Author Archives: BIeditor

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Less Radical Surgery is a Healthier Choice for Women with Breast Cancer

Brandel France de Bravo, MPH and Diana Zuckerman, PhD

Updated 2017

Experts have long advised that lumpectomy patients live as long as mastectomy patients. But the latest research, based on hundreds of thousands of women, indicates that women with DCIS or early-stage breast cancer are more likely to live longer, healthier lives if they choose less radical surgery.

Four studies indicate that lumpectomy patients live longer.

In a study of almost half a million women with breast cancer in one breast, Harvard cancer surgeon Dr Mehra Golshan reported in 2016 that those undergoing double mastectomies did not live longer than women undergoing a mastectomy in only one breast.[1] On average, women who underwent a lumpectomy instead of mastectomy lived longer than women undergoing either a single or double mastectomy for cancer in only one breast.

Similarly, a study of more than 37,000 women, also published in 2016, women with early-stage breast cancer who underwent lumpectomy with radiation were more likely to be alive 10 years later, compared to women who underwent mastectomies.[2] They were also less likely to have died of breast cancer or of other causes. This was true even when age and factors that could influence survival were taken into account.

Dr. Shelly Hwang and her colleagues found similar results in a 2013 study of more than 112,000 California women who had lumpectomies to remove their early-stage breast cancer were more likely to be alive and free of breast cancer 5 years after surgery than women who had mastectomies.[3] The women had been diagnosed between 1990 and 2004 with either Stage 1 or 2 breast cancer. All of them had either a lumpectomy with radiation or a mastectomy. After surgery, their health was monitored for an average of 9 years (the women were all studied for 5-14 years). The women who had a lumpectomy and radiation tended to live longer than the women who had mastectomies, when controlling for age at diagnosis, race, income, education levels, tumor grade or the number of lymph nodes with cancer. Lumpectomy with radiation was especially effective for women who were 50 years and older with hormone-receptor positive tumors: they were 19% less likely to die of any cause during the study than women just like them who had mastectomies. Perhaps more surprising, they were 13% less likely to die of breast cancer than women just like them who had mastectomies.

In a study published in 2014, Dr Allison Kurian and her colleagues at Stanford studied 189,734 California patients diagnosed from 1998 to 2011 with early-stage breast cancer in one breast, ranging from Stage 0 (DCIS) to Stage 3.[4] The study showed that the percentage of women having both breasts when only one breast had cancer (called bilateral mastectomies) increased dramatically, but there was no advantage to that more radical approach. Instead, the women who underwent lumpectomies (removing only the cancer, not the entire breast) lived longer and were more likely to be alive 10 years after diagnosis compared to women undergoing a mastectomy. Women who had both breasts surgically removed did not live longer than those undergoing a mastectomy on one breast.

Compared to women in other countries, women in the U.S. who are diagnosed with early-stage breast cancer are more likely to remove both breasts even if only one has cancer. It is not known why bilateral mastectomy provides no medical advantage, but a study of more than 4,000 cancer patients by Dr. Fahima Osman at the University of Toronto indicates that having a healthy breast removed in addition to the breast with cancer increases the chances of medical complications.[5] Removing the healthy breast (“contralateral breast”) doubled the chances of having wound complications in the first month after surgery: from about 3% for women who had only the breast with cancer removed to about 6% for women who also had the healthy breast removed. About 4% of women who had a single mastectomy experienced some kind of complication (not necessarily wound-related) in the 30 days after surgery, compared to 8% of women who had both breasts removed. The risk of cancer in that healthy breast was already less than 1% per year unless the woman has a BRCA gene or some other very high risk factor.[6] Hormone pills such as tamoxifen or aromatase inhibitors can further reduce that already low risk.

The Bottom Line: these enormous studies of women in the U.S. and other countries make it clear that women with DCIS or early-stage breast cancer should undergo surgery to remove only the DCIS lesion or cancer, not the entire breast. The women who undergo lumpectomy with radiation usually live longer than those who undergo mastectomy or bilateral mastectomy. In addition, mastectomy patients who have breast implants are more likely to kill themselves compared to mastectomy patients without implants. Unfortunately, the fear of breast cancer and desire to “get rid of the problem” has resulted in too many women undergoing mastectomies or bilateral mastectomies that threaten their lives. Physicians and breast cancer advocacy groups need to make sure that patients understand why lumpectomy with radiation is a better idea.

