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Silicone Syndrome
Silicone implant incompatibility syndrome (SIIS)
Autoimmune/inflammatory syndrome induced by adjuvants (ASIA)
Do silicone breast implants cause autoimmune disorders?
Do silicone breast implants make you sick?
Is there a Silicone Breast Implant Disease?
Are silicone breast implants safe?
Silicone breast implants and illness
Silicone breast implant controversy
Do silicone breast implants cause cancer?
Do silicone breast implants cause lymphoma?
Breast Implant-Associated Anaplastic Large Cell Lymphoma (BIA-ALCL)
Vasey Silicone Disease

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OPINION: The "Dark" side of silicone breast implants.

April 21, 2007 ***Addendum 2.12.13 | 5.25.17

Frank Vasey, MD



(Click here to view Frank Vasey MD's Curriculum Vitae)

Thinking about getting silicone breast implants or encouraging the woman in your life to get them…

You already know or think you know the benefits of these implants? As I am not an expert in the "bright side" of silicone breast implants, I will not comment. The "dark side" is another story. I have learned a lot from the 2000 sick women with mostly, but not exclusively, gel-filled silicone breast implants. The outside of a saline-filled implant is still silicone, but much less than a gel-filled implant. If as predicted the saline-filled implant fails in 10-15 years, you know it. The implant goes flat as an airless tire. On the other hand, the outside "envelope" of the gel-filled implant can disintegrate and there could be no obvious indication of this rupture. The silicone/silica debris could be spreading into your lymph system or through connective tissue planes down your arms or under the axilla (arm pit). One patient expressed silicone gel from below her knee in my office.


Figure 1.
This is a breast capsular biopsy demonstrating particles of silicone/silica debris being attacked by macrophages. Similar debris has been described in regional lymph nodes. Macrophages are cells of the immune system that circulate throughout the body and play a key role in an immune reaction. Also, the element silicon has been shown to be increased in peripheral blood in women with silicone implants in comparison to contrasts without implants (work done at UC Davis California)


Figure 2.
Photograph by Eric Gaillard/Reuters, obtained through Google Images shows a popularized defective Poly Implant Prostese (PIP) silicone gel implant after surgical removal prior to rupture demonstrating accepted implant leak. (Click here to read an article reviewing accepted and understood silicone leakage or silicone "sweating")

From my perspective…

The immune system activation from silicone/silica causes a unique fibromyalgia syndrome. Based on an FDA MRI-based study of almost 400 women with gel-filled implants, 13 years after they were placed, the risk of systemic illness is 10-25%. The 25% (about 75 women) was the extra-capsular rupture group. (Brown et al. 2001)


Figure 3.
Dr. Jui-Lien Chou, Breast Center at Wellness Lubbock, obtained through Google Images shows an MRI image of a ruptured implant

The good news is the syndrome tends to stabilize and improve when you remove and do not replace the implants. I believe the systemic illness is a function of the degree of excitability of the woman's immune system to silicone/silica (implants are about 20% silica) coupled with the amount of the material exposed to the immune system.

Here is what to look for if you have them…

Usually local problems under the muscle occur first. The breast hardens and feels like a grapefruit or even a baseball (capsule formation). That is your macrophages in action. The immune system is responsible for wound healing and making scar tissue. The pain spreads into the muscles in the anterior chest, upper back and neck. Exercise tends to spread the silicone/silica debris making you feel worse. On the other hand, exercise makes psychologically-driven fibromyalgia better.

Bladder irritability with the urge to empty your bladder or even gross blood has rarely been noted. This is interstitial cystitis, which I suspect comes from urinary excretion of the silicone/silica debris. No one has proven this. Neuropathy is a malfunction of peripheral nerves. You feel a "blowtorch", an "insect crawling", or "numbness with nothing on your skin".

If you are concerned…

See your doctor, what else! But don't expect him or her to know much about silicone. You want your doctor to be certain you don't have something else. Such things as under active thyroid, hepatitis, lupus, HIV, and polymyalgia rheumatica can all make you tired, achy, and sick. Check your temperature. With "silicone related disorders" you probably won't have a fever, but I have seen about 10 women who did. All fevers I have seen went away when the implants were removed, but you may want a blood culture and a TB skin test, or chest x-ray to try to be sure there is no other explanation for the fever.

