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BREAST IMPLANT INFORMATION
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Augmentation mammoplasty is a surgery performed to enhance the size and/or shape of the breasts. This procedure involves making an incision, lifting the breast tissue, creating a pocket in the breast area, and inserting an implant into this area. Breast implants consist of a shell that contains a filler.

The procedure lasts one to two hours.It can be performed utilizing a general anesthetic or using a local anesthetic with sedation. A patient can usually return to work within a few days to one week after the procedure. The stitches are removed within a week to ten days, but swelling may persist for several weeks.

Anyone considering breast augmentation should understand that breast implants do not last a lifetime and must be replaced periodically. In addition most women, who have breast implants, will develop complications that may require surgery.

During breast augmentation the incision may be made in one of the following areas:

  • Periolar-Incision is made around the nipple
  • Inframammary-Incision is made in the breast fold
  • Transaxillary-Incision is made under the arm
  • Umbilical-Incision is made through the navel. Many surgeons do not think that this method, called Trans-umbilical breast augmentation (T.U.B.A.), has merit.

    Two options are available when considering the placement of the implant:

  • Submuscular-Placement of the implant partially or completely below the pectoralis major muscle
  • Subglandular-Placement of the implant above the pectoralis major muscle and under the gland

    Implants are available with two types of surfaces:

  • Smooth-Implants with a smooth surface are less likely to ripple than textured implants but are more likely to be displaced.
  • Textured-Some studies claim this type of shell surface reduces the risk of capsular contracture, while other studies comparing smooth and textured implants show no difference in the risk of developing this condition. The risk of silica migrating from the shell and into the surrounding tissue is greater for textured implants than for the smooth-surfaced implants.

    The design of the shell is available in two forms:

  • Single lumen-this means that the implant has one shell surrounding the filler.
  • Double lumen- An implant with a double lumen has one shell contained in another shell.

    There are different types of silicone gel-filled implants:

  • Single lumen- Prefilled with silicone-gel by the manufacturer.
  • Double lumen- The outer shell is filled with saline through the valve during surgery and the inner lumen is prefilled with silicone gel. Another type of double lumen implant has prefilled silicone-gel in the outer lumen and the inner lumen is filled with saline during surgery.

    There are different types of saline-filled breast implants:

  • Single lumen-3 types

    1.The implant is filled during the operation with saline (salt water) through a valve.
    2.The implant is filled during the operation with saline through a valve and the volume may be adjusted postoperatively.
    3.The manufacturer prefills the implant.

    Breast implants are available in two shapes:

  • Round
  • Contoured


    Chemical Composition

    The chemical composition of a silicone gel-filled breast implant includes the following:

  • Filler- The filler of a silicone gel-filled breast implant consists of silicone oil, cured polymeric (large) silicones, small amounts of uncured large and smaller silicones, minute amounts(parts per million) of metals, including a metal catalyst(usually platinum).

  • Shell-The shell of a silicone gel-filled breast implant has the following composition:

    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).

    The chemical composition of a saline-filled breast implant consists of the following:

  • Filler-The filler of a saline-filled breast implant is sterile saline.

  • Shell-The shell of a saline-filled breast implant has the following composition:

    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).

    The shell of a saline-filled breast implant and the shell of a silicone gel-filled breast implant have the same general chemical composition.


    Complications

    Local complications associated with breast implants include the following:

  • Iatrogenic injury
  • Redness
  • Bruising
  • Hematoma
  • Necrosis
  • Deformity of Chest Wall
  • Decrease or increase in breast and nipple sensation which may be temporary or permanent
  • Inflammation
  • Delayed wound healing
  • Capsular contracture
  • Granuloma
  • Seroma
  • Displacement
  • Malposition
  • Ptosis
  • Galactorrhea
  • Calcification
  • Scarring
  • Unsatisfactory size or style
  • Rippling/ wrinkling
  • Palpability
  • Visibility
  • Infection
  • Asymmetry
  • Breast pain
  • Tissue atrophy
  • Extrusion
  • Irritation
  • Deflation/Rupture

    More information about rupture/deflation:

    Causes of deflation/ rupture include aging of implant,underfilling or overfilling of a saline-filled breast implant,capsular contracture, trauma or pressure, compression during mammography, damage by instruments during surgery,folding or wrinkling of the implant shell, damage during a biopsy or drainage of fluids, and too much handling of implant especially during TUBA procedure (Trans- umbilical breast augmentation).

