Author Archives: BIeditor

Already Have Implants and Have Problems?

Are Your Breast Implants Making You Sick- (2)

Don’t panic! If you are having any kind of problems, contact your plastic surgeon, unless you are really concerned about the quality of his or her care. If you feel like your doctor or plastic surgeon is not taking you seriously, contact us. Also, make sure you report any problems you are having to the FDA.

What do I do if my implant breaks?

Most experts agree that it is important to remove a ruptured implant as soon as possible, especially if it contains silicone gel. Removal of implants is called explantation.

Usually a ruptured saline implant is harmless, unless the saline contains bacteria, mold, or fungus, which can happen inside a woman’s body. If your implant has broken, and you feel sick, have a temperature, and/or a rash, you should see a doctor immediately. You could have an infection from contaminated saline.

It is important to have ruptured silicone gel implants removed as soon as possible. The longer the silicone is allowed to remain in the body, the more time it has to migrate to other parts of your body, like lungs or lymph nodes, where it can’t be removed. Unfortunately, nobody knows for sure what will happen as a result of silicone in the body because no one has conducted any research on the subject.

Everybody is different. Some women do not respond strongly, if at all, to breast implants. Others become very, very ill.

Remember: If you choose to get your implant removed because you don’t like the way they look or because of health reasons, your breasts will not look the same as they did before surgery.

Also, if you get silicone gel implants removed because of silicone leakage, your surgeon may have to remove part of your own breast as well, leaving your chest smaller than what you started out with.

What if something else is going wrong?

If you want to find out about common implant problems, in addition to problems when implants break, click here.

I am a teenager thinking about getting breast augmentation. What can you tell me to help me decide?

Q. I am a teenager thinking about getting breast augmentation. What can you tell me to help me decide?

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.

It is great that you are doing research about breast implants. Although it may seem that you are “done developing” that is often not true. If you have breast augmentation as a teenager, the 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. Women can continue to develop after age 20, and most will have more cleavage because they will gain a few pounds in their late teens and early 20’s. (In college, this is called the “Freshman 15” but it can happen whether you are in college or not, and not necessarily in the late teens.) Statistics show that most women who have breast augmentation are thinner than average. If they wait until they gain weight a few years later, they may no longer need or want augmentation.

Some women do fine with breast implants, while others have complications or health problems that can interfere with their lives. 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. And, she also discovered that she had grown one cup size – so that when her implants were removed she was exactly the size she had wanted to be. Unfortunately, she is still paying for the augmentation surgery, since she bought the surgery on an installment plan. She was lucky to be able to borrow money from her family to have her implants removed.

You can read about Kacey and other personal stories of women who have had implants. Click here to read about another woman who got her implants when she was young and what she thinks of them today.

You can get more information about implants by checking out our website at at http://www.breastimplantinfo.org/what-you-need-to-know/. Although we believe saline implants are safer than silicone, both have a very high complication rate.

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.html)

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 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/contribute1.html)

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?

Q. 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?

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.

The best way to tell if a silicone breast implant has ruptured or is leaking is to have an MRI with a breast coil. Unfortunately MRIs are expensive, but necessary because a mammogram can not accurately detect a rupture or leak. And, the squeezing from a mammogram can cause a broken implant to leak. A sonogram can be useful but only if the radiologist is specially trained to detect implant ruptures and leaks — and very few are. That’s why an MRI is the best strategy, although that also needs to be read by someone who has experience looking for a rupture or leak in a silicone breast implant.

FDA scientists found that by the time women have implants for at least 10 years, at least one of them has usually ruptured. However, implants often break sooner, sometimes even within the first year. For women with saline breast implants, a broken implant is obvious because it usually deflates quickly. However, when silicone gel breast implants break, there are often no symptoms at all for a year or more. Years later, there are several symptoms that many women report: the breast changes shape or gets smaller, lumps or bumps may appear on the breast or nearby, some women complain of a burning pain, and some women experience symptoms of autoimmune disease, such as joint pain, memory loss, confusion, or chronic fatigue.

