A breast implant is a synthetic, round or tear-shaped silicone shell that is filled with either sterile saline (saltwater) or silicone gel. The implants are placed behind the skin or muscles in the chest to simulate a natural breast.

Breast implants are used in breast augmentation, a cosmetic surgery women chose to alter the size or shape of their breast. Breast implants also may be used in breast reconstruction following mastectomy for breast cancer. The implants offer women the option of having a breast-like shape with a natural feel.

In the United States, silicone implants were removed from the market in 1992. The implants were associated with an increased risk of immune system diseases and connective tissue disorders. Previous studies had indicated a risk of potentially hazardous levels of platinum leaking into the body from silicone implants. For that reason, silicone implants were available only to women who had undergone a mastectomy, had a physical deformity or were in need of a replacement for a damaged implant. They were able to receive the silicone implants only when enrolled in a controlled clinical trial, known as an investigational device exemption (IDE) study.

But to date, all subsequent studies have failed to show any increased risk of connective tissue diseases and autoimmune diseases among women who have chosen to have silicone implants. As a result, the Food and Dug Administration (FDA) lifted its restrictions on silicone implants in November of 2006, allowing their use for breast augmentation in patients 22 years or older, and for breast reconstruction surgery in patients of any age. Even though many other countries have not removed silicone implants from the marketplace, the FDA is requiring the two companies that are allowed to manufacture silicone implants to continue conducting long-term studies on their safety and efficacy.

Breast implant surgery is performed by a plastic surgeon who reviews the patient’s implant options (e.g., size and shape) and offers advice regarding the procedure. Breast implant surgery often leads to a good cosmetic result. However, in the case of breast reconstruction, there is typically little or no feeling in the reconstructed breast because the nerves have been severed.

When choosing breast implants for either augmentation or reconstructive surgery, it is important that the patient realize that the implants will have to be replaced within five to 10 years, if not earlier. For breast reconstruction, the patient’s body type, age and cancer treatment may play a significant role in determining which type of reconstruction will offer the best results.

In the past, breast implants were thought to increase the risk of breast cancer. However, several large studies have refuted that theory and implants are not considered a risk factor for breast cancer. It is important to note, however, that breast implants may interfere with mammograms or breast self-examinations.

Breast implants are used for augmentative surgery for women who wish to change the size, shape or feel of their breast. A great deal of social emphasis is placed on women’s breast size. This may influence why breast augmentation is the most popular type of cosmetic surgery, according to the American Society of Plastic Surgeons (ASPS). Overall, the ASPS estimated there were 329,000 breast augmentation procedures performed in 2006.

Breast implants also are a common choice for women who want breast reconstructive surgery following a mastectomy. In 2006, about 56,000 women chose breast implants for reconstructive surgery following a mastectomy, according to the ASPS.

A breast implant consists of a round or tear-shaped shell that is filled with sterile saline (saltwater) or silicone gel.

Saline-filled implants are the most common type of breast implant. The lumen or shell of these implants is composed of silicone rubber and they are filled with sterile saline (saltwater). If these implants should leak or rupture, the solution is absorbed by the body. Saline implants have not been associated with any risks of disease. There are three basic types of saline implants with the following variations:

• Single lumen implant that is filled during surgery with a fixed amount of saline through a valve. After surgery, the amount of saline in this implant cannot be adjusted.
  
  
• Single lumen implant that is filled with saline during surgery, but the amount can be adjusted after completion of the procedure.
  
  
• Silicone lumen implant that is prefilled by the manufacturer with a set amount of saline. There are no valves in this type of saline, therefore, the volume of saline cannot be adjusted during or after the surgery.
  

Silicone-filled implants are the second form of devices. In the past several years, there has been much controversy regarding the safety of silicone implants. Studies have associated these implants with connective tissue and autoimmune diseases. In addition, there has been concern with leakage of potentially hazardous levels of the metal platinum from silicone implants. Although available in the United States from 1962 to 1992, the FDA withdrew silicone implants from the market in 1992 for the general public. Since that time, silicone implants were only available to women who were receiving breast reconstruction surgery following a mastectomy or those who had a physical deformity. Their use also was allowed to replace earlier implants that had ruptured. These women could only receive silicone implants by being enrolled in a controlled clinical trial, known as an investigational device experimental (IDE) study.

