All posts by BIeditor

Women with Silicone Breast Implants and Unexplained Symptoms

M.C. Maijers et al., “Women with Silicone Breast Implants and Unexplained Systemic Symptoms: A Descriptive Cohort Study.” The Netherlands Journal of Medicine: December 2013

Many women with silicone breast implants suffer from symptoms that may seem unrelated to their implants, such as muscle pain, joint pain, chronic fatigue, numbness, memory loss, and dry mouth. Many women never find an answer to these “mystery illnesses” because women and their doctors do not consider a link between the two. 

A study published in 2013, by researchers in the Netherlands, sheds light on the symptoms that many women with silicone implants experience, and suggests that removing the implants can improve the women’s health dramatically. 

In this study, researchers followed women with silicone gel breast implants who were experiencing unexplained symptoms (which were called “Autoimmune Syndrome Induced by Adjuvants,” or ASIA). Eighty women volunteered and underwent chest x-rays, blood work, and a physical exam to rule out other known causes of their symptoms. The participants filled out a questionnaire about their health and history with breast implants and were followed up with telephone interviews. Most of the women (89%) had breast implants for cosmetic reasons, and had implants for an average of 14 years. Notably, 75% of the women reported that they had allergies before they got their breast implants.

All 80 women in the study had two or more of ASIA symptoms, and most women reported that they had not had new health problems for several years after getting implants, instead their symptoms developed gradually. Although it is unknown which women will develop ASIA symptoms from silicone, the authors caution that anyone who has allergies may be more likely to have a bad reaction to silicone.

Thirty-six out of the 52 women (69%) who had their implants removed experienced reduction in symptoms and 9 out of 52 experienced full recoveries after explantation.  The authors conclude that physicians should consider explanting silicone implants and the scar capsules that surrounds them as the treatment for women with silicone breast implants who have these otherwise unexplained symptoms.

A 2016 review also showed that many women who suffer from autoimmune symptoms after getting breast implants improve after removing the implants. In fact, silicone-related complaints (such as autoimmune symptoms) got better for 3 out of 4 women after they removed their implants. It wasn’t only symptoms that improved, many women diagnosed with autoimmune diseases also improved after they removed their implants, although most of these patients were also taking immunosuppressive therapy before and after removal, and it is not clear if their improved health continued after the immunosuppressive therapy ended.

Read the original 2013 study here.

Read the 2016 study here.

Angelina Jolie’s Decision

Diana Zuckerman, PhD, National Center for Health Research, Huffington Post: May 16, 2013

When I read about Angelina Jolie’s announcement this week, I cringed.

I have greatly admired her willingness to speak out on important issues over the years. Her public announcement about her mastectomies will certainly reassure some women that losing a breast to breast cancer isn’t quite as frightening as it had once seemed. But Ms. Jolie is a powerful role model to millions of women. What are the unintended consequences of the role she is modeling regarding breast cancer?

Is breast cancer so frightening that it is better for a woman to remove her breasts before she is even diagnosed? Obviously, that isn’t what Ms. Jolie is saying. She has one of the breast cancer genes (BRCA1), and that greatly increases her chances of getting breast cancer.

However, the extremely high risk that she quoted from her doctor (87 percent chance of getting breast cancer) was based on old, small studies. Newer studies have found that the risk of getting breast cancer for an average woman with BRCA1 is 65 percent. Since being overweight and smoking increase the risk and exercising and breastfeeding lower the risk, Ms. Jolie’s risk of breast cancer, even with the BRCA1 gene, could be considerably lower.

Of course, the lifetime risk of breast cancer would still be high, but it wouldn’t be nearly as high a risk during the next 10 years or even 20 years. According to experts, a 40-year-old woman with the BRCA1 gene has a 16 percent chance of getting breast cancer before she turns 50. That’s not nearly as frightening, and with regular screening and all the progress in breast cancer treatments, the survival rate from breast cancer is higher than ever. Many breast cancer patients live long and healthy lives. And, it is possible that by the time Ms. Jolie (or any other woman with BRCA1) got breast cancer in the future–if she ever did–the treatments available would be even more effective than they are today.

