From AS-IS Newsletter, January 1995

For some, the decision to remove one's implants is an agonizing one, given the uncertainties as to whether one's health will improve and what the physical outcome will be. For others, the real agony is the actual surgery and the physical aftermath. For still others, the difficult times lie in the recovery, piecing together one's physical, emotional and financial health. Whichever way one looks at it, explantation is no picnic - fear, anger, grief, betrayal, uncertainty and anxiety layer with physical incapacity. While it is usually impossible to make the decision to remove one's implants an easy one, it is possible to lessen the negative and magnify the healing aspects.

In my opinion, preparation is a key ingredient to having explantation go smoothly. First you must be prepared mentally. With few exceptions, explant surgery is not an emergency such as removal of the appendix or trauma surgery to stop hemorrhaging. It does not even have the urgency of most cancer surgery. This is both good and bad- bad in the sense that the need to proceed is less clear-cut and good in the sense that the time can be taken to fully understand the pros and cons of surgery. One can get second or third opinions, take time to read and research and find a physician with whom one feels comfortable. Some people made the mistake of getting implants assuming that such surgery would solve their problems - it is equally silly to assume that removing implants will do the same. I am not going to cover all aspects of making the decision as this has been well covered in previous issues, but do not be passive and allow the surgeon (or anyone for that matter) to make all decisions for you. His/her job is to present all your options, the risks, costs and expected outcomes. He/she cannot make the decision for you because there is not one right answer - you will have to live with consequences, not the surgeon - and each person is a very unique individual.

Secondly, be prepared emotionally - this is not the time to show everyone what a superwoman you are - able to go through surgery and keep up the duties of mother/wife/caretaker. It is ok to be needy, grieve, or be angry. Call in your chips - this might be the time to involve family members such as children/spouses in the tasks of daily upkeep if you haven't already. Call upon extended family, if available, for support. Support groups can be such an asset in this respect as you will meet women there who have gone through this themselves. I am have seen women helping women and it can be such a beautiful healing.

Thirdly, be prepared physically. Stop smoking, preferably six weeks prior to your surgery. Do not take aspirin containing drugs within nine days of your surgery (be careful, even unexpected sources contain aspirin e.g.: Alka-Seltzer.) If you have a question, check with your physician/nurse about medications.

Avoid excessive alcohol in the immediate pre and post-op period. On the day of surgery and on the first few post-op check ups, wear loose comfortable clothing, preferably something which buttons up the front and avoid white which could be stained. Do not wear make-up or jewelry to the surgery suite, but if the nurse allows it, you might want to have heavy socks as the OR is usually chilly. You will probably want to have some snacks or frozen dinners available for the first few days post-operatively as you will not feel up to cooking. Have dishes/items you need within easy reach as you will probably be too sore to reach for high shelves. Be sure you understand all your physician's post-op instructions; it is best to get them in writing so you understand and can remember when follow-up visits are scheduled, what limitations there are on physical activity and when bathing is allowed. Insure that pets or small children will be restrained so they cannot jump on sore incisions. Have your post-operative support bras available and prescriptions filled. Your physician will specify what is required, but if he/she has no recommendations, it is best to wear a good support bra, day and night, for the six weeks post-operatively. Some prefer to hook-in-front sports bra and others prefer a shaped cup, but the most important criteria is the upward lift to relieve strain on traumatized tissue. Finally, be sure that all the questions regarding disposal of the implants are settled. Under no circumstances should implants/tissue be discarded until all legal issue are settled.

When you are prepared as possible, let go of as much anxiety as you can and relax, trusting in your surgeon to do his/her job and in your body to heal. This can be a very difficult step, but it is vital for your healing. If you have religious beliefs, look to them at this point. This is the meaning of the Serenity Prayer, "Lord grant me the courage to change the things I can; serenity to accept those things I cannot change and wisdom to know the difference." A concrete exercise to help with letting go is to concentrate on one's breath, breathing deeply and slowly with the diaphragm. These same techniques are utilized in the LaMaze Method of natural childbirth and will work to lessen pain/discomfort. Sometimes, a simple gesture such as taking a favorite stuffed animal into the OR (if allowed) or a Walkman with soothing tape, will make the OR feel more familiar and less scary. Be aware if you are holding shoulder muscles tensely and relax them if you find that you are.

