Fw: Letter to Nevada Judiciary Committee to help women with implants and silicone injections

[Guest guest]

Do what you can to help, please! Addresses to these people can be found here:

http://www.leg.state.nv.us/72nd/legislators/Assembly/alist.cfm

----- Original Message ----- From: Zuckerman

igroup@...

Sent: Saturday, April 05, 2003 1:43 AM

Subject: Letter to Nevada Judiciary Committee to help women with implants and silicone injections

The Nevada legislature is considering a bill that would help women with implants. Bernie is the chairman and needs to hear from women with implant and injection problems -- especially those that they did not realize were caused by implants. And especially those from Nevada,

Our sample letter is below.

Zuckerman, Ph.D.PresidentNational Center for Policy Research (CPR) for Women & Families1901 Pennsylvania Avenue, NWWashington, DC 20006202 223-4000www.center4policy.org

April 4, 2003

Assemblyman Bernie

Chairman, Judiciary Committee

State of Nevada 401 S. Carson StreetCarson City, NV 89701-4747

Dear Chairman :

I am writing to provide information about breast implants that I hope will be helpful as you consider AB 50. This bill affords seriously injured Nevada patients a limited, additional window of opportunity to seek compensation from manufacturers of silicone used for injection or for breast implants. The compensation would be for personal injury or death caused by the effects of silicone injected or implanted into the body. The limited window of opportunity is a modest acknowledgment of the unique situation resulting from recent compelling medical research documenting serious and potentially fatal diseases related to silicone.

There are three main reasons why there has been a delay a woman’s silicone exposure and the realization that the silicone has caused medical problems.

The illnesses linked to breast implants or injected silicone have been shown to often develop for the first time more than ten or fifteen years after implantation.

It was not until 2001 that research on women with implants for at least seven years was published, and this research indicates that women with implants are at risk for serious and sometimes fatal diseases.

Physicians have been unaware of the newly documented problems and diseases related to implants, and have therefore mistakenly told their patients that their symptoms are not related to silicone.

As this letter details, many prudent and reasonable women with silicone breast implants or injected silicone are only now beginning to know that they have an illness or problem related to the silicone in their bodies. AB 50 provides these women with a limited opportunity to seek redress in court for illnesses that in many cases have only recently been scientifically proven to be caused by breast implants and injected silicone. To bar these women’s claims would be an injustice and set an adverse precedent that rejects the recent findings of solid medical research.

The long-term safety of breast implants is an important issue because the number of women and teenage girls who underwent augmentation surgery more than doubled from 1997 to 2002 1 and is now almost 250,000 a year.2 An additional 80,000 undergo reconstruction after mastectomy.3

When breast implants were first sold in the 1960s, no safety studies had ever been done on women. By 1990, almost one million women had breast implants, but 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, the studies were inadequate, and the FDA could not conclude whether or not the implants were safe or effective. For that reason, silicone gel-filled breast implants have never been approved by the FDA as safe or effective.

In 2000, the FDA reviewed the safety of saline-filled breast implants for the first time. Saline implants have a silicone outer envelope and are filled with salt water. The FDA required studies of local complications, such as pain, infection, hardening, and the need for additional surgery. They did not require studies of diseases or other health problems. Despite extremely high complication rates during the first three years (approximately three out of four reconstruction patients and almost half of first-time augmentation patients), the FDA approved saline implants. As part of the approval process, the FDA has made information about the risks of breast implants available. A consumer handbook and a brochure with photographs of common complications are available online at www.fda.gov/cdrh/breastimplants.

Every day we receive requests for information and for help from implant patients of all ages, often accompanied by heartbreaking stories from those who are in dire straits because of their breast implants. While some women get sick after having their implants only a very short time, most women experience pain or get sick years later. Many women are told by their plastic surgeon that implants are “proven safe” and they have no idea that leaking silicone gel from a ruptured implant could cause pain or make them sick. These are a few brief examples of the email we have received from women who became ill years after getting their implants:

“I have 20-year-old silicone filled implants that are leaking, confirmed by MRI two years ago. Recently one shifted a lot and is definitely abnormal and painful. My regular doctor said they should be replaced by a plastic surgeon and wrote a letter to that effect to my insurance company. The insurance company has refused any treatment and will not even give a referral to the plastic surgeon …[even though] I had them put in for medical reasons 20 years ago.”