Thanks to mammograms, women are getting diagnosed with breast cancer at much earlier stages, making it safe to undergo a lumpectomy (which removes just the cancer) rather than a mastectomy (which removes the entire breast). And yet, American women are undergoing mastectomies at a higher rate than women in other countries–many of them medically unnecessary. Breast cancer experts believe that many women undergoing mastectomies don’t need them and are getting them out of fear, not because of the real risks.

As an actress whose appeal has focused on her beauty, surgically removing both her breasts when she didn’t have cancer was a very gutsy thing to do. But if we care about women’s health, we need to stop thinking of mastectomy as the “brave” choice and understand that the risks and benefits of mastectomy are different for every woman with cancer or the risk of cancer. In breast cancer, any reasonable treatment choice is the brave choice.

Nobody can second-guess Angelina Jolie’s choice–it’s hers alone to make. Fortunately for her, she has access to the best reconstructive surgeons in the country, and they will keep her breasts looking as natural and beautiful as possible, an advantage that most implant patients don’t have. If she has any of the common problems with her breast implants, she can afford to get those problems surgically fixed whenever she wants to. She can also afford breast MRIs every other year ($2,000 each), which the Food and Drug Administration recommends as a way to make sure that the silicone from the implants is not leaking into the lymph nodes.

Angelina Jolie is not in any way an average woman, and what felt right for Angelina Jolie might not be right for most women who are afraid of getting breast cancer, and not even for most women with the BRCA1 or BRCA2 gene.

I thank Ms. Jolie for speaking up about her decision, and I thank the many cancer experts who are doing their best this week to explain why double mastectomies are not the best choice for most women. Let’s use this teachable moment to have a frank discussion of the treatment choices for breast cancer and to encourage women to make decisions based on their own situations, not on the choice of a celebrity, however admirable she is. For each woman, it’s important to weigh her own risk of cancer–in the next few years, and not just over her lifetime–and the risks of various treatments, and to make the decision that is best for her.

Read the original article here.

Breast Cancer Detection and Survival Among Women with Cosmetic Breast Implants

Eric Lavigne et al., “Breast Cancer Detection and Survival Among Women with Cosmetic Breast Implants: Systematic Review and Meta-Analysis of Observational Studies.” The British Medical Journal: April 2013

According to a new research study published in the British Medical Journal, women with cosmetic breast implants who are diagnosed with breast cancer, are more likely to die from the disease compared to women without breast implants who are diagnosed with breast cancer. Combining research from 12 studies, Dr. Eric Lavigne and his colleagues found that women with breast implants were more likely to be diagnosed with a later stage breast cancer, compared to women diagnosed with breast cancer without breast implants.

In a separate analysis combining research from 5 different studies, the researchers report that compared to other women with breast cancer, women who had breast implants before they were diagnosed with breast cancer were 38% more likely to die from the disease.  This occurs because implants interfere with mammography, making it difficult to diagnose breast cancer early.

Read the original study here.

Eileen Swanson


New Jersey

I was diagnosed with Stage II breast cancer in May 1988, after which I had a modified radical mastectomy. In July of 1989, the doctors (including a cancer researcher) determined that I was at high risk for a second primary tumor in the other breast, and I made the decision to have a prophylactic contralateral mastectomy with implants. I opted for saline-filled, because by then there was some talk of silicone gel-filled implants leaking.

Two Mentor saline smooth-shell leaf valve implants were surgically implanted in my chest cavity in July of 1989. The right one deflated in the recovery room. My left side had difficulty healing and there was a lot of swelling, including a swollen lymph node on the left side. I experienced a dizzy spell that required a brain scan. The results of the brain scan were normal, even though my “breasts” were extremely painful after the implant surgery.

In January 1990, the right implant was replaced with a Dow tissue expander, saline implant only. It was filled weekly with saline over a period of around 8 weeks, which was a very painful process requiring Valium and/or Tylenol with codeine. Then a 3rd surgery replaced both my right and left implants with Mentor saline Siltex implants, with textured shell. They hardened almost immediately, and again I had difficulty healing. There was a lot of oozing and swelling. The left side swelled up all the way to my collarbone, and remained swollen until the saline implant was explanted. At one point the implant could even be seen through my wound.

In less than a month, I suddenly became ill with symptoms of widespread joint and muscle pain, stomach cramps and diarrhea, overwhelming fatigue, hair loss, morning “stiffness” so severe that I could barely get out of bed, and a sleep disorder that I later learned is called “fragmented sleep.”

