Category Archives: We Are Quoted

FDA: Breast Implant Safety Studies Will Continue

After two days of testimony on what the FDA should do about troubled long-term safety studies of silicone-gel breast implants, agency officials said the studies would continue.

“The current post-approval studies will continue,” said William Maisel, MD, MPH, chief scientist in the FDA’s Center for Devices and Radiological Health, in remarks after the meeting. “The FDA is committed to seeing them completed and making sure the follow-up rates improve.”

The safety studies in question, of nearly 100,000 women with breast implants, which the FDA said were the largest ever required of manufacturers after their devices were marketed to the public, have lost track of up to 79% of the women they enrolled just three years into planned 10-year efforts.

As a result, FDA epidemiologists testified yesterday, the studies had lost the ability to find rare complications, including connective tissue diseases, that they were designed to look for. […]

Consumer advocates, like Dana Casciotti, PhD, the public health research director at the Cancer Prevention and Treatment Fund, said annual, 27-page questionnaires women were asked to complete should be shortened and simplified.

“I’ve seen copies of these questionnaires, and they are much too long” and technical, she said.

Read the original article here.

25 Reasons Not to Get Breast Implants

Dr. Nalini Chilkov, The Huffington Post: Dec 7, 2017

Last week the FDA reported that breast implants put women’s lives in danger. The big news last week was that a small number of women can get a very rare type of cancer (ALCL: anaplastic large cell lymphoma). It confirmed that death is a possible side effect of breast implants. […]

According to Diana Zuckerman, Ph.D., Elizabeth Nagelin-Anderson, M.A.
and Elizabeth Santoro, R.N., M.P.H.: In 2008, more than 300,000 women and teenagers underwent surgery to have their breasts enlarged with silicone or saline implants, and almost 80,000 breast cancer patients had reconstruction after mastectomy, often with implants. The popularity of breast augmentation has more than tripled since 1997, when there were just over 101,000 of these procedures. More than 40,000 implant removal procedures were also reported in 2008. […]

In a study conducted by FDA scientists, most women had at least one broken implant within 11 years, and the likelihood of rupture increases every year. Silicone-7 migrated outside of the breast capsule for 21 percent of the women, even though most women were unaware that this had happened.

Don’t forget the financial burden and increased health insurance costs that go with multiple surgeries and medical complications. In some cases the surgery to remove implants can be like a mastectomy, complete removal of the breast tissue and sometimes the muscle underneath.

Read the original article here.

 

Former Playmate of the Year on Removing Breast Implants: ‘I Literally Thought I Was Dying’

Kris Pickel, AZ Family: May 4, 2017

Karen McDougal
Karen McDougal

It wasn’t a decision Karen McDougal took lightly.

As a former Playboy Playmate of the Year, her career is built on beauty and fitness, but McDougal says her health deteriorated to the point she felt like she was going to die.

In January, McDougal made the decision to explant & have her breast implants removed.

McDougal says she battled health problems – issues she now believes stemmed from her implants — for more than a decade. Her health issues began eight years after she got her implants.  McDougal said she would get sick for six to eight weeks at a time, get better for a month or two and then get sick again.

It became a running joke among McDougal’s family and friends that she was the “healthiest sick person.”

For a decade, doctors failed to diagnose the cause of her sickness.  She said one doctor told her she was suffering from depression. Another told her that her implants looked great there was no need to replace them. […]

I talked to Dr. Diana Zuckerman, the president of the National Center for Health Research in Washington, D.C. She has a long history on breast implant safety.

“From 1983 to 1993, Dr. Zuckerman worked as a Congressional staffer in the U.S. Congress, working for the House subcommittee that has oversight jurisdiction over the U.S. Department of Health and Human Services, including the FDA,” according to her biography on BreastImplantInfo.org. “She was responsible for more than a dozen Congressional investigations and hearings on a wide range of health issues, including the first Congressional hearings on breast implants. It was Dr. Zuckerman’s congressional investigation of breast implants that first raised questions about the lack of safety data, which led to the FDA requiring safety studies of silicone gel implants in 1991. When the companies did not provide evidence that implants are safe, the FDA restricted their availability in 1992.”