Everyone is waiting for a syndrome definition that can be tested…

Evidently, manufacturers, plastic surgeons and even the federal government do not want to do it. I'd like to do it, but I have no funding and I did ask years ago.

So the status quo continues as I approach retirement…

We let people smoke and we know that kills them. I don't think silicone kills people, but it can make you feel like the flu every day, which is a pretty miserable way to live. If you are sick and your doctor can only diagnose fibromyalgia, you steadily worsen with activity, feel like you need to urinate all the time and have in apparent insects crawling on your burning skin, consider removing and not replacing your silicone breast implants. This is a tough decision, but perhaps important for your health. Good luck.

If I am so smart why isn't your plastic surgeon telling you about this…

If your surgery was recent or you are thinking about surgery, my advice is to read your informed consent and keep it for future reference. Most plastic surgeons do not honestly believe there is a systemic syndrome to silicone because that is the "party line".

Why is that?

Basically, because a definitive study has not been done despite the fact that silicone breast implants have been placed since 1964. That is over 40 years. A 20-year prospective (into the future, not looking back) study of silicone patients and their similar best friends without implants would answer the question of the existence of the syndrome. The fact that a large number of typical symptoms (chronic fatigue, muscle & joint pain, etc.) were statistically worse in women with silicone breast implants over controls who had a breast reduction operation (Fryzeck et al. 2001) does not convince plastic surgeons. Neither does the improvement in symptomatic women post implant removal (Rohrich et al. 2000 & Vasey et al. 1996).

***ADDENDUM - February 12, 2013 - In conclusion, my unsubstantiated definition of a new disease ...

Unsubstantiated Silicone Disease Criteria

You should know the way criteria development is normally accomplished. A cast of thousands is assembled and you submit classic cases of silicone disease with comparison cases of defined rheumatic diseases including rheumatoid arthritis, systemic lupus erythematosis, Sjogren’s syndrome and fibromyalgia among others. The prevalence of the symptoms and physical findings are compared and criteria that effectively separate the conditions are established statistically. My peer reviewed paper in the Journal of Rheumatology entitled “Where there’s smoke there is fire” (Vasey 2003) was a plea to define the newly recognized and still controversial subject of a silicone breast implant (and any other silicone device in the body) syndrome.

This has not been done. Therefore the “unsubstantiated” precedes my opinion regarding Silicone Disease Criteria. Now this opinion is not unfounded. It is based on my experience caring for 2000 sick women over thirty years in Tampa at the University of South Florida College of Medicine and three years in Detroit at Wayne State University School of Medicine.

The women who made the difficult decision to remove the implants stabilized and eventually slowly improved. My experience convinces me that silicone breast implants are not perfectly safe as claimed from the 1960’s until 1990s. It convinces me, but not other physicians who have not seen the patients I have seen. I also conducted with Noreen Aziz MD/PhD a good, in fact, the best outcome study on over 100 symptomatic women with implants. About half the women removed the implants and numerically improved while the other half with implants in place worsened over twenty months on average follow-up. Unfortunately the study remains unpublished but is available to read at the bottom of this page. There were some fair criticisms as we were unfunded and didn’t give the questionnaire to normal women or women with other rheumatic diseases. Still it remains the best study I am aware of on the impact of implant removal on symptoms and the study was used for PhD qualification.

On the positive side no one disputes the psychological benefits of having silicone breast implants. Further, on the positive side, the syndrome does not catch every woman with implants. Based on Lori Brown’s Journal of Rheumatology study in Alabama and the manufacturers “core studies” (available at manufacturers websites) the risk is 1% per year. Both manufacturers report that at about five years after implantation the symptoms in my criteria were “statistically increased”. That means 5% of women were affected after five years. The comparison is to the pre implant status of the same woman. It would have been better to use best friend controls without implants, so now manufacturers and plastic surgeons can argue these healthy twenty-five year old women developed chronic fatigue, muscle and joint pain as a coincidence. While my argument is 5% of thirty year old women becoming sick between age twenty-five and thirty years is too high.

