All posts by BIeditor

I’m a Teenager Considering Breast Implants. What Should I Know to Help Me Decide?

Have Questions?
Here are a few things to consider as you are making a decision about getting breast implants:

Teenagers are not finished developing. Breasts can develop during the late teens and early 20s. Implants could interfere with your normal development, or the resulting size and shape could be not at all what was intended as the breasts continue to develop.

The body you wish you had in your teens might not the body you’re going to want in your 20s.

Teenagers are often self-conscious about how they look. The odds are that you will feel a lot better about your body just a couple of years later, even without any cosmetic surgery. In fact, women who have breast implants tend to feel worse about themselves. Research has shown that of all age groups, teenagers are the most likely to be dissatisfied with their appearance — and that the dissatisfaction lessens with age. A long-term study conducted on both boys and girls ages 11-18 found that body image satisfaction was highest at age 18 for both boys and girls. In other words, older teens feel better about their bodies than younger teens.1 The study also found that the features participants were most dissatisfied with reflected the culturally determined stereotypes emphasized in books, mass media and advertisements.

There are no epidemiological studies or clinical trials on the safety and long-term risks of breast implants and liposuction on patients under 18. So, the risks are unknown. Although the FDA approved silicone gel breast implants only for women ages 21 and older, and saline breast implants only for women 18 and older, there are no legal restrictions on the procedure. The American Society of Plastic Surgeons has an official position against breast augmentation for most teens under 18.

Breast augmentation has a very high complication rate that often requires additional surgery within five to ten years.2 , 3 For a girl of 18, that means she will probably need another surgery while she is in her 20s, her 30s, and every decade after that.

Some women do fine with breast implants while others have complications or health problems that can make them so sick that they call implants “the worst decision I ever made.” Before you decide, make sure you understand the risks and complications of breast implants.

Click here to read about a woman who got her implants when she was young and what she thinks about them today.

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

After Years of Being Unhappy with My Breasts, I Am Thinking of Getting Breast Implants. What Are the Risks?

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Breast implant surgery comes with a high complication rate. Complications can happen immediately after the surgery or years after. The major health risks of breast augmentation surgery are:

Capsular Contracture – The most common complication of breast implants is capsular contracture. Capsular contracture occurs when the scar tissue tightens around the breast implant. This can cause the breast to feel hard and very painful.

Breast Pain, Redness, or Swelling – As with any surgery, augmentation patients should expect to feel pain immediately after surgery. However, pain that lasts for months or longer can have many different causes and requires treatment. It can be a sign of an infection, especially if the pain is accompanied by redness, swelling, and tenderness. Or it can be a sign of nerve damage, which can be temporary or permanent. The weight of breast implants can strain the muscles in your neck, back, and chest and can cause chronic back pain and shoulder pain, and can even cause permanent damage.

Rupture – If a breast implant tears or develops a hole, it is called a rupture. Some 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. Link?

Autoimmune Symptoms and “Breast Implant Illness” – Breast implant companies were required to complete safety studies before they could sell their implants in the United States. When the Food and Drug Administration (FDA) approved breast implants, they admitted that “studies would need to be larger and longer” to find out if implants could cause the kinds of symptoms and diseases many women were reporting, such as joint pain, “brain fog,” fatigue, and other flu-like symptoms that don’t go away. These health issues seem to be caused by autoimmune or connective tissue problems, and many women with these and other symptoms refer to them as “breast implant illness.” Breast implant illness is not a medical diagnosis and most plastic surgeons reject the term. However, many women with this pattern of health problems report that they recovered dramatically (sometimes completely) after their breast implants were removed.

Interference with Breast Cancer Detection – Breast implants make it more difficult to detect breast cancer when they hide cancer tumors. If you are considering getting breast implants or already have breast implants, it is important to know how they can make mammography and breast exams less accurate.