“About 6 years ago I had saline breast implants put in. I am now very sick with all the symptoms of Chronic Fatigue Syndrome/ Fibromyalgia, and I also am starting to get the symptoms of Rheumatoid Arthritis, but all blood work comes back O.K. I am also getting constant pain in shoulders and area around my implants. I am starting to wonder if it's the implants? I am not looking for a lawsuit, just answers…”

“I am a 44 year old woman that has had silicone breast implants for 19 years. I have never had any serious health problems before, until now. The past few months I have been coughing up small amounts of "something " that appears to have the same characteristics of silicone gel. A few months before this I developed symptoms of asthma and have been treated as such. I had a chest X-ray that showed that I have emphysema, even though I have never been a smoker.”

“In 1996, I had silicone breast implants [put in]. My doctor recommended them over saline. I've been having pain in my left breast and a mammogram suggests the left breast [implant] is ruptured. Since having the implants, I have a horrible case of fibromyalgia, in which I'm looking at early retirement as my memory and concentration interferes with my job.”

These are just four examples of how the long-term risks of implants are not always obvious during the first few years of use and how debilitating some of these illnesses can be. Below, I will describe studies published in medical journals, which indicate that the pain and diseases these women report are more common among women with breast implants. It is clear that women with breast implants are not always aware of problems in the first years after surgery.

Local Complications

According to the Institute of Medicine, there are substantial risks involved with surgery for breast implants. This is true for all types of breast implants currently for sale.

In addition to infection and other immediate surgical risks, one of the primary health risks is the need for additional surgery when an implant ruptures. All breast implants will eventually break, and studies show that most implants last 7-12 years. Some break during the first few months or years, and some can last more than 15 years. In a study conducted by researchers at the FDA, most women had at least one broken implant after 11-15 years, and the likelihood of rupture tends to increase over time.4 Silicone migrated outside of the breast capsule for 21% of the women who had broken implants, even though most of them were unaware that this had happened. Silicone gel leaks are not usually obvious, and they only learned of the leakage when MRI’s were performed as part of the FDA research.

Because all implants are "foreign bodies" a woman’s body reacts by forming a capsule of scar tissue around the implants that can become too tight for the implant (capsular contracture). If that occurs, the breasts can become extremely hard, misshapen, and cause discomfort or severe pain. Correction of severe capsular contracture requires additional surgery. Although capsular contracture can happen at any time, it tends to get worse if a woman has had implants for a longer period of time.

According to the Institute of Medicine, women with any kind of breast surgery, including breast implant surgery, are at least three times more likely to have an inadequate milk supply for breastfeeding.7 Concerns about the safety of breastfeeding have also been raised, but more research is needed to determine whether silicone or other chemicals in implants can harm a nursing child. In addition, several researchers have shown that bacteria can grow in saline implants,16 and have expressed concerns about those bacteria being released into the body if the implant breaks. The effect of the bacteria on the woman, or a nursing baby, has never been studied.

The Risk of Disease Over the Years

To discover whether implants cause a disease, it is necessary to study thousands of women who have had implants for at least 10 years. Unfortunately, most research that has focused on autoimmune or connective-tissue diseases has studied women who have had implants for a relatively short period of time, ranging from a few months to a few years. These studies are the basis for the widely publicized statements regarding the lack of evidence that implants cause systemic disease, which have been made by the Institute of Medicine, Judge Pointer’s scientific panel, and in the New England Journal of Medicine.7, 8, 9 Since connective-tissue and auto-immune diseases may take years to develop and to be diagnosed, studies that include women who had implants for just a few months or years can not determine whether or not breast implants increase the long-term risks of getting these diseases. These earlier reports are now outdated, because new research studying women who have had implants for longer periods of time indicate a link between implants and serious and deadly diseases.

