< Prev | 1 | 2 | 3 | Next >

Past Controversy over Silicone-Filled Breast Implants

Both saline and silicone-filled breast implants are reconstructive options for many breast cancer patients. However, many women will recall past controversy about silicone-filled implants. In 1992, the U.S. Food and Drug Administration imposed a ban on the general use of silicone gel-filled breast implants. Silicone implants were only allowed in closely monitored medical trials until they are determined to be safe for widespread use. Questions concerning the safety of silicone implants arose after manufacturing defects and implant misuse led to silicone leakage and rupturing in many patients. When silicone gel is free in breast tissue, it was thought that it could move to nearby tissues or to the lymph nodes. Some physicians attributed silicone leakage to immune-related disorders and other sicknesses. Many women who experienced silicone leakage reported:

breast pain fatigue myalgias (muscle pain) arthralgias (joint pain) hair loss memory loss

After extensive study of the safety of silicone-filled breast implants, the FDA ruled that certain silicone-filled breast implants may be used during breast augmentation and reconstructive surgeries. Those implants must be made by Allergan or Mentor and can only be used for augmentation in women 22 years of age or older and for reconstruction in women of any age. By contrast, the FDA has approved saline-filled implants made by either Allergan or Mentor for breast augmentation in women aged 18 or older and for reconstruction in women of any age. The reason for the difference in age requirements is, according to the FDA, due to differences in risks among the implants. For example, silicone gel-filled implants will require frequent MRI monitoring to detect silent rupture (a rupture that can go undetected by the patient or physician). There is no risk of silent rupture for saline-filled implants. In addition, the health consequences of a ruptured saline-filled breast implant are different from those of a ruptured silicone gel-filled breast implant (see section below on Possible Complications With Breast Reconstruction for more information). Any implant other than the four named above is considered by the FDA to be "investigative" and women must be part of clinical trial in order to receive it.

Finding a Plastic Surgeon

If a woman is contemplating breast reconstruction, she should discuss her options with a plastic surgeon. It is important to make sure that the plastic surgeon is certified by the American Society of Plastic Surgeons and has experience with breast reconstruction.

Women may contact the American Society of Plastic Surgeons (ASPS) at 1-800-635-0635 to find out if their plastic surgeon is board certified. The ASPS was formed in 1972 and provides women with a list of ASPS certified members in the caller’s area. The ASPS website also allows women to search for a plastic surgeon by name, city, state, or zip code.

Possible Complications With Breast Reconstruction

As with any type of surgery, breast reconstruction has certain risks women should consider before deciding on reconstructive surgery. The most common complication with breast implants is capsular contracture: the scar or capsule around the implant begins to tighten and squeezes down on the soft implant, causing the breast to feel hard. Capsular contracture may be treated with additional surgery to remove the scar tissue. Occasionally, patients with capsular contracture may have to have the breast implant removed and replaced with a new one.

Another risk associated with breast implants is the possibility of rupture. If a saline-filled breast implant ruptures, the patient and physician will know because the implant will deflate and the saline solution leaks into the body immediately or over a period of days. The implant will lose its original size or shape. On the other hand, silicone-filled implant ruptures are called silent rupture because the patient and physician must not know that a rupture has occurred. Thus, the FDA recommends that patients with silicone-filled implants received an MRI three years after implantation and then every two years thereafter to screen for a rupture. However, some patients will experience symptoms of a rupture, including hard knots or lumps surrounding the implant or in the armpit, change or loss of size or shape of the breast or implant, pain, tingling, swelling, numbness, burning, or hardening of the breast.

Health experts do not know all of the reasons that breast implants might rupture. However, according to the FDA, some of the causes include:

• damage during implantation or during other surgical procedures
• folding or wrinkling of the implant shell
• trauma or other excessive force to the chest
• compression of the breast during mammography

Other rare complications from general surgery may also occur during breast reconstruction, including: bleeding, fluid collection, excessive scar tissue, infection, and problems with anesthesia. Women who smoke may experience a slower rate of healing or more noticeable scars since nicotine often interferes with the body’s natural healing process. Rarely, these complications may require additional surgery.

Note: It is not possible for women to breast-feed from the reconstructed breast. Even with nipple reconstruction and tattooing of the areola, the breast still lacks the proper glandular tissue and ducts necessary to produce milk. There has been no evidence that breast reconstruction causes a recurrence of breast cancer.

CONTINUED