Infection – Infections can happen after breast augmentation surgery if bacteria get into the incision site. Or bacteria can thrive around and implant. These infections can be serious. The Food and Drug Administration (FDA) warns that toxic shock syndrome, a life-threatening complication from bacterial infections, has been reported following breast augmentation surgery.

Pregnancy and Breastfeeding Concerns – Pregnancy can cause drastic changes in breast size and shape, so having implants may affect the shape of breasts after the baby is born. In addition, 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.

Breast Implant Associated-Anaplastic Large Cell Lymphoma (BIA-ALCL) – Cancer experts agree that women with breast implants are more likely to develop ALCL, a rare cancer of the immune system that develops in the scar tissue (capsule) that forms around a breast implant.

Extrusion – Extrusion, or when a breast implant comes through the skin and becomes exposed, is an uncommon, but dangerous, complication of breast implant surgery.

In addition to the health risks, there also are financial costs. For more information about the costs of breast implants, click here.

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

How Do I Find Out If My Silicone Gel Breast Implants Are Leaking, and What Should I Do If They Are?

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If your silicone gel implant ruptures, you might – or might not – notice a change in the size or shape of your breast. You might feel pain, tenderness, swelling, numbness, burning, or tingling on or around your breast. However, you might not have any symptoms, and might not realize that your implant is broken and possibly leaking. This can be harmful to your health, and the longer the implant is leaking silicone in your body, the more harm it can cause.

The best way to know whether your silicone breast implant has ruptured is to have an MRI with a breast coil. Unfortunately, MRIs are expensive and MRIs to check for implant rupture may not be covered by insurance.

Because most women don’t realize that a silicone gel implant has ruptured,  the FDA recommends having breast MRIs regularly to detect ruptures that have no symptoms.  When silicone breast implants were first approved, the FDA recommended that all women undergo a breast MRI 3 years after getting breast implants, and every other year after that. However, because of the expense and the reluctance of plastic surgeons to encourage MRIs for silent ruptures, very few women followed the FDA’s advice.  As of October 2020, FDA now recommends an MRI 5-6 years after the initial surgery and every 2-3 years after that. That way any leaks can be caught early, helping to protect your health.

A mammogram is not usually an accurate way to diagnose a ruptured silicone-gel breast implant. In addition, the pressure from mammography could cause the implant to break and could cause a broken implant to leak.

If even one of your silicone gel implants is ruptured, it should be removed as soon as possible. The longer the silicone is leaking into your body, the more time it has to migrate to your other organs, such as your lungs or liver, or even your brain. When that happens, the silicone can be impossible to remove.

To read more about breast implant ruptures or leakage, click here. To read more about removing ruptured breast implants, click here.

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

My Saline Breast Implant Deflated. What Should I Do?

Have Questions?

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. 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. If your breast implant ruptures, you should have it removed to prevent infection, leakage, pain, and other problems.

Because 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.

You will also need to decide whether to have your implants replaced. If you have had problems with one or both of your breast implants, it is likely that those problems will develop if your implants are replaced. Before you undergo surgery, learn about the many health issues that can be caused by breast implants. You might be surprised to learn that health issues that seemed unrelated to your implants might actually be caused by them. Some women find that replacing their implants leads to an endless cycle of future surgeries. To learn more about how to find a plastic surgeon, click here.

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

Is it Safe to Breastfeed with Breast Implants?

Have Questions?

According to the Institute of Medicine, any kind of breast surgery, including breast implant surgery, makes it more likely that a woman trying to breastfeed will not have enough milk to breastfeed (lactation insufficiency).

Unfortunately, little is known about the safety of breast milk among women with breast implants. Pediatricians believe the milk is safe, but there is so little research that we don’t know if that is true. Some women believe that their children are sick because of their breast implants, while others think their children were not harmed at all by nursing with implants.

A few years ago, a chemistry professor at American University, Dr. Susan Maharaj, reported finding high levels of platinum in the breast milk of women with breast implants. She also reported that children who had been breastfed by women with breast implants had dangerously high levels of platinum in their bodies. Platinum is used to help make breast implants, but is supposed to be used in very tiny microscopic amounts. Children who had been breastfed before the same mothers got breast implants did not have high levels of platinum.

