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Testimonies and Publications from the NCHR


The articles in this section focus on NCHR’s testimonies that have been presented at FDA meetings. If you want to learn more about the debate around breast implant safety click on a link to learn more.

2017

American Health Care Act

2016

FDA Approval of Mentor Implants

2013

FDA Approval of Natrelle 410 Implants

2012

Breast Implant Regulation In the U.S. and Europe

2011

FDA Hearing on Silicone Gel Breast Implants

Safety and Regulatory Update

FDA Review of Link Between Cancer and Breast Implants

2008

Informed Consent Critiques

2005

April

2003

FDA Hearing Silicone Gel Implants

FDA Hearing on Saline Breast Implants

1993

Congressional Presentation on the FDA’s Regulation of the Breast Implant Industry

Crystal Hefner Shares The Health Problems Breast Implants Can Pose

Bruce Y. Lee, Forbes
July 24, 2016

Crystal Hefner, formerly Crystal Harris and the 30-year-old Playboy model and wife of Playboy founder Hugh Hefner, announced the recent removal of her breast implants by […] sharing a post on Facebook that began, “My Breast Implants Slowly Poisoned Me.” She rattles off a litany of health problems that she says she suffered from the implants such as:

  • Intolerance to foods and beverages
  • Unexplained back pain
  • Constant neck and shoulder pain
  • Cognitive dysfunction (brain fog, memory loss)
  • Stunted hair growth
  • Incapacitating fatigue
  • Burning bladder pain
  • Low immunity
  • Recurring infections
  • Problems with my thyroid and adrenals.
  • Days in 2016 when I couldn’t get out of bed.

She explains that at first she was diagnosed with Lyme disease and toxic mold, but then learned via social media that her symptoms resembled “breast implant illness.”

After visiting a breast implant illness website and Facebook group with almost 3,000 members, she realized that her symptoms matched. On June 15th, 2016, plastic surgeon Dr Lu-Jean Feng removed Hefner’s breast implants. […] Her Facebook post continues: ”Instantly I noticed my neck and shoulder pain was gone and I could breathe much better. I know I won’t feel 100% overnight. My implants took 8 years to make me this sick, so I know it will take time to feel better. I also have other illnesses to address, but with the toxic bags removed, my immune system can focus on what it needs to.” […]

Read the full article here. 

Testimony of Diana Zuckerman, PhD at the FDA on Silicone Gel Breast Implants

Diana Zuckerman, PhD, President National Research Center for Women and Families,  April 2005

I’m Diana Zuckerman. I am President of the National Research Center for Women and Families, and I’m very pleased to be here. I have no conflicts. I’m a psychologist and epidemiologist and president of a nonprofit center that scrutinizes research to see what the implications are for health and safety.

We’ve heard that implants are the most studied medical product in the United States, but in 1991 there were about a million women with breast implants. The number of empirical published studies at that time was zero.

And at that time when they submitted their PMA, Inamed had only studied 39 breast cancer patients. Thirty-nine. And in their augmentation sample they had lost 65 percent of their augmentation patients at three to six months, according to the FDA summary.

Now, it brings us to 2003. Things have changed a little. We’re looking at the two to three year data that was available in 2003. It showed very high complication rates, including a lot of reoperations. It showed an increase in auto-immune symptoms, just about all of them that were measured. And it also showed no improvement and some worsening in most self-esteem and self-concept measures.

Now we know that most of the people talking have said this product has improved the quality of their life. But as has been pointed out by Panel members, the data just don’t support it. There is some improvement on body image, but not on quality of life, not on all of these other measures that have been touted as the main advantage of implants.

It’s very worrisome that all the patients in these studies are white, just about all of them. And, yes, I understand that most people getting breast implants for augmentation are white, but that is certainly not true of reconstruction patients. There are many, many thousands of reconstruction patients in this country that are women of color, and yet just a handful — I thought it was six African-American women, and five Asian American women, but according to the data shown this morning, it’s actually even lower. And I don’t understand how it could possibly be acceptable to approve a product with no data.

The reason why it’s important to have racial diversity in these samples is because there are racial differences in scarring and in auto-immune disease. African-American women are more likely, more susceptible to auto-immune disease. So we’d want to know are they more at risk, and we can’t conclude that because not only weren’t they analyzed separately, there weren’t even enough women to analyze separately.

That brings us to 2005. I thought that we’d have additional year of data. I was very interested to see what would the new data show and how would it be different. So I thought there’d be more data on complications compared to last time, but no, there aren’t. And I thought that there’d be another year of data on auto-immune, and no, there aren’t. And I thought there’d be another year of data on self-esteem and quality of life, and no, there aren’t. There is rupture data, and that’s great. But it was really for the three-year MRI data. It’s called four-year data, but since MRIs were done in the third year, it doesn’t take us very far.

When Inamed compared ruptured and intact implants, they did not evaluate connective tissue disease symptoms for most women with ruptures. I say that based on the FDA’s scientific analysis in your package.

They did find a significant increase in muscle pain. They didn’t find too many increases, but they had a very, very small sample to work with, partly because it just wasn’t measured.

The Adjunct Study has, according to Inamed, included 25,000 paients, but they didn’t follow-up on them. This is very upsetting because this was such a great opportunity to provide really good data and longer term data. And let me say that the young woman who testified about her problems not being reported, whether she was in the Adjunct Study or the Core Study, her problems should have been reported. And it says something about the commitment of the sponsor that they seem to think as long as it was the Adjunct Study, it doesn’t matter. I think it does matter. They should be taking care of patients in their studies, and they should be reporting them regardless of which — I don’t know which study she was in, but whichever one it is, she should have been reported.

And also remember that Inamed started their studies in 1990. Had they followed those women, we’d have at least a dozen years of safety data, the data we want. But they didn’t do that.

The literature review that FDA did talked about the Danish registry, but the mean number of years of women, and that was less than four years –not long enough.

It talked about the Danish rupture study. Forty percent of the implants were tested with a faulty MRI, so that study was not helpful.

And basically the data that many of you talked about showing up to ten years of rupture is faulty data. And I hope that Dr. Blumenstein will say something more about that later.

The FDA study did have a 21 percent extracapsular leakage for implants that were seven years old or more, and they also found an increase in fibromyalgia, which has not really been discussed at this meeting.

Thank you.

NCHR Press Release on Inamed High Complication Rates for Breast Implant Patients

October 16, 2003

In a split decision, an advisory committee to the FDA recommended approval for Inamed’s silicone gel breast implants on October 15th. “The news is not good for breast implant patients, especially those with breast cancer,” noted Dr. Diana Zuckerman, President of the National Center for Policy Research for Women & Families, a Washington-based think tank. “The company’s own research indicates high complication rates for the first three years, including the need for additional surgery for 46% of breast cancer patients. The long-term risks remain unknown.”

