All posts by BIeditor

Silicone: Now a Solid ‘Maybe’

We Are Quoted, , , ,
Melissa Healy, The Los Angeles Times: November 27, 2006.

The days before Thanksgiving are typically quiet in the offices of plastic surgeons. But a long-awaited decision to approve silicone breast implants for women older than 22 prompted a flurry of excited calls and inquiries last week from prospective patients. […]

The agency’s decision “does create a whole host of questions” for women considering silicone breast augmentation and for the doctors who perform those procedures, said Dr. Walter Erhardt, chairman of the American Society of Plastic Surgeons’ public education committee. […]

Cleared but questioned

The FDA’s approval — after 14 years of study — had been expected to end the controversy around silicone gel implants.

The devices were pulled from the general marketplace in 1992 amid concerns that they could rupture and endanger women, possibly contributing to autoimmune diseases. Although a link to health problems was never proved, long-term safety has remained an issue. In the meantime, the implants have remained available to cancer survivors and a wide range of women who agreed to enroll in studies of the implants’ safety.

But the new recommendations present patients and their plastic and aesthetic surgeons with additional uncertainties: Who will pay for the recommended MRI scans? What danger does the FDA foresee if patients, as expected, fail to get them? Does the FDA consider that a ruptured implant device — even one that presents no discomfort or proven danger to the patient — must necessarily be surgically removed and replaced? If so, whose financial responsibility would that be?

“Do you think [insurance companies] are going to say, ‘No problem, we want what’s best for the patient?’ ” asks plastic surgeon Marcel Daniels of Long Beach. “No. A lot of third-party payers have ruled out payment for any treatment — including complications — related to breast implants.”

What to do if those MRI scans detect cracks or breaks in an implant “is another conundrum that’s created by this [FDA] recommendation,” said Erhardt, of Albany, Ga. By calling for costly MRIs to detect silent ruptures and potential replacement surgery in such cases, the FDA is suggesting to patients and physicians that leakage may present safety concerns. “But we still don’t have science that [a silent rupture] creates a harmful situation for the patients. And the FDA hasn’t addressed that either,” Erhardt said. […]

The specialized MRI images required to detect the integrity of a breast implant typically cost between $1,500 and $1,800, said Diana Zuckerman, director of the National Research Center for Women & Families, a nonprofit research and education organization in Washington, D.C. Costs at some centers can reach up to $4,000, and many women would have to travel long distances to get the recommended images, added Zuckerman, whose organization testified against the latest silicone implant approval.

“These young girls are often going into debt that they can’t really afford to get out of, and they’re paying for something on installment that they can barely afford,” Zuckerman said. “I certainly think any woman who is not affluent would be crazy to choose silicone because of the additional cost.” […]

Read the original article here

FDA Ends Ban on Silicone Implants

We Are Quoted, , ,
David Brown and Christopher Lee, The Seattle Times: November 18, 2006.

The Food and Drug Administration ended its 14-year ban on the cosmetic use of silicone breast implants yesterday, despite lingering safety concerns from some health advocates.

The FDA is requiring that manufacturers tell women that the implants “are not lifetime devices” and that most recipients will need at least one additional surgery to remove or replace their implants. The agency is requiring the makers, Mentor Corp. and Allergan Inc., to conduct an extensive study of at least 40,000 implant recipients over the next decade and provide their findings to the government. […]

Silicone implants were first marketed more than 30 years ago, but a moratorium was placed on them in 1992 after many women who had received them reported pain, deformity and serious illness caused when the implants ruptured or leaked. At the time, the FDA concluded there was “inadequate information to demonstrate that breast implants were safe and effective.” A major implant manufacturer, Dow Corning Corp., was pushed into bankruptcy because of lawsuits stemming from the problematic devices. […]

Diana Zuckerman, president of the National Research Center for Women and Families, said the approval was the product of corporate lobbying rather than good science.

Zuckerman, a former Capitol Hill staffer who has worked on breast implant safety issues for more than 15 years, said too little is known about the long-term health risks of the implants. She said what is known indicates that some women will experience joint pain, chronic fatigue and leakage. […]

Read the original article here.

Reconstructive Breast Implantation After Mastectomy

Published Journal Articles
Diana Zuckerman, Commentary published in the Archives of Surgery: July 2006.

Henriksen et al provided useful data on the short-term complications of breast reconstruction with implants. Although the invited critique described the complication rate as “alarmingly high and arguably unacceptable,” the complication rate is even higher in other studies with superior study designs.

