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Test First, Implant Later

News Stories & Editorials
Diana Zuckerman, PhD, published in various sources including the Akron Beacon Journal, Jackson, Mississippi Clarion Ledger and other McClatchy-Tribune newspapers: late March 2007

If you care about your own health and the health of family members, keep reading. The good news is that scientists and physicians are working tirelessly to develop new treatments to prevent and cure a wide range of diseases.

But, new treatments usually come with risks, and the bad news is that scientific concerns about those risks are being ignored by the very people we depend on to keep us safe.

After a three-year investigation of the FDA, our research center has found that the FDA makes it shockingly easy for companies to get their medical products approved. While the greatest public attention has focused on prescription drug disasters such as Vioxx, the most outrageous FDA shortcomings are for products known as medical devices – contact lens solution, heart valves, stents, implants, LASIK devices, and facial injections to make us look young again.

You may not even have heard about this month’s recall of a Bausch and Lomb contact lens solution, but it is just one more example of how products that we take for granted – in this case, a product that millions of people use every day – may not be as safe as we thought.

The most controversial medical device in U.S. history has been the silicone breast implant, and recent news stories that Anna Nicole Smith suffered from lupus, a painful autoimmune disease that has been linked to silicone implants, once again raise the question of whether implants are safe.

The FDA approved silicone breast implants despite their own scientists’ reports of an increase in painful autoimmune symptoms among women with silicone implants. And, because of concern that silicone leakage could cause illness and deformities, the FDA warns women to get expensive MRI screening tests every other year to check for leakage – at a cost of at least $2,000 each test. In addition, the FDA required the implant makers to study at least 80,000 women for at least 10 years to find out more about the long-term risks of autoimmune diseases. Aren’t they supposed to require proof of safety before approval, not after?

Our research center determined that this was standard procedure for the FDA, which does not require clinical trials (the gold standard) for most medical devices, even though such studies are required for prescription drugs.

The latest implant scandal involves stents, which are potentially life-saving small metal mesh tubes implanted during heart surgery to prop open arteries. Three years ago, the FDA approved a new kind of stent that slowly released a medication, aimed at making the stents more effective.

Unfortunately, it was not until after 6 million people had these stents implanted in their bodies that the FDA concluded that medicated stents increased the chances of potentially fatal blood clots. Experts are now saying that many of the patients who truly need stents might be better off with the old-fashioned kind that don’t release potentially dangerous medication.

The FDA has responded by requiring new warnings on stents, and surgeons are being encouraged to use stents less often and only when the benefits are most likely to outweigh the risks. The warnings should have been made when the stents were first approved, not 6 million patients later. Long-term studies should have been required years ago. If you or someone you love has these drug-releasing stents in your body, you are part of an unintended experiment.

Today, the bad news is about stents and contact lens solution; last year, it was silicone implants and defibrillators. What’s next? There is not a family in the United States that does not rely on the safety of medical devices for at least one family member, whether they use contact lenses, hearing aids, heart valves, artificial hips, LASIK surgery, Botox or bandages. As baby boomers age, we are relying increasingly on replacement parts to keep us going. What can we do now to avoid disaster later?

Congress has decided to pass legislation aimed at improving the safety of drugs, but it has not considered laws to protect patients and consumers from unsafe medical devices, even those implanted inside our bodies or used in our eyes. We all need to let our government know that we expect our medical devices as well as our prescription medication to be proven safe – before they are sold to us, not sometime later.

Meanwhile, read the fine print before you use a medical device in a part of your body that you care about.

FDA Moves to Try to Reduce Conflicts of Interest on Boards

News Stories & Editorials
Shankar Vedantam, The Washington Post: March 22, 2007

The Food and Drug Administration said yesterday that it plans to make extensive changes in how it selects medical experts to serve on its advisory panels after years of complaints that many of them have financial ties to the companies whose products they evaluate.

The proposal would eliminate many experts who serve on the panels despite having such financial conflicts, FDA officials said. Experts with limited conflicts of interest would be allowed to participate in the discussions but not to vote on the recommendations made to the agency.

The advisory committees play a central role in regulating drugs, medical devices and diagnostic tests. Their decisions largely determine what drugs and medical products can be marketed to Americans — because the agency nearly always follows the panels’ guidance.