Inamed’s “core” study included 221 breast cancer reconstruction patients, 494 augmentation patients, and 225 revision (replacement) patients. According to the FDA, their complication rates are very high. For example, 46% of reconstruction patients underwent at least one re-operation within 3 years, 25% had removal or replacement, 6% had a diagnosed ruptured implant, 6% had breast pain, and 6% were diagnosed with necrosis, a painful and disfiguring condition where the skin or tissue dies. Complications were lower but still substantial for augmentation patients (for example, 21% with re-operations, and 1% diagnosed rupture) and revision patients (33% with re-operations and 4% diagnosed ruptures). The FDA assumed that the rupture rate was higher than reported, since three out of four ruptures would not be diagnosed unless a woman underwent an MRI.

The largest study, called the Adjunct Study, enrolled 15,465 reconstruction patients and 9,881 “revision” patients (who had replaced their previous breast implants with new Inamed silicone gel implants). The Adjunct Study was the compromise developed by the FDA to enable large numbers of mastectomy patients and women with broken gel implants to use silicone gel implants at a time when the company had not proven that their product was safe. Although women wanting silicone breast implants were required to participate in the Adjunct Study, the company apparently made little effort to comply with this requirement: barely half (54%) of the breast cancer patients who received Inamed implants stayed in the study for one year. Even fewer — 27% — stayed in the study for three years.

Women who wanted silicone gel implants to replace broken gel implants were also required to participate in the Adjunct Study, but they were even less likely to stay in the study than breast cancer patients. Less than half (44%) stayed in the study for one year and only one in five (20%) stayed for three years. “Most women did not stay in these studies for even one year, making the largest study useless in determining whether the implants are safe” explains Dr. Zuckerman. “Inamed was told that they were supposed to study the safety of implants as a condition of sale. The main concern about silicone implants is the health risks when they break, but the company did not study women long enough to find out what those risks are.”

Inamed also gathered data about health symptoms experienced by their patients. In the FDA review of Inamed’s data, FDA scientists noted the following:

  • Muscle pain, joint pain, hair loss, rashes, and fatigue all increased within two years of getting implants.
  • In terms of their quality of life, almost every measure of emotional and physical health, including social interactions and self-esteem, declined within two years of getting implants. The improvements were in self-reported sexual attractiveness.

In its description of the components of the implant shell, the FDA noted the presence of 24 potentially toxic metals, including arsenic, lead, mercury, and platinum. (FDA Review Team Memo, p. 9)

In its review of scientific studies conducted by other researchers, FDA scientists noted:

Cancer — “The finding of excesses in lung (or respiratory), cervical, vulvar, and leukemia have been reported in more than one study. These findings are difficult to interpret, and further research is needed to clarify this issue.” (FDA Review Team Memo, p. 35)

Mammography — “The possibility that implants may delay cancer detection is of concern.” ( p. 38)

Silicone Migration — “Cases of distant migration of gel to breasts, axillary lymph nodes, abdomen, groin, arm, and fingers have been reported, some with serious consequences and deformities…” (FDA Review Team Memo, p. 37)

Inamed also reported results from a 5-year study started in 1990, but it included only 29 reconstruction patients. The study started with 547 augmentation patients, but most were not studied for all five years. Since most of the patients dropped out of the study and most had breast implants that the company is no longer selling, results from this study were not useful.

“The findings show many areas of concerns and unanswered safety questions, and provide worrisome evidence that women with silicone gel implants will face numerous complications directly related to the implants, symptoms such as pain and fatigue, and declines in health and mental health,” concludes Dr. Zuckerman. “Although the rupture rate is low during the first two years, it is expected to increase every year, as it has in other studies.”

The FDA advisory panel held their public meeting on October 14-15 in Gaithersburg, MD to decide whether to recommend Inamed’s silicone gel breast implants for FDA approval. All the plastic surgeons on the panel recommended approval. Most of the other doctors and scientists on the panel voted against approval, including a toxicologist, epidemiologist, statistician, radiologist, dermatologist, and cancer surgeon. The pediatric surgeon who chaired the panel only votes to break a tie, but stated publicly that he would have voted against approval.

Silicone gel breast implants have been available under FDA-imposed restrictions since 1992 because implant makers did not provide adequate research evidence that they were safe. The FDA is expected to make a final decision about whether or not to approve the implants within a few months.

Testimony of Diana Zuckerman, PhD at the FDA on Saline Breast Implants

Diana Zuckerman, PhD, President National Center for Policy Research for Women & Families, July 9, 2002

My name is Dr. Diana Zuckerman and I am President of the National Center for Policy Research (CPR) for Women and Families, a nonprofit research-based organization that explains medical and scientific information so that it can be used to improve the health and well-being of women, children, and families.

Our research center works on a wide range of health issues, with particular attention to the safety of medical products. Unfortunately, as the new research on hormone replacement therapy has reminded us, manufacturers’ claims about medical products are not always supported by research. Our goal is to balance the hype by scrutinizing the research and determining the facts — whatever they may be.

In the case of breast implants, the more than 150,000 adverse reactions reported to the FDA is inconsistent with the manufacturers’ claims that implants are very safe and that implant patients are so satisfied that even when their implants break or cause hardness or pain their only desire is to replace a problematic implant with an even larger one. So, we have used our expertise in epidemiology, biostatistics, and public health to carefully scrutinize the research.

I was at the FDA Advisory Committee meeting when saline implants were approved in 2000. For those of you who weren’t here, I want you to know that the Advisory Committee expressed a great deal of concern about the extremely poor quality of the data and the exceedingly high complication rates. I heard the shocked gasps in the audience when the Advisory Committee voted to recommend approval despite their very strongly expressed concerns.

The Advisory Committee recommended approval with the caveat that long-term safety data, and better studies, be required of the manufacturers, Mentor and McGhan. I am sorry that many of those members are not here today. I think they would be very disappointed that the manufacturers made many of the same “mistakes” or misrepresentations now that they were criticized for two years ago.

For example, Dr. Brent Blumenstein, the statistician on the Advisory Committee, clearly stated that the McGhan presentations did not meet the standards of “good, peer-reviewed articles” and specifically stated that “accuracy is not manifest in the presentation of the data.” The FDA statistician, Telba Irony, specifically criticized using Kaplan-Meier analysis when many women are lost to follow-up and the researchers don’t know if those who dropped out are like those who are in the study. Both statisticians criticized the large number of patients who were lost to follow-up. Of course, in the new data presented today, even more women are lost to follow-up.

In the Mentor study, Dr. Blumenstein criticized the company for taking patients out of the analysis if they had their implants removed. He said “This is an extreme limitation and misrepresents the data.” He concluded by saying “I cannot accept the accuracy of any of the data here because of the limitations I’m pointing out…. I cannot feel good about any of the data presented with respect to accuracy and giving that information to an individual patient and having that patient understand what the real risks are.”

Phyllis Silverman, the FDA statistician stated “because of the approximately 50% loss to follow-up with the large, simple trial, the ability to draw meaningful conclusions from this trial is limited.” I agree — and obviously it’s even worse for the new Mentor data, which has a 95% loss to follow-up at 5 years or a 76% loss at six years.