For example, a study conducted by implant manufacturer Inamed found that 46% of reconstruction patients needed additional surgery within the first 2 to 3 years after getting silicone gel breast implants – more than twice as high as the 21% reported by Henriksen et al. One explanation is that the women in the Henriksen study had breast implants for an average of only 23 months, compared to 2-3 years in the Inamed study. Henriksen et al reported that 31% developed at least one serious complication and 16% developed at least 2 serious complications. The Inamed study reported that 25% underwent implant removal, 16% experienced Baker III-IV capsular contracture, 6% experienced necrosis, 6% had breast pain, and 6% had scarring, in addition to infections and other complications.

Henriksen et al concluded that “reconstruction failure (loss of implant) is rare.” However, in addition to the short follow-up, Henriksen et al did not use Magnetic Resonance Imaging (MRIs) to detect rupture, thus under counting the number of ruptures according to the FDA. A study using MRIs found that 20% of reconstruction patients had ruptured implants by the third year; very few ruptures were detected without MRIs. Food and Drug Administration scientists concluded that the risk of rupture would likely increase exponentially every year.

Henriksen et al’s lack of MRI use also helps explain the lower rate of additional surgery. If a woman underwent an MRI and learned that her implant was ruptured, she would probably have surgery to remove it.

In his critique, Singh states that “the immunologic and systemic complications ascribed to implants (silicone or saline) have been debunked by the Institute of Medicine’s 1999 definitive report.” However, most research on diseases among implant patients was published after 1999. The IOM report included only 17 studies of autoimmune diseases among implants, almost all of which studied small numbers of women for short periods of time. Many of the studies reported higher levels of disease or symptoms among women with breast implants, which would have reached statistical significance if maintained in larger studies conducted for a longer period of time. For example, the study by Schusterman et al, included only 250 women with implants, all of whom had implants for 2 years.

In 2001, Food and Drug Administration scientists reported a significant increase in fibromyalgia and several other autoimmune diseases among women whose silicone gel breast implants were leaking, compared to women with silicone implants without extracapsular leakage. The National Cancer Institute (NCI) found a doubling of deaths from brain cancer, lung cancer, and suicides among women with breast implants compared to other plastic surgery patients. National Cancer Institute findings regarding autoimmune diseases were not definitive. National Cancer Institute scientists concluded that more research was needed to determine if implants increase the risk of cancer or autoimmune diseases.

The unanswered questions about diseases and the high complication rate for breast cancer patients raise important safety issues about breast implants. It is difficult for patients to receive informed consent when definitive long-term data are not yet available.

References:

1 Henriksen TF, Fryzek JP, Holmich LR et al Reconstructive breast implantation after mastectomy for breast cancer: clinical outcomes in a nationwide prospective cohort study. Arch Surg. 2005; 140: 1152-1159.

2 Inamed Corporation’s McGhan Silicone-Filled Breast Implants, October 14-15, 2003, slides presented by the FDA, http://www.fda.gov/ohrms/dockets/ac/03/slides/3989s1_02-update_files/frame.htm

3 Brown SL, Pennello G, Berg WA, et al. Silicone gel breast implant rupture, extracapsular silicone, and health status in a population of women. Journal of Rheumatology. 2001; 28:996-1003.

4 FDA Summary Memorandum, Inamed PMA Review Team, March 2, 2005., http://www.fda.gov/ohrms/dockets/ac/05/briefing/2005-4101b1_tab-1_fda-Inamed%20Panel%20Memo.pdf

5 Brinton LA, Lubin, JH, Murray MC, et al. Mortality among augmentation mammoplasty patients: an update. Epidemiology. 2006; 17: 162-169.

6 Brinton, LA, Buckley, LM, Dvorkina, O et al. Risks of connective tissue disorders among breast implant patients. American Journal of Epidemiology. 2004, 180: 619-627.

Invited Testimony of Diana Zuckerman, PhD, Before the Standing Committee on Health, Canadian Parliament, Ottawa, June 8, 2006

Testimonies and Statements by NCHR
Diana Zuckerman, PhD, National Center for Health Research

I am Dr. Diana Zuckerman, President of the National Center for Health Research. Our independent, nonprofit organization is a think tank that gathers and explains research information and uses it to improve the health and safety of women, children, and families.

I am speaking from the perspective of someone trained in psychology and epidemiology, who was a university faculty member and researcher at Harvard and Yale and taught courses in research methods before moving to Washington, DC to work on health issues in the U.S. Congress, U.S. Department of Health and Human Services, White House, and for nonprofit organizations.