Zuckerman said many studies over the years have been funded by organizations representing plastic surgeons and implant makers, all of which have a financial interest in making implants look safe.

She says the companies and organizations sometimes help shape studies with results that are not scientifically valid.

Zuckerman also said some studies might have been manipulated in a number of ways.

“I’ve spoken with some of the women in some of the studies who said as soon as they started complaining to their plastic surgeon about how sick they were feeling, suddenly they stopped hearing from the plastic surgeon about coming in to continue the study,” she said. “Suddenly, they weren’t in the study anymore. One very effective way to have studies proving that a product is safe is to just get rid of the patients in the study who aren’t feeling well — just stop talking to them and stop asking them how they are.”

Zuckerman said there are additional problems with some studies, including basing data on hospital records when most symptoms of chronic illnesses, such as fatigue and hair loss, do not require hospital stays. Also, many studies are done over short periods of time, between two and five years after the implant surgery, when illness may not start showing until several years later.

Zuckerman says if a woman decides to have her implants removed, there is a specific procedure. The implants must be removed with the scar tissue that forms around each implant, the capsule, still in place.

Read the full article here.

FDA Agrees with WHO, Links Breast Implants to Rare Cancer. How Worried Should Women Be?

Rita Ruben, Forbes: March 22, 2017

The Food and Drug Administration has received nine reports of women dying of a rare blood cancer years after getting breast implants, according to information the agency released Tuesday.

The FDA says it now agrees with the World Health Organization that such cases are linked to the breast implants and not some unfortunate coincidence. As of Feb. 1, the FDA says, it had received a total of 359 reports of breast implant-associated anaplastic large cell lymphoma (BIA-ALCL).

The FDA reports suggest that implants with a textured surface are more likely to be associated with the cancer than smooth implants—of the 231 reports that contained information about the implant’s surface, 203 were reported to be textured implants, while 28 were reported to be smooth. The Australian Therapeutic Goods Administration (TGA) analyzed 46 confirmed cases of BIA-ALCL, including three deaths, and none of the cases occurred in women with smooth implants.

BIA-ALCL on average is diagnosed about a decade after implant surgery, according to the WHO. The first reported case of a woman with breast implants developing ALCL was published in a 1997 letter to the journal Plastic & Reconstructive Surgery. While that case was a woman with saline-filled implants, the FDA says the filling, be it saline (salt water) or silicone, doesn’t seem to make much of a difference, although no well-designed studies have yet been conducted to settle that issue.

BIA-ALCL is rare, but just how rare isn’t clear. As the FDA notes, it medical device reports can’t answer that question, because they don’t represent all cases, and the denominator—the total number of women who’ve received breast implants—isn’t known.

ALCL is more common in the breasts of women who’ve had implants than in those who don’t have implants, in whom the cancer almost never develops in the breast. A U.S. studypublished in January concluded that over their lifetime, 3.3 women out of every 100,000 with textured breast implants will develop BIA-ALCL. But the TGA estimates that the disease is more common, affecting 1 in 10,000 to 1 in 1,000 women with breast implants (that agency says it has received no reports of BIA-ALCL in women with smooth implants).

“There is no reason to think it is less likely to develop in women in the U.S., and given the dramatic increase in diagnoses in recent years, it is clear that it was under-diagnosed and under-reported for many years,” Diana Zuckerman, a health advocate who has long questioned the safety of breast implants, told me.  Zuckerman serves as president of both the National Center for Health Research and the Cancer Prevention and Treatment Fund, nonprofits based in Washington, D.C.

Read the full article here.

Can Breast Implants Cause Cancer? WJLA Investigates


“You have cancer — again.”

“What? Breast cancer?”

“No … a new one.”

So went the conversation between a stunned 40-year-old Raylene Hollrah and the plastic surgeon who performed her reconstructive surgery after she survived breast cancer seven years earlier.

Her new cancer diagnosis? Breast Implant-Associated Anaplastic Large Cell Lymphoma, or BIA-ALCL for short. Of all the potential side effects of breast implants, she did not recall her surgeon ever mentioning a small but increased risk of cancer.