A response rate under 50 percent can not provide useful safety data, because we know nothing about the women who are no longer in the study. If we don’t know if they are alive or dead, or healthy or sick, we don’t really know if these implants are safe.

Are these manufacturers unable to afford good researchers to do this research? They have spent millions of dollars to advertise in every major women’s magazine, including those read by millions of teenage girls.

Perhaps lack of research skills is not the problem here. Two members of Congress wrote to the FDA last month and again yesterday to ask about a criminal investigation of Mentor and to ask to see inspection reports for both Mentor and McGhan. I have a copy of their letters, which specifically asked that this Advisory Committee be informed of the criminal investigation, since it might have implications for the integrity of the research data. The Congressmen also asked that you be provided information about studies published by the National Cancer Institute last year. One showed an increased risk of cancer for women with saline or silicone implants compared to other women. The other showed an increase risk of deaths from brain cancer, lung cancer, and several other diseases among women with saline or silicone breast implants, compared to other plastic surgery patients.

I agree with these Congressmen that in order for you to make wise recommendations to the FDA, you need all relevant information. That would include any information that raises questions about the long-term safety of breast implants, as well as inspections and investigations that apparently raise questions about the research conducted by these companies and the manufacturing quality control practices of the companies.

On behalf of our research center, I am respectfully asking each of you to carefully scrutinize these studies and express your views about their quality — or lack thereof — in the strongest and clearest possible terms. I also ask you to request information about the NCI studies — which were co-authored by an FDA scientist, who also analyzed the adverse reaction reports for breast implants several years ago. If you don’t insist on better long-term research and on accurate reporting of that research and of adverse reactions, teenage girls and women will continue to assume that breast implants are proven safe, despite the lack of long-term safety research.

 

Testimony of Diana Zuckerman, PhD, at the FDA for Silicone Gel-Filled Breast Protheses

Diana Zuckerman, PhD, President National Center for Policy Research for Women & Families, October 15th, 2003

To the General and Plastic Surgery Devices Panel Center for Devices and Radiological Health Food and Drug Administration Regarding Premarket Approval Application for Silicone Gel-Filled Breast Prostheses:

I am Dr. Diana Zuckerman, President of the National Center for Policy Research 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.

It’s very difficult to testify as the last public comment. Since you already discussed the key questions last night, I wonder how I can say anything you haven’t heard and might want to hear or be willing to hear. I will express my sympathy to you for the very difficult work you have put in, and let you know that after I left this meeting very late last night, I had to rewrite this testimony. So, I may have been up even later than you all were.

Let me start by saying I am speaking from the perspective of someone trained in psychology and epidemiology, who was a university faculty member and researcher and taught courses in research methods before moving to Washington to work in the Congress, U.S. Department of Health and Human Services, and for nonprofit organizations.

I have read every published epidemiological study on breast implants and would like to briefly discuss the Inamed studies in the context of those other studies.

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

The FDA’s study, described by Dr. Lori Brown yesterday, is the best designed study ever conducted on the topic. One reason for its superiority is that 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.

You know from hearing testimony from women yesterday and today that most women who have had problems with rupture had implants for a long time — usually much longer than seven years.

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

I have heard the Institute of Medicine report, the Mayo Clinic Study, the Harvard Nurses study, and the meta analysis all cited as clear proof that breast implants are safe. First of all, its important to note that they are pretty much all the same thing. The Institute of Medicine report was based on the same studies as the meta analysis, and they both included the Mayo Clinic study and the Harvard Nurses study as key components.

Almost all the studies included in the Institute of Medicine report suffered from the same shortcomings that many panel members described for the Inamed safety research: too small, and too short. 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 National Cancer Institute study finding a doubling of brain cancer, tripling of lung cancer, and quadrupling of suicide is also an exceptionally well-designed study, because all the women in the study had breast implants for at least 8 years. Again, other studies included women who had implants for an average of 8 years, but not a minimum of 8 years. And again, that means that other studies included women who were not exposed for a long enough time to develop a disease and be diagnosed.

Most of the Scandinavian studies were funded by Dow Corning, and had some shortcomings such as measuring illness in terms of hospitalization rather than diagnosis. Again, think of how unlikely it is that a 30 year old woman will be hospitalized for rheumatoid arthritis.

Signs and Symptoms

Now that you know some of the shortcomings of the research literature on systemic disease, let’s take another look at the signs and symptoms. Think about the testimony you heard from the women, many of whom were happy with their implants and never suspected that their problems with fatigue or aches and pains might be related to their implants. This is not conclusive evidence, but it is a pattern that needs to be considered — especially with data showing an increase in every symptom over a period of only two years on a cohort of young augmentation patients.

Cosmetic Problems

Even if the data on systemic illness and signs and symptoms are not conclusive, let’s look again at some of the photos you have seen 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. You saw her photo yesterday. 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. Little attention was given to the 6% necrosis rate among reconstruction patients in the Inamed Core study.

Inamed Research Quality

Like many of you, I applaud Inamed’s excellent response rate in their Core study.

But like Dr. Whelan and Professor Dubler, I share your amazement about the lack of long-term research.

The company started to analyze the safety of silicone gel breast implants in 1990. It was terrible that they included only 29 breast cancer patients. But, they also lost most of their patients to follow-up before ending the study after 5 years.

The company was given the opportunity to test their silicone gel implants on thousands of patients in the Adjunct study. They enrolled thousands of patients and then failed to follow-up on most of them, making that study useless.

And, the core study is almost entirely White women. Women of color get breast cancer, for example, but only 6 African American women and only 5 Asian American women are in the reconstruction sample. And, of course both groups are more likely to have scarring problems, and African Americans are more susceptible to autoimmune diseases.

What does approval mean?

If Inamed silicone gel implants are approved, and the company is required to continue research for 7 or even 10 more years, consider the company’s track record so far.

You need to know that the FDA can’t truly enforce any requirement of post-market research. The FDA has leverage before a product is approved, since the company will comply in order to get their product approved. It has no real leverage after approval.

If Inamed silicone gel implants are approved, the FDA can try to improve informed consent. But again, it can’t enforce that.

If Inamed silicone gel implants are approved, the FDA can specify that it is approved for women ages 18 and older. But physicians will be free to use these implants on 17-year olds or younger girls — just as they do now, with saline implants.

If Inamed silicone gel implants are approved and you try to require women to get MRI’s, that can’t be enforced either. Even in the Inamed study, where the MRI’s were presumably free, many of the women did not comply.

Perhaps most important, approval is the seal of approval. We live in a sound bite world. If you recommend that silicone gel implants be approved, despite all the members who said last night that long-term safety is unknown, the message will be: “silicone gel implants are safe.” That will be your legacy. If you’re not sure that they truly are safe, then you should vote against approval.

A final word about the inadequacy of the 1-year, 2-year, and 3-year data. I agree with those who questioned why in the world the FDA issued a guidance asking for only 2 years of safety data, for a product whose main concerns are long-term safety. It doesn’t seem quite fair to then change their mind. On the other hand, the company has not exactly done everything they could do, in their 1990 study or their Adjunct study, to collect safety data. Is it really unfair to expect that a company would try to improve their product in the last 10 years, or try to evaluate the safety of their product. Better guidance would have been helpful, but the real responsibility is with the sponsor.

