FDA Silicone Implant Monitoring Program Shows No Increase in Breast Cancer Risk

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Most women who have mastectomy to treat breast cancer go on to have one or both breasts reconstructed. There are many ways to reconstruct a breast. Tissue from the back, belly, or buttocks can be used to create a new breast. Saline or silicone gel implants are probably the most common choice. Saline and silicone gel implants are also used to improve breast size or appearance in healthy women.

In the late 1980s and early 1990s, doctors and women were concerned about possible links between certain health problems and silicone breast implants. Doctors thought the implants might increase the risk of inflammatory autoimmune diseases, such as arthritis and lupus, as well as breast cancer and other health problems. So since the late '80s, the U.S. Food and Drug Administration (FDA) has worked with implant manufacturers to actively monitor the experiences of women with silicone breast implants.

In June 2011, the FDA released the results to date of the silicone implant monitoring program.

There is no evidence that silicone implants increase the risk of breast cancer or autoimmune diseases.

Local complications, especially implant rupture or tightening of the tissue capsule that forms around the implant (capsule contracture), commonly develop over time. Other local complications may include scar formation, pain, infection, wrinkling of the skin over the implant, or an imbalance in the size of the breasts.

The FDA reported that these local complications often require repeat surgery within 10 years after the original implant surgery:

  • 20% to 40% of women who had breast enlargement surgery with silicone implants required repeat surgery within 10 years after the original surgery.
  • 40% to 70% of women who had breast reconstruction surgery with silicone implants required repeat surgery within 10 years after the original surgery.

There may be a link between breast implants -- both silicone and saline -- and a very rare form of lymphoma -- anaplastic large-cell lymphoma (ALCL) -- in tissue near the implant. Lymphoma is cancer in the lymphatic system.

Earlier this year the FDA emphasized that even if there is a link between implants and ALCL, the risk of breast ALCL in women with breast implants is still extremely low.

The results of the silicone implant monitoring program are based on the experiences of about 1,700 women, most of whom have been followed for 8 to 10 years, and another group of more than 80,000 women, most of whom have been followed for 2 to 3 years.

Based on the results, the FDA believes that currently-available, FDA-approved breast implants are safe when used as recommended by the manufacturer. Still, the FDA recommends that women with breast implants have regular implant checkups. These checkups should include breast MRI scans, which can help doctors see if the implant capsule has ruptured. The FDA urges women with implants (silicone or saline) to tell their doctors about any changes or symptoms in a breast with an implant. The FDA plans to continue its breast implant safety monitoring program for many years.

If you have a breast implant, you can be reassured by the FDA's results and its advice for women and their doctors about implants. Still, don't hesitate to call your doctor if you notice any changes in your breast. Be sure you have a regular follow-up plan and definitely call your doctor if you have symptoms or problems with your implant, such as pain, lumps, swelling, or asymmetry.

If you've been diagnosed with breast cancer and are considering reconstruction with an implant, you should also be reassured by the FDA's results. Be sure you have a regular follow-up plan and ask your doctor about potential local complications that might require repeat surgery. It's also a good idea to talk to your doctor about the possible link between breast implants and rare breast ALCL. Still, remember that the FDA doesn't think that this possible link should discourage women from implant reconstruction.

Visit the Breastcancer.org Reconstruction pages to learn more about breast implant surgery and other breast reconstruction options.

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