I have read every published epidemiological study on breast implants and will briefly discuss what is known and not known, based on those studies. I will also tell you about a criminal investigation of one of the implant manufacturers, Mentor, and the many calls and emails we have received from women in Canada who are finding it impossible to have their leaking silicone gel breast implants removed in a timely manner.

Who conducts research on breast implants?

Clinical trials are a major source of information on the short-term risks of silicone breast implants. In clinical trials, the goal is to follow women prospectively to determine what complications and health problems occur, and to compare that to a control group. Although silicone implants have been on the market for 40 years, the only well-designed clinical trials have data for only 2-3 years and they do not include a control group. The clinical trials have been conducted by the implant companies as part of their effort to obtain approval to market the implants in Canada and the US.

Epidemiological studies are the major source of information about what actually happens to women who have breast implants for at least five years. Almost every published epidemiological study on breast implants has been paid for by companies that sell or sold breast implants. In fact, one company in the U.S. has received many millions of dollars from Dow Corning to conduct most of these studies, almost all of them in Europe, and every one of those studies has concluded that implants are safe. However, careful scrutiny of the results in the peer-reviewed articles indicates serious health problems among women with those implants. For example, one study reported that women with breast implants were significantly more likely to report breast pain and take anti-depressants, but still concluded that breast implants were safe.

More importantly, a small number of studies have been conducted by independent researchers, not using implant company funds or funds from plastic surgeons. These include government-funded researchers in Canada and the U.S. Their findings almost always indicate problems with implants that are in direct contradiction to the findings of the studies funded by implant companies. I will focus on their findings today.

What do we know about the health effects of ruptured silicone gel implants?

The FDA funded, designed, and conducted the best study on the health of women with ruptured silicone implants. FDA scientists concluded that most women with implants for 11 years or more have at least one ruptured implant, even if they don’t realize it. They also found that 21% of women with implants for at least 7 years have at least one implant that is leaking silicone outside the scar tissue, and that women with leaking implants were more likely to report fibromyalgia or several other painful and debilitating autoimmune diseases. The FDA study is superior to other studies because it focused on women who were basically happy with their implants, and who had implants for at least 7 years. That length of time is key. Other studies have included women who had implants for an average of 7 years — but not at least 7 years.

Most women who have had problems with rupture had implants for a long time — usually much longer than seven years.

Cosmetic Problems

More independently funded research is needed on the risks of ruptured silicone gel implants. Meanwhile, let’s look at some of the cosmetic results of silicone gel implant problems.

Here is a 29-year old woman who had her implants removed after 7 years. Her capsular contracture was so painful that she apparently preferred getting her implants out to keeping them in. This photograph is from the FDA’s website.

That is obviously not a good outcome, but here is a woman who wasn’t so lucky — Sharyn Noakes. Her ruptured implant had leaked into her healthy breasts. When the silicone was removed, this is all that was left of her breasts.

And this is Kathy Nye, a breast cancer survivor who suffered from necrosis and her implant extruded through her skin. Inamed reported a 6% necrosis rate among reconstruction patients in their Core study.

Signs and Symptoms

Now that you have seen some of the cosmetic problems, let’s take a look at the women’s symptoms. In data presented to the FDA, Inamed and Mentor both found that women with implants for only two years had a significant increase in auto-immune symptoms such as joint pain and nervous system symptoms. FDA asked a statistician to determine if this was due to aging. It wasn’t. And, these findings are consistent with what we have heard from thousands of women with silicone breast implants. Most were happy with their implants for years and never suspected that their increasing problems with fatigue or aches and pains might be related to their implants. The women’s personal experiences are not conclusive evidence, but they indicate a pattern that needs to be considered — especially since they are consistent with Inamed and Mentor’s own data showing an increase in autoimmune symptoms over a period of only two years on a cohort of young augmentation patients.

What do we know about the health risks of silicone gel implants more generally?

Aleina Tweed, an epidemiologist at the British Columbia Centre of Excellence for Research on Women, conducted a study of breast augmentation patients in Canada, most of whom had implants for 10 years or longer. She found that the women with implants visited doctors and specialists more often, and were four times as likely to be hospitalized, compared to other women the same age from the same communities.