Letting go is the preparation for moving on and as difficult as it may be, it must be done. You have chosen this surgery for many reasons not least of which is the hope of moving on to better things (like your health and peace of mind!) While the former may not be in the cards for everyone who goes through this surgery, the latter can belong to anyone who chooses it. Surgeons who deal with many explant patients are finding that up to 90% of their patients get relief of local pain caused by implants and that anywhere from 1/2 to 2/3 of the patients will have some improvement in symptoms. Be aware that complete resolution of symptoms is rare and also understand the improvement, if it comes, may be slow. Understand that it is very common to have a period of grieving and allow yourself to do so. It often doesn't show up until a few weeks after surgery. Those that know it is a normal part of the process of healing will get through it faster than those who feel they shouldn't be experiencing any negative emotions. I like to use the analogy of a marriage that didn't work (most of you have had your implants longer than many marriages). You had them for a reason and it didn't work out, like marriages sometimes don't - or worse, it's a bad marriage - he's beating you up, stealing your money and sleeping with your best friend and you know you'll be better off without him. Even so, that first weeks he's gone, the house can seem very empty and the bed very cold.

If you have lost a limb, there is a lot of societal support and sympathy, but for this surgery, often no one knows of your loss unless you share it, so take care of yourself and allow yourself to grieve. (I personally like to get into bed with a good book and chocolate bar!) If you are having problems grieving, seek professional help. Other practical suggestion for getting out of the dumps include taking care of yourself (wash the face, brush one's hair/teeth, even wear make-up, eat right, whether you feel like it or not,) gentle exercise (such as walk on the beach) and service to others (volunteer at your local hospice if your are physically capable - it really puts things in perspective!)

Part of letting go involves letting go of anger and bitterness as well. Do not allow your anger to hinder healing. I am not saying all anger is bad - often it helps one to overcome passivity and act productively. But if anger is eating you up inside, you must let go, no matter how justified it is! If all you can think about is how you have been wronged or who has done you harm, you do not have any kind of life except one that revolves around negativity. Make your life positive outlets - become politically active, for example, fighting legislation that would erode the right of consumers to sue in product liability cases - or join the Fibromyalgia/Chronic Fatigue Syndrome Societies to petition Congress for more research funds for the treatment of these conditions. The self-help bookshelves are full of suggestions, but you must choose to take them. If you choose to deal with explantation instead of letting it deal with you, you will find the lessons learned from your experience with explantation, as difficult as they may be, will ultimately be worth it!

If Your Breast Implant Breaks
All implants break eventually. Some even break during the first few months, and the older your implant is, the more likely it is to break. However, it is not always obvious when an implant is broken. Here is some useful information.

When a saline breast implant breaks
When saline breast implants break, the contents usually leak very quickly. When this happens, the implant deflates, much like a balloon that has lost the air inside. A woman can see that her saline implant has broken because her breast has changed in size and/or shape in a short period of time. Its less common for saline to leak slowly, although it can happen. When the saline leaks out of its envelope, the body absorbs it. Its usually harmless, unless there is fungus or bacteria inside the implant. Leakage of non-sterile saline from the implant could lead to a potentially serious infection.

How do I know if my saline breast implant has broken?
Saline implant ruptures are usually obvious. You should be able to see the difference in the size and/or shape of your breast. An MRI or other imaging technique is not usually required.

When a silicone breast implant breaks
When a silicone gel breast implant breaks, the contents usually leak very slowly. A ruptured silicone gel implant can go completely unnoticed for many years. Sometimes the rupture is discovered only when the implant is removed.

When a silicone implant breaks, one of two things can happen to the leaking silicone gel:

Intracapsular rupture
One possibility is that the leaking silicone can be contained within the scar tissue capsule, which is the thick layer of scar tissue that naturally builds up around the implant. When this happens, the silicone stays where it is.