We are not doctors and we are not providing medical advice, but we can tell you what we know from research and from speaking with many experts and women who have had implants.

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

Fibromyalgia and Ruptured Silicone Gel Breast Implants

Helpful Articles
FDA Consumer Magazine: November/December 2001.

Women whose silicone breast implants have ruptured and spread silicone gel beyond the fibrous scar that forms around the implant may be at increased risk for fibromyalgia, an FDA study indicates.

FDA researchers asked 344 women with silicone gel implants if they had experienced persistent joint pain, swelling or stiffness; rash on their breasts or chest; or fatigue. Those in the study also were asked whether a physician had diagnosed them with Raynaud’s disease, Sjögren’s syndrome, scleroderma, chronic fatigue, or fibromyalgia–a chronic condition marked by fatigue, musculoskeletal aches and sleep disturbances.

The women also had a magnetic resonance imaging (MRI) examination to detect whether their implants were intact or ruptured, and whether silicone gel had leaked outside of the scar tissue immediately surrounding the implant.

The study found that women with a ruptured implant in which the silicone hadn’t leaked beyond the scar tissue were no more likely than women with intact implants to report that they had either the persistent symptoms or diagnosed illnesses listed on the questionnaire.

However, the women with silicone gel that had migrated outside the fibrous scar around the implant were nearly three times more likely to report that they had been diagnosed with fibromyalgia or other connective tissue disease than women without extracapsular silicone gel.

“If other studies are consistent with these findings, women should be informed of the potential risk of developing fibromyalgia if their breast implants rupture and silicone gel escapes outside the fibrous scar capsule,” says lead study investigator S. Lori Brown, Ph.D., M.P.H., of the FDA’s Center for Devices and Radiological Health.

The study, supported in part by the FDA’s Office of Women’s Health and the National Institutes of Health, was published in the May 2001 Journal of Rheumatology. An estimated 6 million to 8 million Americans have fibromyalgia. About 80 percent of those affected are women.

The FDA took silicone gel breast implants off the market for general use in 1992 because of safety concerns. They continue to be allowed in FDA-approved studies for women seeking breast reconstruction or revision of an existing breast implant. Additionally, those who need to have an existing implant replaced for medical reasons, such as implant rupture, are also eligible for these studies.

Read the original article here.

 

Safety and Benefits of Mentor Silicone Breast Implants From the April 2005 FDA Analysis and Meeting

How Safe Are They?
Marcy Oppenheimer, MD, National Center for Health Research

In 2005, the Mentor Corporation sought FDA approval to market its silicone gel-filled breast implants. At a hearing before an FDA advisory panel on April 13, the company provided evidence claiming that the implants are safe and effective.

Based on the information provided, FDA scientists indicated that the data failed to show that the implants were safe, and also raised questions about effectiveness.

No Research on Most of their Implants

Mentor is seeking approval of implants of three different shapes. Each is available with two alternative shell surfaces; smooth and textured, for a total of 6 different implant styles. The Core Study, the primary clinical trial that Mentor provided to the FDA in support of FDA approval, includes only one of the implant shapes, and therefore only two of the six implant styles. There are no clinical data on the other two shapes for either type of shell surface.

Rupture Rate

Rupture rates refer to the percentage of implants that break each year. Why do rupture rates matter? According to FDA’s guidance to industry:

FDA believes that device rupture is one of the primary safety concerns presented by breast implants. When a silicone gel-filled breast implant ruptures, the patient and the physician may be unaware of it, the body does not have a mechanism for eliminating the silicone gel, and the gel can migrate outside of the capsule into the breast area, the lymph nodes, and distant locations (i.e., extracapsular gel migration).

