Myrl Jeffcoat myrlj@jps.net

22 mars, 2005 10:27

What Medical Studies Are Needed?

Many factors must be explored in greater depth to fill in the gaps of the silicone disease puzzle. While many doctors believe that there is at least the possibility of a connection, more definitive proof of a cause-effect relationship is needed to satisfy most practitioners in the medical establishment.

Just as some smokers puff away into old age while others die of lunch cancer in their forties, woman’s susceptibility to silicone may also vary widely. This is precisely why it is vital to gather data on many more women than the small groups of patients investigated by individual physicians thus far. Only well-designed studies, involving thousands of women, will reveal the degree to which silicone implants are likely to trigger autoimmune diseases. These studies may yield information for people with other types of silicone implants as well.

In addition, a national implant and explant registry needs to be established by the FDA. This registry would enable the FDA to be notified about any breast implant that is removed and the reasons for removal. All removed specimens could then be processed at an independent centralized laboratory for analysis, thereby overcoming the biases of individual surgeons or physicians.

Also, Medic Alert, in Turlock, California, has begun a program to enroll women with breast implants, and, for a small fee, to provide them and their physicians with the latest information. Several key topics regarding silicone disease require more investigation:

1) Patient Predisposition

Some women may have immune systems that are especially vulnerable to silicone exposure and are easily triggered into an autoimmune response. Screening procedures need to be developed to help doctors identify these women and to evaluate the roles played by a previously weakened immune system; hormonal factors; smoking and use of alcohol and other drugs; history of disease or trauma; interactions between silicone and other biological substances; environmental factors; types of physical activity; ethnic background; and other complex factors in the development of silicone-related disease.

2) Genetic Markers for Silicone Sensitivity

Can silicone sensitivity be inherited? Do some women have genes that make them more likely to reject silicone in their bodies? Research efforts such as the Human Genome Project may one day lead us toward recognition of genetic predeterminants of everything from life span to cancer risk. People with similar rheumatic conditions have been shown to have certain genetic markers, so perhaps there are “finger-prints” for susceptibility to silicone disease as well—or conversely, a set of genes that make a person immune from the disease. For example, the FDA’s Fred Miller, a rheumatologist, found a genetic marker (HLADQA10102) in women who have dermatomyositis/polymyositis and breast implants that is much more common that it is in women without implants who have these disease. And at USF, we observed a set of identical twins with implants who both presented the same symptoms in a similar time frame. This common course implies a genetic component toward predisposition, which, if confirmed, could make it possible for women one day to be tested for susceptibility. Women who have no symptoms but who test positive could have their implants taken out before the disease launches its first offensive. Similarly, women with the genetic predisposition could avoid placing the implants in the first place.

3) Silicone Gel as Adjuvant

Can silicone serve as an adjuvant (or immune enhancer) that results in the formation of new substances in the body that get wrongly defined as enemies by the immune system? Maybe. Most previous studies asserting that silicone could have this function are based on direct injections of silicone, however, which typically include silicone mixed with other substances.

Another concern that must be investigated is whether the autoimmune response activated by silicone is self-perpetuating. If this occurs, removal of silicone from the body will not be enough to stop the disease from progressing. This may occur in some patients and not others, and individuals may also have different self-perpetuating “trigger” thresholds.

4) How Silicone Spreads in the Body

Some women with implants which rupture show no symptoms beyond the chest area; others may end up with silicone traveling throughout the body, with traces of it in the liver, ovaries, and other organs, as well as joints and muscles. Research needs to determine all the aspects of anatomy, body chemistry, and other factors that expedite migration of silicone particles within the body, as well as to teach us the mechanisms that allow silicone to travel through the lymphatic system.

More comprehensive urinalyses and studies at the molecular level may also help determine whether tiny particles of silicone can find their way into the bloodstream. If they can, this news could be especially disturbing, suggesting that silicone can very easily find its way to the heart and other internal organs. It is reassuring, however, that heart, kidney, and liver failure have not been observed in women seen at USF.

5) Breast Implant as Infection “Ally”

One theory proposes that leaked silicone gel or the envelope itself could privde a hiding place for infection agents, particularly bacteria or fungi within the body. If the immune system cannot detect these “invisible” infections, it cannot attack them; the hidden invaders can then multiply and reach critical levels that overwhelm the immune system once they spread throughout the body. Experiments with silicone and infectious agents in the laboratory are needed to assess this hypothesis. More careful and precise methods of study of the removed breast capsule could help answer these questions.