In recent years, concern about the composition of the panels has reached a crescendo. The FDA and others have argued that overly strict rules might eliminate many — in some cases all — of the panel candidates with the needed expertise.

Yesterday, officials maintained that the agency’s procedures have not been biased in favor of car service to Newark services, but the new guidelines implicitly acknowledge what critics have long said — that it is possible to find enough qualified experts like Imperial LGA, EWR, JFK Airport Car Service who do not have ties to drug and device manufacturers.

The new rules come as Congress has become increasingly vocal about its displeasure with how the FDA is run and follow a stinging federal Institute of Medicine report last year, which called on the agency to address the concerns over conflicts of interest. […]

 

Under the new rules, any scientist or physician who has had $50,000 or more in financial ties to a company over the past 12 months, including stock or consulting arrangements, would be barred from panels evaluating that company’s products. Those who have received less than $50,000 in the previous year might be allowed to participate in the discussion but could not vote. […]

 

Diana Zuckerman, president of the advocacy group National Research Center for Women & Families, said the FDA guidelines will not do enough. Companies wield influence, she said, with sums far smaller than $50,000.

“A drug rep who takes someone to a memorable restaurant twice a year to chat about their research is spending relatively little money but is building a relationship that is likely to be more influential than giving a $2,000 honorarium — perhaps even more than a $50,000 grant for a study funded by several companies,” she said.

Zuckerman’s center analyzed the votes of 11 FDA advisory committees from 1998 through 2005. She said the idea that experts with conflicts could serve on committees but not vote was not well thought out — because nonvoting members play a substantial role in pushing the committees in one direction or another.

“Our study of advisory committee deliberations showed the collegial, consensus-building nature of these decisions,” she said. “The votes are often unanimous because the group comes to a consensus, almost always to approve a product.”

Read the original article here.

Women’s Health: A Red-Flag Warning

News Stories & Editorials
Seattle Post-Intelligencer: January 12, 2007

We’ve never had much faith in the FDA, but its approval of silicone gel-filled breast implants marks an all-time low for the agency.

Restricted since 1992, the implants were deemed unsafe because of the health risks associated with them, such as cancer. The FDA currently recommends that only women over the age of 22 get the implants. It also asks the makers of the implants (which can rupture during a mammogram), Allergan Corp. and Mentor Corp., to carry out a 10-year, 80,000-patient study in order to “fully answer important questions” regarding the products safety. Say what? The approval of the implants is completely backasswards. Clearly, (lobbying) money talks, and in this case, it jiggles for a few years before it hardens and leaks toxins into your lymph nodes, joints, uterus and liver.

Roughly 5 percent of U.S. women likely will get the implants in the next decade.

We spoke to two experts on the matter: Diana Zuckerman, president of the National Research Center for Women and Families at the University of Pennsylvania Center for Bioethics, and Susan Wood, a research professor at George Washington University’s School of Public Health. The two scientists want you to know a few things:

  • Post-approval studies are common, but the sheer scope of this one should be a red flag. Also, neither the age of breast-implant recipients nor the collection of data by the two companies can be enforced.
  • Although you can pay for the implants in installments, you can’t do so for their removal — and they will need to be removed or replaced. Health insurance seldom covers those additional surgeries.
  • You’ll need to get pricey MRIs regularly. And no, your insurance probably won’t cover them.
  • By no means should you take the FDA’s approval of the implants to mean that they’re safe. For example, their effect on breast milk, says Zuckerman, has “never, ever, ever been tested” by the FDA.

How’s that for looking after public safety?

FDA Advisory Committees: Does Approval Mean Safety?

New Cancer Research
Diana Zuckerman, PhD, Cancer Prevention and Treatment Fund

Executive Summary

The U.S. Food and Drug Administration (FDA) has the responsibility to determine if newly developed medical products are safe and effective. Whether it is a prescription medication, a medication sold over the counter, a medical device, a vaccine, or another type of biologic, the product can be marketed for general sale in the United States only if it has FDA approval.

FDA advisory committees are the most visible part of the FDA approval process. They meet in public to review the most controversial and cutting-edge medical products, examining applications for FDA approval. Committee members discuss the strengths and weaknesses of the studies and their enthusiasm or concerns about the medical product under review. At recent FDA advisory committee meetings on controversial drugs and medical devices such as Vioxx®, silicone implants, and antidepressants, the media have provided the Congress and the general public with a glimpse of the approval process.