  • Silicone gel-filled implants are associated with two types of rupture:

    1.Intracapsular rupture-Gel is contained within fibrous capsule. These ruptures are typically silent ruptures, which means that there isn't a visible change of the breast and the patient doesn't feel a difference in the breast. MRI is currently the best method for detecting a rupture of a silicone-gel filled implant.

    2.Extracapsular rupture- Gel migrates out of the scar capsule and can form granulomas in the breast, chest wall, arm, and armpit. Silicone can also travel to organs far from the site of rupture (e.g. the liver). A patient may experience a change in the size and shape of the breast, hard lumps in the chest, tenderness or pain, numbness, tingling, or burning. This type of rupture is called symptomatic.

  • Saline-filled breast implants and deflation

    1.This occurs when saline escapes through a faulty valve or a tear in the elastomer shell.

    2.Deflation can be immediate or slow (taking several days to notice).

    Systemic complications associated with breast implants include the following:

  • Fungal infections-Some patients with immune dysfunction induced by silicone implants have fungal infections (e.g. systemic candidiasis) associated with depressed natural killer T cell levels.
  • Diseases resembling Sjogren's disease, mixed connective tissue disease, rheumatoid arthritis, lupus erythematosus, polymyositis, dermatomyositis, and scleroderma.
  • Fibromyalgia
  • Chronic fatigue syndrome
  • Neurological disorders (e.g. MNDS)
  • Multiple chemical sensitivity
  • Carcinomas including but not limited to the lung and vulva.
  • Pneumothorax
  • Bacterial infections-Some patients with implants become ill as a result of bacteria such as Enterococcus and Staphylococcus aureus which can be cultured out of breast capsules.

    Mycobacterial infections also occur.

    Toxic Shock Syndrome is a rare life-threatening syndrome caused by a bacterial infection that can occur after implantation. Symptoms include the following: fever, headache, sore throat, lethargy, vomiting, dizziness, diarrhea, a rash that looks like a sunburn, confusion and fainting. It may rapidly progress to severe and intractable shock. A patient should seek medical treatment immediately for this condition.

    Silicone-gel breast implants and systemic complications

    The shell surrounding a silicone gel-filled breast implant is a silicone polymer that can break down due to disruption of the shell or a time-related lipolysis reaction. Silicone gel from the filler can travel into the surrounding tissue.It can migrate to distant organs after it escapes from the capsule. Also, chemicals including silica and platinum can leach from the shell and migrate into the capsule surrounding the implants. Cells in the immune system called macrophages pick up these chemicals, then travel through the lymphatic system, and distribute them throughout the body to the peripheral nervous system, central nervous system, and organs. A chronic illness may develop that can affect every organ system in the body.

    Gel bleeds cause systemic complications in some patients with silicone gel-filled implants

    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.

    Saline-filled breast implants and systemic complications

    The shell surrounding a saline-filled breast implant is a silicone polymer that can break down. Chemicals can leach from the shell and migrate into the capsule surrounding the implants.This occurs in textured implants more than smooth saline-filled breast implants. Cells in the immune system called macrophages pick up these chemicals, then travel through the lymphatic system, and distribute them throughout the body.Silica has been reported in lymph nodes in saline breast implant recipients who have never had silicone gel implants. A chronic illness may develop that can affect any and every organ system in the body.

    Symptoms associated with systemic complications

    According to Andrew W. Campbell, M.D. , Medical Director of the Center for Immune, Environmental, and Toxic Disorders, these are the most common complaints compiled from over 4,000 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
  • decreased libido
  • muscle tremors
  • recurrent flu-like illnesses
  • severe allergies
  • irritable bowel syndrome
  • night sweats
  • uncomfortable urination
  • chest pain
  • cough
  • Raynaud's phenomenon
  • enlarged thyroid.