Many plastic surgeons believe that silicone is “perfectly safe.” However, experts who have read the research agree that a ruptured silicone gel breast implant should be removed as soon as possible, especially if it is leaking. The MRI can help the plastic surgeon know where the problem areas are so he or she can avoid leakage during removal. Removing broken implants soon means there is less chance that the silicone will leak outside the scar tissue that surrounds the implant. It is important to have the procedure performed by a plastic surgeon who is very experienced in removing leaking silicone implants. Old or broken silicone gel breast implants should be removed “en bloc.” This means that the entire implant and the entire scar tissue capsule surrounding it are all removed together. This makes it easier to remove any silicone that may have leaked from the broken gel implant and also helps remove silicone or other chemicals that may have seeped out from the silicone envelope into the scar capsule.

A study conducted by Dr Noreen Aziz from the National Cancer Institute and Dr Frank Vasey from University of South Florida found that most women who had rheumatological symptoms (such as joint pain) felt significantly better after getting their breast implants removed and not replaced. Those who didn’t get their implants removed usually got worse. Those who had them removed and replaced (with silicone implants or saline) implants did not get better.

For examples of women who had less pain and other symptoms after their implants were removed, see the personal stories on our website at http://www.breastimplantinfo.org/personal-stories/. You also might want to check out www.explantation.com to hear from women who have had their implants removed and not replaced. Many felt healthier, happier, and more attractive afterwards.

We hope this information is helpful. Check our website for more information, or feel free to write to us.

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.html)

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 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.html)

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

Are Your Breast Implants Making You Sick- (2)

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 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.html)

Should I get silicone or saline implants? Is there a price difference?

Q. Should I get silicone or saline implants? Is there a price difference?

A. We believe that saline breast implants are safer than silicone gel implants.

All breast implants have risks. The most common is when the breast gets hard and painful, known as capsular contracture. Many women with implants have that problem after a few years, but it appears to be more common with silicone gel breast implants than saline implants.

Implant surgery usually costs between $5,000-8,000, including the implants and one follow-up visit. Silicone gel breast implants cost about $1,000 more than saline implants.

However, there are a lot of extra expenses that you need to be aware of.

For example, saline implants and silicone implants both have a high complication rate, and almost half the women will need additional surgery to fix implant problems within 3-4 years. Some problems are cosmetic (if the breasts look phony) and some problems are more serious (such as infections, allergic reactions, or auto-immune reactions). That additional surgery often costs $5,000 or more. That is why we suggest that women considering breast implants make sure they have at least $5,000 in their savings that they will save and not spend until they need it for their next implant surgery.

All breast implants will eventually break, but when saline implants break it is obvious (they deflate quickly) and when silicone gel breast implants break, there are often no symptoms at first. Having no symptoms might seem like an advantage, but it is really a disadvantage because silicone can leak out of the tear in the implant, and get to parts of the body where surgeons can’t remove it. Leaking silicone can cause pain and allergic or auto-immune reactions. When it is removed, the breast may be deformed.

Because of concerns about leaking silicone, the FDA warns that women with silicone gel breast implants need to get an MRI to check for leakage after 3 years, and then every other year after that. Unfortunately, breast MRIs cost about $2,000 each, sometimes more. That may seem very expensive, but it is the only accurate way to know if your implants are broken or leaking. If they are leaking, it is important to have them removed immediately.

Given the expense and the risks, why would any woman get silicone gel breast implants? There is one advantage: they feel more like a real breast. Saline implants may not feel as warm as the rest of the body in cold weather. (A figure skater told us they were painfully cold!) And, women with saline implants sometimes say that they make swooshing water noises. Most plastic surgeons prefer silicone gel implants because they tend to look and feel more natural. However, many women tell us that does not make up for the added risks and added costs.

But, it is important to know that all breast implants – saline or silicone – can cause serious health problems. They can even cause a type of cancer of the immune system, known as anaplastic large cell lymphoma (ALCL).