Crystal Hefner Removes Breast Implants, Says They ‘Slowly Poisoned’ Her

Chloe Tejada, The Huffington Post CanadaJuly 21, 2016

Talk about horrifying.

On Tuesday, Crystal Hefner posted an update to her social media accounts, revealing to her fans that she removed her breast implants after they caused several major health problems and bad side effects.

In the photo, posted on her Instagram and Facebook pages, the 30-year-old Playboy model — who’s been married to Hugh Hefner since 2012 — is seen lying convalescing on a hospital chair, wearing a blue gown, a robe and a towel resting on her forehead — an IV line attached to her hand.

 “My Breast Implants Slowly Poisoned Me,” she titled her post.

“Intolerance to foods and beverages, unexplained back pain, constant neck and shoulder pain, cognitive dysfunction (brain fog, memory loss), stunted hair growth, incapacitating fatigue, burning bladder pain, low immunity, recurring infections and problems with my thyroid and adrenals,” she wrote.

Hefner went on to explain that symptoms started a few years ago but she ignored them, despite the fact that she was not feeling well.

“The aches, the bladder pain, brain fog, fatigue. I ignored it, labeling myself a hypochondriac, despite truly worrying that there was something wrong with me. I joked about losing my memory to age, and about getting ‘lazy.'”

As the negative side effects worsened, her work as a model and DJ suffered.

“I began to cancel appointments and shoots because everything exhausted me,” she said. “I’ve had days in 2016 when I couldn’t get out of bed. I’ve felt such despair knowing life was happening all around me but I couldn’t participate… the fatigue was so severe that I could barely leave the house or drive. I was afraid to get up there in front of a crowd and go blank with brain fog.” […]

After announcing that she had been diagnosed with Lyme Disease and toxic mold, commenters said her symptoms were similar to the effects of those suffering from Breast Implant Illness.

She became a patient at The Lu-Jean Feng Clinic in Ohio, where, after discussing it with Dr. Lu-Jean Feng, she had her implants removed.

“Instantly I noticed my neck and shoulder pain was gone and I could breathe much better,” she wrote about how she felt after the surgery. “I know I won’t feel 100% overnight. My implants took 8 years to make me this sick, so I know it will take time to feel better. I also have other illnesses to address, but with the toxic bags removed, my immune system can focus on what it needs to.” […]

Here’s to wishing Crystal a safe, and healthy recovery.

Read the original article here. 

Experts Decry Tying Medical Research Funds to FDA Standards Changes


WASHINGTON—Moves in Congress to link billions of dollars in new medical research funding to revised standards for drug and medical-device approvals are troubling some public-health experts, who say the combination makes it too easy for lawmakers to support lower patient-safety standards.

These safety advocates say legislation to beef up research funding for the National Institutes of Health should be separated from product-approval changes at the Food and Drug Administration.

“This is the first time this has been done this way, and it’s a deal with the devil,” said Dr. David A. Kessler, onetime FDA commissioner during the 1990s under presidents of both parties. “It’s time to uncouple the promise of research funding from the requirement that FDA standards be lowered.”

The linkage was first made last July when the House passed a bill to ease FDA approvals of drugs and devices in ways broadly endorsed by the drug and device industry. That legislation carried a big infusion of cash for medical research—$8.75 billion for NIH and $550 million extra for the FDA, both over five years. The measure, called the 21st Century Cures Act, passed 344-77 with broad bipartisan support.

In the Senate, the leader of a parallel effort said he hopes to bring a package of 19 FDA and NIH bills to the floor soon—along with a separate measure on NIH funds. Sen. Lamar Alexander (R., Tenn.) chairman of the committee that approved the package, said finding the source of the funding is “the last remaining important issue” on the legislation, which he considers “the most important bill Congress considers this year.” […]

The new FDA commissioner, Dr. Robert M. Califf, said in a recent talk that “this legislation, if not carefully crafted, could pose significant risks for FDA and American patients…Innovative therapies are not helpful to patients if they don’t work, or worse, cause harm,” he said.

Patient-advocacy groups like the National Center for Health Research and Public Citizen have said several bills now in Congress could jeopardize safety. […]

Read the original article here.

FDA Review Indicates Possible Association Between Breast Implants and a Rare Cancer

FDA: January 26, 2011.

FDA review indicates possible association between breast implants and a rare cancer
Agency requesting health care professionals to report confirmed cases

The U.S. Food and Drug Administration today announced a possible association between saline and silicone gel-filled breast implants and anaplastic large cell lymphoma (ALCL), a very rare type of cancer. Data reviewed by the FDA suggest that patients with breast implants may have a very small but significant risk of ALCL in the scar capsule adjacent to the implant.

The FDA is requesting that health care professionals report any confirmed cases of ALCL in women with breast implants.

In an effort to ensure that patients receiving breast implants are informed of the possible risk, FDA will be working with breast implant manufacturers in the coming months to update their product labeling materials for patients and health care professionals.

“We need more data and are asking that health care professionals tell us about any confirmed cases they identify,” said William Maisel, M.D., M.P.H., chief scientist and deputy director for science in FDA’s Center for Devices and Radiological Health. “We are working with the American Society of Plastic Surgeons and other experts in the field to establish a breast implant patient registry, which should help us better understand the development of ALCL in women with breast implants.”

According to the National Cancer Institute, ALCL appears in different parts of the body including the lymph nodes and skin. Each year ALCL is diagnosed in about 1 out of 500,000 women in the United States. ALCL located in breast tissue is found in only about 3 out of every 100 million women nationwide without breast implants.

In total, the agency is aware of about 60 cases of ALCL in women with breast implants worldwide. This number is difficult to verify because not all cases were published in the scientific literature and some may be duplicate reports. An estimated 5 million to 10 million women worldwide have breast implants.

The FDA notification is based on a review of scientific literature published between January 1997 and May 2010 and information from other international regulators, scientists, and breast implant manufacturers. The literature review identified 34 unique cases of ALCL in women with both saline and silicone breast implants.

Most cases reviewed by the FDA were diagnosed when patients sought medical treatment for implant-related symptoms such as pain, lumps, swelling, or asymmetry that developed after their initial surgical sites were fully healed. These symptoms were due to collection of fluid (peri-implant seroma), hardening of breast area around the implant (capsular contracture), or masses surrounding the breast implant. Examination of the fluid and capsule surrounding the breast implant led to the ALCL diagnosis.

