems will develop if your implants are replaced. Before you undergo surgery, learn about the many health issues that can be caused by breast implants. You might be surprised to learn that health issues that seemed unrelated to your implants might actually be caused by them. Some women find that replacing their implants leads to an endless cycle of future surgeries.

If you are worried that your breasts will look deflated after implants are removed, you can get a breast lift instead of replacing your implants. Whether or not you decide to replace your implants, finding an experienced explant surgeon is important. Women are likely to be more satisfied with the way their breasts look and feel and how healthy they feel if they go to a surgeon who is experienced in removing implants with or without replacement. An experienced explant surgeon can also minimize any leaking or cosmetic problems caused by the explant surgery. To learn more about how to find a plastic surgeon, click here.

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