Questions have arisen about committee members’ financial ties to the companies submitting applications, their commitment to scientific scrutiny, the independence and objectivity of the deliberative process, and inconsistencies between the panel members’ expressed concerns and their approval recommendations.

This report describes the results of a study conducted by the National Research Center (NRC) for Women & Families, providing the first objective analysis of the key role of FDA advisory committees as part of the FDA approval process. The purpose of this report is to better understand the strengths and weaknesses of the FDA’s advisory committee process for FDA’s two largest centers, the Center for Drug Evaluation and Research (CDER) and the Center for Devices and Radiological Health (CDRH).

The study analyzes the voting patterns and committee discussions of a random sample of 6 of 16 drug advisory committees and 5 of 18 medical device advisory panels:

Drug Committees
Antiviral Drugs
Arthritis Drugs
Dermatologic and Ophthalmic Drugs
Gastrointestinal Drugs
Pulmonary and Allergy Drugs
Reproductive Health Drugs

Medical Device Panels
Immunology Devices
Microbiology Devices
Obstetrics and Gynecology Devices
Ophthalmic Devices
Radiological Devices

Data for these advisory committees were collected from the FDA Web site, based on transcripts of advisory committee meetings from January 1998 through December 2005. In that time, the 11 randomly selected advisory committees considered 89 prescription drugs and medical devices, including arthritis medications, LASIK devices, erectile dysfunction drugs, and devices to improve the accuracy of mammograms. There were 866 committee member votes.

Findings

As described by FDA officials, its advisory committees meet only to discuss the most controversial or innovative products, or products whose data are not clear-cut. The public might expect, therefore, that many of the drugs and devices reviewed by advisory committees would not be recommended for approval. The data indicate that this is true for some advisory committees, but not others. Overall, the 11 randomly selected advisory committees recommended approval for 79% of the 89 products reviewed between 1998 and 2005. The device advisory panels were even more likely to vote for approval than the drug advisory committees, recommending approval 82% of the time compared to 76% for drugs.

Despite the controversies surrounding many of these products, the votes for or against approval were rarely close. On the contrary, committee members agreed unanimously for 66% of the drugs and 75% of the medical devices that they recommended for approval.

Drug and Device Approval Recommendations

A review of the meeting transcripts indicates that advisory committee members frequently expressed strong concerns about the safety or the efficacy of the drug or device under review. However, those concerns were not necessarily reflected in their recommendations for approval.

There were many examples of committee members who strongly criticized the studies or the medical products under review, and then recommended approval anyway. FDA officials at the meetings almost never expressed concerns about the disconnect between the committee members’ explicitly expressed doubts about safety and effectiveness and their votes in favor of approval.

Of the 50 drug committee voting sessions in the study, 38 (76%) recommended approval of the drug. Most of the votes were unanimous, and almost all (93%) of those unanimous votes recommended approval.

Some of the committees were much more likely to recommend approval than others. The percentage of drugs they recommended for approval ranged from 50% for reproductive health drugs to 100% for arthritis drugs. The percentage of individual votes cast to recommend approval ranged from 50% for reproductive drugs to 98% for arthritis drugs.

What happens after the meetings are over? Of the 38 drugs recommended for approval by the drug advisory committees, all were subsequently approved by the FDA except one drug whose application was withdrawn before FDA made its decision. The FDA also approved four (36%) of the 11 drugs that the drug advisory committees voted against, including products that were opposed by almost all the committee members.

Of the 39 device panel voting sessions studied, 32 (82%) recommended approval of the device. Most of the votes were unanimous, with almost all (92%) of those unanimous votes recommending approval.

The percentage of devices that were recommended for approval ranged from 67% for microbiology devices to 88% for ophthalmic devices. The number of panel member votes cast to recommend approval ranged from 57% for microbiology devices to 91% for radiological devices. Three of the five randomly selected devices panels – the Radiological Devices Panel, the Immunology Devices Panel, and the Microbiology Devices Panel – had unanimous support for approval whenever they recommended approval during the eight years of the study.

