OPTIONS IN BREAST AUGMENTATION

Breast augmentation is not only a medical decision, it is a personal one. The perception we have of ourselves defines who we are and how we introduce ourselves to the world. Not every woman may feel the need for breast augmentation, but for many women it has afforded a state of great personal satisfaction and well-being. There are many options available today for the woman who decides that augmentation is right for her. The more you know about the procedure and the options involved, the better equipped you will be to make the decision that is best for you.

Remember, medical personnel can give you their recommendations and family members may tell you what they think YOU should do, but only you can make the breast augmentation decision that is right for You. This booklet is designed to help you make an educated, informed decision and is not intended to replace any discussion with your doctor.

Breast implant manufacturers have developed many styles, unique features, shapes and sizes of breast implants. While this booklet discusses implants that are manufactured by Mentor, there are other options and implants available. Your doctor can discuss these choices with you.

As an additional service to you and your doctor, Mentor employs a Nurse Consultant. She is available to answer any technical questions relating to Mentor products and can be reached at Mentor by calling our toll-free patient information line: (800) MENTOR-8.

ANATOMY OF THE BREAST

The breast is made up of fatty, glandular and fibrous tissues. Within it are blood vessels, milk ducts, fat, glands and sensory nerves. A layer of fat surrounds the breast to give it a soft consistency and contour. Beneath the breast there is the pectoralis major, a large muscle which assists in arm movement.

Women's breasts vary greatly in both size and shape. The size and shape of your breasts are determined by the amount of breast tissue and fat present in them. It is also affected by factors such as age, past pregnancies, genetics and skin elasticity. Even breasts on the same body may vary, making one slightly different from the other. Such variations in size and shape are normal and they occur in most women.

CHOOSING BREAST AUGMENTATION

Some of the most common goals realized by women who have had breast augmentation are: enlargement of breasts; reshaping of breasts that are misshapen; reshaping and enlarging breasts that have lost their shape or fullness due to pregnancy or age; and balancing breasts differing in size and/or shape. Psychological and emotional benefits have included an enhanced self-esteem, a more satisfying body image and personal gratification.

Breast augmentation can achieve many different goals. Every woman's decision is different and should be made by her, based on her needs, desires and expectations.

However, before you undergo breast augmentation you need to be well-informed of the procedure, the different choices involved, the results you can expect, and all of the potential risks and complications that could occur.

Most importantly, you need to review these matters with your doctor and discuss any of the concerns you may have, being sure all your questions have been answered.

TYPES OF BREAST IMPLANTS

Breast implants come in many shapes and sizes, with differing inner and outer materials. Together, you and your doctor will select the options that are best suited for you and most likely to achieve the results you desire. In this section we will discuss some of the most important differences between various types of breast implants.

All breast implants have an outer pliable envelope enclosing either a liquid (saline) or soft-solid (gel) Substance. The implant shapes are generally round, oval or contoured. The surface of the implants has traditionally been smooth to the touch, but now there is another option, a textured Surface.

To achieve fullness and create the most natural breast-like feeling possible, the implants are filled with either:

(1) saline (salt water) or,

(2) silicone gel, a soft-solid (gel) substance.

Saline is much like the fluid that makes up 70% of the human body. If the implant should leak and the saline is released, it can be safely absorbed by your body (see Potential Risks and Complications). Silicone gel-filIed implants are available only to select patients having revisionary surgery of an existing gel-filled implant or for women having breast reconstruction after cancer surgery. Federal law requires patients using gel-filled implants to participate in a mandated Mentor Adjunct Study.

THE BODY'S REACTION TO BREAST IMPLANTS

The body's natural response to any foreign object is to reject it. The degree of this rejection response is partly dependent on the biocompatability of the materials that make up the foreign object. The more biocompatible a material is, the less the body will reject it.