“I did everything to keep cancer away,” Hollrah told 7 On Your Side. “Yet, I put a device in my body that caused cancer.”

The US Food and Drug Administration is not prepared to say that the textured breast implants Hollrah chose cause lymphoma, a cancer of the immune system.

But in 2011 and again in 2016, the FDA cautioned of a “possible association” between ALCL and implants.

“This has created a certain amount of anxiety and concern among the medical community,” said Dr. Mark Clemens of MD Anderson Cancer Center, one of the leading experts on ALCL in the world.

Clemens met Hollrah after her diagnosis, explanted her implants and asked her questions about what she was told and when. His research, and others of patients and surgeons, reveals that patients never think to ask about ALCL and only one-quarter of surgeons always discuss the risk with patients in the initial consultation.

“We would like surgeons to always discuss the small, rare, but potential risk of this serious disease,” said Clemens, who serves on the board of the American Society of Plastic Surgeons (ASPS) as the liaison to the FDA. ASPS urges its board-certified members to always talk to patients about the risks as part of the informed consent process.

When 7 On Your Side filed a Freedom of Information Request (FOIA) about ALCL cases reported to the FDA, we received more than 800 documents representing 441 cases, more than one-third unconfirmed, and at least 12 deaths. Even since the 2011 advisory from the FDA about ALCL and implants, when manufacturers responded to reported adverse events, they often listed many risks but didn’t include ALCL.

“They should. Absolutely,” said Madris Tomes, CEO of Device Events, and a former FDA analyst who managed the build of a new adverse event reporting system. Tomes looks for patterns of problems with medical devices, but spotty reporting makes pinning down exact numbers for ALCL tricky.

Whether silicone or saline, Song explained why patients choose textured implants. They have a more natural, teardrop look, thinner at the top, thicker at the bottom. Texturing is intended to keep them from rotating. Researchers are evaluating whether that texturing, or a bacteria, or genetics make a patient more vulnerable to developing lymphoma.

7 On Your Side spoke with a leader in the field of women’s health, Diana Zuckerman, PhD, President of the National Center for Health Research. Zuckerman was our chief source for information about the risk of suicide after implants. Regarding BIA-ALCL, she wrote:

“It is not true that textured implants are the only ones associated with BIA-ALCL. This summary of a recent medical journal article clearly says that “most women with ALCL have at least one textured implant” but that doesn’t mean they all do.

Read the entire article here.

The above article was published in February 2017. In August 2014, the National Comprehensive Cancer Network (NCCN), a nonprofit alliance of leading cancer centers, provided guidelines for the diagnosis of “breast implant associated ALCL (BIA-ALCL), based on clear evidence that breast implants can cause ALCL.  In 2017, the World Health Organization (WHO) and the Food and Drug Administration (FDA) both issued statements confirming that breast implants can cause ALCL.  To read about the FDA’s 2017 report on breast implants and ALCL, click here (insert hyperlink to http://www.breastimplantinfo.org/implantalcl/)

Can Having Breast Implants Lead to Suicide? 7 On Your Side Investigates

Kimberly Suiters, WJLA ABC7: November 7, 2016

Three-hundred thousand women will get breast implants this year, making it the number one cosmetic surgery in the U.S. Research shows the typical breast implant patient has high self-esteem and good mental health, higher and better than the general population. According to implant manufacturers, satisfaction rates top the 83-97 percentile range, excellent results for any kind of surgery. So why would some women with breast implants have a higher rate of suicide than women who don’t have them?

“Maybe just a coincidence,” Dr. Scott Spear, a well-known plastic surgeon in Washington, D.C., told 7 On Your Side. “There may be an association between breast implants and suicide, but it’s probably a loose association.”

That’s not the way Diana Zuckerman, PhD, president of the National Research Center for Women and Families, sees it. Not at all.

“When you look at suicide and implants, the women with breast implants are more likely to kill themselves.”

How much more likely? Anywhere from two to 12 times. Zuckerman wrote about that conclusion after evaluating seven studies on the topic.

