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Capsular Contracture


After getting breast implants, breast pain, hardness, and numbness can develop and last for years. These common complications may never go away. The most common complication of breast implants is capsular contracture. When you get breast implants, your body naturally responds by forming scar tissue around the implants. Capsular contracture occurs when the scar tissue tightens around the breast implant. This can cause the implant to harden and become very painful. It can also change the shape of the implant, making it look abnormal, as shown in the photo below.

A 29-year-old woman with Baker Grade IV capsular contracture. Photo courtesy of Walter Peters, Ph.D., M.D., F.R.C.S.C., University of Toronto.

To fix capsular contracture, doctors used to perform a “closed capsulotomy.” This painful procedure involves squeezing the breast very hard to break the scar tissue capsule. This procedure should never be done. Most plastic surgeons do not perform this procedure anymore, but some do. The squeezing can break the implant and the capsule. Closed capsulotomies are not effective, and capsular contracture often comes back.

There are different grades of capsular contracture (Baker I, Baker II, Baker III, and Baker IV). They are graded based on the severity of symptoms:

Baker Grading System for Capsular Contracture

Baker I Breast is soft
Baker II Breast is slightly firm
Baker III Breast is firm and possibly misshapen and uncomfortable
Baker IV Breast is hard, painful, and misshapen

Health insurance companies that will pay for breast implant removal usually cover removal when there is severe capsular contracture (Baker III and Baker IV). This is because severe, painful capsular contracture interferes with mammography (breast cancer screening). It can also interfere with daily activities, such as reaching above your head.

The same 29-year-old woman as above one year after her implants were removed and not replaced. Think of how much pain she was in to be willing to look like this! Photo courtesy of Walter Peters, Ph.D., M.D., F.R.C.S.C., University of Toronto.

Capsular contracture does not usually get better by itself. If your breasts become very painful or hard, you will need surgery. Your surgeon would need to remove the scar tissue capsule and the implant. It is possible that some of your own breast tissue will be removed during the surgery because it is attached to the scar tissue. This can reduce the size of your natural breast and/or change their appearance.

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

 

Rupture


If an implant tears or develops a hole, it is called a rupture. Some implant ruptures happen during the first few months, but the older an implant is, the more likely it is to rupture. It’s not always obvious when an implant has ruptured. Here’s what you need to know.

Saline Implant Ruptures

When a saline (salt water) breast implant ruptures, it will probably leak very quickly. The implant deflates much like a balloon that has lost the air inside. As this happens, your breast will change in size and/or shape. If a saline implant leaks slowly, it might not be immediately noticeable. When the saline leaks, the body absorbs it. It is usually harmless unless bacteria, yeast, or mold are inside the implant. They can cause a serious infection. If you notice a change in the size or shape of your saline implant along with symptoms like swelling, redness, or fever you should see a doctor immediately.

Silicone Implant Ruptures

When a silicone gel breast implant ruptures, it usually leaks very slowly. A ruptured silicone gel implant may not be obvious for many years. This is why silicone gel implant ruptures are sometimes called “silent” ruptures. Sometimes, the rupture is discovered only when the implant is removed.

When a silicone implant ruptures, the silicone can either stay inside the capsule (the thick layer of scar tissue that naturally grows around the implant) or it can leak outside the capsule. It is more serious when the silicone leaks outside of the capsule. When this happens, silicone can migrate to the lymph nodes, and from there can go to the lungs, liver, or other organs where it’s impossible to remove. The longer a woman waits to have a ruptured silicone gel implant removed, the more silicone is likely to leak inside her body and cause health problems.

How Do I Find Out If My Silicone Implant Has Ruptured?

If your silicone gel implant ruptures, you might notice a change in the size or shape of your breast. You might feel pain or tenderness, swelling, numbness, burning, or tingling. Or, you might not have any symptoms, making it impossible to know you have a rupture.

Because most women don’t notice when a silicone gel implant ruptures, the FDA recommends having a breast MRI 3 years after getting breast implants. After that, a breast MRI should be done every other year to check for a rupture.

A mammogram is the least accurate way to diagnose a ruptured silicone-gel breast implant. In addition, the pressure could cause the silicone to leak outside the capsule.

What Should I Do If My Implant Ruptures?

If your saline implant has ruptured, you should see a doctor. This is especially important if you feel sick, have a temperature, a rash, or other unexplained symptoms. You could have an infection and require treatment.

If you have ruptured silicone gel implants, they should be removed as soon as possible. The longer the silicone is allowed to remain in the body, the more time it has to migrate to other parts of your body. Once the silicone has moved to other parts of your body, it can’t be removed and may cause other health problems.

Since breast implant removal includes costs (such as anesthesia) that are similar whether you have one implant removed or two, it is usually best to remove them both at the same time, whether or not you want them to be replaced. For example, if your implants were put in at the same time, and one is ruptured, it is likely that the other will rupture soon. One surgery is much less expensive than two.