Scientists are continuously researching new materials that are biocompatible to the body. At present, the most common biocompatible material utilized in breast implants is silicone. This material is used in many medical implants such as pacemakers and joint replacements, as well as consumer products like antacids and preservatives (see Potential Risks and Complications).

The body will form scar tissue, made from collagen, around the surface of the implant - this is called the capsule. Capsule formation is a normal reaction to any implant.

In some women the collagen capsule can contract, causing a condition known as capsular contracture. This results in a firmer or hardened breast which may cause discomfort or pain. However, the textured surface of the Mentor Siltex® implant is designed to disrupt the body's collagen interaction with the implant surface and the resulting capsule formation.

MENTOR BREAST IMPLANTS

Mentor offers a variety of different implants: oval shapes with a smooth surface; round shapes with a smooth or textured Siltex surface; the Contour Profile-, a family of anatomically shaped, textured implants; and the Spectrum", a family of postoperatively adjustable, smooth or textured implants. The special design of the Spectrum allows doctors to adjust the volume of the implant during a simple office procedure weeks after surgery.

No medical implant is designed to last forever and Mentor breast implants should not be considered lifetime implants. Mentor does, however, provide a Lifetime Replacement Policy for its all-saline-filled mammary implants. The Mentor Lifetime Replacement Policy ensures that Mentor will replace its all-saline-filled mammary implants due to deflation or due to loss of envelope or valve integrity during the lifetime of the patient-recipient.

THE SURGICAL INCISION AND PLACEMENT CHOICES

Usually breast implants are surgically inserted utilizing one of three traditional incisions: the inframammary incision, the periareolar incision, or the transaxillary incision. All of these incisions allow the implant to be placed either submuscular (below the chest muscle) or subglandular (between the chest muscle
and your breast tissue).

No one incision and placement is right for every woman. Therefore, by knowing your options and discussing them with your doctor, together you can decide upon the best combination for you.

The inframammary incision is made in the skin fold below the breast, and the breast implant is inserted through this incision. The breast tissue is minimally disturbed, and the remaining incision scar is concealed within the fold of skin under the breast.

The periareolar incision is made along the edge of the colored area around the nipple, and the breast implant is inserted through this incision. The incision scar is well camouflaged in this area.

The transaxillary incision is made in the armpit and the implant is inserted through this incision.

An additional option that patients with ptotic or sagging breasts may elect to have during the breast implant surgery is a mastopexy (breast lift).

THE SURGICAL PROCEDURE

There are many important factors that may have an effect on your particular procedure, your recovery, and your results. They should be well understood and carefully discussed with your doctor. Some of these factors are:

• Your overall health Your chest structure and overall body shape
• Your healing capabilities (which can be affected by smoking, alcohol and various medications)
• Prior breast surgeries Bleeding tendencies |
• Infections
• Shifting of implant Scarring from the incision
• Predisposition to develop a hardened capsule around the implant (this subject will be discussed in detail later)

The implantation procedure can be performed as either an inpatient (requiring an overnight stay in the hospital) or outpatient (no overnight stay required) basis, depending on your doctor and the method of surgery you have chosen.

Before	After
Before	After
Before	After
Before	After

 

RECOVERY PERIOD

During the first 24 to 48 hours after your surgery, you will experience the most discomfort. Your breasts will be swollen and very tender. Although every woman's recovery time is different, you should be able to resume many of your regular activities after about one week. You will need to wait at least one month before resuming any strenuous activities.

Should any problems occur after surgery, contact your doctor immediately. This is especially important if your temperature is elevated, or one of your breasts is noticeably more swollen and tender to the touch, painful, red or inflamed.

PATIENT REGISTRY

Federal law requires that all implanted breast implants be registered with the manufacturer. As an additional service of this requirement, we also offer the inclusion of your name in our confidential patient registry to provide us with the ability to inform you of any significant updates regarding breast implants, should the FDA so request.