Both the U.S. Senate and the FDA have investigated the safety of silicone implants. Studies have failed to demonstrate a definitive connection between silicone implants and chronic diseases. As a result, in August of 2005 the FDA granted conditional approval to two companies that manufacture silicone implants. In order to gain final approval, these companies had to satisfy a number of conditions established by the FDA. In November of 2006, the FDA lifted its restrictions on silicone implants, allowing their use for breast augmentation in patients 22 years or older, and for breast reconstruction surgery in patients of any age. In addition, the FDA is requiring the approved companies to continue conducting long-term studies on the safety and efficacy of their silicone implants.

The outer shell of silicone implants is composed of silicone rubber similar to the composition used in saline implants. Some patients claim that silicone implants feel more natural than their saline counterparts. Although the United States limited the use of silicone implants to patients with specific conditions for 14 years, they have always been widely available in other countries, including many in Europe and Asia.

There are three types of silicone-filled breast implants with the following variations:

• Single lumen (shell) implant that is prefilled by the manufacturer with a set amount of silicone gel. There are no valves with this type of implant and the volume of silicone cannot be adjusted.
  
  
• Double lumen implant that is composed of two shells. The inner lumen is prefilled by the manufacturer with a set amount of silicone gel. The outer lumen contains a valve that is filled with saline through a valve during surgery. Adjustments to the volume of saline in the outer shell cannot be made following completion of surgery.
  
  
• Double lumen with an outer shell that is prefilled by the manufacturer with a set amount of silicone gel. The inner shell is filled with saline during surgery through a valve. This type of implant allows for adjustment of the amount of saline in the inner shell after surgery.
  

Breast implants come in all shapes and sizes in order to accommodate individual differences and preferences. Some of the options that should be considered when selecting a breast implant include:

• Shell surface (smooth vs. textured)
  
  
• Size (volume contained in the implant)
  
  
• Shell thickness (also referred to as the envelope or lumen)
  
  
• Single or double lumen (shell)
  
  
• Fill design
  
  
• Shape (round or contoured)
  
  
• Profile (how far it projects forward)
  

When weighing in her surgery options, it is important that the patient realize that she will have to replace the implant within five to 10 years, if not earlier. Implants that rupture, cause scarring or cosmetic problems are the main reasons for replacement.

Breast reconstruction surgery with implants is performed by a plastic surgeon who is skilled in this complex procedure. It is not uncommon for a patient to need two or more surgeries in order to achieve the optimal implant positioning and proportion. The patient may require surgery on the opposite breast to ensure symmetry (similar size and shape) with the reconstructed breast. This surgery also includes nipple reconstruction and possible tattooing of the reconstructed nipple to create a more natural-looking areola (the dark area of skin around the nipple).

Also, if the reconstruction takes place immediately after mastectomy, it is possible for the cosmetic results to be affected by chemotherapy, radiation therapy or other factors that might delay the healing process. For example, chemotherapy or radiation therapy can increase the occurrence of skin necrosis, in which dead tissue forms around the implant. This, in turn, can lead to an infection. If the infection cannot be cured with antibiotics, the implant may need to be removed.

It is important to note that not every breast cancer patient is a candidate for breast implant reconstructive surgery. Patients should discuss this and any other related issues with a qualified plastic surgeon.

The pros and cons of all aspects of each type of augmentation or reconstruction should be discussed with the plastic surgeon prior to selecting a procedure. If a patient does decide to proceed with breast implant surgery – either for augmentation or reconstruction purposes – the next step is to choose what type of implant is best suited for the individual. It is advisable that she consider the following factors before the breast implant procedure:

• Implant status. Whether the implant is or is not approved for use in the United States. If it is investigational, the patient will need to become part of a controlled clinical trial to receive the experimental implant.
  
  
• Size and shape. It is important to choose the correct size and shape (round or contoured) depending on the cosmetic result the patient hopes to achieve. Here, the plastic surgeon can offer advice and guidance.
  
  
• Surface of the implant. According to the Food and Drug Administration (FDA), a few studies have shown that textured surface implants, which were initially designed to reduce the risk of capsular contracture, show no such decrease in this complication compared to smooth-surfaced implants. Capsular contracture is scar tissue that develops and tightens or squeezes the implant.
  
  
• Implant palpability/visibility. The feel and look of the implant. Textured implants and larger implants may be easier to feel and see. The same is true when patients have less skin or tissue left to cover the implant.
  