FDA thus recommended that manufacturers provide data on the “rate and rate of change of rupture over the expected lifetime of the device.” At the hearing, Mentor’s consultants estimated that the lifetime of their silicone gel breast implants is 25-47 years, which is much longer than previous implants have been found to last. However, the company provided minimal data to support that estimate or to predict rupture rate over that period of time.

Mentor pointed to two studies as proof of a low rupture rate. The Core Study contains data on patients who have had implants for two to three years, but the most accurate measure of rupture was used only during the first or second year. This study is obviously inadequate to establish the rupture rate of a device with a lifetime of more than 25 years.

The other study presented by Mentor, the Sharpe/Collis study, was an unpublished, 10-year case series of patients in one plastic surgery practice in the UK. This study had many inadequacies including:

• All patients were treated by one surgeon, who may not be typical of all surgeons.

• Only augmentation patients were included. Reconstruction and revision patients have increased risk of rupture, but were not in the study.

• Patients with capsular contracture or a prior surgical procedure were excluded. These patients have increased risk of rupture.

• All implants were placed above the chest muscle. In the U.S., implants are typically placed below the chest muscle, which increases the risk of rupture.

• Patients with implants removed during the first four years were excluded. These patients may have had ruptured implants not counted in the study.

• Data are subject to selection bias, because patients were limited to voluntary participants from one surgeon’s practice. Patients who were unhappy or angry with their surgeon were unlikely to participate

The FDA concluded that this study is “of limited value in characterizing the rupture rate” of Mentor implants. Other rupture data presented by Mentor included publications not specific to their own breast implants.

In summary, Mentor was unable to predict the rupture rate of its silicone breast implants. The company presented two years’ worth of MRI data, with an additional 10 years of scientifically unsound data, to characterize the rupture rate of a device with a lifetime that they predicted would be 25-47 years.

Health Consequences of Implant Rupture

No one knows the exact health consequences of implant rupture, although it is known that silicone leaks from some ruptured implants. FDA requested that Mentor elucidate the health consequences of implant rupture, but Mentor failed to do so.

FDA concluded that the Core Study data “are of limited value” in assessing health consequences. Similarly, the published articles Mentor cites “do not completely address all the health consequences of rupture, and the literature is not specific to Mentor implants.”8

Data from another implant maker, Inamed, raises important concerns about implant safety. Inamed analyzed local complications among a small number of patients with confirmed ruptured implants, compared to patients with confirmed intact implants.9 These data are presented below since Mentor data were so short-term that they were not able to present this type of analysis.

Table of Complication Frequency in Patients With and Without Ruptured Implants

It is clear from the table that patients with confirmed ruptures have higher rates of infection, lymphadenopathy, redness, seroma, and skin rash, which are shown shaded above. These symptoms are generally associated with an inflammatory reaction and/or with infection. While these data are based on a small number of patients (only 17 in the confirmed rupture group), they suggest that implant rupture may cause an inflammatory process in the body.

Danish data submitted by the implant manufacturers show that women with ruptured implants are twice as likely to report non-serious pain in the affected breast compared to women with intact implants, and are six times more likely to report breast hardness. In addition, women with extracapsular rupture (where the silicone has leaked outside the immediate area of the implant) are 3 times more likely to report a connective tissue disease, 2 times more likely to report pleuritis, and 1.7 times more likely to report than women with intact implants, although these numbers were not statistically significant.10

Based on a very conservative rupture rate estimate developed by the FDA, 25,000 ruptures would occur among augmentation patients in the U.S. each year if implants were approved for general use. What risks would these women face? No one, including the implant manufacturers or the FDA, can tell them.

Re-operation Rates

Women getting silicone breast implants can expect to have several follow-up surgeries. Mentor’s Core Study indicated that after only two years, 25% of reconstruction patients, 12% of augmentation patients, and 26% of revision patients can expect to undergo a second surgery related to their implants. For the augmentation and revision patients, the most common cause of re-operation is capsular contracture, an often-painful hardening of the breast. For the reconstruction patients, the most common cause of re-operation was asymmetry.