Why has that important Canadian study received so little attention? Probably because no one was paid to do PR on the study. In contrast, studies funded by Dow Corning, the maker of silicone, have received enormous publicity. You may have heard that hundreds of studies, including studies at Harvard and the Mayo Clinic and a report of the U.S. Institute of Medicine, provide clear proof that breast implants are safe. However, the Institute of Medicine report is outdated – completed in 1999 and based on studies conducted before that. And, it was based on the other studies that are so often quoted, such as the Mayo Clinic study and the Harvard study – studies that were all funded by Dow Corning and other implant makers.

Almost all the studies included in the Institute of Medicine report suffered from the same shortcomings: they were too small, and they lacked statistical power because they included women who had implants for too short a period of time. For example, the Mayo Clinic study included only 749 women with breast implants, only 125 of whom were reconstruction patients. To be in the study, women had to have implants for at least one month. The average length of time was about 7.5 years, which means that only about 375 women had implants for more than 8 years. Since diseases like lupus, scleroderma, and rheumatoid arthritis are not very common among women in their 20’s and 30’s, this study doesn’t have the power to detect most of the diseases it measured. The authors themselves acknowledged that major shortcoming.

So, while I agree with the Institute of Medicine that there is not sufficient evidence to conclude that implants cause autoimmune disease, the report can’t be considered conclusive proof that implants don’t cause autoimmune disease.

The U.S. government has also funded some important studies of breast implants, and like the Canadian study, they tend to report serious health problems for women who have implants for a long period of time. The National Cancer Institute study found a doubling of brain cancer, lung cancer, and suicide. It is an exceptionally well-designed study, because all the women in the study had breast implants for at least 12 years. Another major strength of the study is that it compared women with silicone implants to women who underwent other kinds of plastic surgery, such as liposuction. This is important because all plastic surgery patients tend to be above average in health and income, but also tend to smoke more than other women.

How do the many implant studies funded by Dow Corning compare to the government funded studies in Canada and the U.S.? Many of the Dow Corning studies focused on women with implants for a short period of time, and at least one on women with ruptures for a short period of time. Many measured illness in terms of hospitalization rather than diagnosis. Remember that most women getting breast augmentation are in their 20’s or 30s, with many in their teens. Think of how unlikely it is that a 30-year old woman will be hospitalized for rheumatoid arthritis.

Inamed and Mentor Research Quality and Integrity

Inamed and Mentor both started clinical trials to analyze the safety of silicone gel breast implants in 1990. Both companies lost track of almost all of their patients to follow-up within 5 years. If only they had done a good job on those studies, we would have great long-term data today. But they didn’t, and so we don’t.

The companies both were given the opportunity to test their silicone gel implants on thousands of patients in the Adjunct Studies that they conducted. They enrolled thousands of patients and then failed to follow-up on most of them, making those studies useless.

Last year, shortly after Inamed and Mentor silicone implants were considered by advisory committees in Canada and the U.S., I heard from several Mentor employees who expressed concerns about the accuracy of the data that Mentor provided to the FDA, and also informed me that the patch used on Mentor implants leaks silicone and should be fixed. I contacted the FDA and arranged for the Mentor employees to speak to FDA officials. As a result, the FDA started a criminal investigation, interviewing me and several former Mentor employees. I was told several weeks ago that the investigation is still underway. I would be glad to put those former Mentor employees in touch with officials at Health Canada as well.

What does approval matter?

Although there are restrictions on silicone gel breast implants in Canada and the U.S., tens of thousands of women have continued to get them. Many of those women were not breast cancer patients.

Even so, approval matters. If Health Canada approves silicone gel breast implants, it will send a clear message that it believes that the implants are safe, and more teenage girls and women will certainly choose silicone implants as a result.

The study by Aleina Tweed shows that in Canada, women with breast implants have more health problems and their efforts to get well are costly to the Canadian system. Most of the women had at least one surgery to fix an implant problem, and 17% had four or more additional surgeries. Tweed’s findings are especially striking to us because our Center hears from many Canadian women with breast implants who tell us that they can’t get help from most Canadian plastic surgeons. Many have discovered — often after years of symptoms – that their implants are leaking. They need a plastic surgeon to remove them, and often can’t afford to pay for the surgery. But the waiting list is very long. We know a patient who contacted Dr. Mitchell Brown’s office this spring, because she heard he is an excellent surgeon who knows how to remove leaking silicone implants. She was told she would need to wait until December 2006 just to see him for a consultation. She was told that if she needed surgery, that would have to wait until December 2007. My staff found that hard to believe, so we also contacted Dr. Brown’s office more than a week later and we were told the exact same thing. My staff asked if there was a shorter wait if she could pay for the surgery, and we were told that the wait was much shorter.