Extracapsular rupture
Silicone can leak outside of the scar tissue capsule. When this happens, silicone can migrate to other parts of the body, including the lymph nodes under the arm and major organs such as the lungs where, it is impossible to remove. The longer a woman waits to have a ruptured silicone gel implant removed, the more time the silicone has to travel in her body.

How do I find out if my silicone implant has ruptured?
Symptoms of rupture
If your silicone gel implant ruptures, you could notice a change in the size or shape of your breast, pain or tenderness, swelling, numbness, burning or tingling. It is also highly possible to have a silent rupture, where you would not experience any of these symptoms. In this case, you would not know that your implant has broken.

"Breast coil" MRI the best diagnostic tool to detect rupture
Since you often cant see a difference in your breast when a silicone gel implant breaks, it is important to have a "breast coil" MRI. A mammogram is not reliable enough for detecting a broken silicone gel implant, and the squeezing could make the contents of the implant leak outside the scar capsule.

Can broken implants make me sick?
According to the FDAs research, women with leaking silicone implants are more likely to report fibromyalgia (a painful disorder) or several other painful and debilitating diseases that may indicate an autoimmune response. There is no research on the health risks of broken saline implants.

What do I do if my implant breaks?
Most experts agree that it is important to remove a ruptured implant as soon as possible, especially if it contains silicone gel. Removal of implants is called explantation.

Saline Rupture
Usually a ruptured saline implant is harmless, unless the saline contains bacteria, mold, or fungus, which can happen inside a womans body. If your implant has broken, and you feel very sick, have a temperature, and/or a rash, you should see a doctor immediately. You could have an infection from contaminated saline.

Silicone Rupture
It is important to have ruptured silicone gel implants 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, like lungs or lymph nodes, where it cant be removed. Unfortunately, nobody knows for sure what will happen as a result of silicone in the body because no one has conducted any research on the subject.

Everybody is different. Some women do not respond strongly, if at all, to silicone. Others become very, very ill.

Explantation surgery
Removal of an intact implant is generally not recommended due to the risks involved in having surgery, such as infection, bleeding, and reaction to the anesthesia. However, women who are very ill sometimes find that their health improves dramatically after removal. A study of removed implants that were not replaced by Noreen Aziz and her colleagues found that 97% of women with pain and other rheumatology symptoms felt better after their implants were removed and not replaced. Many symptoms lessened or disappeared over the next few months. In contrast, 96% of the women who did not have their implants removed became even more ill.

Removing intact implants is not always complicated, but it can be very difficult to remove certain kinds of implants, such as foam covered implants (sometimes called the Meme), implants with hard capsules surrounding them, and implants that have ruptured. This kind of explanation sometimes involves removal of not just the implants, but also removal of some of the tissue and muscle surrounding the implant.

Removal of a silicone gel implant is more complicated than having it put in. This is particularly true if the implant is leaking or has ruptured, because its very important to ensure that silicone gel from a broken implant does not spill or remain in the body.

The surgeon who performed the original surgery is not necessarily the best choice for removing the implants. Explantation results can be excellent or disastrous. Some plastic or cosmetic surgeons are very experienced at implantation, but not explantation. However, there are some plastic surgeons who are very experienced at removal and are especially skilled at getting the best possible cosmetic result. The surgeon you choose should be experienced with explantation, board certified, and should be willing to show you pictures of many patients' post-explantation results, or better still, offer to have former patients talk to you. Find out if they were happy with their doctor and with their results.

Most experts believe that removing the implants en bloc is very important. This means that the entire implant and the entire scar tissue capsule surrounding it are all removed together. Although it is more difficult than removing just the implants, it makes it easier to remove any silicone that may have leaked from a broken gel implant, and also helps remove silicone or other chemicals that may have bled from the silicone outer envelope. You should ask your doctor if he/she would use this procedure.

Removing implants en bloc is particularly recommended by experts if you have been sick since receiving your implants. Some experts believe that symptoms such as joint pains, chronic flu-like symptoms, memory loss, confusion, or a burning sensation could be a result of silicone that has leaked from your implant, and perhaps outside the scar tissue capsule. If this is the case, leaving the scar tissue capsules, or part of them, and/or silicone in your body probably isn't going to let you recover as well as you might. It is also possible that while the silicone did not make you sick before, silicone that is left behind after explantation could make you sick later, because your body will respond to this foreign material.