The bottom line: all breast implants will break, all breast implants are likely to cause complications that require additional surgery, and some women will have a bad reaction within a few weeks or months of getting their breast implants. Some complications are very serious. But some breast implants are safer than others, and since all silicone gel breast implants are more likely to leak as they get older, we believe that saline implants are safer.

Photos of what happens when removing silicone
deforms the breast. Click for larger view.

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, we invite your tax-deductible contributions to NCHR (see http://www.center4research.org/contribute.html)

Is it safe to breastfeed with breast implants?

Q. Is it safe to breastfeed with breast implants?

A. We are not doctors and we are not providing medical advice, but we can tell you what we know from research and from speaking with many experts and women who have had implants.

According to the Institute of Medicine, any kind of breast surgery, including breast implant surgery, makes it more likely that a woman trying to breastfeed will not have enough milk to breastfeed (lactation insufficiency).

Unfortunately, little is known about the safety of breast milk among women with breast implants. Pediatricians believe the milk is safe, but there is so little research that we don’t know if that is true. Some women believe that their children are sick because of their breast implants, while others think their children were not harmed at all by nursing with implants.

A few years ago, a chemistry professor at American University, Dr. Susan Maharaj, reported finding high levels of platinum in the breast milk of women with breast implants. She also reported that children who had been breastfed by women with breast implants had dangerously high levels of platinum in their bodies. Platinum is used to help make breast implants, but is supposed to be used in very tiny microscopic amounts. Children who had been breastfed BEFORE breast implants by the same mothers did not have high levels of platinum.

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 NCHR (see http://www.center4research.org/contribute.html)

Scientific Research

Public Health Implications of Differences in US and European Union Regulatory Policies for Breast Implants
This article explains why there was a massive recall of PIP breast implants in Europe but not in the U.S., and explains the strengths and weaknesses of the standards for allowing breast implants on the market in different countries. It was published in Reproductive Health Matters in December, 2012.

Cancer of the Immune System and Breast Implants: Research and Implications for Women’s Health

A study published in December 2013 raises concerns about a cancer associated with breast implants.  Our published response letter highlights the need for access to timely treatment for all patients with implants.

Research on Silicone Breast Implants and Unexplained Symptoms
A study published in 2013 sheds light on the signs and symptoms that many women with silicone implants experience, and suggests that removing the implants can improve the women’s health dramatically.

Reasonably Safe? Breast Implants and Informed Consent
This article summarizes the latest research on what is known and not known, and what patients need to know. It was published in Reproductive Health Matters in May 2010.

Adolescents, Celebrity Worship, and Cosmetic Surgery
This study shows that media portrayals of celebrities influence how adolescents feel about their looks and influence their decisions to undergo cosmetic surgery. It was published in Journal of Adolescent Health in November 2011.

Teenagers and Cosmetic Surgery: Focus on Breast Augmentation and Liposuction
This article gives physicians the information they need to make a decision about breast augmentation and liposuction for adolescents. It was published in Journal of Adolescent Health in October 2008.

What Do Women Need to Know and When Do They Need to Know It?
This summary of what women need to know before deciding whether to get breast implants was written by former president of the American Society of Plastic Surgeons and the director of FDA’s Office of Women’s Health. It was published in Plastic and Reconstructive Surgery in June 2008. It is not out of date.

Reconstructive Breast Implantation After Mastectomy
This brief article points out that a medical journal about breast implant surgery after mastectomy was misleading. It was published in Archives of Surgery.

Teenagers and Cosmetic Surgery
March, 2005

Safety and Benefits of Mentor Silicone Breast Implants From the April 2005 FDA Analysis and Meeting
This article describes the risks and benefits of Mentor silicone breast implants, based on 3-year studies provided to the FDA.

Symptoms and Complications from Inamed (Allergan) Silicone Gel Breast Implants
This article describes the risks and benefits of Allergan silicone breast implants, based on 3-year studies provided to the FDA.

Breast Implants and Mammography: What we Know and What we Don’t Know PDF version
Experts agree that breast implants interfere with mammography. This article explains why and what you can do about it.