  
• Implant placement. Implants are placed either under the chest muscle (submuscular) or under the breast glands (subglandular). The type of placement may influence the performance of mammograms, breastfeeding or breast self-examination.

Additional information should be considered as there are variations in the surgical incision site, although most surgeons will utilize the mastectomy scar for re-incision (for reconstruction). For breast augmentation surgery, implants may be inserted through an incision at the bottom crease of the breast, in the armpit, along the lower edge of the areola or the navel. The plastic surgeon who performs the breast augmentation or reconstruction surgery will recommend a particular method or implant depending on the individual needs of the patient.

Patients may be asked to donate blood prior to the breast implant procedure in case a transfusion later becomes necessary. It is important for the patient to tell the physician about all medications she may be taking to ensure that none of them will adversely interact with medications used during surgery.

Patients are typically asked to refrain from eating or drinking for eight to 12 hours prior to surgery. The patient should also abstain from smoking, which can delay healing time, and avoid taking certain vitamins or even aspirin for a period of time prior to surgery. The patient´s physician may provide additional instructions prior to the surgery. 

Breast augmentation and reconstruction are often performed on an outpatient basis, meaning that no overnight hospital stay will be required. The surgery is normally performed using general anesthesia (the patient is asleep during the procedure), but in certain cases it can be performed using local anesthesia (which numbs only the breast area). The entire procedure can be performed in an hour or it can take several hours, depending on the patient´s condition, implant choice and any other extenuating circumstances. If the reconstruction is occurring at the time of a patient's mastectomy, the surgery is not typically performed on an outpatient basis and is likely to take considerably longer.

For breast augmentation, the plastic surgeon makes an incision at the bottom crease of the breast, armpit or along the lower edge of the areola. The implant is inserted through the incision either under the chest muscle beneath the breast or simply under the breast tissue. Some plastic surgeons prefer placing the implant behind the chest muscle in order to reduce the risk of capsular contraction, in which the surrounding tissue hardens around the implant.

The surgical placement of an implant following a mastectomy is similar in that it can be placed either behind the remaining breast tissue or behind the chest wall. However, the mastectomy incision is often used to insert the implant. There are two common ways for a plastic surgeon to perform immediate reconstruction following a mastectomy. These include:

• One-stage breast reconstruction. This takes place at the same time as the mastectomy. An implant is placed under the skin where the breast tissue was removed. Very few women are able to achieve a one-step process because additional adjustments are usually required.
  
  
• Two-stage breast reconstruction. This procedure is more common. The first stage requires the placement of an expander at the time of the mastectomy. These expanders are silicone shells filled with saline also regulated by the FDA. Since they are only intended to be in place for a maximum of six months, they have different specifications than regular breast implants. These expanders stretch the skin and gradually create a larger pocket for the breast implant. In all, the process takes about four to six months until the expander is replaced with a breast implant. Women who are extremely active and want to avoid spending long periods recuperating tend to opt for this procedure. Even though patients have soreness and tenderness in the chest, they are able to return to their normal routines in a shorter period of time.

A third option for breast cancer patients is delayed reconstruction. The patient may decide months or even years after treatment for breast cancer has been completed that she would like breast implant surgery. The medical, financial and emotional considerations of choosing immediate versus delayed reconstruction should be discussed with the surgeon, plastic surgeon and oncologist.

Immediately following breast implant surgery, swelling, pain, bruising and tenderness are normal. These complications can last for several weeks and sometimes longer, but should diminish over time. It is recommended that the patient discuss issues such as scarring, pain and recovery times with the plastic surgeon as these vary among individuals. In some cases the surgeon will place a drain in the tissue to prevent the accumulation of blood and fluid. This will then be removed within several days after the surgery.

The surgeon will most likely prescribe medications for pain and nausea. Any symptoms that may indicate an infection, such as fever or redness of the breast, should be evaluated by a physician. Also, a post-operative bra, compression bandage or athletic bra is often recommended as it provides additional support during recovery.

For breast augmentation, the nipple is left intact. However, because the nipple is removed with mastectomy, breast cancer patients may choose to have nipple reconstruction, followed by a darkening of the skin around the nipple (areola) with a tattoo. The tattooing can be performed on an outpatient basis at a hospital or sometimes in the plastic surgeon’s office.

