Updates on Breast Implants

The Food and Drug Administration has just published a new brochure for women considering breast implants, including breast cancer patients who are considering breast reconstruction after mastectomy. (The brochure is available online at http://www.fda.gov/cdrh/breastimplants.)

It comes on the heels of another contentious year in the debate over the safety of breast implants. News touting their safety is regularly offset by news warning of potential problems from their use. For example:

• A recent report in the New England Journal of Medicine argued that current evidence does not demonstrate that breast implants are associated with an increased risk of connective-tissue diseases. Dr. Esther Janowsky of the University of North Carolina at Chapel Hill and colleagues reviewed a number of previous studies and concluded that eliminating the implants would not lead to a reduction in the incidence of these illnesses.

• A new antibiotic solution developed by plastic surgeons at the University of Texas Southwestern Medical Center at Dallas may help reduce or eliminate capsular contracture, the most common risk associated with reconstructive and cosmetic breast-implant surgery. Writing in the journal Plastic and Reconstructive Surgery, Dr. William Adams said that the new solution inhibits bacterial growth from organisms commonly found around breast implants, which can cause hardening of the implants.

• In contrast, scientists at the Food and Drug Administration recently reported that breast implants might rupture more often than previously thought. They looked at rupture rates among women who received implants before 1988 as part of a National Cancer Institute study. Using magnetic resonance imaging (MRI) scans of 344 women, they found that 69 percent had at least one ruptured implant. And 21 percent had silicone gel that had leaked outside of one or both breasts. One-third had at least one surgery to have an implant removed or replaced.

And yet, this past May the FDA said that implants filled with saline (salt water) were safe enough to stay on the market despite high rates of complications, including ruptures. But David Feigal, director of the FDA's Center for Devices and Radiological Health, warned: "It's clear from these studies that there is a possibility that a substantial number of women who get these implants will require additional surgery at some point to remove or replace their implants because of complications. Women should understand that breast implants do not last a lifetime. And they should be aware that women who choose not to replace their implants after removal may have cosmetically unacceptable dimpling or puckering."

A three-day FDA advisory committee that met earlier this year found complications including:

• 9.2 percent of saline-filled implants used for reconstruction on cancer patients ruptured and deflated within three years of implantation;
• 40 percent of cancer patients needed repeated surgery after three years;
• 24 percent suffered from painful breast hardening from scar tissue.

Nonetheless, the American Society for Aesthetic Plastic Surgery says the benefits of saline implants outweigh the risks, citing a recent study showing that 95 percent of women surveyed say they would make the same choice to have implants again.

Basics of Breast Reconstruction

Reconstruction is an option offered to some women who have a breast removed because of cancer. It is important to realize that the reconstructed breast will have a different appearance and will not have natural feelings. It may be done at the time of the mastectomy (immediate reconstruction), or performed months to years after the mastectomy (delayed reconstruction).

Body type, age, general medical condition and cancer treatment will determine which reconstruction method will give the best results. If you are a smoker, this may make a difference in the type of reconstruction that is appropriate for you. The breast may be reconstructed with tissue from one's own body or an implant.

• Implants - Saline (salt water) and silicone (liquid plastic) implants are both available to women with breast cancer, although the use of silicone implants has been dramatically reduced. The implants are generally placed under the skin behind the chest muscle. Implant procedures usually begin with a tissue expander-an inflatable implant containing a metal port for saline injection-to stretch the skin. Then the skin expander is replaced with a permanent implant.

• Tissue Flaps - Muscle, blood vessels, fat and skin from another part of the body can be moved to the chest area to form a new breast. Tissue can be taken from the lower stomach area (called a Tram flap), back or buttocks.

After the first reconstructive surgery, smaller surgeries are usually needed to complete the process. Creating and tattooing the nipple is one extra step in reconstruction. Small changes in the shape of the reconstructed breast might also be needed, as well as surgery on the opposite breast to create similarly shaped breasts.

Breast implants can pose some difficulty in breast imaging. Both saline-filled and silicone gel-filled implants are opaque to x-rays, meaning that any breast tissue behind the implant may not be seen on a mammogram. Women who have breast implants should make sure that they inform the technician so that special "displacement" views can be taken in addition to the "standard" compression views to better visualize the breast tissue. Using the displacement views, satisfactory breast images can be obtained for most women and their breasts can be effectively monitored for possible breast problems.

Breast implant surgery (whether breast reconstruction or augmentation) or treatment of complications may not be covered by your health insurance. You should check with your insurance company regarding these coverage issues because, for some women, health insurance premiums may increase, coverage may be dropped, or future coverage may be denied. Before surgery, be sure to get, in writing, answers from your insurance company about what will be covered and how future premiums might be affected.

Special Concerns

The following special issues regarding breast implants should be considered for women with breast cancer:

• The physical and cosmetic results with breast implants may be affected by chemotherapy, radiation therapy, or any other factor that significantly alters the healing process.
• Skin necrosis (cell death) may occur because circulation to the remaining tissue has been changed by a mastectomy (breast removal). Also, skin necrosis may be increased as a result of radiation treatment.
• It usually takes more than one operation to achieve the desired cosmetic outcome, especially if this procedure includes building a new nipple.

While many women believe breast implants cause debilitating systemic illnesses, such as autoimmune disease, the current evidence is inconclusive. However, most women with breast implants will experience some local complications, which could include rupture, pain, capsular contracture (a tightening of the scar tissue or capsule the body forms around the breast implant), and infection.

The decision to have breast-implant surgery is a highly personal one. Some women choose breast reconstruction to regain their breast contour and improve body image. Others want the convenience of not needing an external prosthesis. Whatever the reason, make sure to explore all available options with your doctor, and don't hesitate to discuss any questions or concerns that you might have. While implants can be removed, most physicians recommend against this unless they are causing significant medical complications.

SOURCES:
New England Journal of Medicine, March 16, 2000; 342:781-790, 812-815
Plastic and Reconstructive Surgery, January 2000
The Food and Drug Administration (http://www.fda.gov/cdrh/breastimplants)
The Susan G. Komen Breast Cancer Foundation (http://www.komen.org)

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