Health Complications from Breast Implant Surgery: A Canadian Study with Implications for the U.S.
This study shows the medical problems of women with breast implants, and was conducted by the British Columbia Centre of Excellence for Women’s Health.

Where There’s Smoke, There’s Fire: The Silicone Breast Implant Controversy
This article explains why breast implants can cause joint pain and other serious health problems. It was published Journal of Rheumatology.

Silicon, Silicone, Breastfeeding, and Breast Implants
This short article explains that we still don’t know the impact of breast implants on the safety of breast milk. It was published in Pediatrics.

The European Perspective: Do Silicone Breast Implants Cause Disease?
This summary of European studies of breast implants explains why you can’t believe everything you read in medical journals.

Are Breast Implants Safe?
This summary of what is known and not known about the safety of breast implants was published in Medscape General Medicine and Plastic Surgery Nursing.

Fibromyalgia and Ruptured Silicone Gel Breast Implants
This summary of a study by scientists at the FDA explains that their research found that women with ruptured breast implants are more likely to be diagnosed with fibromyalgia and several other diseases. It was published in FDA Consumer Magazine.

Government Studies Link Breast Implants to Cancer, Lung Diseases, and Suicide
This is a summary of two articles that were written by scientists at the NIH and FDA.

Higher Rates of Lung, Brain Cancers In Patients With Breast Implants
This article summarizes research showing that women with breast implants are more likely to develop lung cancer or brain cancer than women without breast implants. It was published in Oncology Spectrums.

Do Breast Implants Cause Disease?
This article explains why the meta-analysis of studies of breast implant safety, often used as the reason why there is no reason to be concerned about breast implants, was fundamentally flawed.

Summary of Studies of Saline and Connective Tissue Diseases
This article summarizes major epidemiological studies about the connection between saline breast implants and connective tissue diseases.

Cancer risk at sites other than the breast following augmentation mammoplasty.
This is the abstract for the article by NIH and FDA researchers that found that women with breast implants are more likely to develop lung cancer or brain cancer than women without breast implants. It was published in Annals of Epidemiology.

Study of Silicone Gel Breast Implant Rupture, Extracapsular Silicone, and Health Status in a Population of Women
This is the abstract for the article by NIH and FDA researchers that found that women with leaking silicone gel breast implants are more likely to develop fibromyalgia than women with breast implants that are not leaking. It was published in Journal of Rheumatology.

Prevalence of Rupture of Silicone Gel Breast Implants Revealed on MR Imaging in a Population of Women in Birmingham, Alabama
This is the abstract for the article by FDA researchers and medical school faculty that found that many women with silicone gel breast implants are unaware that their implants are ruptured or leaking, and that MRIs are needed to diagnose rupture and leaking. It was published in American Journal of Roentgenology.

Study of Rupture of Silicone Gel-filled Breast Implants (MRI Component)
Sixth World Biomaterials Conference, May 2000

Study of Re-operations and Self-Reported Silicone-Gel Breast Implant Rupture (Interview Component)
Sixth World Biomaterials Conference, May 2000

What Does the Institute of Medicine Report Say About Breast Implants?
This article summarizes the findings of the Institute of Medicine report about the safety of breast implants, which has frequently been misquoted and misunderstood.

FDA Study Shows That Most Silicone Gel Filled Breast Implants Rupture

by Patricia Lieberman, Ph.D. and Diana Zuckerman, Ph.D.

How long to breast implants last? Studies by FDA scientist Dr. Lori Brown and her colleagues indicate that most women with silicone gel-filled breast implants will have at least one broken implant within 10 years.

In the first study, the FDA interviewed 907 women in the Birmingham, Alabama area who had breast implants for at least six years. In the second study, 344 women with silicone gel breast implants who had been interviewed in the first study and had not had additional surgery after getting their implants received a Magnetic Resonance Imaging (MRI) exam, to determine whether their implants were broken.

Interview Study
In the Interview Study, women with breast implants were asked if they had any additional breast surgery after getting their implants. If their implants were removed, they were asked why. Women who had surgery because they suspected their implants were ruptured were asked about what symptoms they had and whether they knew of a possible reason that their implants could have ruptured.

