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Virginia NOW

The facts on breast implants are chilling. This is particularly so

when considering the medical profession's attitudes about corrective

actions and opposition to removal of breast implants.

First, all breast implants use silicone which can be damaging to the

woman. One of the things that happens with an implant in some women

is capsular contracture, which is the formation of scar tissue around

the implant. This scar tissue can contract, deforming the breast and

causing hardness, painful swelling, and rupture. Ruptures can also

occur due to other reasons and are the main cause of problems with

implants.

Breast implants have an extremely high rupture rate and, therefore,

are defective. Manufacturers told women that implants would last a

lifetime and that ruptures occurred less than one percent of the

time. But recent studies, published in the American Journal of

Radiology and the ls of Plastic Surgery, reveal a rupture rate of

5 to 51 percent.

A third study, published in Plastic and Reconstructive Surgery, ties

rupture to the age of the implant. Of implants aged one to nine

years, 36 percent had ruptured. Of those aged 10 to 17 years, 96

percent had ruptured. The FDA Commissioner, Dr. Kessler, has stated

that " even with a conservative rupture rate of 5 percent, some

75,000, of the estimated 1 to 2 million women with implants, would be

at risk for potentially serious adverse health effects. That is not a

safety standard that the FDA can accept. "

Dr. Kessler states that studies have shown that silicone is a potent

stimulant to the immune system and could generate antibodies that

attack collagen, a component of connective tissue. In 1992, the FDA

received more that 23,000 reports of problems with implants,

including complaints of " bleeding " implants, connective tissue

disorders that could produce arthritis-like pain and swelling in the

joints, fibrous tissue spreading around the implants and swelling of

skin and limbs.

When silicone leaks from a breast implant into the body, there is a

cellular immune reaction which has the symptoms of an inflammation.

Because silicone cannot be metabolized, the immune systems keeps

trying to rid the body of the silicone. The body then begins

attacking its own cell tissue and organs resulting in autoimmune

disease.

Traditional autoimmune, or connective tissue disorder diseases,

include rheumatoid arthritis (the deforming type) and lupus. But

women with implants that rupture or leak suffer from a specific group

of problems including joint pain, skin rashes, numbness and fatigue.

These symptoms have not been grouped together before. This fact has

led to misinformation. Most studies did not look for atypical

symptoms but traditional diseases. All major studies are flawed in

some way with respect to this issue.

Saline Alternative

Although silicone implants are still available for reconstruction

after mastectomy, another alternative is the Saline implant. The

procedure varies according to the particular circumstances. In

augmentation patients, under general anesthesia an incision is made

under the breast, a pocket is formed and the deflated saline implant

is inserted. A valve in the implant is used to fill the device with

saltwater until the desired fullness is reached.

In reconstructive patients, a temporary balloon-like tissue expander

is inserted; at office visits over 8 to 10 weeks, the balloon is

gradually filled with saltwater to stretch the tight post-mastectomy

skin. In a separate surgery under general anesthesia, an implant

replaces the expander. Some new types can be filled directly to avoid

the second surgery.

Mentor H/S and McGhan Medical have an implant with a rough surface

marketed to inhibit scar tissue around the implant.

Risks of Saline Implants Include:

Saline implant envelops are made of 30% fumed silica, a known

carcinogen. The result of an ongoing evaluation will be available in

1998.

Repeat surgery-Dr. Kessler has recommended that implants be replaced

every 8 years.

Rupture and deflation requiring surgery.

Capsular contracture the formation of scar tissue around the implant.

This scar tissue can contract, deforming the breast and causing

hardness, painful swelling, and rupture.

Hiding of breast cancer signals - implants are radio opaque.

Autoimmune disease, as discussed above, because the saline implants

are made of 30% fumed silica.

Contamination of breast milk.

Changes in nipple/breast sensation.

Fungal or bacterial infections - saline does not remain sterile in

the body, e.g., the envelop is semi-porous.

Wrinkling and related problems.

The Non-Silicone Alternative

Another alternative type of breast implant is that of tissue transfer

from another part of the body, usually from the lower abdomen or

buttocks. This type of implant, called flap surgery, carries none of

the dangers of Silicone or Saline implants, but has new risks. For

example, tissue that is transplanted may not re-establish blood flow

and may " die, " causing severe scarring and infection.

Difficulty Obtaining Implant Removal

Doctors do not want to remove silicone implants. One would think

doctors would be anxious to remove implants, especially after all of

the problems that have been documented. Insurance companies should

also have an interest in having implants removed from any woman

covered. But we hear nothing from them. On the contrary, this surgery

is often denied by Health Maintenance Organizations (HMO) and

Virginia Blue Cross and Blue Shield. Insurance companies should be

required by law, if necessary, to pay for removal of implants.

The only way to protect your health is to avoid both silicone and

saline implants.

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