POTENTIAL RISKS AND
COMPLICATIONS

There are inherent risks and complications with breast augmentation as there are with any surgery. You should be aware of the potential risks and discuss any concerns you may have with your doctor before your implant surgery is performed. The following information is provided to you by Mentor and the FDA. It contains important facts regarding breast implants and the potential risks associated with them.

Information for Women Considering
Saline-Filled Breast Implants

Saline-filled breast implants (silicone envelopes filled with salt water) were already in use in 1976 when the Food and Drug Administration (FDA) began regulating medical devices. Under this 1976 law, manufacturers could continue selling devices already on the market ("grandfathered"). But the 1976 law made it clear that at some time in the future, the FDA would require manufacturers to submit their research data showing that these products are safe and effective. Women need to know that until this call for research data occurs, laboratory, animal, and human tests on some of these 11 grandfathered" products - including saline breast implants - may not have been completed by the manufacturer or reviewed by the FDA.

Women considering saline-filled breast implants for breast enlargement or reconstruction should receive the following information about implants (and, when appropriate, other options for reconstruction) before surgery is scheduled. This will allow them time to review the material and discuss

possible risks and benefits with their doctor. For some women, breast implants can improve their quality of life. Some breast cancer survivors believe that getting implants has been an important part of their recovery. However, other women find external breast forms to be satisfactory. Reconstruction options include breast implants or surgery using tissue from a patient's own abdomen, back or buttocks to form a new breast. This surgery requires sufficient fat tissue and a longer operation, and like any other procedure, it is not always successful. For each woman, whether her goal is augmentation or reconstruction, the benefits may be different. With her doctor's advice, each woman must decide whether or not she wishes to accept the possible risks in order to achieve the expected results.

Breast implant surgery presents the same general risks associated with anesthesia and any other surgery. After the surgery, there are other special risks related to saline-filled breast implants. (The manufacturer's package insert for these devices gives additional, more detailed information. Your doctor has a copy and can provide it to you.)

Most Common Risks

Other Known Risks

1. Calcium deposits in the tissue around the implant: When calcium deposits, which are not harmful, occur, they can be seen on mammograms. These deposits must be identified as different from the calcium that is often a sign of breast cancer. Occasionally, it is necessary to surgically remove and examine a small amount of tissue to see whether or not it is cancer. This can frequently be done without removing the implant.
   
   
2. Additional surgeries: Women should understand there is a fairly high chance they will need to have additional surgery at some point to replace or remove the implant when and if it wears out. Also, problems such as deflation, capsular contracture, infection, shifting, and calcium deposits can require removal of the implants. Discuss the risk of these additional surgeries with your physician. Many women decide to have the implants replaced, but some women do not.

3. Infection: Infection can occur with any surgery. The frequency of infection with implant surgery is not known, but a prospective patient should ask her doctor what his or her experience has been. Most infections resulting from surgery appear within a few days to weeks after the operation. However, infection is possible at any time after surgery. Infections with foreign bodies present (such as implants) are harder to treat than infections in normal body tissues. If an infection does not respond to antibiotics, the implant may have to be removed. After the infection is treated, a new breast implant can usually be put in.
   

4. Hematoma: A hematoma is a collection of blood inside the body (in this case, around the implant or around the incision). Swelling, pain and bruising may result. The chance of getting a hematoma is not known, but a woman thinking about breast implants should ask her doctor about his or her experience. If a hematoma occurs, it will usually be soon after surgery. (It can also occur at any time after injury to the breast.) Small hematomas are absorbed by the body, but large ones may have to be drained surgically for proper healing. Surgical draining causes scarring, which is minimal in most women.
   
5. Delayed wound healing: In rare instances, the implant stretches the skin abnormally, depriving it of blood supply and allowing the implant to push out through the skin. This complication usually requires additional surgery.
   
6. Changes in feeling in the nipple and breast: Feeling in the nipple and breast can increase or decrease after implant surgery. Changes in feeling can be temporary or permanent and may affect sexual response or the ability to nurse a baby. (See the paragraph on breast-feeding.)
   