What happens if I remove my implants and dont replace them?
Some surgeons discourage patients from removing their implants without replacing them, because they believe implants are safe and because theyre concerned that the patient will be very unhappy with her appearance after the implant is removed. The breast tissue stretches from the implant, and if the surgeon isnt skilled in explantation without replacement, the breast is unlikely to be as attractive as it was before the implant surgery. If the surgeon is not skilled at removing ruptured implants, the silicone can spill into healthy breast tissue, which then may need to be removed as part of the surgery. However, after an experienced explant surgeon removes implants, many women are very pleased with the way their breasts look and feel.

(Thanks very much to Dr. Lu-Jean Feng of Cleveland Ohio for these remarks regarding capsule removal after saline implants)


A biological capsule will form around any implant. Any saline implant removal will require a total capsulectomy. Like anything else in life, there are few exceptions. Here are the few exceptions which would have to be fulfilled before I would entertain the possibility of not removing the saline capsule.


(1) The capsule has to be tissue paper thin and without contracture.
(2) The patient has to be without any local or systemic symptoms.
(3) The saline implant has to be smooth shelled.
(4) There has to be no previous history of gel filled implant insertion.


All these conditions have to be fulfilled before I would consider not taking the saline capsule out. As you can see, few patients would fulfill these criteria. Invariably, I take out the entire capsule around saline implants.


Drfeng@aol.com

Sample Letter Requesting that Implants be Sent to a Specialized Pathologist or Returned to Patient


Date..

To Whom It May Concern:

I am having my breast implants removed on (insert date) My surgeon is (insert Plastic Surgeons name) I would like for my implants to be sent to Dr. Pierre Blais in Canada for evaluation and analysis.

It is necessary that the implants to be sent and addressed to Dr. Blais in a certain manner.

In the event that you are unable to send them to Dr. Blais, I am requesting that the implants be given to me after surgery so that I can forward them to him. In the event that the implants are to be given to me to send to Dr. Blais, the implants would need to be placed in a sterile specimen bag and given to me after surgery. (doctors name) is familiar with this procedure.

If you are able to send them directly to Dr. Blais, they need to be placed in a specimen bag at room temperature and then placed in a crush-resistant box. The box needs to be labelled in the following manner:

On the outside of the box, please print:

"FAILED MEDICAL IMPLANT / FOR RESEARCH- -NO COMMERCIAL VALUE--NOT FOR REUSE."

The implants need to be sent via UPS or Airborne Express.

The implants are to be sent to the following address:

Pierre Blais
Innoval
496 Westminster Ave.
Ottawa, Ontario
K2A 2V1

Please do not send these to your pathology department. It is imperative that they NOT be placed in any kind of fixative. They are to be sent directly to Dr. Blais, or given to myself immediately after surgery!

Thank you very much.

Sincerely,

(your signature)

www.orgsites.com/fl/adjuv..._pgg1.php3
The Human Adjuvant Disease Corp. receives several inquiries about silicone and saline implants. These are the most frequently asked questions.

Q:What is the chemical composition of a saline- filled breast implant shell?

A:According to the Office of Device Evaluation (ODE), the office responsible for conducting scientific reviews of medical devices and radiation emitting products, the following is what is in a saline-filled breast implant shell:

1. 80% high molecular weight silicones

2. 20% finely powdered silica

3. catalyst: small amounts (50-100 parts per million) of a tin or platinum

4. impurities: -small amounts of (1-500 parts per million) of various smaller silicones -trace amounts of (<5 parts per million) of volatile (readily evaporating) materials like xylene and other organic compounds (impurities) -trace amounts (<5 parts per million) of metals (impurities)


Q: How do saline implants cause systemic symptoms?

A: The shell surrounding a saline implant is a silicone polymer that can break down due to a lipolysis reaction or disruption. The silicone from the shell migrates into the capsule surrounding the implants. Cells in the immune system called macrophages pick up the silicone, break it down into Silica, and then distribute this chemical throughout the body.A chronic illness may develop that can affect every organ system in the body. Some patients with saline breast
implants have autoimmune, immune, and neurological disorders similar to patients with silicone breast implants.