My plastic surgeon told me that my symptoms were similar to those of silicone gel implant patients. She also told me, for the first time, that the shells of my saline implants were made of silicone. I decided that I wanted the implants out, but by then I had different doctors at the military hospital (my husband was in the military), and they refused. I waited for six months until I was finally explanted in May of 1991. Small incisions were used to deflate the implants of saline and then the shells were pulled out. By the time I got the implants removed, I could not even do stretching exercises, and as a result, my photography business was nearly at a standstill.

I had a brief reprieve, but the illness continued. The pain was unrelenting, and at times so excruciating that I was bedridden and disoriented. My doctors shrugged their shoulders. They had no idea what to do for me.

In 1993, I was diagnosed with fibromyalgia and assured by my rheumatologist that some medication for sleep, followed by increasing amounts of exercise would easily manage the disorder. Having been athletic and very active my whole life, I was ecstatic.

But it did not work out that way. The medication made me so drowsy that even a quarter-dose made me too sleepy to work the next day. I was forced to stop taking it after a few weeks. Aerobic exercise was a distant memory. My rheumatologist had no suggestions for another medication at that time.

In April 1994, I had extreme fatigue, incredible pain, and was suffering from memory loss. I was forced to close my photography business. I realized that I was having difficulty remembering the myriad of details that photography requires.

Sometime in 1994, I learned that in order to insure maximum removal of the silicone, the scar tissue capsules have to be removed. Unfortunately, mine were not. Because the capsules are located under my muscles, I am told that to remove them now could do more harm than good. There are no guarantees that they can be removed fully intact. There is a possibility that the doctors would have to scrape the capsules off my ribs.

In 1997, duodenal ulcers were added to the myriad of problems that I already had. Therefore, most medications (pharmaceuticals, OTCs, and alternatives) and foods are now off limits. I have tried 5 medications for sleep, 6 for ulcers, and 7 for pain. Right now, I can only take Klonopin (chewed), for sleep or pain.

I have every symptom that is listed as being associated with fibromyalgia in the ACR classification. Irritable bowel, Raynaud’s, and cognitive dysfunction, along with the other symptoms I have described.

My marriage ended in divorce. I am on disability and live with my mother in her attic bedroom. I have a friend who recently returned to work following being similarly ill from implants. It cost her $40,000-$50,000 in treatments that are not covered by insurance. I have little hope of being able to do those things since I have no money. I do not expect to receive much from Dow. I received very little from Mentor.

I had 5 saline implants. They were supposed to be safe. I try to tell myself that maybe I would have become ill anyway, however, I have no family history of this sort of illness. And if it is not residual silicone that makes my chest burn constantly, then what?

Many of us pray that our government and the medical community will finally recognize what is making us ill, and do something to help us. I cannot tell you what a relief that would be.

Most of my doctors still are unable to help me, and do not recognize silicone-related illnesses. I have even been laughed at by a rheumatologist because I suggested that my implants had made me ill. Another doctor told me that it was strictly a lawyer-driven, hysterical-women, greed issue. Which, of course, would account for why I live on $560 a month, and why I gave up my dream profession to live this way!

I just want to get well. I just want my life to stop being such hell with no end in sight.

This is Ms. Swanson’s testimony before the FDA Advisory panel on March 1, 2000.

Wanda Shatley


North Carolina

I was diagnosed with a precancerous tumor in 1987, and after a lumpectomy I used McGhan silicone gel implants.

I developed aches and pains, eye problems and a general feeling of unwellness within 2 years, and was diagnosed with fibromyalgia in 1992.

I saw over 60 medical doctors in North Carolina, Florida, Texas, Connecticut and New Jersey, who could not give me a definite diagnosis for my illness.

I became blind in my left eye and my health rapidly deteriorated. I’ve been bedridden with dozens of symptoms since June 1993. I have been diagnosed with MS and lupus. I was hospitalized for 10 days at St Mary’s Hospital, in Connecticut, where they found lesions on my brain and spinal cord, and an ANA of 180.

I was then transferred to a different hospital where I spent another 53 days getting stabilized and prepared for explantation. My implants were removed in 1993, and the right implant was leaking. I was hospitalized a total of 180 days within a one year period due to illness and toxicity from breast implants. I was explanted on my birthday, September 22, 1993, and felt better within 24 hours.

