Breast Implants

Definition

Breast implants are pads of silicone or saline encased in a rubber-like shell. They look like nippleless falsies and are surgically implanted generally under the pectoralis muscle (located under the breast).

Procedure

In 1992, the Food and Drug Administration (FDA) called an immediate halt to silicone breast enlargement. The moratorium is voluntary and it does not apply to breast implants that are filled with salt water (saline). This halt resulted from evidence that the devices had been known to leak or rupture, bleeding silicone into the body. The makers had not been able to determine how often it happened or with what consequences. Nor could the manufacturers say how long silicone implants normally last, or how often migrating silicone prompts the immune system to attack health tissues.

An advisory panel recommended leaving the devices on the market pending safety studies. The FDA, however, after canvassing rheumatologists about implant-related immune problems and reviewing confidential industry documents, called for a halt.

Problems with Breast Implants

Problems with silicone gel and saline implants fall roughly into two broad categories: known risks and complications, and possible risks. The known risks generally involve the breast and nearby tissues, while the possible risks are systemic and involve distant parts of the body.

Even among the known risks, there is uncertainty and disagreement as to how widespread these problems are. The reason the information is so sketchy is that no one has conducted large scientific studies that compare women who have implants with women who do not.

Known Risks

There are two types of known risks: surgical and implant. The surgical risks include bleeding, hematoma (collection of blood that may cause swelling, pain and bruising), thrombosis (abnormal clotting), skin necrosis (skin tissue death resulting from insufficient blood flow to the skin), infection, delayed wound healing, and reactions to the anesthesia. Some surgeons feel that the complications occur more frequently in reconstructive surgery because the skin is tighter after mastectomy to begin with, and because both chemotherapy and radiation can affect the healing process.

The implant risks include:

Capsular Contracture. As a natural reaction to something foreign, such as an implant being inserted, the body forms a protective membrane of scar tissue around the object. This layer of tissue normally shrinks down to some degree against the implant. However, in a number of women the capsule of scar tissue may tighten too much. This contracture squeezes the implant and, as a result, the breast feels firmer and causes a misshapen appearance. Some women are unable to sleep on their abdomens because of their rock-hard breasts. Others are self-conscious during close physical contact, even friendly hugging. Although contracture is not a health hazard in and of itself, it forces some women to have repeated operations to correct the condition.

Calcium Deposits. In some women, calcium forms in the tissue surrounding the silicone gel or saline-filled implant. Like capsular contracture, this may cause hardening and pain.

Leaking and Rupture. The implant's outer envelope may break due to trauma or injury or normal wear and aging. In a silicone gel-filled implant, this would allow the gel to escape and possibly seep into the surrounding tissue or migrate to other parts of the body.

Such trauma is often caused by a closed capsulotomy, a procedure used less often now than in the past, to break up scar tissue around the implant. The procedure involves putting strong pressure on the implant, which can be painful for the patient and results in temporary relief at best. Mammography is another possible source of trauma. Several studies suggest that the longer you have an implant, the greater the chance of leaks and ruptures. One research study found that 17 percent of women with implants had bulging weak spots, which may eventually rupture.

Silent leaks or "gel bleed". Even if an implant does not actually rupture or have an obvious leak, it is now known that most implants allow small amounts of silicone to seep out of the covering. This is called "gel bleed." An FDA memo asserts that even these small gradual leaks pose a serious risk and may result in deposition and migration of silicone in the body, leading to capsular contracture, granuloma, enlarged lymph nodes, and other unknown systemic toxic effects.

Changes in breast sensation and placement. Implant surgery may cause an increase or decrease in the sensitivity of the breast or nipple, as well as, a shifting of the implant, giving the breast an unnatural look.

Interference with Mammography. Silicone and saline implants may make mammography harder to perform and evaluate because they can hide suspicious lumps. Calcium deposits in scar tissue around the implant may also interfere with the interpretation of a mammogram.

Possible Risks

In addition to the recognized adverse effects, questions have been raised about whether implants cause other problems in some women. The biggest concern is about the relationship between the silicone in gel implants and autoimmune disorders. The immune system is part of a larger defense system designed to protect against disease and foreign invaders. In an autoimmune disorder this defense mechanism somehow becomes directed against the body itself, destroying healthy tissue.

Since an implant is a foreign object, the body reacts to it by encasing it in scar tissue (encapsulation). Such autoimmune-like disorders include joint pain and swelling; skin tightening, redness or swelling; swelling of hands and feet; rash; swollen glands or lymph nodes; unusual fatigue; general aching; greater chance of getting colds, viruses and flu; unusual hair loss; memory problems; headaches; muscle weakness or burning; nausea or vomiting; and irritable bowel syndrome.

It has been known for years that small amounts of silicone can spread from breast implants to other parts of the body, but it is not known what the immediate or long-term effects of this might be. It is believed that the white blood cells pick up the tiny amounts of silicone that bleed through the envelope and trap most of it in the scar tissue. For example, small amounts of silicone can escape and travel to the lymph nodes in the armpits. As yet, there is no evidence that the body produces an antibody to the silicone.

The FDA has received reports of women with implants who also suffer from autoimmune diseases such as scleroderma, rheumatoid arthritis, lupus, and chronic fatigue syndrome. Many experts dismiss these reports as anecdotal evidence rather than valid scientific data. So far the causes of autoimmune disease reported in women with implants number 1 in 50,000, which is no greater than the incidence among women without implants. Since the figure is so low, it is difficult to establish a clear link.

Questions to Ask Your Doctor

Have there been any reported risks to saline implants?

How long can an implant remain in before they start to break down or should be replaced?

What are the chances of old implants rupturing or leaking silicone into the body?

If the implants are removed will it prevent any autoimmune disorders from developing? Or decrease an existing autoimmune disorder?

If removal is recommended, how is the procedure performed? Is there a chance of leakage during the removal?

Is there a support group or advocacy group for breast implants in the area?

Should mammography still be routinely done, knowing the possible risks and interference?