We know several patients who tried to arrange surgery with other Canadian plastic surgeons. They were told that silicone would likely leak during the surgery and that they could be left looking deformed, They were discouraged from removing their implants, and told that at least they should replace them with new implants.

If Health Canada approves silicone gel breast implants, the number of teenagers and women needing to have leaking silicone implants removed will increase dramatically. To allow that to happen in a country where few plastic surgeons know how to remove leaking silicone gel breast implants, and those that do have very long waiting lists is not ethical or appropriate. And, according to Aleina Tweed’s research, it will cost the Canadian healthcare system dearly.

The full transcript can be viewed here

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

Implants, Mastectomies Linked to Problems

We Are Quoted, , ,
Lindsey Tanner, Associated Press: December 5, 2005.

Breast implants in women who have undergone mastectomies often result in complications that require more surgery, a study in Denmark found.

Over a period of up to four years, about one-third developed at least one potentially serious complication, including thick, tight scarring and infections, the researchers reported. Implant ruptures were rare, with only five reported among the 574 Danish women studied.

Overall, about 20 percent of the women studied required surgery to treat the problems, according to the study by Danish Cancer Society researchers and scientists at the International Epidemiology Institute in Rockville, Md.

One surgeon said in an accompanying editorial that the numbers are “alarmingly high and arguably unacceptable.”

The study appears in the December issue of Archives of Surgery. It was paid for by the institute, which receives funding from the Dow Corning Corp., a former maker of silicone breast implants.

Diana Zuckerman, president of the National Research Center for Women and Families, said the complication rate for implants in mastectomy patients is actually much higher than the study suggests.

Most participants got implants several weeks after breast removal surgery, whereas most U.S. mastectomy patients who choose implants get them when their breasts are removed, Zuckerman said. That method, involving a single round of surgery, is often easier psychologically because women wake up from their mastectomies with refashioned breasts, but it is also more stressful on the body, she said.

Also, she said the participants in the study did not undergo MRI scans, which are the best way to detect ruptures.

“This study is really missing the boat,” said Zuckerman, whose group has opposed efforts to return silicone implants to the market.

All of the women studied got implants, most of them made of silicone.

Silicone implants have been restricted in the United States for over a decade because of fears that ruptures and leakage might damage women’s health. But some mastectomy patients have continued to receive them.

The American Cancer Society estimates more than 200,000 U.S. women will be diagnosed with breast cancer this year. At least half will have mastectomies, and Zuckerman said about two-thirds of those patients choose some type of reconstructive surgery. […]

Read the original article here

Statement of Diana Zuckerman, PhD on FDA Approval of Breast Implants

Testimonies and Statements by NCHR
Diana Zuckerman, PhD, National Center for Health Research, September 21, 2005

Today the Food and Drug Administration (FDA) issued an “approvable letter” to Inamed Corporation for their silicone gel breast implants. Inamed Corp. was granted this first step in the approval process based on a revised application that is missing most of its breast cancer patients. After their application was rejected by the FDA a few months ago, Inamed belatedly decided to eliminate a defective style of breast implant (Style 153) from their application for approval. Unfortunately, two-thirds of the breast cancer patients in their study had this defective style of implant, which had a tendency to break even during the first three years in the body. When the company resubmitted their application, they removed those women from their study, apparently leaving fewer than 30 breast cancer patients who underwent MRIs to determine if their implants had ruptured or were leaking silicone. Yet the agency had asked that at least 250 breast cancer survivors be studied. In August, the Mentor Corporation also received an approvable letter.

STATEMENT –

“It is absolutely unacceptable to approve a breast implant that hasn’t been carefully studied to make sure it is safe for breast cancer patients. Sadly, this isn’t the first time — rival implant maker Mentor’s long-term data included zero breast cancer patients.

“The approvable letter was sent despite FDA scientists’ scathing criticisms of the company’s data and a vote from FDA’s advisory panel recommending that the implants not be approved. This action by the FDA once again raises questions about whether the agency is making decisions based on scientific evidence.

“This sounds familiar. Just a few weeks ago, the FDA ignored their own scientists when they refused to approve the morning-after pill for over-the-counter sales. Once again, the FDA is ignoring the concerns of their own scientists, this time potentially endangering breast cancer survivors.

“Only scientific evidence and solid safety data can protect women. Wishful thinking should not be a basis for approval.”