Autoimmune Disease

Almost two years after the Institute of Medicine report was published, a new study conducted by FDA scientists found a statistically significant link between implants and fibromyalgia and several auto-immune diseases.10 Their study of patients who had silicone breast implants for at least 7 years found that women with ruptured silicone implants may be at risk for several painful and debilitating diseases. When the silicone had migrated outside of the scar tissue surrounding the implant, women were significantly more likely to report a diagnosis such as fibromyalgia, dermatomyositis, polymyositis, Hashimoto’s thyroiditis, mixed connective-tissue disease, pulmonary fibrosis, eosinophilic fasciitis, and polymyalgia. The association with fibromyalgia remained even after controlling for patient’s age, implant age, location, and implant manufacturer.

Another study, conducted by a scientist who is now at the National Cancer Institute, examined 95 women who had silicone gel-filled breast implants and rheumatologic symptoms. They found that the symptoms improved in 97% of the women who had their breast implants removed.11 In contrast, rheumatologic symptoms worsened in 96% of the women who did not have their implants removed.

Cancer

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 mammography can be performed in ways that minimize the interference of the implants, approximately 30% of the breast tissue will still be obscured.12 Mammograms tend to be less accurate if the woman has capsular contracture (hardening of the scar tissue capsule around the implant). The accuracy of mammograms tends to decrease as the size of the implants increase proportionally to the size of the woman’s natural breast. There is no research evidence that implants cause breast cancer, but the delay in diagnosis can necessitate more radical surgery or can be fatal.

It takes 10-20 years for an exposure to cause cancer, and there are very few published studies that have medically evaluated enough women with implants for enough years to assess whether or not implants cause cancer or other diseases in the long-term. A recent study by scientists from the National Cancer Institute (NCI) of the NIH found that women with breast implants are twice as likely to die from brain cancer, three times as likely to die from respiratory diseases, and four times as likely to commit suicide compared to other plastic surgery patients.13 A second NCI study found a 21% overall increased risk of cancer for women with implants, compared to women of the same age in the general population.14

Silicone From Broken Implants or Injections

Concerns have been raised about the risks if liquid silicone migrates to the lungs, liver, or other organs. As described previously, the one study to investigate the health of women with ruptured breast implants focused on fibromyalgia and auto-immune diseases, but it reported an increase in pulmonary fibrosis, which could be related to the increase in fatal lung diseases reported by NCI. Another recent study, published by the Royal Academy of Medicine in Scotland, found that a woman with a broken silicone gel implant in the calf of her leg was coughing up silicone identical to the kind in her implant.15 This has potentially serious implications for women with breast implants, since silicone gel breast implants are considerably larger and closer to the lungs than calf implants.

The National Center for Policy Research (CPR) for Women & Families is a nonprofit, nonpartisan organization that is dedicated to improving the lives of women and families by using objective, research-based information to encourage new, more effective programs and policies. We are one of many organizations that are very concerned about the long-term health of women with breast implants. In addition, several members of Congress recently sent letters to the National Institute of Health and to the FDA regarding the need for more long-term safety research as well as FDA’s oversight of breast implants. The letter to the FDA addressed the lack of follow up information regarding the long-term effects and safety of breast implants and stated "… we have several questions about the FDA's approval of saline breast implants, FDA's upcoming review of applications for approval of silicone implants, and significant gaps in our knowledge about the safety of these products."

We hope that you will consider that until recently, there were no independent studies of the long-term health risks of breast implants. Even now that the NIH and the FDA have conducted such studies, many physicians and patients are unaware of them. Moreover, many women with breast implants do not have serious health problems until more than 10 or even 20 years after their implant surgery. Even less research information is available about the long-term risks of silicone injections. We hope that you will do all you can to protect the legal rights of women who may suffer as a result of their implants or injections many years after their initial procedure.

Sincerely,

Zuckerman, Ph.D.President