“Some surgeons believe if a woman with implants kills herself, she must’ve had something wrong to begin with; that she got implants because of low self-esteem, depression, to feel better. But women with implants are more likely to kill themselves than with other (plastic) surgeries. Why would a mastectomy patient be 10 times as likely to kill herself as a mastectomy patient who doesn’t have implants?”

Zuckerman doesn’t know that answer definitively, but she is convinced there is something physiological or mental that causes women with implants to have a diminished view of themselves.

The number of women who get to that tragic point is small. According to the CDC: 9.8 women per 100,000 will commit suicide. And middle-aged women, in general, had the largest increase in suicide in the last 15 years, up 63 percent.

Dr. Zuckerman said women going through menopause are one of the highest risk groups. Their bodies have changed after giving birth, and they may be lured in by “Mommy Makeover” marketing.

“But according to research,” she said, “it’s a bad time. A dangerous time.”

[…]

Read the original article here.

FDA Aims To Speed Clinical Trials, Improve Device Safety Through Post-Market Evaluation, But Funding A Hurdle

Inside Health Policy: February 16, 2016

FDA’s device center chief Jeff Shuren, in an interview with Inside Health Policy, highlighted the benefit a robust National Device Evaluation System could have in bolstering the agency’s ability to monitor devices in real-time to better inform the risk-benefit profile of approved products. Such a system, he said, could also help in the premarket approval phase to reduce the clinical trial burden on manufacturers and get products to market faster.

The program is a high priority for the Center for Devices and Radiological Health within FDA. It was recently listed in CDRH’s 2016-2017 priority agenda, and FDA in the fiscal 2017 budget requested $1.8 million in funding to help establish the system as part of President Barack Obama’s Precision Medicine Initiative. The agency will hold a public workshop in March on the effort.

The goal for FDA, according to Shuren, is to move past the traditional scope of a national surveillance system and launch a program that would allow the agency to more accurately track and analyze the use of medical devices in a real-world setting and better understand the benefits and risks of specific products outside of the clinical trial setting.

[…]

Sources point to a lack of funding as a main reason for FDA’s inability to effectively monitor medical devices in the postmarket setting. Some stakeholders pointed to the disparity in user fees between the drug and device centers as a main reason for the lack of available resources, but others defended the amount of money the device industry currently provides as reflective of the gap in market caps between large manufacturers and smaller device start-ups.

Sources say industry is lukewarm on providing additional resources for postmarket in the pending user fee reauthorization agreement, which has led patient and consumer groups to turn their attention to Congress in the hopes that additional funding for the agency’s postmarket goals will be included in next year’s spending bill.

“I think more money is problem number one and without more money the agency is never going to do a good job,” Diana Zuckerman, president of the National Center for Health Research, told IHP.

Stakeholders have suggested the medical device user fee process is more difficult to navigate than the sister program in the drug center, given the financial disparity in the medical device industry between the large corporations and smaller start-ups. Zuckerman, however, argued that no one is expecting a small device company to pay millions in user fees to cover something like postmarket surveillance.

“There are many small companies and, yes, small companies should have user fees that are affordable, but the medium, large and extra-large sized device companies could be paying a lot more,” she said.

Johnson & Johnson, for example, pays roughly $2.4 million in user fees for a new drug application, sources say, and only $5,000 for a 510(k) submission. A spokesperson for J&J did not respond to inquiries.

Increasing the amount of user fees for the large companies, sources say, could help fund FDA’s postmarket surveillance goals. Sources familiar with the user fee discussions tell IHP, however, that the medical device industry, in particular the Advanced Medical Technology Association, has rejected the notion that industry should have to pay more for faster approvals.

[…]

Read the original article here.

Breasts, Buttocks and Botox – The Surprising Trends in Plastic Surgery

Chris Harris, Euronews: March 6th, 2015

[…]The number of US teenagers putting themselves forward for cosmetic procedures is on the rise – 224,000 13-19 year olds had work done on them in 2014, a jump of 2 percent on the previous year.