Safe Enough?

Published Newspaper or Magazine Articles
Diana Zuckerman, PhD, The Washington Times: August 28, 2005

How safe need an implant be before the Food and Drug Administration decides it is “safe enough” for a surgeon to put it in your body? The answer may surprise you.

Congressional leaders from both parties continue their scathing criticism of FDA for failing to protect consumers from unsafe medical products. Vioxx is the most obvious example but far from the only one.

The problem is not just prescription drugs. In just the last few weeks, the FDA announced the potentially fatal risks of heart valves and defibrillators. And, the FDA now seems poised to make another blooper, recently announcing their intention to approve silicone gel breast implants for the first time.

Pundits have had a field day, castigating women’s organizations for expressing concerns about a product that implant makers and plastic surgeons assure us is perfectly safe. They trot out flawed research and old reports to back up their claim, conveniently ignoring evidence that conflicts with their conclusions.

A cardinal rule of medical research is some products that seem safe at first may be found harmful years later. When the National Academy of Sciences first published a report on Agent Orange in 1974, for example, it concluded there was no clear evidence Agent Orange harmed Vietnam veterans. Years later, scientists concluded it causes birth defects and several types of cancer. Similarly, the first Institute of Medicine (IOM) reports of “Gulf War Syndrome” concluded war exposures had not caused health problems. Scientists now agree Gulf war veterans are at increased risk of ALS (Lou Gehrig’s disease), and possibly other fatal diseases.

In 1999, the IOM concluded there was no evidence implants caused diseases. Instead, they were concerned implants could break or interfere with mammograms, cause pain, or require additional surgery. They reviewed all the studies published, but many were of animals or cells. There were very few clinical trials or epidemiological studies of women with implants, and almost all were funded by Dow Corning, the company that makes silicone and commissioned the studies to avoid losing billions of dollars in legal settlements with implant patients who became ill.

As an epidemiologist, I realized the Dow studies were scientifically flawed. Since most cancers or autoimmune diseases take many years to develop and be diagnosed, the studies should have focused only on women who had implants for at least seven to 10 years. Instead, they included many women who had implants for only a few months or years. The studies also included small numbers of women who had implants for 25 years or more — but those “silly putty” breast implants were much thicker and more durable than the implants sold after 1980. It would not have mattered who paid for the research if it was well designed — but it wasn’t. That is why scientists wonder if the studies were designed to prove implants safe, rather than determine if they were safe.

In contrast, in studies funded by the National Cancer Institute or the FDA rather than implant makers, findings were dramatically different. By studying women who had breast implants for at least seven years, they included many women whose implants were possibly leaking. The results showed statistically significant increases in several cancers and autoimmune diseases. They also found a doubling of deaths from brain cancer and a tripling of deaths from lung cancer when women with implants were compared to other plastic surgery patients, even though the two groups are very similar in access to health care, smoking and other health habits that could influence disease.

When symptoms are studied instead of diseases, even short-term research reveals implant problems. In 2003 and 2005, the FDA scrutinized two breast implant makers’ research. A surprising number of patients were found to have pain, broken implants or other problems that required surgical removal of their implants within the first three years. Even more surprising, women were more likely to report autoimmune symptoms, such as joint pain and fatigue after having these implants for two years, compared to how they felt just before getting implants. Statisticians note these differences were not caused by aging.

In a recent rant in this newspaper, Steve Milloy accused me of frightening people about the risks of breast implants, and accused other women’s organizations of ignoring scientific evidence of the safety of implants. I would be happy to sit down with him and together examine every single study. Unfortunately, accurately describing research results sometimes frightens people. But what really frightens people is learning too late they can’t trust FDA-approved medical products, whether painkillers or implants.

Why are so many Americans harmed by FDA-approved products? It has been suggested companies sold products they knew were unsafe. In some cases, the FDA has been accused of ignoring the allegations or even actively helping to conceal them. For example, when the FDA closed its criminal investigation of Mentor, an implant maker, the agency compliance officer resigned in disgust and complained to the FDA commissioner. A congressional investigation continues into the matter, but FDA officials seem ready to approve breast implants before the ongoing congressional investigations are completed.

Are silicone breast implants safe enough for breast cancer patients? Are they safe enough for people you care about? Implant makers have flooded medical journals with articles claiming they are. The few government studies raise important, never-answered questions about long-term safety. The key question here is what does the FDA mean by “safe enough?”