7. Shifting of the implant: Sometimes an implant may shift from its initial placement, giving the breasts an unnatural look. An implant may become visible at the surface of the breast as a result of the device pushing through the layers of skin. Further surgery is needed to correct this problem. If the implant shifts, it may become possible to feel the implant through the skin. (Placing the implant beneath the muscle may help to minimize this problem.) Other problems with appearance could include incorrect implant size, visible scars, uneven appearance and wrinkling of the implant.
   

Unknown Risks

In addition to these known risks, there are unanswered questions about saline-filled breast implants. For example, can the implants bring on symptoms of autoimmune diseases such as lupus, scleroderma and rheumatoid arthritis? Can they bring on neurological symptoms similar to multiple sclerosis in some women? Can the implants increase the risks of cancer? (Because saline-filled implants contain only salt water, any risk that might be related to silicone gel would not occur with this type of product.) There is some concern, but little information, about possible risks from the silicone rubber material of the envelope. Also, questions have been raised about the potential for the saline to become contaminated with fungus or bacteria. If so, these organisms might be released into the woman's body, if her implant deflated.

1. Autoimmune diseases: According to scientific studies, women with breast implants, in general, are not at an increased risk for autoimmune or connective tissue diseases. However, these studies are too small to detect whether there might be a slightly increased risk of any one of these rare diseases. Also, these current studies have looked only for the symptoms of known autoimmune diseases, rather than the variety of symptoms that some women report experiencing. Some of the reported symptoms include:
   

• Swelling and/or joint pain or arthritis-like pain
  
• General aching
  

• Unusual hair loss
  
• Unexplained or unusual loss of energy
  
• Swollen glands or lymph nodes
  
• Greater chance of getting colds, viruses and flu
  
• Nausea, vomiting
  
• Irritable bowel syndrome
  
• Rash
  
• Memory problems, headaches
  
• Muscle weakness or burning
  

2. Breast-feeding and children: Questions have been raised about whether or not breast implants present safety concerns for nursing infants of women with breast implants. Some women with breast implants have reported health problems in their breast-fed children. Only very limited research has been conducted in this area, and at this time, there is no scientific evidence that this is a problem. It is not known if there are risks in nursing for a woman with breast implants or if the children of women with breast implants are more likely to have health problems.
   
3. Cancer: At this time, there is no scientific evidence that women with saline-filled breast implants are more susceptible to cancer than other women.
   

GLOSSARY

Aspiration - The withdrawing of a fluid from the body by means of suction.

Biocompatible - Being biologically compatible by not producing a toxic, injurous or immunological response in living tissue.

Breast Augmentation - A surgical procedure which enlarges the breast through implantation of a prosthesis.

Capsular Contraction - A tightening of the scar tissue envelope surrounding an implant.

Envelope - The outer lining of an implant which traps the inner fluids, sealing them in.

Fibrous Tissues - Connective tissues composed mostly of fibers.

Glandular - Relating to a gland.

Hemorrhage - Abnormal internal or external discharge of blood.

In-Patient Surgery - A surgical procedure in which the patient is required to stay overnight in a hospital.

Milk Ducts - Tubes for the passage of secreting milk.

Opaque - Not transparent, impenetrable by visible light rays and x-rays.

Out-Patient Surgery - A surgical procedure in which the patient is not required to stay overnight in a hospital.

Pectoralis Major - A muscle located in the upper chest which provides support for the breasts and is necessary for arm movements.

Saline - A solution which is made up of water and a small amount of salt. Approximately 71% of an adult's body weight consists of this salt water solution.

Sensory Nerves - The nerves that conduct afferent impulses from sensory receptors to the brain or spinal cord.

Sepsis - The presence of various microorganisms, their poisonous products or their toxins in the blood or tissue.

Silicone - An organic material, derived from sand, which is generally well-tolerated by the body and has the capacity to be formed into various shapes.

Thrombosis - The formation or development of a blood clot.