Chemical sensitivity also occurs in patients with saline breast
implants.

Due to immune dysfunction, a patient with saline breast implants may also have systemic fungal and atypical bacterial infections.

Q: Why did several doctors tell me that my implants were safe and weren't responsible for my symptoms before I was properly diagnosed with a silicone-related disease?

A:Many physicians are unaware that silicone or saline implants can cause systemic symptoms in patients.Silicone-related disease is a controversial topic in medicine.Medical textbooks,medical dictionaries, etc. do not contain any information about illnesses caused by implants. Also,many physicians think that implants would not be F.D.A. approved if they were not safe.

Several years ago, you probably wouldn't have found a physician who could diagnose or provide treatment for illnesses associated with silicone implants.Fortunately, some doctors now understand the systemic symptoms associated with implants.

Q: How many patients with implants have a silicone-related disease? The manufacturers of silicone implants state that the percentage of autoimmune and neurological disorders in implant recipients is the same as the percentage in the general population.

Research regarding silicone implants is ongoing, but it is now
estimated by reputable sources that 25-30% of all implant recipients will develop an autoimmune condition.This statistic is much higher than the percentage disclosed by the manufacturers.

Q: What is a "gel bleed"?

A "gel bleed" occurs when the silicone gel in breast implants slowly leaks through the semi-permeable membrane envelope. The gel then migrates to the capsular area around the implants. Cells in the immune system called macrophages pick up the gel, break it down into Silica and Silicon, and then distribute these chemicals throughout the body. The result is immune dysfunction. The silicone gel also causes oxidants to form that can damage DNA, enzyme systems, and cell walls.
A chronic illness may develop that can affect every organ of the body.


For more information please read Silicone Arthritis and Related
Diseases by Stephen B. Edelson,M.D. et al.

Q: Which types of silicone implants are associated with illnesses?
A:All silicone implants can cause illnesses.This includes
cerebrospinal fluid shunt tubing, slow release hormone implants, cardiac valves, intraocular lens implants, testicular prostheses, penile implants, digital joint arthroplasty prostheses, breast implants, pectoral implants, buttock implants, calf implants, malar implants,jaw implants, and chin implants. Saline implants also can cause systemic symptoms because they have a silicone elastomer shell.

Q: How do implants affect a patient's career, personal life, and mental abilities?

A:Silicone-related diseases can affect every aspect of a patient's life. Some patients may be unable to work because of the debilitating symptoms that they have.Interpersonal relationships may be affected too. Many patients also have cognitive dysfunction and some develop psychological problems; both of these symptoms may occur in patients
with silicone induced immune dysfunction syndrome.


Some patients with silicone-related diseases only develop a few symptoms and have a normal life,but others are completely disabled.


Q:I have been diagnosed with a silicone-related disease.When will I begin to feel better after my implants are removed?

A:Most patients notice an improvement in their health immediately following surgery.Others improve but do not completely recover. A few remain disabled after explantation.Improvement depends on the age of the patient, health before implantation, and the duration of the illness. Significant laboratory and clinical improvement should occur
within the first two years after explantation.

Q: Where can I report an illness or complication that is caused by my implants?

A: Medwatch is the Food and Drug Administration's program for reporting serious reactions and problems with medical products, such as drugs and medical devices.

Q:Where can I find current information on breast implants?

A:The Center for Devices and Radiological Health (CDRH) Breast Implant Listserv provides current information on breast implants. The CDRH distributes a monthly newsletter via email to their subscribers.

Q:What are the complications associated with chin implants?
A:Complications associated with chin implants include the following: bone erosion,nerve damage, hematoma, seroma, infection, implant displacement,asymmetry, mobility, bleeding,swelling,bruising, and silicone-related diseases.


Q:What are the complications associated with cheek implants?

A:Complications include resorption of the bone under the implant,nerve damage,blood clot formation, bruising, swelling,bleeding, infection, and silicone-related diseases.