Can Broken Implants Make Me Sick?

According to research by FDA scientists, women with leaking silicone implants are more likely to report fibromyalgia (widespread body pain and fatigue) or several other diseases, compared to women whose implants are not leaking.1 One study found that 3 out of every 4 women who removed their silicone breast implants saw improvement in their symptoms.2

No research has been published on the health risks of broken saline implants but bacteria from ruptured saline implants have caused women to become ill.

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

Pregnancy and Breastfeeding Concerns


When considering whether to have breast implant surgery, you should take your future plans for childbearing and breastfeeding into consideration.

Pregnancy

Although some researchers believe that having breast implants may harm a growing fetus, there is a lack of research to determine if this is true. Researchers who believe that implants can result in autoimmune issues or birth defects in children have several theories: 1) silicone molecules travel through the placenta from mother to baby, 2) mothers form antibodies from silicone exposure that transfer to their fetuses, and 3) autoimmune issues experienced by the mother are inherited by the baby.[1] However, there are not enough well-done studies to prove that any of these theories are true.

There are other reasons why women who are planning to get pregnant may want to avoid breast implants. Pregnancy can cause drastic changes in breast size and shape, so having implants may affect the shape of breasts after the baby is born. When breast implants are initially placed, the surgeon normally uses the natural shape of the breast as a guide. After pregnancy and breastfeeding, implants may no longer enhance the look of the breast in the way that they did before.

Breastfeeding

Breastfeeding has many health benefits for an infant, including immune strengthening, neurological development, and nutritional intake. Additionally, the skin-to-skin contact during feeding promotes bonding between a mother and child. Studies indicate that women with breast implants may find it difficult to produce enough milk due to pressure on the milk ducts from implants or damage to mammary glands or ducts during the implant surgery. For example, several studies show that women with implants were more likely to need to supplement their baby’s diet with formula, because they were unable to produce enough breast milk to feed their baby.[2] This information is important for any woman who plans to become pregnant in the future, and especially for women who previously had difficulty with breastfeeding.

Mothers with silicone implants have expressed concern that silicone could get into their breast milk. However, researchers are not certain whether silicone leaking out of an implant could be ingested by an infant during feeding.

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

References

  1. Bondurant, S, et al. “Safety of Silicone Breast Implants.” National Academies Press, 1999, www.ncbi.nlm.nih.gov/books/NBK44782/
  2. Schiff, M., Algert, C., Ampt, A., Sywak, M., & Roberts, C. (2014). The impact of cosmetic breast implants on breastfeeding: A systematic review and meta-analysis. International Breastfeeding Journal, 9(1), 17-17. doi:10.1186/1746-4358-9-17

Testimonies and Publications from 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

What do Women Want in Healthcare?

2014

Journal of the American Society of Clinical Oncology Publication

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

Complications of Saline Breast Implants

Elizabeth Nagelin-Anderson, MA and Diana Zuckerman, PhD, National Center for Health Research

What You Should Know Before You Decide on Reconstruction

How risky are breast implants? This is a controversial question, but implant manufacturers have done research showing that local complications, including pain, rupture, and the need for additional surgery, are very common within the first three years.

The FDA required breast implant manufacturers Mentor Corporation and Inamed Aesthetics (formerly called McGhan) to conduct research on the complications of saline breast implants for breast reconstruction and breast augmentation patients. The purpose of this research was to provide women with information so that they can make a more informed decision about whether or not they want saline breast implants. This information is supposed to be made available by plastic surgeons to all patients before they make their decision. The studies did not include diseases or conditions such as cancer, lupus, or fibromyalgia.

This issue brief is based on the FDA’s analyses of data collected by Mentor Corporation and Inamed Aesthetics. It is based on research, not opinion. The 3-year data were analyzed by the FDA in 2000 and the 5-year data were analyzed in 2002. This fact sheet is only about reconstruction patients.

Mentor Saline Implants

Mentor conducted a 5-year study on reconstruction patients. Unfortunately, so many women (almost 60%) dropped out of the study before the five years were completed, that the information is not reliable. For that reason, we are only providing the information collected during the first 3 years after getting implants, which included 78% of the patients.

Important Points from the Mentor Data

  • Most women can expect at least one complication within the first 3 years.
  • 40% of reconstruction patients can expect to have additional surgery within the first 3 years.

Mentor Reconstruction Patients 3-Year Complication Rate

Reconstruction patients experienced the following problems within the first 3 years of receiving their implants:

40% Needed another operation
30% Capsular contracture (hardening of breast)
28% Asymmetry (breasts look different from each other)
27% Implant removal
20% Wrinkled appearance of breast
17% Breast pain
9% Infection
9% Implant leaks/deflates
8% Irritation/inflammation
6% Delayed wound healing
6% Seroma (watery portion of blood collects around implant or incision)
5% Scarring complications
2% Extrusion (implant comes through the skin)
2% Necrosis (death of skin or tissue)
1% Hematoma (blood collects around implant)
1% Position of implant changes

Loss of nipple sensation is not listed since nipples are removed during mastectomy.