I spent $300,000 on treatments not covered by insurance and re-location to Houston, TX for 18 months. Gradually, my health has improved and most of my blood work is back to normal. I have not developed new lesions on my brain or spinal cord. My brain fog improved greatly after explantation, but depression is still a huge factor. I can’t handle stress of any kind. However, I no longer have a diagnosis of fibromyalgia.

It is the FDA’s job to approve medical implants that are safe and effective. I understand that cancer patients need some form of reconstruction, but it should be safe, not almost safe.

Meanwhile, the U.S. Department of Health and Human Services is suing breast implant manufacturers for Medicare health costs of ill breast implanted women. Where is the logic? What information that the company provided would convince me that breast implants are now safe?

This testimony was read for Ms. Shatley at the FDA hearings on October 15, 2003.

The Rising Trend of Breast Implants in America

BBC Persian: April 3, 2013.

With 330,631 breast augmentation procedures performed in the United States in 2012 alone, America is now officially the global leader in this branch of cosmetic surgery and breast implants are now the second most popular plastic surgery in the world. […]

Florence Williams, author of BREASTS: A Natural and Unnatural History: “I think the plastic surgery industry has been masterful at marketing implants and augmentation as very benign procedures It sort of in line with other procedures women get Botox, hair colouring, this is marketed as yet another way improve you image.” […]

Diana Zuckerman, Ph.D. President, National Research Centre for Women & Families Cancer Prevention and Treatment Fund: “Self-esteem is not like having a bad hair day and a good hair day. People feel better about themselves on a good hair day than a bad hair day, but it doesn’t change their self-esteem; it doesn’t change how they really feel about themselves. And so the objective studies that have been done of cosmetic surgery–and this is true for breast implants and other surgeries–show that usually men and women who have cosmetic surgery feel better about the body part that was fixed. If their nose was changed they like their nose better, if their ears don’t stick out they like their ears better. If their breasts are larger they might feel sexier and think their breasts look nicer but it doesn’t actually change that sort of basic feeling of who they are.” […]

Mental health specialists believe anyone considering aesthetic procedure should make sure that they are doing so for the right reasons. If they are looking for a procedure because they feel society wants them to look a certain way or someone is pressuring them to have it done – it is unlikely that the operation will improve their quality of life. If however, they want to do it for themselves to feel younger when they look in the mirror, and if they have weighed in all the risks involved, then they will have a much more positive outcome — both mentally and physically.

 To view the segment (in Farsi) click here.

Breast Implants as Therapy? Not So Much

Diana Zuckerman, PhD, National Center for Health Research, Fem2.0: April 11, 2013

Cross-posted from Fem2.0 with permission.

More than 300,000 teens and women in the U.S. decide to get breast implants every year.  To hear them talk about it, you’d think they were getting therapy instead of surgery.  They almost never say “I want larger breasts” (or even “I want better boobs.”)

What they say is “I don’t like my body and I want to feel better about myself.”  And plastic surgeons will tell their patients “this will really improve your self-esteem.” But their advertisements seemed designed to make us feel insecure about our bodies, not better about ourselves.

Unfortunately, breast implants don’t deliver on that promise of feeling more self-confident. 

On the contrary, the breast implant companies’ own studies prove it.  There are 2 major breast implant companies in the U.S., Allergan and Mentor.  Both tried to prove to the FDA that breast implants helped women’s self-esteem and both failed miserably.  Allergan used 12 different quality of life measures to compare augmentation patients before surgery and 2 years later.  Nine of the 12 (75%) were worse after the women got their breast implants, including self-esteem. 

The results were similar for women getting Mentor breast implants.  The women got worse in their self-reported physical health and mental health, with most showing no difference in their self-concept or how they felt about their body.

Why do they feel worse?  For some women, it is the disappointment that even after plastic surgery they are still not beautiful enough.  And for some women, the complications from breast augmentation — numb nipples, hard or painful breasts, and for some women chronic fatigue or other problems – make them feel physically messed up and guilty because they “made a stupid decision and now I’m paying for it.”

Choosing breast implants

Myth and Reality

Where does the myth of breast augmentation as therapy come from?   Wouldn’t you think that any cosmetic surgery would make women feel better about themselves?