One-third of the women interviewed (303 of 907) reported that they had at least one operation to remove or replace a breast implant. Of the women who had additional surgeries, more than half reported that at least one of their implants was ruptured or leaking. The average time between getting implants and having additional surgery was 11.5 years.

The most common reason for additional surgery was due to complications such as pain, capsular contracture, displaced implant, infection, or a suspected rupture. Those complications occurred in 103 of the 303 women who had additional surgery. An additional 92 women had their breast implants removed because they were concerned about the safety of silicone.

Some women had additional surgery because of diseases or because they had symptoms that they or their doctors thought were due to the implant. Other women had additional surgery that was planned or staged, such as replacing tissue expanders, or to get a different size implant.

Of the 73 women who suspected their implant had ruptured, 51 suspected the rupture because they had pain in their breast, chest, or upper body. Thirty-five suspected rupture because of changes in their breast shape.

Since self-reported medical history is not always accurate, the FDA attempted to check to determine if the women’s reports were accurate. The FDA was able to obtain medical records from about half of the women who had additional surgeries, and found that the women’s reports were quite accurate. There were minor discrepancies between what the women reported and what was recorded in their medical records. Those differences could have been because researchers may have reviewed a medical record from a different surgery than the one the woman reported, the doctor might not have recorded whether an implant had ruptured, or the woman could have been mistaken that her implant was ruptured. In order to eliminate those biases, the FDA performed a second study, using MRIs. The MRI Study, described below, showed even higher rates of implant rupture than the Interview Study.

MRI Study
The FDA recruited women from the Interview Study to have a Magnetic Resonance Imaging (MRI) exam to determine if their implants were ruptured. The study looked at 344 women who had 687 silicone gel-filled breast implants and who did not suspect that their implants were broken. The average time a woman had implants was about 17 years. Three radiologists looked at each of the MRIs and determined if the implants were intact, suspicious for rupture, or ruptured.

Since the study excluded the one-third of the women in the Interview Study who already had their implants removed due to breakage or other complications, the actual rupture rate is even higher than this study reports. More than two-thirds (69 percent) of the women who had not previously had surgery were found to have at least one ruptured implant in the MRI Study.

Almost half (48 percent) of the women who had implants for only six to 10 years had at least one ruptured implant. Even more, 79 percent, of the women who had implants for 11-15 years had at least one ruptured implant, and similarly, 72 percent of women who had implants for 16 to 20 years had at least one ruptured implant. The rupture rate was lower, approximately one in three, among the few women who had implants for 21 years or more. This is probably because implants made prior to 1975 were made with thicker envelopes and thicker silicone gel.

Of particular concern was whether the silicone migrated outside of the scar tissue that surrounds the implant. Migrating silicone is almost impossible to surgically remove, and efforts to remove it can result in surgery resembling a mastectomy. The findings were bad news for patients with gel implants: the radiologists agreed that more than one in five women (21 percent) had silicone gel that had migrated, and could therefore potentially migrate to essential organs.

There were several factors that affected the likelihood that an implant had ruptured, such as the age of the implant, which manufacturer made the implant, and whether the implant was put above or beneath the chest muscle. Unfortunately, most of these findings have not yet been reported, and the study is not yet published.

Implications for Patients and Women Considering Gel Implants

• The results of this study show that most women with silicone gel implants will have a broken implant within 10 years but they are unlikely to detect it unless they get an MRI.

• The study also indicates that estimates of rupture that are based on the women who have surgery to remove broken implants will grossly underestimate the problem. As a result of the many “silent ruptures,” implant patients and their surgeons have been unaware that most women will require repeated surgeries even if they do not have physical complaints about their implants.

• Even more worrisome, gel was migrating outside the scar capsule for more than one in every five women who were unaware that their implants were broken. This puts these women at risk for losing at least some of their own breast tissue when the implants are removed. In the most extreme cases, some of these women will need a mastectomy to remove the silicone, and the silicone could also migrate to the lungs or other vital organs.