The FDA is recommending that healthcare professionals and women pay close attention to breast implants and do the following:

 

  • Healthcare professionals are requested to report all confirmed cases of ALCL in women with breast implants to Medwatch, the FDA’s safety information and adverse event reporting program. Report online or by calling 800-332-1088.
  • Healthcare professionals should consider the possibility of ALCL if a patient has late onset, persistent fluid around the implant (peri-implant seroma). In cases of implant seroma, send fresh seroma fluid for pathology tests to rule out ALCL.
  • There is no need for women with breast implants to change their routine medical care and follow-up. ALCL is very rare; it has occurred in only a very small number of the millions of women who have breast implants. Although not specific to ALCL, health care providers should follow standard medical recommendations.
  • Women should monitor their breast implants and contact their doctor if they notice any changes.
  • Women who are considering breast implant surgery should discuss the risks and benefits with their health care provider.

 

The FDA published its literature review in a document posted on FDA’s website site today titled “Anaplastic Large Cell Lymphoma (ALCL) in Women with Breast Implants: Preliminary FDA Findings and Analyses.”

The FDA also plans to provide an update on its review of silicone gel-filled breast implants in the spring of 2011. This update will include interim findings from ongoing post-approval studies for silicone gel-filled breast implants currently sold in the United States, adverse event reports submitted to the FDA, and a review of the scientific literature on these products.

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

Breast Implants: A Research and Regulatory Summary

Diana Zuckerman, PhD, Elizabeth Santoro, RN, MPH, and Judith Faucette, JD: February 2011

Despite the impact of the battered economy on plastic surgery, breast implants remain very popular. In 2009, nearly 290,000 women and teenagers underwent breast implant surgery for augmentation and approximately 86,000 women underwent breast implant surgery for reconstruction after mastectomy.1 That’s a decrease from 2008, but the number of breast augmentations for women and teenagers is still nearly three times the 1997 rate of 101,176.2

The dramatic increase in breast implant surgery, however, does not necessarily reflect a similarly dramatic increase in the number of women with breast implants. Many women who undergo surgery are replacing old implants that have broken or caused problems. Some women report as many as ten or more surgeries as their implants are replaced over the years. There are no available statistics on how many women undergo their first breast implant surgery every year.

Debate swirls over the risks of breast implants, and physicians and patients are justifiably confused by the conflicting information available. An FDA announcement about the increased risk of a rare type of lymphoma in January 2011 again raises questions about safety. This summary provides information about what is known and not known about the risks of breast implants.

The Role of the Food and Drug Administration (FDA) in Safety Research

Breast implants were first sold in the 1960s, but the FDA did not have the authority to regulate them until 1976. Sales were relatively slow until the 1980s, but by 1990 almost one million women had breast implants, even though there were no published studies about their safety and the FDA had never approved them. Finally, in 1991, the FDA required the manufacturers of silicone gel breast implants to submit safety studies. Unfortunately, these studies were inadequate; for example, in the McGhan prospective study, only 35% of the patients were followed for at least three months, and there were only three reconstruction patients. 3 Because of the lack of clinical data, silicone implants were not approved at that time. Instead, the FDA issued a compassionate need exemption policy on October 23, 1992, which allowed silicone implants to remain available primarily to reconstruction patients and women who already had breast implants that they wanted replaced. Meanwhile, medical journals published articles questioning the health risks of breast implants.

Under the FDA’s compassionate need exemption policy, silicone gel implants were restricted in the U.S. to clinical trial participants, including a large “adjunct study” for reconstruction patients and women with broken implants (revision patients). Smaller numbers of first-time augmentation, reconstruction, and implant replacement patients participated in each company’s “core study.” It is important to note that the definition of reconstruction patients includes many women who are not mastectomy patients. Women can also be “reconstructed” to correct “deformities” such as very droopy breasts and “severe” asymmetry (both subjectively defined by the plastic surgeons). In addition, women who were unhappy with their saline breast implants were often able to find a physician who would enroll them in the adjunct study of silicone gel implants. Implant manufacturers could have collected and published extensive safety data from these studies. However, they did not do so.

Major shortcomings were reported regarding the adjunct and core studies in terms of entry criteria, data collection, and patients’ informed consent. Many patients reported that their physicians encouraged them to enroll in the study as a way to qualify for silicone implants, explaining that they could drop out immediately after getting implants. That anecdotal claim is supported by the enormous loss in participants between enrollment and follow-up—Inamed data discussed at the FDA’s October 2003 Advisory Panel meeting indicated that only 27% of the reconstruction patients and 20% of the revision patients were followed for three years. As a result of this very low follow-up rate, these “studies” did not provide meaningful safety data.

In October 2003, the FDA held an Advisory Panel meeting to consider approval of silicone breast implants made by Inamed. After considering the Advisory Panel recommendations and the scientific data, the FDA decided not to approve Inamed silicone breast implants in January 2004. At the same time that the decision was announced, the FDA issued a new guidance specifying the type of research manufacturers would need to present to obtain approval of any breast implants in the future. A major focus of the guidance document is the need to determine why breast implants break, how long they last, and the health consequences of broken and leaking implants. On April 11-13, 2005, the FDA held another Advisory Panel meeting to consider new research on silicone breast implants that was subsequently submitted by two companies, Inamed (also called McGhan or Allergan) and Mentor (now a subsidiary of Johnson & Johnson). Their studies only followed women for three years, which was not responsive to the FDA guidance asking that they determine how long implants last or the health consequences of leaking or broken implants.

Meanwhile, in late 2005, the FDA Office of Criminal Investigation started an investigation of Mentor, interviewing former Mentor employees. This investigation focused on the sale of defective implants by the company. One employee admitted that executives ordered him to destroy documents related to a high rupture rate of Mentor implants and admitted that some implants were contaminated with fleas.4

Despite the short-term studies and investigation, in November 2006 the FDA approved silicone gel breast implants by Inamed (now Allergan) and Mentor as “reasonably safe” for women who are 22 or older. This was the first time that FDA had approved silicone gel implants, and because of serious concerns about safety, the FDA is requiring each of the two implant makers to study 40,000 women with breast implants for 10 years, recognizing that the 3-year studies were not sufficient to prove long-term safety. Unfortunately, unbiased long-term data are lacking. With few exceptions, the only published data regarding long-term safety are studies funded by implant companies, plastic surgeons, or Dow Corning.

Silicone or saline breast implants by companies other than Inamed and Mentor are not considered to be “reasonably safe” by the FDA. Several of those implants, such as those made by the French company PIP, were sold in other countries and later taken off the market because of a tendency to rupture sooner than other implants, and because the silicone apparently was not tested for health risks in humans because the manufacturer thought the silicone was being used for mattresses.5, 6

“Reasonably safe” does not mean safe for everyone. The FDA found that most implant patients have at least one serious complication within three years after getting silicone or saline implants.