Signs and Symptoms of Connective Tissue Disease

Although not provided by the FDA, an analysis presented by Advisory Panel member Dr. Brent Blumenstein indicates an increase in several signs and symptoms of connective tissue disease, such as joint pain and fatigue, for women who have had implants for two years, compared to prior to getting breast implants. The analysis was conducted on all women in the Mentor Core Study, not just those with a ruptured implant. These differences are maintained even when the impact of aging is statistically controlled.

Benefits

In addition to evaluating the risks of implants, the companies were required to evaluate the benefits as well. It is clear that breast implants increase breast size, but plastic surgeons and implant makers also claim that breast implants help women feel better about themselves and their lives. For that reason, the FDA required implant makers to use objective measures of emotional health, comparing women before they had implants and two years later.

Mentor data show that almost all patients say they are satisfied with their implants after three years. However, their answers to several scientifically developed scales and questionnaires shows that overall, their quality of life remained the same or declined two years after receiving implants. The table below summarizes these results. In the table, a change that was not statistically significant is listed as “no change.”

Table of Quality of Life Changes After Implants

Besides its own data, Mentor submitted a review of the published literature on the efficacy of implants. FDA reviewers, however, found little support for Mentor’s position that implants improved women’s self-esteem or quality of life. With respect to augmentation patients, the FDA found that “the literature does not provide strong scientific support that breast implants have measurable psychological and psychosocial benefits. . .” For reconstruction patients, the FDA concluded that “literature that adequately evaluates the short-term or long-term psychological or psychosocial benefits of breast implants . . . was not provided by Mentor.”

In summary, neither the research conducted by implant makers, nor the published research literature, support the claim that breast implants improve a women’s self-esteem, mental health, or quality of life. This is true whether the patients chose implants after mastectomy, or for augmentation, and whether they were getting breast implants for the first time or to replace problem implants.

Implications of other Research and Federal Activities

Research conducted by an epidemiologist in Canada found that augmentation patients were more likely to be hospitalized, were hospitalized for more days, and used the healthcare system more than similar women who did not have breast implants.[1]

Although the health effects of breast implants are controversial, the U.S. Department of Justice successfully sued silicone breast implant makers to recover the costs of treating patients with illness caused by implants. Mentor and other implant makers agreed to pay more than $11 million to compensate the federal government for these health costs. The law suit was based on government evidence, not made public, that breast implants caused health problems, which resulted in the government paying medical costs and disability payments.

References:

Read the FDA materials here

  1. Tweed A. Health care utilization among women who have undergone breast implant surgery. British Columbia Centre of Excellence for Women’s Health. Available: www.bccewh.bc.ca/PDFs/hcubreastimplants.pdf.

Testimony of Susan Pope Helman, Ph.D.

Other Testimonies About Breast Implant Complications

Statement by Susan Pope Helman, Ph.D.

General and Plastic Surgery Devices Panel Center for Devices and Radiological Health Food and Drug Administration, DHHS

October 15, 2003

Good Morning. I am Susan Pope Helman, Ph.D. and I am from Florida.

As I speak, pretend I am your wife or someone you love very much.

A little over 13 years ago, I was normal. I had two children and took care of my Mother who had Alzheimer’s Disease, while I worked two jobs and put myself through college. I was a productive tax-paying Mom who enjoyed golfing, swimming, bicycling and long walks in the mountains and on the beach. I never missed a day of work.

Then, September 6, 1990, I made the biggest mistake of my life. I trusted my plastic surgeon who stated silicone breast implants were SAFE, that they will last a lifetime, and I would “go to my grave with them.” I assumed they wouldn’t be available unless the FDA had determined they were safe.

Boy, how wrong that was!

Within about 6 months I started getting horrible headaches, couldn’t think “right”, and noticed I was dizzy and nauseated much of the time. I would lose my balance and feel like I was going to fall down.