For a free booklet on treatment options for DCIS, click here. For a free booklet on treatment options for early-stage breast cancer, click here.

References

Wong, S., Freedman, R., Sagara, Y., Aydogan, F., Barry, W., & Golshan, M. Growing Use of Contralateral Prophylactic Mastectomy Despite no Improvement in Long-term Survival for Invasive Breast Cancer. Annals of Surgery. 2016 March; doi:10.1097/SLA.0000000000001698
Marissa C. van Maaren, et al, “10 year survival after breast-conserving surgery plus radiotherapy compared with mastectomy in early breast cancer in the Netherlands: a population-based study”. Lancet Oncol. 2016 Aug; 17(8): 1158–1170. Published online 2016 Jun 22. doi: 10.1016/S1470-2045(16)30067-5
Hwang ES, et al “Survival after lumpectomy and mastectomy for early stage invasive breast cancer: The effect of age and hormone receptor status” Cancer 2013 April 1; 119(7); DOI: 10.1002/cncr.27795.
Kurian, Allison W., Daphne Y. Lichtensztajn, Theresa H. M. Keegan, David O. Nelson, Christina A. Clarke, and Scarlett L. Gomez. “Use of and Mortality After Bilateral Mastectomy Compared With Other Surgical Treatments for Breast Cancer in California, 1998-2011.” The Journal of the American Medical Association 2014; 312(9): 902-914. DOI:10.1001/jama.2014.10707
Osman, Fahima, et al “Increased postoperative complications in bilateral mastectomy patients compared to unilateral mastectomy: an analysis of the NSQIP database.” 2013 Oct; 20(10): 3212–3217. Published online 2013 Jul 12. doi: 10.1245/s10434-013-3116-1
National Cancer Institute. Breast Cancer Treatment (PDQ®). http://www.cancer.gov/cancertopics/pdq/treatment/breast/healthprofessional/page1

Angelina Jolie’s Decision

by Diana Zuckerman, PhD, president of the Cancer Prevention and Treatment Fund

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.

New Research Links Breast Augmentation to Breast Cancer Deaths

By Diana Zuckerman, PhD
May 2013

Women with cosmetic breast implants are more likely to die of breast cancer, according to new research published in the prestigious British Medical Journal. Combining research from 5 different studies, Dr. Eric Lavigne and his colleagues report that compared to other women with breast cancer, women who had breast augmentation surgery before they were diagnosed with breast cancer were 38% more likely to die from the disease. The authors explain that the implants interfere with mammography and by the time the cancer is diagnosed, it is often too late to cure.

In a separate analysis combining 12 studies, the same researchers found that women with breast augmentation who were later diagnosed with breast cancer were more likely to be diagnosed after the cancer had spread. However, the difference in death rates was more significant than the difference in the stage of diagnosis.

In studies funded by breast implant companies, researchers have claimed that breast implants are safe. This independent research is similar to other studies showing that breast implants show up as a large white shape on mammograms, hiding any cancerous tumors that are underneath.

For more information about the study, see a summary of the research in MedScape at http://www.medpagetoday.com/TheGuptaGuide/Oncology/38774 or read the official summary at http://www.bmj.com/press-releases/2013/04/30/cosmetic-breast-implants-may-adversely-affect-survival-women-who-develop-b

Reference:
Lavigne, E, Holowaty, E, Pan, SY et al, Breast Cancer Detection and Survival Among Women with Cosmetic Breast Implants, BMJ, April 30, 2013.

Breast implants as therapy? Not so much

By Diana Zuckerman, PhD
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.”

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 photoshoping, 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.

The rising trend of breast implants in America

Below of is the transcript of a TV interview that aired on BBC Persian on April 3, 2013. To view the segment (in Farsi) click here.

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.

Why have breast implants become so popular? In part, this may be due to the growing consumer confidence with advancements in implant technology and surgical procedure:

Dr. Byron D. Poindexter, board-certified plastic surgeon with The Austin-Weston Centre for Cosmetic Surgery in Reston, VA:

“We’re able to go through what’s relatively small incision down here probably about 4 centimetres at this point and you can squeeze this implant completely through with hardly any effort at all and it just comes out on the other side.”