For those facing the difficult decision to remove the implants or not, I offer my Silicone Disease Criteria ... mine alone:

1. Local problems with the implants: pain, hardening, migration

2. Muscle pain: beginning around the implants and spreading, extending to the anterior chest, shoulders, neck and back. This will be called fibromyalgia by your physician. Fibromyalgia is helped by exercise. Silicone-related myalgia worsens with activity which I believe accelerates the spread of the silicone debris.

3. Neuropathy: both autonomic (visceral as gastroparesis, GERD, severe constipation) and peripheral (mostly asymmetric as numbness and tingling relating to the spread of silicone debris)

4. Bladder problems: with frequency and pain called dysuria. It is like a bladder infection except that urine cultures are sterile (no growth). When severe to the point of blood in the urine (hematuria) physicians may diagnose interstitial cystitis. I believe it reflects the excretion of silicone debris in the urine. The UC Davis group showed the element “silicon” increased in the blood, but they did not test urine.

There you have it -- one man’s opinion.

See your doctor for a possibly better opinion as you definitely need to rule out other conditions which only your own doctor can do.

Below is taken directly from Allergan's Clinical Study Results: (Click here to read full update - In subsection 3.7 What Are Other Clinical Data Findings:)

In Allergan’s Core Study, numerous signs and symptoms were collected at 2, 4, and 6 years post-implant. For primary augmentation patients at 6 years after implantation, statistically significant increases were found for the symptom category of Joint (includes joint pain, stiff in morning, swelling in other joints, and swelling of hands), Muscular (includes back pain, muscle pain, aches, or cramps, muscle weakness, neck pain, paralysis of arms or legs), Gastrointestinal (includes constipation, diarrhea, gastrointestinal pain, heartburn, loss of appetite, stomach pain or cramps, and vomiting), Neurological (includes headaches, loss of balance, numbness/tingle of arms or legs, problems with memory, problems with thinking, and ringing in ears), Urinary (includes problems with urination and urinating too often).and Fibromyalgia (includes back pain, fatigue, neck pain, pain, and pain in the chest). No significant increases were found in the categories of General, Global, Pain, Skin, Fatigue, and Other symptoms. For revision-augmentation patients at 6 years after implantation, no statistically significant increases were found in any of the symptom categories.

The Core Study was not designed to evaluate cause-and-effect associations because there is no comparison group of women without implants, and because other contributing factors, such as medications and lifestyle/exercise, were not studied. Therefore, it cannot be determined whether this increase was due to the implants or not, based on the Core Study. However, you should be aware that you may experience an increase in these symptoms after receiving breast implants.


Below is taken directly from the FDA Website: (Click here to read full update)

FDA - Update on the Safety of Silicone Gel-Filled Breast Implants (2011) - Executive Summary

Connective Tissue Disease:
The FDA has not detected any association between silicone gel-filled breast implants and connective tissue disease, breast cancer, or reproductive problems. In order to rule out these and other rare complications, studies would need to be larger and longer than these conducted so far.

Summary of Key Findings:
#6 - ... Associations that are rare or that take many years to manifest may not be detected using currently available data.

Conclusion:
Based on the totality of the evidence, the FDA believes that silicone gel-filled breast implants have a reasonable assurance of safety and effectiveness when used as labeled. Despite frequent local complications and adverse outcomes, the benefits and risks of breast implants are sufficiently well understood for women to make informed decisions about their use. Manufacturers and physicians should continue to provide balanced and up-to-date information to women considering breast implants to help inform their decisions.

***ADDENDUM - May 25, 2017 - Update

The FDA has reported an increased risk of this rare lymphoma found only next to silicon breast implants from an estimated risk from 1-in-a-million, to be between 1-in-1000 and 1-in-10,000 women with breast implants based on data Regulatory bodies outside the United States. Meanwhile the FDA continues to collect and evaluate information about ALCL in women with breast implants.

Breast Implant-Associated Anaplastic Large Cell Lymphoma (BIA-ALCL) - View FDA Link

Frank B. Vasey MD



Vasey FB, Zarabadi SA, Seleznick M and Ricca L: Where there’s smoke there’s fire: The silicone breast implant controversy continues to flicker: A new disease that needs to be defined. J RHEUM 2003:2092-2094.



The Silicone Breast Implant Controversy: What Women Need to Know. by Frank B. Vasey MD & Josh Feldstein. Publication Date: September 1993.



Click to view my Letter to the Editor at the NEJM in response to the above article.



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