 

Statement of Dr. Diana Zuckerman, President of the National Center for Health Research, Regarding the FDA Breast Implant Decision

Testimonies and Statements by NCHR
Diana Zuckerman, PhD, National Center for Health Research: July 28, 2005

WASHINGTON, July 28 /PRNewswire –The Food and Drug Administration (FDA) has issued an “approvable letter” to Mentor regarding their silicone gel breast implants. This does not mean that these implants have been approved, but it is a warning sign that corporate pressure on the FDA has once again put women’s health at risk.

The FDA letter is a stumbling step in the wrong direction, amid mounting questions about FDA decision-making. Approval would be an embarrassment unless the Senate and the FDA give Mentor a “clean bill of health” after thoroughly investigating allegations that Mentor misrepresented the rupture rate of its implants.

A Senate investigation of the Mentor safety data and the FDA approval process is currently underway, and concerns are growing. Just before the FDA announcement today, key women members of the U.S. Senate sent a letter to the FDA Commissioner, expressing their strong concerns about the lack of safety data on silicone gel breast implants. And, as the public learns about defective pacemakers, recalls of defibrillators and the dangers of several other medical devices, questions still remain as to how safe these breast implants are.

Every week we hear from women with leaking breast implants, who can’t afford the surgery to have them removed. FDA needs to make sure that they don’t approve a product that adds to this frightening situation for so many women across the country.

The FDA needs to listen to its scientists and demand more long-term safety data before issuing any kind of decision. They also need to make sure that the data they are given are accurate. The credibility of the FDA is on the line, as is the health of millions of women.

Dr. Diana Zuckerman is the president of the National Center for Health Research, a nonprofit research and education organization that works to improve policies and programs that affect the health and safety of women, children, and families. Dr. Zuckerman is a nationally-recognized health policy expert with post-doctoral training in epidemiology from Yale Medical School. She was on the faculty of Vassar and Yale, and a researcher at Harvard, prior to becoming a Congressional investigator in the U.S. House of Representatives, where she initiated the first Congressional hearing on the lack of safety data on breast implants, held in 1990. She is widely quoted on a wide range of health issues, especially FDA and medical products. For more information about the Center’s work, click here.

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

Breast Implants: A Woman’s Choice, But a Safe Choice?

Published Newspaper or Magazine Articles
Diana Zuckerman, PhD, National Center for Health Research, Fox News: April 25, 2005

Women have the right to buy products that will make them look better or feel better about themselves. Are silicone breast implants part of that inalienable right to choose?

The companies that make silicone breast implants, the plastic surgeons who use them, and the women who want them are all focused on that right, and angry that it has been restricted for the last 13 years. They question the motives of government officials, women’s organizations, and health advocates that question that right.

On the other side of the debate, consumer groups, public health advocates and others remind us that the Food and Drug Administration has the responsibility of approving medical products only if they are proven safe and effective. Implants are especially worrisome because it costs thousands of dollars to have them removed. If these products are risky or can break inside the body, that risk should outweigh the benefits.

Breast implants have become such a hot topic that pundits who otherwise wouldn’t talk about the FDA or women’s issues have gravitated toward the topic. Many pundits have become instant experts on the subject, even if they have never spoken to any woman about her implant experiences and never read any of the safety studies they quote.

But like most hot topics, this one is complicated. If you talk to women, read the research, and try to figure out why there are such strong opinions on both sides of the issue, you’ll find out why the controversy has continued for 15 years and is not yet resolved.

This is what we already know about breast implants:

Dozens of studies of women who had implants for a short time find no significant increase in diseases. Most of these studies are funded by companies with a financial interest in breast implants. Studies conducted by implant makers and analyzed by the FDA found that more than one in three patients report complications such as breast pain and hardness and the need for additional surgery within the first three years.

Only two studies have been conducted on the health of women with leaking silicone implants. One, conducted by FDA scientists, found a significant increase in fibromyalgia and other autoimmune diseases. A study funded by a silicone manufacturer found an increase in autoimmune symptoms such as fatigue and mental confusion but not in diagnosed diseases.

Studies conducted by the National Cancer Institute are the best-designed because they compare women who had implants for at least seven years to other plastic surgery patients and to women in the general population. They found that all plastic surgery patients, including breast augmentation patients, tend to be healthier and wealthier than women of the same age in the general population. Plastic surgery patients also have similar health habits.