If you ask women (or men) who had plastic surgery how it influenced them, many will say that they feel better about themselves.  But, memory can play tricks on us.  For example, some of us have mostly wonderful memories of our childhood and others have mostly sad memories, but those memories aren’t always accurate.  The best way to find out what the impact of breast augmentation – or any cosmetic surgery – is to interview the people before the surgery and again after they have completely recovered from surgery and gotten used to the “new me.”

Study after study shows that men and women who get plastic surgery usually feel better about the body part that was “fixed” but they don’t feel better about themselves and they don’t feel better about their relationships or their lives.  How we feel about ourselves is a central part of who we are.  It doesn’t change easily. For example, a “good hair day” or a great outfit can help us feel more attractive, at least for a while, and can help us have a good day, but it doesn’t make us feel more worthwhile as people or happier in our lives in general.

Psychologists explain that this is the difference between a “state of mind” (feeling good because I’m having a good hair day) and a personality trait (how I feel about myself because of my high or low self-esteem).

Plastic surgeons like to believe that they make magic by making people feel better about themselves.  And the “beauty industry” helps convince us that if we just buy the right product (whether it is a cosmetic, an outfit, or a surgery) will make all the difference.  For example, “makeovers” – whether in magazines or on TV – work by making the women feel awful about themselves at first and then “curing” their shortcomings.

Teenagers are the most vulnerable

Teenagers are especially likely to feel bad about how they look.  But every year throughout the teen years, boys and girls tend to feel better about how they look.  By the time they are 18, they feel much better than they did at 13 or 14, for instance.  If they get plastic surgery as teens, they think that’s the reason they feel better, but the truth is that even teens who don’t get plastic surgery and don’t necessarily look better than they used to, still feel more comfortable with how they look as they get a few years older.

One more thing to keep in mind: women who get plastic surgery once tend to want more plastic surgeries.  In other words, after fixing one perceived flaw, they find other flaws that bother them and that they want to fix.  That’s another sign that breast augmentation and plastic surgery are not the way to improve self-esteem.

Therapy vs. Plastic Surgery

Why are so many women so unhappy with how they look, and especially with their bodies?  The standards seem to be getting more unattainable.  Let’s face it: thin bodies with very large breasts don’t happen in nature very often.

I’ve talked to actresses about this and I call it the trickle down insecurity effect.  Beautiful women are more likely to become actresses or models than plain Janes, but as they struggle to make it in Hollywood or the beauty industry, they are told they are not quite beautiful enough.  They try extreme diets, personal trainers, professional make-up artists, the best hairdressers, and the most gorgeous outfits.  When even that isn’t enough, they get plastic surgery.  Then regular girls and women see them and feel inadequate as they think “Why can’t I look like that?”

Of course, even movie stars don’t always look as good as they do in magazines or movies.  In real life, there is no photoshopping, airbrushing, or flattering lighting to fix the imperfections.

But the bottom line is: if you want very large breasts, breast implants can help.  If you want to feel better about yourself, breast augmentation isn’t the answer.  Therapy might be.  And, it can also help to stop comparing yourself to women whose images aren’t real, but have instead been manufactured into unattainable ideals of beauty.

Perfecting Bodies Through Chemistry?

Diana Zuckerman, PhD, National Center for Health Research, Fem2.0: February 22, 2013

Cross-posted from Fem2.0 with permission.

Do you like your body?   If there was a simple way to change it, with no risks, would you do it?

If making that change meant you would put your health at risk and have multiple surgeries for the rest of your life, would you hesitate?

Most women say they don’t like their bodies, and research shows that dissatisfaction usually starts during the middle school years and may never go away.  For many of us, it eases up a little in young adulthood as we come to appreciate our attributes and accept any “flaws,” but insecurities rev up again as aging takes its toll.  It seems ironic that we long to regain the body that seemed so imperfect when we were younger.

Breast-Implant-gel

In the U.S., there are thousands of products and procedures that feed on women’s insecurities.  Most are ineffective – the pills and products that promise to melt fat away without diet or exercise, or to make cellulite or wrinkles disappear.  But only a few are actually dangerous to our health.  Breast implants are one of those.