    Multiple Chemical Sensitivity

    Multiple Chemical Sensitivity is an acquired chronic condition with symptoms that recur reproducibly in response to low levels of exposure to multiple unrelated chemicals affecting multiple organs. Symptoms improve or resolve when incitants are removed. MCS may occur after single, high-dose exposures (i.e. chemical spills) or repeated low-level exposures to chemicals. Chemicals may be inhaled, ingested, absorbed by the skin or implanted (i.e. breast implants). A patient with MCS may not be able to eliminate chemicals in his or her body because the chemicals enter the body more rapidly than the body is able to eliminate them. The chemicals may then be stored in the heart, liver, and brain.

    The symptoms of M.C.S. include, but are not limited to, the following: fatigue, headache, trouble breathing, muscle pain and joint pain, dizziness, irregular heartbeat, seizures, cognitive dysfunction including confusion, lack of memory, and lack of concentration. M.C.S. is similar to an allergy in that patients who are affected react to substances that are not harmful to others, but the biological mechanisms are dissimilar. Those with M.C.S. may appear healthy even when they are very ill.

    The elastomer shells of breast implants contain the component silica. Silica is a potent stimulant of nitric oxide synthesis and may act, therefore to stimulate the NO/ONOO- cycle in multiple chemical sensitivity.

    A specific sensitivity to the silicone elastomer is more likely to be a true allergy.

    Please read Multiple Chemical Sensitivity - The End of Controversy for more information about MCS.

    Biotoxins and Implants

    A biotoxin is any toxin produced by a living organism (animal, plant, fungus, bacteria). A toxin is a biologically produced substance that causes injury to the health of a living thing on contact or absorption, by interacting with biological macromolecules such as receptors and enzymes. Toxicity may be acute, chronic, or both.

    Biotoxins from mold cause an illness in some symptomatic patients with silicone and saline-filled implants. A deficit in the ability to detect visual patterns in these patients can be documented by using the VCS test. Patients with neurological symptoms may have abnormal myelin basic protein antibody tests. Implant recipients with endocrine problems may have abnormal MSH tests. Patients with mental clouding may have abnormal VEGF tests. Implant recipients who have a great deal of pain may have abnormal MMP-9 tests. Some patients have a certain HLA type known to be sensitive to biotoxins.

    Visit www.chronicneurotoxins.com for more information regarding biotoxins.


    Platinum Toxicity

    Platinum is used as a catalyst in the manufacture of gel components and the elastomer shell of silicone breast implants. Women exposed to silicone breast implants have platinum levels that exceed that of the general population. In the human body implants are exposed to stress and heat which can cause deterioration and oxidation. The oxidation states of the platinum indicate that the exposure may be toxic. Platinum species remain in the body for a long time after implants are removed.Platinum salts have been associated with carcinogenicity and neurotoxicity.

    Petition to the FDA


    Additional concerns

    Some patients may develop breast pain after augmentation mammoplasty:

  • The severity of pain may vary
  • The length of time that pain persists following surgery may vary
  • Contributing factors related to breast pain include but are not limited to capsular contracture, improper implant size, surgical technique used, and the placement of the implant
  • Pain is one of the primary reasons for implant removal and replacement

    Patients with breast implants should be aware that they affect mammography:

  • Breast implants can interfere with cancer detection
  • Compression during mammography can cause deflation/rupture
  • Patients with breast implants need to inform the receptionist when they schedule mammograms because the procedure may take longer and requires extra views.
  • Women should also inform the technologist before the procedure.
  • The technologist can utilize Eklund displacement view to see the breast tissue more clearly and will be more careful during compression if they know that the patient has implants.
  • Calcium deposits form hard lumps around the implant and can mimic the appearance of a tumor. In this case, a biopsy is needed to distinguish cancer from calcium deposits.

    Some physicians do not recommend mammograms to be used as screening tests on women with silicone gel implants and they recommend that mammograms should be avoided in patients with saline implants > 5 years old. A recent study indicates that women with breast implants have better breast cancer detection using ultrasound than mammogram.