Breast implants are not meant to last indefinitely. Rupture, deflation or several other complications are possible. Although some patients may have implants that take 10 years or more to rupture or deflate, others may experience problems within the first few months.

Patients should immediately notify their physician if they experience any of the following signs and symptoms that may indicate that a silicone implant has ruptured:

• Decreased breast size
• A change in the shape of the implant
• Hard lumps in the areas that surround the implant
• An uneven appearance of the breast
• Tingling, swelling, numbness, burning or any changes in sensations

If a silicone breast implant does rupture and the silicone gel escapes the capsule, it is possible for the gel to cause lumps, known as granulomas, to form in the breast, chest wall, armpit, arm or even distant organs such as the liver. It is difficult and at times impossible to remove silicone gel that has migrated to other areas. In addition, silicone implant ruptures may not always cause symptoms (known as "silent rupture"). Therefore, the Food and Drug Administration (FDA)  advises patients with silicone implants to undergo MRI (magnetic resonance imaging) testing at three years after implantation and then every two years thereafter to screen for rupture.

When a saline implant ruptures, the body absorbs the fluid. Still, if a decrease in breast size or an uneven appearance of the breast causes a woman to suspect that her saline implant has ruptured, she should contact her physician.

Women who have had breast implants will still need to have regular screening for breast cancer. However, breast implants may interfere with normal mammography, affecting both the performance and the interpretation of mammograms. Additionally, women with implants are at risk of having them rupture during the compression required to perform a proper mammogram. The occurrence is fairly uncommon with only 41 cases of implant ruptures during mammography reported to the FDA between 1992 and 2002. It is best to discuss cancer screening options with a qualified physician, preferably an oncologist or plastic surgeon.

Breast implant surgery can be very beneficial for women who have had a mastectomy because of breast cancer. For many, breast implants not only restore the appearance of their breast, they also restore their self-esteem and confidence. Breast implants may also be psychologically beneficial for women with visual differences between the breasts, or for women who are dissatisfied with the appearance of their breasts.

Breast implants can pose certain health risks. According to the Food and Drug Administration (FDA), which is charged with approving and monitoring the safety of breast implant devices, there are several potential complications associated with breast implants. Among the more common complications following breast implant reconstruction surgery is asymmetry (a noticeable difference between the reconstructed breast and the opposite breast). It is also possible to experience tenderness, pain and swelling in the breasts, including the nipple, following surgery. Breast tissue atrophy, calcium deposits that develop around the implant and capsular contracture, in which scar tissue tightens around the implant, are also common side effects of this type of reconstruction.

Perhaps the most common problem of all is rupture or deflation of the implant. An implant that ruptures or tears due to trauma, mammography or normal wear-and-tear allows the contents of the implant (saline or silicone) to leak into the body. In addition to normal aging of the device, there are other factors that may contribute to rupture or deflation of an implant, including:

• Excessive handling during surgery
  
  
• Damage from surgical instruments or procedures (e.g., biopsies)
  
  
• Compression from mammography
  
  
• Improper filling of a saline implant
  
  
• Trauma to the breast area

Physicians can use magnetic resonance imaging (MRI) with specialized equipment to determine if an implant has become ruptured or has leakage. If a silicone implant ruptures or is leaking, surgery is usually recommended to remove the device. Silicone gel can cause damage to surrounding tissues, such as granulomas (lumps) and it can travel to tissues outside of the immediate area.

Saline implants can also rupture as well as leak through an unsealed or damaged valve. This may be noticed immediately or may not become apparent for months by a loss in size or change of shape of the breast. Additional surgery is recommended to remove the deflated parts of the implant and replace it, if desired by the patient.

Other potential risks of breast implants include:

• Capsular contracture. When an implant is placed in the breast tissue, a lining or "capsule" forms around it. In some patients, the lining can shrink or tighten, placing pressure on the implant. There are several suspected causes of capsular contracture, including bacterial infection of the implant shell. The condition is most likely to occur within the first few months following surgery. The more severe forms of capsular contracture may require additional surgery.
  
  
• Galactorrhea. Milk production is inadvertently stimulated.
  
  
• Hematoma. Swelling, pain and especially bruising may result from a collection of blood around the surgery site.
  
  
• Iatrogenic injury/damage. Excessive handling or possibly damage caused by surgical instruments to the implant.
  