The FDA just approved a new kind of breast implant, which many plastic surgeons promise will be safer and better than other kinds of breast implants.  It is made of thick silicone gel (nicknamed “gummy bear implants” for its consistency), which is supposed to prevent it from breaking, leaking, or wrecking havoc with your body.

What’s the proof that this product is safer, or even safe at all?  Apparently, that’s a secret.

When breast implants were first sold in the U.S. in the 1960s, no testing was required to make sure they were safe.  For the next 30 years, more than a million women in the U.S. got breast implants, not realizing that studies on women had never been done to prove they were safe or to determine how many months or years they would last.

In 1990, I was working as an investigator in the U.S. House of Representatives when a Senate staffer called me.  She told me that her mom had gotten breast implants after a mastectomy, which had resulted in terrible problems including silicone leaking out of her nipples.  Her mom was cured of cancer but the implants had put her through hell.  I was sure that the FDA had very strict rules about safety testing, but I promised I’d look into it.

I found out that I was wrong: the FDA had never required clinical trials for breast implants.  We held a Congressional hearing, I continued my investigation, and soon my office – and the media – was full of horror stories about women whose health had been ruined by breast implants.

Thanks to Congressional and media pressure, the FDA changed their policies.  They eventually required breast implant companies to conduct studies on hundreds of women with breast implants, to find out how safe their products were.  Public meetings were held so that women could testify about their experiences, scientists could openly discuss the research, and the media could report what was said.  Some companies failed to do the newly required research and their implants were no longer allowed to be sold in the U.S.  And, although all breast implants were found to have high complication rates, the FDA, under tremendous pressure from implant companies and plastic surgeons, decided that women were capable of making an informed choice about the risks they were willing to take.

I have no doubt that women are capable of making an informed choice.  But the FDA is still not providing the full information that women need to make an informed choice, and neither are the plastic surgeons.

In a giant step backwards, some FDA officials are reverting to their old ways.  They approved “gummy bear” implants with no public meeting and they have not made the study findings public.  Instead, in a press release that the agency quietly released on February 20, they report that the new breast implants have the same kind of complications as other types of implants – such as hard, painful, or lopsided breasts and the need for additional surgery – but don’t say how often those complications occur.  They also reported a new complication: the silicone gel in these new implants can crack.  What happens to women when that happens?  The FDA isn’t saying.

Since I did my investigation in 1990, I have been one of the FDA’s strongest critics and biggest fans.  I have often been horrified by some of the decisions FDA makes to approve unsafe or inadequately tested medical products, but I also know that when the FDA does its job well, it can save millions of lives.

When I did the Congressional hearing on breast implants, I was 7 months pregnant.  My son is now a college senior.  In those 22 years, the FDA regained and is now again at risk of weakening its public health focus, as Congressional pressure on the FDA to protect patients has been replaced by Congressional pressure to get products to market as quickly as possible and thus “create jobs.”  Whether it is breast implants, riskier birth control pills, TB drugs that do more harm than good, or sleeping pills with questionable benefits, the FDA is allowing drugs to be sold that do a lot of harm.  And when the FDA fails to hold medical products to a high standard, it is women – the consumers of most medical products – who are harmed the most.

Read the original article here

Statement of Dr. Diana Zuckerman on FDA Approval of New Silicone-Gel Breast Implant Natrelle 410

Diana Zuckerman, PhD, National Center for Health Research: February 21, 2013

Yesterday the FDA quietly approved yet another questionable style of breast implants, the Natrelle 410 Highly Cohesive Anatomically Shaped Silicone-Gel Filled Breast Implant made by Allergan, Inc.

The FDA based its approval on data from 941 women, which is a very small sample. The FDA reports that the complications from these implants are similar to those for other breast implants: pain and hardness caused by scar tissue (capsular contracture), the need for additional operations to fix implant problems, the need to remove the breast implants because of problems, uneven appearance (asymmetry), and infection.  The studies also found cracks in the gel of some Natrelle 410 implants, which has not been found in other breast implants.

Unlike other breast implant approvals, the FDA did not hold a public Advisory Committee Meeting to discuss the data, nor did they make the study data public for these new breast implants.  What are they afraid of?  It seems likely that the FDA decided it was better to hide this information than to make it public at a meeting where implant patients could talk about the health problems that have been caused by these implants.