Almost all (94%) the devices recommended for approval were subsequently approved by the FDA, and close to half (43%) of the devices that were not recommended for approval obtained FDA approval anyway.

Overall, the study found:

  • Many advisory committees recommend approval for almost every product they review, usually unanimously;
  • Individual committee members can have a disproportionate influence on approval recommendations;
  • Voting patterns differ for drugs and devices, but not when we compare committee members with clinical, scientific, and consumer perspectives;
  • Committee members describe pressure to conform and to recommend approval, and they candidly admit that their votes for approval may not be consistent with their concerns about safety and effectiveness;
  • FDA officials passively acquiesce when they do not respond to committee members’ statements indicating that votes recommending approval are not necessarily based on scientific evidence of safety and effectiveness; and
  • The FDA almost always approves products recommended for approval but also often approves products that advisory committees reject.

Implications and Conclusions

The findings suggest that when the FDA schedules meetings for several of its advisory committees, the outcome is almost certainly going to be FDA approval for the products under review. In most cases the advisory committee will recommend approval, but even products that are not recommended for approval are frequently approved by the FDA. Even lopsided votes against approval apparently do not have much weight, since the FDA subsequently approved many of those products.

Although FDA officials describe the advisory committees as providing diverse perspectives and expertise, the large number of unanimous or nearly unanimous votes suggests that either the data are exceptionally convincing or that the committee members are reluctant to disagree with their colleagues or believe that the FDA wants the advisory committee members to come to consensus.

By combining information from the NRC study with studies of conflicts of interest on FDA advisory committees, it is possible to understand how a few committee members with conflicts of interest can have a disproportionate impact on approval recommendations. NRC’s analysis of meeting transcripts indicates that many committee members’ votes seem inconsistent with their concerns about the safety or efficacy of the drug or medical device under review. These transcripts clearly illustrate the pressures that committee members describe to conform to their colleagues or to be able to vote ‘yes’ even if it means changing the wording of the question so that they can do so in good conscience. The report includes examples of committee members directly trying to influence the views or votes of other committee members.

If the FDA is relying on advisory committees to help determine the conditions of approval, one would expect that FDA officials would provide explicit oral instructions about the types of conditions that the FDA is willing to impose, and that the FDA would impose most of the conditions and then enforce them. That is not the case, however.

Committee members frequently recommended unenforceable or vaguely worded conditions of approval and expressed their intention to recommend approval for products that they did not believe were proven safe or effective. Their candor suggests that they would welcome guidance from the FDA officials present, to make sure their recommendations were appropriate. Nevertheless, during committee discussions FDA officials showed remarkably little interest in providing oral guidance regarding the criteria for approval, or the realities of approval conditions to advisory committee members during the eight years of the study. Conditions of approval imposed by the FDA often did not reflect the conditions recommended by the advisory committees. Conditions that were imposed were rarely enforced.

Overall, the findings indicate that committee members, intentionally or unintentionally, move toward a consensus that often seems inconsistent with their differing views or perspectives in making decisions that may have life-or-death consequences for millions of Americans. Voting for approval contingent upon conditions is a popular compromise, but the FDA does not impose most of the specified conditions on the companies when it grants approval. The Committees’ tendency toward approval seems to reflect the FDA’s goals; in fact, the FDA appears to be even more geared toward approval than the advisory committees. The FDA approved almost all the prescription drugs and devices recommended by the advisory committee, and also frequently approved products that were opposed by the committee members.

Whatever the reasons, many of today’s FDA drug and device advisory committees are rubber stamps for approval almost every time they meet. Moreover, even when an overwhelming majority recommend “nonapproval,” there is a good chance that FDA officials will approve the product anyway. Approval is even more likely for medical devices than it is for drugs.

Recommendations

If the FDA wants to restore confidence in the FDA, and restore the independence that FDA advisory committees were intended to provide, it is essential that the FDA make changes in the policies and process governing its advisory committees. The following recommendations are based on the assumption that the Congress and the FDA are committed to that end:

1. The FDA should stop granting conflict-of-interest waivers for committee members, except under very restricted conditions.

2. The FDA should provide explicit and specific oral guidance whenever needed during advisory committee meetings regarding appropriate criteria for safety and effectiveness, and appropriate criteria for conditions of approval.