But despite these innovations, breast augmentation remains a very intrusive and potentially risky operation. Some critics argue that that many patients are oblivious about these potential risks:

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. I don’t think there is an understanding that these are major surgical procedures and that they have the inherent risks of other procedures People for example don’t realize that 1 in 6 women who get implant actually lose sensation in their nipples they also don’t understand that 1 in 5 women need a re operation because of complications within 3 years of their implants.”

Pregnancy, breastfeeding, and weight loss can also take a toll on breasts, leaving them deflated and without volume. Breast implants can bring back that lost volume, but can it make a patient feel better inside about herself and her body 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.”

But what about cultural norms? For once, the fashion magazines aren’t to blame—if anything, they favour the flat-chested to concave look. Many major movie stars are also kinda small in the chest— so what is driving the demand?

Florence Williams:

“I think there’s no question that we live in a breast obsessed culture and in some areas that’s become less pronounced for example major movie stars but I think pornography is actually a major factor certainly there’s more availability of pornographic images now than ever before. I think a lot of young people grow up learning about the human body from the Internet this is really different. there are thousands of images of naked breast that boys and girls will see by the time they reach adulthood and so many of those breasts are not real, they’re either digitally enhanced or surgically enhanced. So I think there’s this incredible expectation on women themselves and also from men to look a certain way.”

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.

Will Breast Implants Improve Your Life?

by Diana Zuckerman, PhD

Despite the claims of plastic surgeons that breast implants improve patients’ self-esteem and quality of life, there is no scientific support for those statements. The only scientific data available are from studies conducted by two breast implant companies, Allergan (formerly Inamed) and Mentor. The companies were required to conduct the studies and provide the results to the FDA when the companies applied for FDA approval for their silicone gel breast implants. The FDA then reviewed the results and reported them in a summary for each company’s data that is on the agency web site.

The studies included questionnaires for women just before they got breast implants and two years later. The questionnaires included scientifically valid and reliable measures of self-esteem, self-confidence, and other measures of “quality of life,” including physical health, mental health, and social relationships. There were three types of patients that were separately studied by each company: breast augmentation patients, breast reconstruction patients (using implants to replace breasts lost to mastectomy), and revision patients. Revision patients were patients who already had breast implants that needed to be replaced with new implants, so they were studied when they had implants that had ruptured or caused other problems and were soon to get replacement implants, and two years after the implants had been replaced. The results of those studies are below.

In summary, for Allergan augmentation patients, 12 quality of life scores differed significantly in the pre-test (before implants) and post-test (2 years after implants). Nine of the 12 (75%) were worse after getting implants. For Allergan revision patients, 9 of 9 (100%) that differed significantly were worse after getting their replacement implants. For reconstruction patients, only two scores were significantly different after getting breast implants, and both showed improvement in physical functioning, which probably reflects the fact that many of these women were being treated for breast cancer at the pre-test and their quality of life was better as cancer survivors two years later.

Allergan (Inamed)

Here are the details from the FDA Summary for women with Allergan (Inamed) breast implants. (http://www.fda.gov/ohrms/dockets/ac/05/briefing/2005-4101b1_tab-1_fda-Inamed%20Panel%20Memo.pdf)

“With respect to the Health Status Questionnaire (SF-36 and MOS-20), the core augmentation cohort….There were small, statistically significant declines in some subscales of these measures in breast implant recipients over time. However, the 2-year values for the augmentation cohort were generally numerically higher than normative values for the general female population” (page 71).

Although the FDA summary does not mention it, most of the significant differences showed lower scores on quality of life after getting implants. Nine of 12 were worse for augmentation patients and nine of 9 were worse for revision patients.

Quality of Life measures include the SF-36, a scientifically valid measure of 8 health concepts: physical functioning; role-physical; bodily pain; general health; vitality; social functioning; role-emotional; and mental health. The 8 scales can then be collapsed into two summary scales with the first 4 scales comprising the Physical, and the last 4 scales comprising the Mental Health.