However, compared to other plastic surgery patients, breast augmentation patients are twice as likely to die of brain cancer, three times as likely to die of lung cancer, and four times as likely to commit suicide. They are more likely to report autoimmune diseases, but their medical records indicate that patients are not always accurate in their reporting (for example, many women who report having rheumatoid arthritis actually have osteo-arthritis instead). These government scientists concluded that the results were inconclusive and more research was needed.

The testimony of women with breast implants was surprisingly consistent with these research studies. Many of the women praising their implants had them for just a year or two. The women who were testifying against implants usually had them for 10 years or more. Many spoke of being happy with their implants for years, and then slowly becoming disabled from chronic fatigue, mental confusion, and aches and pains at the ripe old age of 32. After years of being told that their illness was unrelated to their implants, they eventually had their implants removed, and only then learned that the implants had ruptured and were leaking.

Ed Brent, a widower from Atlanta, described his wife, P.J., as very happy with her implants for years. When she became ill, she sought medical treatment but none of the doctors were able to help her. Frustrated by the lack of effective medical care and feeling guilty because her children became seriously ill after she breastfed them with implants, P.J. Brent committed suicide.

Ed testified that after her death, doctors found exceptionally high levels of platinum in her blood, and in the blood of the children she breastfed after implants (but not those breastfed before). Platinum is a potentially toxic substance that is used to make breast implants. Research published last year found high levels in the breast milk, blood and urine of women with implants, compared to other women.

This is what we don’t know about breast implants:

We don’t know how long they last, although many studies suggest that 10-15 years is likely.

We don’t know how often they leak silicone outside the implant area, but the FDA estimates one in four women with leaking implants have such leakage. Will that eventually become 100 percent if a woman doesn’t have her implants removed? Nobody knows.

We don’t know what percentage of women will get sick from breast implants that are intact and what percentage will get sick from breast implants that are leaking. No studies have been done to examine that over time.

We don’t know if breast implants make most women feel better about themselves. According to the companies’ own studies, women who got breast implants two years earlier tend to feel worse about their lives and themselves, not better, than they felt before getting their implants.

Can women make an informed choice about breast implants? Most women who make a decision about breast implants get their information from their plastic surgeon, the implant maker’s patient booklet, or the Internet. The plastic surgeons tend to be very positive, the company brochures tend to be confusing, and the Internet has information ranging from extremely positive to extremely negative and everything in-between.

The bottom line: men and women have a right to choose safe medical products, and it is the FDA’s job to determine if a medical product is safe. Whether the product is a painkiller, an anti-depressant, or a breast implant, FDA approval should be made on science, not wishful thinking or philosophical musings about choice.

Read the original article here. 

 

Silicone Implants Backed by FDA Panel

We Are Quoted, , , , ,
Marc Kaufman, Washington Post: April 14, 2005.

A Food and Drug Administration advisory panel recommended yesterday that silicone gel breast implants made by Mentor Corp. be allowed back on the market for wider use — a surprise decision that came a day after the same panel rejected the application of a rival company.

Mentor officials were delighted by the panel vote.

In explaining their decision, several panel members said they were more impressed by Mentor’s data on how and why implants rupture and by the lower rupture rate of its implants. While Inamed reported a yearly ruptue rate of about 1.4 percent, the yearly Mentor rate was 0.2 percent — a figure that had been questioned by FDA reviewers.

The panel decision was sharply questioned by Inamed officials, who had been criticized the day before for not having sufficiently long-term data.

“Inamed views today’s panel decision as curious and inconsistent with the decision reached by the panel yesterday on Inamed’s [application] — we look forward to working with Dr. [Lester M.] Crawford and FDA staff on addressing these inconsistencies,” Inamed president and chief executive Nicholas L. Teti said in a statement.

About 260,000 American women had their breasts enlarged with implants last year, and an additional 60,000 had received them after surgery for breast cancer.

Because of health concerns, the FDA in recent years has allowed silicone gel implants to be used only in women who had mastectomies and in some who take part in clinical trials; all others received implants filled with a saline solution. Many women say the silicone gel looks and feels more natural, and it is widely used in other parts of the world.

The panel’s decision was also criticized by some public interest groups, which have long argued that the potential dangers of silicone gel implants remain insufficiently studied.

“I think this was a triumph of wishful thinking which overruled the lack of science,” said Diana Zuckerman, president of the National Center for Policy Research for Women and Families. “Because of all the conditions, it’s far from a done deal regarding the FDA. It’s not helpful to women to have a product approved on the basis of two years of safety data.”

[…]

Read the original article here.