Technique #1: Implant Only

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Placement of an Implant Only to Replace Breast Volume

This technique is very basic in that a prosthetic implant is placed beneath the chest wall skin and the large chest wall muscle – the pectoralis major – to add volume to the breast area. This is the easiest of the operations to undergo and the recovery time will be the shortest of all the procedures. The only scar will be the mastectomy scar as the implant can be placed through this incision. These are the only advantages.

Requirements for Implant Only Breast Reconstruction

When the breast tissue is removed at the time of the mastectomy, only a thin layer of skin and underlying fat remains. Through this layer courses a delicate network of blood vessels that keep the skin alive. Deep to this skin and fat layer, lying on the chest wall is the pectoralis muscle which is attached to the collar bone (clavicle), the breast bone (sternum) and at the lower breast area is attached to the ribs. This situation presents several limitations in the use of this technique.

1. The muscle is relatively tight and does not completely cover the entire area of the chest wall that the breast tissue once covered. It is smaller than needed to completely cover an implant of sufficient volume for most women. This limits the operation to women whose other breast is small or in bilateral cases where the desired breast volume will be small.

2. Requirement of a foreign material: a breast implant. Over thirty years of accumulated breast implant experience both for cosmetic augmentation and reconstruction has revealed the fact that if the implant can be placed as deep into the body as possible it will have fewer complications.

These complications can take several forms:

• WRINKLING where the folds of the implant may be seen under the skin.
• CAPSULAR CONTRACTURE which is excessive scar formation around the implant which may cause discomfort, deformity or firmness of the breast mound.
• COLD INTOLERANCE due to the thin outer covering layer of only skin and fat on the lower portion of the implant.
• SKIN EROSION which will lead to implant exposure and ultimately the removal of the implant.

This may result in or from INFECTION of the implant. Once an implant pocket, or space around the implant, becomes infected and the implant is removed, it may not be able to be replaced due to the high risk of repeat infection. All these complications are increased with this technique. In addition, there are other complications associated with implants that will be discussed later and in addition a description of the different types currently available (saline or silicone gel filled) and the advantages and disadvantages of each can be found later in the text.

3. This type of reconstruction can only be done safely as a delayed operation. This is related to the tenuous blood supply of the skin and fat layers (flaps) and the possibility that there may be insufficient blood supply to allow the incision to heal . If this happens over the area where the implant has no muscle coverage, the implant will become exposed and infected.

4. This is not a treatment option for patients who have undergone radiation treatments to the breast(s). The effects of radiation cause delayed or inadequate skin healing and the muscle loses some of its ability to stretch to accommodate the implant.

5. Increased incidence of hardening around the implant, also called capsular contracture. The interface between the skin/fat flap and the implant has an increased risk of causing this over formation of scar tissue. Complete muscle coverage will lessen the likelihood of this occurring.

Potential Risks

Although this operation may seem tempting from the aspect of short surgery time (1.5 hours) and relatively rapid recovery time (3-4 weeks), the long term results are quite limited and the risk of short and long term complications is high.

As mentioned, this first technique for reconstruction requires a breast implant to replace the volume of the breast mound. Actually, three of the four operative techniques require an implant to replace the volume removed at the time of the mastectomy.

Here are some of the potential complications associated with implant only breast reconstruction:

Wrinkles or folds in the implant shell may occur and be visible or able to be felt beneath the overlying tissue. These conditions are increased in frequency if you are thin, small framed or there is a small amount of overlying tissue. Large implants or the formation of scar tissue (capsular contracture) may also distort the implant and cause folds or wrinkling. The placement of the implant beneath the muscle lessens the likelihood of these being felt, however, they may still exist in the lower portions of the breast. Surgical revision may be desired by some patients exhibiting folds or wrinkles, but some times this is ineffective. For some patients these features tend to diminish with time however reports of folds leading to thinning or erosion of the overlying tissue and subsequent implant exposure and removal do exist.