Inamed Augmentation Patients

All Statistically Significant Changes are as follows:

SF-36 Role Emotional: Significantly worse after getting implants
SF-36 Role Physical: Significantly worse after getting implants
SF-36 General Health: Significantly worse after getting implants
SF-36 Social: Significantly worse after getting implants
SF-36 Vitality: Significantly worse after getting implants
SF-36 Mental Health: Significantly worse after getting implants
MOS-20 Health Perceptions: Significantly worse after getting implants
MOS-20 Mental Health: Significantly worse after getting implants
Tennessee Self-Concept Scale: Physical Self: Significantly better after getting implants
Body Esteem-Total Score: Significantly better after getting implants
Body Esteem-Sexual Attractiveness: Significantly better after getting implants
Body Esteem-Physical Condition: Significantly worse after getting implants
Scores on the Rosenberg Self Esteem Scale were worse after getting implants, but the difference was not statistically significant.

Allergan Reconstruction Patients

SF-36 Role Physical: Significantly better after getting implants
MOS-20 Physical Functioning: Significantly better after getting implants

Inamed Revision Patients

SF-36 Role Emotional: Significantly worse after getting implants
SF-36 General Health: Significantly worse after getting implants
SF-36 Social: Significantly worse after getting implants
Mental Health: Significantly worse after getting implants
MOS-20 Health Perceptions: Significantly worse after getting implants
MOS-20 Mental Health: Significantly worse after getting implants
Tennessee Self-Concept Scale Physical Self: Significantly worse after getting implants
Rosenberg Self-esteem Scale: Significantly worse after getting implants
Body Esteem-Physical Condition: Significantly worse after getting implants

Mentor

Below are the data from the FDA Summary for women with Mentor breast implants (http://www.fda.gov/ohrms/dockets/ac/05/briefing/2005-4101b1_Tab-1_fda-Mentor%20Panel%20Memo.pdf)

Similar to the Inamed findings, when there were statistically significant changes from pre-test (before implants) to post-test (after implants) for Mentor patients, almost all were worse after getting breast implants compared to before getting implants. For augmentation patients, scores on physical health and mental health were significantly worse, scores on the Rosenberg self-esteem scale were better, and there was no change on the Tennessee self-concept scores or body esteem scale. For revision patients, scores on physical health, mental health, body esteem and Tennessee self-concept scale all were worse after getting breast implants, and there was no change in the Rosenberg self-esteem scale. No scores were better after getting their breast implants replaced, even though problem implants were replaced with new ones. For reconstruction patients, there were no significant changes on any of the scales.

The data below are not as detailed as the Allergan (Inamed) data, because the FDA memo did not provide as much specific information. However, it includes differences in scores that were provided by the FDA.

Mentor Augmentation Patients

Physical Health: Significantly worse after getting implants (1.0)
Mental Health: Significantly worse after getting implants (1.1)
Tennessee self-concept scores: No significant change
Body Esteem scale: No significant change
Rosenberg Self-Esteem Scale: Significantly better after getting implants (0.6)

Mentor Reconstruction Patients

Physical Health: No significant change
Mental Health: No significant change
Tennessee Self-Concept Scale: No significant change
Body Esteem Scale: No significant change
Rosenberg Self-esteem Scale: No significant change

Mentor Revision Patients

Physical Health: Significantly worse after getting implants (1.8)
Mental Health: Significantly worse after getting implants (2.5)
Tennessee Self-Concept Scale: significantly worse after getting implants (6.6)
Body Esteem Scale: significantly worse after getting implants (5.0)
Rosenberg Self-esteem scale: no significant change

FDA also noted the following about the literature review on Quality of Life information (provided by Mentor):

Page 70: “…the literature does not provide strong scientific support that breast implants have measurable psychological and psychosocial benefits for women seeking breast augmentation.”
Page 73: “Literature that adequately evaluates the short-term or long-term psychological or psychosocial benefits of breast implants as a reconstructive procedure utilizing appropriate control group was not provided by Mentor.”

In summary, whether women were getting breast implants for augmentation, reconstruction after having a mastectomy, or to replace breast implants that had broken or were not satisfactory for whatever reason, on most measures of the quality of their lives the women were worse after getting breast implants. There were a few improvements but they were outnumbered by aspects of their lives that they felt worse about or that didn’t change after spending thousands of dollars for plastic surgery.

Perfecting Bodies Through Chemistry?

by Diana Zuckerman, Ph.D.
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.

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.

For more information about the FDA’s recent decision on Allergan breast implants, see http://center4research.org/nrc-in-the-news/press-releases/statement-of-dr-diana-zuckerman-on-fda-approval-of-new-silicone-gel-filled-breast-implant-natrelle-410/.