Q: What diagnostic tests are available for silicone?
A:Please refer to the section "Diagnostic Tests For Silicone-Related Diseases" on this website.


Q: What illnesses are associated with silicone implants?

A:Clinical syndromes resembling the following disorders are associated with silicone implants:systemic lupus erythematosus, rheumatoid arthritis, scleroderma, Sjogren's disease, polymyositis, mixed connective tissue disease, multiple sclerosis ,and other neurological disorders.


Chemical sensitivity is also associated with implants.


Some patients with immune dysfunction caused by silicone implants have fungal infections(ie systemic candidiasis) and atypical bacterial infections.

Q: What are the symptoms of a silicone-related disease?

A:According to Andrew W. Campbell, M.D. , Medical Director of the Center for Immune, Environmental, and Toxic Disorders,these are the most common symptoms experienced by patients with silicone prosthetic devices:

breast pain or tenderness

fatigue, usually made worse by exercise

cognitive function problems, such as attention deficit disorder,

calculation difficulties, memory disturbance, spatial disorientation,

frequently saying the wrong word

psychological problems such as depression, anxiety, personality changes, mood swings

sleep disturbance and non-restorative sleep

headaches of a greater intensity than before implantation

changes in vision

seizures

loss of balance

numbness and tingling

lightheadedness

paralysis

joint and muscle aches and pains

shortness of breath

lymph node enlargement

weight gain

low grade fevers

abnormal heart rhythm

hair loss

dry eyes and mouth

frequent canker sores in the mouth

low back pain

skin changes and/or rashes

severe muscular weakness

intolerance of bright lights

intolerance of alcohol

decreased libido

ringing in ears

muscle tremors

recurrent flu-like illnesses

severe allergies

irritable bowel syndrome

night sweats

uncomfortable urination

chest pain

cough

Raynaud's phenomenon

enlarged thyroid.


Q: What should I know about implants before I have surgery?
A:First,you should consider the reason(s) why you want to have implants. You should have plastic surgery because you want to enhance your appearance or because you need to have it for reconstructive purposes.Do not have plastic surgery because someone else (ie your spouse) wants you to do it. Also, there is a condition called "body dysmorphic disorder" that affects some patients who have plastic
surgery. Patients with body dysmorphic disorder or B.D.D. have an altered perception of their appearance (ie.they may have an obsession with a minor physical imperfection which may be imagined)that can affect their ability to have a normal life.You shouldn't have surgery if you think that you may have B.D.D.


Next, you need to find a plastic surgeon who has experience with the procedure that you want. Ask your physician how many of his/her patients have had the same procedure. Ask to see photos of other patients who have had the same procedure performed by that doctor. Ask to speak to other patients who were satisfied with the outcome of their surgeries.

Finally,you need to understand the complications that may occur with the procedure that you are having. Ask your plastic surgeon to discuss complications and silicone-related diseases with you before you have surgery.

Q: I have a silicone-related disease and I feel like my family and friends do not understand what I am going through.I feel "alone".

A: Joining a support network can help you to cope with the medical and personal problems that you are experiencing. Support groups are located on the internet. There are also chat forums on the internet now where patients can interact with each for advice and compassion.

You're not alone.

You need to explain to your family and friends what is happening to you. Maybe they do not understand how serious your condition is. Provide information to them about your disease. Show them websites and articles that you have regarding silicone-related diseases.


These illnesses not only have an impact on the patient's life, but also can affect others who are close to them. Perhaps you should encourage your family and friends to join a support network with you.


Q: If I have a silicone-related disease and I decide to have children, will they be affected too?

A:It is possible that if you have children, they might be ill from the toxic effects of silicone. The number of children who are affected by "second generation silicone-related diseases" is unknown at this time.Smalley et al investigated T cell proliferative responses to silicone dioxide (silica) in 24 childen born to silicone gel breast implant recipients. The authors found that T cells were significantly stimulated by silicone dioxide. A second part of their study consisted of the investigation of 11 children, four born before implantation, and seven born after implantation. None of the pre-implant offspring showed T cell responses to silica while five of the seven post-implant children were positive in this test.