Calcification in the tissue surrounding the implant may also result from the operation. It is not known whether this is due directly to the operation itself or the effects of the implant. It is probably a combination of both factors. Calcification around the implant may lead to a hardened, distorted breast or may interfere with the early detection of cancer recurrence if the implant is placed in front of the pectoralis muscle, or if an implant is placed in the other breast to achieve better symmetry.

Breast Implants

The implant for breast augmentation is a foreign object. Each patient’s tolerance to surgery, medication or implantation with a foreign object may be different. There are currently multiple types of implants available for surgical breast implantation. The standard implant consists of a silastic ( silicone rubber) outer envelope which is filled with a silicone gel or saline also known as salt water. Various forms of these implants have been available for over 30 years. There is also a variety of implants which use a combination of these two fills and these are called double lumen or bilumen implants. They consist of either an inner shell of saline or silicone and a smaller outer shell of the other material.

Breast Implant Shape and Texture

The outer shell of the implant can either be smooth or it can be textured. The smooth walled implants were the first to be developed and have been in use for approximately 30 years. The textured implant, like the name implies, has a rough surface. The characteristics of the rough surface are intended to break up the outer scarring and hopefully produce a softer, more natural breast. Recent reports in the literature have failed to show any benefit with this implant surface in preventing hardness when placed in a location beneath the muscle, the preferred location in breast reconstruction. In addition, the wrinkling with textured implants is more severe and more obvious. Anatomic or tear drop shaped implants were developed to try and mimic the shape of the breast when seated or standing. Again, recent studies show no difference between round implants and tear drop shaped implants as the round implants assume a natural position when you are upright. The disadvantage of the tear drop shaped implants lies in the fact that they are all textured (see above) and if malposition occurs, it is uncorrectable without surgery. They also have a higher rate of failure and resultant leakage.

Breast Implant Advantages and Disadvantages

Each implant has its advantages and disadvantages. Many surgical choices exist and most surgeons take into account the current implant technology and their own training and experience with these implants to advise as to implant choice.

Silicone Implants: The advantages of gel filled implants are that they come pre-sealed and the likelihood of contamination and infection is lower as they require less handling at the time of surgery. They are considered the most natural appearing and feeling breast implant. Disadvantages are related primarily to the controversies regarding silicone gel.

A silicone implant failure will require a general anesthetic to remove it and to remove the silicone containing scar capsule. A saline filled implant can be removed and replaced in the office facility under local anesthesia. The scar capsule need not be removed with a saline implant.

Saline Implants: The inflatable (saline filled) implant has advantages and disadvantages. The advantage of having saline rather than silicone fill is that should rupture occur, the saline will be rapidly absorbed by the body.

Saline is a substance found naturally within the body and causes no adverse reaction if leakage occurs. It is the same fluid run into the IV at the time of surgery.

The major disadvantage with inflatable implants is the possibility of spontaneous deflation. This deflation can occur from normal wear along the edge of the implant or from the filling valve itself. Should this occur, rapid deflation and loss of volume results. This would require a second operation for implant replacement. The implant manufacturers list the life expectancy of an implant to be between 10 and 25 years. They offer a warranty which will replace the implant.

Another disadvantage is that the saline implant has a slightly more firm feeling initially then do the gel filled implants. Folds or wrinkles are more commonly felt in saline implants than in gel filled implants.

Scar Tissue and Breast Implants

Because of the foreign body characteristics of the implant there are several concerns directly related to the presence or consistency of this foreign body. The first is a natural tendency of any foreign implanted object to form scar tissue around it. This is true of a pacemaker, artificial knee or breast prosthesis.

The unique thing about a breast prosthesis is that it is compressible and the others are firm. This compressibility is desirable in that it mimics the natural appearance and feel of breast tissue. ALL PATIENTS FORM CAPSULES OF SCAR AROUND THEIR IMPLANTS. However, each patient’s capsule will vary in degree ranging from thin to heavily thickened.