3. The FDA should demand more from advisory committee members, and then be more responsive to their concerns.
For a PDF copy of the 50-page report, click here.


Decisions in the Dark: The FDA, Breast Cancer Survivors, and Silicone Implants

Press Releases
February 3, 2006

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 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 Research Center for Women & Families, 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.”

The report was released at a National Press Club Newsmaker event today, sponsored by the National Research Center (NRC) for Women & Families. NRC is a nonpartisan, nonprofit research and education organization that works to improve policies and programs that affect the health and safety of women, children and families.

View a PDF of the report.

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

Testimony & Briefings
Diana Zuckerman, PhD, Cancer Prevention and Treatment Fund: June 8, 2006

I am Dr. Diana Zuckerman, President of the National Research Center for Women & Families. 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 post construction cleaning services carmel.

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 recent 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.

explants
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.

Ruptured Implant
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.

necrosis - implant extrusion
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.

Do women with non-cancerous breast conditions eventually get cancer?

Breast Cancer
Susan Dudley, PhD, Cancer Prevention and Treatment Fund

In addition to the more than 200,000 women who are diagnosed with breast cancer in the U.S. every year, even more women are told they have an abnormal breast condition that is not cancer.

These conditions may be discovered by the woman herself, by a doctor’s examination, or by a mammogram. Sometimes it is not possible to make an accurate diagnosis until a biopsy is done to remove a tissue sample that can be examined in a laboratory.

Lumps that are not cancer include 1) cysts that are filled with fluid, or 2) fibroadenomas, which are smooth, and hard, often feeling like a marble under the skin. There can also be thickened but harmless areas called pseudo-lumps. White spots that show up on a mammogram are called microcalcification, and may also require a biopsy. Since only 1 in 12 breast lumps is cancerous, and only 20% of microcalcifications are related to cancer, most women get good news after a breast biopsy.

Doctors know that the overall risk for breast cancer increases with age. For a woman in her 20’s in the United States, the risk is very low. By the time she reaches her 70’s, her chance of breast cancer is 1 in 7. But does having one of these non-cancerous conditions change those odds?

Some of them may – but doctors have not known how much risk one of these abnormal conditions adds. Now, a study by Dr. Lynn Hartmann and her colleagues, published in the New England Journal of Medicine can help women and their doctors understand which specific breast conditions add to a woman’s risk, and which ones don’t.[1]

The study included more than 9,000 women who had biopsies for suspicious breast conditions that turned out not to be cancer. Afterward, the researchers monitored their health for approximately 15 years. In that time, 8% of the women developed breast cancer. It turned out that specific changes in breast cells that could be seen in the first non-cancerous biopsy could help predict which women were most likely to get breast cancer.

  • The biopsies from about two-thirds of the women showed that the cells were growing and reproducing at a normal rate, and were changing in ways that are not dangerous. This is called nonproliferative fibrocystic change. The risk of developing breast cancer in the next 15 years was not increased for these women unless their mother, sister, or daughter had the disease.
  • Similar predictable cell changes were found in the biopsies from another 30% of the women. But in this group, the cells were growing and reproducing too fast. This is called proliferative fibrocystic change. In this group, the risk of developing breast cancer over the next 15 years increased from about 5 cases in 100 women with normal cells, to about 9 cases of breast cancer in 100 women with proliferative fibrocystic changes.
  • Less than 4% of the women with non-cancerous biopsies had changes in their breast cells that were very abnormal and cells that were growing and reproducing too fast. This is called proliferative fibrocyctic change with atypia. Their risk of developing breast cancer in the next 15 years increased from about 5 in 100 to about 19 in 100.

For all these groups, the risks are higher if the non-cancerous condition occurred when the woman was very young – in her thirties or forties. A strong family history of breast cancer can also increase the risks for later developing the disease.

Almost all of the women in this study were white, so we can’t be sure that the risks are the same for other racial groups. Still, the results will help women and their doctors decide whether they need to get more frequent breast cancer screening or to take other preventive measures after they have had non-cancerous breast disease.

References:

  1. Hartmann, LC, et al. (2005). Benign Breast Diesease and the Risk of Breast Cancer. New England Journal of Medicine, July 21, 2005, pages 229-237