6) Silicone as Carcinogen

So far, only animal studies have confirmed a causal link between silicone exposure and cancer, according to data obtained from the FDA and S=Dow and reported by The Public Citizen Health Research Group, a nonprofit consumer group. While some animal studies have reportedly shown a significant increase in cancer risk in areas of the body other than the breast among implant recipients, other studies have been inconclusive. Additional studies must be performed to confirm or refute this connection. Cancer is often the result of long-term exposure to an activating substance, and many women have had implants for only a few years—so it is difficult at this time to know the real risks. Women with implants need to be monitored for many years to see if their cancer rates are higher than those for the general population. A reassuring Canadian study was recently published in the New England Journal of Medicine, however.

7) Effects of Implantation

Implants that are nicked during surgery increase the risk of leakage and make the prosthesis especially prone to rupture. What isn’t known is how likely it is for such damage to occur during implantation. Data are also lacking on whether the implantation procedure and resultant structural change due to surgery can cause late-developing musculoskeletal pains due to direct disruption of tissue planes, ligaments, or nerves. Is there a difference depending upon whether the implants are placed on top of or behind the chest muscles? Also, further exploration is needed to determine whether implants play a role in infection. (The skin over the breast of women who receive implants following mastectomy is sometimes incapable of holding implants in place, due to the trauma of chemotherapy, radiation, and previous surgery.)

8) New Body Configuration

As a result of anatomical accommodation of implants by the body, pains in the chest wall, shoulders, and neck may be due to changes in posture, weight, and body biomechanics. This hypothesis is unlikely, but needs to be explored more fully by comparing implant recipients with other women whose body configurations have been changed in similar ways.

9) Rate of Shell Breakdown

While small amounts of silicone “bleed” through the silicone rubber casing, the life span of these casings within the body remains unknown, though implants were never intended to be once-in-a-lifetime prostheses. The rate at which shells break down, how much silicone bleeds through them, and what kind of trauma can cause rupture—these factors need to be better studied.

Artificial joint implants made of silicone that were placed in the 1960s are now reaching a point when material fatigue predisposes them to fracture. And while today’s new breast implants can reportedly withstand tremendous pressure per square inch, what happens over time with loss of silicone from the envelope? And how vulnerable are implants to puncture by surgical instruments, needles, and broken ribs? Characteristics that have value in predicting future performance—such as tensile strength and fatigue resistance—need to be precisely determined by hundreds of trials.

10) What Happens to Gel in Body Tissues?

This issue opens a huge number of unanswered questions. Does the chemical composition of the gel change after it leaks into the body? Is silicone metabolized in the tissues? How can silicone-induced connective tissue disease be distinguished from “standard” connective tissue disease on a chemical basis? Is there a way to measure antibodies associated with silicone exposure? While some evidence shows silicone may cause changes in molecular structure, much research is still needed to answer all of these questions. In addition, it needs to be determined whether certain organs are more sensitive than others to silicone.

11) Silicone as a Threat to the Fetus and Newborn

Also still to be determined is whether silicone that escapes from an implant can penetrate the placental barrier and adversely affect an unborn child. Additionally, we need to explore whether leaking silicone can end up in breast milk (women with implants are not recommended to breast-feed), and how the breast-feeding infant may be affected by its consumption. Further, it has been theorized that the implantation procedure itself may restrict some blood supply to the milk producing system, or apply pressure to milk-collecting sacs, not allowing them to expand and thereby reducing milk flow or supply.

12) Emotional Disorders and Silicone Disease

Are rheumatic disorders from silicone exposure playing a role in such emotional problems as depression, anxiety/panic, even chronic fatigue syndrome? Definitive criteria for determining a causal link need to be established. Many case studies make it clear that patients become depressed, enraged, even suicidal, over their illness. But is silicone itself a depressant, or are these women’s emotional disorders purely a reaction to their symptoms?

13) Silicone and Sexuality

Numerous women have reported a drastic fall in libido, if not a total loss of sex drive, during the downward course of their silicone-related illness. Is this the result of their feeling poorly all the time, or their feeling self-hate over their physical appearance? Or does silicone exposure have a specific and deleterious effect on the sex drive itself? The experiences of many more women will have to be documented to clarify this issue.