Contractures of a fibrous capsule may occur independent of it’s thickness resulting in discomfort, pain, excessive breast firmness, an implant which can be felt and/or may recreate wrinkles or folds in the prostheses shell. It may also create displacement of the prosthesis. Although the cause of capsular contracture is not known, several reports have implicated infection, blood collection, implant volume, patients own immune system, implant type, gelbleed or leakage, trauma and foreign body reaction as possible etiologies. There is no one common factor present in patients who develop hardening of their breasts. If the implant becomes displaced and/or uncomfortable treatment may be indicated. Currently the recommended treatments are surgical.

With submuscular placement of the implants, approximately 10 to 15% of patients will develop some unnatural firmness. Of these, approximately 1/3 (5% of total) will desire some treatment.

The rate of contracture is much higher, up to 80% if the implant is placed above the muscle.

Saline Implants: Saline has a lower contracture rate than silicone gel filled implants. As mentioned, treatment is currently surgical in nature. It usually consists of re-operation through the initial incision with removal of the implant, cutting the scar tissue and replacement of the implant. The chance of excessive capsular contracture for all patients with implants will increase in time and may necessitate re-operation. Occasionally there will be an underformation of this scar tissue which may result in migration or increased movement of the implant. This malposition is most commonly appreciated when lying on one’s back when the implants settle to one side.

Silicone Implants: Silicone gel filled implants, in addition to the possibility of gross failure and leakage, will also experience what is called gel bleed. This is the microscopic leakage of gel through an intact implant shell. This bleed has been implicated in causing an increased immunologic response in some women. This was the basis for the implant controversy of the early 1990’s. The implants were the center of an argument as to whether or not gel implants caused systemic illness and in particular, autoimmune diseases.

The Safety of Breast Implants

Multiple scientific studies from such centers as Harvard Medical School affiliated hospitals, John’s Hopkins, and Mayo Clinic have failed to show any significant increase in systemic illness in women with implants. The Institute of Medicine (a subsection of the National Academy of Sciences) released a report in June, 1999 finding that women with silicone breast implants are no more likely than the rest of the population to develop cancer, autoimmune diseases or neurologic illness. This was a 440 page report requested by Congress. The report was compiled by a panel of 13 scientists specializing in many different clinical subspecialties. In 1990, the FDA placed restrictions on the availability of gel implants: patients with reconstructive needs or patients requiring replacement of a gel implant were the only women allowed to receive them. Cosmetic augmentation patients were restricted to saline implants only. Women receiving gel implants are required to enter a nation wide study to follow and record implant data.

In addition, many experimental studies both past and ongoing continue to show the safety of silicone gel implants. The American Society of Plastic and Reconstructive Surgeons (ASPRS) as well as various manufactures are continuing their ongoing research in this direction.

IN SUMMARY, THE FDA HAS ELECTED NOT TO REMOVE THESE IMPLANTS FROM THE MARKET BASED ON THEIR PROVEN CLINICAL HISTORY AND LONG IMPLANTATION RECORD. THEY ARE HOWEVER, LIMITING THE AVAILABILITY OF THESE IMPLANTS ONLY TO WOMEN DESIRING BREAST RECONSTRUCTION (OR REPLACEMENT OF AN EXISTING IMPLANT). FOR THIS REASON, SALINE IMPLANTS OR SILICONE IMPLANTS MAY BE USED FOR YOUR OPERATION BUT I PREFER THE SALINE FILLED DUE TO THE EASE OF LEAK DETECTION AND REPLACEMENT.

The role of implants in breast reconstruction was brought to light in review of a large national study. This poll showed an overwhelming acceptance of breast reconstruction and breast implants by women who have been implanted.

What should a woman who is contemplating surgery for breast implants do?

For now, the best course of action is to discuss this situation frankly with her physician. It is perfectly reasonable to ask the physician to see the informational material that comes with the implant that describes the possible adverse effects. Most of this information has been summarized in this consent form. She needs to talk over the known local breast related risks as well as the less well understood non-breast related risks described above and to weigh these risk against benefits of the procedure. That way she can make informed decision about whether to proceed with the surgery.