Types of Breast Implants

The 40-year history of silicone breast implants is a history of trying to reduce complications, especially common problems such as breast hardness and pain caused by capsular contracture. Although breast implants were not studied in clinical trials for the first 25 years that they were used, clinical experience indicated that design modifications would seem to improve outcomes when they were first introduced, but later be found ineffective at fixing targeted problems and often cause new ones. For example, since the mid-1960s implant modifications have included adding a Dacron patch, removing the Dacron patch, changing the thick gel to a thinner gel, changing the thinner gel to a thicker gel, making the silicone shell textured, covering the shell with polyurethane foam, removing the foam when it was found to break down to a carcinogen, making the shell smooth, changing the shape of the implants, and reducing “silicone bleed.” All of these changes were “studied” informally when patients underwent surgery, rather than in clinical trials. A Congressional report summarizing these changes referred to the patients as “guinea pigs.”3

The silicone gel breast implants that were reviewed by the FDA in 2005 and 2006 were essentially identical to those made in the early 1990s. Inamed’s Senior Director of Regulatory and Clinical Affairs testified to the FDA that “it is basically the same product it was 10 years ago—it is essentially the same product.7

In addition to changes in silicone gel breast implants, implant makers have tried to improve the product by using materials other than silicone gel. Saline breast implants have a silicone envelope and are filled with salt water. Saline breast implants have been available for decades, but it was not until May 2000 that the FDA approved saline implants for the first time. Before approving these devices, the FDA required 3-year studies of local complications such as pain, infection, hardening, and the need for additional surgery. They did not require studies of other health problems. In addition to saline, three other kinds of implants were made available in recent years, primarily outside the United States: Trilucent implants (with soybean oil filler), and Novagold and PIP hydrogel implants, which were filled with a plastic gel. Although never approved as safe in the U.S., these implants were vigorously promoted by plastic surgeons and the media as a “natural” and safer alternative to silicone or saline implants. Clinical trials, however, were apparently never conducted on humans with these implants, and all were removed from the market in 2000 because of safety concerns.8, 9, 10, 11 Their removal from the market after being enthusiastically praised by doctors and patients serves as a reminder that the long-term risks of implants are not always obvious during the first few years of use.

Frequency of Local Complications

Risks associated with surgery include infection, hematoma (blood or tissue fluid collecting around an implant), and the risks associated with anesthesia.

Pain and Capsular Contracture: All implants are “foreign bodies.” A woman’s body reacts to the introduction of this foreign object by forming a capsule of scar tissue around the implants. When this capsule becomes too tight for the implant—a common problem—it is called capsular contracture. Capsular contracture can cause the breasts to become very hard or misshapen and can cause mild discomfort or severe, chronic pain. Research submitted in support of Inamed’s 2003 application to the FDA showed severe capsular contracture occurring in 16% of reconstruction patients and 8% of augmentation patients within 3 years.

Comparing Inamed data on saline breast implants and silicone gel breast implants shows many of the same types of complications; however, complication rates from silicone gel implants tend to be higher.12, 13 For example, 46% of silicone gel reconstruction patients and 21% of saline reconstruction patients underwent at least one additional operation within three years, 25% of silicone patients and 8% of saline patients had implants removed, and 6% of silicone patients and 16% of saline patients had breast pain. Complication rates were lower but still substantial for augmentation patients.

A study of Danish women who had breast implants for an average of 19 years found that women with implants were almost three times as likely to report breast pain compared to breast reduction patients. The question was not asked of women in a control group since it was assumed they did not experience breast pain.14 In addition, two-thirds of the women with implants in the Danish study reported moderate or severe breast hardness.

There are other well-documented local complications that can result from breast implants. For example, some women lose sensitivity in their nipples, and others become overly sensitive. These problems can interfere with sexual intimacy. The cosmetic outcome is also sometimes disappointing, with breasts looking or feeling unnatural or asymmetrical.

Rupture: All breast implants will eventually break. When silicone gel breast implants break, there are often no symptoms, so accurate estimates of rupture rates depend on magnetic resonance imaging (MRIs). Patient testimony before the FDA and clinical evidence indicate that some breast implants break during the first few weeks or months, while others last more than 15 years. In a study conducted by researchers at the FDA, most women had at least one broken implant within 10 years, and the likelihood of rupture increased over time.15 The women in the FDA study had not had their implants removed, did not know that their implants were broken, and were not seeking help because of implant concerns. Despite the fact that these women were “satisfied customers” rather than women seeking medical care, MRIs found that silicone had migrated outside of the breast capsule for 21% of the women in the study. Most of the women were unaware that this had happened. Inamed’s study of their silicone gel implants found that 1-6% break within three years.13 A Danish study of ruptured silicone gel implants reported that most lasted for ten years; however, by the time the women in that study had implants for 15 years or more, a substantial percentage of the implants broke every year.16

Leakage: Numerous studies have shown silicone leakage into the scar capsules surrounding breast implants, even for implants that are not ruptured. More worrisome, researchers at Case Western Reserve and the Armed Forces Institute of Pathology reported finding silicone in the lymph nodes of women with breast implants, which can then migrate to other organs.17, 18 Recent case studies have confirmed that silicone can migrate to the lymph nodes.19, 20 Silicone in the lymph nodes can only be removed by removing the lymph nodes. Silicone in organs such as the lungs, liver, and brain cannot be removed. The health risks associated with migrated silicone gel are unknown. However, case reports have indicated fatalities and serious health risks when liquid silicone injected in the breasts migrated to the lungs or other organs. Although silicone implants are filled with gel rather than the liquid form of silicone, the implants sometimes leak a silicone liquid or thin gel.

A study published by the Royal Academy of Medicine in Scotland found that a woman with a broken silicone gel implant in her calf was coughing up silicone identical to the kind in her implant.21 This has potentially serious implications for women with leaking breast implants, since silicone gel breast implants are considerably larger and closer to the lungs than calf implants.

Mammography: Breast implants interfere with the detection of breast cancer because implants can obscure the mammography image of a tumor. Implants therefore have the potential to delay the diagnosis of breast cancer. Although special techniques are designed to minimize the interference of the implants, the most recent research indicates that 55% of breast tumors will still be obscured. That is much higher than the 33% obscured in women without implants in the same study.22 Mammograms also tend to be less accurate if the woman has capsular contracture. In addition, women with implants may be reluctant to undergo mammograms because of fear of rupture, and a study by FDA scientists indicates that silicone or saline implants sometimes rupture when women undergo mammograms.23 The alternative, undergoing a regular breast coil MRI to check for cancer, is prohibitively expensive for many women at $2,000 each time and needs to be read by an expert. There is no research evidence that implants cause breast cancer, and research findings on whether there is a delay in diagnosis have been inconsistent. A delay in diagnosis could have serious health implications and decrease women’s options for breast-conserving surgery. Such delays have been reported by patients.23

Breastfeeding: According to the Institute of Medicine (IOM), women who have had any kind of breast surgery, including breast implant surgery, are up to three times more likely to have an inadequate milk supply for breastfeeding.24 Concerns about the chemicals from the implants passing to infants through breastfeeding have also been raised. There is insufficient research information available to make a determination on this risk. However, a study presented at the American Chemical Society’s 2004 August meeting found exceptionally high concentrations of platinum, a known potential toxin, both in women with silicone breast implants and in the children they bore and breastfed.25 The American Academy of Pediatrics always encourages breastfeeding unless there is clear evidence of risk, whether from implants or any other exposure. However, they have not yet reviewed or formally commented on the aforementioned study.