I couldn’t figure out why!

The second year, all of my hair fell out. I was diagnosed with fibromyalgia. I could not concentrate, and I seemed to be in a “fog” most of the time.

When the pain would come I would thrash back and forth in bed and could not focus or see or get up.

My life was destroyed.

I lost a wonderful job, my car, my salary, my home, my productivity and sense of well-being as a person.

The illnesses began with a vengeance around 1997. Both breasts burn like they are on fire and throb with pain. I have sores, blisters in my mouth and on my hands that bleed and boils on my bottom most of the time.

I wondered why I felt so bad. I had the implants removed in 1992. The implants were in my body less than 2 years!

In 2001, I found out the reason. The capsules which contained bacteria, silicone and giant T-cells were left inside my body and continued to make me more sick.

I also found out both implants had ruptured and all of the silicone was never accounted for. The silicone had migrated throughout my body. I have had brain scans that show many lesions–I was told that I had the brain of an “old lady”–and other tests that show polyneuropathies, multiple sclerosis, lupus and autoimmune disease.

Two years ago, a plastic surgeon removed the remaining capsules and silicone that spilled out into my chest wall, as well as much of my breasts and several lymph nodes and scar tissue. She stated she “was unable to remove it all.” And Susan, “You must live like this for the rest of your life.” I continue to receive cortisone injections every three months to help control the pain.

I was treated like a guinea pig in a horrible experiment that never should have been allowed to happen!

Without the Grace of God and my husband I don’t think I ever would have made it through the whole ordeal. I have been told I will never totally recover.

If FDA approves these silicone gel breast implants, we know that women will be told the FDA says they are “completely safe”. How many more women will have to go through the problems caused by broken implants, as I did?

I really want this panel to seriously consider the experiences of women like me. If you doubt that all my problems are caused by breast implants, then just think about the ones that OBVIOUSLY are: the breast pain, the silicone throughout by entire body, the devastation of losing my own breasts because of silicone leakage.

My hopes are that you will make it clear that a company that wants to sell breast implants needs to provide at least ten years of good data before expecting their implants to be approved by the FDA.

Thank you.

This testimony was presented to the FDA by Dr. Helman on October 15, 2003.

Testimony of Becky S.

Other Testimonies About Breast Implant Complications

Statement by Becky S.

General and Plastic Surgery Devices Panel Center for Devices and Radiological Health Food and Drug Administration, DHHS

October 15, 2003

I got silicone gel implants at age 33 to look more appealing after childbearing. Eight years later, I was diagnosed with an autoimmune disease.

In 1995, after many years of pain and ugliness, a mammogram indicated that I had a rupture on the right side. My breasts were atrociously ugly and the fact that my intention was to be more beautiful was ironic. I was also aware that something else was wrong. I was achy, tired, and I began stumbling while trying to jog. I was also having intense pain around both my breasts and under my arms, which I passed off as capsular contracture. I had a new baby around that time and he was keeping me pretty tired. Finally, after a visit to my gynecologist, and me telling him about my aches and pains and numbness and my unrelenting headache, an MRI was ordered. It came back positive for multiple plaques in my brain.

Then, I learned I had a ruptured implant and I had them both removed. I was actually relieved to be able to get them out. I was ready to go without anything until the plastic surgeon acted like it was an unspoken agreement that I would have saline implants put in during the explantation surgery. Like a dummy, I didn’t stop him. I thought that he must know how ugly I would look if I didn’t have replacement implants put back in. I acquiesced as I respected this doctor and looked upon him as a friend. He scoffed at my queries about autoimmune diseases. He said that “some women are looking to make money” and there was nothing that supported any fact that silicone implants were a cause of autoimmune diseases.

He showed me the Harvard Nurses study, saying it proved that there was no link between my implants and my illness. Little did I know that the Harvard Nurses Study included many women who had implants for just a few months or years.