The silicone gel in the Natrelle 410 implant contains more cross-linking compared to the silicone gel used in Allergan’s previously approved Natrelle implant. This increased cross-linking results in a silicone gel that’s firmer. Cross-linking refers to the bonds that link one silicone chain to another. Some physicians believe this will make the implant last longer, but there is no evidence to support that because these implants have only been studied for 7 years.

The FDA admits that Allergan’s studies did not compare the safety and effectiveness of the Natrelle 410 implant to other previously approved silicone gel-filled breast implants on the market.

As a condition of approval for the Natrelle 410 breast implants, Allergan must:

  •  Continue to follow, for an additional five years, approximately 3,500 women who received the Natrelle 410 implants as part of the company’s continued access study;
  • Conduct a 10-year study of more than 2,000 women receiving Natrelle 410 silicone gel-filled implants post-approval to collect information on long-term local complications (e.g., capsular contracture, reoperation, removal of implant, implant rupture) and less common potential disease outcomes (e.g., rheumatoid arthritis, breast and lung cancer, reproductive complications);
  • Conduct five case-control studies to evaluate whether women with Natrelle 410 implants, or other silicone gel-filled breast implants, are more likely to develop rare connective tissue disease, neurological disease, brain cancer, cervical/vulvar cancer and lymphoma;
  • Evaluate women’s perceptions of the patient labeling; and
  • Analyze the Natrelle 410 implants that are removed from patients and returned to the manufacturer.

Unfortunately, Allergan has not done a good job of doing post-market studies once their implants have been approved.  And, even if they do these studies, by the time these studies are done to find out what the risks are, hundreds of thousands of women could have these inadequately studied devices in their bodies, and could have been harmed by them.

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?


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 may be able to keep your breasts, and have a lumpectomy rather than a mastectomy (which removes the entire breast). Studies show that early-stage breast cancer patients who undergo a lumpectomy (which removes only the cancer and a small area around it) and radiation will likely live just as long as women who have a complete mastectomy. 

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 unlikely that you need a mastectomy. Women with LCIS do not have breast cancer and most will never get breast cancer, though they do need regular mammograms.

Breast Reconstruction Options after Mastectomy

If a woman needs to have a mastectomy, there are several choices for reconstruction. Many breast surgeons and breast cancer patients believe that breast reconstruction is an important step in recovering physically and mentally from a mastectomy.

Breast implants are the most common form of breast reconstruction after mastectomy. This is probably because breast implants are the easiest form of reconstruction and most plastic surgeons are not skilled enough to perform the other types of breast reconstruction discussed below.  There are silicone gel breast implants and saline breast implants on the market, and both options have a high complication rate for reconstruction patients. Some of the most common complications of breast implants include implant rupture, capsular contracture (painful hardening and abnormal shape of the breast), breast painautoimmune symptoms, and interference with mammography for breast cancer screening. In addition, women who have breast implants, either for mastectomy or healthy breasts, are more likely to develop a type of lymphoma (cancer of the immune system) called ALCL.

An alternative to breast implants is autologous tissue transfer (also known as a flap or flap procedure), where the body’s own tissue is used to reconstruct breasts. There are various types of autologous tissue transfer.

Flap reconstruction with muscle and fat, also called the TRAM flap, uses muscle and fat from the abdomen. Reconstruction methods using fat and muscle create a more natural looking reconstruction than those using only fat due to their added firmness.   Also, the larger amount of tissue used during muscle and fat reconstructions enables the surgeon to create larger breasts than those with fat only.

Surgeons can also perform flap reconstruction with fat only, also called the DIEP Flap, which takes skin, vessels, and fat from the abdomen.  Surgeons can take tissue from most areas of the body that have a large fat supply. Reconstruction with only fat takes more time than other procedures because the tissue has to be harvested and removed from the body before the reconstruction can take place. To be a good candidate for this procedure, women need more body fat to create the breast.

The last option for flap reconstruction is commonly called the Lat Flap, and uses the latissimus dorsi (upper back muscle) to reconstruct breasts. This procedure is more likely to fail than some other flap procedures, but less likely to have surgery-related complications or need reoperations within the first two years. However, since the latissimus dorsi is a large and important back muscle, the procedure can lead to serious difficulties moving, lifting, or performing strenuous exercise.

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

 

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