Only 78% of the reconstruction patients who originally enrolled in the study completed all 3 years. Women who had their implants removed, and women who left the study for any reason were not followed. Complications were measured up until a woman left the study, but percentages were based on the total number of women who started the study. So, the complication rate is actually even higher.3

Inamed Saline Implants

Inamed, formerly called McGhan, conducted a 5-year study on breast reconstruction patients. They collected information at the 3-year point from 71% of the reconstruction patients who originally enrolled in the study.

At the 5-year point they collected information from 57% of the reconstruction patients. This is a problem, since no information is available for 43% of the patients. Women who had their implants removed, and women who left the study for any reason were not followed. Complications were measured up until a woman left the study, but percentages were based on the total number of women who started the study. So, the complication rate is actually even higher, and the 3-year data are more reliable than the 5-year data.

Important Points from the Inamed Data

  • Most women can expect to experience at least one complication at some point within 5 years after implant surgery.
  • 40% of reconstruction patients can expect to have additional surgery within the first 5 years.

Inamed Reconstruction Patients 3-Year and 5-Year Complication Rates

Reconstruction patients experienced the following complications during the first three years and first five years after surgery.

3 Year 5 Year
39% 45% Needed another operation
33% 39% Asymmetry (breasts look different from each other)
25% 36% Capsular contracture (hardening of breast)
23% 28% Implant replacement/removal – any reason
20% 27% Implant can be felt or seen
23% 25% Wrinkled appearance of breast
15% 18% Breast pain
12% 17% Implant is in a bad position
6% 8% Implants leaks/deflates
7% 7% Irritation/inflammation
6% 6% Intense skin sensation
6% 6% Scarring complications
5% 6% Infection
5% 5% Calcium deposits form around implant
4% 4% Seroma (watery portion of blood collects around implant or incision)
4% 4% Skin/tissue necrosis (death of skin or tissue)
3% 3% Delayed wound healing
3% 3% Implant extrusion (implant comes through the skin)
3% 3% Skin Rash
1% 1% Hematoma (blood collects around the implant)

Loss of nipple sensation is not listed since nipples are removed during mastectomy.

Most complications for Inamed patients through the first 5 years are similar to those reported after the first 3 years. Since it is well known that some complications, such as rupture and capsular contracture, increase over time, women with complications were apparently more likely to leave the study than those who continued. Some of these women have left their plastic surgeons and could not be contacted.4

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

References

What to Ask Your Plastic Surgeon


When you’re considering breast implants, it is often hard to know what questions to ask and who to ask. For many plastic surgeons, breast augmentation is a large part of their practice and their salary. Keep in mind that you may not receive completely objective responses, but here’s a good place to start:

Before you go in, make sure the plastic surgeon is very experienced in breast augmentation. Any physicians or dentists may call themselves cosmetic surgeons even if they aren’t well trained in surgery. That’s perfectly legal, but their patients are taking a risk.

Ideally, you will want to see a plastic surgeon who is board certified in plastic surgery (not in some other medical specialty), because that will help assure you that they received the appropriate training to perform breast augmentation. You can find out if a doctor is board-certified by the American Board of Plastic Surgery online.

However, not all board certified plastic surgeons are skilled at implanting or removing breast implants. Check online for complaints about any plastic surgeons that you are considering. If there are serious complaints about patients who were harmed by the surgeon, look for a plastic surgeon with better ratings.

Once you decide to see a surgeon, here are some questions to ask during your appointment:

  • Ask to see before and after photographs of your plastic surgeon’s patients. Some doctors use photographs of patients whose surgery was done by other surgeons. If the doctor says that the photos are of his/her patients, ask when those patients had surgery. If it was a long time ago, ask to see more recent photos.
  • Ask to see photographs of her or his patients that were taken at least three years after the surgery. Many patients look good immediately after surgical scars have healed but their breasts look different years later.
  • Ask your doctor for a patient booklet or other written information that includes the risks of breast implants and read that information at least one week before surgery so you have time to ask questions and gather more information.
  • Ask for a copy of the informed consent form at least one week before surgery.
  • Ask whether there is a warranty on the implants and, if so, what is and isn’t included.
  • Ask whether the doctor will remove your implants for free if you have serious problems. If so, will the surgical center services also be free? What if you want them removed, but the doctor doesn’t think it is necessary?

If you’re still unsure about getting breast implants, seek advice from someone that has gone through breast implant surgery at least 5 -10 years ago. They may be able to help you make the decision that is best for you. Click here to read some personal stories from women who had breast implants.

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

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.