I so wanted to believe him. I so wanted to be able to have implants. I wanted to think that he was right. In 1995, I had the silicone implants removed and saline implants put in. I didn’t like them, but I finally was without pain and that was a relief. In 1997, the left saline implant ruptured and deflated, and I had it replaced. Then 3 months later, the other saline implant ruptured and deflated exactly the same way. I had that one replaced too. I had begun to read up on the problems that “those women” had with their implants and it sounded very familiar. I remember wishing I had known about this before I ever got the first silicone implants, and thinking that, I am already sick and it’s too late to do anything about it. I also remember thinking that, it is now 5 years after the first allegations surfaced and there is still no proof. It was and is very disheartening to me. My common sense told me that no human or animal body could withstand the “hits” from the toxic substances in silicone without reacting to it, eventually. Yet a solid scientific link had not been discovered. I was also unaware that many stories were written with a biased trend in favor of implants. Many authors were dependent on large drug companies or medical device manufacturers for a part of their income and the reporting was one-sided and heavily in favor of silicone implants.

The ruptured silicone implants have spilled silicone throughout my chest area and under my arms. I still have silicone lumps that I must have biopsied to make sure they are silicone and not breast cancer. If the manufacturers were making any money on silicone clean-ups and autoimmune diseases, we would have had our proof long ago, along with a cure.

I used to be a Registered Nurse before the “MS-like disease” took away my mobility and my ability to think clearly under pressure. I used to have a life. Now, there are a long list of activities I can no longer do. I used to be a very active and outgoing attractive woman/mother/nurse. My hair has thinned so much that my son calls me “that creature from Tales From The Crypt.” I get frustrated easily. I stopped hugging people for fear they would feel the hard balls on my chest. Now, I have two saline implants that need to be removed as soon as possible. They are long past their “safe” date in today’s standards and a recent mammogram showed that the left one has a slow leak with loss of volume.

I went to a well-respected plastic surgeon for a consult. She found two more silicone spots in my chest and estimated that an explantation with a cleaning up of the silicone and a mastopexy would cost about $9,000.00. For an explantation alone, I would need about $7,000.00. My husband is semi-retired. Needless to say, we are not making the kind of money we used to make on a two-person income in a thriving medical community. It seems that the bills are always so large and nothing is ever left to save. We are finally selling our former home, but there doesn’t seem to be a buyer right now. My promise to myself is to take that money and immediately have my implants removed. I may never regain my strength and mobility back, but I will have peace of mind about removing the silicone-covered implants.

In the meantime, none of the women in the Dow Corning settlement have ever received a dime. They keep talking like they are going to do it, but we may all be dead by the time they ever get around to it. Meanwhile, many of us don’t have the money to get our implants taken out. I call this the “Merry-Go-Round” of implantation because once you get on it, it is very difficult to get off.

Becky S.

Becky presented her testimony to the FDA on October 15, 2003

Testimony of Marcy Gross

Other Testimonies About Breast Implant Complications

Statement by Marcy L. Gross

General and Plastic Surgery Devices Panel Center for Devices and Radiological Health Food and Drug Administration, DHHS

October 14, 2003

Good morning.

I am Marcy Gross, a health policy consultant and member of the State of Maryland’s Women’s Health Promotion Council.

I retired last November after 25 plus years at HHS, most recently in the position of Senior Advisor for Women’s Health at the Agency for Healthcare Research and Quality (AHRQ). During part of my tenure at HHS, I also participated in the former Secretary’s ad hoc Working Group on Silicone Breast Implants.

I give you this brief resume to establish my familiarity with the issues you have under consideration today, but am here speaking entirely as a private citizen, and base my remarks on my own personal views and on information available to the general public.

One legacy of my 6 year tenure at AHRQ is a good appreciation of the need for women and policy makers to have a strong evidence base for making decisions on health care issues. My concern today is that an adequate evidence base for the premarket approval of silicone gel-filled breast prostheses does not exist, and that the short-term assurances drawn from the applicant’s study will override acknowledgment of the troubling gaps in research on long-term risks.