Autoimmune and Connective Tissue Diseases

The greatest controversy regarding the risks of breast implants concerns the question of whether they increase the risk of autoimmune disease and connective tissue disease. Studies from the 1990s tended to show no increase in risk, but more recent studies suggest that there is an increased risk of these diseases.

A study conducted by FDA scientists found a statistically significant link between implants and fibromyalgia, as well as several connective tissue diseases.26 The study focused on women who had silicone breast implants for at least six years, and found that women with leaking silicone implants were significantly more likely to report a diagnosis of painful and debilitating diseases such as fibromyalgia, dermatomyositis, polymyositis, Hashimoto’s thyroiditis, mixed connective tissue disease, pulmonary fibrosis, eosinophilic fasciitis, and polymyalgia. The risk of fibromyalgia remained even after controlling for patient’s age, implant age, and implant manufacturer. Extracapsular leakage was evaluated in the study using an MRI.

A study by Aziz et al examined 95 women who had silicone gel-filled breast implants and rheumatologic symptoms. These researchers found that the symptoms improved in 42 (97%) of the 43 women who had their breast implants removed and not replaced.27 In contrast, rheumatologic symptoms worsened in 50 (96%) of the 52 women who did not have their implants removed.

Scientists at the National Cancer Institute (NCI) found a statistically significant increase in reported connective tissue diseases among breast augmentation patients, but also found that many of the women made errors in their self-reported diagnoses.28 For example, many women who reported having rheumatoid arthritis had osteoarthritis instead, according to their medical records. The NCI study included women who had breast implants for at least seven years. The findings suggest that there are increased symptoms among women with breast implants, but it is not clear if there is an increase in specific diagnoses. As a result, the researchers concluded that the associations between breast implants and arthritis, scleroderma, Sjogren’s syndrome, and other connective tissue diseases need further study.

The Danish study mentioned above, focusing on Danish women who had breast implants for an average of 19 years, found that they were significantly more likely to report fatigue, Raynaud-like symptoms (white fingers and toes when exposed to cold), memory loss, and other cognitive symptoms than women of the same age in the general population.14 Ten percent of the women with implants had already had their implants removed and not replaced, which might have reduced these symptoms. Despite stating that women with implants were between two and three times more likely to report those symptoms, the researchers concluded that long-term exposure to breast implants “does not appear to be associated with” autoimmune “symptoms or diseases.” The study was funded by implant manufacturer Dow Corning.

Prior to these recent studies, most published research that focused on autoimmune or connective tissue diseases studied women who had implants for a relatively short time, ranging from a few months to a few years. The minimum exposure to breast implants was usually one month. These studies were the basis for a report on implants by the IOM, a report by Federal District Judge Sam Pointer’s National Science Panel, and a meta-analysis published in the New England Journal of Medicine regarding the lack of evidence that implants cause systemic disease.24, 29, 30

All three of these reports are based on the same 17-20 epidemiological studies that were published prior to 1999. Since many connective tissue and autoimmune diseases are relatively rare among young women and most take many years to develop and be diagnosed, these studies are not designed to answer questions about long-term safety. Their major flaws are as follows:

•The case-control studies relied on women accurately telling a stranger whether they had breast implants, and most included very few women who admitted to having breast implants. The accuracy of their responses was not verified.

•The studies include substantial numbers of women who had implants for just a few months or years, and therefore do not have the statistical power to determine whether or not breast implants increase the long-term risks of getting these diseases.

•The number of women in the studies who had breast implants for 10-15 years or more is too small to conclusively evaluate an increased risk of disease.

•Disease diagnoses were based on medical records or self-reports, not medical exams. Several studies had an even greater flaw—autoimmune disease was based on hospital records rather than medical diagnoses. Most women with autoimmune symptoms or diseases are not treated in hospitals.

Among the studies reviewed by the IOM, only one study, by Schusterman et al, included a diagnosis based on a medical exam, and all the women in that study had implants for less than two years—too short a time to meaningfully evaluate disease risk. In addition, several European studies that purported to show no increased risk of autoimmune diseases actually indicated an increased risk of neurological or autoimmune disease that was similar for women who had breast augmentation or breast reduction.31, 32 When comparing breast augmentation patients to breast reduction patients, the researchers reported that the augmentation patients were not significantly more at risk. However, the articles clearly stated that both groups had a higher proportion of women with these diseases than expected. Therefore, the interpretation of “no increased risk” was inappropriate. Rather, both types of breast surgery patients were apparently at increased risk compared to the general population.

These findings raise concerns about autoimmune disease that need to be answered with long-term studies. In addition, former FDA researchers have reported that silicone stimulates an immune response, and their cellular analyses indicate that these responses are associated with atypical forms of connective tissue disease.33

In summary, research on connective tissue and autoimmune diseases raises unanswered questions about long-term safety. Results are not conclusive because of relatively short-term follow-up and limitations of the outcome measures. Self-reports tend to show significant increases in health risks, whereas studies that rely on medical records and hospitalization are less likely to show significant increased risks. In industry-funded studies, even when studies indicate an increase in symptoms among women with implants, the authors sometimes conclude that there is no evidence of increased health problems. Overall, there is evidence of increased symptoms in several studies, and more research is needed to draw conclusions about the safety of implants in terms of systemic autoimmune disease.

Cancer, Lymphoma, and Lung Disease

Implant manufacturers claim that there are dozens of long-term studies proving that implants are safe. Most of these “long-term” studies include large numbers of women who have had implants for a short period of time, ranging from one month to several years. Although the women may have implants for an average of 5 or 8 or even 10 years, the number of women with implants for more than 10 years is quite small. Epidemiologists estimate that 15-20 years of follow-up would be necessary to conduct a well-designed study of cancer after exposure, whether to asbestos, tobacco, or breast implants. Most of the implant studies were funded by Dow Corning, conducted by a core group of researchers at a research institute that receives substantial funding from Dow Corning, and have been used to defend the company from liability.

There are very few published studies that have medically evaluated sufficient numbers of women with implants for a long enough period of time to evaluate whether or not implants cause cancer. A study by scientists from the NCI found that women with breast implants were more likely to die from brain cancer, lung cancer, and other respiratory diseases, compared with other plastic surgery patients.34 The NCI study compared augmentation patients to other plastic surgery patients, who were very similar in socio-economic status, health status, and health habits (including smoking). Another strength of the study was that all the women had implants for at least 12 years. Although this is not a long enough follow-up period for a conclusive cancer study, it is considerably longer than other implant studies.

A second NCI study found a 21% overall increased risk of cancer for women with implants, compared with women of the same age in the general population.35 The increase was primarily due to an increase in brain cancer, respiratory tract cancers, cervical cancer, and vulva cancer.