“You go from flat-chested to something. And it’s like, oh, wow, I really look good! But after a woman gets sick and has her implants out, it’s like ending up with a radical mastectomy. Then they are left worse than before,” Cecilia commented, having gone through this experience herself. “Women don’t want to talk about it because they cant deal with this issue.”

Patients who have gone through an involved explantation have described how in order to gain support emotionally they get together with other women in the same position, pull their shirts off, and compare. Joyce remarked, “It’s scary…scary what we look like. A lot take showers in the dark. They do not undress in front of their husbands, or allow themselves to be seen nude. You can imagine what this does to a marriage. Women are humiliated.

“It’s devastating enough for a woman either not to have breasts or lose them the first time,” Joyce continued. “But when you have to go back and lose them for a second time, it’s really more than what a normal person can bear.”

I still have a chest, if you want to call it that,” Cecilia added. “My last mammogram shows 36 different silicone granulomas, and one breast is larger than the other. I’m looking at more surgery to get the silicone out, but it really can’t be retrieved. I’m past embarrassed. I could pull of my shirt on TV and wouldn’t faze me. I don’t care anymore,” she lamented.

“Women have to realize that they are the same person they were before they lost their breasts,” Joyce explained. “It’s still me. My husband, well, he has to love me for what I am on the inside, not what I look like on the outside. If that’s the only thing a man cares about, it’s not worth trying to stay in the marriage to begin with.”

14) Silicone Gel versus Saline Gel Implants Although saline (salt water) is harmless to the body if it leaks, it should be noted that saline-filled implants are encased in a silicone rubber envelope that may shed silicone particles into the body. Many women who have had silicone-gel implants removed only to have them replaced with saline-filled implants may not be in the position of safety they assume. More studies comparing the pros and cons of the two types of implants are presently required by the FDA and are now underway.

It’s the saline, too…

Margo worked as an office manager for a physician, running three ob/gyn offices. With saline implants following reconstruction from fibrocystic disease, she began to get tired just a few months after getting the prostheses. Her problems with saline implants were a bad as any woman with silicone gel-induced illness.

“I was just tired,” she said. “Then I kept getting the same flu and weird rashes. I had horrid chest pains as time went on and terrible pain in my muscles. I was diagnosed as having one virus or flu after another. I even wondered if I had contracted AIDS, because I had every viral study you could imagine done. Iwas a my wit’s end.” Margo was finally diagnosed as having lupus and silicone-associated connective tissue disease in 1989 at the USF Department of Rheumatology. She reported, “People are aware of the dangers of silicone implants, but we’ve got sick women with saline implants, too. I just don’t think there’s a safe implant on the market.”

15) Treatment

At this time the only treatment for silicone-induced disease is to rid the body of all silicone, by removing the implants and the fibrous tissue around them. We need to seek vigorously more effective ways to detoxify the entire body of silicone particles, and to develop drug treatments targeted specifically to conditions caused by silicone. Identification of antibodies against silicone produced by the body would greatly expedite this research. Symptomatic relief for some patients has been found in aspirin and the aspirin like medications called nonsteroidal anti-inflammatory drugs like Motrin, Naproxen, Indocin, Feldene, and others. In severe circumstances, cortisone, Plaquenil, and other immunosuppressive approaches could be used.

Here’s our idea of a perfect study. All women who have implants should be monitored by a rheumatologist once a year for 20 years after implantation. For each implant recipient monitored, another woman of similar age and health who has no implants should be monitored at the same intervals. The prevalence of back pain, neck pain, fibromyalgia, swollen lymph nodes, swollen joints, chronic fatigue, and other autoimmune functions would be checked in both groups.

Such a study would yield mountains of conclusive data about the course of silicone disease and its true significance in women with implants. Unfortunately, it would demand a lot of effort and cost a fortune.

And who should pay for it? Of all the questions asked so far about silicone disease, this may be the toughest to answer. Although USF recently received $15,000 from the St. Petersburg Medical Clinic to pursue the connection between silicone and disease, it is only a drop in the bucket considering what is needed to generate definitive results. [pages 37-43 - retyped from: “The Silicone Breast Implant Controversy – Frank Vasey, MD, and Josh Feldstein]