I can see from the information posted on the panel’s web site for the hearing that FDA’s background work has been exhaustive, encompassing extensive literature and statistical reviews, assessment of the toxicology and chemical testing, and extensive consideration of clinical data. All this data and more will come to you again over the next two days.

But, the basic facts are simple, and have not varied in the 12 plus years since silicone implants were pulled from the market:

1. The studies available on the health aspects of silicone gel implants are short-term analyses, often involving mere handfuls of mice studied over the course of a few weeks in the case of toxicology and chemical testing; and, in the case of Inamed’s Core Study, involving patients studied over a two-three year period.

2. Yet, even these short term assessments indicate that the rate of ruptures and other complications which lead to re-operations remains high, unacceptably high in my view: 20 percent plus for patients using implants to augment their figure, and 45 percent plus for reconstruction patients.

Thanks to our longer life span, breast implants will stay in a woman’s body for the rest of her life, which can be 50 years or more, or so many women are told. Even when it is acknowledged that they will have to be replaced, women are given a time line of 10 to 20 years. Thus, a two-three year study simply doesn’t offer the kind of assurance of safety needed to understand the health implications of accepting an implant. It is a set-up for future medical problems for the women who have this type of device implanted, especially when retrospective studies show that by 10 years, most women with silicone gel implants will experience at least one broken implant. At least these women know they have a problem and seek further surgery: Silent ruptures are also a documented and recurring problem.

Sometime in the next few days, I feel certain that you will hear someone say that none of the several important studies of possible health risks of implants has shown that they cause a health problem. You may even hear it said that, well, we use silicone in many other implanted devices such as heart valves, knee joints, etc, so why should silicone from breast implants be different?

My response is that having bubbles or globules of migrating gel floating through a human body, into and around organs, is, on its face, a health risk. As for the silicone in other implanted devices: one doesn’t expect bits of a heart valve to break off and migrate to a patient’s brain, liver, or other organs. Further, patients who get knee or hip joint replacements are routinely warned that a small number of patients will have an immune system reaction to silicone fragments shed by newly implanted joints.

There is no health imperative behind the push to reintroduce silicone breast implants. On the contrary, they are used in an elective, cosmetic procedure that often causes serious health complications associated with ruptures and the surgery itself. Although there are other options available to breast cancer patients that carry fewer risks, for some, access to silicone gel implants is felt as important to their recovery. We know that this will make them more vulnerable to future illness and complications and will obscure future cancer screening procedures. But, again, we lack the kind of long-term studies that would allow their choice to be fully informed.

This FDA panel will be making a decision that affects the lives and pocketbooks of women involved quite substantially. There are substantial, emotional issues involved in the decision and results. Implants are also an expensive procedure, especially when the cost of care for complications, re-operations, infections and other medical side affects are added in. Some 225,000 to 250,000 new procedures were done last year. If costs of surgery are estimated as $5,000 each, the total cost approximates $1.2 billion dollars. While much of this is paid for by the patient, the cost for reconstructive procedures after cancer surgery is most often covered by insurance, as are some of the costs for any follow-up treatments needed.

What is the policy recommendation here? FDA found the middle ground 12 years ago. And while I would still prefer not to see the 4-fold increase in implants that has since occurred, at least the current policy sends a strong cautionary signal to women with choices. That should not change until we are more confident that these implants are safe for long-term use. That will take more time and more research, the kind of research that should have been initiated 10 years ago.

I thank you for your time and attention this morning. I see that your agenda runs well into the evening, and I wish you luck–and stamina.

Marcy Lynn Gross passed away unexpectedly on June 19, 2005. Marcy was an important national advocate for women’s health, and formerly a senior adviser with the U.S. Department of Health and Human Services. She worked closely with the National Research Center for Women & Families to prevent medically-unnecessary mastectomies. The Center is naming an internship in her honor. For more information about Marcy’s national contributions to women’s health, click here.