Swedish and Danish studies also found a significantly increased risk of lung cancer among augmentation patients, but did not control for smoking.36, 37

In January 2011, the FDA announced that women with breast implants seem to be more likely to have ALCL (anaplastic large cell lymphoma), a rare cancer of the immune system. The risk of developing ALCL is very low, but much higher in women with implants than it is in the general population. ALCL is especially rare in the breast area, but for women with implants it has been found in fluid surrounding the implant and in the scar capsule, but not the breast tissue itself. There is not enough evidence to suggest that ALCL is more likely in a particular implant type, or to determine its cause in women with implants.38 As a result of this concern, the FDA is now requesting that providers report cases of ALCL in women with breast implants, to determine how great the risk is compared to women without implants.

Suicide and Depression

The same Swedish and Danish studies cited in the previous section, as well as a Finnish study, all found that women who have breast implants for augmentation were three times as likely to commit suicide as women in the general population of those countries.36, 37, 39 The NCI study cited in the previous section also found a statistically significant increase in suicides for women with breast implants, but that study compared augmenation patients to other women plastic surgery patients of the same age, race, and education.34 A recent study of mastectomy reconstruction patients in the U.S. also found a higher rate of suicide among implant patients compared to women who underwent mastectomies without reconstruction.40

The statistically significant increase in suicide in five studies has been subject of considerable debate. Review articles funded by the American Society of Aesthetic Plastic Surgeons41 and by Dow Corning42 conclude that the increased risk of suicide is likely to predate implant surgery, and that women who choose breast implants are more likely to be depressed or have low self-esteem, as well as demographic traits that put them at higher risk of suicide. However, these assumptions are not supported by research data. For example, the NCI study controlled for all the demographic variables associated with suicide (such as age and race) and compared augmentation patients with other plastic surgery patients, who are as likely to be insecure about their appearance as augmentation patients.34 Similarly, the most important demographic predictors of suicide, which are age, race, and sex, were already controlled in the Scandanavian studies finding an increased risk of suicide.36, 37, 39

In support of the theory that poor mental health predates augmentation, one study pointed out that 8% of Danish augmentation patients had a psychiatric admission prior to augmentation surgery, compared to 6% of women undergoing other cosmetic procedures. Like other plastic surgery patients in an era where plastic surgery is quite common and generally accepted, patients tend to be less satisfied with the body part that they are having surgically altered, but not less satisfied with their general appearance or themselves.43 However, Danish women needed a psychiatric referral in order to qualify for free augmentation surgery, which could easily explain this small, non-significant difference.44

It is also important to note that a recent Danish study found an increase in depression among women who had undergone breast augmentation.13 In that study, the women with breast implants were five to seven times more likely to be taking antidepressants than comparison samples of women who underwent breast reduction surgery or women of the same age from the general population. Among the augmentation patients, the women who had their implants removed and replaced at least once were more likely to be taking antidepressants than those who still had their original implants. Although it is impossible to determine whether the women were also more depressed prior to breast augmentation, the relationship between multiple surgeries and use of anti-depressants suggests that complications from the implants may contribute to depression.

General Health, Quality of Life, and Self-Esteem

It is difficult to assess the impact of breast implants on health and mortality generally, because women who undergo breast augmentation tend to be healthier and more affluent than women in the general population. For example, NCI researchers found a lower mortality rate among augmentation patients compared to the general population of women their age, but a higher mortality rate among augmentation patients compared to other plastic surgery patients. The authors concluded that plastic surgery patients are a more appropriate comparison sample, because they are more similar to augmentation patients in social class, health, health habits, and other key variables.34

A Canadian study of women with implants compared to the general population of women of the same age found that the augmentation patients were greater than four times more likely to be hospitalized, experienced more hospitalizations, and visited physicians and specialists more often. In other words, augmentation patients cost the healthcare system significantly more than other patients of the same age and geographic location.45

A study of women who had breast implants after mastectomy came to the surprising conclusion that women with implants had a significantly better survival rate than other women of similar age, race, and diagnosis.40 However, a critique of that study by NCI researchers pointed out that the better survival rates could have been the result of other advantages of the implant sample: including lower rates of obesity, higher social class, better prognosis, treatment at designated cancer centers, and use of adjuvant treatment.46

It is often assumed that breast implants improve the self-esteem and quality of life of women who undergo augmentation, as well as those having reconstruction after breast cancer. However, the research does not support this assumption. Studies of augmentation patients show no difference or improvement in self-esteem, compared to women who do not undergo augmentation.43 Studies by NCI researchers and other national experts indicate that women who have undergone reconstruction report the same quality of life as women who did not have reconstruction after mastectomy. In fact, implant patients are more likely to report that cancer harmed their sex life than women who underwent mastectomy without reconstruction.47 Self-selection makes it difficult to interpret these data, but the Inamed data presented at the October 2003 FDA meeting indicated a decrease in all quality of life measures two years after implants compared to before surgery. Overall, these findings indicate that implant companies have yet to prove that implants objectively improve women’s quality of life.48

The Hidden Costs

The initial surgery for breast implants is the first, but not the greatest expense for implant patients. If silicone breast implants last approximately 7-10 years before breaking, replacement surgery will add greatly to the cost. The implant itself may have a warrantee for free replacement, but the surgical and anesthesia costs are not free, nor are the costs of the medical facility. These expenses may not be affordable for all implant patients, especially since the initial breast augmentation is often available on an installment plan.

Cosmetic surgery is not covered by health insurance, and problems resulting from cosmetic surgery are usually excluded from coverage. In some states, major health insurance providers have refused to insure women with breast implants. Some insurers have sold health insurance to women with implants, but charged them more, and some insurers have refused to cover certain kinds of illnesses for women with breast implants, or refused to cover any problems in the breast area. For women who were diagnosed with diseases that were excluded, it would not matter if those diseases were unrelated to the implants.

What if a woman no longer wants breast implants? Implants can be removed and not replaced, but the breast tissue stretches from the implant, and the breast is unlikely to be as attractive as it was before the implant surgery.49 Women with leaking silicone implants often lose breast tissue as part of the removal surgery. According to testimony presented at the October 2003 FDA meeting, this may result in surgery that is similar to a mastectomy.

Conclusions

In 1990, breast implants had been sold for more than 25 years but there were no published epidemiological studies or clinical trials. There are now more than 100 studies of women with implants, most of them funded by Dow Corning, implant companies, or medical associations with a financial interest in the outcome. These studies are persuasive in showing that breast augmentation does not dramatically increase the risk of diseases in the short-term. A co-author of most of those studies, who served as a consultant to Inamed, argues that studies “with a mean follow-up of a decade and almost three decades of follow-up for the longest-term implant recipients” is “long enough.”50, 51 However, there are numerous shortcomings in the studies he cites and co-authored, such as including many women whose implants were only a few months or a few years old at the time of the study, and therefore did not have the statistical power to draw meaningful conclusions about long-term safety. The small number of women providing relevant long-term data is especially a problem when studying diseases such as cancer, scleroderma, and lupus which take years to develop and diagnose. Careful scrutiny of the research indicates an increase in symptoms in many studies, but it is primarily in the studies where all the augmentation patients had implants for at least six years that increases in disease risks are statistically significant. It is also notable that the independently funded studies tend to focus on women with implants for longer periods of time, and often show increased risks that are not apparent in the industry-funded studies.

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

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