  
• Infection, including toxic shock syndrome (TSS). Infections are not uncommon following any surgical procedure. However an infection that does not respond to antibiotics may force the removal of the implant until the infection has been successfully treated. In rare cases, TSS can create a life-threatening bacterial infection within the body that can lead to amputation or death. Any patient experiencing sudden fever, vomiting, diarrhea, fainting, dizziness or a sunburn-like rash should seek immediate medical attention.
  
  
• Malposition/displacement. Any of a number of reasons can cause the implant to shift, including poor initial placement, trauma or capsular contracture.
  
  
• Necrosis. Dead tissue around the implant, which, in turn, can lead to infection. The dead tissue can be caused by smoking, chemotherapy, radiation, excessive heat or cold therapy or the use of steroids.
  
  
• Nipple/breast sensation changes. These changes (e.g., numbness, pain, hardness, over sensitivity) in the sensitivity of the breast and nipple can range from mild to severe and from temporary to permanent.
  
  
• Palpability/visibility. The implant is said to be palpable when it can be felt through the skin and visible when it can be seen through skin.
  
  
• Ptosis. This undesirable cosmetic result is a sagging or drooping of the breast.
  
  
• Scarring. All incisions heal by forming a scar, but the degree will vary from patient to patient.
  
  
• Seroma. The watery portion of blood pools around the implant or at the site of the incision, causing swelling, pain and possibly bruising. While it may heal on its own, if it does not, a drain may need to be inserted.
  
  
• Unsatisfactory style/size. The end result can, at times, be cosmetically or aesthetically displeasing to the patient or physician. 
  
  
• Wrinkling or rippling. At times, the implant can wrinkle or have ripples that are noticeable through the skin.

It is important that women who choose breast implant surgery for reconstruction or augmentation be aware that implants have the potential to interfere with breastfeeding, mammograms or breast self-examinations.

The implant surgery itself does not affect the milk ducts and many women who have had breast augmentation have breastfed their children successfully. However, according to the Institute of Medicine (IOM), a woman who has had breast augmentation may experience lactation insufficiency. This means that a nursing mother may find it difficult to create an adequate milk supply for her baby. It appears that these difficulties are more common among implant surgeries that use the areola as the incision site, which may sever some of the ducts that carry milk to the nipple.

Breast implants are devices that do not last indefinitely and there is a strong possibility that the implant will eventually rupture. When deciding whether to have breast implants, it is recommended that the patient consider that the implants will have to be replaced within five to 10 years, if not earlier. Some implants have been known to deflate or rupture within just a few months of surgery, while others may last for 10 years. Common causes for rupture include:

• Normal wear and tear
• Routine mammography
• Trauma to the chest (e.g., car accident) 
• Assault or other strong blow to the chest
• Sports injuries

It is important to note that insurance companies almost invariably cover reconstructive surgery required because of a disease process. Augmentation generally desired for cosmetic reason – even those that have ruptured – may or may not be covered under a patient’s policy.

There are a number of studies that continue to assess and review the safety of breast implants. Some of the areas of research include:

• Impact of implants on mammography and breast cancer detection
  
  
• Relationship of silicone implants with autoimmune diseases, connective tissue disorders and cancer
  
  
• Risk of high levels of platinum leakage that could be harmful to women
  
  
• Mortality rates of women with breast implants

Preparing questions in advance can help patients have more meaningful discussions with their physicians regarding their conditions. Patients may wish to ask their doctor or healthcare professional the following questions about breast implants:

1. Am I a good candidate for breast implants?
   
   
2. What are the advantages and disadvantages of each type of implant?
   
   
3. What type of breast implant would be best for me?
   
   
4. Will I need more than one surgery for the breast implants?
   
   
5. Do I need to make adjustments with daily activities with implants?
   
   
6. Will having implants affect my ability to breastfeed in the future?
   
   
7. How will breast implants affect the diagnosis and treatment of breast cancer?
   
   
8. What modifications must be made for mammography with implants?
   
   
9. What is the risk of rupture or leakage with my implant?
   
   
10. How do I know if an implant has ruptured?
    
    
11. What signs indicate the need for medical attention with breast implants?
    
    
12. How often will I need to replace the implants?
    
    
13. Can I receive implants at the time of my mastectomy?
    
    
14. Where can I go to research qualified plastic surgeons for implant surgery?