The most popular jobs were nose reshaping, male breast reduction, ear surgery, laser hair removal and laser skin resurfacing.

ASPS says parental consent is required for operations on teenagers under 18.

Diana Zuckerman, president of the National Center for Health Research, said: “There is no question that reconstructive surgeries can benefit children and youth. Surgical procedures to correct cleft lips and palates, for example, are not controversial. Plastic surgery to correct unattractive facial features that can attract ridicule, such as prominent noses and ears, are generally accepted in the United States.

“However, cultural phenomena such as surgical makeovers on numerous television programs and unrelenting pressures on teens to conform to beauty standards make it increasingly difficult to agree on what constitutes a “normal” appearance and when the desire to improve one’s appearance is questionable or even crosses the line to psychopathology.”

Read the original article here.

Breast Implants as Therapy? Not So Much

Diana Zuckerman, PhD, National Center for Health Research: 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.

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

Breast Cancer Survivors Making Surgery Decisions With Limited Information, Says New Report; Former Director of FDA Office on Women’s Health Speaks at Release of ‘Decisions in the Dark’

February 03, 2006

Breast Cancer Survivors Making Surgery Decisions With Limited Information, Says New Report;

Breast cancer survivors who undergo reconstructive surgery using silicone implants have access to very little research-based information about the likely risks, according to a report released today by the National Research Center (NRC) for Women & Families. Dr. Susan Wood, former director of the U.S. Food and Drug Administration’s (FDA) Office of Women, was a speaker at a National Press Club Newsmakers’ event where the report was released.

Decisions in the Dark: The FDA, Breast Cancer Survivors, and Silicone Implants warns that industry-funded data indicates that reconstructive surgery patients experience substantially more complications, ruptures and a greater need for additional corrective surgeries than women who receive implants for augmentation purposes. The report also highlights FDA research showing that silicone implants interfere with mammography and may limit future breast cancer treatment options such as lumpectomy and sentinel node biopsy.

The report reveals that:

* After selling silicone breast implants to tens of thousands of mastectomy patients in the last 5 years, under the conditions that they participate in clinical trials, implant manufacturer Implant included only 80 mastectomy patients in their longitudinal safety study submitted to the FDA, and Mentor Corporation included 0 breast cancer patients in their only long-term study;

* Industry-funded research reveals that reconstruction patients experience two to three times as many complications and additional surgeries as augmentation patients;

* Most ruptures (86 percent) are “silent” and can only be detected with MRIs, yet Inamed included less than 30 women in their sample of breast cancer patients undergoing MRIs to determine rupture rates, and the medical societies for plastic surgeons do not advise women to undergo MRIs.

* Research consistently indicates that reconstruction patients are not enjoying life more than mastectomy patients without reconstruction, and there is evidence they may be more likely to commit suicide; and

* Breast implants can limit treatment options for later breast cancer.

“For a woman to survive breast cancer and then find herself facing additional surgeries because of a poorly tested product is terribly unfair,” said Dr. Diana Zuckerman, President of the National Center for Health Research, and author of the report. “It’s critical that implant manufacturers include breast cancer survivors in their research, and that they carefully test for any adverse health impacts that occur over the lifetime of these devices.”

“It is disturbing that the FDA would consider approving these devices despite the lack of data for breast cancer patients,” said Dr. Susan Wood, former director of the FDA’s Office of Women’s Health.

The report focuses on the lack of adequate short- or long-term clinical data being provided to the FDA by implant manufacturers for all breast cancer patients. However, those least represented in the current research are women of color, such as African American, Asian and Hispanic breast cancer patients.

“We have good reason to believe the medical experiences of these women differ from those of white patients,” said Bettye Green, RN, President of African American Women in Touch and a breast cancer survivor and nationally- respected advocate who spoke at the event. “Women need better information about implants and their long-term safety and effectiveness so that they can make informed choices about the risks of reconstructive surgery.”

Pam Noonan-Sarceni, a breast cancer survivor, said she would not have chosen silicone implants had she known years ago what she knows now. “I trusted my doctors when they told me the implants were safe and would last forever.”