    Additional surgeries will be necessary at some point after initial augmentation and may include:

  • Replacing implants (exchange)
  • Removing implants without replacing them (explantation)
  • Removal or release of a capsule
  • Draining a hematoma or a seroma
  • Moving the implant (repositioning)
  • Biopsy
  • Cyst removal

    Concerns about breast feeding after implantation

  • Some women develop lactation insufficiency.

    Effects on Children

    Research has demonstrated that children with ventriculoperitoneal shunts and other types of silicone implants may experience complications.

    Second-generation effects are also possible, which may be due to one of the following:

    • silicone leaching from the elastomer shell of a breast implant
    • the rupture of a silicone gel-filled breast implant
    • a gel bleed

    Breast feeding a child may result in the development of an illness. An unborn child may also be affected via the placenta.

    Breast Implants and Suicide

    According to at least four studies in recent years, women with breast implants are more likely to commit suicide than women in the general population.Psychiatric illnesses may be related to systemic complications occurring after augmentation. In most cases warning signs are evident to those closest to the patient.

    Persons who are seriously contemplating suicide may:

    • Give away prized possessions, make a will, or put affairs in order
    • Withdraw from others around them
    • Have a change in sleeping or eating habits
    • Lose interest in prior activities and relationships
    • Experience a lift in spirits after being very depressed due to the fact that the person feels a sense of relief thinking that all of her problems will be solved by suicide and the person has the energy to follow through with an attempt
    • Have a prior suicide attempt
    • Have a recent loss (i.e. death, divorce, separation, broken relationship, loss of job, money, status, self-confidence, self-esteem, loss of religious faith, and loss of sexual interest)
    • Have a change in personality
    • Have menstrual abnormalities (missed periods)
    • Have a fear of losing control
    • Have low self-esteem
    • Feel hopeless
    • Have difficulty concentrating and a decline in the quality of work
    • Have a plan to commit suicide
    • Be unwilling to communicate
    • Neglect appearance
    • Be careless
    • Exhibit hostile behavior
    • Be late frequently

    Threats of suicide must be taken seriously. The National Suicide Prevention Lifeline provides aid to individuals in a suicidal crisis by connecting them to the closest suicide prevention and mental health service provider: 1-800-273-TALK (8255). For more information about suicide visit the Suicide Crisis Center Web Site.


    Explantation

    Explantation may be necessary at some point for patients with breast implants.Patients who have their implants removed without replacement may have a cosmetically undesirable appearance of the breasts that may be irreversible.

    Changes in appearance may include:

  • Loss of breast tissue
  • Dimpling
  • Puckering
  • Wrinkling
  • Scarring

    Factors that are associated with the degree of deformity at explantation include:

  • The size of the breast of the natural breast
  • The size of the implant
  • The number of implant-related procedures (i.e. implant exchange & surgeries to correct complications) prior to explant surgery
  • The type of implant
  • The integrity of the implant

    The worst deformities after explantation are associated with the following:

  • Mastectomies with implant reconstruction
  • Multiple cosmetic surgeries
  • Severe capsular contractures
  • Ruptured silicone implants

    Some patients have a procedure called a donut mastopexy when the breast implants are removed. This is a type of breast lift that involves removing the top layer of dermis to reposition the nipple areolar complex and removing excess skin. The surgeon should change gloves and instruments between explantation and the mastopexy to avoid contamination with bacteria found in the scar capsule. Contamination can cause hypertrophic scars at the site of incision. If scarring and asymmetry occur after explant surgery, a revision surgery may be necessary to correct these problems.

    If silicone has leaked from a breast implant then en bloc implant resection is necessary

    A procedure called en bloc implant resection is used to remove the scar capsule around the implant to keep silicone from being released into the system.

    Silicone that is picked up by the lymphatic system travels into the axillary lymph node system and can be detected on an ultrasound. Removal of lymph nodes may not be needed unless they are abnormal. Scarring that can result from excising the lymph nodes can interfere with the channels that normally drain the breasts.Many patients on a detoxification program called the Silicone Immune Protocol have silicone move through the lymphatic system.


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